Welcome!

News Feed Item

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, N.J., April 16, 2014 /PRNewswire-USNewswire/ -- 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 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, 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.

SOURCE GS1 US

More Stories By PR Newswire

Copyright © 2007 PR Newswire. All rights reserved. Republication or redistribution of PRNewswire content is expressly prohibited without the prior written consent of PRNewswire. PRNewswire shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.

Latest Stories
The dynamic nature of the cloud means that change is a constant when it comes to modern cloud-based infrastructure. Delivering modern applications to end users, therefore, is a constantly shifting challenge. Delivery automation helps IT Ops teams ensure that apps are providing an optimal end user experience over hybrid-cloud and multi-cloud environments, no matter what the current state of the infrastructure is. To employ a delivery automation strategy that reflects your business rules, making r...
Modern software design has fundamentally changed how we manage applications, causing many to turn to containers as the new virtual machine for resource management. As container adoption grows beyond stateless applications to stateful workloads, the need for persistent storage is foundational - something customers routinely cite as a top pain point. In his session at @DevOpsSummit at 21st Cloud Expo, Bill Borsari, Head of Systems Engineering at Datera, explored how organizations can reap the bene...
Kubernetes is an open source system for automating deployment, scaling, and management of containerized applications. Kubernetes was originally built by Google, leveraging years of experience with managing container workloads, and is now a Cloud Native Compute Foundation (CNCF) project. Kubernetes has been widely adopted by the community, supported on all major public and private cloud providers, and is gaining rapid adoption in enterprises. However, Kubernetes may seem intimidating and complex ...
In a recent survey, Sumo Logic surveyed 1,500 customers who employ cloud services such as Amazon Web Services (AWS), Microsoft Azure, and Google Cloud Platform (GCP). According to the survey, a quarter of the respondents have already deployed Docker containers and nearly as many (23 percent) are employing the AWS Lambda serverless computing framework. It’s clear: serverless is here to stay. The adoption does come with some needed changes, within both application development and operations. Tha...
In his session at 21st Cloud Expo, Michael Burley, a Senior Business Development Executive in IT Services at NetApp, described how NetApp designed a three-year program of work to migrate 25PB of a major telco's enterprise data to a new STaaS platform, and then secured a long-term contract to manage and operate the platform. This significant program blended the best of NetApp’s solutions and services capabilities to enable this telco’s successful adoption of private cloud storage and launching ...
In his general session at 21st Cloud Expo, Greg Dumas, Calligo’s Vice President and G.M. of US operations, discussed the new Global Data Protection Regulation and how Calligo can help business stay compliant in digitally globalized world. Greg Dumas is Calligo's Vice President and G.M. of US operations. Calligo is an established service provider that provides an innovative platform for trusted cloud solutions. Calligo’s customers are typically most concerned about GDPR compliance, application p...
The past few years have brought a sea change in the way applications are architected, developed, and consumed—increasing both the complexity of testing and the business impact of software failures. How can software testing professionals keep pace with modern application delivery, given the trends that impact both architectures (cloud, microservices, and APIs) and processes (DevOps, agile, and continuous delivery)? This is where continuous testing comes in. D
The 22nd International Cloud Expo | 1st DXWorld Expo has announced that its Call for Papers is open. Cloud Expo | DXWorld Expo, to be held June 5-7, 2018, at the Javits Center in New York, NY, brings together Cloud Computing, Digital Transformation, Big Data, Internet of Things, DevOps, Machine Learning and WebRTC to one location. With cloud computing driving a higher percentage of enterprise IT budgets every year, it becomes increasingly important to plant your flag in this fast-expanding busin...
Smart cities have the potential to change our lives at so many levels for citizens: less pollution, reduced parking obstacles, better health, education and more energy savings. Real-time data streaming and the Internet of Things (IoT) possess the power to turn this vision into a reality. However, most organizations today are building their data infrastructure to focus solely on addressing immediate business needs vs. a platform capable of quickly adapting emerging technologies to address future ...
SYS-CON Events announced today that Synametrics Technologies will exhibit at SYS-CON's 22nd International Cloud Expo®, which will take place on June 5-7, 2018, at the Javits Center in New York, NY. Synametrics Technologies is a privately held company based in Plainsboro, New Jersey that has been providing solutions for the developer community since 1997. Based on the success of its initial product offerings such as WinSQL, Xeams, SynaMan and Syncrify, Synametrics continues to create and hone in...
You know you need the cloud, but you’re hesitant to simply dump everything at Amazon since you know that not all workloads are suitable for cloud. You know that you want the kind of ease of use and scalability that you get with public cloud, but your applications are architected in a way that makes the public cloud a non-starter. You’re looking at private cloud solutions based on hyperconverged infrastructure, but you’re concerned with the limits inherent in those technologies.
Nordstrom is transforming the way that they do business and the cloud is the key to enabling speed and hyper personalized customer experiences. In his session at 21st Cloud Expo, Ken Schow, VP of Engineering at Nordstrom, discussed some of the key learnings and common pitfalls of large enterprises moving to the cloud. This includes strategies around choosing a cloud provider(s), architecture, and lessons learned. In addition, he covered some of the best practices for structured team migration an...
No hype cycles or predictions of a gazillion things here. IoT is here. You get it. You know your business and have great ideas for a business transformation strategy. What comes next? Time to make it happen. In his session at @ThingsExpo, Jay Mason, an Associate Partner of Analytics, IoT & Cybersecurity at M&S Consulting, presented a step-by-step plan to develop your technology implementation strategy. He also discussed the evaluation of communication standards and IoT messaging protocols, data...
With tough new regulations coming to Europe on data privacy in May 2018, Calligo will explain why in reality the effect is global and transforms how you consider critical data. EU GDPR fundamentally rewrites the rules for cloud, Big Data and IoT. In his session at 21st Cloud Expo, Adam Ryan, Vice President and General Manager EMEA at Calligo, examined the regulations and provided insight on how it affects technology, challenges the established rules and will usher in new levels of diligence arou...
Most technology leaders, contemporary and from the hardware era, are reshaping their businesses to do software. They hope to capture value from emerging technologies such as IoT, SDN, and AI. Ultimately, irrespective of the vertical, it is about deriving value from independent software applications participating in an ecosystem as one comprehensive solution. In his session at @ThingsExpo, Kausik Sridhar, founder and CTO of Pulzze Systems, discussed how given the magnitude of today's application ...