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Five things you missed at the FDA refurb workshop

by Gus Iversen, Editor in Chief | November 02, 2016
Business Affairs HTM Parts And Service

"Competition is at the core of America's economy," said Ambrogi, "greater competition gives consumers lower prices and increased innovation." She called the health care market a "focus of FTC advocacy" and referred to an executive order issued by President Obama in April 2016 calling for increased competition and the elimination of unwarranted regulations.

During one of the panels, Scot Mackeil, senior anesthesia biomedical engineer at Massachusetts General Hospital, connected the dots and asked the FDA if regulating ISOs and HTMs could possibly run contrary to those goals.

"On one side of this room we have Olympus, Hitachi and Pentax from Japan, Siemens, Karl Storz and Bayer from Germany, the Dutch company Philips, Agfa from Belgium, Medtronic from Ireland," said Mackeil. "On the other side we have professional associations representing America's clinical engineers, a number of our top-tier third-party servicers and remarketers."

Instead of creating regulations that would enhance the power of multinational corporations, Mackeil asked the FDA if it would consider a "180-degree turn-around" and instead, require these companies to provide parts and training as a provision to doing business in the U.S.

As attendees murmured their surprise, the FDA replied that the "venue and everyone participating has given us a lot to think about ... that this is not something that we are going to solve alone ... we're going somewhere and we need this community's help in order to get there."

About that limited evidence...

Perhaps the most frequently cited statistic at the workshop was ECRI's finding that 96 adverse incidents had taken place out of 2.1 million reports issued over a 10 year period. As Thomas G. Green, president of Paragon Services pointed out, those numbers also include equipment serviced by OEMs and at least one case in which an OEM mis-serviced a device.

Even if the rate of adverse incidents were twice as high, Maguire, with Geisinger, said it would not warrant FDA involvement.

But the limited data on adverse events is a problem bigger than third-party servicers. In fact, a recent FDA summary report cited multiple leading U.S. health centers for “their failure to keep written medical device reporting procedures and to report adverse events,” according to a report at the Regulatory Affairs Professionals Society website.

At the workshop, there was a lot of talk from both OEMs and third-parties about the ways in which event reporting could be improved. "The FDA should encourage collaboration between manufacturers and on-site teams for education and training, efforts to standardize maintenance documentation, and further voluntary reporting, so there is no longer a concern about missing evidence," said Maguire.

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