GS1 Standards Assist Manufacturers in Meeting New FDA Requirements for Unique Device Identification
GS1 Standards can help manufacturers comply with a new regulation released by the U.S. Food and Drug Administration (FDA) that establishes a national unique device identification (UDI) system for medical devices to increase patient safety. A new GS1 UDI resource Web page (www.gs1us.org/hcudi) is now available to offer GS1 Standards implementation guidance.
GS1 Standards, specifically the Global Trade Item Number® (GTIN®), are already recognized across the healthcare industry as a unique identifier of medical/surgical products for every level of packaging and supports UDI regulation. More than 2,600 healthcare organizations use GS1 Standards.
"The highly anticipated UDI rule marks a turning point for healthcare and supports years of industry collaboration and demand to identify problems with medical devices much earlier, track recalls more efficiently, and improve patient safety," said Michael Pheney, vice president, healthcare, GS1 US. "In preparation for the UDI regulation, GS1 US has been leading the charge by proactively working with many of the largest healthcare manufacturers to adopt the GTIN and we expect implementation to accelerate as other healthcare organizations strive to meet the FDA's requirements and timeline."
The UDI system also includes the first database that will store information about all medical devices and can be accessed by both providers and patients, leading to better decisions concerning patient care. Using consistent, global standards will also enable providers to harness data for longer-term goals, such as comparative effectiveness, outcomes research and population health management.
A recent report by McKinsey & Company, titled "Strength in Unity: The Promise of Global Standards in Healthcare," also supports implementing global standards across the entire healthcare supply chain, including the medical device industry. In 2009, the number of adverse events for the medical device sector topped 28,000 patients. Medical device recalls currently occur approximately 15 times per week and the report maintains that many recalls require hundreds of hours of manual labor and still fail to remove all affected products from inventories or locate every exposed patient. Standardized identification and automated tracking of products, as outlined in the UDI regulation, can reduce the time delay between recall notification and product removal.
The UDI rule has implications beyond the U.S. healthcare supply chain. Pheney added, "Other regions of the world continue to strive for enforced unique device identification. The FDA UDI rule supports global alignment efforts to use data standards that provide global product visibility and can identify recalled products that need to be removed from the supply chain."
GS1 Healthcare US®, a healthcare standards group, has been at the forefront of industry education about how standards can improve patient safety and 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, and guidance on GTIN implementation. A free, live Webinar titled, "FDA UDI Regulation is Final, Are You Ready?" scheduled for September 26 and October 14, 2013. Multiple sessions about UDI implementation at the Global GS1 Healthcare Conference, October 1-3, 2013, San Francisco, Calif. Along with industry partners AHRMM, HSCA and SMI, co-sponsorship of a workshops series focused on GS1 Standards Implementation, including sessions on UDI.
For more information about GS1 US, visit www.gs1us.org.