GS1 US Applauds U.S. FDA for Releasing Draft Regulation Requiring Unique Device Identification System for Medical/Surgical Supply Chain

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UDI implementation anticipated to improve safety and efficiency in U.S. healthcare system; Draft regulation recognizes GS1 Global Trade Item Number (GTIN) as a valid unique identifier for industry compliance

A UDI system will improve the speed and accuracy of product recalls as well as adverse event reporting ... to the benefit of patients, healthcare providers and manufacturers in the U.S. and around the world.

GS1 US, the information standards organization, and GS1 Healthcare US today applauded the U.S. Food and Drug Administration (FDA) for publishing important draft regulation that will require the implementation of a national unique device identification (UDI) system. GS1 Healthcare US is a cross-industry group driving the adoption and implementation of GS1 Standards in the U.S. healthcare industry.

The regulation (http://www.ofr.gov/OFRUpload/OFRData/2012-16621_PI.pdf), published on July 3, 2012, recognizes the GS1 GTIN as a valid unique identifier for medical/surgical products for every level of packaging.

According to the FDA, a UDI system has the potential to improve the quality of information in medical device adverse events reports, which will help the FDA identify product problems more quickly, better target recalls and improve patient safety. The FDA is seeking comment on the proposal for 120 days.

“A UDI system leveraged by all constituents in the U.S. supply chain will improve the speed and accuracy of product recalls as well as adverse event reporting,” said Siobhan O’Bara, vice president for healthcare, GS1 US. “Organizations representing all aspects of the supply chain have been working together for many years to support UDI capabilities, and we are thrilled that the much-anticipated UDI draft regulation is now published. The industry is ready, willing and able to implement UDI to the benefit of patients, healthcare providers and manufacturers here in the U.S. and around the world.”

As part of the 2007 Food and Drug Administration Amendments Act (section 226), Congress mandated the FDA establish a unique device identification system for medical devices requiring the label of devices to bear a unique identifier. According to the rule, the unique identifier must adequately identify the device through distribution and use, and may include information on the lot or serial number.

“Many in the supply chain have been supporting, and preparing for, a system in which we all use a single set of data standards to globally communicate important product information every step of the way, ensuring we are all speaking the same electronic language,” said Joe Pleasant, chief information officer for Premier, a leading national healthcare alliance. Pleasant is a board member for GS1 US and serves on the Global GS1 Healthcare Leadership Team. “With regulation in place, we should see a rapid increase in the adoption and implementation of GS1 standards that facilitate the flow of accurate information in the supply chain.”

Supported by the healthcare supply chain and patient-safety and advocacy groups, a national UDI system for medical devices would:

  •     Improve the FDA’s capabilities in pre- and post-market surveillance;
  •     Increase accuracy of electronic information in the healthcare supply chain;
  •     Facilitate improved tracking, storage/inventory and retrieval of products, an aspect especially important in product recall efforts that have a direct impact on patient safety;
  •     Reduce medical errors by enabling medical information systems to more accurately track the type and dosage of products used in treatment and diagnoses;
  •     Increase accuracy of healthcare product information stored in patient’s health record;
  •     Support other patient safety technology, such as the development of the electronic medical record and RFID/barcoding; and
  •     Harmonize product tracking and tracing efforts in the U.S. with the UDI guideline published by the International Medical Device Regulators' Forum (IMDRF) (formerly the Global Harmonization Task Force), an international voluntary group of representatives from medical device regulatory authorities and industry around the world.

To learn more about how GS1 Standards-- including the GTIN and the GS1 Global Data Synchronization Network™ (GDSN®), a single, synchronized data source for product information – will foster UDI regulation compliance across the industry, visit http://www.gs1us.org/healthcare.

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. More than 200,000 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). http://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 twenty-seven local GS1 Healthcare user groups around the world that supports the adoption and implementation of global standards developed by GS1. For more information, visit http://www.gs1us.org/healthcare

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Jon Mellor
GS1 US
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