Unique Device Identifier

Unique Device Identification, often abbreviated UDI, requires medical device manufacturers to label their products with both a unique device identifier and production identifiers (such as expiration date and lot or serial number).

GS1 has also certified 29 data pools across 24 countries called the Global Data Synchronisation Network (GDSN) to which manufacturers will upload product data and that will be searchable by the public.

The intent is to reduce medical errors and more quickly identify medical devices in the case of adverse events or recalls, in addition to providing an accessible source of definitive device identification information. Scanning barcodes containing standardized product information not only streamlines recall management, but also offers hospitals the opportunity to better manage inventory and integrate standardized product information into their electronic medical records.

The timeline for Direct Healthcares Group’s implementation of GS1 barcodes is in line with the NHS’s, FDA’s and other Global Healthcare systems suggested timeline for UDI:

Class* III – Sept 24, 2014
All Other Implantable, Life Supporting, Life Sustaining Devices – Sept 24, 2015
All Other Class II Devices – Sept 24, 2016
All Other Class I and Unclassified Devices – Sept 24, 2018
*Class is the MDD medical device classification

For more information and for the full text of UDI, visit GS1’s website: https://www.gs1uk.org/our-industries/healthcare