Protecting patients with consistent service for medical devices

Imagine having to undergo a computed tomography (CT) scan to determine whether or not you have a life-threatening disease. The anxiety and stress of not knowing what the scan will show can take a toll. 

Now imagine your anxiety level if you find out that exposed wiring in that CT machine was repaired using common household electrical tape or that it was held together using bent screws. While this might sound far-fetched, it isn’t.

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Medical imaging device manufacturers have discovered tin foil, sheet metal screws, non-labeled wiring, hand-secured wire nuts, zip ties, and tape used by third-party service companies in attempts to repair imaging equipment such as CT, MRI, and ultrasound.

While these quick, make-shift repairs might work for MacGyver, it isn’t safe for patients or effective for doctors who are relying on the medical device. 

If a medical imaging device malfunctions due to improper servicing, a diagnosis could be missed, care could be delayed, or the patient could be severely injured or even killed. If an X-Ray is fuzzy due to poor calibration, a fracture could be missed. If a CT scanner is out of operation, a car accident victim might have to wait hours to get scanned. If an MRI machine has the wrong parts, it could explode or suffocate the patient. If any electrical device is improperly sealed, the patient or healthcare provider could get a severe electric shock.

It is exactly these kinds of problems we want to avoid.

In addition to being responsible for innovating, designing, manufacturing, packaging, labeling, assembling and upgrading medical devices, imaging manufactures also often provide servicing activities for installed devices – both their own and those originally manufactured by other companies.

Service provided by original equipment manufacturers (OEMs) is regulated by the U.S. Food and Drug Administration (FDA). But service activities performed by non-OEM entities (i.e., third parties) do not have the same oversight and are not held to the same quality, safety, and regulatory requirements. Further, these third-party servicers are currently not even required to register with the FDA, creating an enormous blind spot in this very important industry, which leads to some of the rigged-up repairs OEMs have finally been called upon to rectify. 

As I testified to the Energy and Commerce Health Subcommittee, all entities that service a medical device should have appropriate oversight and be held to consistent quality, safety, and regulatory requirements. That’s why the medical imaging industry strongly supports H.R. 2118, “Ensuring Patient Safety through Accountable Medical Device Servicing,” introduced by Reps. Ryan Costello (R-Pa.) and Scott Peters (D-Calif.) last week.  The bipartisan bill takes an important step toward ensuring consistency in regulation for the proper servicing of medical devices by requiring third-party servicers to step out of the dark and register with the FDA, submit adverse event reports, and hold themselves accountable by maintaining a complaint handling system.

Patients expect that medical imaging devices operate in a safe and effective manner. They also expect that medical devices are covered by the same regulations – no matter who services the device. In fact, in a recent public opinion survey published by the Medical Imaging & Technology Alliance, 90 percent of Americans agree that all medical devices should be covered by regulations, regardless of who performs the service, and 74 percent of Americans think that, like OEMs, third-party servicers should be strictly regulated under FDA requirements.

Many third-party servicers do operate safely and effectively, as do the devices they service. But by not operating under the same quality, safety, and regulatory requirements as OEMs, third-party servicers are forcing patients to take a leap of faith about the upkeep of the device. That’s a risk patients shouldn’t have to take.

Costello and Peters’ bill is a reasonable and common-sense solution that will protect patients who rely on the safety, effectiveness and reliability of our technologies and will not be costly or burdensome to third-party servicers or anyone else.

I urge Congress to move quickly to pass this bipartisan legislation. On behalf of imaging device manufacturers, our industry looks forward to working with the Congress, the FDA, and other stakeholders to develop policies that protect patients through safe and effective medical device servicing.

Joe Robinson is vice president, Health Systems Solutions, Philips Healthcare and Chairman of the Board of the Medical Imaging & Technology Alliance.


The views expressed by this author are their own and are not the views of The Hill.