GS1 Named an Accredited Issuing Agency for Unique Device Identifiers by the U.S. Food and Drug Administration
GS1 Global Supply Chain Standards Support Patient Safety and Help Manufacturers Address New Regulation Requiring Unique Identification of Medical Devices
Lawrenceville, NJ -- (December 17, 2013) — GS1, a leading global standards organization, was accredited today 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 comp
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.
For more information about GS1 US, visit www.gs1us.org.
GS1 is a neutral, not-for-profit organization dedicated to the design and implementation of global standards and solutions to improve the efficiency and visibility in supply chains. GS1 is driven by more than a million companies, who execute more than six billion transactions a day with the GS1 System of Standards. GS1 is truly global, with local Member Organizations in 108 countries, and with Global Office in Brussels, Belgium. For more information, visit http://www.gs1.org
About GS1 US
GS1 US, a member of GS1, is an information standards organization that brings industry communities together to solve supply-chain problems through the adoption and implementation of GS1 Standards. Nearly 300,000 businesses in 25 industries rely on GS1 US for trading-partner collaboration and for maximizing the cost effectiveness, speed, visibility, security and sustainability of their business processes. They achieve these benefits through solutions based on GS1 global unique numbering and identification systems, bar codes, Electronic Product Code-based RFID, data synchronization, and electronic information exchange. GS1 US also manages the United Nations Standard Products and Services Code (UNSPSC). www.GS1US.org.
About GS1 Healthcare US®
GS1 Healthcare US is an industry group that focuses on driving the adoption and implementation of GS1 Standards in the healthcare industry in the United States to improve patient safety and supply chain efficiency. GS1 Healthcare US brings together members from all segments of the healthcare industry to address the supply chain issues that most impact healthcare in the United States. Facilitated by GS1 US, GS1 Healthcare US is one of over 30 local GS1 Healthcare user groups around the world that supports the adoption and implementation of global standards developed by GS1. For more information, visit www.gs1us.org/healthcare