Premier Inc., one of the nation’s largest hospital group purchasing organizations, isn’t waiting for FDA to get around to requiring unique device identification. It announced in a release published on devicelink.com that it will require all medical device manufacturers it has contracts with to adhere to standards that essentially require unique device identification — which usually consists of bar codes or RFID and can help in tracking devices in case of recalls, and preventing medical errors.
Industry originally opposed unique device identification because of the difficulties in coming up with a single system that would work for all medical devices. FDA and industry have struggled to come up with one, and the process has taken a very long time, even though Congress finally mandated unique device identification in the FDA Amendments Act of 2007. Premier apparently had enough, and imposed its own standards. It hopes its action will force FDA to act.
Premier has adopted the GS1 supply chain standards. This includes a Global Trade Identification Number, the Global Location Number, and the Global Data Synchronization Network. The first is a standardized number used to identify medical devices at various packaging levels. The second is a standardized number used to identify who has been in contact with a device. The third stores data from the first two, and allows users to access information about each device.
