A guide for hospitals on meeting UDI regulations

 In May 2020, the UDI regulations became mandatory in Europe, with the target of achieving complete traceability throughout the healthcare industry. UDI Stands for ‘Unique Device Identification’ and denotes a series of numbers that gives a device a unique worldwide identification. These numbers must be marked on to the medical devices or instruments, as a machinereadable code (such as a Datamatrix code), to ensure error free detection. ISO compliant standard codes are typically used, as these have been implemented very successfully for a long time in other sectors and industries (such as aerospace and automotive).

The introduction of the UDI regulations should provide greater levels of safety for patients, by offering opportunities for hospitals to record the location, transportation and process history of an instrument or device – through operations and processes, such as sterilisation. If a problem arises, the UDI code allows the specific instruments to be identified, located and isolated. 

Hospitals may also want to consider using this information to asset track the large numbers of instruments they have in circulation. This can allow them to monitor their levels of use and to highlight future requirements for additional instruments and devices.