A Roundtable Discussion: Unique Device Identification: Shedding Light on Its Great Promise for Healthcare

摘要

Joe Sheffer How are manufacturers doing in terms of introducing unique device identification (UDI) into devices? What are the challenges and successes that you are hearing? Lena Cordie As a consultant who works on UDI solutions for medical devices, I've seen a huge effort with data collection—first finding the data in all their multiple sources, then making sure the data are accurate, mapping them to the Global UDI Database (GUDID) fields, and ensuring they meet the GUDID business rules. Another challenge that I've seen is how to apply the UDI rules to devices that come in for repairs, refurbishment, or remanufacturing—how to interpret and apply the regulations to those devices. Jay Crowley Those are great points. Interestingly, and I think this is true as we move through this conversation, the challenges with. UDI aren't necessarily related to UDI, in and of itself, but rather to activities around it For example, take GUDID: It's about finding the data that is in multiple sources, data that is not in an electronic form or not answered in a way that is transferrable to GUDID. A lot of the issues with data collection and submission have to do with a lack of a master data management approach or solution among companies. This is going to become exponentially more difficult as UDI is implemented in other countries besides the United States,