GS1 certified for medical device UDIs

Standards organization GS1 has been certified as an issuing agency for the Unique Device Identification (UDI) numbers to help track medical devices through the US supply chain.

The UDI system was introduced by the US Food and Drug Administration (FDA) in September and is intended to improve adverse event reporting, allow easier recall of devices, fight against counterfeiting, and improve patient safety. It requires all UDI numbers to be assigned by an FDA-accredited issuing agency.

A UDI number generally must be applied to the medical device label, its packaging, and, in some cases, the device itself, notes GS1 adding that standards such as the Global Trade Item Number (GTIN) are already widely used by healthcare manufacturers as a unique identifier of medical/surgical products.

"Global GS1 standards support the FDA's vision for a harmonised global supply chain, which is increasingly important as healthcare products are manufactured, shipped and sold across borders,” commented Siobhan O'Bara, who heads up industry engagement activities at GS1 US.

"Using GS1 standards, healthcare organisations around the world are able to uniquely identify and locate medical devices through every step of the product lifecycle, improving supply chain visibility and patient safety," she added.