March 2015

Post-Market Risk Management: AAMI Seeks Comments on Document

A draft white paper developed by AAMI and a working group of industry partners and federal regulators spells out six specific risk principles that medical device manufacturers and the U.S. Food and Drug Administration (FDA) ought to consider in post-market risk management.

AAMI is seeking public feedback on the 15-page paper, titled “Risk Principles and Medical Devices: A Post-Market Perspective,” which is intended to articulate a mutual view of risk, with the ultimate goal of better coordination and understanding between manufacturers and the FDA’s Center for Devices and Radiological Health (CDRH). That could lead to less contention when it comes to post-market quality and safety issues, such as recalls.

“If CDRH and industry have a shared view of risk based on a common set of risk principles, then less time will be lost resolving differences in understanding between regulators and industry, as well as all other stakeholders who are involved with or impacted by post-market safety and device quality issues,” according to the paper. “A common and consistent approach to risk will optimize and expedite patient care.”

The six risk principles identified in the white paper are:

  1. Evaluation and Judgment. The emphasis hereis 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 whichthe 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”?

ANSI/AAMI/ISO 14971:2007/(R)2010, Medical devices—Application of risk management to medical devices

  • List: $170
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  • Order Code: 14971

To order, call 1-877-249-8226 or link to the AAMI Store.

The CDRH plans to elicit additional feedback from stakeholders during an anticipated spring public workshop on post-market risk management. AAMI President Mary Logan hopes this white paper can inform future conversations on risk.

“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 said. ”The more feedback we receive on this draft paper, the better the end result will be.”

The deadline to submit comments, which may be e-mailed to Logan at mlogan@aami.org and Lauren Clauser at lclauser@aami.org, is May 20, 2015. The paper is available here at in the Risk Management Hot Topic area.

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 (ANSI/AAMI/ISO 14971) should be changed to include more post-market issues to help both industry and regulators.

The working group was comprised of representatives selected by three national industry trade associations—AdvaMed, Medical Imaging Technology Alliance, and the Medical Device Manufacturers Association—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 plannned for Sept. 29-30, 2015.