Under FDA regulations, most medical devices will now include a Unique Device Identifier (UDI) in human- and machine-readable form, creating a system to track and monitor the quality, safety and durability of every medical device. The public will be able to search and download information on specific medical devices.
In this Medical Development Insights interview, I discuss with Jonathan Bretz and Dick O’Brien some of the critical issues that companies now face in coming into legal compliance and the importance of “safety surveillance” through UDIs. Without reliable and consistent identification of medical devices, it is extremely difficult to identify counterfeit products and to help staff distinguish between devices that are similar in appearance but serve different functions.
These issues have recently taken on greater importance as it has been revealed that the federal Centers for Medicare & Medicaid Services has pushed back against plans to include UDIs on Medicare and Medicaid claim forms.