FDA Rejects Push for New Regulatory Action on Medical Device Service


Posted May 15, 2018

The Food and Drug Administration (FDA) has concluded that there is insufficient evidence to justify imposing additional regulations on third-party servicers of medical devices. The announcement came this morning with the publication of a highly anticipated report on the quality, safety, and effectiveness of medical device servicing that was required as part of the FDA Reauthorization Act of 2017.

“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,” the FDA wrote in the report.

Despite this lack of evidence, the FDA said it does not intend to extend medical device reporting requirements to third-party service providers or require registration by such entities.

“We do not believe this information alone would address the outstanding fundamental questions regarding the quality, safety, and effectiveness of servicing,” the FDA stated in the report.

Some original equipment manufacturers had pushed the FDA for expanded regulatory oversight in this area, saying there have been significant problems with the quality of service by some third-party servicers, an assertion vigorously rejected by those vendors.

Although the agency does “not believe that additional, formal regulatory action is warranted,” it did provide a list of actions it intends to pursue. These are:

  • Promoting the adoption of quality management principles, including new and existing quality management standards and best practices.
  • Clarifying the difference between servicing and remanufacturing through future guidance that will allow for “more consistent interpretation and categorization.”
  • Strengthening cybersecurity practices associated with the servicing of medical devices.
  • Fostering a multi-stakeholder approach to evidence development to assess the quality, safety, and effectiveness of medical device servicing.

AAMI President and CEO Robert Jensen said several aspects of the FDA report align with initiatives being pursued by the association.

“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 healthcare. 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.”

However, not all stakeholders were as positive in their assessment of the report. The industry trade association AdvaMed said the FDA had not gone far enough with its recommendations and called on Congress to step in.

“Today’s report from the FDA was disappointing, given the agency’s decision not to exercise its authority over unregulated third-party servicers. The limited actions proposed in FDA’s report, while welcome, do not go far enough to effectively address the scope of the problem,” said AdvaMed’s Chief Advocacy Officer JC Scott in a statement. “We call on Congress—at a minimum—to require third-party servicers to follow FDA quality systems, adverse event reporting, and registration regulations. This action will help improve patient safety and provide the assurance the American public deserves that the medical devices and equipment it relies on are being serviced to the highest standards.”

The FDA is accepting comments on the report (docket FDA-2018-N-1794) until Nov. 12 via www.regulations.gov.