4 April 2024

 

CEO Blog

The vital role of a dynamic medical device nomenclature – by Deniz Bruce, CEO of the GMDN Agency

Introduction

In the ever-evolving landscape of healthcare, medical devices play a crucial role in patient diagnosis, treatment, and management. From simple syringes to complex imaging technologies, these devices impact millions of lives worldwide. Ensuring effective communication, safety, and regulatory compliance of these medical devices, requires a standardised nomenclature system. 

As CEO of the GMDN (Global Medical Device Nomenclature) Agency, in this blog post, I delve into why an up-to-date and dynamic nomenclature such as the GMDN matters, and how it benefits patients, healthcare providers, manufacturers, and regulatory bodies.

1. Communication and Information Exchange

• The Tower of Babel Dilemma: Imagine a scenario where each healthcare provider uses a different name for the same medical device. It would make communication between each other extremely
  difficult. A standardised nomenclature bridges this gap, allowing seamless communication across borders, different jurisdictions, languages, and healthcare settings.

• Patient Safety: Accurate device descriptions are critical for patient safety. A common language ensures that everyone — from clinicians to supply chain managers — understands the intended use, risks, and benefits of a device.

2. Streamlining Processes

• From Procurement to Patient Care: An efficient healthcare system relies on streamlined processes. A
  universal nomenclature simplifies procurement, inventory management, and electronic health records (EHRs). It enables healthcare providers to group devices effectively during product ordering and tracking.

• Benefits Packages: Universal health coverage benefits packages can be optimised when devices are categorised consistently. This ensures that patients receive the right devices at the right time.

3. Regulatory Approval and Innovation

• Innovation and Naming: As medical technology advances, new devices emerge. A dynamic nomenclature such as the GMDN accommodates these innovations as soon as they are designed. Regulatory bodies can assess and approve novel technologies promptly, and traceability across different jurisdictions becomes a reality.

• Navigating Regulatory Pathways: For manufacturers seeking regulatory approval, a standardised nomenclature eases the process, ensuring that devices are grouped and classified correctly.

4. Access and Management

• Global Access: In resource-limited settings, access to safe and effective medical devices is critical. A harmonised nomenclature facilitates equitable distribution and management.

• Quality Control: Regulatory agencies and healthcare institutions can monitor devices more effectively when they share a common language. This, in turn, enhances quality control and patient outcomes.

Conclusion

An up-to-date and dynamic nomenclature isn’t just a technicality; it’s a lifeline for healthcare systems and patients. As we continue to innovate and improve medical devices, let’s ensure that our language keeps pace. By doing so, we empower healthcare professionals to enhance patient safety and contribute to a healthier world.

Remember, whether you’re a clinician, a policymaker, or a curious reader, understanding the importance of medical device nomenclature benefits us all.

Let’s speak the same language—one that transcends borders and enhances patient safety.

As a dynamic nomenclature, the GMDN must continually evolve to reflect the pace of change within the medical devices sector. New GMDN Terms are added to keep the nomenclature up to date with current medical technology.

The GMDN database is updated daily, and members who use our “My Terms” lists are notified via email if a GMDN Term in their list is modified or made obsolete.

New Terms are added to cover new device types and to maintain the nomenclature as a system of mutually exclusive concepts. GMDN Terms are also expanded to manage product variations that are not clinically significant. Wording changes are also made to ensure consistency.

Yearly average changes in the GMDN Database for financial year 2023/24 was a follows (01/04/23 – 31/03/24):

• New GMDN Terms: 0.91%

• GMDN Terms Obsoleted: 0.44%

• GMDN Terms Amended*: 1.78%

• Total GMDN Terms 24,975

The GMDN is used by Regulators in over 90 countries worldwide and has members in 148 countries across the globe. It has become a critical component of the global regulatory infrastructure for medical devices.