The FDA has announced a new initiative to better define the terms and safety issues associated with refurbished medical devices, as well as draw a clearer line distinguishing the responsibilities of original manufacturers from the responsibilities of third-party entities.

To do this, the administration has opened a docket (which closes on May 3) inviting "the widest range of interested persons" to chime in and share their thoughts, perspectives and opinions.

The docket is not intended to address the reprocessing of single-use or reusable medical devices, (for which the FDA already issued final guidance last year). Instead, the devices in question are endoscopes and radiation-emitting devices subject to the electronic product radiation control (EPRC) provisions of the federal Food Drug and Cosmetic Act — including radiography, fluoroscopy and CT equipment.
According to the FDA, stakeholders have voiced concern regarding the possibility of unqualified personnel performing service, maintenance, refurbishment and device alterations on medical devices without adequate documentation.

Among other things, the docket will examine and refine the following definitions:

Recondition: Restores and/or refurbishes a medical device to the OEM's 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.

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