Language selection

Government of Canada / Gouvernement du Canada

Search

Evaluation of the Medical Devices Program 1999-2000 to 2011-2012

Prepared by
Evaluation Directorate
Health Canada and the Public Health Agency of Canada

February 2014

(PDF Version - 599 K)

Table of Contents

Executive Summary

The Medical Devices Program (MDP) is managed through the Health Products and Food Branch (HPFB) of Health Canada. It evaluates and monitors the safety, effectiveness and quality of diagnostic and therapeutic medical devices, so that consumers and health care professionals can use them with confidence. Program activities include creating and maintaining the regulatory framework for medical devices, interacting and communicating with partners and stakeholders, performing risk-benefit assessments of medical devices, conducting post-market surveillance, and enforcing compliance with regulations. The program involves the following key program participants: the Medical Devices Bureau (MDB) within the Therapeutic Products Directorate (TPD), the Marketed Health Products Directorate (MHPD), the Biologics and Genetic Therapies Directorate (BGTD), the Health Products and Food Branch Inspectorate (the Inspectorate), and the Regions and Programs Bureau (RAPB).

The evaluation of the MDP is part of Health Canada's Five-Year Evaluation Plan. In accordance with the Treasury Board Policy on Evaluation (TBS, 2009), the evaluation assessed the relevance and performance (effectiveness, efficiency, and economy) of Health Canada's activities under the MDP. The evaluation covered the period from 1999 to 2012, with an emphasis on the last five years. The results of the evaluation will inform the implementation of current and future activities of the MDP.

An independent evaluation consulting firm conducted the evaluation on behalf of Health Canada. The evaluation drew on several lines of evidence, including a literature review, a document review, a review of administrative data, three case studies, two surveys (of manufacturers and other stakeholders), a focus group with medical device manufacturers, and key informant interviews.

Findings

Relevance

The evaluation found government oversight of medical devices to be both necessary and relevant. In addition to their diagnostic and therapeutic benefits, there are significant risk and safety issues associated with medical devices that warrant an ongoing role for government. The existing environment is also characterized by significant change and uncertainty as novel technologies and products emerge that blur the existing boundaries among medical devices, pharmaceutical drugs, and biologics. These factors speak to the need for government oversight in this area in order to manage potential health and safety risks. Such a role, furthermore, is consistent with federal and Health Canada roles and responsibilities, as described in federal statutes and regulations, and aligns directly with Health Canada's strategic outcome to inform and protect Canadians from health risks associated with food, products, substances, and environments.

MDP activities are also well aligned with federal priorities to strengthen consumer safety. The federal government has devoted substantial resources over the past decade to broader initiatives intended to improve the safety of health products, including medical devices, through modernizing the regulatory framework for these products and, more recently, signalled its commitment to the long-term sustainability of the MDP by including medical devices in recent updates to its cost recovery framework and user fees.

Performance - program implementation

Over the period of the evaluation,Health Canada has made progress in implementing its planned activities and, in the process, has responded to several emergent issues and challenges. However, a number of unresolved issues and challenges remain.

On the pre-market side, in addition to implementing a new cost recovery framework, Health Canada has also undertaken several other initiatives that are intended to increase the efficiency of the submission review process. In particular, it has piloted electronic submissions for Class III and IV medical devices and, more recently, taken steps to increase the use of foreign information in Class III and IV applications. There is broad support among external key informants for measures to expedite the review process, particularly through the use of foreign reviews and data.

Health Canada has recently chosen not to proceed with planned amendments to the investigational testing provisions of the Medical Devices Regulations that would have introduced Good Clinical Practices (GCP) requirements and an inspection program for investigational testing, concluding that the risks involved did not warrant an increased regulatory burden. Health Canada's position is inconsistent with its main international counterparts in the United States (US) and Europe, where GCP requirements for investigational testing are in place.

Prior to implementation of the new cost recovery framework, Health Canada's review performance fluctuated over time for all three classes of device subject to pre-market review, and over the period of the evaluation, the 90% target had usually not been met. Review performance has been improving over the past three years, including under the new cost recovery framework. A more thorough analysis would consider review performance in relation to changing resource levels and trends in submission types and volumes.

Combination products, which combine more than one type of regulated health product (e.g., drug-device combinations, or biologic-device combinations), present a number of challenges for pre-market review. Reported difficulties include inconsistent application of the criterion for classifying products; inappropriate classifications of some products as medical devices, which some internal key informants suggested may result in under-estimating their risks; and difficulties in completing reviews of combination products in a timely fashion. Finally, although fees for drug submissions are substantially higher than for medical devices, submission fees for combination products regulated as devices are paid solely to MDB at rates set for medical devices. Many key informants, both internal and external to Health Canada, emphasized an urgent need for Health Canada to develop and implement policy and guidance relating to the review and licensing of combination products. Although the US Food and Drug Administration (FDA)'s general approach to combination products is similar to Health Canada's, unlike Health Canada, the FDA has developed a considerable body of policy and guidance for industry in this area.

Recommendation 1:

Health Canada should review its approach to the review and licensing of combination products.

Like combination products, single-use devices (SUDs) have also presented policy and regulatory challenges for Health Canada over the evaluation period. Unlike medical devices that are designed, labelled, and sold for multiple uses, SUDs are produced by manufacturers to be used once and then discarded. Reprocessing of SUDs has become common in Canada and is carried out by hospitals and by third-party reprocessors. In response to concerns about the safety risks associated with reprocessing expressed by the Office of the Auditor General (OAG) in 2004, Health Canada undertook a review of its authorities to determine its ability to regulate the reprocessing of SUDs, ultimately concluding that it does not have the authority to regulate the use of a device after its sale and therefore does not have the authority to regulate reuse.

It is unclear if this conclusion remains valid for all reprocessing situations, suggesting that a reassessment of Health Canada's role in light of market developments may be warranted in future. Furthermore, Health Canada's long-held stance on the issue is at odds with that of its international counterparts. In the US, where federal and state jurisdictions are similar to Canada, all hospitals and third parties that reprocess SUDs are subject to the same regulatory requirements as original equipment manufacturers. Likewise, the European Union (EU) has recently proposed similar amendments to the Medical Devices Directive. In Canada, calls for some type of regulation or oversight of reprocessing on the part of Health Canada continue from health care facilities, original equipment manufacturers, and third-party reprocessing firms.

Recommendation 2:

Given the growing re-use of SUDs, Health Canada should review the implications of SUD reprocessing.

On the post-market side, one of Health Canada's main accomplishments has been the implementation of the Canadian Medical Devices Sentinel Network (CMDSNet) to supplement the existing system of medical device problem reporting. CMDSNet is intended to encourage voluntary problem reporting by health care professionals, among whom reporting has historically been low. The CMDSNet was launched in 2009 and, in its first three years, processed one third of all voluntary problem reports submitted to Health Canada and was an important source of safety signals. Health Canada plans to expand CMDSNet to include more health care institutions.

Health Canada has also implemented a standardized approach to signal detection, assessment, and risk management, which is used across all regulated health products, including medical devices. While Health Canada's post-market surveillance activities for medical devices have improved in recent years, opportunities for improvement include becoming more engaged in current discussions concerning the introduction of a device identification and registration system for medical devices; implementing a public database of medical device problem reports, such as exists in the US; and enhancing collaboration with international regulators to collect and monitor safety information. Other possible changes -- both of which are in place in the US -- include electronic submission of problem reports and introducing regulatory amendments requiring health care institutions to report medical device problems that result in serious illness, injury, or death. Health Canada is currently experimenting with electronic submission of adverse drug reaction reports and, under the Food and Consumer Safety Action Plan (FCSAP), planned to introduce mandatory adverse drug reaction reporting for health care institutions, though such legislation has not been implemented to date.

Recommendation 3:

Health Canada should explore additional measures to enhance the post-market surveillance and monitoring of medical devices.

In the area of compliance and enforcement, Health Canada has implemented significant changes to its inspection program for medical devices. Under the new risk-based approach, domestic Medical Device Establishment License (MDEL) holders are inspected on an established cycle and are rated as either compliant or non-compliant according to the risk given to observations noted during inspections. In 2012, in response to recommendations made by the OAG, Health Canada conducted a pilot project to assess the possibility of expanding the inspection program to foreign establishments, and based on the results, plans to include foreign establishments in the medical device inspection program beginning in 2013-2014.

The presence of unlicensed devices on the Canadian market is a concern for industry stakeholders, who are critical of what they perceived as Health Canada's failure to enforce compliance in this area and insufficient penalties in the event of non-compliance. Concerns about the presence of unlicensed medical devices on the Canadian market were also expressed by the OAG in 2004. To date, Health Canada has not analysed the extent of the problem or the health and safety risks it poses.

Recommendation 4:

Health Canada should determine the extent to which unlicensed medical devices are available on the Canadian market, and take steps to discourage this practice and ensure compliance with regulation.

In the area of communications and stakeholder engagement, Health Canada aims to provide Canadians with more information on health products, and to make the regulatory system more open to consumer and other stakeholder input and involvement. Arguably the most important aspect of Health Canada's role in communication and stakeholder engagement is the communication of post-market risk and safety information to health professionals and the public. Since 2005, Health Canada has communicated risk and safety information primarily through the MedEffect website. In February 2013, Health Canada launched a revised system for disseminating risk communications online, which appears to be a substantial improvement over the MedEffect system in several ways, including the availability of an advanced search feature and a new format for risk communications. Health Canada recently initiated an evaluation of its risk communications for health products, including medical devices, following through on long-standing plans to assess the effectiveness of its risk communications products.

Performance - outcomes

Over the period of the evaluation, Health Canada has engaged in many activities that should, in theory, contribute to the expected outcomes of the MDP. However, for various reasons, data to support definitive conclusions on outcomes achieved are relatively limited.

Immediate outcomes

In the immediate term, Health Canada's activities are expected to produceincreased awareness and understanding by non-industry stakeholders of risks and benefits related to medical devices. However, based on the limited results from the stakeholder survey, it is not possible to draw conclusions on this question.

The evaluation found a reasonably high level of awareness and understanding among industry of Health Canada's regulatory activities for medical devices, with the exception of its compliance activities and related enforcement actions. Most industry survey respondents were aware of various types of information made available by Health Canada and had also used this information. However, only a minority of respondents believe that Health Canada has consulted adequately with industry; that the existing consultation mechanisms are effective; and that Health Canada takes the concerns of industry into account in regulatory and policy development.

In the short term, Health Canada's activities are also intended to produce increased safety and effectiveness of medical devices. There are clearly processes in place that are designed to ensure that medical devices are safe and effective, but no concrete evidence of improvements in these areas.

Finally, in the short term, Health Canada's activities are expected to lead to increased industry compliance with regulatory requirements. While compliance information is relatively limited, the available data seem to suggest that serious non-compliance is relatively uncommon. Over the period of the evaluation, however, Health Canada has not reported regularly or consistently on the nature, seriousness, frequency, or prevalence of non-compliances related to medical devices, and has focused its reporting, instead, on quantifying activities and outputs. That said, the Inspectorate has recently developed an annual inspection summary report that will be published on the Health Canada website. The 2012-2013 report includes a description of Inspectorate activities and outputs, describes the overall compliance rate of industry, and lists the common observations cited in non-compliant establishments. The report does not contain any information on actions taken by the Inspectorate in response to non-compliance.

Recommendation 5:

Health Canada should continue to build on its current approach to performance reporting to emphasize compliance and enforcement outcomes to a greater extent.

Intermediate outcomes

In the intermediate term, Health Canada activities are expected to lead stakeholders to adopt safe behaviours with respect to the use of medical devices. It is known that some hospitals and health care facilities are engaged in SUD reprocessing in Canada and that unlicensed medical devices are available on the Canadian market and are presumably being used, although the magnitude of the problem and the safety risks involved are unknown.

Health Canada activities are also expected to result in increased use of scientific evidence and risk-benefit analysis to inform decision making related to medical devices. The use of scientific evidence and risk-benefit analysis is formally integrated into Health Canada's Decision-Making Framework for Identifying, Assessing and Managing Health Risks, and also into various pre-market and post-market processes. Health Canada has established a number of Expert and Scientific Advisory Panels to provide guidance on regulatory and policy development, and has implemented some, though not all, of their recommendations.

In the intermediate term, Health Canada also hopes to achieve a timely response to identified risks related to medical devices. For the most part, data were not available to support an objective analysis of this outcome. While in 2012, MHPD neared its target of completing 90% of signal assessments within its performance target, a similar analysis could not be undertaken for a wide range of other program activities. While it is important for Health Canada to establish and strive to meet performance standards, comparisons against external criteria or standards, such as the response of other regulatory agencies to specific risks, may also be informative.

In the intermediate term, Health Canada expects to achieve increased international harmonization of regulatory requirements for medical devices. Health Canada has developed several agreements with other regulatory agencies, including the FDA and Australia's Therapeutic Goods Administration (TGA). Health Canada has also been a long-standing active participant in the Global Harmonization Task Force (GHTF), has adopted nine GHTF standards, and is in the process of adopting another two. Health Canada is also a member of the International Medical Device Regulators Forum (IMDRF), the successor to the GHTF. Key informants were generally of the view that although Health Canada has made progress in this area, more could be done to harmonize Canada's pre-market and post-market processes for medical devices with other jurisdictions.

Long-term outcomes

In the long term, it is likely that Health Canada's activities contribute to reduced health risks and adverse events associated with the use of medical devices. For example, actions such as removing unsafe medical devices from the market through recalls or preventing counterfeit products from entering Canada avert adverse health effects in humans that would have occurred had these actions not been taken. As for increased public confidence in medical devices and the regulatory system, the evaluation found no public opinion research conducted by Health Canada or any other entity that would shed light on this question, thus no conclusions are possible.

Ultimately, Health Canada hopes to achieve a sustainable, cost-efficient, responsive, and science-based regulatory system for medical devices in Canada. Limited information on financial and human resources makes it difficult to draw conclusions regarding the sustainability and cost-efficiency of the system, although submission review performance has been improving in recent years, and several other initiatives are underway that are intended to enhance process efficiencies. With respect to the responsiveness and scientific basis of the regulatory system, while Health Canada has formally integrated scientific evidence and risk-based analysis into decision making, there are some concerns about the timeliness of its response to risks and the extent to which it takes stakeholder concerns into account in policy and regulatory development.

Performance - efficiency and economy

Changes in HPFB's approach to financial reporting over the period of the evaluation made it challenging to consistently match MDP expenditures and budgets, so as to compare and analyze this information over time. HPFB has recently restructured its financial reporting to comply with Treasury Board requirements, which should improve the accuracy of this information and facilitate future analysis.

While activity-based financial reporting has not taken place since 2008-2009, within TPD coding has been updated as of 2012-2013 so that functional activity information will be available in the future.  Activity-based reporting is important to support activity-based costing, which in turn is important to analysing the efficiency with which program activities are carried out. HPFB undertook an activity-based costing exercise in 2007 to support the proposal for updated user fees, and used the results of this analysis to calculate unit costs for a variety of regulatory activities, including submission review. The available data indicate that the timeliness of submission review for all classes of medical devices has been improving since at least 2009-2010, and that improvements in performance have continued under the new cost recovery framework. However, without analysing the unit costs of submission review and other cost-recovered activities, it is unclear if improvements in timeliness also represent improved efficiencies. In addition to enabling an assessment of the extent to which efficiencies may have been realized under the new cost recovery framework, such analysis would also assist the MDP in identifying where future adjustments to the framework may be necessary. For example, such analysis would assist the MDP in determining if adjustments to the framework need to be made to accommodate review of combination products. To this end, HPFB is reviewing its costs, fees, and performance associated with the MDP, as per its commitment in the User Fee Proposal and the Regulatory Impact Analysis Statement associated with the Fees in Respect of Drugs and Medical Devices Regulations.

Management Response and Action Plan

Evaluation of the Medical Devices Program
Recommendation Response Key Activities Deliverables Responsible Directorate Timeframe
1. Health Canada should review its approach to the review and licensing of combination products Agree A combination product combines a drug component and a device component into a singular product and can be subject to either the Medical Devices Regulations or the Food and Drug Regulations. Examples include drug eluting stents and balloons, bone putty with growth factors and skin substitutes with cellular components. Health Canada receives about 1750 Class III and IV medical device applications annually; of these, about seven are for combination devices. The majority of combination products are drug eluting stents.

In addition to the Drug Medical Device Combination Product Policy, posted on an interim basis in 2006, Health Canada developed and posted the Drug-Device Interface Classification Guidance in 2013 to provide further clarity to industry.

Moving forward, as part of continuous improvement activities, the Therapeutic Products Directorate and the Biologics and Genetic Therapies Directorate will strive to improve the management of the licensing and evaluation of combination devices.

 TPD to develop and share within HPFB an SOP detailing the review of drug eluting stents under the Medical Devices Regulations. Health Canada will make the SOP available to interested manufacturers of combination devices. TPD June 2014
Combination products will be included in TPD`s monthly Workload Management Forum and shared with BGTD, to better manage their review process, including achievement of performance targets. TPD June 2014
2. Given the growing re-use of Single Use Devices (SUD), Health Canada should review the implications of SUD reprocessing. Agree Health Canada has taken several steps to address the risks associated with the reprocessing and reuse of SUDs. These include:
  • 2004, 2005, and 2007 Information Letters to stakeholders expressing Health Canada's concerns and providing updates on developments regarding reuse of SUDs
  • 2005 establishment of a Scientific Advisory Panel on Reprocessing of Medical Devices
  • 2007 coordination and participation in the ad hoc Federal/Provincial/Territorial (F/P/T) working group of infection control specialists. The working group, co-chaired by Health Canada and Manitoba, reviewed evidence of the safety of SUD reuse and developed a Pan-Canadian Framework Statement. The Framework provided direction to the P/Ts on SUD reuse and third-party SUD reprocessing. It was agreed to in principle by all members and was to be used as the basis for further work within the provinces/ territories under their respective mandates.
 Draft a discussion paper to be used to develop a policy position on SUDs which outlines the issues, international and P/T landscape, as well as considerations and options to address the reuse and reprocessing of SUDs. TPD January 2014
   
  • 2012-2013 participation in various stakeholder fora (e.g., Canada's Medical Technology Companies (MEDEC), Ontario Hospital Association) and engagement of P/T health ministries via Canadian Agencies for Drugs and Technologies in Health (CADTH) Policy Forum to discuss SUD reuse and seek information on cases of adverse incidents with reprocessed SUDs.

Health Canada will continue to use the Canadian Medical Devices Sentinel Network to gather evidence of adverse incidents associated with reprocessed and reused SUDs. To date, no incidents of patient harm have been reported via the Network. Health Canada will also continue to monitor international and other developments in this area.

      
3. Health Canada should explore additional measures to enhance the post-market surveillance and monitoring of medical devices. Agree Canada has one of the safest and most rigorous health product safety systems in the world.  Once approved, medical devices are subject to continuous monitoring and review, based on the latest information available.   All potential safety issues are systematically assessed using a risk-based approach.

Health Canada continues efforts to expand the Canadian Medical Devices Sentinel Network (CMDSNet). Launched in 2009, CMDSNet is a pilot project consisting of a network of health care facilities across Canada that report adverse events for medical devices.  The system has been a valuable source of safety signals.

In the October 2013 Speech from the Throne, the Government committed to introduce legislation that would enhance authority for mandatory reporting by health care institutions of serious events impacting patient safety, including medical device incidents.

Health Canada is reviewing its post-market surveillance system for health products, including medical devices.  This includes the development of a strategy to move from a passive surveillance model to an active surveillance model for the management of health product risks.

Health Canada has established a project priority within the Departmental Investment Plan aimed at modernizing the Information Technology tools across the Medical Devices regulatory product lifecycle.  Within the scope of this Investment Plan project, Health Canada is now planning for the development and implementation of an electronic problem reporting framework in order to enhance post-market surveillance and monitoring of medical devices. The project will explore the adoption of best practices and electronic tools used by the US Food and Drug Administration (US FDA) for the data entry, processing, and analysis of medical device problem reports.  This solution will include the expansion of the Electronic Submissions Gateway (ESG) which has currently been implemented jointly with the US FDA under the Regulatory Cooperation Council (RCC). The ESG provides a "single window" for industry to electronically submit regulatory information to both the US FDA and Health Canada.

 Introduction of new authorities for reporting of medical device incidents. MHPD December 2013 (completed)
Strategy for active surveillance of health products, including medical devices. MHPD June 2014
Develop a proposal, to be reviewed through the departmental process, on electronic tools to support the data entry, processing, and analysis of medical device problem reports. MHPD/RMOD December 2014
4. Health Canada should determine the extent to which unlicensed medical devices are available on the Canadian market, and take steps to discourage this practice and ensure compliance with regulation. Agree Medical devices must be licensed by Health Canada prior to being imported or sold on the Canadian market. Health Canada uses a risk based compliance and enforcement approach which includes both reactive as well proactive compliance activities.  When Health Canada becomes aware of unlicensed products it has a range of compliance actions available that are aimed at preventing unlicensed medical devices from entering or remaining on the Canadian market, including stop sale or recall of a product, product seizures / forfeiture, and detention or disposal. In fiscal year 2012/13, Health Canada conducted close to 600 establishment inspections to verify compliance with a range of regulatory requirements, including device licensing.

In addition to active compliance and enforcement, Health Canada also undertakes the following activities to  monitor and promote compliance:

  • Annual proactive Compliance Monitoring Projects, targeting specific medical devices (or groups of related devices) in the marketplace to determine their level of compliance with the Medical Devices Regulations. These projects are also used as an opportunity to educate retailers and health care providers in Canada.
  • Issuing notices to Healthcare facilities, Medical Professional Associations and Industry regarding the purchasing/selling of licensed medical devices, including a September 2013 Notice to Industry and Healthcare Facilities that included a reminder to them of their roles and responsibilities under the Medical Devices Regulations.
  • Providing "It's Your Health" articles to the public on "Buying Medical Devices over the Internet" (2011) and "Medical Test Kits for Human Use" (2011).
 Input on medical device import requirements to support the creation of a Single Window Initiative (SWI) IT solution that will assist with identifying and refusing importation of unlicensed medical devices. Inspectorate December 2014
    The vast majority of medical devices available on the Canadian market are imported. In 2012, Industry Canada estimated that approximately 80% of the Canadian market was supplied by imported medical devices. Over the last two years the Canada Border Services Agency (CBSA) referred around 1900 medical devices to Health Canada of which 35% were refused entry on the account of being unlicensed medical devices. With that in mind, Health Canada is currently engaging with the CBSA in the development of the Single Window Initiative (SWI), which aims to facilitate trade and create a single integrated import declaration form for importers to meet requirements of participating Government Agencies, including Health Canada. As a result, the SWI will facilitate trade for compliant industry, as well as provide an effective way to process the import refusal of unlicensed medical devices, thereby preventing them from reaching the Canadian marketplace and discouraging such a practice through subsequent compliance promotion.      
5. Health Canada should build on its current approach to performance reporting to emphasize compliance and enforcement outcomes to a greater extent. Agree Health Canada currently uses the overall compliance rating (i.e. % compliance) of industry as an outcome based performance indicator to measure and assess the results of the Inspectorate's outputs (i.e. inspection targets, # of incidents opened/closed) in achieving program objectives. This performance measure is reported monthly and included in the Health C Dashboard, as well as used in the Departmental Performance Report, Report on Plans and Priorities, and Performance Measurement Framework (PMF).

Since the period reviewed in this evaluation, Health Canada has also developed an Annual Inspection summary report for external publication. The report describes in detail the overall compliance rate of industry per program and lists the common observations cited in non-compliant establishments. It also provides specific examples of observations cited against the Food and Drugs Act and Regulations and provides links between inspections conducted by activity (i.e. manufacturer, importer, distributor, etc.), observations noted and their associated risk category. The aim of publishing this report is to address many of the performance outcomes in the PMF, including "Increased awareness and understanding among industry of Health Canada's regulatory framework", and "Increased industry compliance with Health Canada's regulatory requirements."

 First annual inspection summary report prepared for publication. Inspectorate March 2014

1.0 Introduction

The Medical Devices Program (MDP) is managed through the Health Products and Food Branch (HPFB) of Health Canada. It evaluates and monitors the safety, effectiveness and quality of diagnostic and therapeutic medical devices, so that consumers and health care professionals can use them with confidence. Program activities include creating and maintaining the regulatory framework for medical devices, interacting and communicating with partners and stakeholders, performing risk-benefit assessments of medical devices, conducting post-market surveillance, and enforcing compliance with regulations. The program includes the following key participants: the Therapeutic Products Directorate (TPD), the Marketed Health Products Directorate (MHPD), the Biologics and Genetic Therapies Directorate (BGTD), the Health Products and Food Branch Inspectorate (the Inspectorate), and the Regions and Programs Bureau (RAPB).

The evaluation of the MDP is part of Health Canada's Five-Year Evaluation Plan. Using the Treasury Board Policy on Evaluation (TBS, 2009), the evaluation assessed the relevance and performance (effectiveness, efficiency, and economy) of Health Canada's activities under the MDP, covering the period from 1999 to 2012, with an emphasis on the last five years. The results of the evaluation will inform the implementation of current and future activities of the MDP.

An independent evaluation consulting firm conducted the evaluation on behalf of Health Canada. The evaluation drew on several lines of evidence, including a literature review, a document review, a review of administrative data, three case studies, two surveys (of manufacturers and other stakeholders), a focus group with medical device manufacturers, and key informant interviews. This report presents the evaluation findings, draws conclusions, and makes recommendations.

1.1 Organization of the report

The report is divided into several sections. Section 2 provides a detailed profile of the MDP, and Section 3 describes the evaluation methodology. Sections 4 through 7 provide the evaluation findings pertaining to relevance, governance and implementation, achievement of outcomes, and efficiency and economy. Section 8 concludes and presents recommendations. Three appendices accompany the main report. Appendix A contains the evaluation matrix; Appendix B contains the list of references, and Appendix C contains supplementary data tables.

2.0 Profile of the Medical Devices Program

The MDP evaluates and monitors the safety, effectiveness and quality of diagnostic and therapeutic medical devices, so that consumers and health care professionals can use them with confidence. Health Canada derives its authority to deliver the MDP from the Food and Drugs Act and the Medical Devices Regulations. According to the Act:

The Medical Devices Regulations, which apply only to devices intended for human use, define four classes of medical devices, all of which fall within the purview of the MDP. Generally, medical devices are classified based on risk criteria such as invasiveness and length of time intended to stay in the body; whether the device depends on an energy source; whether the device is diagnostic or therapeutic in nature; and whether the device transmits energy to patients (radiation-emitting devices, for example). Based on these criteria, medical devices are classified as follows:

A major responsibility of the MDP is to review and authorize and/or license medical devices for sale in Canada.

2.1 Roles and responsibilities of Medical Devices Program partners

As noted above, the main partners in the MDP are the TPD, the MHPD, the BGTD, the Inspectorate, and the RAPB. Other partners involved in program delivery and/or management include the Policy, Planning and International Affairs Directorate (PPIAD), the Resource Management and Operations Directorate (RMOD), and the Environmental and Radiation Health Sciences Directorate (ERHSD) under the Healthy Environments and Consumer Safety Branch (HECSB). The roles and responsibilities of each of these partners are briefly described below.

