Legislation requiring the Department of Health and Human Services (HHS) to issue a final rule on universal device identifiers (UDI) has been introduced as part of a Senate bill to reauthorize user fees for the Food and Drug Administration (FDA). The provision mandates that HHS act on the UDIs, which can be used to track malfunctioning devices, by the end of this year.
In 2007, Congress approved FDA's plan to create UDIs, which would allow the agency to track problematic devices and recall them if necessary. But FDA's UDI proposal has been stalled at the Office of Management and Budget (OMB) since July 2011.
In February, Sens. Charles Grassley (R-Iowa), Herb Kohl (D-Wis.) and Richard Blumenthal (D-Conn.) sent OMB a letter asking it to release the delayed rule. A month later, a bipartisan group of four senators, including Grassley, introduced legislation to enable FDA to improve oversight of medical devices. That measure includes a UDI provision that would require the FDA to issue a final rule on the identifiers this year.
Medical device suppliers expected the government's certification requirements for electronic health records would eventually incorporate UDIs, according to an InformationWeek Healthcare article. The FDA has held discussions on this topic with the Office of the National Coordinator of Health IT, according to the article.
Besides tracking malfunctioning devices, UDIs could also improve supply chain efficiency and tell surgeons in advance which devices had been implanted in a patient prior to surgery.
One question that has yet to be settled, InformationWeek noted, is which of two standards UDIs will have to follow. A consortium of large healthcare systems would prefer the GS1 standard, but FDA is inclined to allow suppliers to use the competing HBCC standard, since they already identify some devices that way.