GS1 receives US FDA accreditation

Medical Equipment GS1 400

Global standards organisation GS1 has received accreditation by the US Food and Drug Administration (FDA) as issuing agency for unique device identifiers (UDI).

Global GS1 Standards meet the government’s criteria for UDI and will help manufacturers address requirements of the new FDA UDI regulation, which was published in September 2013 to support patient safety and supply chain security.

The Unique Device Identification system aims to create a common worldwide system for product identification that will improve healthcare business processes and patient safety. The US FDA UDI rule is the first to be released but is expected to be followed by other similar regulations worldwide.

“GS1’s single, global system of standards across the entire healthcare supply chain is fundamental to enable an efficient and effective implementation of UDI by all healthcare stakeholders worldwide and to assist them in complying with the new regulation,” said Miguel Lopera, president and CEO of GS1, which has headquarters in Brussels, Belgium.

The GS1 System is an integrated suite of global standards that provides for accurate identification and communication of information regarding products, assets, services and locations.

GS1 Standards, including the Global Trade Item Number (GTIN), are already in use by leading healthcare manufacturers, and are recognised across the healthcare industry as a unique identifier of medical/surgical products for every level of packaging. Healthcare manufacturers in the U.S and around the world can create and maintain a compliant UDI number (i.e. GTIN) by following the requirements of the US FDA UDI Rule and the GS1 General Specifications.

“Global GS1 Standards support the FDA’s vision for a unified global supply chain,” said Maria Palazzolo, GS1 Australia’s CEO. “Using GS1 Standards, healthcare organisations around the world are able to uniquely identify and locate medical devices through their own business and throughout the whole supply chain, improving product visibility and patient safety.”

According to the FDA rule, a UDI number generally must be applied to the medical device label, its packaging, and in some cases the device itself. By unambiguously identifying medical devices, GS1 Standards benefit patients, the healthcare system and the medical device industry.

GS1 standards assist healthcare organisations around the world to quickly and efficiently identify devices when recalled, improve the accuracy and specificity of adverse event reports and provide a foundation for a global, secure distribution chain. They also offer a clear way of documenting device use in electronic health records and clinical information systems. GS1’s global coding systems are compliant with relevant international ISO standards.

The GS1 System is the most widely used set of supply chain standards in the world and is used by most stakeholders in healthcare supply chains.


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