2.1.1 Therapeutic Products Directorate

The TPD is responsible for regulating pharmaceuticals and medical devices for human use under the authority of the Food and Drugs Act and Regulations and Medical Devices Regulations. It undertakes scientific research, risk assessments, and policy development, and evaluates submissions from manufacturers regarding the safety, effectiveness, and quality of pharmaceutical products and medical devices. More specifically, the TPD engages in the following activities as part of the MDP, primarily through the Medical Devices Bureau (MDB):

While device testing and research and laboratory investigations were performed by the MDB in the past as part of its post-market monitoring activities, decommissioning of laboratory capacity was completed by the end of June 2010, and the function was officially ended in August 2010.

Two divisions within the MDB are responsible for carrying out many of these activities. The Device Licensing Services Division (DLSD) determines the classification of medical devices for licensing and ensures that regulatory requirements for licensing are being adhered to, while the Device Evaluation Division (DED) is responsible for reviewing medical device submissions. Within the DED, there are four primary areas -- In Vitro Diagnostics, Musculoskeletal, Cardiovascular, and General and Restorative -- corresponding to the broad types of medical devices.

A variety of other offices, bureaux, and divisions within the TPD also have responsibilities with respect to medical devices, as summarized in Table 1.

Table 1: Offices, bureaux, and divisions within TPD with responsibilities related to medical devices
Entity Roles/responsibilities
Director General's Office (DGO)
  • Overall responsibility for TPD
  • Approves new licences for Class III and IV medical devices
Office of Submissions and Intellectual Property (OSIP), formerly the Submission and Information Policy Division (SIPD)
  • Manages initiatives on records management for TPD
  • Liaises with MDB to ensure combination products involving drugs are reviewed by appropriate bodies within TPD and/or BGTD (for biologics)

Office of Planning, Performance and Review Services (OPPRS)
formerly the Office of Business Transformation (OBT)
  • Manages initiatives relating to workload, efficiencies, and process improvements for TPD
Office of Risk Management (ORM)
  • MDB provides information to risk management officers within ORM for use in briefing senior departmental officials
  • Works with MDB to develop/implement options in response to post-market issues/adverse events
Bureau of Policy, Science and International Programs (BPSIP)
  • Performs policy work on behalf of MDB, including developing and publishing policies and guidance documents; MDB provides technical input
  • Performs international work on behalf of MDB, such as developing Memoranda of Understanding (MOUs) with other governments; MDB provides technical input
  • Manages external advisory bodies
  • Provides biostatistical training and expertise to the review function
  • Manages second level of appeals and opportunity to be heard processes
Bureau of Cardiology, Allergy and Neurological Sciences (BCANS)
  • Works with MDB on reviews of combination products
Bureau of Gastroenterology, Infection and Viral Diseases (BGIVD)
  • Works with MDB on reviews of combination products
Bureau of Metabolism, Oncology and Reproductive Sciences (BMORS)
  • Works with MDB on reviews of combination products
Bureau of Pharmaceutical Sciences (BPS)
  • Works with MDB on reviews of combination products
Source: Preliminary interviews

2.1.2 Marketed Health Products Directorate

MHPD works to assure that HPFB programs "take a consistent approach to post-approval safety surveillance, assessment of signals and safety trends and risk communications concerning all regulated marketed health products" (MHPD, 2011). Its responsibilities include developing post-market surveillance policy; conducting clinical and epidemiological post-market safety surveillance; carrying out risk management activities, including the issuance of risk communications; and conducting regulatory oversight of advertising.

Within MHPD, various bureaux have specific responsibilities. The Marketed Health Products Safety and Effectiveness Information Bureau (MHPSEIB) is responsible for verification reviews of mandatory problem reports, a function that was transferred to it from the Inspectorate in October 2011. MHPSEIB receives all mandatory problem reports, conducts verification reviews of these reports, and, depending on the nature of the reports, sends them on to the appropriate stakeholders within the MDP for further action. MHPSEIB is also responsible for responding to Access to Information (ATI) requests related to medical devices.

The Marketed Pharmaceuticals and Medical Devices Bureau (MPMDB) is responsible for signal detection, signal assessment and other types of safety assessment, and development of recommendations in response to identified safety issues, as well as deciding on the need for risk communications and coordinating content development of risk communications. The Therapeutic Effectiveness and Policy Bureau (TEPB) is responsible for the dissemination of risk communications, including email notifications and web posting on the Healthy Canadians website.

2.1.3 Biologics and Genetic Therapies Directorate

The BGTD regulates drugs and products derived from living sources, as well as radiopharmaceuticals. Products regulated by the BGTD include blood and blood products, vaccines, hormones, enzymes, cytokines, monoclonal antibodies, gene therapy products, and cells, tissues, and organs. As a partner in the MDP, the BGTD is involved in reviewing combination products -- i.e., products that have both a medical device and a biologic component -- through joint reviews with the MDB. An example of a combination biologic-device would be tissue-engineered products containing living cells or blood components and cellular products manufactured with a device; a more specific example is autologous cell therapy product processed with a device to treat cardiovascular disease. Additionally, the BGTD is involved in reviewing devices that are intended to inactivate pathogens in blood components.

2.1.4 Inspectorate and RAPB

The Inspectorate and the RAPB Regional Operations are responsible for delivering the Inspectorate Program. The main role of the Inspectorate is "to deliver a national compliance and enforcement program for all products under the mandate of the Branch, with the exception of food products that are the responsibility of the Canadian Food Inspection Agency" (Inspectorate, 2011a). With respect to medical devices, the Inspectorate carries out the following activities:

RAPB is the operational arm of Health Canada in the regions. Responsibilities include compliance promotion activities, as well as enforcement of laws and regulations through inspections, investigations, and evaluations of compliance with standards affecting manufacturing, packaging and labelling, importing, distributing, and selling of medical devices. The RAPB regions are responsible for receiving voluntary medical device problem reports and conducting compliance verifications of these reports.

2.1.5 Other partners

Various other Health Canada partners also have responsibilities under the MDP.

2.2 Program activities

The MDP consists of five main activities delivered by the program partners. These activities are briefly described below.

2.3 Program logic

The implementation of the activities identified above corresponds with specific immediate, intermediate, and long-term outcomes. In the immediate term, MDP activities are expected to lead to increased external stakeholder awareness and understanding of medical device-related risks and benefits. They are also expected to improve industry awareness and understanding of Health Canada's regulatory framework for medical devices; to enhance the safety and effectiveness of medical devices; and to increase industry compliance with the regulatory framework.

The achievement of these immediate outcomes is expected to lead to intermediate outcomes of external stakeholder adoption of safe behaviours associated with medical devices; increased use of scientific evidence and risk-benefit analysis by Health Canada to inform decision making; timely regulatory response to identified risks; reduced exposure to health risks associated with the use of medical devices; and harmonization of Canada's regulatory framework for medical devices with international approaches.

In the long term, Health Canada hopes to reduce adverse events associated with the use of medical devices; increase public confidence in medical devices and the related regulatory system; and produce a sustainable, cost-efficient, responsive, and science-based regulatory system for medical devices in Canada. These outcomes are expected to contribute to Health Canada's ultimate goal of improving the health and well-being of Canadians.

2.4 Description of the Medical Devices Program - Logic Model Footnote 2

The Medical Devices Program (MDP) uses the following resources (inputs) to deliver its activities, produce outputs and accomplish its outcomes: funding; human resources; facilities, infrastructure; Acts, regulations, policies and priorities; science and technology; and, research data.

The MDP consists of five main activities delivered by the Program partners, namely:

These activities are targeted at different groups, namely:

As a result of each activity, the Program generates a number of products and/or services, namely:

The implementation of the activities identified above corresponds with specific immediate, intermediate, and long-term outcomes. In the immediate term, the development, implementation and maintenance of the regulatory framework for MDs as well as communication with partners and stakeholders are expected to lead to increased external stakeholder awareness and understanding of MD-related risks and benefits as well as to improved industry awareness and understanding of Health Canada's regulatory framework for MDs.  This latter outcome together with compliance and enforcement activities are expected to increase industry compliance with the regulatory framework.  Similarly, conducting risk and benefit assessments together with surveillance and monitoring activities are expected to enhance the safety and effectiveness of MDs.

The achievement of these immediate outcomes is expected to lead to intermediate outcomes.  In this manner, increased external stakeholder awareness and understanding of MD-related risks and benefits together with improved industry awareness and understanding of Health Canada's regulatory framework for MDs are expected to lead to a harmonization of Canada's regulatory framework for MDs with international approaches.  Increased external stakeholder awareness and understanding of MD-related risks and benefits is also expected to lead to external stakeholder adoption of safe behaviours associated with MDs.  This latter outcome together with increased industry compliance with the regulatory framework and enhanced safety and effectiveness of MDs are expected to contribute to a reduced exposure to health risks associated with the use of MDs.  Enhanced safety and effectiveness of MDs is also expected to lead to increased use of scientific evidence and risk-benefit analysis by Health Canada to inform decision making and timely regulatory response to identified risks.

In the long term, intermediate outcomes of external stakeholder adoption of safe behaviours associated with MDs, increased use of scientific evidence and risk-benefit analysis by Health Canada to inform decision making, timely regulatory response to identified risks, and a reduced exposure to health risks associated with the use of MDs are expected to contribute to a reduction of adverse events associated with the use of MDs, increased public confidence in MDs and the related regulatory system, and to a sustainable, cost-efficient, responsive, and science-based regulatory system for MDs in Canada.  This latter outcome is also expected to be influenced by the harmonization of Canada's regulatory framework for MDs with international approaches.

The ultimate outcome of the Program is to help ensure access to safe and effective MDs and to provide information for healthy choices.

2.5 Resources

The MDP is funded by Health Canada and by industry through cost recovery. In 2011-2012, total MDP expenditures were $29.9 million. Revenues from cost recovery were $14.0 million.

2.5 Program context

Management and delivery of the MDP, like all federal regulatory programs, is influenced by a number of overarching policies, directives, and pieces of legislation, which provide the context for such programs. Regulations are one of a number of government instruments to achieve policy outcomes. The 2012 Cabinet Directive on Regulatory Management requires regulatory programs to demonstrate efficiency and effectiveness by ensuring that the benefits of regulation justify the costs and by demonstrating tangible results for Canadians (GoC, 2012). Inherent in the Directive is the need to consult with affected bodies at all stages of the regulatory process; to select the appropriate mix of government instruments, including regulatory and non-regulatory responses; to impose the least possible cost on business and Canadians that is necessary to achieve the policy objectives; to take advantage of opportunities for coordination and collaboration with provincial/territorial governments and internationally, including limiting the number of specific Canadian regulatory requirements and minimizing differences with key trading partners (i.e., the US) and to measure and report to Canadians in a timely manner on the performance of regulatory programs.

Regulatory programs that impose a user fee, such as the MDP, are subject to the User Fees Act. This Actrequires regulating authorities to consult with clients and service users and establish service standards comparable to those in other countries prior to amending fees or creating new ones (GoC, 2011e).

The Communications Policy of the Government of Canada (TBS, 2012) requires federal institutions to, among other things, provide the public with "timely, accurate, clear, objective and complete" information about policies, programs, services and initiatives in all regions of Canada and in a range of formats, and to consult the public when establishing priorities and planning programs and services

In May 2012, the federal government released the Regulatory Roadmap for Health Products and Food (HPFB, 2012c). The Roadmap envisions an efficient and transparent regulatory system that protects and improves consumer safety, reduces regulatory burden for small business, supports scientific innovation, and increases the variety of health options and benefits available to Canadians. These goals are consistent with the Cabinet Directive on Regulatory Management, which requires federal departments to consider the impact on small businesses of new or amended regulations, while protecting and advancing the public interest in health and safety. Thse goals are also guided by the Government of Canada's Red Tape Reduction Action Plan, which aims to reduce administrative burden on business.

3.0 Methodology

This section of the report describes the evaluation methodology.

3.1 Evaluation design and methods

The evaluation design was developed based on the findings of an evaluability assessment completed as a first step in the evaluation. The evaluability assessment consisted of a preliminary review and assessment of available documents and administrative data, as well as preliminary interviews with 21 key program stakeholders, including representatives of TPD, the Inspectorate/RAPB, BGTD, MHPD, PPIAD, and HECSB.

The evaluation design and the evaluation matrix (Appendix A) were developed based on the evaluability assessment. The evaluation matrix addresses 10 key questions and a number of sub-questions relating to program relevance and performance (effectiveness, efficiency, and economy), in accordance with the Treasury Board's Policy on Evaluation.

The evaluation consisted of several data collection methods. Some of the data collection methods, in particular the survey of stakeholders and the key informant interviews, were designed to capture information to support concurrent evaluations of HPFB's Human Drugs and Biologics Programs, as well as the evaluation of the MDP.

Literature review. The literature review addressed evaluation questions related to program relevance, long-term outcomes, and alternate approaches. Peer-reviewed (i.e., scientific and academic) and grey literature was considered in the review. Relevant literature was located through online searches.

Document review.The document review addressed all of the evaluation questions to the extent that supporting documents were available. The review encompassed government documents, primarily produced by Health Canada, related to MDP planning, management, and ongoing operations. Several hundred documents were reviewed as part of the evaluation.

Administrative data review. The administrative data review addressed evaluation questions related to program outcomes. The review considered data produced by the TPD, MHPD, and the Inspectorate. Although theoretically distinct, the document review and the administrative data review were, in practice, two aspects of the same task, as the majority of administrative data was included in program documents.

A library of approximately 1,000 individual documents, sources of administrative data, and pieces of literature was developed. The library included 678 documents; 185 web pages; 118 journal articles, and various other types of sources, which were reviewed over the course of the evaluation.

Case studies. Three in-depth case studies were conducted. The case studies examined the licensing of combination products, the CMDCAS, and the reprocessing of single-use devices (SUDs). These topics were selected from among a list of 28 potential topics identified by the MDP prior to the project launch, and were chosen because they were identified in preliminary interviews as being especially topical. Each case study consisted of a document review and a small number of key informants interviews with Health Canada representatives and external stakeholders. For the case study on SUDs, a focus group with hospitals and health care facilities was also conducted.

Survey of industry. The bilingual survey of industry used a web-based approach and focused on evaluation questions related to outcomes. The survey targeted manufacturers of Class II, III, and IV medical devices. Guidance and direction from Public Works and Government Services Canada on public opinion research and surveys limited the evaluation to surveying individuals who were known to have had contact with Health Canada for reasons related to the MDP. Thus, the survey sample was drawn by Health Canada from the Medical Devices Active Licence Listing, which consists of all manufacturers currently licensed to sell Class II, III, and IV medical devices in Canada, whether they are based inside or outside of Canada. After cleaning, the final sample consisted of 3,476 manufacturers.

The survey achieved 206 completions, representing a completion rate of 6.5%.Footnote 3 This response is somewhat lower than the 10% rate that is typical of web-based surveys of industry in the evaluator's experience, and may be due to the fact that an initial communication was not sent to potential respondents. Instead, the survey invitation was disseminated by the evaluator.

Survey of other stakeholders. A bilingual web-based survey was also used to reach users of medical devices, including health care professionals and patients/consumers. This survey was also intended to capture outcome information from users of human drugs and biologics to support concurrent evaluations of Health Canada's regulatory activities in those areas. In particular, the survey was intended to capture information on the impact of Health Canada's communication and consultation activities on stakeholder awareness and understanding of risks related to therapeutic products, as well as information on the impact of these activities on stakeholder use of these products.

As was also the case with the industry survey, the evaluation was limited to surveying individuals who were known to have had contact with Health Canada. Accordingly, the evaluation requested to use Health Canada's MedEffect listserv, which consists of over 20,000 subscribers to MedEffect's e-notice, as the survey sample. In light of concerns about privacy, the possibility that use of the listserv for survey purposes might cause subscribers to unsubscribe to MedEffect, and the fact that the listserv includes individuals who are not within the survey's target group (such as Health Canada employees and health care professionals and consumers residing outside of Canada), however, the listserv was not made available.

To support the survey, Health Canada provided a list of stakeholders identified through its Stakeholder Information Management System (SIMS) database. After cleaning, the final sample consisted of 651 potential respondents.

The questionnaire included separate modules for medical devices, human drugs, and biologics. A total of 16 stakeholders responded to the survey, representing a completion rate of 2.6% overall.Footnote 4 Of these, eight (1.2% of potential respondents) responded to the module relating to medical devices. While the reasons for this low response rate are not clear, they may include the lack of an initial communication from Health Canada.

Focus group with manufacturers of Class I medical devices. The focus group addressed many of the same types of questions as the industry survey. Eight individuals representing Canadian Class I manufacturers were recruited to participate based on a list of all manufacturers currently licensed in Canada, and seven participated. All participants received an honorarium for their participation, which helped offset the opportunity cost of their participation during regular business hours. The focus group was conducted by telephone.

External key informant interviews. The key informant interviews focused on evaluation questions relating to program implementation and effectiveness. The interviews addressed questions relating to medical devices, human drugs, and biologics in order to support all three evaluations without overburdening key informants with multiple requests for interviews. Interviewees include industry representatives, researchers and academics, patient and consumer organizations, health care providers, professional associations, and others.

A total of 81 potential key informants, identified by Health Canada and the evaluator, were contacted to be interviewed. Of these, 44 participated in an interview, including 15 industry stakeholders and 29 other external stakeholders. A total of 19 interviewees provided comments that pertained directly to the MDP; of these, 13 were external stakeholders, and six were industry stakeholders.

Interviews were conducted by telephone in each key informant's preferred official language. The interviews were digitally recorded to ensure accuracy, and the notes were returned to key informants for review and approval. Key informants were assured of the confidentiality of their responses.

For final reporting, data from all lines of evidence was integrated or triangulated in order to arrive at the overall evaluation findings. Triangulation is a process through which answers to research questions generated by different data collection methods are compared. Where different methods produced similar findings, those findings were assumed to have greater validity, and therefore, greater confidence in the results is warranted.

3.2 Limitations of the methodology and mitigation strategies

There are several important methodological limitations to note. First, given the vast scope and complexity of the subject matter, the document review and the literature review were both limited by the time and resources available to complete them. The document review was further limited to documents that were provided to the evaluation by Health Canada, or that were publicly accessible. Although the evaluation made every attempt to request relevant documents from Health Canada as the research proceeded, it was clearly not in a position to identify all documents that might be relevant. Some of the responsibility for identifying relevant documents therefore lay with the program partners themselves.

The stakeholder survey is seriously limited as a direct result of the sample development process. The sample for the survey was small, especially in comparison to the actual health care provider and patient/consumer populations. Furthermore, for reasons that are not entirely clear, the survey achieved a very low overall response rate, and only eight stakeholders responded to the component pertaining to medical devices. While the use of the MedEffect list might not have produced a higher response rate, it would have, at minimum, increased the number of completions to a level worth reporting. Thus, it would have provided some data to support outcome questions relating to the impact of Health Canada's risk communications on stakeholder awareness, understanding, and behaviour. In the absence of survey data, there is very little information to support conclusions on these questions. That being said, even if the MedEffect list had been used, the opinions and information collected by the survey would not have represented the general population of stakeholders in Canada. Rather, the opinions and information would have reflected a group of stakeholders who receive frequent communications from Health Canada.

Like the stakeholder survey, the industry survey sample was also limited by a low response rate. While the low response rate in this case was somewhat mitigated by the fact that the original sample was reasonably close to a census of licensed Class II, III, and IV manufacturers, the survey findings are nonetheless limited by self-selection bias.

With respect to the external key informant interviews, approximately half of those who were identified ultimately did not participate in an interview. It is unknown if the interview findings would have been substantially different had these individuals participated. However, it is important to note that many of those who chose not to participate indicated that they were not familiar enough with the program to give meaningful responses. Like all key informant data, the findings from the interviews should not be interpreted as representing the views of stakeholders in general.

Finally, it is important to note that although two rounds of interviews with program representatives were initially planned, only the preliminary round of interviews took place. An interview guide was prepared for program representatives, and a request was made to Health Canada to identify program personnel to participate in a second round of interviews, the purpose of which was to provide the program with an opportunity to respond to the preliminary evaluation findings and address any gaps in information. Due to time constraints, the evaluation proceeded to final reporting without completing the planned second round of interviews. However, throughout the process, the evaluation consulted with program personnel by means of conference calls and email to request additional information and clarify issues.

4.0 Findings: relevance

This section of the report presents the evaluation findings on relevance.

4.1 Ongoing need

The scientific literature suggests that in addition to their therapeutic benefits, there are significant risk and safety issues associated with medical devices that warrant an ongoing role for government. For example, risks to patients may result from medical device failures stemming from design or construction flaws. Similarly, risks may arise from poor "human factors engineering" (e.g., devices designed with poor ergonomics may be prone to error because they are difficult to use properly, which may lead to patient harm). As another example, radiation exposure from medical imaging technology and medical treatments increases the risk of adverse health events for patients, particularly the risk of developing cancer, but also the risk of other complications such as skin toxicity (Hoppe et al., 2008) and death from radiation overdose (Israelski & Muto, 2004).

Moreover, as medical technology becomes more complex, evaluating medical technology, including medical devices, naturally becomes more complex (Goodman, 2002, p. 3). This is particularly true as novel technologies and products emerge that blur the existing boundaries among medical devices, drugs, and biologics. Indeed, the emergence and growth of new medical technologies, combination products, and personalized medicine underscores the need for an ongoing regulatory role.

Personalized medicine refers to a form of the practice of medicine that aims to tailor prevention and treatment efforts to subgroups of patients by integrating information related to "the pathophysiology of a disease, the mechanism(s) underlying the beneficial and adverse effects of a therapy, as well as the impact of genetic and environmental variability on pathophysiology and treatment response" (Brown, 2012, p. 119). The literature commonly associates personalized medicine with closer integration of diagnostics and therapeutics. Diagnostic devices that facilitate the practice of personalized medicine are often referred to as "companion diagnostics". These and other types of combination products are presenting challenges as regulatory agencies around the world struggle with developing an appropriate framework to manage risks associated with these products.

Thus, the use of medical devices carries with it a number of potential health and safety risks. In the absence of government intervention, it is not clear that these health and safety risks would be satisfactorily mitigated. Indeed, Zuckerman, Brown, and Nissen (2011) found that between 2005 and 2009, most of the medical devices recalled by the US FDA underwent little or no pre-market review. It is also clear that the current environment is characterized by significant change and uncertainty as new technologies emerge. These factors speak to the need for government oversight in this area and to the relevance of the MDP.

4.2 Alignment with federal priorities

The evaluation found the MDP to be aligned with the priorities of the Government of Canada. While federal Budgets and Speeches from the Throne have not mentioned medical devices directly in recent years, the federal government has devoted substantial resources over the past decade to broader initiatives intended to improve the safety of health products in general through modernizing the regulatory framework for these products.

This process of regulatory renewal has been underway for approximately the past decade. The goal of renewal is to ensure continued, timely access by Canadians to safe and effective health products in the face of several major challenges to the existing regulatory system. According to Health Canada, these challenges include an outdated regulatory toolkit; the system's current incapacity to consider products through their entire lifecycle, from discovery through to examining 'real-world' benefits and risks; the impact of scientific and technological changes, globalization of the marketplace, and a more informed and engaged public; and insufficient resources for long-term efficiency and sustainability (HPFB, 2007a).

The Branch's plans for regulatory renewal were articulated in the 2007 Blueprint for Renewal (HPFB, 2007a) and, more recently, in the Regulatory Roadmap for Health Products and Food, released in May 2012 (HPFB, 2012c). The broad goals of regulatory renewal, as expressed in these documents, include the following:

The federal government has undertaken several major initiatives that are clearly aligned with the objectives of regulatory renewal. Beginning in 2006 the federal government allocated $172.5 million over a five-year period to the Therapeutic Product Safety Initiative (TPSI). The TPSI was intended to enhance approaches to safety across the full lifecycle of market health products through several activities. With respect to medical devices, the TPSI was meant to contribute to the development of an investigational testing unit (ITU) in the MDB, and to support the Inspectorate's transition to a four-year cycle for medical device establishment inspections (Health Canada, 2006b).

More recently, Budget 2008 devoted $489.4 million under the Food and Consumer Safety Action Plan (FCSAP) to ensure that consumer products and food are safe and beneficial to Canadians' health (Health Canada, 2008b). The FCSAP is a horizontal initiative -- involving Health Canada, the Public Health Agency of Canada (PHAC), the Canadian Food Inspection Agency (CFIA), and the Canadian Institutes of Health Research (CIHR) -- with an overall goal to modernize food, health, and consumer product safety regulations and practices in Canada, using proactive interventions and active oversight to respond as early as possible to potential risks.

Medical devices are implicated in three strategies under the Health Products component of the FCSAP, as summarized in Table 2.Footnote 5 

Table 2: Involvement of medical devices in the FCSAP
Strategy Description
Strategy #6: Consumer Information Strategy for Health Products A multi-pronged strategy to make more information available to consumers, make consumer information more accessible and consumer friendly, and make the regulatory system more open to consumer input and involvement
Strategy #10: Risk-based Border Integrity Initiatives Development of a national program to increase coordination and collaboration, with the objective of protecting Canadians from using or consuming non-compliant imported health products, and associated activities
Strategy #11: Corrective Action/Fines and Penalties Implementation of modern compliance and enforcement tools through amendments to the Food and Drugs Act, including the authority to order a recall of unsafe health products, order label changes, and order actions to effect compliance, and modernization of the fines and penalties framework

In 2008, the Government of Canada introduced legislation - Bill C-51 - embodying several elements of regulatory modernization. The provisions relevant to medical devices included (but are not necessarily limited to) (GoC, 2008; Health Canada, 2010c; Tiedemann, 2008):

With the dissolution of Parliament on September 7, 2008, Bill C-51 did not become law (GoC, 2008). Since then, the federal government has taken a more incremental approach to regulatory modernization. Its most recent vision for modernization is expressed in the Regulatory Roadmap for Health Products and Food, released in May 2012. The Roadmap envisions a phased approach to modernization, with full implementation of all phases expected to be completed within a minimum of five years (HPFB, 2012c).

The federal government has also signalled its commitment to regulatory modernization for health products by undertaking revisions to its existing cost recovery framework. The 2007 Cost Recovery Initiative (CRI) was also in part a response to concerns raised by the Office of the Auditor General of Canada (OAG) in 2004 and 2006 about Health Canada's ability to fulfill its regulatory requirements given its resource levels.Footnote 6 In response to the OAG's concerns, the CRI was intended to "contribute to a stable funding platform to provide important regulatory services for Canadians" (Health Canada, 2010a). A major milestone of the 2007 CRI was achieved with the coming into force of Fees in Respect of Drugs and Medical Devices Regulations on April 1, 2011 (GoC, 2011b; HPFB, 2011a).

The major federal initiatives described above clearly demonstrate alignment between MDP, HPFB, and federal priorities, particularly with respect to regulatory modernization for health products, including medical devices. Furthermore, MDP activities are consistent with Health Canada's current Program Activity Architecture (PAA) and, in particular, with the strategic outcome focused on helping to ensure that Canadians"are informed of and protected from health risks associated with food, products, substances and environments"and helping to ensure thatproducts Canadians use "are as safe as possible, and that threats to health are addressed effectively" (Health Canada, 2011b).

4.3 Consistency with federal roles and responsibilities

The evaluation found the MDP to be consistent with federal roles and responsibilities, as these are defined in law.Footnote 7 Health Canada's mandate is set out in the Department of Health Act, which defines the Minister's duties to include the preservation of Canadians' health and well-being. Roles the Minister is required to fulfill include promoting the physical, mental, and social well-being of people in Canada; protecting them against health risks; conducting investigations and research in public health, including monitoring diseases; establishing consumer product safety standards; and collecting and distributing health-related information (GoC, 2011a, sec. 4(2)). More broadly, the Minister's jurisdiction covers all matters related to the health of Canadians that have not otherwise been assigned by the government to another body.

