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ISOs and HTMs across the U.S. issue strong opposition to FDA registration proposition Registration mandate for ISOs still a possibility

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MITA responds to 'unfounded' third-party concerns regarding ISO registration

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.

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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.
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Richard Geertson

H.R. 2118

May 19, 2017 07:34

Does any sentient being actually believe "this isn’t about whether manufacturers service medical devices better than ISOs. This is about protecting patient safety..."

"We applaud the fact that many ISOs do a great job and provide high-quality service for their customers."
Really? Yes, the applause is deafening...
"The not to cast blame or wait for more adverse events to become public before we take action."

And... what adverse events would those be? OH, that's right! You don't know because 'they haven't become public' which is why out of sheer magnanimity, the OEMs have only patient safety in mind by imposing burdensome regulations on the competition...

My cynicism meter is off the charts.

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