AAMI recently held its AAMI/FDA Risk Management Summit in Herndon Va, which brought together more than 200 risk management experts, regulators, educators, and leaders in the medical device industry and healthcare delivery. The goal of the 2-day summit was to build a shared perspective on risk management and identify existing challenges and barriers to effective practices.
AAMI reports that the topic addressed by the final panel at the event underlined the perspective of a majority of summit participants—that risk management needs to be embraced as a crucial component of product development and support in healthcare technology, and not viewed simply as a box to check to satisfy regulatory requirements.
Many panelists reportedly admitted to having more questions for the group than answers. However, they agreed that risk management must extend beyond a failure modes and effects analysis (FMEA) or a file submitted to the US Food and Drug Administration (FDA); it must be a vital part of a product’s lifecycle. According to AAMI, risk management has largely been viewed as a regulatory requirement codified in the FDA’s Quality System Regulation (21 CFR 820) and preamble, and addressed in the standard ANSI/AAMI/ISO 14971 and other guidance documents.
Presenter Tina Krenc, the director of R&D Quality Assurance at Abbott Laboratories, provided a larger view of risk management. She said the process should never stop: Rather, it should begin during the research and development phase and continue all the way through product retirement.
A key challenge with the early implementation of risk management, according to many presenters, is that there is no perceived engineering benefit to it. Some presenters revealed that many companies view risk management as “just more paperwork,” and many participants agreed that a stack of documents is not usually seen as a measurement of success.
As a counterargument, some presenters noted that a problem that costs thousands of dollars to fix early in the concept, definition, and design stages could grow into a $300,000 to $500,000 problem if not addressed.
The general consensus among presenters at the summit was that industry stakeholders need to reshape how risk management is perceived. Representatives of risk management groups emphasized that they likely need to revise their marketing in order to convince investors that risk management is in their best interest from the start. There is a need to characterize risk management as “value added” rather than a necessary evil, they said.
AAMI reported that this was the seventh summit it has hosted in partnership with the FDA that addressed a major issue affecting the healthcare technology community. A full report of the summit proceedings and priority actions will be published in late 2015 to help guide future initiatives on this issue. For details, see the original news release on the AAMI website.
