Scientific Advisory Committee on Health Products for Women (SAC-HPW) Summary: Findings, Advice, 2019-05-16-17
May 16-17 2019
Summary of Findings and Advice
The Medical Devices Action Plan (MDAP)Footnote 1was launched in December 2018 to communicate on Health Canada’s strategies to strengthen the regulatory framework for medical devices. One of the key commitments in the MDAP is to expand scientific expertise that will help inform regulatory decision-making practices and policies. As part of this commitment, Health Canada has established a new external Scientific Advisory Committee on Health Products for Women (SAC-HPW). The mandate of the SAC-HPW is to provide Health Canada with timely patient-centered, scientific, technical, medical and clinical advice on current and emerging issues regarding women’s health and the regulation of medical devices and drugs.
The SAC-HPW is made up of 10 core members with a variety of expertise, knowledge, and perspectives, including patient groups; health professionals such as pharmacists, physicians and nurse practitioners; scientists; academia, and policy.
The initial meeting of SAC-HPW was held in Ottawa on May 16 and 17, 2019. The objective for the inaugural meeting was to provide members with an orientation to the various programs within Health Canada and to obtain advice that will help inform the regulatory and scientific review of medical devices that are used in women.
Overall Summary of Advice
- Risk information should be truthful, comprehensive, and clear
- Use of an interactive decision support tool for patients and health care professionals (HCPs) developed in conjunction with or done by decision support tool researchers in academia
- Clearly separate industry and Health Canada information on the labels
- Consider requiring a one or two page summary of risk information (including alternatives) aimed at consumers
- Public education is key to reaching a broader audience (not just patients and HCPs)
- Require real life photos in labels, as the current ones look more like advertising and thus misleading, include examples of implant degradation both in situ and after explanation, and qualitative data and user quotes where possible
- Use self-help non-industry funded consumer groups or advocacy groups to help educate on risks and engage in supporting incident reporting
- Health Canada should request sponsors to provide evidence that breast implant for the two named uses improves self-esteem over the life cycle of the product, psychosocial evidence is needed for all cosmetic products and research needed on gender related drivers for enhancements
- Evidence needs to be realistic, complete, comprehensive, and respectful
- Most members recommended that distinction between cosmetic and therapeutic products should be clearly made, but the evidence standards required should not be lowered. One member requested, given that cosmetic uses were also purported to be “therapeutic”, the manufacturer should be able to provide evidence of such an intervention being effective (e.g., “improves self-esteem”) over the life cycle of the product, and make such evidence available upon request.
Summary of Discussions
1. Welcome and Opening remarks
SAC-HPW’s initial meeting will focus on implementing some of the initiatives under the MDAP. The issues for SAC-HPW consideration during this meeting are:
- Session 1: Clinical evidence requirements for medical devices
- Session 2: Lifecycle management of medical devices (using mesh implants as a case study), and
- Session 3: Knowledge transfer to patients (using breast implants as a case study)
2. Chair’s address, Introduction of Members, Review of Affiliations and Interests, Review of Agenda, Review/Approval of the Terms of Reference
The SAC-HPW members introduced themselves, discussed their relevant work and affiliations and interests. There were no declared affiliations and interests that restricted SAC-HPW members’ participation. SAC-HPW reviewed and provided comments on the SAC-HPW Terms of Reference (TOR) and accepted the proposed agenda. The comments were reviewed by the Health Canada Management Committee.
3. Health Canada presentation - Regulatory Overview of Drugs and Medical Devices, and how the SAC-HPW can help inform decision-making
This presentation focused on Health Canada’s mandate, organizational structure, regulatory framework for drugs and medical devices, special access programs, regulatory issues in a global environment, reimbursement process and how Health Canada utilizes scientific advisory bodies to inform decision-making.
The discussions revolved around the current considerations of sex and gender differences in the pre-market space. As an example, a Clinical Trial Application (CTA) for a drug product is reviewed to determine whether it meets specific requirements under Division 5 of the Food and Drug Regulations (F&DR). Health Canada evaluates the CTA to ensure there is no undue risk to participants and that the objectives of the trial are achievable, regardless of funding source. If there is a clinical research objective that is sex and/or gender related, there must be sufficient evidence to support the safety and efficacy of use in the targeted population. In addition, drug product labelling must indicate the subpopulation in question and use of the drug would be restricted to the targeted population in which it has proven to be safe and effective.
The discussion lead to the use of participation-to-prevalence ratio (PPR), which is a term used by the United States Food and Drug Administration (US FDA) for the ratio of the number of targeted population among trial participants divided by the percentage of the targeted population in the disease population for drugs or devices in both sexes. CTA requirements under Division 5 of the F&DR that grant Health Canada the authority to reject indications in which the sample size does not capture the representative population. Health Canada’s role is to protect Canadians from harm while supporting innovation. Health Canada maintains the safety of Canadians enrolled in clinical trials for new drugs by consulting on the clinical study design and protocol.
