Those of us who have cars that need servicing don’t always take them to a manufacturer’s dealership. Concern that dealers are more expensive than independent repair shops is a common reason car owners do this.
But what about medical devices that need servicing? Should hospitals and other healthcare facilities turn to non-manufacturers for repairs in order to protect their bottom lines?
The Food and Drug Administration regulates medical devices in the United States. The FDA not only approves medical devices but also oversees their repair. However, the agency’s protections extend only so far. It regulates repair work on medical devices provided by original equipment manufacturers (OEM). Third-party servicers – those companies that do not make the medical devices – currently are not subject to government scrutiny.
Misdiagnosis and CAT Scans
This can be troublesome for medical devices of all kinds, but especially for medical imaging devices, such as those that provide computerized axial tomography scans; more commonly known as CAT scans. These devices are routinely used to detect serious health problems, including traumatic brain injuries. If they aren’t working properly, then patients may be wrongly diagnosed and serious health issues go untreated.
So it’s imperative that medical imaging devices are fixed or overhauled correctly. Independent companies to which hospitals turn for medical device repairs – or their in-house maintenance staff – face no outside oversight. There are no checks and balances to help insure the quality of their work or the safety of hospital patients who are examined by their repaired or refurbished medical devices.
Federal Protection for Medical Device Repairs
That’s why Congress recently introduced a bill that closes the loophole that lets independent medical device repair companies escape federal reach. Titled “Ensuring Patient Safety through Accountable Medical Device Servicing,” this legislation seeks to bring non-OEM medical device repair companies under regulation and help protect hospital patients. Among other provisions, this bill requires all medical device service companies to report adverse medical events.
It’s a reasonable assumption that a hospital’s medical imaging devices work properly. But hospitals may intentionally or unintentionally employ companies that recklessly avoid necessary steps to properly repair these hi-tech devices. And people then can suffer when they do.
If you or a loved one had a serious health issue and was harmed because of a wrong or missed diagnosis, a medical malpractice attorney can conduct a thorough investigation to uncover all the factors that resulted in this preventable medical error.
The choice of a lawyer is an important decision that should not be based solely on advertising.
Authored by Gray, Ritter & Graham, P.C., posted in Blog May 22, 2017