FDA Announces New Medical Device Identification System
(WASHINGTON) — The government has come up with a new way to identify medical devices, in what the U.S. Food and Drug and Administration calls a landmark step for the agency. It’s called the unique device identification system (UDI).
The FDA announced Friday a new standardized system to track and identify medical devices in hopes that it will help to quickly catch problems — like issues seen in the past with artificial hips and pacemakers.
“A consistent and clear way to identify medical devices will result in more reliable data on how medical devices are used. In turn, this can promote safe device use by providers and patients as well as faster, more innovative, and less costly device development,” Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health, said in a release.
The new system will require two things: that devices have a unique barcode that will hold the make, model and lot number of the device, and that all that information is available in a public database so that doctors, patients and the government can work together to identify safety issues quickly.
As the FDA admitted, the devil will be in the implementation of this, which will begin next year with high-risk devices like heart stents and defibrillators.
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