Finally, there was a discussion on how Health Canada considers international differences in regulating drugs and medical devices. Health Canada participates on the International Conference on Harmonisation (ICH), which establishes global standards for evidentiary requirements, and the International Coalition of Medicines Regulatory Authorities (ICMRA), which facilitates international cooperation and regulatory alignment.
4. Health Canada presentation - Medical Devices Action Plan
The Medical Devices Action Plan (MDAP) was published in December 2018. The intent of the MDAP is to improve medical device market authorization by increasing research, reviewing evidence requirements and expanding the use of scientific expertise. The MDAP also proposes to strengthen post-market surveillance, inspection and enforcement and increase information and risk communication for medical devices to the public. Establishing SAC-HPW is strategically aligned with the MDAP, as the recommendations obtained from SAC-HPW will help inform on the development of clinical evidence requirements and provide valuable scientific expertise on the regulatory issues of medical devices.
The MDAP seeks to strengthen the monitoring of medical device adverse events and subsequent evaluations. The Committee indicated that there are potential challenges on the collection of medical device adverse events due to early discharge activities and patients attending different hospitals. Underreporting of medical device adverse events may be attributable to lack of patient knowledge of adverse event reporting, which impacts Health Canada’s ability to detect and assess safety signals. The SAC-HPW may provide Health Canada with suggestions that will improve patient/regulator engagement, including targeted communications to Canadians as to how to report adverse reactions to Health Canada.
One of the key initiatives is to increase reporting of adverse events. Health Canada is implementing a phased approach to new mandatory reporting requirements of medical devices for hospitals. The first phase will focus on hospital and the second phase with focus on increasing awareness of voluntary reporting in healthcare facilities. At this time, mandatory reporting by health care professionals is not being pursued. These approaches may be considered for the future once mandatory reporting is mandatory for hospitals in addition to other strategies to incentivize reporting and implement follow up mechanisms.
5. Health Canada presentation - Medical Devices Regulations “101”
The Medical Devices Regulations and the various departments involved in the regulatory life cycle of medical devices was introduced. Health Canada’s role in regulating the sale, advertising and importation of medical devices was described, while the use of medical devices is provincially governed.
The risk-based classification system used to categorize medical devices was explained. Class I (lowest risk), Class II, Class III and Class IV (highest risk) are determined by: the level of invasiveness, duration of contact, body system affected, local or systemic therapeutic affect, etc. For example, transvaginal synthetic mesh products are classified as Class III medical devices, but transvaginal biological meshes are considered Class IV. However, despite breast implants fitting the Class III category, they are classified as Class IV medical devices due to the risks these products pose. Most medical devices are appropriately categorized, and exceptions to classification, such as breast implants, are based on risks posed to human health. Under Vanessa’s Law, Health Canada has the ability to request information to address safety concerns.
The review process of a Medical Device License Application and amendments and the pre-market data requirements of the various classes of medical devices was explained. Once a medical device is being marketed, details of sale is not annually provided unless there is a safety issue. As part of the safety assessment, Health Canada would request the manufacturer to submit data. The Committee proposed Health Canada to request manufacturers to submit the number of medical device units sold and the reported incidents on an annual basis to enable proactive identification of risk prevalence and severity.
The Committee was introduced to Health Canada’s post-market regulatory activities that are conducted by the Marketed Health Products Directorate (MHPD). While the manufacturer is responsible for maintaining the safety and effectiveness of medical devices, Health Canada provides regulatory oversight and post-market surveillance to identify new or increased safety risks. When a safety issue is identified, Health Canada initiates compliance verification by requesting the manufacturer to submit a mandatory report with necessary information to assess the safety issue. However, although the mandatory reporting for medical devices captures sex-specific information, it does not gather gender-related information or the patient’s health condition to inform the assessment of the safety signal. The compliance verification process for breast implants was further discussed.
The Committee was also introduced to Health Canada’s compliance and enforcement activities conducted by the Regulatory Operations and Enforcement Branch (ROEB). ROEB issues Medical Device Establishment Licence (MDEL) to medical device manufacturers, importers and sellers of Class I-IV medical devices. In addition to an MDEL, manufacturers of higher classes of medical devices require a Medical Device License (MDL) issued by the Medical Device Bureau (MDB) in the Therapeutic Products Directorate at Health Canada. Inspectors verify compliance under the Medical Device Regulations in order to uphold the MDL and/or MDEL. The MDEL and MDL inspections of medical devices manufactured at foreign sites was further discussed.
6. Session #1: Clinical Evidence for Medical Devices
Health Canada presented on the current clinical evidence requirements for medical device licences and clinical trial authorizations. One apparent challenge is that the life cycle for medical devices is comparatively shorter and faster than that of drugs, and as a result, lengthy clinical trials are less feasible for medical devices.
