OVERVIEW
Regulatory agencies increasingly require a unique device identifier (UDI) to ensure a medical device has future traceability to a manufacturer. The objective is to unambiguously identify all medical devices in the healthcare supply chain through distribution and use. A device identifier and product identifiers are combined to create the UDI incorporated into barcode labels on all Medtronic products.
UNDERSTANDING UDI AND GS1
Medtronic manages all global regulation for standard product information by following GS1 standards. GS1 standard data fields align to meet the regulatory requirements for device identifier and production identifiers, which become the UDI for each product.
Unique Device Identifier in GS1 terms
The Device Identifier (DI) and Production Identifiers (PI) of the UDI are represented in the GS1-128 barcode symbology below.
A Medtronic barcode may also have additional data fields not included in UDI. For example, Medtronic is expanding its use of the GS1 AI (20) internal product variant to reduce the number of times we change a product Global Trade Item Number during a product lifecycle. The AI (20) data field, when present on a barcode, is for Medtronic internal controls. The AI (20) variant is not part of UDI.
The Human Readable Interpretation (HRI) below the barcode is used for the human eye to determine the information encoded in the barcode without having to scan the label. The inclusion of an Application Identifier (AI) in the barcode symbology is used to interpret what the HRI data represents.