GS1 Healthcare US Releases Implementation Guideline for Using GS1 Standards to Address FDA Unique Device Identification
New Industry Resource Guides Healthcare Suppliers and Providers in Using GS1 Standards in the Context of Recent Regulation
LAWRENCEVILLE, NJ – (April 16, 2014) – GS1 Healthcare US® has published an implementation guideline for using GS1 Standards to address the U.S. Food and Drug Administration’s new regulation for Unique Device Identification (UDI). The guideline, titled “Using the GS1 System for FDA Unique Device Identification (UDI) Requirements”, is designed for medical device trading partners, including medical/surgical manufacturers, and is available for free download at www.gs1us.org/udiguide. GS1® was named the first accredited issuing agency for FDA UDI in December of 2013.
“With the UDI rule now final, and implementation deadlines just around the corner, industry partners are transitioning from educating themselves about the regulation to implementing the multiple components to meet the requirements,” says Michael Pheney, vice president of healthcare, GS1 US. “The guideline is an important resource for industry members implementing today, as well as for those preparing to meet future deadlines.”
GS1 Standards, including the Global Trade Item Number® (GTIN®) which is already recognized across the healthcare industry as a unique identifier of medical/surgical products for every level of packaging, can be used for UDI. The UDI rule provides phased implementation deadlines based on risk class. With the first deadline of September 24, 2014, manufacturers of Class III devices and devices listed under the Public Health Services Act must act swiftly to meet UDI requirements.
The guideline, developed by a collaboration of medical device industry members, introduces the applicable GS1 Standards, including the GTIN, GS1 data carriers, GS1 application identifiers, direct part marking, and the Global Data Synchronization Network™ (GDSN®), and provides detailed guidance on how to implement these standards in the context of the UDI regulation.
In addition, the detailed document provides guidance in the following areas:
- Assigning, encoding, and storing GTINs for UDI device identifiers
- Defining and encoding GS1 application identifiers for UDI production identifiers, including serial number, batch/lot, production date and expiration date
- Encoding GS1 BarCodes for UDI AIDC format
- Helpful tips for suppliers and data “receivers”
“For decades, the U.S. healthcare industry has struggled to overcome problems caused by bad or conflicting data in its supply chain, including multiple, differing or proprietary descriptions of medical/surgical products. Sharing unreliable or unverifiable product data has led to challenges in the product recall process, shipping the wrong product and storing expired or outdated inventory, among other serious, and preventable, problems,” said Pheney. “With FDA UDI, and the acceleration of GS1 Standards in the healthcare supply chain, the industry bolsters its efforts to improve patient safety, reduce costs and improve efficiencies.”
The guideline is the newest addition to GS1 US’s suite of resources about UDI, which includes the GS1 US UDI resource site (http://www.gs1us.org/hcudi), educational webinars, UDI workshops and other helpful tools for industry. UDI will also be one of many healthcare topics featured during GS1 Connect, an annual business conference hosted by GS1 US, which takes place this year from June 8-12 in San Diego. To register for GS1 Connect, visit www.gs1connect.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 support the adoption and implementation of global standards developed by GS1. For more information, visit www.gs1us.org/healthcare.
About GS1 US
GS1 US, a member of the global information standards organization GS1®, 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, barcodes, 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.
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