Currently, the regulations regarding tracking and traceability of medical devices stipulate that products should be marked with unique device identification (UDI) “where appropriate,” which clearly is a subjective term. But this situation will not remain for much longer. FDA is expected to require device manufacturers to adopt UDI, and industry must work with the agency to come up with a feasible system.1
FDA mandated bar codes for drugs and biologics back in 2004 but did not extend the provision to devices after industry convinced FDA that implementing a standardized identification system for devices would be too difficult. However, that conclusion was reached before the uproar over safety issues involving implantable cardioverter-defibrillators and other devices. In the coming years, FDA is not likely to retreat from any idea that it believes will improve patient safety, so mandated UDI is inevitable. Similar conclusions are being drawn within the European Union.
But UDI should not be seen just as another negative bureaucratic burden. A properly implemented UDI system can actually benefit device manufacturers, hospitals, patients, and everyone along the supply chain. Ideally, with each device permanently marked with a UDI code, even nonsterilized products such as screws and plates could be fully tracked by some type of reader from fabrication through surgical insertion. This would simplify inventory, reduce waste, enable back stocking, and allow manufacturers to rapidly identify and isolate lot numbers in the case of suspected early failure and defects. It also could prevent the use of counterfeit or reject products.
1. Erik Swain, “Identifying What Will Work,” Medical Device & Diagnostic Industry 28, no. 9 (2006): 16.
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