An editorial by Patrick Hope, executive director of the Medical Imaging & Technology Alliance (MITA)

In an April 27 column in HealthCare Business News entitled “New legislation would mandate all ISOs register with FDA,” Robert Kerwin (representing independent companies that service medical devices) raises concerns about H.R. 2118, the Medical Device Servicing Safety and Accountability Act, bipartisan legislation which would take important steps toward ensuring consistent requirements for servicing of medical devices. Unfortunately, some of his assertions are unfounded.

As Joe Robinson, MITA’s board chairman and vice president, Health Systems Solutions for Philips Healthcare, testified before the House Energy & Commerce Subcommittee on Health, H.R. 2118 contains three provisions. ISOs would need to: (1) register with the FDA, (2) maintain a complaint handling system, and (3) report any adverse events.



Hospital in-house personnel are explicitly excluded from this legislation. Mr. Robinson said this bill presents a “reasonable and commonsense solution that will protect patients who rely on the safety, effectiveness and reliability of our technologies and not be costly or burdensome to third-party servicers.”

Just to clear the air, this isn’t about whether manufacturers service medical devices better than ISOs. This is about protecting patient safety and ensuring that medical devices effectively do the job they’re supposed to do, plain and simple.

We applaud the fact that many ISOs do a great job and provide high-quality service for their customers. Good quality comes from all corners: manufacturers, ISOs, big businesses, and small businesses alike. Greater visibility into the service marketplace will benefit all of these players.

But as it stands now, the FDA knows almost nothing about third-party servicing of medical devices. Even Dr. Jeff Shuren, FDA’s director for the Center for Devices and Radiological Health, said “there isn’t a great window on exactly what’s happening out there” due to the lack of reporting requirements for third-party servicers.

This legislation seeks to address that concern by requiring third parties to make themselves known to the FDA and implement simple reporting and complaint handling processes. That’s it.

Mr. Kerwin has shared valid concerns that these requirements might overburden his member companies because of registration fees or the need to hire additional staff such as compliance officers. However, the vast majority of medical device manufacturers are small businesses themselves, and they readily adhere to these and far more stringent FDA requirements without issue.

Registration fees are nominal, and we would support a small business exemption. Also, the legislation says nothing about staff requirements or compliance officers. That’s just not in the bill and the requirements would not necessitate such steps being taken.

Another argument Mr. Kerwin makes against legislation is the frequently-cited ECRI study indicating a low incidence of adverse events. The ECRI study is based on a severely limited database where participation by manufacturers is mandatory and only voluntary for third parties. Therefore, we have to ask ourselves, “How do we know what we don’t know?” Even Dr. Shuren testified that “the absence of evidence doesn’t mean the absence of a problem.”

The ECRI study is flawed and doesn’t tell us the full story.

The point, though, is not to cast blame or wait for more adverse events to become public before we take action. Regulation, when done right, is preventive, not punitive, and builds the public’s trust in all of our businesses.

We all have a shared goal – to ensure the safety and efficacy of medical devices for patients regardless of who is servicing the equipment. H.R. 2118, if passed, would put patient safety first, without placing any undue burdens on third parties.