FDA Seeks Industry Feedback On Refurbished Medical Devices

By Jof Enriquez,
Follow me on Twitter @jofenriq

The U.S. Food and Drug Administration (FDA) is soliciting information from companies and third-party entities who refurbish, recondition, rebuild, remarket, remanufacture, service, and repair medical devices.

In a docket issued in the Federal Register, FDA stated that "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 health care establishments."

Specifically, stakeholders are concerned that third parties engaged in the aforementioned activities may use unqualified personnel to perform service, maintenance, refurbishment, and device alterations on medical devices without adequate documentation.

"Possible public health issues arising from these activities include ineffective recalls, disabled device safety features, and improper or unexpected device operation," FDA stated.

The agency said it wants to seek responses to stakeholders' concerns from third-party entities, and find out the challenges third parties face in maintaining or restoring devices to their original or current specifications. FDA said OEMs also requested that the agency clarify companies' responsibilities when third parties repair, service, or refurbish their manufactured devices.

Although similar, this docket is not intended to address the reprocessing of single-use or reusable medical devices, for which FDA already issued final guidance last year.

According to RAPS, FDA is seeking comments and suggestions to help define key terms pertaining to activities performed to medical devices, including, but not limited to:

• 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.”

Also, FDA is inviting interested persons to comment on the benefits and risks related to those defined activities, including such key issues as:

• Existing evidence regarding actual problems with the safety and/or performance of devices that result from aforementioned activities
• Potential risks (patients/users) and failure modes (devices) introduced as a result of performing the previously defined activities on medical devices
• Information third-party entities need in order to perform these activities for the safe and effective operation of the medical device

Above issues and public comments received will be discussed at a public meeting later in 2016, according to FDA.