The Association for the Advancement of Medical Instrumentation (AAMI) is seeking comments on a just-released draft whitepaper that spells out six specific risk principles that the medical device industry and the Food and Drug Administration (FDA) ought to consider in post-market risk management.
The 15-page paper, developed by AAMI in coordination with a working group of industry representatives and federal regulators, is intended to articulate “a shared view of risk” with the ultimate goal of better coordination and understanding between manufacturers and regulators when it comes to post-market activities, such as medical device recalls.
“It is hoped that a shared view will minimize the differences in analyses of risk and resulting conclusions reached by industry and CDRH [Center for Devices and Radiological Health] related to appropriate remedial actions,” reads the paper. “A common and consistent approach to risk will optimize and expedite patient care.”
The draft paper, “Risk Principles and Medical Devices: A Post-Market Perspective,” comes ahead of an anticipated spring public workshop on the subject of post-market risk management by the CDRH, the arm of the FDA responsible for oversight of the medical device industry.
The focus on risk principles stems from a belief shared by the working group members that there can be little, if any, progress in making headway on sometimes contentious post-market quality and safety issues until there is agreement on what industry and the agency should keep in mind in the first place.
“We hope this white paper enriches the vital conversation on risk management,” says AAMI president Mary Logan. “More collaboration and understanding on expectations between industry and regulators can only mean a smoother process with post-market compliance issues and will help to enhance patient safety.”
The six risk principles identified in the white paper are:
1. Evaluation and Judgment. The emphasis here is making an “informed” judgment by looking at an assortment of data, including (but not limited to) experience with the device, company standards, the history of similar devices, and potential planned mitigations.
2. Loss of Benefit Assessment. In short, “multiple benefit/risk scenarios” must be considered “in order to arrive at the optimal outcome.”
3. Populations. Are there subpopulations included in the “indication for use” at greater risk or benefit than the overall population?
4. Use Environment and Clinical Assessment. The context of the environment in which the device will be used must be part of the evaluation.
5. Communication. Risks and problems associated with any given device “should be communicated effectively to relevant stakeholders.”
6. Recovering Loss of Benefit and Mitigation. What can be done to “return the benefit of the device to acceptable levels”?
Logan emphasized the importance of collecting comments from all stakeholders on the ideas expressed in the paper. The deadline to submit comments, which may be e-mailed to Logan at [email protected] and Lauren Clauser at [email protected], is May 20, 2015.
“Now is the time for all participants in post-market compliance activities to weigh in and help to harmonize expectations between the FDA and industry,” Logan says. ”The more feedback we receive on this draft paper, the better the end result will be.”
The working group’s discussion identified a number of other next steps. They include deciding how to “weigh” the risk principles; how to handle the recall of products with compliance issues (technical violations); how to make precedents more transparent so that industry can learn from them; and to what extent an existing standard on risk management to medical devices (AAMI/ANSI/ISO 14971) should be changed to include more post-market issues to help both industry and regulators.
The whitepaper includes many other next steps, as well as details on the risk principles themselves. The working group was comprised of representatives selected by three national industry trade associations—AdvaMed, the Medical Imaging & Technology Alliance (MITA), and the Medical Device Manufacturers Association (MDMA)—as well as representatives selected from the FDA and AAMI.
The white paper is but one example of AAMI’s leadership in focusing attention on the issue of risk management in the medical device world. The spring edition of Horizons, AAMI’s biannual supplement, will focus on the issue, as will a joint AAMI/FDA summit planned for Sept. 29-30, 2015.