Scanning for Interoperability: Using the FDA UDI System to Improve Implant Documentation and Recall Management

In 2013 the US FDA published a rule establishing the UDI system, intended to identify a medical device through distribution and use. Over the past six years, UDI has increasingly appeared as the unique standard, scannable identifier on millions of medical devices not only in the US but around the world. In the US, AccessGUDID, a free FDA-sponsored publicly available database, enhances the value of UDI through searchable, downloadable and API ready access to over 2.4 million records, each associated with a single device identifier on a device label. Hospitals and their health system vendors are beginning to take advantage of these public resources by developing and using IT systems that scan the UDI and pull data from AccessGUDID to better document implants and other devices as part of health information. We detail the work for a hospital implementing the application through webinar training.  We show how use  of scanning the UDI improves documentation of implants reducing the exposure of patients to expired and recalled products. You will see how the decision was made to use UDIs as part of their efforts to improve OR operations, and describe how UDIs are routinely being scanned and documented, and the efforts being taken to improve the UDI system. Each area lead discusses their own perspective on the impact of UDI today and opportunities for the future.