A public opinion survey commissioned by the Medical Imaging & Technology Alliance (MITA) finds the majority of Americans believe proper servicing and maintenance of all medical and radiation-emitting electronic devices is crucial to protecting patients, and that all medical device servicers should be consistently regulated by the U.S. Food and Drug Administration (FDA) regardless of whether they are an original equipment manufacturer (OEM) or a third party.
“Although many third-party service organizations perform quality work, the lack of consistent oversight and regulation is a direct threat to millions of patients who rely on medical devices for their health,” said MITA Board Chairman Nelson Mendes, president and CEO of Ziehm Imaging Inc. “It’s clear from this survey that Americans overwhelmingly agree with our view that FDA should extend regulatory oversight, including minimum quality, safety and regulatory requirements, to all entities servicing medical devices.”
The survey was designed to measure the extent to which Americans assume that medical device maintenance is consistently regulated by the government, and the extent to which they believe consistent regulation of these technologies is important.
Key findings include:
- 90% of Americans agree that all medical devices should be covered by regulations, regardless of who performs the service.
- 74% of Americans think that, like OEMs, third-party servicers should be strictly regulated under FDA guidelines.
- 85% of Americans agree the government should take action to resolve concerns around third-party servicing of medical devices.
- 82% of Americans would think twice before seeking treatment at a facility that allows device maintenance by unregulated servicers.
Currently, only medical device service activities performed by a manufacturer are regulated by the FDA. If a device fails to perform in a safe and effective manner due to improper servicing by an unregulated third-party organization, it could result in low image quality – which could lead to a delayed or missed diagnosis – and potentially put the patient at risk for serious physical injury.
“Patient safety should be the top priority for all companies performing service on medical devices, and we believe the FDA should be consistent in its regulation across the space including third parties and original equipment manufacturers,” said Dennis Durmis, vice president and head of commercial operations, Radiology Americas at Bayer. “Part of the FDA's public health mission is to help ensure patient safety, but currently this necessary check and balance is only being applied to a portion of the medical device services being performed in the market.”
This research was conducted by KRC Research from November 10-13, 2016 via an online survey of N=1,022 members of the U.S. general population (ages 18+, representative in terms of gender, age, income, education, race/ethnicity, geography).