The MDP's primary authority derives from the Food and Drugs Act (the Act) and the Medical Devices Regulations, which define the parameters of a medical device and give legislative support to Health Canada's role in regulating the use of medical devices and taking actions to enforce compliance with those regulations. The Act limits the purposes for which any food or health product in general may be advertised or sold (GoC, 2011c, sec. 3). Sections 19-21 of the Act relate directly to devices, prohibiting the sale of harmful devices, the use of inaccurate labelling, or the use of misleading labels to create the appearance of meeting a standard.

The Medical Devices Regulations elaborate on the requirements for the safety and effectiveness of any medical devices designed, manufactured, or distributed in Canada; the standards for labelling and advertising; and the actions that may be taken for each class of medical device that is believed to not meet these requirements, including requests for information, the prohibition of sales, or other corrective actions (GoC, 2011d, sec. 9-27, 39-43).

5.0 Findings: governance and implementation

This section reports the evaluation findings on program governance and implementation.

5.1 Program governance

The MDP is administered primarily by the TPD, the MHPD, and the Inspectorate. In response to the 2004 report of the OAG, Health Canada established a Director-General-level steering committee and a permanent program secretariat to provide oversight and direction for the MDP, with members from all three directorates (HPFB, 2007a, p. 15). As of 2007, regular program management meetings involving all three Directors General, managers, and staff were being held to discuss issues (HPFB, 2007b, p. 14).

HPFB implemented a new governance structure in 2012-2013. Under the new structure, a Program Executive Committee has overall responsibility for the Branch's six programs. These include the MDP, the Pharmaceutical Drugs Program (human and veterinary drugs), the Biologics Program, the Natural Health Products Program, the Food Safety and Nutrition Program, and the Nutrition Policy and Promotion Program. Each of these programs is governed by a Program Executive Committee Sub-Committee. Within HPFB, a variety of committees and working groups also exist to manage various aspects of MDP activity.

According to information provided by the Branch, whereas in the previous governance structure, planning was done only at the Directorate level and decisions were reported along program lines to senior officials, in the new model, Programs drive planning and reporting and the Directorates provide functional activities to deliver Program outcomes. The new approach is expected to more directly align the work done by all Directorates with the strategies, outcomes and priorities of the Programs.

The participation of the other Health Canada partners in the MDP is formalized to varying degrees. The BGTD participates formally in the MDP through the Drug-Device Combination Products Policy (DDCPP). Under the DDCPP, a combination product has to satisfy only one set of regulations -- either the Food and Drug Regulations or the Medical Devices Regulations -- rather than both. The classification of the product depends on "the principal mechanism of action by which the claimed effect or purpose of the product is achieved" (Health Canada, 2005a). Combination products can be presented to either the BGTD or the TPD for classification. Within the TPD, various bureaux (BCANS, BGIVD, BMORS, and BPS) also become involved in the review process for specific types of combination products, as does the CCRPB within the ERHSD and the Centre for Blood and Tissues Evaluation within the BGTD, when appropriate. The review process for combination products is described in detail in Section 5.2.1.

In addition to these Health Canada partners, external organizations and stakeholders are involved in MDP governance in various ways. Health Canada collaborates with the SCC, Canada's national accreditation body, in the initial accreditation, surveillance, witness, special, and re-accreditation audits of international conformity assessment bodies (registrars) (Health Canada, 2009a). Through the CMDCAS, SCC-accredited auditors conduct audits of medical device manufacturers' quality management systems (QMS) on behalf of Health Canada. This addresses the quality system requirements found in Section 32 of the Medical Devices Regulations.

The TPD also collaborates with industry and other stakeholders through the Bilateral Meeting Program (BMP). Through this program, the TPD holds bilateral meetings with various national stakeholder organizations between one and four times per year, depending on the organization; other HPFB directorates are also often involved in the bilateral meetings to ensure that all relevant issues are covered (TPD, 2006). These meetings are held to discuss regulatory issues, exchange information, and share expertise and responsibilities. As part of the BMP, the TPD meets three times per year with MEDEC, the largest industry association representing Canada's medical device technology companies.

Under the National Border Integrity Program, the Inspectorate works with the CBSA to ensure that imported health products meet the requirements of the Food and Drugs Act and its Regulations. Health products held at the border by the CBSA may be referred to the Inspectorate for a recommendation on whether to allow entry into Canada based on compliance with the Food and Drugs Act and its Regulations. Products that are non-compliant with legislative and regulatory requirements are recommended for refusal into Canada.

Finally, a variety of Expert Advisory Committees (EAC) and Expert Advisory Panels (EAP) have played a role in guiding MDP activities over the evaluation period. Their activities are described in Section 6.6 of this report.

5.1.1 Performance measurement

There are a number of performance measurement strategies (PMS) that are directly relevant to the MDP. These include frameworks for the TPSI, the FCSAP, and the CRI, as well as the MDP Results-based Management and Accountability Framework (RMAF) and HPFB logic model and accompanying PMS. Data on MDB performance, which include metrics on the volume of applications received, review times, workload, and backlog statistics has historically been the main focus of MDB performance reporting. Reports on MDB metrics are to inform senior managers and other decision-makers, and are also shared with MEDEC. In addition, monthly dashboard reports were implemented with the CRI and are used to inform decisions on priorities and resource allocation. Health Canada also reports annually against established performance standards for the MDP in the Departmental Performance Report, which is tabled in Parliament.

5.2 Program implementation

The MDP has made progress over the period under evaluation in implementing its planned activities and, in the process, has responded to several emergent issues and challenges. The discussion below focuses on pre-market activities, post-market surveillance and monitoring, compliance and enforcement, and communications and stakeholder engagement.Footnote 8

5.2.1 Pre-market activities

Over the period under evaluation, as part of this activity, the MDP has emphasized the development of policies, processes, and tools to facilitate a growing number of investigational testing applications and submissions for medical device licenses, and experimented with mechanisms for introducing efficiencies into its QMS audit process through international collaboration. The review process for combination products and the regulation of SUDs also emerged as significant issues during this time.

Investigational testing

Investigational testing is conducted by manufacturers or device sponsors on medical devices that do not yet meet the safety and effectiveness requirements set out in Sections 10 to 20 of the Medical Devices Regulations. In order to proceed with investigational testing, manufacturers and sponsors are required to obtain authorization from Health Canada confirming that the corresponding testing regulations have been met. Applications for investigational testing are refused if the MDB determines that the device is unsafe for testing, that testing is not in the best interests of patients, or that the testing objective is impossible.

The OAG has been critical of Health Canada's approach to investigational testing. In its 2004 report on the MDP, the OAG noted that once approved, investigational tests are not adequately monitored by Health Canada, nor does Health Canada, unlike the US FDA, require medical device manufacturers to follow Good Clinical Practices (GCPs) when conducting investigational testing (OAG, 2004, p. 13). The OAG recommended that Health Canada undertake an assessment of the risks of investigational testing and take necessary steps to manage those risks (OAG, 2004, p. 13).

Health Canada agreed with the OAG's recommendations and began drafting amendments to the investigational testing provisions of the Medical Devices Regulations (TPD, 2009b). In a discussion document released in 2007, Health Canada noted that "[a] comparison of the medical devices frameworks of the FDA, EU and Therapeutic Goods Administration (TGA) shows that HC is the only jurisdiction that does not require in regulation that medical device IT conforms to GCP"; Health Canada also noted that Canada was the only jurisdiction that did not have or was not planning to implement an inspection program for investigational testing sites (Health Canada, 2007).

According to program representatives, Health Canada concluded in 2012 that the risks associated with investigational testing did not warrant an increased regulatory burden. Program personnel reported that this conclusion was reached on the basis of internal analysis and consultation. An Issue Analysis Summary on investigational testing was initiated, but was never completed. It is therefore unclear what evidence formed the basis for the Department's conclusion.

Since 2008, ISO 14155 (Good Clinical Practices) has been recognized by the MDB. According to Health Canada, the use of recognized standards is intended to improve consistency in the interpretation of the regulations; more specifically, if an application contains a "Declaration of Conformity" to a recognized standard, this will in many cases eliminate the need to review the test data for the aspects of the device addressed by the standard (Health Canada, 2006a).

While Health Canada has not moved forward with regulatory amendments relating to investigational testing, it took steps in 2005 to address an expected increase in the number of investigational testing applications. In that year, Health Canada established the ITU within the MDB for this purpose (TPD, 2007a). The ITU could not be fully staffed in its first year and faced capacity challenges in subsequent years when its review section was required to handle a large number of Class III and IV device New and Amendment applications, and an increase in the number of combination product applications which are reviewed jointly with drugs (TPD, 2008).

It is unclear whether these challenges persist to the present day. Contrary to expectations, the number of investigational testing applications has not been steadily increasing, but rather has fluctuated over time, as has the timeliness of these reviews.Footnote 9 Information on the level of resources devoted to review of investigational testing applications over time - an essential factor in this analysis - was not available to the evaluation. See Appendix C for more detailed information.

Two other points are worth noting in relation to investigational testing. First, the existing guidance documents for investigational testing on Health Canada's website date to 1999. Second, the ITU is responsible for reviewing investigational testing incident reports. Information related to this activity was not available to the evaluation, and consequently the evaluation was not able to assess the extent to which the ITU has fulfilled this role in practice.

Submission review and market authorization

Medical devices are classified according to the potential risk they present to a user, and a more extensive review process is undertaken for each higher-risk class of device. Each medical device application submitted for licensing is first screened for completeness and quality of the information provided. If the application passes the initial screening process, Health Canada reviews it for product safety, effectiveness, and quality to determine the probable benefit/risk ratio that the device presents. An overview of pre-market information requirements can be found in Appendix B. The product may then be granted market authorization or rejected if the application is found deficient and the applicant cannot or does not address the deficiencies. Health Canada has recently indicated its intention to analyse the present categorization of medical devices and adjust it "to better reflect the management of benefit, harm, and uncertainty" (HPFB, 2012c, p. 14).

Generally speaking, Health Canada's approach to classifying medical devices is similar to that of the US, the EU, and Australia. Despite some differences among jurisdictions in classification schemes, in all cases, the class of medical device increases with the level of risk associated with its use.

The 2004 Report of the OAG on Canada's regulation of medical devices found that the MDP effectively manages risks in the pre-market phase, noting that the highest-risk devices were subject to the highest level of review; pre-market review processes were consistently followed and properly documented; and expertise and experience were incorporated into the review process (OAG, 2004, p. 15). However, in the same report, the OAG noted that Health Canada had consistently failed to meet its performance targets for reviewing Class III and IV license applications, primarily due to a shortage in human resources, and recommended that Health Canada take steps to meet its performance targets in order to help ensure timely access to safe medical devices (OAG, 2004, pp. 16-18). In its 2011 report, the OAG acknowledged that although Health Canada had increased funding available for the MDP and was planning on increasing user fees (OAG, 2011, pp. 2-3), it continued to have difficulties meeting performance targets.

In theory, processing applications within established performance targets is expected to facilitate timely access to effective medical devices, thus increasing available treatment options without putting end-users at greater risk. Target review times vary by device class, procedure, and priority level. In total, the time expected for a first decision increases with the class (and so expected risk) of the device, from 15 days for Class II to 75 days for Class III and 90 days for Class IV (HPFB, 2006).

Health Canada's approach to measuring review performance changed with the implementation of the new cost recovery framework in April 2011. Prior to that date, MDB's performance target was completing 90% of all decisions for each class within the target time frame. While the MDB is still accountable for achieving this performance target, an additional metric was established with the implementation of the new cost recovery framework -- namely, requiring submissions, on average, to meet the target review time for first review for their submission class (II, III, IV).

To enable comparisons over time, the evaluation analysed timeliness of submission review using the 90% target for all decisions. The analysis found that:

See Appendix C for more detailed submission review data.

The available performance data are consistent with the perceptions of industry key informants, who noted that Health Canada's review process is not as timely as desired and is unpredictable with respect to timelines. Among respondents to the industry survey, 18% believe that the new cost recovery framework has improved the timeliness of regulatory services, while 22% did not. The remainder were the either neutral (31%) or did not know (29%).Footnote 10

In interviews with industry, it was implied that Health Canada may be deliberately using mechanisms such as screening periods and requests for additional information to gain additional time to complete reviews without being penalized for lack of timeliness. While the evaluation could not confirm or refute this claim, the following points are notable:

A more detailed analysis of submission review data, taking into account factors such as changes in resource levels and number of applications over time, may provide further insight into Health Canada's review performance. For example, it would be informative to consider annual review performance in light of the ratio of the number of full-time equivalents (FTEs) to the number of applications each year for each submission class.

Combination products

Ideally, analysis of submission review performance would take into consideration the impact of combination product applications. Finding the most efficient process to review all components of a combination product without compromising safety or quality has been an ongoing challenge for Health Canada. At present, combination products are classified as either a device or a drug prior to review, based on the principal mechanism of action of the product; once classified, the product review is led by MDB or the appropriate TPD bureau or BGTD centre. Regardless of which group leads a review process, the other consulting groups are contacted and brought into the process. The consulting group provides its recommendation for product approval, although the final recommendation is entirely under the control of the lead group. This system was intended only to operate on an interim basis until more comprehensive regulatory changes could be made to accommodate combination products (Health Canada, 2005a).

The case study on combination products identified numerous issues arising from this approach, including (but not limited to) inconsistent application of the criterion for selecting regulations and the lead reviewing body according to a product's principal mechanism of action; challenges in completing combination product reviews within the 90-day target for medical devices;Footnote 11 and lack of accommodation within the current performance tracking system and fee structure for joint reviews.Footnote 12

Over the past few years, Health Canada has completed a very small number of joint reviews of combination products: 31 between 2007-08 and 2012-2013, including 12 amendments and 19 new Class III and IV applications. This represents 0.3% of all new and amendment Class III and IV applications over this period.  There have been no clear trends in the number of these submissions over time, and Health Canada representatives noted that it is difficult to anticipate future trends. Nonetheless, Health Canada key informants interviewed as part of the case study emphasized the need for more policy and guidance to guide the review of combination products. In its 2012-2013 mid-year review report for the MDP, Health Canada indicated that:

[w]ork is underway to develop a project plan to adequately assess the policy and workload implications of combination devices. Currently, impacts are limited, but larger volumes could put program at risk of missing Class IV medical devices review standards (HPFB, 2012b, p. 2).

To this point, HPFB's July 2013 integrated dashboard report -- developed to support performance reporting under the CRI -- showed that while only two reviews of devices involving human/animal tissue (a type of combination product) were completed between April 1, 2013 and July 31, 2013, both exceeded the service standard for submission review by more than 10% (Health Canada, 2013f). However, Health Canada representatives also reported that of three reviews of devices involving human/animal tissue to report on as of August 31, 2013, all were within the service standard.

Health Canada representatives noted that HPFB's ongoing initiative to implement an enterprise approach to informatics within the Branch should improve its ability to track workload across product categories. Program representatives noted that in future, analysis of submission review performance should be better positioned to consider the impact of combination production applications.

It is of note that this issue of combination products is not unique to Canada. While an exhaustive comparison of international approaches to combination product review was beyond the scope of this evaluation, the review process in the US is similar to Canada's, in that combination product submissions are assessed by a coordinator and assigned to a lead review body from among the separate drugs, device, and biologics centres (Patterson, 2003). However, unlike Health Canada, the FDA has a dedicated Office of Combination Products that is responsible for coordinating these reviews, and the FDA may choose to apply either or both of its device and drug regulations to a combination product. The FDA also has an Intercenter Agreement between the Center for Biologics Evaluation and Research (CBER) and the Center for Devices and Radiological Health (CDRH) for the review of combination products, which transfers the responsibility for the regulation of medical devices related to licensed blood and cellular products to CBER. As well, in August 2013, the FDA consolidated the primary responsibility for regulating wound care products containing live cells in CBER. Finally, the FDA has developed a considerable body of guidance for industry related to combination products (FDA, 2013).

Other initiatives to improve submission review

In addition to implementing a new cost recovery framework, Health Canada has undertaken several other notable initiatives intended to improve the efficiency, as well as the quality, of the submission review process.

Both industry and non-industry key informants were supportive of expanded use of information and knowledge from other jurisdictions during the review process. Industry key informants consider timely review as especially critical for medical devices compared to pharmaceutical drugs and biologics because of greater difficulties in protecting intellectual property and the relatively short period of market exclusivity granted to medical devices.

Quality management systems certification

As part of the license application submitted to Health Canada to sell a Class II, III, or IV medical device in Canada, a manufacturer must submit an ISO 13485:2003 QMS certificate. A manufacturer obtains a QMS certificate by undergoing an audit from a Health Canada Recognized Registrar, recognized by Health Canada under Section 32.1 of the Medical Devices Regulations. Currently, Registrars are accredited by the SCC on behalf of Health Canada. In order to be accredited, they need to meet the ISO 17021 standard, as well as the CMDCAS Sector Qualification Q90R0. Health Canada decided to use third parties to audit and certify QMS because of the large number and location of manufacturers around the world that sell medical devices in Canada. The CMDCAS program is similar to the EU notified bodies program, which also relies on third parties to conduct audits, but different from the approach used in the US and Australia, where the regulatory agency is responsible for conducting these audits.

Health Canada's current approach to QMS certification does not appear to be controversial from the perspective of stakeholders, and, in fact, a few interviewees commented positively on Health Canada's approach to using third parties to conduct QMS audits. It is important to note that Health Canada has undertaken a number of initiatives to introduce efficiencies into the QMS audit process:

Single-use devices

Single-use devices (SUDs) have presented unique policy and regulatory challenges for Health Canada over the period under evaluation. Unlike medical devices that are designed, labelled, and sold for multiple uses, SUDs are produced by manufacturers to be used once and then discarded.

SUDs have become increasingly available over the past few decades. Examples of SUDs are needles, lancets, syringes and urinary catheters. As the Canadian Agency for Drugs and Technologies in Health (CADTH) points out, there is "a financial advantage for a manufacturer to release SUDs rather than multi-use devices because they can be brought to market sooner and do not require the same degree of documentation and validation" (CADTH, 2008a, p. 1). Furthermore, "there is no requirement for a manufacturer to prove that a device cannot be reprocessed" (CADTH, 2008a, p. 1). Here, reprocessing can be defined as including "all steps performed to make an original single-use device previously used on one patient ready for use on another patient"; this is distinct from reuse, which "refers to the repeated use or multiple use of any medical device, including devices intended for single use with reprocessing between uses" (Polisena et al., 2008, p. 437).

Given the higher costs of purchasing new SUDs, many health care facilities in Canada have become involved in reprocessing of these devices. A 2008 study by CADTH examining practices among 398 respondents from among 572 acute care hospitals found the following:

The available evidence does not support the conclusion that there are inherently greater health and safety risks associated with reprocessed SUDs.Footnote 15 However, many stakeholders, including health care facilities and the provinces and territories, have expressed concern about the potential health risks and legal liability issues associated with the practice, and have called upon Health Canada to regulate in the area.Footnote 16

The OAG assessed the issue of SUD reprocessing in its 2004 report, noting that Health Canada had "not developed a position on managing the risks related to the reuse of single-use devices" and recommending that it "take action, such as regulating reprocessed single-use devices, to manage the health and safety risks related to the reuse of single-use medical devices" (OAG, 2004, p. 26). In response, Health Canada undertook a review of the current federal statutory and regulatory authorities to determine its ability to regulate SUD reprocessing and consulted with stakeholders, including the provinces and territories, "to determine the best approach to minimize the health and safety risks related to the reuse of single-use medical devices" (OAG, 2004, pp. 26-27).

The consultation and review included the establishment of a Scientific Advisory Panel on Reprocessing of Medical Devices (SAP-RMD) to provide recommendations. Health Canada has implemented several of the recommendations of the SAP-RMD, including developing interim recommendations for hospitals and health care facilities on reprocessing SUDs (Health Canada, 2005b) and developing guidelines for the reprocessing of SUDs (Health Canada, 2011b).

The Panel's main recommendation was that reuse of SUDs not be allowed occur unless they are regulated by Health Canada and there is clear evidence of safe reprocessing and compliance with validated protocols. Health Canada initially intended to develop a regulatory framework for reprocessing of SUDs. Later, in 2007, Health Canada concluded that "the Food and Drugs Act, from which the Medical Devices Regulations derive their authority, is not intended to apply to the use of a device after its sale. Therefore, Health Canada does not have the authority to regulate reuse" (TPD, 2007b, p. 2).Footnote 17

It is uncertain if this conclusion remains valid for all reprocessing situations. Currently, there is at least one third-party reprocessing firm actively involved in the sale of reprocessed SUDs to Canadian health care facilities. In this and similar situations, it would appear that a transfer of ownership (i.e., a sale) does indeed occur, implying that Health Canada may have jurisdiction in these circumstances.

Health Canada's position on this issue has not changed since 2007. Further, Health Canada representatives indicated that Health Canada does not intend to seek the authority to regulate SUD reprocessing, as Health Canada has no evidence to suggest that this activity presents a safety issue. Thus, in Canada at the present time, policies and practices related to the reprocessing of SUDs are set solely at the provincial/territorial and regional health authority level. CADTH reports that at present three provinces) do not reprocess any SUDs; six reprocess SUDs through third-party reprocessors; three reprocess non-critical SUDs within hospitals and outsource semi-critical and critical SUDs to third-party reprocessors; and one province does not reprocess any critical or semi-critical SUDs (CADTH, 2011).

In the US, where the vast majority (84%) of SUD reprocessing is conducted by third-party reprocessors, (U.S. Food and Drug Administration, 2009), the FDA responded to the potential risks arising from this practice by publishing guidance in 2000 indicating that hospitals and third parties that reprocess SUDs would be "regulated in the same way as original equipment manufacturers" and be subject to all the regulatory requirements of the Food, Drug, and Cosmetic Act that are applicable to the original manufacturer, including registration and listing; Good Manufacturing Practices (GMPs) under the Quality System regulation; submission of adverse event reports; labelling, tracking, corrections, and removals; and pre-market notification and approval(FDA, 2000). With the passage of new legislation in 2002, the FDA imposed additional requirements for about 70 types of reprocessed devices, implemented new labelling requirements, and began inspecting reprocessors and monitoring reports of adverse events (GAO, 2008a). It is important to note that in a 2008 report on SUD reprocessing in the US, the US General Accounting Office (GAO) noted the FDA's conclusion "that the available data, while limited, do not indicate that reprocessed SUDs present an elevated health risk" (GAO, 2008a).

Conversely, CADTH reports that in the EU, practices vary among member countries. Reprocessing is illegal in some countries (e.g., France) and permitted in other countries with guidelines and standards (e.g., Sweden, Germany), while others have no specific regulations or policies (CADTH, 2011). In 2012, the European Commission proposed amendments to the Medical Device Directive recommending harmonized regulation for reprocessing of SUDs, allowing for member states to prohibit reprocessing. Under this option, reprocessors would be considered manufacturers of the reprocessed device, and therefore held to the same obligations of medical device manufacturers, including appropriate labelling for the reprocessed device. The Commission suggests the proposed amendments will lead to the development of a high quality and strictly regulated reprocessing sector in the EU (European Commission, 2012a, p. 25, 2012b, p. 45).

Stakeholder views differ on whether Health Canada should provide some type of oversight of SUD reprocessing, with some supportive of Health Canada's position that responsibility for reprocessing of single-use devices falls under provincial jurisdiction and others arguing that Health Canada has an overriding responsibility to protect the health of Canadians and, consequently, should demonstrate leadership by either regulating reprocessing of SUDs or otherwise intervening in this area.

Post-market surveillance and monitoring

Enhancing post-market surveillance and monitoring of the safety and effectiveness of therapeutic products, including medical devices, is one of the main themes of HPFB's regulatory modernization initiative. Key activities in this area include ongoing collection and assessment of national and international post-market safety data and reports, and national and international cooperation relating to post-market surveillance. During the evaluation period, Health Canada implemented improvements to its post-market surveillance system by introducing the Canadian Medical Devices Sentinel Network (CMDSNet) and by implementing a standardized approach to signal detection, assessment, and risk management for all therapeutic products, including medical devices.

Problem reporting

Problem reporting historically has been the pillar of Health Canada's approach to post-market surveillance and monitoring of medical devices. Problem reporting may be mandatory or voluntary, and may come from manufacturers, health care professionals, institutions, or the public.

Section 59 of the Medical Devices Regulations requires manufacturers and importers of medical devices sold in Canada to submit a mandatory problem report for incidents involving failure of a medical device, deterioration in its effectiveness, or inadequacy of labelling or directions for its use, as well as for incidents involving death or a serious deterioration in health of a patient, user, or other person, or the potential for these outcomes if the incident were to recur. Under Section 60, if the incident involves death or a serious deterioration in health, a preliminary mandatory problem report must be submitted within 10 days of the manufacturer or importer becoming aware of the incident, while those not involving death or a serious deterioration in health must be reported within 30 days of the manufacturer or importer becoming aware of the incident. Prior to October 2011, manufacturers and importers were required to submit mandatory problem reports to the Inspectorate's Medical Device Compliance unit. Since that date, they have been required to submit these reports to MHPD's Canada Vigilance Program.

The number of mandatory problem reports submitted to Health Canada fluctuated significantly between 2006-2007 and 2011-2012, from a low of 2,395 reports in 2006-2007 to a high of 7,806 reports in 2010-2011, before falling to 4,367 reports in 2011-2012 (Inspectorate, 2011d, 2012c). The reasons for these fluctuations could not be determined by the evaluation.Footnote 18 Overall, a total of 28,420 mandatory problem reports were submitted.

Voluntary problem reports may be submitted by medical device users, patients, and other persons who experience a problem with a medical device. They may also be submitted by industry. Voluntary problem reports may be the result of problems encountered during the use of a medical device, concerns over the safety or performance claims of a device, deficiencies in the device's design or labelling, a defect in the manufacturing process, or perceived contravention of a regulatory requirement (Inspectorate, 2011c). Whereas problem reporting is not mandatory for health care institutions in Canada, in the US, all hospitals, nursing homes, and outpatient treatment and diagnostic centres are required under the Safe Medical Devices Act to report medical device problems that result in serious illness, injury, or death.Footnote 19

Unlike mandatory reports, which are submitted to MHPD, voluntary problem reports are submitted to RAPB regional operations and are considered incidents that result in compliance verification. Each report is classified according to the degree of risk it presents:

Generally speaking, the annual number of voluntary problem reports submitted to Health Canada increased between 2006-2007 and 2010-2011 (Inspectorate, 2011d, 2012c). In that time period, Health Canada received 2,246 voluntary problem reports, of which almost three quarters (72%) were classified as Type II. The remainder were Type III (15%) and Type I (13%). See Appendix C for more information.

It is important to note that mandatory and voluntary problem reports do not reflect the actual number of medical device incidents, since more than one problem report may be submitted in relation to the same incident. Furthermore, some incidents may be unreported. The number of incidents and the number of medical devices implicated in the mandatory and voluntary problem report data is unknown to the evaluation.

Key informants were of the view that while industry is typically compliant with reporting requirements and may, in some cases, over-report so as to err on the side of caution, under-reporting is common among health care practitioners and other stakeholders. Key informants identified numerous factors that may influence the decision to report, and gave several suggestions for improving voluntary problem reporting rates among health care providers and other stakeholders; see Table 3.

