Premier Tells Medical Device Makers to Adopt GS1 Supply Chain Standards

July 30, 2008—Premier, an organization that operates a purchasing network for more than 2,000 U.S. hospitals and 53,000 other health-care sites, has announced it will require manufacturers to support global supply chain standards enabling the identification and tracking of medical devices and products. The standards—set by GS1—could pave the way for the adoption of RFID technology within the medical device supply chain. GS1, a private, nonprofit organization that establishes and promotes global supply chain standards, develops Electronic Product Code (EPC) standards through its EPCglobal branch.

To satisfy Premier's mandate, manufacturers will need to employ a Global Trade Item Number (GTIN) to identify a particular medical product, and a Global Location Number (GLN) to distinguish any parties that have been in contact with that product as it moves through the supply chain—from manufacturer to distributor, then on to hospital and nursing station. The suppliers will have to upload the GTINs, GLNs and associated product data to the Global Data Synchronization Network (GDSN), a network of data pools that stores product information that trading partners (such as hospitals and other health-care organizations) can then access.

Joe Pleasant

Premier is currently phasing in support for the three GS1 standards, with full adoption of the standards within its contracting and operations expected to be implemented within the next five years. The goal, says Joe Pleasant, Premier's CIO and senior VP, is to ensure that the correct products are delivered to the proper place at the right time, ultimately improving patient safety and reducing supply chain costs.

At present, manufacturers, suppliers and hospitals often use their own numbering systems to identify and label products. "Because there isn't a standard that everyone agrees to," Pleasant says, "it makes it next to impossible to locate product recalls."

The inability to carry out comprehensive product recalls is one reason the U.S Food and Drug Administration (FDA) has been investigating the use of unique device identification (UDI) systems to track and trace medical devices. From the FDA's perspective, the main purpose of a UDI system would be to reduce medical errors by providing a more automated method of collecting device-related information, such as the manufacturer, make and model, as well as unique attributes, serial numbers, identifying lot and manufacturing numbers, and expiration dates.