The FDA is thinking about a unique device identification system for the nation’s many medical implants and gadgets:
“Much like the bar code rule for drugs and biological products, unique identifiers for medical devices could have many potential benefits for improving the quality of care for patients,” said Daniel Schultz, MD, director of the Center for Devices and Radiological Health at the FDA. “A unique device identifier system could have broad applications in reducing medical errors, facilitating device recalls, improving medical device adverse event reporting and encouraging cost effectiveness by improving delivery and supply chain efficiency.”
…The number and complexity of medical devices is growing. It is important for FDA to quickly identify new risks and work with industry and device users to manage these risks appropriately. A UDI system may be used to identify a device and the information associated with that device throughout its lifetime. For example, a UDI could identify which devices are compatible, such as implanted devices being used safely with magnetic resonance imaging (MRI) systems.
We think this could also help with black-market recycled medical devices turning up on eBay or in your local OR…
The FDA is soliciting comments on this system.