GS1 Healthcare US Releases Implementation Guideline for Using GS1 Standards to Address FDA Unique Device Identification

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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 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


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


-- 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

(, 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

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

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@).


-0- 04/16/2014

/CONTACT: Shannon Sullivan,(609) 620-4534,; or Rebecca Oles, (408) 623-5324,

/Web Site:


ST: New Jersey




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0000 04/16/2014 14:00:00 EDT

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