April 07, 2017 Industry news
EU regulations demonstrate how GS1 standards deliver patient safety and supply chain security
Final EU Regulations on medical devices and in-vitro diagnostics now state that manufacturers need to implement the new EU system of Unique Device Identification (UDI) - applying a UDI number to the medical device label, its packaging and, in some cases, the device itself.
By using UDI, the EU regulations align themselves with the requirements of the U.S. Food and Drug Administration (FDA) and join a globally harmonised framework for identification of medical devices – enhancing quality of care, patient safety and business processes.
“Using GS1 standards for UDI benefits patients, the healthcare system and the medical device industry. We’re working with healthcare organisations to help them identify medical devices, which will help make recalls quicker and more efficient – particularly compared to the often incomplete paper-based systems often used today.”
“GS1 standards for UDI provide the foundation for a global, secure healthcare supply chain by recording accurate data for adverse events and documenting the use of medical devices in electronic health records and clinical information systems,” added Glen. “This is a huge step forward for patient safety and will support the great improvements in efficiency that the Scan4Safety programme is already delivering throughout the NHS.” - Glen Hodgson, Head of Healthcare, GS1 UK.
These new regulations mark a significant achievement, and are the culmination of over four years of intensive work by the European Parliament and the European Commission with the active support of the healthcare community.
The GS1 standard for item identification (the GTIN) is used across the global healthcare industry as a unique identifier for medical and surgical products at every level of packaging. Since 2013, GS1 has been accredited as an issuing agency for UDI by the US Food and Drug Administration (FDA).
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