The FDA has released its report “FDA Report on the Quality, Safety, and Effectiveness of Servicing of Medical Devices In accordance with Section 710 of the Food and Drug Administration Reauthorization Act of 2017 (FDARA).”
The executive summary of the report states: “We believe the currently available objective evidence is not sufficient to conclude whether or not there is a widespread public health concern related to servicing of medical devices, including by third party servicers, that would justify imposing additional/different burdensome regulatory requirements at this time. Although we do not believe that additional, formal regulatory action is warranted, based on the available information and findings, we intend to pursue the following actions:
Download a PDF of the report here.
AAMI and others have responded to the report, according to a news item on the AAMI website.
AAMI President and CEO Robert Jensen welcomed the FDA report.
“We’re still analyzing the full FDA report, although it looks like a significant positive step toward progress in the servicing of medical devices,” Jensen said. “The emphasis appears to be on using data to make informed decisions, and that’s an idea central to the very essence of safety in health care. There is a strong commitment on the part of the FDA to promote quality management principles and strengthen cybersecurity practices. Here at AAMI, we’re addressing those ideas in the revision to the standard ANSI/AAMI EQ56. In addition, AAMI has plans to develop a medical device servicing guide to provide the stakeholder community an opportunity to pilot and give feedback on actionable, pragmatic quality management practices and potential evidence development. We encourage all stakeholders to read the FDA report in full and consider how they can contribute to the shared goal of safe and effective servicing of medical devices.”
AAMI’s medical equipment management (EQ) standards committee is proposing a revision to the existing EQ56 standard, which focuses on recommended practices for medical equipment management programs. The proposed revision would build on the standard to include quality management principles and address cybersecurity practices.
“It is encouraging to see that the direction the EQ committee is taking mirrors the priorities the FDA listed in its report,” said Patrick Bernat, director of HTM standards at AAMI. “There is a direct connection between what we are planning to do and what the FDA says needs to be done.”
The FDA also is looking into creating a public-private forum to “address the challenges associated with delivering high quality, safe, and effective servicing of medical devices,” saying: “If there is sufficient interest and broad willingness to participate by stakeholder groups, we would facilitate the creation of such a community.”
Stephen Grimes, managing partner and principal consultant for Strategic Healthcare Technology Associations LLC, commended the FDA for its focus on collaboration.
“The FDA’s report on quality, safety, and effectiveness of medical devices was thoughtful in its findings and measured in its planned next steps. I believe the HTM community will find much to like and support in the report,” Grimes said. “I believe we should applaud the FDA’s efforts here and appreciate that they are willing to first try ‘collaboration’ rather than ‘regulation’ in the matter of ensuring service quality, safety, and effectiveness.”
The International Association of Medical Equipment Resellers and Servicers (IAMERS) vowed to help move the discussion forward.
“IAMERS is grateful for the FDA’s thoughtful review in its report today of the comments and information supplied by IAMERS,” said Robert J. Kerwin, general counsel for the group. “IAMERS hopes to continue to work with FDA on quality management systems and best practices. IAMERS welcomes the establishment by FDA of ‘Collaborative Communities’ as mentioned in the report and pledges to participate as FDA has recognized the contributions and importance of third-party independent servicers to the healthcare ecosystem.”
The FDA is accepting comments on the report (docket FDA-2018-N-1794) until Nov. 12 via www.regulations.gov.
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