GS1 accredited by US regulator as official issuing agency for medical device identifier
- US Food and Drug Administration accredits GS1 as issuing agency for unique device identifiers
- Global GS1 standards authorised for use by medical device manufacturers to address requirements of the new US food and drug information regulation
- Announcement makes GS1 standards central to identifying and locating medical devices to improve patient safety
GS1, a leading global standards organisation, has been accredited by the US Food and Drug Administration (FDA) as an issuing agency for unique device identifiers (UDIs).
The UDI rule*, published in September 2013 to support patient safety and supply chain security, requires all UDI numbers for medical devices to be assigned by an FDA-accredited issuing agency.
This announcement benefits patients, the healthcare system, and the medical device industry as GS1’s standards will now enable healthcare organisations to uniquely identify and locate medical devices through every step of the product lifecycle, improving supply chain visibility and patient safety.
As healthcare products are increasingly being manufactured, shipped and sold across borders, the announcement will support the development of a truly harmonised global supply chain leading to greater efficiencies and reduced costs for healthcare organisations worldwide. UK manufacturers exporting to the US will require a UDI number and GS1 UK are accredited to provide them.
GS1’s global standards were recognised as being able to ensure the uniqueness, consistency and broad compatibility of device identification, and are now authorised for use by medical device manufacturers to address requirements of the new FDA regulation.
Chris Doyle, Industry Marketing Manager - Healthcare at GS1 UK commented: “This is a key development for the global healthcare industry as organisations can now use common standards to help them improve medical device identification and supply chain efficiency, which ultimately leads to enhanced patient safety and care. With the UK Department of Health also announcing in August that all procurement by trusts should be compliant with GS1 standards, it is becoming a truly global solution in support of the healthcare industry.”
GS1’s standards assist healthcare organisations around the world to quickly and efficiently identify devices when recalled, improve the accuracy of adverse event reports, and provide a foundation for a global, secure distribution chain. They also offer a clear way of documenting device use in electronic health records and clinical information systems.
The GS1 System is the most widely used set of supply chain standards in the world and is used by most stakeholders in healthcare supply chains.
* US FDA rule and guidance for UDI
Notes to Editors
About GS1 UK
For more than 35 years GS1 UK has been working with its members to enable the efficient movement of goods and sharing of information. It drives supply chain efficiency alongside 111 other not-for-profit GS1 member organisations in 150 countries worldwide. Having introduced the first truly global bar code numbering system in 1973, at least five billion GS1-compliant bar codes are now scanned everyday – making it the most widely used supply chain standards system in the world. GS1 identification numbers are now also commonly used in RFID tags, Electronic Data Interchange (EDI) messages and for real-time global data exchange.
Providing independent support, GS1’s team of technical and business consultants also assist members with on-site implementation of appropriate supply chain information solutions.
Its 27,000+ UK members range from SMEs to major UK companies and include grocery retailers and food service companies, food manufacturers, healthcare and pharmaceuticals companies, and NHS Trusts. Its supervisory board includes senior directors from Tesco, Morrisons and Sainsbury’s, as well as Unilever, P&G, Diageo and the NHS.
GS1 UK actively supports The Food Chain – a UK charity set up to ensure that people living with HIV can access the nutrition they need to lead healthy, independent lives. For more information, visit www.foodchain.org.uk