Table 3: Factors influencing voluntary problem reporting and suggestions for improvement
Factors influencing voluntary problem reporting Suggestions for improving voluntary problem reporting
  • poor definition of what, when, and how patients and health care providers/facilities should report problems, and who should report
  • health care practitioners are too busy, feel it is not worth their time, or do not consider themselves accountable to Health Canada
  • reporting processes are onerous
  • failure of collective action (i.e., everyone believes someone else has reported)
  • insufficient feedback from Health Canada when problems are reported
  • lack of awareness of opportunities for reporting
  • streamlining the reporting process
  • increasing educational efforts
  • collaborating with professional organizations to encourage reporting
  • making reporting mandatory for health care providers
  • paying health care practitioners to report
  • enhancing efforts to provide feedback to stakeholders who report
  • exploring best practices in other jurisdictions

Health Canada has begun to implement electronic adverse reaction reporting for drugs, but it is not clear if similar plans are in place for medical devices. Health Canada currently accepts medical device problem reports via email, but electronic submission of voluntary reports directly into a database is not yet available. If implemented, electronic submission might both encourage reporting by health care providers and facilities, and expedite and facilitate analysis of problem reports by Health Canada.

Canadian Medical Devices Sentinel Network

In 2004, the OAG criticized Health Canada's approach to adverse event reporting and emphasized the need for an improved post-market surveillance system so that adverse events can be reported in a timely manner as they occur (OAG, 2004, p. 1). The OAG also found that Health Canada had done little to encourage increased problem reporting by health care professionals, who are usually the first to observe adverse events (OAG, 2004, p. 22). In the interests of establishing a more proactive problem reporting system for medical devices, Health Canada established CMDSNet.

CMDSNet was piloted in April 2009 with 10 sites across Canada. By 2012, there were 12 participating centres comprising over 200 sites located in British Columbia, Alberta, Saskatchewan, Manitoba, the Northwest Territories, Ontario, Quebec, Nova Scotia, New Brunswick, and Newfoundland and Labrador (Turpin, 2012).Footnote 20 At each participating site, specific reporters are selected and provided with specialized training to submit information to and interact with the Network effectively. Reports they submit are acknowledged by CMDSNet, triaged according to the risk presented, data-entered, and transferred to the Inspectorate and manufacturers for review. Research is undertaken to verify the signal and report findings back to the original reporter, the results are coded for future queries, and key information is spread through the Network via monthly electronic internal and external bulletin reports. The goal of the project is to provide post-market evaluators with more comprehensive incident data, allowing for earlier regulatory interventions, which it is hoped will help provide Canadians with more timely and current safety information on medical devices (MedEffect, 2010; Turpin, 2012, pp. 2-4).

Table 4 lists the number of CMDSNet reports entered into the MDS since the program launched in April 2009. Of the voluntary problem reports processed by CMDSNet in its first three years, approximately half indicated some potential harm, and approximately 5% indicated risk of serious injury or death, with the risk level of the remaining 34% categorized as "unknown/other" (Turpin, 2012). In its first three years, CMDSNet processed 35% of all voluntary problem reports submitted to Health Canada. However, since the implementation of CMDSNet, the total number of voluntary reports submitted to Health Canada has declined, as has the number of voluntary reports submitted by stakeholders outside of the network. The explanation for these patterns is unknown.Footnote 21

Analysis of MHPD's signal assessments for medical devices shows that of 44 signal assessments completed between 2009 (when the CMDSNet was established) and 2012, the CMDSNet accounted for 20.5% of all signals (MHPD, 2013). The prominence of CMDSNet as a source of safety signals is notable.

Table 4: Voluntary problem reports processed by CMDSNet
Fiscal year Total # of voluntary reports # of voluntary reports processed by CMDSNet # of voluntary reports excluding CMDSNet CMDSNet reports as % of all voluntary reports
2006-2007 260 - 260 -
2007-2008 341 - 341 -
2008-2009 374 - 374 -
2009-2010 446 159 287 36%
2010-2011 421 123 298 29%
2011-2012 404 169 235 42%
Total 2246 451   35%
Source: (Inspectorate, 2011d, 2012c) and information provided by Health Canada.

Health Canada plans to expand CMDSNet and to obtain stable permanent funding to staff the program (Turpin, 2013). In 2011, eight new sites were approved, but only two were recruited due to resource issues. Health Canada has plans to implement the remaining six sites; the Toronto Sick Kids Hospital was recruited in June 2013 and will join the program in September of that year.

An initiative similar to CMDSNet has been underway in the US since 2002, when the FDA's CDRH launched its Medical Product Safety Network (MedSun) as a supplement to mandatory and voluntary reporting under the MedWatch program. In addition to facilitating mandatory reporting,MedSun also enables and encourages participants to submit voluntary reports of incidents involving potential harm or other safety concerns (FDA, 2012a). As of 2012, approximately 280 hospitals were participating in the MedSun Network (FDA, 2012b).

Unlike Health Canada, the FDA also has a number of other tools at its disposable for post-market surveillance of medical devices. In particular, the FDA has the authority to order a post-approval study as a condition of approval for a device approved under a pre-market approval order, and to order manufacturers of certain Class II and Class III devices to conduct post-market surveillance studies (FDA, 2012b).

Signal detection, assessment, and risk management

Mandatory and voluntary problem reports are not the only source of information about potential post-market health and safety risks associated with medical devices. In recent years, Health Canada has sought to expand the sources of information it considers in post-market surveillance as part of broader Branch-wide plans to implement a standardized post-market surveillance management framework for all product lines. To this end, MHPD, as the lead body for Health Canada's post-market surveillance activities, has defined its core processes and developed procedures to ensure that relevant information is handled in a consistent manner to identify and understand risks and take appropriate action (MHPD, 2008).Footnote 22 MHPD's core processes are briefly described below.

Core process #1: Information collection and processing - MHPD collects information from mandatory and voluntary problem reports, post-market reports from manufacturers, environmental scans of medical and scientific literature, media reports, national and international information, and information from similar research by the pre-market regulatory directorate and the Inspectorate.

Core process #2: Signal detection and management - All of the above may be sources of potential signals, which MHPD defines as the indication of a "new potential causal association, or a new aspect of a known association, between an intervention and an event or set of related events" requiring verification (MHPD, 2012a). After undergoing a preliminary review, potential signals are prioritized and classified in one of three ways:

Potential product issues are systematically reassessed every six months for a maximum of 18 months, while identified signals are assigned for signal assessment. Findings from the signal assessment are summarized and recommendations for action are produced (MHPD, 2012b). Options include the following:

Core process #3: Risk management - Following review and approval by the Director's Office, the recommended action is taken.

Between 2005 and 2012, 81 signal assessments relating to medical devices were completed (MHPD, 2013).

While recognizing that Health Canada's post-market surveillance and monitoring activities have improved in recent years, many, if not most, external key informants believed there is still room for improvement. In addition to their concerns about under-reporting by health care practitioners, key informants identified several areas for improvement:

It was also suggested that by streamlining the pre-market approval process by, for example, increasing information-sharing with other jurisdictions, more resources could be allocated to post-market surveillance as well as compliance and enforcement activities.

5.2.3 Compliance and enforcement

Strengthening compliance tools and approaches, with a view to achieving increased industry compliance with the regulatory frameworks for therapeutic products, including medical devices, has been a key objective of Health Canada over the evaluation period. Health Canada has, among other things, implemented changes to its inspection program for medical devices, increased its oversight of imported products, and developed an approach to counterfeit health products. Planned enhancements to compliance tools and approaches were not implemented since proposed legislative changes did not proceed.

Medical devices inspection program

Over the evaluation period, the Inspectorate implemented significant changes to its inspection program for medical devices, in response to the OAG's 2004 recommendations that it engage in active inspections to ensure that manufacturers are compliant with regulations (OAG, 2004, p. 19). Under the new program, which was implemented in 2010 and is intended to shift towards a more risk-based approach to inspection, domestic MDEL holders are inspected according to the following cycle: manufacturers every three years, importers every four years, and distributors every five years (Inspectorate, 2012b, p. 6).Footnote 25 However, establishments may be selected for inspection outside of this cycle using risk-based criteria (e.g., newly licensed establishments, re-inspection of establishments that previously received a non-compliance rating); additionally, a targeted inspection may be conducted if the Inspectorate has concerns about an establishment's compliance with specific legislative or regulatory provisions (Inspectorate, 2012b, p. 6).Footnote 26

Domestic establishments are rated as either compliant (C) or non-compliant (NC) according to the risk given to observations noted during inspections. There are three levels of risk, with Risk 1 being the highest level of risk and Risk 3 being the lowest (Inspectorate, 2011e). If one or more observations are classified as Risk 1, the overall inspection rating may be NC.

As shown in Table 5 below, between 2006-2007 and 2011-2012, the Inspectorate carried out a total of 1,419 inspections, completing 95% of its target number of inspections, on average, over this time period. On average, 15.5% of Canadian MDEL holders were inspected each year between 2006-2007 and 2009-2010.Footnote 27 It is unknown how this inspection rate compares with international regulators.

Table 5: Medical device establishment inspections carried out, 2006-2007 to 2011-2012
Fiscal year Number of Canadian MDEL holders Target number
of inspections		 Number of inspections completed Percentage
of target inspections completed		 Percentage of MDEL holders inspected
2006-2007 1,500 159 144 90.6% 9.6%
2007-2008 1,313 221 210 95% 15.9%
2008-2009 1,338 239 250 104.6% 18.7%
2009-2010 1,269 243 226 93.0% 17.8%
2010-2011 N/A 243 245 100.8% N/A
2011-2012 N/A 395 344 87.1% N/A
Sources: For number of Canadian MDEL holders: (Inspectorate, 2006a, 2007, 2008, 2009b)

For target number of inspections, number of inspections completed, and percentage of target inspections completed: (Inspectorate, 2011d, 2012c)

Percentage of MDEL holders inspected calculated by evaluator (number of inspections completed/number of Canadian MDEL holders).

Although many of the Class I medical device manufacturers who participated in the focus group reported that their manufacturing facilities had been inspected by Health Canada in the past, none were able to identify the impetus for those inspections or tie the inspection's timing to any significant event. As such, the general perception was that these inspections took place at relatively large, random intervals -- with some participants noting that they operated for a number of years prior to having an inspection at all. With the implementation of the new inspection program, Class I manufacturers can expect to be inspected every three years. However, it is unclear how long MDEL holders may operate before being inspected for the first time.

Participants suggested that these inspections mainly focused on internal processes and the ability for firms to undertake recalls, and did not focus on their product or the manufacturing process itself. Some focus group participants stated that identified improvements coming out of the inspections generally involved the rewording of their own internal documentation in order to more closely align with Health Canada's requirements. There were no instances of suggestions for substantive manufacturing change. Some industry key informants, for their part, expressed concern that inspectors are not properly trained, and this has the effect of compromising some elements of the quality of inspections.

Finally, it is important to note that in response to concerns raised by the OAG in its 2011 report on medical devices, Health Canada recently completed a project to evaluate expanding the medical device inspection program to include foreign establishments, which are approximately one quarter of all license holders. The goals of the pilot were to gain insight into compliance levels of foreign establishments and their understanding of relevant regulations; explore the feasibility of foreign assessments; and investigate options for conducting a foreign MDEL inspection program (Health Canada, 2013d). Under the pilot, 19 paper-based assessments and three on-site assessments were completed between March 2012 and September 2012. Health Canada also plans to integrate foreign MDEL holders into the medical device inspection program beginning in 2013-2014.

Compliance verifications

In addition to monitoring compliance through its inspection program, the Inspectorate also conducts compliance verifications and investigations as potential non-compliances related to medical devices are identified through voluntary or mandatory problem reports received. These issues may be identified by consumers, industry, provincial/territorial or federal regulatory agencies, international partners, or the Inspectorate's own monitoring activities. Between 2006-2007 and 2011-2012, the Inspectorate carried out 36,777 compliance verifications and investigations, of which approximately three quarters (77%) arose from mandatory problem reports. The remainder were related to recalls (12%), voluntary problem reports (6%), lack of a device license (2%), and lack of an establishment license (2%); see Appendix B for more detailed information. There is no information on the time required to complete these compliance verifications, their outcomes, or subsequent actions taken by the Inspectorate.

Recalls

The Medical Devices Regulations define a recall as any action taken by the manufacturer, importer, or distributor of a device that has been sold to recall or correct the device, or to notify its owners and users of its defectiveness or potential defectiveness. This occurs after the manufacturer, importer, or distributor becomes aware that the device may be: hazardous to health; may fail to conform to claims made about the device's effectiveness, benefits, performance, or safety; or may not meet the requirements set out in the Food and Drugs Act or Medical Devices Regulations (GoC, 2011d, sec. 1).A medical device recall may include the following:

  1. the removal of the medical device from the market and its consignees
  2. an on-site correction of the medical device
  3. an advisory concerning a problem or potential problem with instructions to work around the problem until an on-site correction can be implemented
  4. the supply of revised labelling related to corrective action
  5. the supply of instructions to stop using the medical device and destroy remaining units in stock (Health Canada, 2011a)

Industry is responsible for initiating recalls, but must inform Health Canada when recalls are initiated; Health Canada may also request industry to undertake recalls (Inspectorate, 2006b, p. 8), although it does not currently have the power to require a recall. Like problem reports, recalls are split into three health hazard classifications (Type I, Type II, and Type III), which are assigned by the Inspectorate according to the degree of risk presented.

Between 2005 and 2012, the Inspectorate posted a total of 5,037 medical device recalls on Health Canada's online Medical Device Recall Listing.Footnote 28 The number of recalls per year has followed a general upward trajectory over time, which may be due to a variety of factors, including a growing number of medical devices on the market and greater recognition by industry of the need to recall unsafe products. Of the total number of recalls, 5% were Type I, 61% were Type II, and 33% were Type III. See Appendix C for more information.

Oversight of imported products

As previously noted, the Inspectorate provides a leadership role in the National Border Integrity Program in collaboration with the CBSA. The Program, which received funding under Strategy #10 of the FCSAP, "addresses the challenges created by an increase in the importation of new health products; the rapid expansion of global trade; and the complexity of the supply chain, including consumer direct access to less expensive or socially stigmatized products available through internet marketing" (Inspectorate, 2010a, p. 3). The National Border Integrity Program consists of four main "pillars," as summarized in the list below.

Pillars of the National Border Integrity Program

Source: (Inspectorate, 2010a)

Table 6: Medical device shipments inspected by the Regional Border Integrity Unit
Fiscal Year Personal Shipments Commercial Shipments Total
Refusals Releases Refusals Releases
(Suspected) Counterfeit All Other (Suspected) Counterfeit All Other
2009-2010 0 11 64 10 38 46 169
2010-2011 0 1 170 0 157 301 629
2011-2012 0 2 726 0 251 384 1,363
Total 0 14* 960 10 446 731 2,161
Source: (Inspectorate, 2010e, 2011g, 2012d)

*These shipments were considered commercial but were reported as personal based on destination.
Counterfeit and unlicensed medical devices

In an initiative related to the Border Integrity Program, the Inspectorate has developed a Policy on Counterfeit Health Products, the primary objective of which is "to manage the risk to Canadians and to have the counterfeit product removed from market using the most appropriate level of intervention and notifying parties at risk"(Inspectorate, 2010d). In addition, because the sale of counterfeit health products is a violation of the Criminal Code, the Inspectorate refers confirmed cases to the Royal Canadian Mounted Police (RCMP) and supports RCMP investigations by providing compliance and enforcement expertise and lab analysis.

Based on the data presented in Table 6 above, however, it does not appear that counterfeit medical devices are a significant problem in Canada. On the other hand, while industry key informants noted that counterfeiting is less of an issue for medical devices than for pharmaceuticals and biologics, it was observed that there should more oversight of "virtual companies" that import devices from abroad, as well as of hospital purchases of these products. Indeed, both industry key informants and Class I focus group participants expressed concerns about the sale of unlicensed medical devices in Canada -- which they noted places compliant firms at a competitive disadvantage -- and were critical of what they perceived as Health Canada's failure to enforce regulatory compliance in this area. Many argued that Health Canada needs more tools to take action against firms selling unlicensed medical devices and that penalties for non-compliance should be more severe.

Concerns about the presence of unlicensed medical devices on the Canadian market were expressed by the OAG in 2004, which urged Health Canada to "take a more active approach to dealing with unlicensed devices by ensuring that they are easy to identify and that actions taken against sellers of unlicensed devices will discourage this practice" (OAG, 2004, p. 25). According to HPFB's Blueprint for Renewal, the Branch has "developed an action plan to address risks posed by unlicensed medical devices" (HPFB, 2007a, p. 15). The action plan was not available to the evaluation. Program representatives reported that Health Canada has undertaken some compliance promotion activities, such as road shows and workshops, to increase industry understanding of regulatory requirements.

Some industry key informants expressed concerns that Health Canada has not always been responsive to trade complaints related to the sale of unlicensed medical devices or to other non-compliances such as inappropriate advertising. While a risk-based approach to enforcement and compliance is appropriate, it could at times result in the Inspectorate being unlikely to react in a timely fashion to issues or complaints which are perceived to be low-risk in nature. That said, risk-based approaches do not necessarily provide a strong understanding of compliance across the regulated industry as a whole, nor are they always well-equipped to identify new or emerging risks.

Compliance and enforcement actions

The evaluation did not find any information on the frequency with which the various types of compliance and enforcement actions described in the Inspectorate's Compliance and Enforcement Policy (see Table 7 below) have been deployed in response to non-compliances, or in what types of non-compliance situations the various measures have been used. While industry key informants appreciate the opportunity to comply voluntarily with regulation prior to enforcement action being taken, they also perceive an inability or unwillingness on the part of Health Canada to take enforcement action when it is appropriate, and they expressed concerns about insufficient penalties for non-compliance.

Table 7: Voluntary and regulatory compliance measures
Voluntary measures Regulatory measures
  • Consent to forfeiture
  • Product detention
  • Product disposal
  • Stop-sale
  • Recall
  • Customs activities
  • Injunction
  • Prosecution
  • Forfeiture
  • Public warning or advisory
  • Letters to trade and regulated parties
  • Regulatory stop-sale
  • Search and seizure
  • Seizure and detention
  • Suspension or cancellation of marketing authorization or product license
  • Refusal, suspension, or amendment of establishment license
  • Warning letter
Source: (Inspectorate, 2009a)

5.2.4 Communications and stakeholder engagement

Health Canada has pursued two broad or overarching plans in relation to communications and stakeholder engagement in the evaluation period, namely providing Canadians with more information on health products, including more timely and accessible information, and making the regulatory system more open to consumer and other stakeholder input and involvement. Over the evaluation period, Health Canada's activities in this area include introducing Summary Basis of Decision (SBD) documents, issuing risk and safety information to stakeholders, and consulting with stakeholders with respect to policy, guidance, and regulatory development.

Summary Basis of Decision

Launched in 2005, the SBD initiative was undertaken as part of Health Canada's commitment to enhance the transparency of the medical device and drug review process (TPD, 2009a). SBD documents provide health care professionals, consumers, and patients with the scientific and benefit/risk-based considerations involved in granting market authorization. The documents contain general information on the medical device being examined and scientific and regulatory considerations, such as the standards used to design the device, manufacturing and quality control information, and pre-clinical and clinical trial data.

In its first phase, the SBD initiative covered a subset of Class IV applications. In the second phase, launched in June 2012, Health Canada is targeting publication of five to seven SBDs per year for newly licensed Class III and IV devices with novel technology. In response to findings from an evaluation of Phase I, Health Canada implemented a number of process changes to reduce the time to publish SBDs; as a result of the changes, the target for SBD publication was reduced from 20 weeks to 12 weeks. Changes to the process include limiting the ability of market authorization holders (MAHs) to request changes to the SBD and to appeal the SBD (TPD, 2012).

Since the launch of the initiative, a total of 49 SBDs have been released for medical devices. Detailed information can be found in Appendix C.

Post-market safety and risk communications

While the SBD initiative is part of Health Canada's plans to increase transparency relating to regulatory decisions, an important part of Health Canada's role is to provide Canadians with risk and safety information related to therapeutic products.

Since 2005, Health Canada has communicated post-market safety and risk information to health professionals and the public primarily through MHPD's MedEffect website. Footnote 29 The MedEffect Canada Initiative was created to improve access to safety information and adverse reaction information for marketed health products, while also providing a single window approach to post-market surveillance activities. The single window approach is intended to provide the public and health professionals with centralized, easy-to-find information online, with the goal of increasing awareness of the importance of reporting adverse events related to health products, while also making it easier for health professionals and members of the public to report adverse events (MedEffect, 2011; MHPD, 2007).

MHPD publishes safety and risk information regarding health products using a variety of risk communications documents. Since 2005, many of these communications have been posted on the "advisories, warnings and recalls" link on the MedEffect website. However, other distribution methods are also used, including mail-outs and hard copy publications, dissemination to professional associations to encourage posting on their website and publication in their journals and newsletters, and distribution to licensing bodies, provincial ministries, and foreign regulatory agencies. In addition, the MedEffect e-notice is a free service that delivers advisories, warnings, and recalls; the quarterly Canadian Adverse Reaction Newsletter; and MedEffect content updates directly to subscribers. Redundancy in electronic and print format, duplication of information across multiple publications, and dissemination through electronic distribution lists is expected to increase the probability that a large number of health professionals and interested members of the public are exposed to safety information about medical devices.

HPFB's guidance document on risk communications includes a decision tree that is intended to serve as a guide for selecting the type of risk communication document to use. It also identifies what type of communication is appropriate in a given situation, according to the assessed level of risk -- high, medium, or low (Health Canada, 2008c). The guidance document notes that Health Canada considers many factors when evaluating emerging product safety concerns and deciding on the urgency with which the risk must be communicated, including data availability and reliability; magnitude of the risk; seriousness of the event relative to the disease being treated; extent of patient exposure; potential to prevent or mitigate the risk in the patient population; relevance to clinical practice; and disproportionate impact on vulnerable populations (e.g., children or the elderly)"(Health Canada, 2008c, pp. 8-9).

As of April 12, 2012, there were 234 risk communications related to medical devices posted on MedEffect (see Appendix C for more details). The majority of posted communications targeted health professionals. In total, 60% of the risk communications targeted health professionals, of which 33% were Notices to Hospitals and 27% were For Health Professionals. The remainder (35%) targeted the public, of which the majority were Public Advisories (13%) or Public Communications (12%).

In its 2011 report, the OAG noted that despite plans to do so dating to 2007, Health Canada had not assessed whether its risk communications for medical devices effectively reach their target audiences and do so in a timely manner, and recommended that the Department undertake such an assessment (OAG, 2011, p. 28). In response, Health Canada promised to:

undertake a systematic evaluation of the effectiveness of its risk communications for all product lines, including medical devices. The plan will identify current gaps and challenges with risk communication evaluation and will highlight short-term, medium-term, and long-term activities aimed at systematic evaluation of Health Canada's risk communication tools. This plan will be initiated in the 2011-12 fiscal year with an anticipated completion date of the 2013-14 fiscal year (OAG, 2011, p. 28).

To this end, Health Canada has recently developed and begun implementing a project to evaluate the effectiveness of health product risk communications within HPFB. According to the April 2013 Project Charter, the project will evaluate the effectiveness of Health Canada issued/endorsed Dear Healthcare Professional Letters, Notices to Hospitals, and Public Communications between September 1, 2011, and September 1, 2012 (Health Canada, 2013c). A logic model and one-year Performance Measurement and Evaluation Plan (PMEP) have been developed for the project, and the one-year evaluation is expected to be completed in December 2013.Footnote 30 Medical devices are included within the scope of the project.

Finally, it should be noted that Health Canada very recently (in February 2013) launched the Recalls and Safety Alerts Database, a revised system for disseminating risk communications to health professionals and the public (Health Canada, 2013g). The new database appears to be an improvement over the "advisories, warnings and recalls" listing on MedEffect in several ways, including the availability of an advanced search feature and a new format for risk communications. Even more recently, in mid-March 2013, Health Canada eliminated the online Medical Device Recall Listing.Footnote 31 Whereas information on product recalls was previously available through the Recall Listing as well as through the "advisories, warnings and recalls listing" on MedEffect, this information is now available in one centralized location through the Recalls and Safety Alerts Database.Footnote 32   MHPD indicated that it is currently in the process of reviewing its existing performance targets for the content development of risk communications and for the dissemination of risk communications, which are contained within its guidance document for industry on the issuance of risk communications.Footnote 33  Additionally, MHPD indicated that Health Canada is looking at areas where more focused improvements in risk communications could be made.

Other communication and stakeholder engagement activities

Over the period of the evaluation, the MDP has undertaken a number of other communication and stakeholder engagement activities intended to increase the amount of information available to stakeholders and increase transparency. These activities include the following:

6.0 Findings: achievement of outcomes

This section presents the findings with respect to the evaluation questions on outcomes. While Health Canada has engaged in many activities that should produce the expected outcomes, data to support a definitive conclusion regarding the extent to which expected outcomes have been achieved are relatively limited. For this reason, the evaluation findings pertaining to program outcomes should be considered as a baseline.

6.1 Stakeholder awareness and understanding

In the short term, Health Canada's communication and stakeholder engagement activities are expected to produce increased awareness and understanding by non-industry stakeholders of risks and benefits related to medical devices. The survey of stakeholders was intended to be the main source informing conclusions relating to this outcome. However, due to methodological limitations, the stakeholder survey achieved a very poor response. As a result, beyond qualitative information from key informant interviews and a limited number of survey respondents, there is little evidence to support conclusions on this outcome.

Stakeholder views on Health Canada's consultations

Non-industry key informants and survey respondents had mixed views regarding Health Canada's consultation processes. While many interviewees were satisfied with the available opportunities to provide feedback to Health Canada, some believed that more could or should be done, such as allowing for consumer participation in advisory panels and potentially even the product review process. However, a few cautioned against including "lobbyists" in the consultation process and individuals who lack knowledge of the issues under consideration, since in their view, this may have an adverse effect on consultations. Non-industry key informants were typically unaware of instances where stakeholder feedback had been incorporated into regulatory and policy development and change. The case of SUDs was mentioned as an example in which Health Canada was felt to not have taken stakeholder feedback into account.

Among the small number of respondents to the stakeholder survey, there was no consensus on the adequacy of Health Canada's consultations with health care providers and the general public over the past 10 years, the effectiveness of Health Canada's existing consultation mechanisms as a means for these groups to express their concerns and interests to Health Canada, and the extent to which Health Canada has taken the concerns and interests of health care providers and the general public into account.

Stakeholder views on Health Canada's communications

Similarly, the available evidence from key informants and stakeholder survey respondents is inconclusive with respect to their view of Health Canada's communications. Among the small number of stakeholder survey respondents, almost all consider Health Canada to be their most important source of information about the safety of medical devices, but fewer consider Health Canada to be their most important source of information about the effectiveness of medical devices. Half reported having used at least one of Health Canada's risk communications, and all of these said the information was somewhat or very accessible, understandable, of high quality, and useful. A minority indicated that Health Canada has influenced their understanding of risks associated with medical devices.

For the most part, key informants did not express strong opinions regarding the adequacy of Health Canada's communications to non-industry stakeholders. A number of suggestions for improving communications to non-industry stakeholders were identified, as summarized below.

Key informant suggestions for improving communications to non-industry stakeholders

6.2 Industry awareness and understanding

In the short term, Health Canada's communication and stakeholder engagement activities are expected to produce increased awareness and understanding among industry of the regulatory framework for medical devices. Overall, the evaluation found a reasonably high level of awareness and understanding among industry, although there are areas for improvement.

