The FDA has scheduled a two-day public workshop this fall to tackle complex questions related to the third-party servicing and refurbishment of medical devices.
The Association for the Advancement of Medical Instrumentation (AAMI) reports that the topic has already generated passionate debate in the healthcare technology community; multiple stakeholders, including original equipment manufacturers (OEM) and large health care systems, have offered different perspectives on how to support patient safety and control costs in an environment where organizations vary in how they repair and generally maintain devices.
Titled “Refurbishing, Reconditioning, Rebuilding, Remarketing, Remanufacturing, and Servicing of Medical Devices Performed by Third-Party Entities and Original Equipment Manufacturers,” the workshop is scheduled for October 27-28 at the FDA’s campus in Silver Spring, Md. The registration deadline for the workshop is Sept. 23.
The planned workshop follows the FDA’s announcement in March that it was collecting comments from all interested parties on this issue because of safety concerns, particularly as it relates to the use of third-party entities. That notice generated 176 comments.
“FDA is currently reviewing all of the comments and will use them to inform a set of working questions designed to promote an understanding of challenges and best practices to mitigate risks associated with these activities,” the agency said in a Federal Register notice about the October workshop.
In the notice, the agency said that the goals of the workshop include establishing working definitions for third-party and OEM activities; discussing benefits, challenges, and risks for stakeholders; identifying best practices when it comes to third-party activities; and determining whether “specific procedures are necessary for each activity as it relates to third-party services performed.” The big question for many observers is how far the FDA might go in terms of regulatory action.
AAMI was one of many organizations to submit comments to the FDA, and the association provided an overview of the service industry, taking note of the different players and perspectives. AAMI also noted its general preference for “standards over regulation” in tackling problems related to health care technology.
Additionally, AAMI had urged all stakeholders to weigh in with fact-based comments. AAMI President Mary Logan stresses the need for inclusive participation at the workshop itself. “We need to have the complete diversity of perspectives represented—OEMs, parts companies, HTM professionals, and other stakeholders,” Logan says.
To register for the FDA workshop, click here.