FDA workshop: is it servicing or remanufacturing?

December 12, 2018
by John R. Fischer, Senior Reporter
Stakeholders from all areas of the medical equipment industry gathered Monday and Tuesday in Maryland for the FDA’s Medical Device Servicing and Remanufacturing Activities workshop.

Held at the Hilton Washington, D.C. North Gaithersburg Hotel, the aim of the one-and-a-half-day event was to facilitate an exchange of ideas between diverse parties for the building of a collaborative community dedicated to ensuring that standards of safety, effectiveness and quality are met in the manufacturing and servicing of medical devices. The main intent of this meeting was to discuss what constitutes servicing versus remanufacturing activities, one of many topics to be addressed in a future draft guidance that will be issued by the FDA.

“We’ve seen these incredible advances in technology, materials, digital health, AI and a list of other innovations,” said Dr. William H. Maisel, deputy director for science and chief scientist of the FDA Center for Devices and Radiological Health, in his welcoming remarks to the roomful of attendees. “Our vision statement isn’t just about getting these devices to patients. It’s about making sure that once they get to patients, they remain of high quality, and are safe and effective.”

The formation of collaborative communities was proposed by the FDA in its May 2018 report which concluded a two-year investigation into the difference between the quality, safety and effectiveness of servicing provided by ISOs and in-house HTM professionals for medical devices, compared to OEMs. The report found no evidence to suggest that servicing by third-party providers leads to potential adverse events that may pose harm to patients.

The first day of the workshop consisted of two-breakout sessions. The first comprised two scenarios for each table that pertained to equipment or components plagued by different challenges, and the practices used to solve the problem.

Participants were tasked with determining if each practice was an example of servicing or remanufacturing, based on a proposed flowchart that the FDA is considering issuing as a visual guide to help address the most common and important considerations in distinguishing the two types of activities. The objective was to create an exchange of thoughts as to what considerations are needed to make such determinations and to suggest any improvements for the flow chart.

For one table, a scenario outlined was the patching of a small hole in the liquid helium reservoir of an MR system. The hole was patched with materials that are different than an OEM reservoir. The table determined that classifying such a repair depends on whether or not the party providing the service has access to and can meet the original specifications laid out by the OEM without changing them.

“One of my arguments would be you can put a material on there that can seal it but would it seal it for as long as the original material would? Would it seal it longer,” said Jim Nestel P.E., director of operations for Hitachi Healthcare Americas.

The next session addressed the subject of labeling, challenging attendees to question what specifications and considerations should be included in device labels to ensure high quality, safe and effective servicing.

“For our table, there was no consensus as to what falls into labeling and what falls within intellectual property," said Rob Kerwin, legal counsel for the International Association of Medical Equipment Resellers and Servicers (IAMERS). "There was also no consensus on whether there should be a warning on non-OEM, FDA-registered devices manufactured by ISO-certified companies with respect to things such as warnings, which may be omitted when non-OEM equipment is installed. But there was recognition of a need to address counterfeit or safety issues, though such should not lock access to the device.”

Following the end of the second session, a panel discussion was held on a set of proposed guiding principles. Topics discussed included documentation, risk management, cybersecurity, certification and educational opportunities, as well as AI and big data.

The subjects were addressed again the following day during a larger panel discussion in which stakeholders from all viewpoints discussed the nuts and bolts of what should make up a collaborative community, including how it should work alongside OEMs, ISOs, in-house personnel and other parties; how it should be structured; and what areas of interest must be agreed on in establishing one.

Reflecting on the meeting, panelist Diana Upton, president of IAMERS, told HCB News that reaching a consensus on what a collaborative community should look like will take a while but that she hopes to see more frequent gatherings such as this to help all medical equipment personnel come to an understanding on what such a community should encompass and how all types of parties can play a role in its development and success.

“IAMERS believes in Collaborative Communities," said Upton. "In many ways IAMERS is a good example of ‘Collaborative Communities’. We have, as members, independent sellers and servicers, original equipment manufacturers, on-line sellers, and a variety of parts and specialty companies. We successfully communicate and do business with many stakeholders. For some of the guidance issues outlined by the FDA, we hope to see more C-suite participation to build on the trust and rapport.”

Looking ahead, AAMI president Rob Jensen said AAMI would be happy to act as the convener of a phone call with the stakeholders. Several panelists and those in the audience suggested additional parties who should be on the call, most notably healthcare organizations and the federal government stakeholders such as the VA. No specific date was set for the call.

A white paper entitled “Evaluating Whether Activities are Servicing or Remanufacturing” was issued by the FDA to provide additional insight into how they are approaching the discussion surrounding the definitions of servicing and remanufacturing.

Comments concerning the white paper are being accepted at https://www.regulations.gov in Docket No. FDA-2018-N-3741 until January 25, 2019.