CEO Blog - How can the GMDN support post-market medical device surveillance and vigilance?

2 August 2023

CEO Blog by Deniz Bruce

As the CEO of the Global Medical Device Nomenclature (GMDN) Agency, I am continuously amazed by the benefits that a standardised medical device nomenclature can provide to the healthcare industry.

From improving supply chain efficiency to reducing inventory carrying costs, adopting a standardised nomenclature has the potential to revolutionise how we approach healthcare and medical device management. Still, one area where the GMDN can be particularly useful is in post-market surveillance and vigilance.

The GMDN is currently used by medical device Regulators in more than 70 countries worldwide, making it the most widely used and trusted medical device nomenclature globally.

Post-market surveillance and vigilance are critical components of ensuring the safety and efficacy of medical devices. Healthcare professionals and Regulators alike rely on this process to identify and address any issues that may arise after a device has been approved and put on the market. However, this process can be complex and time-consuming, especially when dealing with many devices and Manufacturers.

One of the key advantages of the GMDN in post-market surveillance is its integration with the UDI and DI systems. The UDI is a unique numeric or alphanumeric code assigned to a specific medical device that provides information about its identity, manufacturer, and version. The DI, on the other hand, is a component of the UDI that indicates the specific version or model of a device. These systems enable tracking and traceability of medical implants throughout their lifecycle, from production to patient use and beyond.

By utilising the GMDN as part of the UDI/DI system, post-market surveillance becomes more efficient and effective. When adverse events or safety concerns arise related to a particular medical implant, Regulatory Authorities can easily review similar devices by referencing the GMDN code.

This allows for targeted investigations and recalls, minimising patient risk and ensuring timely interventions. Furthermore, the standardised coding and traceability facilitated by the GMDN help in identifying patterns, trends, and potential safety issues across different devices, manufacturers, and regions.

Another of the key benefits of using the GMDN in post-market surveillance is improved data management. With a standardised nomenclature in place, it becomes much easier to collect and analyse data on medical devices. This can help Regulators and healthcare professionals identify trends and patterns across different devices and Manufacturers, allowing them to detect potential issues sooner and act more quickly.

Yet another benefit of using the GMDN in post-market surveillance is improved communication between different stakeholders in the healthcare industry. Because the GMDN provides a standardised system for naming and categorising devices, it becomes much easier for different stakeholders to communicate and share information. This can be particularly useful when dealing with cross-border issues, as the GMDN provides a common language that can be understood by healthcare professionals and Regulators around the world.

In addition, the GMDN can help improve inventory management and supply chain efficiency. By providing a standardised system for categorising devices, tracking, and managing inventory becomes much easier. This can help healthcare providers ensure that they have the right devices on hand when they are needed while also reducing the risk of overstocking or understocking.

However, it is important to note that adopting the GMDN is not a quick fix. It requires a long-term commitment from healthcare providers and Regulators alike. At the GMDN Agency, we are committed to ongoing development and improvement. We work closely with Regulators, Manufacturers, and healthcare providers to ensure that our system is up-to-date and meets the evolving needs of the medical device industry. We also provide training and support to ensure that our system is used correctly and effectively.

So, in my view, the benefits of adopting the GMDN are clear. By providing a common language for naming and categorising medical devices, the GMDN can help streamline the post-market surveillance process, improve data management, and facilitate communication between different stakeholders in the healthcare industry. This can all lead to improved patient outcomes, reduced costs, and more efficient supply chain management.

Deniz Bruce CEO, GMDN Agency