Working Party Names GMDN as the Standard for Categorizing High-Risk Medical Implants

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An independent working group has endorsed the Global Medical Device Nomenclature (GMDN) as the preferred method for categorizing high-risk implants in the US and, de facto, internationally.

The Learning UDI Community (LUC) working party, brings together leaders from across the US healthcare sector to assess how the Unique Device Identifier (UDI) dataset is being used. Its role is to coordinate industry efforts to accelerate adoption of the UDI, enabling better standards for identifying and categorizing medical devices in order to raise patient safety standards.

Mark Wasmuth, chief executive of the GMDN Agency, which manages and maintains the GMDN database that categorizes the medical devices, said: “There has, in the past few years, been a realization about how hard it is to identify patients who have received types of implants.

“Improving this is an important area for medical device regulators, and this is being tackled by the LUC working party.  Given the scale of the US medical devices market, we expect its decision to use the GMDN for categorizing high-risk implants will be adopted by most countries in the near future.

“The GMDN, which is free to medical device manufacturers as well as other interested parties such as regulators and academics, is particularly well suited for this role because it features accurate definitions and is updated in real-time.

“Following the decision by the US FDA in 2013 to use the GMDN as the categorization system for America’s national regulation, it is now used in healthcare information systems to give real-time analysis of device use.  This is a great leap forward in protecting patients because it enables the latest types of products to be assessed.”

The LUC working party was created by the US regulator, the Food & Drugs Administration (FDA) and Advancing Health Care through Supply Chain Excellence (AHRMM), the US membership group for health care supply chain professionals.

In the LUC’s 2019 published report on ‘Device Categorization’ they conclude that in order to extract key device information to support device evaluation, the use of the GMDN aided this process because it is directly linked to products in the GUDID (UDI database).

A further study on ‘High-Risk Implants’ went further and concluded that “Use of the GMDN term assigned to UDI-DIs and their associated implantable collective codes supports the most accurate programmable approach to identifying implantable devices.”

As the de facto standard for identifying millions of medical devices worldwide, the GMDN collects and collates data which, cross-referenced with the UDI code, gives regulators, sellers, and buyers the tools they need to improve device safety and medical efficiency.

Currently, the GMDN lists more than 23,000 groups of medical devices, with around 700 new terms created between January and November 2019.



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