Posted 03 March 2016
By Zachary Brennan
The US Food and Drug Administration (FDA) on Thursday announced that it’s seeking more information on medical devices that are refurbished, reconditioned, rebuilt, remarketed, remanufactured, serviced or repaired in order to investigate a number of potential safety issues.
The call for more information comes as manufacturers of devices that are being refurbished by other companies have also requested clarification of their responsibilities when their devices have been altered.
“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,” FDA said. “Possible public health issues arising from these activities include ineffective recalls, disabled device safety features, and improper or unexpected device operation.”
FDA is interested in comments concerning the service, maintenance, refurbishment and alteration of medical devices, including endoscopes, some of which FDA has recalled in recent months because of contamination issues.
In addition, FDA says it wants to know more about the challenges third-party entities face in maintaining or restoring devices to their original or current specifications, though this docket for public comment is not intended to address the reprocessing of single-use or reusable medical devices.
The following questions address some of what FDA is interested in discussing on these devices: Who are the different stakeholders involved with these types of medical device activities? What are their respective roles? What evidence exists regarding actual problems with the safety and/or performance of devices that result from these activities? What are the potential risks (patients/users) and failure modes (devices) that result from performing the previously defined activities? What information do third-party entities need in order to perform these activities in a way that results in safe and effective operation of the medical device? Specific examples should be submitted, the agency says.
In addition to general comments, FDA is asking for assistance in defining and revising the definitions for the following terms:
- Recondition: “Restores and/or refurbishes a medical device to the OEM’s [original equipment manufacturer] original specifications. Under limited circumstances the medical device may be restored and/or refurbished to current specifications.”
- Service: “Maintenance or repair of a finished device after distribution for purposes of returning it to the safety and performance specifications established by the OEM and to meet its original intended use. Servicing cannot change the intended use(s) of the device from its original purpose(s).”
- Repair: “Return the device or component to original specifications including replacing non-working components or parts outside of routine or periodic upkeep for the current owner of the device.”
- Refurbish: “Restore device to a condition of safety and effectiveness that is comparable to when new. This includes reconditioning, repair, installation of certain software/hardware updates that do not change the intended use of the original device, and replacement of worn parts.”
- Remanufacture: “Process, condition, renovate, repackage, restore, or any other act done to a finished device that significantly changes the finished device’s performance, safety specifications, or intended use.”
- Remarket: “The act of facilitating the transfer of a previously owned device from one party to another by sale, donation, gift, or lease.”
FDA also said it intends to hold a public meeting later in 2016 to further engage the device industry and healthcare community.
Federal Register Notice