26 November 2024

By Edward Glenn, Senior Nomenclature Developer at the GMDN Agency

In the ever-evolving landscape of medical devices, ensuring patient safety and effective device management is paramount. One of the key systems aiding in this endeavour is the Global Medical Device Nomenclature (GMDN). This standardised system plays a crucial role in the implementation of Unique Device Identification (UDI), a regulatory requirement designed to enhance the traceability and safety of medical devices.

What is GMDN?

The GMDN is a comprehensive system of internationally recognised Terms used to name and group medical devices. Managed by the GMDN Agency, it provides a standardised naming convention that helps in the clear and consistent medical device type identification across different regions and regulatory frameworks.

Understanding UDI

The Unique Device Identification (UDI) system is a regulatory framework 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. The UDI system assigns a unique identifier to each medical device, which includes a device identifier (DI) and a production identifier (PI). Each country’s UDI system also has separate data elements requirements, for example the AccessGUDID maintained by the FDA and the National Library of Medicine in the United States, has more than 60 data elements, of which the GMDN is one. This system enhances the ability to trace devices throughout their lifecycle, from manufacturing to patient use.

The Role of GMDN in UDI Implementation

• Standardised Terminology:

The GMDN provides a standardised set of Terms that are used within the UDI system. This standardisation ensures that all medical devices are described consistently, which is crucial for reducing ambiguity. Consistent terminology improves communication among manufacturers, regulators, and healthcare providers by ensuring everyone has the same information regarding device identification and classification. This uniformity is essential for effective regulation, monitoring, and management of medical devices.

Example: A manufacturer produces a range of surgical gloves. By using GMDN Terms, these gloves are consistently described across all documentation and databases as e.g., “Nitrile surgical glove, non-powdered.”  This standardisation ensures that when healthcare providers, regulators, or other stakeholders refer to these gloves, they all understand exactly what type of product is being discussed, reducing the risk of miscommunication.

• Regulatory Compliance:

Using GMDN Codes helps manufacturers ensure their devices meet the regulatory requirements for UDI. This is particularly important for global companies that need to comply with multiple regulatory bodies, such as the FDA in the United States, the MHRA in the United Kingdom, and other national regulatory authorities. By using GMDN, manufacturers can streamline their compliance processes, reduce the risk of regulatory issues, and facilitate smoother market access across different regions.

Example: A global medical device company needs to comply with both FDA regulations in the United States and TGA regulations in Australia. By using GMDN Codes, the company can ensure that their devices are correctly identified and classified according to the requirements of both regulatory bodies. This helps streamline the approval process and ensures that the devices can be marketed in multiple regions without additional modifications.

• Traceability:

The use of GMDN Codes enhance the traceability of medical devices by providing a consistent framework for identifying and tracking devices in-country and across different jurisdictions. This traceability is vital for early signal detection of performance issues, enabling quicker responses to potential problems. GMDN Codes also support category-level analysis, helping to identify trends and patterns in device performance. This precise identification is crucial for managing recalls, ensuring that affected devices can be quickly and accurately located and addressed, thereby protecting patient safety.

Example: An insulin pump is found to have a software issue. Using UDI, the manufacturers and hospitals can quickly identify all affected devices and trace their distribution across different countries. This enables the company to issue a targeted recall, promptly removing all defective pumps from the market. Where UDI varies across jurisdictions (e.g., due to different documentation, language, or electrical plug) the GMDN can help find all related UDI-DI. Where a generic or common fault may exist across different makes/models the GMDN becomes an essential tool for identifying possible affected devices. The UDI and GMDN codes used in harmony are powerful for protecting patient safety and maintaining regulatory compliance.

• Improved Data Quality:

The use of GMDN supports the creation of high-quality, consistent data for medical devices. This data is essential for various regulatory processes, including submissions, clinical evaluations, and market access. High-quality data also facilitates robust data analysis using real-world evidence, which can be gathered from pre-market and post-market surveillance programs. This comprehensive data collection and analysis help identify the most appropriate technologies for patients, improving overall healthcare outcomes.

Example: During a clinical evaluation, a researcher needs to analyse data from several types of cardiac pacemakers. By using GMDN Codes, the researcher can pool data from different models and manufacturers that fall under the same GMDN Term, such as “Cardiac Pacemaker, Implantable.” This aggregated data provides a more comprehensive understanding of the performance and safety of these devices, supporting better clinical decisions and regulatory submissions.

• Facilitating Innovation:

As medical device technology evolves, the GMDN system is continuously updated to include new Terms and classifications. This ensures that innovative devices can be accurately identified and integrated into the UDI system. By keeping pace with technological advancements, the GMDN supports the ongoing development and adoption of new medical technologies, fostering innovation in the medical device industry. This dynamic updating process helps ensure that the UDI system remains relevant and effective in managing the latest medical devices.

Example: A new type of wearable health monitor is developed, capable of continuously tracking multiple vital signs. The GMDN system is updated to include a new Term for this innovative device. This allows the new health monitor to be accurately identified and integrated into the UDI system, ensuring that it can be properly regulated while supporting the adoption of innovative medical technology. This can only be of benefit both patients and healthcare providers.

Conclusion

The integration of GMDN into the UDI framework is a significant step towards improving the safety, traceability, and management of medical devices. By providing a standardised language and ensuring regulatory compliance, GMDN plays a vital role in the successful implementation of UDI. As the medical device industry continues to innovate, the collaboration between GMDN and UDI will be essential in maintaining high standards of patient care and device management.