Summary Report: Stakeholder Consultation Workbook for the Medical Devices Inspection Cycle
Health Canada has been conducting a review of its medical devices inspection program for Medical Device Establishment Licence (MDEL) holders in an effort to develop a risk-based inspection cycle. As part of this review, Health Canada consulted with stakeholders during the fall of 2011. This report provides a summary of the feedback that was received both from on-line consultations, and from participants of the Medical Devices Program information sessions held in Halifax, St-John's, Vancouver, Calgary, Winnipeg, Toronto and Montreal. In total, ten responses were received from ten participants, one of which was from a medical device industry association.
The on-line consultation workbook was available through the Health Canada website from August 15 through to November 16, 2011. As part of the consultation workbook stakeholders were asked to comment on four options for scheduling inspections.
Option one proposed using a series of risk factors to classify each MDEL holder into a quantitative risk category; Option two proposed classifying MDEL holders based on risk associated with the activities conducted (For example : manufacturing, importing or distributing) and previous inspection results; Option three proposed classifying MDEL holders based on the risk associated with the activities conducted and the type of device being manufactured/sold (For example : Risk Class I-IV); and Option four proposed classifying MDEL holders based on the risk associated with the activity, device type and previous inspection results. The feedback received is summarized below.
Option One: A series of risk factors classifies each MDEL holder via a quantitative risk - based approach.
Almost half of the respondents did not approve of this option. Although this took into account a series of risk factors, it did not consider every aspect of risk associated with medical device establishments. Additionally, stakeholders felt this option was not significantly different from the current inspection framework.
Option Two: Activities conducted and previous inspection results
This option was not approved by about half of the respondents. Despite this fact, there was agreement that activities conducted and the results of previous inspections should be considered when measuring the risk posed by the establishment. The Concerns that participants had with this option, was that it did not consider the risk class of devices (I-IV) being imported/distributed, and it was felt that new establishments should be inspected within the first year of operation.
Option Three: Activity and risk class based
This option considered both the activities conducted by an establishment as well as the risk class of devices being manufactured or sold. This was the least favoured option as it did not consider the compliance history of an establishment.
Option Four: Intrinsic and compliance risk
This option was only slightly more favourable then Option Three. It considered establishment activity, risk class of devices and previous inspection results. However, participants felt it was the most complex. Companies with same activities and same device risk class could end up having a different inspection cycle based on their compliance history, and there was a concern that biases held by a compliance officer may render this approach too opinion-dependent.
Participants indicated that the following items should be considered when evaluating the risk associated with an establishment :
- the activities conducted by an establishment
- compliance history
- history of addressing previous deficiencies
- diligence in filing mandatory problem reports
- if the establishment is newly licensed
They felt that other proposed indicators of risk should not be considered. For example, concerns raised by the media or public opinion may not always be reliable or accurate. Similarly, a change in company management is not necessarily associated with an increase in risk.
Participants indicated that between two to five years was an appropriate inspection cycle for manufacturers, importers and distributors depending on the activity. They also felt that Health Canada should inspect establishments that do not have International Standards Organization (ISO) certification more frequently than those who do.
Participants acknowledged that it may not be feasible to inspect companies prior to issuing an MDEL. However, they indicated that new establishments should be inspected within the first year of their operation.
When asked about an alternative or proposal for risk-based cycle, suggestions were that Health Canada impose ISO requirements on distributors/importers and consider inspection programs that have been adopted for other types of health products.
On the question regarding expectations in relation to service standards, participants indicated that they would like the final inspection report to be issued within 5 days and that the establishment response letter should be submitted within 30 to 45 days from the final inspection report.
Stakeholder comments were reviewed by the Inspectorate, and were instrumental in developing the new Medical Devices Inspection Cycle. The general comments provided by stakeholders were of particular value, and led to a model that is a hybrid of the options described above. The details of this cycle, which was implemented in April, 2012, can be found in the Health Canada document "Policy for the Inspection of Medical Device Companies".
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