June 3 marked the deadline for the FDA’s request for comment on repair and remanufacturing of medical devices by hospitals, manufacturers, and independent service organizations. The open call, issued March 4 in the Federal Register, caused a stir in the HTM community due to concerns over potential regulation.

Now that the waiting has begun, the question on everyone’s mind is: What will the FDA do next?

A panel of experts presenting on the topic June 5 at AAMI 2016 were divided in their opinions. The FDA has reportedly signaled it will hold a public workshop on the matter by October, but there is little indication of what it will entail.

What’s certain, said Mary Logan, president of AAMI, is that “you should be there.” It’s rare for local HTM professionals to attend the FDA’s Washington, DC-based public workshops, she said. “The diversity of perspectives needs to be there. The voices need to be there for the whole community.”

She stressed that for the present, the FDA has only issued a request for information—not a proposed rule, which would signal imminent regulation. “To me, that suggests they don’t have a predetermined idea of what they’re going to do, or if they’re going to do anything.”

AAMI’s publicly available comments to the FDA provided a general overview of competing interests across the HTM field and advocated for a standards-based approach to medical device repair rather than regulation. The organization declined to respond to the FDA’s specific repair-related questions or to offer definitions of specific terminology.

“It’s really clear that terminology needs to be defined, but we didn’t think the FDA should do it and we didn’t think that AAMI should do it,” Logan said. “It needs to be a consensus-based process.”

“We should establish standards rather than standards,” agreed Dale Munson, manager of service and biomedical training at Medtronic. “We are regulated to death.”

Gabe Viscomi, vice president of service at Block Imaging, framed the comment period as the FDA’s effort to complete their “due diligence.”

“I’m seeing this as them casting a line to investigate. I feel that they’re ultimately going to find very little evidence” of the need for medical device repair regulation, Viscomi said. He compared the current initiative to the FDA’s exploration of medical device repair in 1997, which found few instances of danger to patients.

“I’m not as optimistic as I was 20 years ago when we last fought this battle,” countered Binseng Wang, director of Quality & Regulatory Affairs for WRP32 Management LLC. He noted that the FDA’s last exploration into this matter led to the regulation of reprocessed single-use devices. He expects that certain device categories, such as endoscopes, might come under increased scrutiny.

The session moderator, Dave Francoeur, senior director of program development and support at Sodexo said that while “there isn’t anyone in this room that doesn’t believe that patient safety is the foremost of what we do,” many biomeds recognize deep down that certain members of their profession lack adequate training and expertise—a perception to which the FDA may be responding.

During the question and answer portion of the session, David Jamison, executive director of Health Devices for ECRI Institute, commented that the organization had conducted its own analysis of more than 2.1 million service records from the last 10 years gathered through a variety of channels, including the MAUDE database, Health Devices, ECRI’s confidential contracted accident investigations, and PubMed.

ECRI found that only 96 of the records, or .005%, demonstrated problems.


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