The Unique Device Identification (UDI) System serves to identify medical devices in the United States. The use of UDIs is mandated by the Food and Drug Administration Amendments Act of 2007. The Act requires devices to bear a unique identifier that can label devices through distribution and use, including the lot or serial number. Although the Food and Drug Administration (FDA) already mandates use of UDIs, two Senators have now called for them to be added to health insurance claim forms.
According to the FDA, UDIs help improve patient safety, modernize post-market surveillance and facilitate medical device innovation. The FDA wants to use UDIs to include data about medical devices in its post-market Sentinel initiative—a massive electronic database of insurance claims data designed to evaluate the safety of medical products. Ideally, the system will help isolate and track adverse events and affect more efficient product recalls. Not only will this increase patient safety, but also help protect the integrity of the Medicare program.
The FDA issued its final rule requiring medical devices to bear a UDI in 2013. Specifically, a two-part identifier is required, containing both a device identifier and a production identifier. The agency has set a seven-year period for manufacturers to phase in UDIs, depending on the medical device class and type, however implementation has been subject to substantial delays. The agency has already extended some compliance deadlines. The FDA claims that the benefits of the UDI system cannot be fully realized until their use is integrated into the health care delivery system.
Senators Charles Grassley and Elizabeth Warren have called for the UDI system to be linked more closely to the health insurance system by updating plans to include UDIs to health insurance claim forms. The senators cite a troubling report by the Office of the Inspector General (OIG) which found that recalls of defective devices have resulted in millions of costly claims for monitoring, replacement and follow-up care. For example, earlier this year, a report found evidence that serious infections caused by contaminated duodenoscopes exceeded cost estimates. After this incident, the Senate Health, Labor, Education and Pensions (HELP) Committee recommended that UDIs be integrated into insurance claims to prevent further occurrences.
With offices located in Philadelphia, Reading and Bethlehem, Pennsylvania, the experienced Philadelphia medical product liability lawyers at Galfand Berger serve clients throughout Pennsylvania and New Jersey who have been injured due to a defective product. To schedule a consultation, call us at 800-222-8792 or fill out our convenient online contact form.