In a move that has already generated vigorous discussion on 24×7’s Web site, the Food and Drug Administration (FDA) on March 4 issued a request for comment on the “Refurbishing, Reconditioning, Rebuilding, Remarketing, Remanufacturing, and Servicing of Medical Devices performed by Third-party entities and Original Equipment Manufacturers.”
While the motive is not entirely clear, the proposed rule published in the Federal Register states, “FDA is taking this action, in part, because various stakeholders have expressed concerns about the quality, safety, and continued effectiveness of medical devices that have been subject to one or more of these activities that are performed by both original equipment manufacturers (OEM) and third parties, including healthcare establishments.”
The notice goes on to state that “some third-party entities…may use unqualified personnel to perform service, maintenance, refurbishment, and device alterations on their equipment and…the work performed may not be adequately documented. Possible public health issues arising from these activities include ineffective recalls, disabled device safety features, and improper or unexpected device operation. OEMs have also requested clarification of their responsibilities when their devices have been altered by a third-party entity.”
The FDA is soliciting stakeholders to address a range of issues, including:
- Specific examples of problems related to the safety or performance of devices resulting from the specified activities
- Potential risks and failure modes introduced by performing the previously defined activities
- How risk varies depends on who performs a given activity (ie, OEMs versus third parties, including hospitals)
- What information third parties need in order to ensure these activities result in safe and effective operation of the medical device
Comments may be submitted electronically or in writing through May 3, 2016.
As William Hyman noted in his article about the proposed rule on the 24×7 Web site, the comment period’s “potential outcomes could include no changes in the current service situation from the FDA perspective, greater regulation of third-party entities, and/or requirements for more useful and complete information from manufacturers to ISOs.”
I encourage you to review the FDA’s notice and to submit your feedback during the comment period. OEMs are sure to do so—it is likewise vital that any evaluation of repair and maintenance activities at the hospital and ISO level include input from relevant stakeholders. After all, if the outcome could affect you, you ought to have a say. Seize this opportunity.
Jenny Lower is chief editor of 24×7. Contact her at firstname.lastname@example.org.