FDA Remanufacturing Workshop Promotes Continued Collaboration


Posted December 18, 2018

FDA Remanufacturing Workshop Flowchart
The FDA's proposed thought process for evaluating if an activity is servicing or remanufacturing. Expand.

When it comes to the longstanding debate surrounding medical device servicing, original equipment manufacturers (OEMs), independent service organizations, healthcare technology management (HTM) professionals, and others affected by this issue don’t always see eye to eye. However, all agree on the importance of medical device safety and effectiveness.

It was with that spirit that stakeholders put their heads together at a Dec. 10–11 public workshop hosted by the Food and Drug Administration (FDA) in Gaithersburg, MD, with the goal of discussing the distinction between medical device servicing and remanufacturing. The FDA intends to use feedback from the workshop and a public docket to issue draft guidance in 2019.

According to a white paper published prior to the event, the FDA defines servicing as “the repair and/or preventative or routine maintenance of one or more parts in 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,” while remanufacturing constitutes “processing, conditioning, renovating, repackaging, restoring, or any other act done to a finished device that significantly changes the finished device’s performance or safety specifications, or intended use.”

During the workshop, stakeholders applied a flowchart from the white paper to real-world situations, such as patching a small hole in the liquid helium reservoir of a magnetic resonance system. The goal was to explore how decision points and definitions would be interpreted by different groups across the various scenarios, as well as to provide feedback.

“Some activities are clearly servicing, while others are clearly remanufacturing. But some activities can fall into a gray area in which it’s less clear which category the activity falls under,” said Patrick Bernat, director of HTM standards at AAMI. “There seems to be a shared commitment from the various stakeholders to work together on the issues that have been identified surrounding medical device servicing and remanufacturing and develop solutions. Ultimately, the main outcome from the workshop was some established groundwork for continued discussions and future collaboration.”

The formation of a “collaborative community” to address the challenges associated with delivering high quality, safe, and effective servicing of medical devices was proposed by the FDA in a congressionally mandated report about the issue published in May 2018. The report said that “available objective evidence” did not support concluding there is (or isn’t) a systemic problem with third-party service of medical devices; it also noted a need for more “robust, systematically-collected, quantitative data.”

During this month’s workshop, Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, said that medical device servicers “play a critical role” in ensuring that devices remain high quality, safe, and effective but that “there are differing perspectives about what, if any, steps should be taken to ensure or continue to ensure high-quality servicing.”

“Regardless, I think we can all appreciate that technology and our ecosystem continually change and, even in the absence of overt problems, we must continue to evolve,” Shuren said.

Samantha Jacques, director of clinical engineering at Penn State Health, who participated in the workshop, said she appreciated that stakeholders had “ample opportunity” to provide their points of view.

“Although there was very few points all stakeholders agreed on, the topics that gathered the most support were training, quality management systems, information/evidence generation and sharing, and cybersecurity,” said Jacques, who is a member of the BI&T Editorial Board. “Going forward, I hope a multi-stakeholder steering team is formed that can define and create task forces to address these priority topics and work toward defining some middle ground where all parties can agree and move forward.”

To help move toward resolution of this issue, AAMI President and CEO Rob Jensen offered for the association to host the next public–private forum on the subject.

“We at AAMI believe that continuing these productive talks and potentially establishing collaborative communities will help advance patient safety in the interest of all parties,” Jensen said. “We intend to provide a quality venue and a neutral site to advance this conversation.”

The FDA is accepting feedback on its whitepaper (docket number FDA-2018-N-3741) at www.regulations.gov until Jan. 25.