The U.S. FDA has ruled that there is insufficient evidence to currently “justify imposing additional/different burdensome regulatory requirements” on third-party servicers of medical devices. The decision appeared in the agency’s report on the quality, safety, and effectiveness of medical device servicing—which was mandated as part of the FDA Reauthorization Act of 2017.
In the report, the FDA said the agency didn’t come to this decision lightly; it considered information presented at a public workshop, as well as responses to a request for comments, and evaluated evidence related to the quality, safety and effectiveness of medical device security.
After all, the FDA wrote: “Stakeholders have differing views about the quality, safety, and effectiveness of servicing performed by original equipment manufacturers (OEMs) and third-party entities, and the need for imposing additional regulation.”
Based on this information, the agency said that it has concluded:
- The currently available objective evidence is not sufficient to conclude whether or not there is a widespread public health concern related to servicing, including by third party servicers, of medical devices that would justify imposing additional/different, burdensome regulatory requirements at this time.
- The objective evidence indicates that many OEMs and third-party entities provide high quality, safe, and effective servicing of medical devices.
- Most comments, complaints, and adverse event reports alleging that inadequate “servicing” caused or contributed to clinical adverse events and deaths actually pertain to “remanufacturing” and not “servicing”.
- The continued availability of third-party entities to service and repair medical devices is critical to the functioning of the U.S. healthcare system.
Still, despite the fact that the FDA does “not believe that additional, formal regulatory action is warranted,” the agency said that it will:
- Promote the adoption of quality management principles
- Clarify the difference between servicing and remanufacturing
- Strengthen cybersecurity practices associated with the servicing of medical
- Foster evidence development to assess the quality, safety and effectiveness of medical device servicing
Further, the FDA revealed that as part of its 2018-2020 strategic priorities, the agency’s Center for Devices and Radiological Health is seeking to establish so-called “Collaborative Communities.” “We believe there may be value in the creation of a public-private forum, such as a Collaborative Community, to address the challenges associated with delivering high-quality, safe, and effective servicing of medical devices,” the FDA wrote in the report. If stakeholder groups are willing to get behind this, the FDA said it will facilitate the creation of a Collaborative Community.
To AAMI President and CEO Robert Jensen, the FDA’s report is a step in the right direction. Although he says AAMI is still analyzing the full report, “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.”
“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,” Jensen adds. To read the report in its entirety, click here.