An editorial by Robert J. Kerwin
IAMERS General Counsel

On Tuesday, May 2, 2017, the U.S. House of Representatives Subcommittee on Health held a hearing on H.R. 2118, the “Medical Device Servicing Safety and Accountability Act.”

This bill, if added to the 2017 Medical Device User Fee Amendments (MDUFA) IV Act, would require independent service organizations (ISOs) to register with the FDA within 18 months, and also require them to establish a complaint handling system comparable to those used by original equipment manufacturers (OEMs).



The bill seeks to amend Section 510 of the Federal Food, Drug and Cosmetic Act. Although the breadth of the regulations to be potentially imposed is not known at this point, the law would appear to mandate implementation of a potentially costly quality management system in order to satisfy the complaint handling requirement.

Notably, the bill only applies to ISOs, and exempts — for reasons not stated — equipment service conducted by hospital in-house biomedical engineers or hospital technology management (HTM) professionals.

Dr. Jeffrey Shuren, FDA CDRH director, was asked about the bill, and initially did not take a position. “We are not at the stage where the agency or the administration has made a determination one way or the other," he said.

When questioned further by subcommittee members, Dr. Shuren conceded that requiring ISOs to register with the FDA would give it, “a window on those entities that are providing that kind of service.”

Joe Robinson, Philips North America senior vice president, testified that the legislation would protect patients and ensure effective device performance through increased visibility and accountability for medical device servicers.

On behalf of the independent servicer members of IAMERS, I suggested that the legislation is a solution for which there has been no evidence of a problem, stating “there has been no evidence to support that there is a systemic problem.”

“We want these areas to be safe, but we also are worried about the folks who are servicing [devices] through [independent] organizations ― that they don’t incur additional costs, as it could reduce their access to medical technologies," said Rep. John Shimkus (R-IL).

Representative Michael Burgess (D-TX) expressed concerns over pictures of poor workmanship that had been supplied to the subcommittee.

It was not at all clear what position the subcommittee would ultimately take with respect to the legislation, and whether it will be added to MDUFA IV or be the subject of further hearings.

It is the belief of IAMERS that there is an absence of real-world evidence to support the legislation, and that the subcommittee should not be persuaded by anecdotal information regarding nameless independents. To implement these regulations without that evidence may only serve to burden ISOs with extra costs and expenses in an era where value and competition are as important as ever.

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