On Tuesday, the U.S. Food and Drug Administration proposed that most medical devices sold in the United States carry a unique device identifier, or UDI. A UDI is a unique code that provides basic information about a device, such as the name of the manufacturer and the type of device. It may also include other information about the device, such as its expiration date
The information will be made available to the public in a UDI database. No identifying patient information will be included.
Officials say the system will help the FDA identify product problems more quickly, move on recalls more quickly and improve patient safety. The FDA will take public comment on the proposal for the next 120 days.
"The safety of medical devices is a top priority for the FDA, Congress, industry, and patients," said FDA Commissioner Margaret A. Hamburg, M.D. "The unique identification system will enhance the flow of information about medical devices, especially adverse events and, as a result, will advance our ability to improve patient safety."
The FDA is proposing to phase in the system, focusing on the highest risk medical devices first. Low-risk devices would be exempt from some or all of the requirements. Over-the-counter devices sold in stores also would be exempt.
Consumers Union, the advocacy arm of Consumer Reports, issued a statement Tuesday applauding the FDA for issuing the proposed regulations and said it would file formal comments to the proposed regulations later this year.
“These regulations are long overdue and are critical for protecting patients from faulty and dangerous medical devices,” said Lisa Swirsky, senior policy analyst for Consumers Union. “Effective post-market surveillance of medical devices depends on having UDI in place. Once it is fully implemented, this system will enhance the FDA’s ability to identify problem medical devices more quickly and inform patients when their safety is at risk.”
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