The USA’s FDA (Food and Drug Administration) and the European Commission have introduced new regulations over the last few years to ensure that all medical devices are appropriately identified and barcoded.
This means that all medical devices must be identified with a Global Trade Item Number (GTIN) or its equivalent using the HIBCC (Health Industry Business Communications Council) system which is a UDI-DI (Unique Device Identification – Device Identifier). Some medical devices must be further identified with a batch number, serial number, expiry date, or manufacturing date, depending on the type of medical device it is.
All devices will be recorded in centralised databases. For the USA this is GUDID (Global Unique Device Identification Database) , and for the EU this is EUDAMED (European Databank on Medical Devices). The UK does not require UDI-DI as the UK does not have to meet EU requirements.
Basic UDI-DI, UDI-DI and UDI-PI
First of all, each device must be assigned a unique Basic UDI-DI (Basic Unique Device Identification – Device Identifier), a unique reference for the type of device it is, and this will be used in database records but never shown in a barcode on the item. The GS1 system has developed the GS1 Global Model Number for this purpose, and this is a unique key that begins with a GS1 company prefix number and which is alphanumeric and variable length of up to 25 characters.