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TO HEALTH, MEDICAL, AND NATIONAL EDITORS:
GS1 Healthcare US Releases Implementation Guideline for Using GS1
Standards to Address FDA Unique Device Identification
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 NetworkT (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
-0- 04/16/2014
/CONTACT: Shannon Sullivan,(609) 620-4534, ssullivan@gs1us.org; or Rebecca Oles, (408) 623-5324, rebecca@olescommunications.com
/Web Site: http://www.gs1us.org
CO: GS1 US
ST: New Jersey
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SU: NPT LEG
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-- DC06626 --
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