Lawmakers Dive into Hot Debate over Medical Device Service

Posted May 3, 2017

A congressional hearing Tuesday about the regulation of medical technologies brought into sharp relief a debate about service and repair that has been roiling the industry for years.

On one side, original equipment manufacturers (OEMs) call into question the safety of medical device repairs done by independent service organizations (ISOs). On the other, ISOs contend that calls for regulation are attempts to put them out of business. OEMs, however, dispute that claim.

“In raising these issues, some have questioned our motives, accusing us of wanting to overburden third-party service providers,” said Joe Robinson, senior vice president of health systems solutions for Philips North America. “I want to emphatically state that our only goal is to ensure that all service and maintenance always results in safe and effective operation of medical devices. This is a patient safety issue pure and simple.”

Robinson testified in front of the health subcommittee, part of the House Energy and Commerce Committee, on behalf of the Medical Imaging & Technology Alliance (MITA) in support of a bill introduced by Reps. Ryan Costello (R-PA) and Scott Peters (D-CA) on April 25. The proposed Medical Device Servicing Safety and Accountability Act would extend the Food and Drug Administration’s current registration and quality system requirements to ISOs.

H.R. 2118 takes an important first step … by requiring that all independent service organizations step out of the dark and register with the FDA, file adverse events reports, and maintain a complaint-handling system,” Robinson said. “These are minimum requirements that will give the agency information about how many businesses are engaging in servicing medical equipment, and we hope will help get a better handle on adverse events to ensure that they never happen again.”

This legislation, which is being considered in conjunction with the reauthorization of the Medical Device User Fee Amendments (MDUFA), would “bring more oversight and patient protections to the third-party servicing process,” said Rep. Gene Green (D-TX).

However, Robert J. Kerwin, general counsel for the International Association of Medical Equipment Remarketers and Servicers (IAMERS), told the subcommittee that “this is a solution for which there has been no evidence of a problem.”

“While some can present anecdotal stories of bad workmanship―and we, in turn, could present some on behalf of the manufacturer should that have any merit (and we think not)―there has been no evidence to support a systemic problem. I am sure the hospitals would be contacting this body if such were happening,” he said.

When asked to provide a regulatory perspective on whether third-party service was indeed a systemic patient safety issue, Jeffery Shuren, director of the FDA’s Center for Devices and Radiological Health, seemed reluctant to provide a conclusion and instead deferred to the judgement of Congress.

“We are not at the stage where the agency or the administration has made a determination one way or the other on whether―or what―action should be taken, but if Congress has a perspective on what we should be doing, that would be very helpful,” he said.

However, Shuren did tell the subcommittee that “the absence of evidence doesn’t mean the absence of a problem.”

“This is one of the challenges that we face,” he acknowledged. “We don’t have reporting requirements by third-party servicers in terms of problems that they may encounter or for complaints that they have (adverse events that occur or malfunctions), and as a result, there isn’t a great window on exactly what’s happening out there.”

Requiring ISOs to register with the FDA would give the agency at least “a window on who are those entities that are providing that kind of service,” he said

But registration would come at a cost―an Annual Establishment Registration Fee of $3,382 in 2017, according to the FDA’s website, as well as additional costs associated with developing and implementing a complaint management system, additional staffing and training, and other costs related to compliance.

ISOs, and some lawmakers, are concerned about the effects increased costs would have on the healthcare system, especially on smaller hospitals in rural America.

“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).

Both the FDA and Congress are pushing to get MDUFA IV approved on schedule to maintain adequate funding and staffing levels at the agency, making subcommittee members wary of adding additional legislation that does not have unanimous—or near unanimous—support.

The obvious conflict between OEMs and ISOs “might cause this bill not to be included,” Shimkus warned, “unless y’all get together to work something out that seems to be helpful.”

Robert Jensen, president and CEO of AAMI, said Tuesday’s hearing underscores the need for all parties in the service debate to join the conversation.

“U.S. healthcare is a complex system of systems, and patient safety should be at the forefront of our thinking when it comes to change. We hope that any decisions about the regulation of the service and support of medical devices are based on fact and come from a full understanding of the data and the potential ramifications for the larger system,” said Jensen, who was not at the hearing.