AAMI Seeks Comments on Draft White Paper Post-Market Risk Management
According to a press release dated 12 February, 2015, AAMI has-released a draft white paper that spells out six specific risk principles that the medical device industry and the U.S. Food and Drug Administration (FDA) ought to consider in post-market risk management.
https://www.aami.org/news/2015/021115_Press_AAMI_Seeks_Comments_on_Risk_Management.html
The draft paper was developed by AAMI in coordination with a working group of U.S. industry representatives and FDA regulators, and 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.
The draft paper titled Risk Principles and Medical Devices: A Post-Market Perspective can be downloaded at https://www.aami.org/hottopics/risk/AAMI/020615_AAMI_risk_white_paper_draft.pdf.
AAMI is requesting that comments be emailed to Mary Logan at [email protected] and Lauren Clauser at [email protected]. The deadline to submit comments to AAMI is 20 May, 2015.
Members of Medical Device Risk Management forum are welcome to discuss the draft AAMI white paper and the proposed Risk Principles here, particularly as they relate to the globally harmonised risk management process of ISO 14971.
...continued: "Several of the industry experts expressed that they would like to carry the risk principles further to provide standards for risk evaluation by codifying what are defensible judgments, in order to harmonize industry and regulatory perspectives on this important point. This was not discussed at any length and may or may not become part of further work. It is included here to memorialize the request from industry to address it." ...Stating the obvious is alright but, "memorialization" merits action. "Some industry experts would like to work on a definition of “baseline,” which is a term used by CDRH but not by industry." ....This need is obvious.
If the purpose of this white-paper is emphasize the need for more work, it is successful. It does a good job of discovering the shortcomings and disconnects to date. Specifically some examples: "There were too many possible factors to explain each one. It is still worth sharing the long list because it represents the best thinking of the industry and CDRH experts who did this work together." --- It is a finite list and explanations are possible and needed. "If a newer product has increased benefit, does previously acceptable risk ever become no longer acceptable?" --- Industry has been baffled by this state-of-the-art requirement a very long time. "Whether reliability and quality issues will impact safety..." Totally ambiguous. "Likely/known off-label uses and misuses..." Again the industry has it's hands tied with this issue. Once in the user's hands, are manufacturers really liable? "How long on market without updates/change..." Again state-of-the-art ambiguity. "How to make precedents more transparent so industry can learn from them." This appears to be a very key issue in that this is a direct path to preventing failing pre-market risk analysis. Several of the industry experts expressed that they would like to carry the risk principles further to provide standards for risk evaluation by codifying what are defensible judgments, in order to harmonize industry and regulatory perspectives on this important point. This was not discussed at any length and may or may not become part of further work. It is included here to memorialize the request from industry to address it. Some industry experts would like to work on a definition of “baseline,” which is a term used by CDRH but not by industry.
Retired at Menson and Associates LLC
9 年James, thanks for posting this. It needs wide spread input.