GMDN Case Studies
GMDN in a Swedish context
The Global Medical Device Nomenclature (GMDN) was introduced in Sweden in 2011, coinciding with the formation of the MTPReg group. This group is responsible for setting codes for all medical equipment owned by Swedish public healthcare providers. Sweden’s decentralized healthcare system, managed by regions, local authorities, or municipalities, is divided into public and private sectors. Each of the 21 regions has its own medical equipment register, with codes set by the MTPReg group. The MTPReg register synchronizes nightly with all regional registers to ensure new codes are available locally.
In 2007, representatives from all 21 regions agreed to create a national code system, MTPReg, to standardize medical equipment coding across Sweden’s approximately 80 hospitals. The MTPReg group, consisting of six part-time Medical Engineers, handles around 1,000 new code requests annually. Each request includes detailed information and photos of the medical device. The MTPReg code number combines the GMDN Code and an MTPReg identification number, ensuring consistency and accuracy in the national inventory.
More information can be found here.
Real World Evidence of how GMDN can support UDI implementation
Unique Device Identification (UDI) is a regulatory initiative established by various health authorities, including the FDA (Food & Drug Administration) in the United States, the TGA (Therapeutic Goods Association) in Australia and the MHRA (Medicines and Healthcare products Regulatory Agency) in the UK amongst others, to support their regulatory frameworks.
A UDI is assigned to each medical device by an Issuing Agency (e.g., GS1, HIBBC) authorised by regulatory authorities. This consists of two parts: a device identifier (DI) and the production identifier (PI). While the core structure of UDI is globally harmonised based on the IMDRF’s UDI Guidance, each country’s UDI system may also have specific data element requirements. For example, the AccessGUDID maintained by the FDA and the National Library of Medicine (NLM) in the United States, has more than 60 data elements, one of which is the GMDN Code.
This system enhances the ability to trace devices throughout their lifecycle, from manufacturing to patient use. The integration of GMDN into UDI databases is a significant step towards improving the safety, traceability, and management of medical devices. By providing a standardised terminology and supporting regulatory compliance, GMDN plays a vital role in facilitating the effective implementation of UDI. As the medical device industry continues to innovate, the alignment between GMDN and UDI will remain essential for healthcare intelligence and device lifecycle management.
Links to UDI databases that incorporate GMDN:
MHRA Public Access Registration Database (PARD)
National Wound Care Strategy Programme
The Global Medical Device Nomenclature (GMDN) is an internationally recognised system that ensures uniform categorisation of medical devices, facilitating the identification and sharing of issues across countries to enhance safety. The National Wound Care Strategy Programme (NWCSP), commissioned by NHS England, aims to address sub-optimal wound care in the UK by developing innovative solutions to improve wound healing, prevent harm, increase staff productivity, and produce financial savings in line with the NHS Long Term Plan.
Over the past two years, the NWCSP has been developing a new wound product classification system and a comprehensive repository of wound management products. This system, created in collaboration with clinicians, suppliers, the GMDN Agency, and procurement professionals, ensures consistent naming, coding, and grouping of products. The NWCSP continues to refine this system to maintain high standards of care and safety, with ongoing feedback from the GMDN Agency to improve the utility and effectiveness of the nomenclature.
More information can be found here.
Discovery
South African founded company, Discovery, has operations across the globe. They use their pioneering shared-value insurance model to achieve their purpose to make people healthier and to enhance and protect their lives.
Lucinda Mnisi, Risk Manager, at Discovery in South Africa explains in this video how they are using the GMDN to support this purpose.
Strata Decision Technology
At Strata, we empower healthcare organizations with software and data solutions to develop achievable budgets, effective strategic plans, and leverage data for market opportunities and growth. Our partnership with the Global Medical Device Nomenclature (GMDN) Agency helps these organizations categorize and analyse complex medical device data, enhancing patient care through efficient data management.
Healthcare leaders strive to improve financial, operational, and quality outcomes, often requiring deep data analysis. To facilitate this, we’ve launched a project to provide a logical grouping structure for high-cost areas of the hospital charge master. By using the GMDN Database, we ensure detailed and consistent data analysis, enabling faster and more accurate insights into cost variations and care delivery.
More information can be found here.
LFH Regulatory
GMDN Agency video interview with Laura Friedl-Hirst, Managing Director at LFH Regulatory.
Laura talks about the importance of harmonisation across global medical device regulation and how that impacts and benefits clients of LFH Regulatory. She also talks about how her organisation uses the GMDN Database in support of their clients.
Laura says: “We utilise the GMDN Database essentially for our clients, if they have a new product, they need to understand the product description. We find the system very easy to navigate and as well it allows us in future to run post market surveillance searches pretty easily and it is more effective for us.”
To find out more about LFH Regulatory please visit: www.lfhregulatory.co.uk