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
SYS-CON Events announced today that Catchpoint Systems, Inc., a provider of innovative web and infrastructure monitoring solutions, has been named “Silver Sponsor” of SYS-CON's DevOps Summit at 18th Cloud Expo New York, which will take place June 7-9, 2016, at the Javits Center in New York City, NY. Catchpoint is a leading Digital Performance Analytics company that provides unparalleled insight into customer-critical services to help consistently deliver an amazing customer experience. Designed...
Companies can harness IoT and predictive analytics to sustain business continuity; predict and manage site performance during emergencies; minimize expensive reactive maintenance; and forecast equipment and maintenance budgets and expenditures. Providing cost-effective, uninterrupted service is challenging, particularly for organizations with geographically dispersed operations.
When building large, cloud-based applications that operate at a high scale, it’s important to maintain a high availability and resilience to failures. In order to do that, you must be tolerant of failures, even in light of failures in other areas of your application. “Fly two mistakes high” is an old adage in the radio control airplane hobby. It means, fly high enough so that if you make a mistake, you can continue flying with room to still make mistakes. In his session at 18th Cloud Expo, Lee...
DevOps is not just last year’s buzzword. Companies with DevOps practices are 2.5x more likely to exceed profitability, market share, and productivity goals. But how do you enable high performance? What can you do right now to start? Find out from DevOps experts including Gene Kim, co-author of "The Phoenix Project," and the Dynatrace Center of Excellence.
With the proliferation of both SQL and NoSQL databases, organizations can now target specific fit-for-purpose database tools for their different application needs regarding scalability, ease of use, ACID support, etc. Platform as a Service offerings make this even easier now, enabling developers to roll out their own database infrastructure in minutes with minimal management overhead. However, this same amount of flexibility also comes with the challenges of picking the right tool, on the right ...
SYS-CON Events announced today that Column Technologies will exhibit at SYS-CON's @DevOpsSummit at Cloud Expo, which will take place on June 7-9, 2016, at the Javits Center in New York City, NY. Established in 1998, Column Technologies is a global technology solutions provider with over 400 employees, headquartered in the United States with offices in Canada, India, and the United Kingdom. Column Technologies provides “Best of Breed” technology solutions that automate the key DevOps principal...
SYS-CON Events announced today that Interoute, owner-operator of one of Europe's largest networks and a global cloud services platform, has been named “Bronze Sponsor” of SYS-CON's 18th Cloud Expo, which will take place on June 7-9, 2015 at the Javits Center in New York, New York. Interoute is the owner-operator of one of Europe's largest networks and a global cloud services platform which encompasses 12 data centers, 14 virtual data centers and 31 colocation centers, with connections to 195 ad...
Join us at Cloud Expo | @ThingsExpo 2016 – June 7-9 at the Javits Center in New York City and November 1-3 at the Santa Clara Convention Center in Santa Clara, CA – and deliver your unique message in a way that is striking and unforgettable by taking advantage of SYS-CON's unmatched high-impact, result-driven event / media packages.
SYS-CON Events announced today that Commvault, a global leader in enterprise data protection and information management, has been named “Bronze Sponsor” of SYS-CON's 18th International Cloud Expo, which will take place on June 7–9, 2016, at the Javits Center in New York City, NY, and the 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. Commvault is a leading provider of data protection and information management...
There will be new vendors providing applications, middleware, and connected devices to support the thriving IoT ecosystem. This essentially means that electronic device manufacturers will also be in the software business. Many will be new to building embedded software or robust software. This creates an increased importance on software quality, particularly within the Industrial Internet of Things where business-critical applications are becoming dependent on products controlled by software. Qua...
As someone who has been dedicated to automation and Application Release Automation (ARA) technology for almost six years now, one of the most common questions I get asked regards Platform-as-a-Service (PaaS). Specifically, people want to know whether release automation is still needed when a PaaS is in place, and why. Isn't that what a PaaS provides? A solution to the deployment and runtime challenges of an application? Why would anyone using a PaaS then need an automation engine with workflow ...
With an estimated 50 billion devices connected to the Internet by 2020, several industries will begin to expand their capabilities for retaining end point data at the edge to better utilize the range of data types and sheer volume of M2M data generated by the Internet of Things. In his session at @ThingsExpo, Don DeLoach, CEO and President of Infobright, will discuss the infrastructures businesses will need to implement to handle this explosion of data by providing specific use cases for filte...
SYS-CON Events announced today that Pythian, a global IT services company specializing in helping companies adopt disruptive technologies to optimize revenue-generating systems, has been named “Bronze Sponsor” of SYS-CON's 18th Cloud Expo, which will take place on June 7-9, 2015 at the Javits Center in New York, New York. Founded in 1997, Pythian is a global IT services company that helps companies compete by adopting disruptive technologies such as cloud, Big Data, advanced analytics, and DevO...
SYS-CON Events announced today that Avere Systems, a leading provider of enterprise storage for the hybrid cloud, will exhibit at SYS-CON's 18th International Cloud Expo®, which will take place on June 7-9, 2016, at the Javits Center in New York City, NY. Avere delivers a more modern architectural approach to storage that doesn’t require the overprovisioning of storage capacity to achieve performance, overspending on expensive storage media for inactive data or the overbuilding of data centers ...
CIOs and those charged with running IT Operations are challenged to deliver secure, audited, and reliable compute environments for the applications and data for the business. Behind the scenes these tasks are often accomplished by following onerous time-consuming processes and often the management of these environments and processes will be outsourced to multiple IT service providers. In addition, the division of work is often siloed into traditional "towers" that are not well integrated for cro...