Medtech

Authorities around the world have agreed on common requirements for identification of medical devices, Unique Device Identification (UDI), according to ISO/IEC 15459. GS1 follows this ISO standard and is an approved issuer of UDI.

Many countries already use GS1 standards in healthcare. In the UK, GS1 standards are used for patient identification. In the Netherlands the standards are used in operations where the identified implant is linked to the patient’s chart. This improves traceability and ultimately patient safety. In France surgical instruments are uniquely identified so that each instrument can be associated with a patient and the most recent five patients operated on with that instrument can be traced.

The US is one country which has come furthest and passed legislation within healthcare and the EU Commission is well on the way to doing so.

Documents

Labelling disability aids for traceability – labelling individual items (pdf)

Case study: St. Antonius hospital – Traceability of implants (pdf)

Are you ready for UDI? (pdf)

How GDSN enables UDI (pdf)

 

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Do you have questions regarding GS1 and healthcare? Please contact our sector manager Mats Björkqvist, tel +46 8 50 10 10 34