WHO Advances International Harmonized Nomenclature for Medical Devices

Regulatory NewsRegulatory News | 05 February 2019 |  By 

The World Health Organization (WHO) reported Monday on recent progress toward the development of its international nomenclature for medical devices, known as the International Classification of Medical Devices (ICMD).

WHO discussed work in progress at the 4th Global Forum on Medical Devices, which took place last December.

“Having a nomenclature system in place for medical devices facilitates their management and regulation by standardizing terms that enable communication despite linguistic and other barriers,” WHO said in its recap of the forum. “This major project aims to have a comprehensive international harmonized nomenclature for medical devices, which would be freely available, downloadable.”

An example site to showcase ICMD is now available for browsing. WHO’s 2018 survey on medical device nomenclatures received a total of 43 responses, with 23 offers to collaborate or provide feedback and 11 different systems of nomenclature proposed for ICMD.

A September-November 2018 WHO consultation to pilot the agency’s new ICMD system drew more than 30 proposals and comments from a wide range of stakeholders, including Brazil’s ANVISA, the ECRI Institute, the GMDN Agency, Stryker and the Taiwan Food and Drug Administration. The GMDN Agency is among those that proposed its international coding system in support of ICMD’s development.

The initiative is centered on global harmonization for the plethora of nomenclatures of medical devices that currently exist across many different countries. It is being developed based on the International Classification of Diseases and Related Health Problems (ICD) platform, which serves as an ontological database for classifications and is suitable for linkage with unique device identification (UDI) systems.

The work around ICMD is in line with the United Nations’ (UN) third sustainable development goal: Ensure healthy lives and promote wellbeing for all at all ages. It seeks to address the problem with the current lack of nomenclature harmonization. The problem relates to upwards 10,000 types of medical devices presenting difficulties for selection, procurement and use, according to WHO.

“The nomenclature and classification of medical devices is an ongoing priority item for the WHO Medical Devices unit” in order to “progress towards access to medical devices to achieve universal health coverage and facilitate emergency interventions,” the UN agency said.

WHO reported that 90 countries have an official nomenclature for medical devices. The approaches to system implementation varied as 26% were nationally developed, 12% only use the Universal Medical Device Nomenclature System and 10% only use the Global Medical Device Nomenclature (GMDN).

A July 2018 survey of national medical device regulators “indicated an increasing usage by countries of the GMDN, since the last WHO survey in 2014,” GMDN Agency CEO Mark Wasmuth noted in the August 2018 proposal to WHO. Wasmuth also noted that the GMDN is the only nomenclature required in a national UDI database—the US Food and Drug Administration’s GUDID—compliant with guidelines developed via the International Medical Device Regulators Forum (IMDRF).

WHO is an official IMDRF observer and uses GMDN in its publications. Yet Angela Silvestri, director of regulatory affairs at Stryker, cautioned in the firm’s proposal that “selection of an international code based on the number of countries alone could lead to more ‘rework’ of product data, overly burdening not only industry, but registrations and responsible authorities in the largest medical device markets.”

Sources for the first ICDM database include the WHO list of priority medical devices for cancer management, the interagency list of medical devices for essential interventions for reproductive, maternal, newborn and child health and the WHO list of assistive devices. It will also include an upcoming essential list of medical devices for emergency interventions. The more than 2,000 terms that have been generated under this project cover “almost entirely the capital medical devices,” WHO said.


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