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FDA names GS1 accredited issuing agency for UDI

Manufacturing Group | December 23, 2013

GS1 Global Supply Chain Standards support patient safety and help manufacturers address new UDI regulation.

GS1 was accredited last week by the U.S. Food and Drug Administration (FDA) as an issuing agency for unique device identifiers (UDIs). Global GS1 Standards, administered in the U.S. by GS1 US, were recognized as able to ensure the uniqueness, consistency and broad compatibility of device identification, and authorized for use by manufacturers to address requirements of the new FDA UDI regulation. The UDI rule, published in September 2013 to support patient safety and supply chain security, requires all UDI numbers to be assigned by an FDA-accredited issuing agency. 

“Global GS1 Standards support the FDA’s vision for a harmonized global supply chain, which is increasingly important as healthcare products are manufactured, shipped and sold across borders,” says Siobhan O’Bara, senior vice president, industry engagement, GS1 US. “Using GS1 Standards, healthcare organizations around the world are able to uniquely identify and locate medical devices through every step of the product lifecycle, improving supply chain visibility and patient safety.” 

The GS1 System is an integrated suite of global standards that provides for accurate identification and communication of information regarding products, assets, services and locations. GS1 Standards, including the Global Trade Item Number (GTIN), are already in use by leading healthcare manufacturers, and are accepted across the U.S. healthcare industry as a unique identifier of medical/surgical products for every level of packaging. Healthcare manufacturers in the U.S. and around the world can create and maintain UDI numbers (i.e. GTINs) by following the requirements of the U.S. FDA UDI Rule and the GS1 General Specifications. 

According to the rule, a UDI number generally must be applied to the medical device label, its packaging, and, in some cases, the device itself. By unambiguously identifying medical devices, UDIs based on GS1 Standards benefit patients, the healthcare system, and the medical device industry. GS1 Standards assist healthcare organizations around the world to quickly and efficiently identify devices when recalled, improve the accuracy and specificity 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. GS1’s global coding systems are compliant with relevant international ISO standards.

GS1 Healthcare US, a U.S. healthcare standards group, has been at the forefront of industry education about how standards can improve patient safety and supply chain efficiency, and more recently, how GS1 Standards can support UDI. GS1 Healthcare US has introduced a suite of resources to help industry members, from manufacturers to providers, meet the requirements and timelines of the UDI rule. Resources and tools include:

  • A comprehensive UDI Resource Website (www.gs1us.org/hcudi) that provides information on how GS1 Standards can help meet UDI requirements, perspectives from GS1 US experts, steps to get started, FAQs, and guidance on GTIN implementation.
  • Along with industry partners AHRMM, HSCA and SMI, co-sponsorship of a complimentary workshops series focused on GS1 Standards Implementation, including sessions on UDI.

Source: GS1 US

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