AAMI News July 2018

FDA’s Service Report Brings Relief to HTM, but Questions Remain

Members of the healthcare technology management (HTM) community are expressing their support for the announcement by the Food and Drug Administration (FDA) that it would not impose additional regulation on third-party servicers of medical devices, with the agency citing a lack of “objective evidence” to justify such a move.

At the same time, HTM professionals concede the debate is far from over, and some in the medical device industry are signaling displeasure with the FDA’s move and are calling on Congress to step in.

Potential Legislation

Following the publication of the FDA’s highly anticipated report on the quality, safety, and effectiveness of medical device servicing, the industry trade association AdvaMed said it was time for lawmakers to act on H.R. 2118. This bill, which was introduced in the House in 2017, would require third-party servicers to follow the FDA’s quality system, adverse event reporting, and registration regulations. 

During the AAMI 2018 Conference & Expo, Robert J. Kerwin, general counsel for the International Association of Medical Equipment Remarketers and Servicers, speculated about the potential future of this bill.“There is a movement to take the contents of H.R. 2118 and to bring it forward in legislation. We believe there will be an effort to do so in the summer,” Kerwin said during a June 4 session.

Finding Common Ground

Many stakeholders—on all sides—have applauded the FDA’s call to “foster a multi-stakeholder approach” to address this issue. During a separate session on June 4, Pat Baird, a regulatory affairs specialist at Philips, discussed how breaking down long-standing silos could move the conversation forward.

“We need a lot more collaboration,” Baird told attendees. “We all have to get along—we all have to work together—and we don’t have a lot of experience with that because we’ve lived in these much different worlds. So, I think that we have to build those bridges … and to build that bridge there’s going to need to be a lot of communication and a lot of trust.”

One way to build this collaboration and trust is through standards development, according to several AAMI 2018 presenters. AAMI’s medical equipment management standards committee is proposing a revision to the existing EQ56 standard, which focuses on recommended practices for medical equipment management programs. The proposed revision would build on the standard to include quality management principles and address cybersecurity practices—two of the main areas highlighted in the FDA’s report.

In the nearer term, AAMI is planning to convene representatives from the stakeholder community to develop a medical device technical service guide.

“Most people—no matter which community they are associated with—can agree on perhaps 80% of the solution to this issue,” said AAMI President and CEO Robert Jensen. “Our goal is to develop a guide that will articulate that 80% in writing and create a potential solution to the remaining 20%. Then we intend to provide this ‘straw guide’ to the field and seek feedback on how to make it stronger. We believe this will help the community find solid common ground that may, later, be appropriate for a servicing standard.”