MITA Testifies at MDUFA IV Hearing

05.02.17

MITA Calls on Congress to Protect Patients through Consistent Medical Device Servicing 

Washington, D.C. – Today at an Energy and Commerce Subcommittee on Health hearing on the Medical Device User Fee Act (MDUFA IV), the chairman of the Medical Imaging & Technology Alliance (MITA) called on the U.S. Food and Drug Administration (FDA) to require consistent regulation of third party and original equipment manufacturer (OEM) medical device servicers to ensure patient safety and proper device functionality.

Joe Robinson, chairman of the MITA board of directors and senior vice president of health systems solutions at Philips Healthcare, said that 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.

Robinson said the medical imaging industry strongly supports H.R. 2118, “Medical Device Servicing Safety and Accountability Act,” introduced by Reps. Ryan Costello (R-PA) and Scott Peters (D-CA) earlier this 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 register with the FDA, submit adverse event reports, and hold themselves accountable by maintaining a complaint handling system.

“Many third-party servicers do operate safely and effectively, as do the devices they service. But by not operating under the same FDA regulatory structure 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,” said Robinson.

Robinson also called Costello and Peters’ bill a “reasonable and common-sense 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.”

There are two main categories of patient harm that can occur if imaging devices are not serviced properly:

1.) Direct bodily harm resulting from improper functioning of the device due to mechanical, maintenance, or calibration issues or healthcare-associated infections.

2.) Indirect harm resulting from delayed diagnosis or misdiagnosis due to poor image quality.

“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,” said Robinson. “It is exactly these kinds of problems we want to avoid.”

 

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The Medical Imaging & Technology Alliance (MITA), a division of NEMA, is the collective voice of medical imaging equipment and radiopharmaceutical manufacturers, innovators and product developers. It represents companies whose sales comprise more than 90 percent of the global market for advanced medical imaging technology. For more information, visit www.medicalimaging.org. Follow MITA on Twitter @MITAToday.

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