Five years in the making, proposed regulations creating a system to more accurately track medical devices, including those implanted in patients, were finally released by the Food and Drug Administration in early July. But will it take several more years for the industry and patients to see the benefits?
As proposed, the agency's unique device identifier commonly known as UDI would require manufacturers to put a standard number and tracking code on medical devices. The FDA would load those codes into a public database, presumably making it easier to track down faulty products and identify safety hazards.
"The safety of medical devices is a top priority for the FDA, Congress, industry and patients," says 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."
Congress mandated the creation of a UDI system in 2007. The agency delivered a proposal to the Office of Management and Budget in 2011, where it languished until now. Under the proposed rule, the identification system would be phased in over seven years, which may be too long for those who for years have bemoaned the lack of a reliable tracking system within health care.
A UDI system "has the potential to generate significant savings for the health care industry through improved efficiencies and automated processes. Given the dramatic changes in finances and urgent patient safety needs, health care organizations and patients will benefit most from a swift implementation of a UDI system," Dan Sweeney, senior vice president of information and data services at Novation, said in a statement.
Comments on the proposed regulation are due to the FDA by Nov. 7.