Industry views on Health Canada's consultations and communications

Although key informants representing the medical devices sector believe that Canada generally consults adequately with industry regarding policy and regulatory changes, results from the industry survey were more mixed. Just under one third (30%) of respondents believe that Health Canada has consulted adequately with the medical devices industry over the past 10 years, while 36% believe that, as a whole, the existing consultation mechanisms are an effective way for the medical devices industry to express its concerns and interests to Health Canada. Furthermore, 34% of industry respondents believe Health Canada has taken the concerns and interests of the medical devices industry into account in policy and regulatory development. Some industry key informants expressed similar views, and a few commented that it sometimes appears as though Health Canada has already established an opinion or chosen a course of action prior to the consultation process.

Industry respondents expressed more positive views of pre-submission meetings. Half agreed that these meetings are an effective mechanism for ensuring that product submissions meet Health Canada's requirements. On the other hand, a minority of industry key informants reported that it takes a long time to complete the pre-submission process, and doubts were expressed about the impact of the process on review times, screening deficiencies, and requests for additional information. Almost one quarter could not rate the effectiveness of the pre-submission meetings.

Only 15% of industry survey respondents believe that the Ombudsman Office is an effective mechanism for dispute resolution regarding submission decisions. However, over half of respondents did not know, possibly because they have not used the Office. In interviews, a few industry key informants reported difficulty in accessing the Ombudsman Office (for example, because of restrictions on when the Office could be used, or because of unclear guidelines).

Fewer than half (45%) of industry survey respondents believe that Health Canada provides industry stakeholders with timely information on whether the medical device submission review process is meeting established service standards. In this context, it is important to note that the MDB reports regularly to MEDEC with respect to its performance. Thus, this survey finding may reflect the views of industry respondents who are not MEDEC members, and/or suggest that MEDEC is not passing information on to its members.

It is important to note that on these questions about consultations and communications, between one fifth and 54% of respondents to the industry survey indicated that they did not know, suggesting that they perceive themselves as being insufficiently familiar with Health Canada's consultations and communications processes to respond. For more information, see Appendix C.

Industry key informants' suggestions to Health Canada for improving communications to and consultations with industry are summarized below. As described in Section 5.2.4, industry has opportunities, as do other stakeholder groups, to communicate and consult with Health Canada through the gazetting process for new and amended regulations and through public consultations on proposed policy and guidance. Industry also has opportunities to consult and communicate with Health Canada through the BMP and pre-submission meetings which are not available to other stakeholders.

Industry suggestions for improving communications and consultations

Industry awareness, understanding, and use of information

As noted above, Health Canada's communications and consultations activities are expected to produce increased awareness among industry of the regulatory framework for medical devices. Two thirds or more of survey respondents rated themselves as having a strong understanding of quality system requirements for medical devices (80%); requirements for mandatory problem reporting for medical devices (69%); and submission requirements for medical device manufacturers applying to have a new Class II, III, or IV medical device approved for sale in Canada (67%). In comparison, industry understanding of Health Canada's regulatory compliance activities appears to be weaker.

The vast majority of industry survey respondents were aware of Health Canada's quality system requirements; submission requirements for Class II, III, and IV devices; mandatory problem reporting requirements; and compliance activities. Majorities also reported having used this information. Fewer were aware of and had used the electronic submission process; this is likely because electronic submission is relatively new and is currently only available for Class III and IV submissions.

Health Canada's information on quality system requirements, submission requirements, and mandatory problem reporting requirements received the highest ratings from users for being accessible, understandable, and useful. Information on compliance activities and the electronic submission process received a lower rating on these dimensions. However, there is room for improvement in all areas: no more than two thirds of users rated these types of information as "very" accessible, understandable, or useful.

Large majorities of survey respondents (between 84% and 89%) believe that Health Canada has clearly outlined time frames for problem reporting; defined what problems must be reported; and identified where reports must be submitted, though slightly fewer (74%) believe the Mandatory Medical Device Problem Reporting Form is clear and understandable. Majorities reported that in the event of a reportable problem, they could provide all of the required information and complete the report in the required time frame.

See Appendix C for more detailed results from the industry survey.

6.3 Safety and effectiveness of medical devices

In the short term, Health Canada's activities are expected to result in increased safety and effectiveness of medical devices on the Canadian market. While there are clearly processes in place that are designed to ensure that devices that are on the Canadian market are safe and effective, there is no concrete evidence of improvements in the safety and effectiveness of medical devices in Canada over the evaluation period.

At the pre-market stage, the information requirements for pre-market reviews are complex and detailed, and risks appear, for the most part, to be effectively managed, although there is a perceived need for increased policy, guidance, and/or regulatory development in relation to combination products. While external key informants generally agreed that Health Canada considers the appropriate type and quality of information in pre-market review, the survey of industry revealed some ambivalence among industry concerning the adequacy of Health Canada's pre-market processes for supporting the safety, effectiveness, and quality of medical devices sold in Canada:

At the post-market stage, Health Canada has introduced the CMDSNet as a means of encouraging voluntary problem reporting by health care professionals and facilities, and has developed a standardized approach to post-market signal detection, assessment, and risk management. Nonetheless, key informants identified opportunities for improvement, including further efforts to increase voluntary reporting by health care providers, increased collaboration among regulatory agencies in collecting and sharing post-market safety data, and increased use of foreign data and reviews at the pre-market stage to enable more resources to be devoted to post-market surveillance. Among industry survey respondents, 64% believe that Health Canada's post-market surveillance and monitoring activities support an adequate level of safety of medical devices in Canada.

In the area of compliance and enforcement, Health Canada has increased its oversight of imported products and implemented a risk-based inspection program for medical device establishments, and has plans to include foreign establishments (which represent approximately one quarter of license holders) in the medical device inspection program beginning in 2013-2014. Concerns were raised about the sale of unlicensed products and insufficient penalties in the event of non-compliance. Just over 60% of industry survey respondents believe that Health Canada's compliance and enforcement activities effectively support an adequate level of medical device safety (62%) and quality (61%). See Appendix C for more information from the industry survey.

Among the small number of respondents to the stakeholder survey, most agreed that they have confidence in the safety and the effectiveness of medical devices on the market in Canada. A minority agreed that access to medical devices is timely and that there is access to a sufficient variety of products.

Finally, it is not necessarily clear that increasing the safety and effectiveness of medical devices falls within Health Canada's mandate as it is currently defined, which, it could be argued, does not extend beyond helping to ensure that products that are approved for sale in Canada are safe and effective.

6.4 Industry compliance

In the short term, Health Canada's activities are expected to lead to increased industry compliance with regulatory requirements relating to medical devices. Overall, the evaluation had difficulty assessing the level of industry compliance with regulatory requirements, since the available information is primarily activity- and output-, rather than outcome-, related.

Nevertheless, the following information gives some indication of industry compliance:

More dated information, covering the period from March 2004 to March 31, 2009, indicates that in this time:

Over the period of the evaluation, Health Canada has not reported regularly or consistently on the nature, seriousness, frequency, or prevalence of non-compliances related to medical devices, and has focused its reporting, instead, on quantifying activities and outputs. Furthermore, Health Canada has not historically reported on the actions it has taken in response to non-compliance. That said, the Inspectorate has recently developed an annual inspection summary report that will be published on the Health Canada website. The 2012-2013 report includes a description of Inspectorate activities and outputs, describes in detail the overall compliance rate of industry, and lists the common observations cited in non-compliant establishments (Health Canada, 2013e).  The report does not contain any information on actions taken by the Inspectorate in response to non-compliance.

6.5 Adoption of safe behaviours

In the intermediate term, MDP activities are expected to lead to adoption of safe behaviours related to the use of medical devices by external stakeholders. The survey of non-industry stakeholders was intended to be the main source of data to support a response to this question. As already noted earlier in this report, the stakeholder survey could not supply the necessary evidence to support conclusions due to a poor response. The following information is available:

It is not possible on the basis of this limited information to draw conclusions on the extent to which this outcome has been achieved.

6.6 Use of scientific evidence and risk-benefit analysis

In the intermediate term, the MDP envisions an increase in the use of scientific evidence and risk-benefit analysis to inform Health Canada decision making. Health Canada has clearly integrated the use of scientific evidence and risk-benefit analysis into its decision-making processes and activities, although the evaluation could not determine whether their use has increased over the period under evaluation.

The use of scientific evidence and risk-benefit analysis is formally integrated into Health Canada's decision-making process. The Health Canada Decision-Making Framework for Identifying, Assessing and Managing Health Risks sets out an approach to decision making in which risk analysis and management activities are central (Health Canada, 2000). The framework is used to guide the MDP decision-making process, although the evaluation could not assess the consistency with which it is applied in practice.

The use of scientific evidence and risk-benefit analysisFootnote 36 (and/or risk-based analysis) is also formally incorporated into Health Canada's pre-market and post-market processes. Some examples are given below (note that this is not intended to be an exhaustive list).

In addition to incorporating scientific evidence and risk-benefit/risk-based analysis into its processes, Health Canada has established a number of Expert and Scientific Advisory Panels (EAPs/SAPs) to provide guidance on regulatory and policy development in various areas, and although it has not implemented all of the recommendations of any advisory group, it has used some of their recommendations to guide policy and regulatory development. Some examples are provided below; see Appendix C for a detailed summary.

Among industry survey respondents, more than half of respondents believe that pre-market reviews of medical device submissions are rigorous (57%); that Health Canada's policies and regulations related to medical devices are based on an appropriate analysis of risk (58%); and that Health Canada's policies and regulations are based on the best available evidence and scientific knowledge (53%). In all three cases, about one quarter were neutral, while about 5% disagreed. See Appendix C for more information.

6.7 Timely regulatory system response to identified risks

A timely regulatory system response to identified risks is expected to result from MDP activities in the intermediate term. Generally speaking, there is insufficient evidence to support a broad conclusion on this outcome.

Stakeholders who participated in this evaluation through interviews and surveys offered mixed opinions on the timeliness of Health Canada's response to risks. Among key informants, some believe that Health Canada does respond to risks in a timely manner, particularly if the perceived risks are high, while others hold the opposite view. From the standpoint of public health, a few interviewees argued that Health Canada should err on the side of caution by releasing information to Canadians as soon as possible. Key informants also observed that it is difficult to be sure if Health Canada is responding in a timely manner, because it is difficult to determine precisely when the Department first knew about the risk.

From an industry standpoint, concerns were expressed by key informants that Health Canada does not always respond in a timely manner to issues that industry had identified and communicated to the government. It was noted that some trade complaints, such as the sale of unlicensed medical devices, could have serious implications for patient health. Industry key informants also reported that it has taken several years for Health Canada to address gaps in its regulatory and policy framework, including issues related to reprocessing of SUDs and the need for clearer guidance related to regulation of combination products.

Among respondents to the industry survey, 46% agreed that over the past 10 years, Health Canada has responded in a timely manner to identified risks related to medical devices; only 3% disagreed, while one fifth were neutral and almost one third did not know. As for non-industry stakeholders, five of eight survey respondents agreed that Health Canada identifies safety risks associated with medical devices in a timely manner, and five believe that Health Canada responds to these safety risks in a timely manner.

For the most part, data were not available to support a more objective analysis of the timeliness of Health Canada's response to risk. It is known that in 2012, MHPD completed 86% (12 of 14) of signal assessments relating to medical devices within the performance target of 130 days, thus nearing its target of 90%. However, a similar analysis could not be undertaken for a wide range of other program activities, such as review of mandatory and voluntary problem reports, response to trade complaints, compliance verifications, HRAs, risk communications, and other post-market actions. It is not clear whether Health Canada has established performance standards for these activities.

While it is important for Health Canada to establish and strive to meet performance standards, comparisons against external criteria or standards may also be informative. In the signal assessment example noted above, the variable examined is the time elapsed between the date the signal was assigned and its approval date. This measure does not reveal the timeliness with which Health Canada identified the safety issue in the first place, or the timeliness with which the Department assigned the signal for assessment. A more telling analysis would include the total time elapsed between Health Canada's initial detection of a safety signal and the eventual outcome or action taken by the Department. Further objectivity of the analysis could be derived by comparing Health Canada's response to safety signals to that of other regulatory agencies.

6.8 International harmonization

In the intermediate term, MDP activities are expected to produce increased international harmonization of regulatory requirements for medical devices. The evaluation found evidence that the MDP has been working toward greater international harmonization and has made progress in some areas, particularly with respect to information-sharing.

Health Canada's TPD defines harmonization as "the development, adoption, and implementation of international technical standards for the development, registration, and control of pharmaceuticals and medical devices," as well as "the convergence of regulatory practices and processes" (TPD, 2004, p. 9). One of Health Canada's main international activities has been the development and implementation of various international agreements with other regulatory agencies, including:

Consistent with overarching government directives, in particular the Cabinet Directive on Regulatory Management, these international agreements are expected to decrease burden on industry and provide for more efficient use of government resources while ensuring safe and accessible medical devices for Canadians. The evaluation could not determine how frequently Health Canada engages in information-sharing or other collaborative efforts under these agreements.

Health Canada has also been a long-standing participant in international standard-setting bodies relating to medical devices. In 1992, Canada helped to found the Global Harmonization Task Force (GHTF) along with Australia, the EU, Japan, and the US. The GHTF is an international effort at harmonizing medical device regulations among the partnering countries. The two overarching goals of the initiative are to improve patient safety and increase access to safe, effective medical devices across the world (GHTF, 2012). The outputs of the initiative include guidance documents on various aspects of medical device regulation, with the idea that member countries can adopt the guidelines and make progress towards harmonization. The GHTF also collaborates with standard-setting bodies such as the International Organization for Standardization (ISO) and the Asian Harmonization Working Party (AHWP) to develop harmonizing standards. Health Canada's participation in the GHTF has included attending regular GHTF Steering Committee meetings and acting as Chair on a rotating basis, as well as chairing two GHTF Study Groups (Pre-Market Evaluation and Quality Systems). Program personnel reported that Health Canada has adopted nine GHTF guidances to date, and is in the process of adopting an additional two.

In 2011, the senior members of the GHTF agreed to take the initiative in a different direction. They acknowledged the accomplishments of the GHTF since its inception in 1992, but noted that widespread and uniform adoption of its regulatory approaches had not occurred among its members. They also pointed out that the membership of the GHTF is no longer reflective of the evolving global medical device market (Kelly, 2011). The members of the GHTF recommended the creation of the International Medical Device Regulators Forum (IMDRF) as a new form of collaboration between regulatory authorities from different countries. The Forum is intended to allow more detailed discussion between regulatory authorities and lead to improved ways to increase harmonization. The Forum would be led by representatives of regulatory agencies, but would also be open to input from industry members, academics, health care professionals, and other stakeholders (Kelly, 2011). The Forum Management Committee comprises members from Australia, Brazil, Canada, China, the EU, Japan, the US, and the World Health Organization (WHO). Forum participants held their inaugural meeting in Singapore in February 2012 (IMDRF, 2012). Health Canada is currently chairing one of the IMDRF working groups.

Generally speaking, key informants believe that while Health Canada has made progress in this area, more could be done to harmonize Canada's pre-market and post-market processes for medical devices with those of other jurisdictions. Stakeholders also noted obstacles to harmonization. For example, standards, guidelines, policies, or regulatory approaches employed in other jurisdictions may not be entirely appropriate in a Canadian context.

Key informants were generally of the view that increased harmonization will improve access to medical devices; furthermore, many believe it will improve the safety of these products. Three reasons were given to support this belief:

6.9 Long-term outcomes

In the long term, MDP activities are expected to contribute to a reduction in health risks and adverse events associated with the use of medical devices, as well as increased public confidence in medical devices and the related regulatory system. MDP activities likely have an impact in these areas, although it is important to realize that many other factors may also influence these outcomes.

MDP activities such as approval of safe medical devices, post-market surveillance and monitoring, and compliance and enforcement should contribute to reduced health risks and adverse events associated with the use of these products. For example, actions such as removing unsafe medical devices from the market through recalls or preventing counterfeit products from entering Canada avert adverse health effects in humans that would have occurred had these actions not been taken.

As for public confidence, the evaluation did not find any public opinion or other research that would provide insight into the degree of public confidence in medical devices and the related regulatory system. Of the eight respondents to the non-industry stakeholder survey, six agreed they have confidence in the safety of medical devices on the market in Canada, while five said they have confidence in the effectiveness of medical devices on the market in Canada. Only two agreed that access to medical devices in Canada is timely and that there is access to a sufficient variety of products.

Ultimately, Health Canada hopes to achieve a sustainable, cost-efficient, responsive, and science-based regulatory system for medical devices in Canada. A lack of information on financial and human resources makes it difficult to draw conclusions regarding the sustainability and cost-efficiency of the system, although submission review performance has been improving in recent years, and several other initiatives are underway that are intended to enhance process efficiencies. As for the responsiveness and scientific basis of the regulatory system, the evidence indicates that Health Canada has formally integrated scientific evidence and risk-based analysis into MDP decision making. There appear to be some concerns about the timeliness of the Program's response to risks and the extent to which it takes stakeholder concerns into account in policy and regulatory development.

Unintended consequences

The evaluation identified relatively few unintended consequences arising from Health Canada's regulatory approach to medical devices. Some concerns were expressed about potential negative economic impacts for industry. For example, industry key informants noted that uncertainty around approval timelines for medical devices, combined with the financial burden associated with cost recovery, may cause manufacturers to delay or avoid submitting new health products for approval in Canada. Ultimately, this may result in reduced access by patients to these products, as well as to an observed "trade deficit" with respect to medical devices (i.e., Canada tends to import more of these devices than it exports). Finally, some industry key informants suggested that Health Canada sometimes does not enforce compliance with licensing requirements, which may place compliant medical device manufacturers at a competitive disadvantage. The evaluation could not determine the extent to which these unintended consequences identified by key informants have, in fact, occurred.

7.0 Findings: efficiency and economy

Overall, the available financial and human resource information is insufficient to support an analysis of efficiency and economy. As a result, the evaluation could not assess the extent to which program resources were used as planned, whether program outputs were produced efficiently, or whether expected outcomes were produced economically.

For fiscal year 2007-2008 and earlier, financial reporting was based on Health Canada's former PAA. Under this PAA, medical device activities fell under the Health Products and Food Program Activity. Program sub-Activities were as follows:

Under this PAA, financial reporting was linked to these four Program sub-Activities and to sub-sub-Activities representing, at a more detailed level, the functional activities carried out by Health Canada personnel as part of the sub-Activities. However, it is not possible to link this information to what, since 2008-09, has been considered the MDP.

In 2007-08, Health Canada's PAA was restructured. Under the new PAA, the relevant Program Activity is Health Products, and the Program sub-Activities are as follows:

Financial reporting was linked to these four Program sub-Activities from 2008-2009 through 2011-2012. However, the available expenditure data did not include overhead, which is not coded at the sub-Program level but only at the Program level (i.e, Health Products). Historically, therefore, the available financial information did not provide an accurate picture of total MDP expenditures. Similarly, limited information was available on MDP budgets. For example, in 2010-2011 and 2011-2012, financial reporting at the Program sub-Activity level did not include budgeted amounts. Instead, budgeted amounts were only reported at the Program level (i.e., Health Products). This, combined with the difficulties in understanding total MDP expenditures, has made it impossible to compare budgeted amounts against actual expenditures for the MDP over time.

Health Canada representatives indicated that HPFB has recently implemented a number of improvements to its approach to financial reporting.

Table 8 presents total MDP expenditures for 2009-2010 to 2011-2012, based on financial information provided by HPFB and RAPB.

Table 8: Total expenditures ($), MDP, 2009-2010 to 2011-2012
Directorate 2009-2010 2010-2011 2011-2012
w/o revenue w/ revenue Revenue w/o revenue w/ revenue Revenue w/o revenue w/ revenue Revenue
Therapeutic Products 10,799,801 6,282,114 4,517,687 10,876,306 6,003,152 4,873,154 12,291,147 4,980,775 7,310,372
Inspectorate 1,251,433 -7,775,597 9,027,030 1,220,700 -11,003,859 12,224,559 2,642,364 -560,576 3,202,940
Marketed Health Products 1,014,737 1,014,737   1,131,106 1,131,106   2,548,700 1,523,592 1,025,108
Other Branch MDP costs 657,139 657,139   479,771 479,771   6,444,793 5,153,793 1,291,000
HPFB Regions 171,835 171,835              
Total MDP - HPFB 13,894,945 350,228 13,544,717 13,707,883 -3,389,830 17,097,713 23,927,004 11,097,584 12,829,420
RAPB 2,529,150     2,951,521     5,975,992 -4,795,997 1,179,995
Total MDP - HPFB and RAPB 16,424,095 350,228 13,544,717 16,659,404 -3,389,830 17,097,713 29,902,996 6,301,587 14,009,415
Notes:
  1. Figures include Employee Benefit Plans (EBP).
  2. Overhead was not coded to sub-activity levels prior to 2011-2012. Therefore, total MDP expenditures do not include overhead in 2009-2010 and 2010-2011.
  3. HPFB Regions includes British Columbia, Alberta, Nunavut, Northwest Territories region, Ontario, Quebec, Atlantic, and Manitoba and Saskatchewan region
  4. Other Branch MDP Costs consists of ADM, Litigation, Office of Consumer and Public Involvement, Policy Planning and International Affairs, HPFB Obligations, HPFB Unallocated Funding.
  5. There is no revenue for 2009-2010 and 2010-2011 for RAPB.Cost recovery revenue was allocated to RAPB starting in 2011-2012.

Source: HPFB and RAPB.

In addition to the limitations, described above, of HPFB's historic approach to reporting on the budgets and expenditures of the MDP, a number of other shortcomings in the data also limit their usefulness for analyzing efficiency and economy. For example, while there is information on the number of FTEs allocated to various HPFB directorates and other entities involved in the MDP, the number of FTEs allocated to various program activities is unknown.Footnote 38

A related challenge, from the point of view of assessing efficiency and economy, is that reporting by functional activities, which took place under the previous PAA, has not taken place since 2008-2009. Some examples of functional activities (also referred to as Functional Areas) include screening, product assessment, new submissions, monitoring and surveillance, and education and outreach. Such task- or activity-based reporting is essential to analyzing efficiency and economy because it reflects the time spent by program staff performing various tasks or activities and producing various outputs. As such, this information is important in assessing:

Within TPD, coding has been updated as of 2012-2013 so that functional activity information will be available in the future. In a recent status report to Treasury Board on the financial management and performance of the Human Drugs and Medical Devices Programs under the new cost recovery regime, Health Canada reported that it has introduced financial management controls, including an improved time tracking system, to help validate costing data (Health Canada, 2013h). In addition, Health Canada reported that it has introduced a variety of other measures to support the efficient delivery of regulatory services, including the following:

In the same report, Health Canada noted that the increased revenue resulting from updated user fees has "allowed activities to be better resourced" and that "cost recovery targets for first decisions met 100% service standards in all program areas"; the same information was also reported in the 2011-2012 DPR.

Based on the analysis completed as part of this evaluation and reported in Section 5.2.1, the timeliness of submission review has been improving for all classes of medical devices since at least 2009-2010, and improvements in performance have continued under the new cost recovery framework. However, these improvements in timeliness do not necessarily mean that submission review is being carried out more efficiently, i.e., it is not necessarily the case that program outputs -- in this case, completed reviews -- are being produced at lower cost. A more detailed costing analysis, such as the analysis completed in 2007 to support the proposal for updated user fees (Health Canada and Spearhead Management Canada Ltd, 2007), which calculated a unit cost for a variety of program activities subject to cost recovery, would shed light on the extent to which efficiencies may have been realized under the new cost recovery regime.

Health Canada is reviewing its costs, fees, and performance associated with the MDP as per its commitment in the User Fee Proposal and the Regulatory Impact Analysis Statement associated with the Fees in Respect of Drugs and Medical Devices Regulations. Preliminary results are expected in 2014.

8.0 Conclusions and recommendations

Relevance

The evaluation found government oversight of medical devices to be both necessary and relevant. In addition to their diagnostic and therapeutic benefits, there are significant risk and safety issues associated with medical devices that warrant an ongoing role for government. The existing environment is also characterized by significant change and uncertainty as novel technologies and products emerge that blur the existing boundaries among medical devices, pharmaceutical drugs, and biologics. These factors speak to the need for government oversight in this area in order to manage potential health and safety risks. Such a role, furthermore, is consistent with federal and Health Canada roles and responsibilities, as described in federal statutes and regulations, and aligns directly with Health Canada's strategic outcome to inform and protect Canadians from health risks associated with food, products, substances, and environments.

MDP activities are also well aligned with federal priorities to strengthen consumer safety. The federal government has devoted substantial resources over the past decade to broader initiatives intended to improve the safety of health products, including medical devices, through modernizing the regulatory framework for these products and, more recently, signalled its commitment to the long-term sustainability of the MDP by including medical devices in recent updates to its cost recovery framework and user fees.

Performance - program implementation

Over the period of the evaluation,Health Canada has made progress in implementing its planned activities and, in the process, has responded to several emergent issues and challenges. However, a number of unresolved issues and challenges remain.

On the pre-market side, in addition to implementing a new cost recovery framework, Health Canada has also undertaken several other initiatives that are intended to increase the efficiency of the submission review process. In particular, it has piloted electronic submissions for Class III and IV medical devices and, more recently, taken steps to increase the use of foreign information in Class III and IV applications. There is broad support among external key informants for measures to expedite the review process, particularly through the use of foreign reviews and data.

Health Canada has recently chosen not to proceed with planned amendments to the investigational testing provisions of the Medical Devices Regulations that would have introduced GCP requirements and an inspection program for investigational testing, concluding that the risks involved did not warrant an increased regulatory burden. Health Canada's position is inconsistent with its main international counterparts in the US and Europe, where GCP requirements for investigational testing are in place.

Prior to implementation of the new cost recovery framework, Health Canada's review performance fluctuated over time for all three classes of device subject to pre-market review, and over the period of the evaluation, the 90% target had usually not been met. Review performance has been improving over the past three years, including under the new cost recovery framework. A more thorough analysis would consider review performance in relation to changing resource levels and trends in submission types and volumes.

Combination products, which combine more than one type of regulated health product (e.g., drug-device combinations, or biologic-device combinations), present a number of challenges for pre-market review. Reported difficulties include inconsistent application of the criterion for classifying products; inappropriate classifications of some products as medical devices, which some internal key informants suggested may result in under-estimating their risks; and difficulties in completing reviews of combination products in a timely fashion. Finally, although fees for drug submissions are substantially higher than for medical devices, submission fees for combination products regulated as devices are paid solely to MDB at rates set for medical devices. Many key informants, both internal and external to Health Canada, emphasized an urgent need for Health Canada to develop and implement policy and guidance relating to the review and licensing of combination products. Although the FDA's general approach to combination products is similar to Health Canada's, unlike Health Canada, the FDA has developed a considerable body of policy and guidance for industry in this area.

Recommendation 1:

Health Canada should review its approach to the review and licensing of combination products.

Like combination products, SUDs have also presented policy and regulatory challenges for Health Canada over the evaluation period. Unlike medical devices that are designed, labelled, and sold for multiple uses, SUDs are produced by manufacturers to be used once and then discarded. Reprocessing of SUDs has become common in Canada and is carried out by hospitals and by third-party reprocessors. In response to concerns about the safety risks associated with reprocessing expressed by the OAG in 2004, Health Canada undertook a review of its authorities to determine its ability to regulate the reprocessing of SUDs, ultimately concluding that it does not have the authority to regulate the use of a device after its sale and therefore does not have the authority to regulate reuse.

