Although the 2015 UDI Conference had record participation, many Medical Device Manufacturers were not able to attend, consequently this summarization of highlights from the sessions should be of value.
FDA kicked the first session off with an overview of UDI, a review of compliance dates, a listing of benefits derived from UDI and an update on GUDID status. Biggest achievements since the conference last year: Brookings Institution to create a “roadmap” for provider systems, patients, payers, supply chain personnel, and many others, to adopt and utilize UDIs. Another major achievement noted during the 2015 UDI Conference was the announcement of AccessGUDID. Challenges either addressed or being addressed: Managing input to the UDI helpdesk through implementation of tracking software, software labeling guidance, Contact Lens labeling guidance and UPC for retail guidance. A challenge that FDA is calling upon the Medical Device Manufacturing industry to address is ensuring data quality, such as product codes matching pre-market information.
FDA went on to lay out plans for the future including: working with SMI (strategic market initiative), working with standards organizations, expanding capabilities within AccessGUDID such as moving from basic search capabilities to advanced search capabilities and adding web services capabilities. Also announced were Direct Marking guidance (which incidentally was released during the conference), and the opening of the GUDID after January 1, 2016 to Class II products that are not implantable, life-supporting, and life-sustaining devices. The biggest news from FDA is that Terrie Reed is coming back.
AIM (Global trade association for the Automatic Identification and Data Capture (AIDC) industry) presented a session demonstrating the way that technologies using unique device identification (UDI) are being employed to meet recent U.S. compliance rules. The takeaways from the 2015 UDI Conference are that: various types of direct marking technologies are available and some are a better fit than others depending upon the particular medical device, vision inspection is a very useful tool to help with addressing the accuracy required for the new data elements on the labels, and software was demonstrated that can handle master data management (using information pulled from other systems in real-time), regulatory data upload, label management and printing anywhere in the world via browser using a single solution.
The key takeaway from the track concerning UDI in the supply chain is that medical device manufacturers need to be concerned with getting data all of the way through to the providers. The important thing about GMDN is that terms will change and it is up to you as labeler to make sure you keep pace and keep the GMDN information in your GUDID records up to date. The most salient point from the session on understanding efforts that are similar to UDI around the globe is that harmonization is not taking place to the extent that one might hope. Surmise that there may be some challenges and budget accordingly.