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.

Another reason for opening this conversation, according to the FDA, is to help set clearer lines defining manufacturer obligations and distinguishing them from third-party obligations.

OEMs have requested clarification with regard to their responsibilities when third-parties repair, service, or refurbish devices they manufactured. While, for its part, the FDA said it is "interested in learning more about the challenges third-party entities face in maintaining or restoring devices to their original specifications."

The following seven questions are posed in the docket. Answers submitted will help the FDA evaluate risks associated with the activities it is hoping to refine its definitions of.

1. Who are the different stakeholders involved with the medical device activities listed previously? What are their respective roles?

2. What evidence exists regarding actual problems with the safety and/or performance of devices that result from these activities? Specific examples should be submitted.

3. What are the potential risks (patients/users) and failure modes (devices) introduced as a result of performing the previously defined activities on medical devices? Please speak to issues common to all devices as well as specific risks with specific devices.

4. These activities are performed by OEMs and various third-party entities, including hospitals and humanitarian organizations. Are the risks different depending on who performs the previously mentioned activities?

5. We are interested in knowing if these activities are more difficult or riskier to perform on certain devices versus others. Please cite specific examples in your response, along with an explanation of the source of this particular complexity.

6. 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? Please provide specific examples.

7. What additional challenges do stakeholders encounter with devices that result from these activities?

At this point it is too early to tell what the repercussions of this docket might be, but the FDA has stated that the core interest propelling the discussion is patient safety. In addition, the FDA said it will hold a public meeting later in the year in order to further engage stakeholders on these terms.

To view the docket on the FDA website or contribute comments to it, click here and enter "FDA-2016-N-0436" into the search bar. HCB News will be following the FDA and reporting on new developments as they happen.