It is unclear if this conclusion remains valid for all reprocessing situations, suggesting that a reassessment of Health Canada's role in light of market developments may be warranted in future. Furthermore, Health Canada's long-held stance on the issue is at odds with that of its international counterparts. In the US, where federal and state jurisdictions are similar to Canada, all hospitals and third parties that reprocess SUDs are subject to the same regulatory requirements as original equipment manufacturers. Likewise, the EU has recently proposed similar amendments to the Medical Devices Directive. In Canada, calls for some type of regulation or oversight of reprocessing on the part of Health Canada continue from health care facilities, original equipment manufacturers, and third-party reprocessing firms.

Recommendation 2:

Given the growing re-use of SUDs, Health Canada should review the implications of SUD reprocessing.

On the post-market side, one of Health Canada's main accomplishments has been the implementation of CMDSNet to supplement the existing system of medical device problem reporting. CMDSNet is intended to encourage voluntary problem reporting by health care professionals, among whom reporting has historically been low. The CMDSNet was launched in 2009 and, in its first three years, processed one third of all voluntary problem reports submitted to Health Canada and was an important source of safety signals. Health Canada plans to expand CMDSNet to include more health care institutions.

Health Canada has also implemented a standardized approach to signal detection, assessment, and risk management, which is used across all regulated health products, including medical devices. While Health Canada's post-market surveillance activities for medical devices have improved in recent years, opportunities for improvement include becoming more engaged in current discussions concerning the introduction of a device identification and registration system for medical devices; implementing a public database of medical device problem reports, such as exists in the US; and enhancing collaboration with international regulators to collect and monitor safety information. Other possible changes -- both of which are in place in the US -- include electronic submission of problem reports and introducing regulatory amendments requiring health care institutions to report medical device problems that result in serious illness, injury, or death. Health Canada is currently experimenting with electronic submission of adverse drug reaction reports and, under the FCSAP, planned to introduce mandatory adverse drug reaction reporting for health care institutions, though such legislation has not been implemented to date.

Recommendation 3:

Health Canada should explore additional measures to enhance the post-market surveillance and monitoring of medical devices.

In the area of compliance and enforcement, Health Canada has implemented significant changes to its inspection program for medical devices. Under the new risk-based approach, domestic MDEL holders are inspected on an established cycle and are rated as either compliant or non-compliant according to the risk given to observations noted during inspections. In 2012, in response to recommendations made by the OAG, Health Canada conducted a pilot project to assess the possibility of expanding the inspection program to foreign establishments, and based on the results, plans to include foreign establishments in the medical device inspection program beginning in 2013-2014.

The presence of unlicensed devices on the Canadian market is a concern for industry stakeholders, who are critical of what they perceived as Health Canada's failure to enforce compliance in this area and insufficient penalties in the event of non-compliance. Concerns about the presence of unlicensed medical devices on the Canadian market were also expressed by the OAG in 2004. To date, Health Canada has not analysed the extent of the problem or the health and safety risks it poses.

Recommendation 4:

Health Canada should determine the extent to which unlicensed medical devices are available on the Canadian market, and take steps to discourage this practice and ensure compliance with regulation.

In the area of communications and stakeholder engagement, Health Canada aims to provide Canadians with more information on health products, and to make the regulatory system more open to consumer and other stakeholder input and involvement. Arguably the most important aspect of Health Canada's role in communication and stakeholder engagement is the communication of post-market risk and safety information to health professionals and the public. Since 2005, Health Canada has communicated risk and safety information primarily through the MedEffect website. In February 2013, Health Canada launched a revised system for disseminating risk communications online, which appears to be a substantial improvement over the MedEffect system in several ways, including the availability of an advanced search feature and a new format for risk communications. Health Canada recently initiated an evaluation of its risk communications for health products, including medical devices, following through on long-standing plans to assess their effectiveness.

Performance - outcomes

Over the period of the evaluation, Health Canada has engaged in many activities that should, in theory, contribute to the expected outcomes of the MDP. However, for various reasons, data to support definitive conclusions on outcomes achieved are relatively limited.

Immediate outcomes

In the immediate term, Health Canada's activities are expected to produceincreased awareness and understanding by non-industry stakeholders of risks and benefits related to medical devices. However, based on the limited results from the stakeholder survey, it is not possible to draw conclusions on this question.

The evaluation found a reasonably high level of awareness and understanding among industry of Health Canada's regulatory activities for medical devices, with the exception of its compliance activities and related enforcement actions. Most industry survey respondents were aware of various types of information made available by Health Canada and had also used this information. However, only a minority of respondents believe that Health Canada has consulted adequately with industry; that the existing consultation mechanisms are effective; and that Health Canada takes the concerns of industry into account in regulatory and policy development.

In the short term, Health Canada's activities are also intended to produce increased safety and effectiveness of medical devices. There are clearly processes in place that are designed to ensure that medical devices are safe and effective, but no concrete evidence of improvements in these areas.

Finally, in the short term, Health Canada's activities are expected to lead to increased industry compliance with regulatory requirements. While compliance information is relatively limited, the available data seem to suggest that serious non-compliance is relatively uncommon. Over the period of the evaluation, however, Health Canada has not reported regularly or consistently on the nature, seriousness, frequency, or prevalence of non-compliances related to medical devices, and has focused its reporting, instead, on quantifying activities and outputs. That said, the Inspectorate has recently developed an annual inspection summary report that will be published on the Health Canada website. The 2012-2013 report includes a description of Inspectorate activities and outputs, describes the overall compliance rate of industry, and lists the common observations cited in non-compliant establishments. The report does not contain any information on actions taken by the Inspectorate in response to non-compliance.

Recommendation 5:

Health Canada should continue to build on its current approach to performance reporting to emphasize compliance and enforcement outcomes to a greater extent.

Intermediate outcomes

In the intermediate term, Health Canada activities are expected to lead stakeholders to adopt safe behaviours with respect to the use of medical devices. It is known that some hospitals and health care facilities are engaged in SUD reprocessing in Canada and that unlicensed medical devices are available on the Canadian market and are presumably being used, although the magnitude of the problem and the safety risks involved are unknown.

Health Canada activities are also expected to result in increased use of scientific evidence and risk-benefit analysis to inform decision making related to medical devices. The use of scientific evidence and risk-benefit analysis is formally integrated into Health Canada's Decision-Making Framework for Identifying, Assessing and Managing Health Risks, and also into various pre-market and post-market processes. Health Canada has established a number of Expert and Scientific Advisory Panels to provide guidance on regulatory and policy development, and has implemented some, though not all, of their recommendations.

In the intermediate term, Health Canada also hopes to achieve a timely response to identified risks related to medical devices. For the most part, data were not available to support an objective analysis of this outcome. While in 2012, MHPD neared its target of completing 90% of signal assessments within its performance target, a similar analysis could not be undertaken for a wide range of other program activities. While it is important for Health Canada to establish and strive to meet performance standards, comparisons against external criteria or standards, such as the response of other regulatory agencies to specific risks, may also be informative.

In the intermediate term, Health Canada expects to achieve increased international harmonization of regulatory requirements for medical devices. Health Canada has developed several agreements with other regulatory agencies, including the FDA and Australia's TGA. Health Canada has also been a long-standing active participant in the GHTF, has adopted nine GHTF standards, and is in the process of adopting another two. Health Canada is also a member of the IMDRF, the successor to the GHTF. Key informants were generally of the view that although Health Canada has made progress in this area, more could be done to harmonize Canada's pre-market and post-market processes for medical devices with other jurisdictions.

Long-term outcomes

In the long term, it is likely that Health Canada's activities contribute to reduced health risks and adverse events associated with the use of medical devices. For example, actions such as removing unsafe medical devices from the market through recalls or preventing counterfeit products from entering Canada avert adverse health effects in humans that would have occurred had these actions not been taken. As for increased public confidence in medical devices and the regulatory system, the evaluation found no public opinion research conducted by Health Canada or any other entity that would shed light on this question, thus no conclusions are possible.

Ultimately, Health Canada hopes to achieve a sustainable, cost-efficient, responsive, and science-based regulatory system for medical devices in Canada. Limited information on financial and human resources makes it difficult to draw conclusions regarding the sustainability and cost-efficiency of the system, although submission review performance has been improving in recent years, and several other initiatives are underway that are intended to enhance process efficiencies. With respect to the responsiveness and scientific basis of the regulatory system, while Health Canada has formally integrated scientific evidence and risk-based analysis into decision making, there are some concerns about the timeliness of its response to risks and the extent to which it takes stakeholder concerns into account in policy and regulatory development.

Performance - efficiency and economy

Changes in HPFB's approach to financial reporting over the period of the evaluation made it challenging to consistently match MDP expenditures and budgets, so as to compare and analyze this information over time. HPFB has recently restructured its financial reporting to comply with Treasury Board requirements, which should improve the accuracy of this information and facilitate future analysis.

While activity-based financial reporting has not taken place since 2008-2009, within TPD coding has been updated as of 2012-2013 so that functional activity information will be available in the future.  Activity-based reporting is important to support activity-based costing, which in turn is important to analysing the efficiency with which program activities are carried out. HPFB undertook an activity-based costing exercise in 2007 to support the proposal for updated user fees, and used the results of this analysis to calculate unit costs for a variety of regulatory activities, including submission review. The available data indicate that the timeliness of submission review for all classes of medical devices has been improving since at least 2009-2010, and that improvements in performance have continued under the new cost recovery framework. However, without analysing the unit costs of submission review and other cost-recovered activities, it is unclear if improvements in timeliness also represent improved efficiencies. In addition to enabling an assessment of the extent to which efficiencies may have been realized under the new cost recovery framework, such analysis would also assist the MDP in identifying where future adjustments to the framework may be necessary. For example, such analysis would assist the MDP in determining if adjustments to the framework need to be made to accommodate review of combination products. To this end, HPFB is reviewing its costs, fees, and performance associated with the MDP, as per its commitment in the User Fee Proposal and the Regulatory Impact Analysis Statementassociated with the Fees in Respect of Drugs and Medical Devices Regulations

Appendix A - Evaluation Matrix

Table 1: Evaluation Matrix

EVALUATION OF THE MEDICAL DEVICES PROGRAM (MDP) - EVALUATION MATRIX
Evaluation issues and questions Indicators Data sourcesFootnote 39
SECTION 1: RELEVANCE
Issue #1: Continued need for the program
1. Is there a continued need for the MDP?
  • Need for program identified/documented
 Document review:
  • Official government documents
  • Evidence of current/emerging human health and safety issues related to medical devices
 Literature review
  • Rationale/justification for regulation of medical devices/health products (e.g., welfare economics)
 Literature review
  • Expert/stakeholder assessment of ongoing need
 Key informant interviews (internal and external)
  • Responsiveness of program to needs of Canadians
 Document review

Literature review

Key informant interviews (external)

Survey of industry

Survey of stakeholders
Issue #2: Alignment with government priorities
2. Is the MDP aligned with the priorities of the Government of Canada?
  • Extent to which program objectives are linked to Federal Government priorities
 Document review:
  • recent Speeches from the Throne/Budgets
  • Medical Devices Program (MDP) RMAF
  • Food and Consumer Safety Action Plan (FCSAP) RMAF
  • Therapeutic Product Safety Initiative (TPSI) RMAF
  • Cost Recovery Initiative (CRI)
  • Extent to which program objectives are linked to the strategic outcomes/priorities of Health Canada/HPFB
 Document review:
  • recent Health Canada Reports on Plans and Priorities
  • HPFB Blueprint for Renewal reports and related documents
  • MDB/TPD strategic plans and business transformation progress reports
Issue #3: Alignment with federal roles and responsibilities
3. Is the MDP consistent with federal roles and responsibilities?
  • Extent to which the program objectives are consistent with the legislative framework of the Federal Government
 Document review:
  • federal Acts and Regulations (Department of Health Act, Food and Drugs Act, etc., and relevant regulations, including Medical Devices Regulations)
  • Extent to which the program objectives are consistent with the legislative framework of Health Canada
 Document review:
  • federal Acts and Regulations (Department of Health Act, Food and Drugs Act, etc., and relevant regulations, including Medical Devices Regulations)
  • recent Health Canada Reports on Plans and Priorities
SECTION 2: PERFORMANCE (EFFECTIVENESS, EFFICIENCY, ECONOMY)
Issue #4: Achievement of expected outcomes
4. Is the Program's governance structure likely to support the achievement of expected outcomes?    
a. Is there an established governance structure to coordinate MDP delivery?
  • Extent to which internal and interdepartmental partners' roles, responsibilities, accountabilities, and decision-making authorities are documented and understood
 Document review:
  • descriptions of the organizational structures, mandates, and activities of program partners, as available from:
    • Health Canada website
    • MDP, FCSAP, and TPSI RMAFs
    • health product regulation roles and responsibilities framework documents (2005; 2008)
    • process maps (e.g., MHPD)
    • other internal documents as available

Key informant interviews (internal and external, i.e., other federal departments)
  • Extent of collaboration among internal and interdepartmental partners, as evidenced by:
  • existence of committees, working groups, and teams
  • frequency of meetings of committees, working groups, and teams
 Document review:
  • TPD/MDB, MHPD, HPFBI, and HPFB operational, strategic, and business plans
  • TPD/MDB, MHPD, HPFBI, and HPFB performance reports
  • committee/working group Terms of Reference (as available)
  • meeting agendas/minutes (as available)

Key informant interviews (internal and external, i.e., other federal departments)
  • Nature of industry involvement in MDP governance
 Document review:
  • minutes of meetings/reports of consultations with industry stakeholders (e.g., MEDEC)

Key informant interviews (internal and external)
b. Has a performance measurement framework been designed and implemented?
  • Existence of performance measurement framework(s)
 Document review
  • MDP, FCSAP, and TPSI RMAFs
  • MDP Summative Evaluation Framework
  • Extent to which performance data are collected
 Document review:
  • HPFB performance reports
  • MDP/TPD quarterly, monthly, and annual reports on metrics/performance (2005-2011)
  • HPFBI quarterly reports on performance indicators(medical devices)
  • Health Canada DPRs
  • FCSAP annual reports
  • Formative Evaluation of the Therapeutics Access Strategy

Key informant interviews (internal)
c. Is the performance measurement framework used to support decision-making?
  • Extent to which performance data are used to support decision-making
 Document review:
  • TPD/MDB, MHPD, HPFBI, and HPFB operational, strategic, and business plans
  • MRAPs for relevant evaluations (e.g., Therapeutic Access Strategy)
  • other management planning documents (if available)

Key informant interviews (internal)
5. To what extent has the MDP been implemented as planned?    
a. Has the Program effectively addressed challenges, emerging issues, and changing priorities?
  • Extent to which challenges, emerging issues, and changing priorities have been effectively addressed, e.g.:
  • cost recovery
  • review process for combination devices
  • review process for manufacturing devices
  • product classifications (e.g., medical devices versus consumer products)
  • reprocessing/refurbishing of single use medical devices
 Document review
  • MDB/TPD strategic plans and business transformation progress reports
  • Issue Analysis and Blueprint for Renewal documents
  • Cost Recovery Initiative/related documents
  • communications/consultations with stakeholders (e.g., MEDEC) including reports of such consultations
  • policies, regulations, and guidelines implemented to address challenges, emerging issues, and changing priorities

Key informant interviews (internal and external)

Case studies
b. Have activities been implemented as planned?
  • Extent to which MDP activities have been implemented as planned
 Document review:

For planned implementation:

  • Official government documents
  • TPD/MDB, HPFBI, and HPFB operational and strategic plans
  • HPFBI Inspection Strategy for Medical Devices
  • MDP RMAF
  • FCSAP RMAF
  • TPSI RMAF

For actual implementation:

  • HPFB performance reports
  • MDB quarterly, monthly, and annual reports on metrics and performance
  • HPFBI quarterly reports on MDP
  • TPD annual reports and business transformation reports
  • Health Canada DPRs
  • actual spending data
c. Have the activities produced the expected outputs?
  • Enumeration of outputs (policies, guidelines, regulations, research, MOUs, etc.) produced for each activity
 Document review:

For expected outputs:

  • Official government documents
  • TPD/MDB, HPFBI, and HPFB operational and strategic plans
  • HPFBI Inspection Strategy for Medical Devices
  • MDP RMAF
  • FCSAP RMAF
  • TPSI RMAF

For actual outputs:

  • HPFB performance reports
  • MDB quarterly, monthly, and annual reports on metrics and performance
  • HPFBI quarterly reports on MDP
  • TPD annual reports and business transformation reports
  • Health Canada DPRs
  • actual spending data
  • policies, guidelines, regulations, research, MOUs, etc.
d. Have requirements/ commitments to Central Agencies (i.e., Office of the Auditor General, Cabinet Directive on Streamlining Regulations, Policy on Public Consultation, Policy on Gender- Based Analysis) been addressed?
  • Extent to which requirements and commitments to Central Agencies have been addressed
 Document review (to extent relevant documents may be available)

Key informant interviews (internal and external)
6. To what extent has progress towards expected outcomes been achieved?    
Immediate outcomes
a. To what extent is there increased awareness and understanding among external stakeholders of risks and benefits related to medical devices?
  • Extent and nature of Health Canada communications to/consultations with external stakeholders regarding risks and benefits of medical devices, including:
  • industry, health care professionals, health care facilities, consumer associations, patient groups
 Document review:
  • Health Canada communications, meetings, and consultations with external stakeholders regarding risks and benefits of medical devices

Case studies
Indicators related to TPSI Immediate Outcome #3:
  • Percentage change in the number of public consultations through the use of technology
  • Percentage change in the number of public regulatory consultations
  • Number of consultative committees
 Document review (if available)
  • External stakeholder perceptions of their understanding of the information made available by Health Canada
 Key informant interviews/ consultations (external)

Survey of stakeholders
  • External stakeholder perceptions of their level of awareness and understanding of risks and benefits related to medical devices
 Key informant interviews/consultations (external)

Survey of stakeholders
Indicators related to FCSAP Strategy #6:
  • Number and proportion of product monographs and a subset of summary basis of decisions (SBDs) made available to the public
  • Proportion of post-market issues where a public communication piece is released
  • Number of recommendations, products, and services that increase the accessibility and usability of product safety information
  • Number and type of information posted on the website - specify number and type of targeted group
  • Proportion of target population aware
 Document/administrative data review (if available)

Survey of stakeholders

Key informant interviews/consultations (external)
Indicator related to FCSAP Strategy #10:
  • Proportion of consumers aware of the risks associated with diverted, counterfeit, and unlicensed health products
 Document/administrative data review (if available)
b. To what extent is there increased awareness and understanding among industry of Health Canada's regulatory framework for medical devices?
  • Extent and nature of Health Canada communications to/consultations with industry regarding the regulatory framework for medical devices
 Document review:
  • Health Canada communications, meetings, and consultations with industry stakeholders regarding the regulatory framework for medical devices
  • Industry perceptions of its level of awareness and understanding of Health Canada's regulatory framework for medical devices
 Key informant interviews/consultations (external)

Survey of industry

Case studies
c. To what extent is there increased safety and effectiveness of medical devices?
  • Description of approach to/process for review of medical device applications (Class II, III, and IV, combination devices, manufacturing devices), including extent to which process is risk-based
 Document review

Key informant interviews (internal)

Case studies
TPSI indicators (output-related):
  • Description of approach to/process for review of Investigational Testing applications, including:
  • review capacity
  • establishment of an IT Unit in the MDB
  • interactions with internal/external reviewers/sponsors
  • number of new/amended investigational testing applications received, reviewed, and authorized/refused according to service standards
  • number of pre-investigational testing application meetings
  • Expanded and enhanced capacity for the assessment of IT incident reports:
  • expanded and enhanced review capacity
  • number of IT incident reports reviewed and safety signals assessed
  • number of IT incident reports and safety signals assessed since Program changes made to increase capacity
 Document review (if available)

Key informant interviews (internal)
Indicator related to FCSAP Strategy #5:
  • Trends in proportion of medical device applications processed within service standards and targets (Class II, III, IV, and by medical device type)
 Document/administrative data review:
  • MDB quarterly, monthly, and annual reports on metrics and performance
  • Trends in proportion of medical device applications with screening deficiencies and requests for additional information
 Document/administrative data review:
  • MDB quarterly, monthly, and annual reports on metrics and performance
  • Trends in first decisions for Class III and IV applications by outcome (licence, additional information request, refusal, rejection)
 Document/administrative data review:
  • MDB quarterly, monthly, and annual reports on metrics and performance
  • Extent and nature of signal detection and safety assessment activities related to medical devices
 Document review, especially MHPD documents, e.g.:
  • MHPD work instructions and Standard Operating Procedures for signal detection and assessment
  • documents related to the Canadian Medical Devices Sentinel Network

Key informant interviews (internal)
  • External and internal stakeholder perceptions of safety and effectiveness of medical devices, including perceptions of adequacy of processes in place to ensure safety and effectiveness
 Document review, e.g.:
  • Proceedings of Standing Committee on Health

Key informant interviews/consultations (internal and external)

Survey of industry

Survey of stakeholders

Case studies
d. To what extent is there increased industry compliance with Health Canada's regulatory requirements related to medical devices?
  • (Pre-market compliance) Trends in proportion of medical device applications with screening deficiencies and requests for additional information
 Document/administrative data review:
  • MDB quarterly, monthly, and annual reports on metrics and performance
  • (Pre-market compliance) Trends in first decisions for Class III and IV applications by outcome (licence, additional information request, refusal, rejection)
 Document/administrative data review:
  • MDB quarterly, monthly, and annual reports on metrics and performance
TPSI indicators (output-related):
  • (Post-market compliance) Implementation of four-year inspection cycle for medical device establishments
  • Number of Medical Device Establishment inspections carried out
 Document review

Key informant interviews (internal)
  • (Post-market compliance) Trends in number and type of non-compliances related to medical devices, including:
  • removal of unlicensed medical devices from the marketplace (TPSI indicator)
  • number of regulatory compliance actions (TPSI indicator)
 Document/administrative data review:
  • HPFBI quarterly performance reports on MDP
  • Summary of the Results of the Medical Devices Inspection Program 2004-2009
  • (Post-market compliance) Trends in number and outcomes of compliance verifications, including:
  • proportion of open incidents that have been resolved (TPSI indicator)
  • percentage change in number of recalls issued (TPSI indicator)
 Document/administrative data review:
  • HPFBI quarterly performance reports on MDP
  • (Post-market compliance) Trends in number of voluntary recalls by industry
 Document/administrative data review:
  • HPFBI quarterly performance reports on MDP
  • (Post-market compliance) Trends in number of mandatory problem reports related to medical devices
 Document/administrative data review:
  • MHPD/HPFBI data
  • (Post-market compliance) Trends in number of compliance and enforcement actions
 Document /administrative data review:
  • HPFBI data (if available)
TPSI indicator:
  • Percentage of laboratory analyses resulting in a non-compliance status(i.e., unsatisfactory or investigative status)
 Document/administrative data review
  • Industry self-report data related to compliance and enforcement
 Document review

Survey of stakeholders (industry)

Key informant interviews/consultations (external - industry representatives)

Case studies
  • Adequacy of information technology tools to support compliance tracking
 Document review

Key informant interviews (internal)
  • Adequacy of training related to medical devices delivered to HPFBI and RAPB staff
 Document review

Key informant interviews (internal)
Indicators related to FCSAP Strategy #10:
  • Number of import alerts resulting in detecting/stopping non-compliant products at the border
  • Number of compliance and enforcement actions taken at border
  • Number of promotion and education products distributed
  • Number of training programs and sessions developed and delivered to CBSA staff
 Document/administrative data review:
  • HPFBI documents/data (if available)
Indicators related to FCSAP Strategy #11:
  • Number of regulated parties
  • Number of inspections
  • Proportion of regulated parties where compliance was monitored
  • Proportion of regulated parties in compliance with laws and regulations
  • Monetary penalties assessed
  • Proportion of regulatory/enforcement actions addressed within service standards/targets
  • Number of new tools and proportion of safety incidents in which new tools were used
 Document/administrative data review:
  • HPFBI documents/data (if available)
Intermediate outcomes
e. To what extent do external stakeholders adopt safe behaviours associated with medical devices?
  • Extent and nature of Health Canada risk communications to consumers and practitioners regarding medical devices
 Document review, e.g.:
  • MedEffect postings, Product Safety Updates, Canadian Adverse Reaction Newsletter, It's Your Health, Notices to Hospitals, OCAPI consultations, etc.
TPSI indicator:
  • Number of educational materials published to bring about awareness of health safety issues
 Document review (if available)
  • Extent to which external stakeholders report using Health Canada risk communications, advisories, and publications for decision-making
 Key informant interviews/consultations (external, especially health care practitioners/facilities, patient/consumer groups, etc.)

Survey of stakeholders (especially health care practitioners/facilities, patient/consumer groups, etc.)

Case studies
Indicator related to FCSAP Strategy #6:
  • Trend data on improper or unsafe use of medical devices , including number and characteristics (type, severity, age, gender, etc.) of reported incidents
 Document review:
  • medical device industry data/reports (if available)

Key informant interviews/consultations (external, especially health care practitioners/facilities; patient/consumer groups, etc.)

Survey of stakeholders (especially health care practitioners/facilities; patient/consumer groups, etc.)

