Device identification for traceability in the IVD-reagent supply chain

In China’s IVD-reagent supply chains, there was no consolidated material coding standard.

This caused a series of problems, such as information inconsistency between upstream and downstream enterprises, the lack of traceability in supply chain processes, human-input information that was prone to errors, and high costs with low efficiencies.

To address these issues, DIAN and the Zhejiang Institute of Standardization implemented an IVD-reagent solution based on GS1 standards. They labelled each IVD-reagent individual unit with a GS1 Global Trade Item Number® (GTIN®) and key attributes encoded in a GS1 DataMatrix barcode. They also linked upstream and downstream enterprise information to the GS1 identifiers, as well as upgraded healthcare providers’ supply processing distribution (SPD) systems for compatibility with the GS1 standards.

DIAN has improved overall operating efficiency, reduced logistics information errors and maintained the traceability of IVD-reagents. GS1 standards have also eliminated the labourious work of applying non-standard proprietary codes in hospitals. Since DIAN is manually labelling the IVD-reagents, it is continuing its work to ensure that the labelling is eventually completed by IVD-reagent manufacturers.