Diving into what can be a contentious debate, the Association for the Advancement of Medical Instrumentation (AAMI) reports that the Food and Drug Administration (FDA) is gathering information from original equipment manufacturers (OEMs), third-party companies, and the healthcare community about the refurbishment, reconditioning, rebuilding, remarketing, remanufacturing, and service of medical devices ahead of a public meeting that will be held on this topic later this year. In particular, the agency is interested in learning more about the service, maintenance, refurbishment, and alteration of medical devices, such as endoscopes and radiation-emitting devices, and the impact these activities have on patient safety.
“Stakeholders have expressed concerns that some third-party entities who refurbish, recondition, rebuild, remarket, remanufacture, service, and repair medical devices may use unqualified personnel to perform service, maintenance, refurbishment, and device alterations on their equipment and that the work performed may not be adequately documented,” according to the FDA’s proposed rule. “Possible public health issues arising from these activities include ineffective recalls, disabled device safety features, and improper or unexpected device operation.”
The FDA would also like to hear about the challenges third-party entities and other professionals face while maintaining or restoring devices to their original or current specifications. AAMI president Mary Logan said that the FDA’s initiative highlights a topic of considerable interest and debate within healthcare technology circles.
“This is a very important conversation that the FDA is starting, and we applaud the agency’s interest. There are many opinions about service and repair, and what we hope the conversation will bring out is data that will support a strong analysis of the issues,” Logan said. “The timing is also perfect, following shortly on the heels of AAMI’s November 2015 event on the supportability of medical devices.”
The agency has drafted a list of questions it is seeking answers to: Who are the different stakeholders involved with the medical device activities listed previously? What are their respective roles? What evidence exists regarding actual problems with the safety and/or performance of devices that result from these activities? Specific examples should be provided. What are the potential risks to patients or users and the failure modes introduced as a result of performing the previously defined activities? These activities are performed by OEMs and various third-party entities, including hospitals and humanitarian organizations. Are the risks different depending on who performs them? Are these activities more difficult or riskier to perform on certain devices than others? What information do third-party entities need in order to perform these activities in a way that results in the safe and effective operation of the medical device? What additional challenges do stakeholders encounter with devices that result from these activities?
In addition, the FDA would like input and suggestions for the definitions of terms included in this rule: recondition, service, repair, refurbish, remanufacture and remarket. Of note, the agency said that this proposal would not deal with the reprocessing of medical devices. Comments can be submitted through regulations.gov until May 3.