In 2007, Congress passed the Food and Drug Administration Amendments Act of 2007, which mandated the FDA to create a unique device identification (UDI) system to track and identify medical devices across the medical device life cycle—basically from production through its actual use in clinical practice. Since that time, the FDA published its Proposed Rule for a Unique Device Identification System in the Federal Register. According to the FDA, the mandate does not extend to the use of the UDI in EHRs, payment systems, or incident reporting systems.
The FDA says enhanced capabilities and a number of opportunities exist specifically for health care systems and providers, including streamlining internal supply chains, more effective recall management, and increased access to device information to inform point-of-care decisions, from UDI adoption and implementation.
To explore how to successfully implement UDI, the FDA will host a free Webinar: “The Value of UDI Implementation for Healthcare Systems and Providers,” on Monday, November 5, from 2 pm to 3:30 pm EST.
Do you think a UDI will make your job easier when it comes to recalls? Do you see any other benefit? If you attend the Webinar, share your feedback here.