Case studies
  • Trends in number of mandatory problem reports related to medical devices by industry
 Document/administrative data review:
  • MHPD/HPFBI data
f. To what extent is there increased use of scientific evidence and risk-benefit analysis by Health Canada to inform decision-making?
  • Description of Health Canada's approach to decision-making, including extent to which approach is risk-based
 Document review

Key informant interviews (internal)
  • Extent to which recommendations of expert/scientific advisory groups are used to inform and develop policy/regulatory responses
 Document review:
  • Terms of Reference, meeting minutes, and reports/recommendations of expert/scientific advisory groups
  • policies, guidelines, regulations
  • Extent to which regulatory changes include Regulatory Impact Analysis Statements (RIAS)
 Document review:
  • RIAS in Canada Gazette
  • Comprehensiveness/adequacy of data used in pre-market review (Class II, III, IV)
 Document review (if available)

Key informant interviews (internal)
  • Use of international post-market data to inform pre-market review (Class II, III, IV)
 Document review (if available)

Key informant interviews (internal)
TPSI indicators:
  • Number of international and domestic information sources and partnerships identified
  • Number of domestic and international health problems from use of therapeutic products
  • Number of IT adverse incident reports reviewed and safety signals assessed
  • Percentage change in the number of adverse incident reports received, reviewed, and assessed
  • Percentage change in the number of adverse events analysed
  • Number of high profile/litigious issues
 Document review, e.g.:
  • MHPD/HPFBI data

Key informant interviews (internal)
  • Extent to which Health Risk Assessments (HRAs) and recommendations are developed in response to non-compliance
 Document review, e.g.:
  • HRAs

Key informant interviews (internal)
  • Evidence that information gathered through post-market monitoring/surveillance is used to inform decision-making
 Document review (if available)

Key informant interviews (internal)
  • Stakeholders' perceptions of extent to which use of scientific evidence and risk-based analysis to inform decision-making has increased
 Key informant interviews/consultations (external and internal)

Survey of industry

Survey of stakeholders

Case studies
g. To what extent is there a timely regulatory system response to identified risks?
  • Description of regulatory process
 Document review

Key informant interviews (internal)
  • Elapsed time between initial identification of risk and policy/regulatory response
 Document review (if information available)
TPSI indicators:
  • Percentage change in number of adverse incidents responded to in a timely fashion
  • Timeliness of adverse event analysis
 Document review

Key informant interviews (internal)
  • Trends in number and closure rate of medical device incidents
 Document/administrative data review:
  • HPFBI quarterly performance reports on MDP
  • Internal and external stakeholder perceptions of timeliness of Health Canada's response to identified risks associated with medical devices
 Key informant interviews/consultations (external and internal)

Survey of industry

Survey of stakeholders

Case studies
h. To what extent is Canada's regulatory framework for medical devices harmonized with international approaches?
  • Extent to which main features of Canada's regulatory framework for medical devices is harmonized with that of other jurisdictions
 Literature review:
  • comparison of main features of Canada's regulatory framework with that of selected other jurisdictions (EU, US, Australia, UK)

Key informant interviews (internal and external)

Case studies
  • Description of program's decision-making process regarding harmonization (especially factors considered in decision whether to harmonize)
 Key informant interviews (internal)
  • Extent to which Health Canada is recognized as a responsible medical device regulator and scientific expert (nationally and internationally)
 Document review

Literature review

Key informant interviews (external)
TPSI indicator:
  • Percentage change in the number of requests for implementation of a similar safety system internationally
 Document review

Key informant interviews
i. To what extent is there reduced exposure to identified risks associated with the use of medical devices?
  • Number and nature of risk communications issued by Health Canada due to identified risks
 Document review:
  • Health Canada risk communications
  • Trends in post-market enforcement actions due to identified risks for authorized and unauthorized medical devices
 Document/administrative data review:
  • HPFBI data
  • Trends in ratio of number of serious problem reports to total number of problem reports
 Document/administrative data review
  • Expert assessment of changes in exposure to health risks related to medical devices
 Key informant interviews (internal and external)

Literature review
Long-term outcomes
j. To what extent have adverse events associated with the use of medical devices been reduced? TPSI indicators:
  • Percentage change in the number of adverse event reports related to safety and effectiveness of licensed medical devices
  • Removal of unlicensed medical devices from the market place
 Document/administrative data review

Key informant interviews (internal)
  • Trends in medical device-related illnesses and adverse events
 Document/administrative data review (if available)

Literature review
Indicators related to all FCSAP Strategies:
  • Rate of morbidity/mortality related to health products (i.e., medical devices)
  • Number of incidents of safety issues related to health products (i.e., medical devices)
 Document/administrative data review (if available)
k. To what extent is there increased public confidence in medical devices and the related regulatory system?
  • Level of public confidence in safety of medical devices and the related regulatory system
 Document review:
  • Health Canada public opinion research (if available)
  • Health Canada DPRs

Key informant interviews (external)
TPSI indicators:
  • Percentage change in the number of reviews (positive/negative) by media outlets
  • Percentage change in the number of positive feedback from public surveys/interviews
 Document review
l. To what extent is there a sustainable, cost-efficient, responsive, and science-based regulatory system for medical devices in Canada?
  • Cumulative evidence from all outcome indicators
 All data sources
7. Were there any unintended consequences, either positive or negative, of the program?
  • Unintended consequences identified by internal and external stakeholders
 Key informant interviews/consultations(internal and external)

Survey of industry

Survey of stakeholders

Case studies
Issue #5: Efficiency and Economy
8. Were Program resources used as planned?What accounted for overruns or lower- than-planned expenditures?
  • Comparison of planned versus actual spending for components of MDP and explanations for variances
 Administrative data review, e.g.:
  • planned versus actual spending, SAP data, financial derivation reports, management variance reports (if available)

Key informant interviews (internal)
9. Are there lower-cost approaches to producing Program outputs?
  • Extent to which existing resources could be used to produce outputs at lower cost
  • Availability/accessibility of other, lower cost resources to produce outputs
 Key informant interviews (internal)

Document review
10. Are there alternate ways to achieve similar results at lower cost?
  • Approaches used in other jurisdictions and their costs
  • Internal and external stakeholder assessment of other options
 Literature review

Key informant interviews/consultations (internal and external)

Case studies

Appendix B - List of References

Brown, N. (2012). Patient-oriented Research in the Era of Personalized Medicine. CTS: Clinical and Translational Science, 5(2).

CADTH. (2008a). Reprocessing of single use medical devices: Clinical, economic, and health services impacts.

CADTH. (2008b). Reprocessing of single use medical devices: National survey of Canadian acute-care hospitals.

CADTH. (2011). Reprocessing of Single-Use Medical Devices: A 2011 Update. Retrieved March 19, 2013, from http://www.cadth.ca/media/pdf/SUMD_es-28_e.pdf

European Commission. (2012a). Impact Assessment on the Revision of the Regulatory Framework for Medical Device: Proposals for a Regulation of the European Parliament and of the Council on Medical Devices, and Amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and on in Vitro Diagnostic Medical Device. Retrieved March 15, 2013, from http://ec.europa.eu/health/medical-devices/files/revision_docs/revision_ia_part2_annex1_en.pdf

European Commission. (2012b). Proposal for a Regulation of the European Parliament and of the Council on Medical Devices, and Amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009. Retrieved March 15, 2013, from http://ec.europa.eu/health/medical-devices/files/revision_docs/proposal_2012_542_en.pdf

FDA. (2000). Reprocessing of Single-Use Devices > Letter: Reprocessing of Single Use Devices. Retrieved March 19, 2013, from http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/ReprocessingofSingle-UseDevices/ucm121971.htm

FDA. (2012a). MedSun: Medical Product Safety Network. Retrieved March 13, 2013, from http://www.fda.gov/MedicalDevices/Safety/MedSunMedicalProductSafetyNetwork/default.htm

FDA. (2012b). Strengthening our national system for medical device postmarket surveillance. Retrieved March 19, 2013, from http://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHReports/UCM301924.pdf)

FDA. (2013). Combination Products Guidance Documents. Retrieved August 21, 2013, from http://www.fda.gov/RegulatoryInformation/Guidances/ucm122047.htm

FPT working group. (2008, February 5). Pan-Canadian framework statement (appendix 1).

GAO. (2008a). GAO-08-147 Highlights, REPROCESSED SINGLE-USE MEDICAL DEVICES: FDA Oversight Has Increased, and Available Information Does Not Indicate That Use Presents an Elevated Health Risk -. Retrieved March 19, 2013, from http://www.gao.gov/assets/280/271676.pdf

GAO. (2008b). Medical Devices: FDA Faces Challenges in Conducting Inspections of Foreign Manufacturing Establishments (No. GAO-08-780T). Retrieved from http://www.gao.gov/products/GAO-08-780T

GHTF. (2012, April 12). GHTF: Global Harmonization Task Force. Retrieved April 12, 2012, from http://www.ghtf.org/

GoC. (2008). Bill C-51: an Act to Amend the Food and Drugs Act and to Make Consequential Amendments to Other Acts.

GoC. (2011a). Department of Health Act (S.C. 1996, c. 8).

GoC. (2011b). Fees in Respect of Drugs and Medical Devices Regulations. Canada Gazette Part II, 145(8). Retrieved from http://www.gazette.gc.ca/rp-pr/p2/2011/2011-04-13/html/sor-dors79-eng.html

GoC. (2011c). Food and Drugs Act (R.S.C., 1985, c. F-27).

GoC. (2011d). Medical Devices Regulations (Consolidation) SOR-98-282. Retrieved April 20, 2012, from http://laws-lois.justice.gc.ca/PDF/SOR-98-282.pdf

GoC. (2011e). User Fees Act (S.C. 2004, c. 6).

GoC. (2012). Cabinet Directive on Regulatory Management. Retrieved September 4, 2013, from http://www.tbs-sct.gc.ca/rtrap-parfa/cdrm-dcgr/cdrm-dcgrtb-eng.asp

Goodman, G. R. (2002). Medical device error. Critical Care Nursing Clinics of North America, 14(4), 407-416.

Health Canada. (2000). Health Canada decision-making framework for identifying, assessing, and managing health risks.

Health Canada. (2004). Memorandum of Understanding between The Health Products and Food Branch of the Department of Health Canada and The Therapeutic Goods Administration of the Department of Health and Ageing of Australia on the Subject of Quality Management System Certification for Medical Devices. Retrieved July 24, 2012, from http://www.hc-sc.gc.ca/ahc-asc/alt_formats/hpb-dgps/pdf/intactiv/austral-cert-eng.pdf

Health Canada. (2005a). Drug/Medical Device Combination Products. Retrieved April 20, 2012, from http://www.hc-sc.gc.ca/dhp-mps/alt_formats/hpfb-dgpsa/pdf/prodpharma/combo_mixte_pol_2006-eng.pdf

Health Canada. (2005b). SAP-RMD panel recommendations.

Health Canada. (2006a). Guidance Document: Recognition and Use of Standards under the Medical Devices Regulations. Retrieved September 25, 2013, from http://www.hc-sc.gc.ca/dhp-mps/md-im/applic-demande/guide-ld/md_gd_standards_im_ld_normes-eng.php

Health Canada. (2006b). Results-based Management and Accountability Framework - Therapeutic Products Safety Initiative submission.

Health Canada. (2007). Discussion Paper for Consultation: Proposed Changes to the Regulatory Framework for Investigational Testing of Medical Devices. Retrieved March 19, 2013, from http://www.hc-sc.gc.ca/dhp-mps/md-im/activit/consultation/pcitmd_cpreeim-eng.php

Health Canada. (2008a). Cost Recovery Initiative: Forecasting volumes for medical devices and pharmaceuticals.

Health Canada. (2008b). Food And Consumer Safety Action Plan (FCSAP): Results-based Management and Accountability Framework (RMAF).

Health Canada. (2008c). Guidance document: Description of current risk communication documents for marketed health products for human use.

Health Canada. (2009a). Medical Devices Program (MDP) Results-based Management and Accountability Framework (RMAF) version 3.

Health Canada. (2009b). Memorandum of understanding between the Food and Drug Administration, Department of Health and Human Services of the United States of America and the Health Products and Food Branch, Health Canada, of Canada regarding sharing and exchange of information about therapeutic products. Retrieved May 28, 2012, from http://www.hc-sc.gc.ca/ahc-asc/intactiv/agree-accord/us-eu-sharing-diffusion-eng.php

Health Canada. (2010a). Cost recovery initiative: Outputs, program activities, inputs and outcomes for the human drugs and medical devices programs (version 1) [chart].

Health Canada. (2010b). Guidance Document for Industry: Issuance of Health Professional Communications and Public Communications by Market Authorization Holders. Retrieved October 21, 2013, from http://www.hc-sc.gc.ca/dhp-mps/pubs/medeff/_guide/2010-guid-dir_indust_hppc-cpsp/index-eng.php

Health Canada. (2010c). Regulatory modernization: reshaping Canada's health and safety systems for food, health and consumer products. Health Policy Research Bulletins, 16. Retrieved from http://publications.gc.ca/collections/collection_2010/sc-hc/H12-36-16-2010-eng.pdf

Health Canada. (2011a). Guide to Recall of Medical Devices (GUI-0054). Retrieved March 20, 2013, from http://www.hc-sc.gc.ca/dhp-mps/compli-conform/prob-report-rapport/gui-0054_recall-retrait-doc-eng.php

Health Canada. (2011b). Health Canada Report on Plans and Priorities (RPP): 2011-2012 estimates.

Health Canada. (2012a). Performance Measurement and Evaluation Plan (PMEP): EERC One-Year Study.

Health Canada. (2012b, May 7). Memorandum of Understanding between the Health Products and Food Branch - Health Canada - of Canada and the Therapeutic Goods Administration Department of Health and Ageing of Australia regarding Therapeutic Products. Retrieved May 7, 2012, from http://www.hc-sc.gc.ca/ahc-asc/intactiv/agree-accord/austral-therap-eng.php

Health Canada. (2013a). Data for MDB Volumes Comment to PRA (Updated Jan 24-2013).

Health Canada. (2013b). E-Communications: Interim Web Publishing Criteria and Process, Health Canada and Public Health Agency of Canada websites.

Health Canada. (2013c). Evaluating the Effectiveness of (Health Product) Risk Communications (EERC) in the Health Products and Food Branch: Project Charter.

Health Canada. (2013d). Final Report: Medical Device Foreign Establishment Assessment Pilot.

Health Canada. (2013e). Inspectorate Program Inspection Annual Report 2012-2013.

Health Canada. (2013f). July 2013 Integrated Dashboard.

Health Canada. (2013g). Recalls and alerts. Retrieved March 20, 2013, from http://www.healthycanadians.gc.ca/recall-alert-rappel-avis/index-eng.php

Health Canada. (2013h). Status Report on the Financial Management and Performance of the Human Drugs and Medical Devices Programs.

Health Canada and Spearhead Management Canada Ltd. (2007). Costing Model Final Deliverable.

Hoppe, B. S., Laser, B., Kowalski, A. V., Fontenla, S. C., Pena-Greenberg, E., Yorke, E. D., … Rosenzweig, K. E. (2008). Acute skin toxicity following stereotactic body radiation therapy for stage 1 non-small-cell lung cancer: Who's at risk? International Journal of Radiation Oncology, 72(5), 1283-1286. doi:10.1016/j.ijrobp.2008.08.036

HPFB. (2006). Access to therapeutic products: The regulatory process in Canada.

HPFB. (2007a). Blueprint for Renewal II: Modernizing Canada's regulatory system for health products and food.

HPFB. (2007b). Medical Devices Program strategic plan 2007-2012: Building for the future.

HPFB. (2011a). Cost recovery: project summary.

HPFB. (2011b). Draft guidance document: The use of foreign reviews by Health Canada. Retrieved from http://www.hc-sc.gc.ca/dhp-mps/alt_formats/pdf/consultation/drug-medic/draft_foreign_rev_ebauche_exam_etra-eng.pdf

HPFB. (2012a). HPFB Mid-Year Review Report 2012-2013.

HPFB. (2012b). Medical Devices Program: 2012-2013 Mid-Year Review.

HPFB. (2012c). Regulatory roadmap for health products and food.

IMDRF. (2012). Outcome statement of the IMDRF management committee. Retrieved May 30, 2012, from http://www.imdrf.org/pdf/imdrf-meeting-120228.pdf

Inspectorate. (2006a). Health Products and Food Branch Inspectorate - Operational planning project - A3.1 medical devices inspection - 2006-2007.

Inspectorate. (2006b). Recall policy (Policy-0016).

Inspectorate. (2007). Health Products and Food Branch Inspectorate - Operational planning project - A3.1 medical devices inspection - 2007-2008 (post gap).

Inspectorate. (2008). Health Products and Food Branch Inspectorate - Operational planning project - A3.1 medical devices inspection - 2008-2009.

Inspectorate. (2009a). Compliance and Enforcement Policy (POL-0001).

Inspectorate. (2009b). Health Products and Food Branch Inspectorate - Operational planning project - A3.1 medical devices inspection - 2009-2010.

Inspectorate. (2010a). Border Integrity Approach (POL-0059). Retrieved March 20, 2013, from http://www.hc-sc.gc.ca/dhp-mps/alt_formats/pdf/compli-conform/import-export/pol_0059_BI_approach-eng.pdf

Inspectorate. (2010b). Guidance: Medical device inspection program (GUI-0064).

Inspectorate. (2010c). Guidance: Risk classification of medical device observations (GUI-0079).

Inspectorate. (2010d). Policy on Counterfeit Health Products (POL-0048). Retrieved March 20, 2013, from http://www.hc-sc.gc.ca/dhp-mps/compli-conform/activit/pol_0048_counterfeit-contrefacon-eng.php

Inspectorate. (2010e). Regional Border Integrity Unit - Report FY 2009/10 (spreadsheet).

Inspectorate. (2010f). Summary of the Results of the Medical Devices Inspections Program (2004-2009).

Inspectorate. (2011a). Director General's Office - Health Products and Food Branch Inspectorate - Health Canada. Retrieved March 20, 2012, from http://www.hc-sc.gc.ca/ahc-asc/branch-dirgen/hpfb-dgpsa/hpfi-ipsa/dgo-bdg-eng.php

Inspectorate. (2011b). Guidance: Recall of medical devices (GUI-0054).

Inspectorate. (2011c). Guidance: User problem reporting for medical devices (GUI-0060).

Inspectorate. (2011d). Health Products and Food Branch Inspectorate - Medical devices program - performance indicators (Q4 - April 2010 to March 2011).

Inspectorate. (2011e). Inspection Strategy for Medical Device Companies. Retrieved May 11, 2012, from http://www.hc-sc.gc.ca/dhp-mps/alt_formats/pdf/compli-conform/info-prod/md-im/pol-0035_insp_strat_doc-eng.pdf

Inspectorate. (2011f). Procedure - The release to the public of information obtained from adverse reaction and medical device incident reports. Retrieved May 7, 2012, from http://www.hc-sc.gc.ca/dhp-mps/alt_formats/pdf/pubs/medeff/guide/2011-procedure/_2011-procedure-eng.pdf

Inspectorate. (2011g). Regional Border Integrity Unit - Report FY 2010/11 (spreadsheet).

Inspectorate. (2012a). Compliance and Enforcement Risk Evaluation Guide:  An approach to decision-making (GUI-0091).

Inspectorate. (2012b). Guidance on the Medical Device Inspection Program GUI-0064. Retrieved March 19, 2013, from http://www.hc-sc.gc.ca/dhp-mps/alt_formats/pdf/compli-conform/info-prod/md-im/md_insp_prog-prog_insp_mm-eng.pdf

Inspectorate. (2012c). Health Products and Food Branch Inspectorate - Medical devices program - performance indicators (Q4 - April 2011 to March 2012).

Inspectorate. (2012d). Regional Border Integrity Unit - Report FY 2011/12 (spreadsheet).

Israelski, E. W., & Muto, W. H. (2004). Human factors risk management as a way to improve medical device safety: a case study of the therac 25 radiation therapy system. Joint Commission Journal on Quality and Patient Safety, 30(12), 689-695.

Kelly. (2011). Statement from the GHTF chair. Retrieved from http://www.ghtf.org/documents/statement-future-2011.pdf

MedEffect. (2010). MedEffect Canada: Canadian Medical Devices Sentinel Network pilot project. Retrieved April 26, 2012, from http://www.hc-sc.gc.ca/dhp-mps/medeff/cmdsnet-resscmm-eng.php

MedEffect. (2011). MedEffect Canada Initiative - The public interface to post-market surveillance programs and information. Retrieved May 1, 2012, from http://www.hc-sc.gc.ca/dhp-mps/alt_formats/pdf/pubs/medeff/fs-if/2011-medeff-canada/2011-medeff-canada-eng.pdf

MHPD. (2007). About MedEffect Canada. Retrieved April 16, 2012, from http://www.hc-sc.gc.ca/dhp-mps/medeff/about-sujet-eng.php

MHPD. (2008). MHPD adverse reaction / adverse event process (process maps).

MHPD. (2011). Marketed Health Products Directorate - Health Products and Food Branch - Health Canada. Retrieved March 20, 2012, from http://www.hc-sc.gc.ca/ahc-asc/branch-dirgen/hpfb-dgpsa/mhpd-dpsc/index-eng.php

MHPD. (2012a). Standard Operating Procedure: Prioritization and management of potential signal files in MHPD.

MHPD. (2012b). Standard Operating Procedure: Signal assessment.

MHPD. (2013). Activity signal tracking sheet (updated February 2013).

OAG. (2004, March). Report of the Auditor General of Canada: Chapter 2 - Health Canada - Regulation of medical devices.

OAG. (2006). Report of the Auditor General of Canada: Chapter 8 - Allocating funds to regulatory programs - Health Canada.

OAG. (2011). Status report of the Auditor General of Canada: Chapter 6 - Regulating medical devices - Health Canada.

Patterson, N. (2003, September). Faster FDA approvals seen for drug/device combination products. The BBI Newsletter, p. 247.

Polisena, J., Hailey, D., Moulton, K., Noorani, H. Z., Jacobs, P., Ries, N., … Gardam, M. (2008). Reprocessing and Reuse of Single-Use Medical Devices: A National Survey of Canadian Acute-Care Hospitals. Infection Control and Hospital Epidemiology, 29(5), 437-439. doi:10.1086/587648

SSCSAST. (2013). The Standing Senate Committee on Social Affairs, Science and Technology: Twenty-Third Report. Retrieved September 23, 2013, from http://www.parl.gc.ca/Content/SEN/Committee/411/soci/rep/rep23apr13-e.htm

TBS. (2009). Policy on Evaluation. Retrieved from http://www.tbs-sct.gc.ca/pol/doc-eng.aspx?section=text&id=15024

TBS. (2012). Communications Policy of the Government of Canada. Retrieved September 4, 2013, from http://www.tbs-sct.gc.ca/pol/doc-eng.aspx?id=12316&section=text

Tiedemann, M. (2008). Bill C-51: An Act to amend the Food and Drugs Act and to make consequential amendments to other Acts. Retrieved March 19, 2013, from http://www.parl.gc.ca/About/Parliament/LegislativeSummaries/bills_ls.asp?Language=E&ls=c51&source=library_prb&Parl=39&Ses=2

TPD. (2004). Therapeutic Products Directorate (TPD) business transformation progress report 2003-2004.

TPD. (2005). Issue analysis summary: The reuse of single-use medical devices.

TPD. (2006). TPD bilateral meeting program.

TPD. (2007a). Therapeutic Products Directorate (TPD) annual report 2006-2007.

TPD. (2007b). Update on reprocessing and reuse of single-use medical devices: Letter from TPD to hospital administrators, risk managers, infection control practitioners, health care associations and ministries of health.

TPD. (2008). Therapeutic Products Directorate (TPD) annual report 2007-2008.

TPD. (2009a). Summary Basis of Decision (SBD) Initiative - Frequently Asked Questions. Retrieved April 13, 2012, from http://www.hc-sc.gc.ca/dhp-mps/alt_formats/hpfb-dgpsa/pdf/prodpharma/sbd_qa_smd_fq-eng.pdf

TPD. (2009b). Therapeutic Products Directorate (TPD) annual report 2008-2009.

TPD. (2012). Frequently Asked Questions: Summary Basis of Decision (SBD) Project: Phase II. Retrieved March 11, 2013, from http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/sbd_qa_smd_fq-eng.php

Turpin, C. (2012, January). Canadian Medical Devices Sentinel Network Pilot (CMDSNet): Improving medical device safety.

Turpin, C. (2013). Canadian Medical Devices Sentinel Network - Pilot to Implementation.

U.S. Food and Drug Administration. (2009). Reprocessing of Single-Use Devices - Executive Summary - Survey on the Reuse and Reprocessing of Single-Use Devices (SUDs) in U.S. Hospitals. WebContent. Retrieved July 19, 2012, from http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/ReprocessingofSingle-UseDevices/ucm121678.htm

Zuckerman, D. M., Brown, P., & Nissen, S. E. (2011). Medical device recalls and the FDA approval process. Archives of Internal Medicine, 171(11), 1006-1011. doi:10.1001/archinternmed.2011.30

Appendix C - Supplementary Data Tables

Table 1: Pre-market information requirements for medical devices
Requirements Description
Classification Classes are determined according to a number of classification rules in the Medical Devices Regulations. If more than one rule applies when classifying a medical device, the highest class applies.
Safety and effectiveness All devices must comply with these requirements before entering the market, and manufacturers must maintain documentation to continue to show their device meets the requirements. However, the amount of evidence and documentation required to prove the device meets the requirements depends on the class of device. The requirements relate to various aspects of the device, such as its design, manufacturing process, risks, performance, transportation, storage, materials (compatibility), sterilization, and labelling.
Labelling The labelling requirements on medical devices must be legible and easily understood by the user, and include information such as the name of the device; name and address of the manufacturer; the identifier of the device; expiry date; purpose of the device; directions for use; and special storage conditions.
Quality systems Manufacturers of Class II, III, and IV devices must show their devices are manufactured in accordance with the ISO 13485:2003 standard. Class II devices must meet the quality systems of the standard, but are not required to meet the design requirements; Classes III and IV must adhere to all the requirements, including design. The quality system is audited by an approved Registrar (third party), and upon successful completion, the manufacturer receives the quality systems certificate.
Establishment license Manufacturers of Class I devices need to obtain an establishment licence unless they are distributing their devices solely through a licensed distributor. Manufacturers of Class II, III or IV devices require device licenses and do not require an establishment license to distribute the devices they manufacture. The information required to obtain an MDEL includes, among other things, company information and activities, the classes of devices that are to be sold by the applicant, and signed attestations that documented procedures are in place regarding distribution records, complaint handling, recalls, mandatory problem reporting, and other applicable regulatory requirements.
Medical device license application For Class II, III, and IV devices, manufacturers must obtain a licence before marketing their products in Canada. They must submit a licence application to Health Canada that includes information set out in the Medical Devices Regulations. The application must include information on the device, such as its name; class; name and address of manufacturer; and name and address of the manufacturing establishment. As the class of the device increases, there are requirements for additional documents, such as pre-clinical and clinical studies, a copy of the quality management system certificate, documents proving the device meets safety and effectiveness requirements, and others.
Source: (GoC, 2011; Industry Canada, 2010; Inspectorate, 2012a)
Table 2: Investigational testing applications received and percentage completed within target
IT applications 2003/04 2004/05 2005/06 2006/07 2007/08 2008/09 2009/10 2010/11 2011/12
Total IT applications 108 123 150 147 146 128 150 188 146
Completed within target 86% 84% 91% 97% 79% 76% 90% 89% 92%
Source: (Health Canada, 2013)
Table 3: Medical device applications received by fiscal year
Class 2003/04 2004/05 2005/06 2006/07 2007/08 2008/09 2009/10 2010/11 2011/12
Class II 2431 4136 3235 2981 3411 3185 3560 4125 3491
Class III 1109 1350 1258 1356 1327 1416 1568 1495 1103
Class IV 345 315 327 342 383 360 405 421 469
Source: (Health Canada, 2013)
Table 4: Percentage of all decisions for medical device applications processed within target time frame
Class 2003/04 2004/05 2005/06 2006/07 2007/08 2008/09 2009/10 2010/11 2011/12
Class II 92% 51% 75% 82% 70% 81% 64% 72% 80%
Class III 61% 62% 76% 97% 86% 64% 55% 60% 82%
Class IV 59% 82% 87% 89% 59% 47% 56% 68% 76%
Source: (Health Canada, 2013)
Table 5: Percentage of medical device submissions with additional information requests
2003/04 2004/05 2005/06 2006/07 2007/08 2008/09 2009/10 2010/11 2011/12
25% 26% 37% 40% 42% 49% 46% 51% 54%
Source: (Health Canada, 2013)
Table 6: Medical device mandatory problem reports, 2006-2007 to 2011-2012
Fiscal year Type I Type II Type III Total
n % n % n % n % % change
2006-2007 2,390 99.8% 4 0.2% 1 0.0% 2,395 8.4% -
2007-2008 5,361 99.4% 32 0.6% 0 0.0% 5,393 18.9% 125.2%
2008-2009 4,024 99.7% 11 0.3% 1 0.0% 4,036 14.2% -25.2%
2009-2010 4,476 99.9% 4 0.1% 0 0.0% 4,480 15.7% 11.0%
2010-2011 7,803 99.9% 4 0.1% 0 0.0% 7,807 27.4% 74.3%
2011-2012 4,366 100.0% 1 0.0% 0 0.0% 4,367 15.3% -44.1%
Total 28,420 99.8% 56 0.2% 2 0.0% 28,478 100.0% -
Source: (Inspectorate, 2011a, 2012b)

