THE POWER OF ONE: UDI – ISSUE NO. 173

Last week I attended the UDI Conference in Orlando. The event was organized by the US FDA as an opportunity to update the industry on their draft UDI guidance document, as well as discuss the issues related to implementation and the impact on the entire supply chain, including the end of the chain - delivery of care to the patient. UDI stands for "unique device identification." In simplest terms, it means every medical device will have a "license plate" - a unique identification number which is specific to that device - unique to that one device. For the industry, this will mean an enormous investment in the technology, tools and methods to mark, track, read and record those numbers. So why do it? Patient safety. Dr. Natalia Wilson of Arizona State University most directly addressed this in her presentation. She shared the incredible value of being able to know, for instance, down to the individual implant and in whom it has been implanted if and when problems arise. Such item level tracking will also make it easier for post market surveillance - to identify sooner when a problem or issue with a device might exist. In this instance the efforts of the many in our industry will enable the incredible power of one.