Health Canada seeks input from the Committee as to how to compare different clinical studies to facilitate consistent regulatory decision-making and address the challenge of providing access to innovative products. The MDAP draft guidance document on evidence requirements will apply to all devices, to be followed by device specific requirements for high-risk devices.
Health Canada described the concept of “established technology” and its use as a comparator device during the review of clinical data for a new device. However, the definition of “established technology” could be further improved to ensure appropriate use to maintain access to safe and effective medical devices.
The committee also deliberated the appropriate use of “safe” and “effective” when associated with a medical device. It was emphasized that, although the device may have the potential to cause harm to certain individuals, it provides a health benefit on a population basis.
7. Session #1 - Committee Deliberations Summary
Clinical Evidence Requirements for Medical Devices
- Define sex as a biological variable and determine what the minimal requirements would be for the adverse effect to be considered “sex-related”
- Implement pre-clinical requirements to test for sex as a biological variable
- Request for sex-disaggregated data in clinical trials, particularly in usability studies, as the safety and efficacy of the medical device can be impacted by its use
- Consider Canadian Institutes of Health Research’s guidance documents and training modules on how to integrate sex and gender into research
- Factor in social, gender and cultural-biased factors in clinical studies
- Leverage real-world and qualitative evidence when medical devices may be of interest to the subpopulations that are usually not captured by the inclusion criteria in traditional clinical trials (e.g., pregnant women, lactating women, adolescents, transgender populations, etc.)
- Clearly separate Health Canada-reviewed information from the manufacturer’s information on patient labels (i.e., brochures, information for users, etc.)
8. Session #2: Lifecycle Management of Medical Devices
The role of the MHPD in Health Canada’s post-market surveillance process for medical devices was illustrated using transvaginal mesh as a case study.
9. Session #2 - Committee Deliberations Summary
Lifecycle Management of Medical Devices
- Increase use of, or develop a product registry to monitor real-world adverse events
- Compel manufacturers to provide reports of how many medical devices have been sold to get a better risk representation when a safety signal has been identified
- Mandate patient follow up to obtain quantitative and qualitative adverse reaction reports
- Monitor the business lifecycle of the manufacturer to eliminate potential biases when reporting health incidents
- Use additional sources of data to monitor adverse reactions (e.g., national, provincial, and territorial healthcare databases, the provincial and territorial colleges, private clinics, the National Association of Pharmacy Regulatory Authorities (NAPRA), patient advocacy organizations, etc.)
- Capture social factors (e.g.., education, mental health, financial support, family network, etc.) in reports to better understand the safety signal and adverse events
10. Session #3: Knowledge Translation to Patients
Health Canada provided an overview of labelling requirements for breast implants to illustrate Health Canada’s role in providing medical device safety information to patients. In addition, Health Canada’s risk communication tools for health products with potential or existing health risks were also discussed. As a demonstration, Health Canada shared the recently published safety alert for breast implants to obtain the Committee’s input and additionally proposed improvements of the Health Product Complaint Form (FRM-0317) to make it more user friendly and easily accessible.
11. Session #3 - Committee Deliberations Summary
Knowledge Transfer to Patients and Healthcare Professionals
- Present clear statements on the benefits, risks, uncertainties of the health products, and the limitations of Health Canada’s’s regulatory review, realistic images and real life personal experiences to ensure full informed consent
- Better inform healthcare professionals on Health Canada’s reporting process for adverse reactions
- Construct patient focus groups for pertinent subpopulations (e.g., adolescent females, lactating/pregnant women, cancer survivors, transgender, geriatric females, etc.)
- Ensure Health Canada-reviewed information is clearly distinguishable from the manufacturer’s information on patient labels (e.g., brochures, information for users, etc.)
- Indicate on the label the type of clinical data used to authorize a medical device (e.g., front label statement “not tested in women”)
- Update individuals on the reporting outcomes and actions from the report to incentivize consumers and patients to report directly to Health Canada
- Consult with academics whose research examines best practices for decision-support tools
- In the risk communication piece, provide a full range of alternative health product/intervention options to patients so they are aware of alternatives
- Patient and consumer risk communication pieces should convey the same risk information
- Upcoming regulation of mandatory reporting by hospitals is a good first step, but given the proliferation of private surgical clinics and use of office out-patient clinics, these sites need to be included. This could be done by the Colleges, requiring such reporting from such sites and staff. Mandatory reporting for other aspects of care is already in place.
12. Closing Remarks and Adjournment of Meeting
The Chair of SAC-HPW provided an overall summary of advice from the meeting. The comments to the Terms of Reference were incorporated into an updated version and was approved by the Committee and Health Canada Management Committee. In addition, the Committee provided the some suggestions for potential agenda topics for future meetings to Health Canada. The Chair thanked the members for their contributions and closed the meeting.
The Record of Proceedings (RoP) is available upon request. Please submit your request to: email@example.com.
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