Note: Type II and Type III mandatory problem reports are presumed to be data entry errors.
Table 7: Medical device voluntary problem reports, 2006-2007 to 2011-2012
Fiscal year Type I Type II Type III Total
n % n % n % n % % change
2006-2007 24 9.2% 197 75.8% 39 15.0% 260 11.6% -
2007-2008 60 17.6% 226 66.3% 55 16.1% 341 15.2% 31.2%
2008-2009 41 11.0% 281 75.1% 52 13.9% 374 16.7% 9.7%
2009-2010 44 9.9% 318 71.3% 84 18.8% 446 19.9% 19.3%
2010-2011 57 13.5% 307 72.9% 57 13.5% 421 18.7% -5.6%
2011-2012 71 17.6% 284 70.3% 49 12.1% 404 18.0% -4.0%
Total 297 13.2% 1,613 71.8% 336 15.0% 2,246 100.0% -
Source: (Inspectorate, 2011a, 2012b)
Table 8: Types of post-market surveillance activities for medical devices, 2005-2012
Year received Risk communication Signal assessment (SA) Review report Causality assessment Other* Total
2005 6 3 1  -  - 10
2006 20 15 3  - 1 39
2007 19 8 7 1 1 36
2008 16 8 5  - - 29
2009 26 7 8  - - 41
2010 22 17 7 2 - 48
2011 14 17 4 1 - 36
2012 9 3 3 2 - 17
No date 17 3 1  - - 21
Total 149 81 39 6 2 277
Source: (MHPD, 2013)

* "Other" includes a "causality, signal assessment" and an "IAS"
Table 9: SAs received and approved, 2005-2012
Year # SAs received % of total SAs approved % of total
2005 3 3.7% -  
2006 15 18.5% 7 8.6%
2007 8 9.9% 10 12.3%
2008 8 9.9% 9 11.1%
2009 7 8.6% 6 7.4%
2010 17 21.0% 12 14.8%
2011 17 21.0% 18 22.2%
2012 3 3.7% 14 17.3%
Missing date 3 3.7% - -
Cancelled / closed - - 5 6.2%
Total 81   81  
Source: (MHPD, 2013)
Table 10: Statistics on SA approval (2012 only)
Year SAs approved SAs meeting performance target
(130 days)		 Mean workdays to approval Median workdays to approval Min. workdays to approval Max. workdays to approval
2012 14 12 102 104 39 153
Source: (MHPD, 2012c, 2013)

Note: Average number of workdays is based on the number of workdays between the SA being assigned and the SA being approved.  Annual statistics could not be calculated for 67 out of 81 SAs due to missing dates (assigned or approved) or incomplete annual data.
Table 11: Sources for completed medical device SAs, 2005-2012
Source Count Percent
Literature 17 21.0%
Medical Device System database (MDS) 10 12.3%
Media 10 12.3%
CMDSNet 9 11.1%
US (FDA) 7 8.6%
Market authorization holder 4 4.9%
Recall 4 4.9%
Health Hazard Evaluation 3 3.7%
MHPD 3 3.7%
Signal assessment 3 3.7%
UK (MHRA) 3 3.7%
Out of the Blue 2 2.5%
Other 11 13.5%
No source indicated 5 6.2%
Total 81 -
Source: (MHPD, 2013)

Note: SAs may have more than one source; therefore, columns will not sum.
Table 12: Recommendations resulting from medical device SAs, 2005-2012
Recommendation Count Percent
Request issuance of a risk communication 37 45.7%
Recommend changes to the product labelling 25 30.9%
Standard monitoring 18 22.2%
Refer to MPMDB for future reassessment 16 19.8%
Request additional safety information 9 11.1%
Compliance and enforcement 7 8.6%
Request consideration by DSEN 1 1.2%
Other 3 3.7%
Cancelled / closed 5 6.2%
No recommendation indicated 3 3.7%
Total 81 -
Source: (MHPD, 2013)

Note: SAs may result in more than one recommendation; therefore, columns will not sum.
Table 13: Compliance verifications and investigations by hazard type, 2006-2007 to 2011-2012
Hazard type Mandatory problem reports Voluntary problem reports Recalls No device licence No establishment licence Total Mandatory problem reports as % of total
2006-2007
Type I 2,390 24 32 1 1 2,448  
Type II 4 197 399 63 21 684  
Type III 1 39 202 28 19 289  
Total 2,395 260 633 92 41 3,421 70.0%
2007-2008
Type I 5,361 60 57 1 1 5,480  
Type II 32 226 411 158 31 858  
Type III 0 55 147 23 44 269  
Total 5,393 341 615 182 76 6,607 81.6%
2008-2009
Type I 4,024 41 32 1 0 4,098  
Type II 11 281 488 173 43 996  
Type III 1 52 258 38 128 477  
Total 4,036 374 778 212 171 5,571 72.4%
2009-2010
Type I 4,476 44 38 0 1 4,559  
Type II 4 318 495 126 21 964  
Type III 0 84 270 17 67 438  
Total 4,480 446 803 143 89 5,961 75.2%
2010-2011
Type I 7,803 57 42 0 0 7,902  
Type II 4 307 545 136 40 1,032  
Type III 0 57 261 10 103 431  
Total 7,807 421 848 146 143 9,365 83.4%
2011-2012
Type I 4,366 71 31 1 0 4,469  
Type II 1 284 502 114 60 961  
Type III 0 49 294 7 72 422  
Total 4,367 404 827 122 132 5,852 74.6%
Source: (Inspectorate, 2011a, 2012b)
Table 14: Recalls listed in the online Medical Device Recall Listing
Year Type I Type II Type III N/A* Total
2005 22 158 108 0 288
2006 28 293 178 0 499
2007 36 307 141 0 484
2008 29 404 182 1 616
2009 26 400 174 1 601
2010 39 508 258 0 805
2011 37 528 280 0 845
2012 45 492 362 0 899
Total 262 3,090 1,683 2 5,037
Note: A single recall might include multiple medical devices.

*These include cases the Inspectorate deemed to be product withdrawals (not recalls) or recalls that did not require a hazard level designation.

Sources: (Inspectorate, 2005, 2006, 2007, 2008, 2009, 2010, 2011b, 2012c)
Table 15: Publicly available SBDs and NDs for a subset of Class III and IV* devices -- 2005-2012
Year posted Number of SBDs Number of NDs
2005 2 5
2006 7 4
2007 5 6
2008 7 6
2009 11 5
2010 7 1
2011 4 1
2012 1 2
Total NDs - 30
Total SBDs 49 -
Total devices posted 31 30
Total devices with one SBD 27 -
Total devices with multiple SBDs 4 -
Total SBDs for devices with multiple SBDs 22 -
Source: (TPD, 2012b, 2013)

Data current as of March 11, 2013.

*All SBDs prior to Phase II of the SBD Initiative (September 2012) cover only a subset of Class IV devices.

The number of SBDs exceeds the number of devices because four of the devices had multiple SBDs (18) released.  All four of these devices were breast implant products. Although it would seem that SBD activity peaked in 2009, four of these were follow-up SBDs for the four breast implant products.
Table 16: Types of post-market safety communications, medical devices (1994-2012)
Target group Communication method # % %
(per target group)
Health professionals Notice to Hospitals 77 33% 60%
For Health Professionals 63 27%
Public Public Advisory 30 13% 35%
Public Communication 27 12%
Information Update 15 6%
Public Warning 7 3%
"It's Your Health" 2 1%
Foreign Product Alert 1 <1%
Unspecified* Unspecified* 12 5% 5%
Total 234 100% 100%
Note: A single communication might cover multiple medical devices. Some MedEffect postings are dated prior to 2005. Data current as of April 12, 2012.

*Unspecified communications includes notices that did not fit into any of the above categories and/or were not clearly addressed to the public or health professionals (e.g., dear customer).

Source: (MHPD, 2012a, 2012b)
Table 17: Risk communications posted on MedEffect related to medical devices
Year Number of communications
Up to 1999 6
2000 3
2001 4
2002 7
2003 9
2004 12
2005 39
2006 37
2007 33
2008 15
2009 22
2010 29
2011 15
2012 3
Total 234
Source: (MHPD, 2012a, 2012b)

Note: A single communication might cover multiple medical devices. Some MedEffect postings are dated prior to 2005. Data current as of April 12, 2012.
Table 18:  Expert Advisory Committees (EACs) and Panels (EAPs) associated with the MDP
Title Description Documented level of activity
Expert Advisory Panel on Breast Implants (EAP-BI) The Panel "will provide [HC] with timely advice related to the safety and effectiveness of silicone gel-filled breast implants." The Panel will "enhance transparency in the decision-making process and provide an opportunity for broader external advice" (EAP-BI, n.d.).
  • A presentation deck about breast implants and the increased risk of connective tissue disorders was developed by A.V. Jovaisas in 2005 (Jovaisas, 2005).
  • There is record of one meeting and one forum held in 2005 (EAP-BI, 2005; SAP-BI, 2005).
  • There are records of several documents that have been developed by the Panel.
  • In response to the EAP's recommendations, Health Canada:
    • Requested, received, and reviewed additional information from breast implant manufacturers, including literature reviews from Inamed and Mentor
    • Reviewed each company's plans for a large-scale, long-term post-approval study to examine rare events linked to hypersensitivity and autoimmune reactions to breast implants, and included these studies as a condition of the manufacturer's licence (HESA, n.d., 2007)Footnote 40
    • Made annual reporting on these long-term studies a condition of the manufacturer's licence, and provided these reports to the public via annually-updated SBDs (HESA, n.d., 2007)
    • Requested that manufacturers' product labelling include a patient brochure in a "decision aid" format that will help prepare the patient to discuss options with their doctor; these brochures include information on product risks and benefits, as well as alternatives (HESA, n.d., 2007)
  • The EAP also recommended the establishment of a national registry (HESA, 2007). Health Canada's response to this recommendation could not be found.
  • According to Health Canada's website, this Panel's mandate has been completed (HPFB, 2012).
Expert Advisory Panel on Di(2-ethyl-hexyl)phthalate (DEHP) in Medical Devices The Panel was "established to review the methodology and conclusions of the Exposure and Toxicity Report prepared by MDB, review and comment on the proposed risk management options, and advise [TPD] in developing position statement on DEHP in medical devices" (Health Canada, 2001).
  • There are records of one meeting held in 2001 and two meetings held in 2003 (Health Canada, 2001, 2003b, 2003c).
  • An Exposure and Toxicity Assessment was developed in July 2001 and revised in February 2002 (Health Canada, 2002a).
  • A final report was developed by the committee in January 2001 (Health Canada, 2002b).
  • Health Canada made a number of general and specific recommendations based on the EAP's findings:

General:

  • Limit exposure of DEHP in patient groups that may be at more risk, including male newborns, infants, and young children; pregnant women carrying a male foetus; and peripubertal males.
  • Take steps to allow health care professionals to identify medical devices containing DEHP.
  • Alternatives to DEHP should not be introduced unless there is adequate data on the safety and effectiveness of the alternative.
  • Medical procedures should not be avoided because of the possible health risks associated with DEHP exposure (Health Canada, 2003a).

Specific recommendations:

  • DEHP should continue to be used in blood bags.
  • Alternative measures should be introduced to protect vulnerable subpopulations. Alternative products that are already available (such as heparin-coated tubing) should be used for all extracorporeal membrane oxygenation (ECMO) for newborns and infants.
  • Tubing and storage bags used for administration of lipophilic drug formulations should not contain DEHP; strategies to decrease DEHP exposure should be taken.
  • Parenteral nutrition solutions containing lipids should be administered to newborns and infants via DEHP-free products.
  • Administration of crystalloid fluids can continue to be done via DEHP-containing products.
  • National professional health care organizations should develop clinical practice guidelines to reduce DEHP exposure.
  • Manufacturers should take steps to inform users through labelling if the device contains DEHP.
  • Manufacturers should conduct research into methods for reducing release of DEHP from products (Health Canada, 2003a).
Expert Advisory Panel on the Special Access Programme (EAP-SAP) The Panel "acts as a forum of advice and a sounding board for management and scientists of [HPFB]. Panel members...meet to discuss options for improving the regulatory framework under which the Special Access Programme will function" (Health Canada, 2007a).
  • Nothing regarding the Panel's activity was available in the documents provided to PRA. According to Health Canada's website, this Panel's mandate has been completed (Health Canada, 2012).
Scientific Advisory Committee on Human Reproductive Therapies (SAC-HRT) No information available.
  • Committee is currently dormant (Health Canada, 2011a).
Scientific Advisory Committee on Medical Devices Used in the Cardiovascular System (SAC-MDUCS) The mandate of the Committee is to "provide HC with on-going and timely scientific, technical, medical and clinical advice on current and emerging issues related to the work of HC pertaining to the evaluation of safety and effectiveness of devices used in the cardiovascular system" (Health Canada, 2011b).
  • There are records of 15 meetings of the Committee between 2003 and 2012 (TPD, 2003, 2012a).Over the last 9 years, the Committee has made many recommendations to Health Canada; Health Canada notes that the Committee's work and recommendations have aided the following decisionsFootnote 41:
  • Recommending a longer term follow-up for annuloplasty rings (TPD, 2009)
    • Preparing to review new medical devices requested through the Special Access Programme, including percutaneous valves, bare metal stents, drug eluting stents, vulnerable plaque imaging, as well as thoracic aortic aneurysm and abdominal aortic aneurysm devices (TPD, 2010a)
    • Investigating battery life of implantable pulse generators (TPD, 2010b)
    • Examining premarket requirements for DF4/IS4 leads  (TPD, 2010a)
    • Addressing manufacturers about safety issues of robotic navigation systems  (TPD, 2010a)
    • Clarifying the role of the Special Access Programme (TPD, 2011a)
    • Decisions about high-voltage pacing (TPD, 2011b)
    • Drafting of internal guidance on clinical trial requirements for drug-eluting stents  (TPD, 2011b)
    • The decision not to require clinical trial data on labelling for cardiovascular medical devices (TPD, 2012a)
    • Requirement for safety data from formal clinical trials as part of licensing for ablation catheter with contract force (TPD, 2012a)
Scientific Advisory Committee on Metabolic and Endocrine Therapies (SAC-MET) The Committee provides HC with "advice related to the evaluation of safety and efficacy data for metabolic and endocrine drug products that are submitted as part of the drug/medical device assessment process and/or from post-market surveillance activities. Involvement of [the Committee] in the regulatory review process is expected to enhance transparency and provide opportunity for proactive external guidance, thus facilitating the drug/medical device assessment process" (Health Canada, 2006a).
  • Committee was cancelled (Health Canada, 2011a).
Scientific Advisory Committee on Musculoskeletal Therapies (SAC-MST) No information available.
  • Committee was cancelled (Health Canada, 2011a).
Scientific Advisory Committee on Neurological Therapies (SAC-NT) No information available.
  • Committee was cancelled (Health Canada, 2011a).
Scientific Advisory Panel on Reprocessing of Medical Devices (SAP-RMD) The Panel provides "scientific and technical advice on current and emerging issues related to the reprocessing of medical devices," including "the feasibility of reprocessing single-use devices [and] the current problems encountered by users in reprocessing reusable medical devices and potential solutions to these problems" (Health Canada, n.d.)
  • A report on the Technical Aspects of Single Use Devices (SUDs) was developed in March 2005 (Health Canada, 2007b).
  • The Panel released recommendations for Health Canada, manufacturers, and health care facilities (Health Canada, 2007b).
  • Health Canada responded to Panel's recommendations in the following ways:
    • Initially committing to develop a regulatory framework for reprocessing of SUDs, going as far as developing an Issue Analysis Summary and submitting the proposed regulation to the Legal Office (Health Canada, 2005a, 2005c, 2006b). The Department later indicated that neither the Food and Drugs Act nor Regulations allow for regulation of reprocessing; the Department indicated that an alternative approach would be pursued through provincial counterparts, but panel members indicated that the provinces were waiting for a national directive regarding SUD reprocessing (Health Canada, 2006c).
    • Preparing a draft advisory letter to send to hospitals and health care facilities, making interim recommendations on reprocessing SUDs (Health Canada, 2005b).
    • Developing guidelines for the reprocessing of SUDs (Health Canada, 2006c, 2006d). A final version of the guidance document was posted online in June 2011, which also includes the Panel's recommendations to include CSA/ISO approved reprocessing instructions (Health Canada, 2011b).
    • In response to the Panel's concerns over perceived inconsistencies in medical device licensing rules and the risk of harm between Health Canada and hospitals, Health Canada advised the Panel that the classification system is part of the Medical Device Regulations and was developed to harmonize with international partners, and that it would therefore be difficult to introduce changes to these rules (Health Canada, 2005c, 2006d).
    • Indicating that the Medical Device Regulations do not give Health Canada the authority to initiate a device recall or corrective action, where such action is deemed necessary to ensure the safety of the device; nor does the Food and Drugs Act authorize the Department torequire that such action be taken at no cost to the purchaser of the device (Health Canada, 2006b).
  • The Panel made a number of other recommendations; Health Canada's response to these recommendations could not be found:
    • Create a public access database of medical device problem reports, similar to the FDA's
    • Consider requiring a licence for consignment and loaner instrument sets
    • Harmonize medical device classification system with health care, industry and international counterparts
    • Require manufacturers to provide adequate and appropriate reprocessing instructions or all medical devices (as per CSA/ISO standards)
    • Endorse the Panel's recommendation on residual organic material
    • Recommend that health facilities audit all aspects of medical device reprocessing to ensure compliance with national standards
    • Recommend that health care facilities only purchase or lease devices for which they have device-specific, validated reprocessing instructions
    • Recommend endorsement of the Ontario MOHLTC document "Best Practices for Cleaning, Disinfecting and Sterilization - in all Health Care Settings" at the Conference of Deputies of Health
    • Recommend ongoing dialogue through working groups that include Health Canada, MEDEC, CSA and health care representatives to address reprocessing issues
Table 19: Industry views on Health Canada's consultations and communications
Statement n=206
Agree Neutral Disagree Don't know
Over the past 10 years, Health Canada has consulted adequately with the medical devices industry. 30% 27% 10% 34%
Over the past 10 years, Health Canada has taken the concerns and interests of the medical devices industry into account in policy and regulatory development. 34% 27% 11% 28%
As a whole, the existing consultation mechanisms are an effective way for the medical devices industry to express its concerns and interests to Health Canada. 36% 28% 10% 26%
Pre-submission meetings are an effective mechanism for ensuring that product submissions meet Health Canada's requirements. 50% 22% 5% 23%
The Ombudsman Office is an effective mechanism for dispute resolution regarding submission decisions. 15% 28% 3% 54%
Health Canada provides industry stakeholders with timely information on whether the medical device submission review process is meeting established service standards. 45% 24% 13% 19%
Source: Survey of industry.

Note: Totals may not sum to 100% due to rounding.
Table 20: Industry understanding of regulations, policies, and activities related to medical devices
Statement Percent indicating their understanding is...
(n=206)
Strong Moderate Poor
Health Canada's quality system requirements for medical device manufacturers 80% 18% 2%
Health Canada's requirements for mandatory problem reporting for medical devices 69% 29% 2%
Health Canada's submission requirements for medical device manufacturers applying to have a new Class II, III, or IV medical device approved for sale in Canada 67% 31% 2%
Health Canada's regulatory compliance activities, including inspections and compliance verifications, and related enforcement actions to address identified risks (e.g., non-compliances) 49% 47% 5%
Health Canada's requirements related to Good Clinical Practices for investigational testing of medical devices 19% 48% 33%
Source: Survey of industry.
Table 21: Industry awareness and use of Health Canada information
Type of information n=206
Aware of information Used information
Information on quality system requirements for medical device manufacturers 99% 90%
Information on submission requirements for medical device manufacturers applying to have a new Class II, III, or IV medical device approved for sale in Canada 99% 88%
Information on Health Canada's requirements for mandatory problem reporting for medical devices <99% 67%
Guidance for medical device manufacturers on how to comply with Health Canada's submission requirements for Class II, III, and IV medical devices 98% 85%
Information on Health Canada's regulatory compliance activities, including inspections and compliance verifications, and related enforcement actions to address identified risks (i.e., non-compliances) 94% 54%
Information on Health Canada's requirements related to Good Clinical Practices for investigational testing of medical devices 80% 18%
Information on the electronic submission process for medical devices 74% 27%
Source: Survey of industry.
Table 22: Industry views on quality of Health Canada information
Type of information Number who used information Percent who believe information was very...
Accessible Understandable Useful
Information on submission requirements for medical device manufacturers applying to have a new Class II, III, or IV medical device approved for sale in Canada 182 58% 56% 64%
Information on the electronic submission process for medical devices 55 51% 47% 53%
Guidance for medical device manufacturers on how to comply with Health Canada's submission requirements for Class II, III, and IV medical devices 174 62% 58% 60%
Information on Health Canada's requirements related to Good Clinical Practices for investigational testing of medical devices 37 46% 51% 46%
Information on Health Canada's requirements for mandatory problem reporting for medical devices 138 62% 59% 62%
Information on Health Canada's regulatory compliance activities, including inspections and compliance verifications, and related enforcement actions to address identified risks (i.e., non-compliances) 112 48% 51% 49%
Information on quality system requirements for medical device manufacturers 186 60% 58% 62%
Source: Survey of industry
Table 23: Level of industry agreement with statements about Health Canada's mandatory problem reporting requirements
Statement Percent (n=206)
Agree Neutral Disagree Don't know
Reporting instructions and requirements
Health Canada has clearly defined what medical device problems must be reported by manufacturers and importers 84% 10% 4% 2%
Health Canada has clearly outlined the time frame for both preliminary and final mandatory problem reporting 89% 6% 2% 3%
Health Canada has clearly identified where within the Department mandatory problem reports must be submitted 84% 11% 2% 3%
Health Canada's Mandatory Medical Device Problem Reporting Form for Industry is clear and understandable 74% 15% 3% 8%
Ability to meet reporting requirements
In the event of a medical device problem that had to be reported, my firm could provide all of the information required on Health Canada's Mandatory Medical Device Problem Reporting Form for Industry 81% 9% 1% 9%
In the event of a medical device problem that had to be reported, my firm could complete Health Canada's Mandatory Medical Device Problem Reporting Form for Industry in the required reporting timeframe 76% 14% 1% 9%
Source: Survey of industry.

Note: Totals may not sum to 100% due to rounding.
Table 24: Industry views on impact of Health Canada activities on safety and effectiveness of medical devices
Statement n=206
Agree Neutral Disagree Don't know
Health Canada's pre-market processes effectively support an adequate level of medical device safety in Canada 65% 18% 2% 15%
Health Canada has adequate pre-market processes in place to ensure the effectiveness of medical devices sold in Canada 66% 18% 3% 14%
Health Canada has adequate pre-market processes in place to ensure the quality of medical devices sold in Canada 69% 17% 2% 13%
Health Canada's post-market surveillance and monitoring activities (e.g., mandatory problem reporting and monitoring) effectively support an adequate level of medical device safety in Canada 64% 17% 5% 14%
Health Canada's compliance and enforcement activities effectively support an adequate level of medical device safety in Canada 62% 20% 3% 15%
Health Canada's compliance and enforcement activities effectively support an adequate level of medical device quality in Canada 61% 20% 4% 15%
Source: Survey of industry.

Note: Totals may not sum to 100% due to rounding.
Table 25: Industry views on Health Canada's use of scientific evidence and risk-based analysis
Statement n=206
Agree Neutral Disagree Don't know
Health Canada's pre-market reviews of medical device submissions are rigorous 57% 23% 4% 16%
Health Canada's policies and regulations related to medical devices are based on best available evidence and scientific knowledge 53% 26% 6% 15%
Health Canada's policies and regulations related to medical devices are based on an appropriate analysis of risk 58% 24% 6% 12%
Source: Survey of industry.

Note: Totals may not sum to 100% due to rounding.

Reference List for Supplementary Data Tables

List of Acronyms

ADM
Assistant Deputy Minister
AHWP
Asian Harmonization Working Party
ATI
Access to Information
BCANS
Bureau of Cardiology, Allergy and Neurological Sciences
BGTD
Biologics and Genetic Therapies Directorate
BGIVD
Bureau of Gastroenterology, Infection and Viral Diseases
BMORS
Bureau of Metabolism, Oncology and Reproductive Sciences
BMP
Bilateral Meeting Program
BPS
Bureau of Pharmaceutical Sciences
BPSIP
Bureau of Policy, Science and International Programs
CADTH
Canadian Agency for Drugs and Technologies in Health
CBER
Center for Biologics Evaluation and Research
CBSA
Canada Border Services Agency
CCRPB
Consumer and Clinical Radiation Protection Bureau
CDRH
Center for Devices and Radiological Health
CFIA
Canadian Food Inspection Agency
CIHR
Canadian Institutes of Health Research
CMDCAS
Canadian Medical Devices Conformity Assessment System
CMDSNet
Canadian Medical Devices Sentinel Network
CRI
Cost Recovery Initiative
DDCPP
Drug-Device Combination Products Policy
DED
Device Evaluation Division
DEHP
Di(2-ethyl-hexyl)phthalate
DGO
Director General's Office
DLSD
Device Licensing Services Division
DSEN
Drug Safety and Effectiveness Network
EAC
Expert Advisory Committee
EAP
Expert Advisory Panel
EAP-BI
Expert Advisory Panel on Breast Implants
EBP
Employee Benefit Plan
ERHSD
Environmental and Radiation Health Sciences Directorate
EU
European Union
FCSAP
Food and Consumer Safety Action Plan
FDA
Food and Drug Administration
FTE
Full-time equivalent
GAO
General Accounting Office
GCP
Good Clinical Practices
GGP
Good Guidance Practices
GHTF
Global Harmonization Task Force
GMP
Good Manufacturing Practices
GRP
Good Review Practices
HC
Health Canada
HECSB
Healthy Environments and Consumer Safety Branch
HIV
Human immunodeficiency virus
HPFB
Health Products and Food Branch
HRA
Health Risk Assessment
IMDRF
International Medical Device Regulators Forum
ISO
International Organization for Standardization
IT
Information technology
ITA
Investigational Testing Authorization
ITU
Investigational testing unit
MAH
Market authorization holder
MAT
Market authorization time
MAUDE
Manufacturer and User Facility Device Experience
MDB
Medical Devices Bureau
MDEL
Medical Device Establishment Licence
MDP
Medical Devices Program
MDS
Medical Devices System
MEDSun
Medical Product Safety Network
MHPD
Marketed Health Products Directorate
MHPSEIB
Marketed Health Products Safety and Effectiveness Information Bureau
MOU
Memorandum of Understanding
MPMDB
Marketed Pharmaceuticals and Medical Devices Bureau
MRI
Magnetic resonance imaging
NC
Non-compliant
OAG
Office of the Auditor General
OBT
Office of Business Transformation
OPPRS
Office of Planning, Performance and Review Services
ORM
Office of Risk Management
OSIP
Office of Submissions and Intellectual Property
PAA
Program Activity Architecture
PHAC
Public Health Agency of Canada
PMAP
Pilot Multipurpose Audit Program
PMEP
Performance Measurement and Evaluation Plan
PMS
Performance measurement strategy
PPIAD
Policy, Planning and International Affairs Directorate
QMS
Quality management system
RAPB
Regions and Programs Bureau
RCMP
Royal Canadian Mounted Police
RMOD
Resource Management and Operations Directorate
SAC-MDUCS
Scientific Advisory Committee on Medical Devices Used in the Cardiovascular System
SAP
Scientific Advisory Panel
SAP-RMD
Scientific Advisory Panel on Reprocessing of Medical Devices
SBD
Summary Basis of Decision
SCC
Standards Council of Canada
SIMS
Stakeholder Information Management System
SIPD
Submission and Information Policy Division
SOP
Standard Operating Procedure
SUD
Single-use device
TEPB
Therapeutic Effectiveness and Policy Bureau
TGA
Therapeutic Goods Administration
TPD
Therapeutic Products Directorate
TPSI
Therapeutic Product Safety Initiative
US
United States
WHO
World Health Organization

Page details

Date modified: