Unique device identification (UDI) and barcoding are neither new technologies nor innovative concepts. But incorporation of UDI into the medical device and healthcare industries has been long discussed and planned and slow to be implemented. Tracking a device throughout its use and lifecycle has far-reaching benefits for medical device manufacturers, healthcare facilities and the growing number of empowered patients and patient advocates, of which are only beginning to be realized. These benefits, along with an overview of UDI requirements in the U.S., challenges healthcare facilities are facing with UDI implementation, and the overall impact to quality and quality systems for both manufacturers and healthcare facilities, will be discussed. This presentation will also highlight what has been, is currently being, and still needs to be, done for the full benefits of UDI to patient safety and global healthcare advancements to be realized.