2021-09-22-世界卫生组织-Member_States_second_information_session_on_medical_devices_nomenclature_108页_9mb

Summary of the Standardization of Medical Devices Nomenclature

Core Content

The World Health Organization (WHO) is working on the standardization of medical devices nomenclature to support global health systems, particularly in the context of the 74th World Health Assembly (WHA74) and the upcoming Executive Board (EB150) in February 2022. The goal is to develop an international classification, coding, and nomenclature system for medical devices that enhances patient safety, access to medical devices for universal health coverage (UHC), and the quality of healthcare services.

Main Objectives

• Create an international classification system for medical devices.
• Support regulatory, procurement, and health technology assessment (HTA) processes.
• Facilitate the achievement of Sustainable Development Goal 3 (SDG3).
• Ensure transparency, harmonization, and evidence-based practices in nomenclature systems.

Key Information

Current Nomenclature Systems

• EMDN (European Medical Device Nomenclature): Developed by the European Commission in May 2021. It is structured, regulator-led, and supports various healthcare processes such as market surveillance, adverse event reporting, and clinical investigations.
• GMDN (Global Medical Device Nomenclature): A long-standing proprietary system. It is widely used but has licensing and cost issues.
• UMDNS (Universal Medical Device Nomenclature System): A closed system with copyright and fee restrictions.
• UNSPSC (United Nations Standard Products and Services Code): An open system, widely used for procurement and budgeting.

WHO Activities

• Conducted consultations with Member States, nomenclature agencies, and stakeholders.
• Aimed to map existing systems (EMDN, GMDN, UMDNS, UNSPSC) to ensure an international classification system.
• Avoided creating a new nomenclature to prevent duplication and ensure alignment with existing systems.
• Collaborated with the International Medical Device Regulators Forum (IMDRF) and other international bodies.

Stakeholder Input

• Member States: Emphasized the need for transparency, harmonization, and open systems.
• Industry Associations: Supported mapping efforts and the use of open systems.
• UN Agencies and NGOs: Used EMDN, GMDN, and UNSPSC, with some relying on proprietary systems. They expressed interest in being part of the pilot mapping study.

Challenges

• Proprietary systems like GMDN and UMDNS pose licensing and cost issues.
• Need for a unified system to simplify transactions and traceability, especially in low- and middle-income countries (LMICs).
• Lack of national lists for approved priority/essential medical devices in some countries.
• Some countries have not yet established national HTA units or policies.

Roadmap

• Conducted four rounds of consultations with nomenclature agencies.
• Completed a feasibility study to map EMDN to GMDN, UMDNS, and UNSPSC.
• Published survey responses with the consent of participants.
• Planned to present a final report to the Executive Board (EB150) in February 2022.
• Aimed to develop a transparent, open, and globally accessible nomenclature system.

Conclusion

WHO seeks to align with existing nomenclature systems to avoid duplication and ensure a global public good. The focus is on creating a harmonized, transparent, and accessible system that supports healthcare systems, especially during public health emergencies. Collaboration with stakeholders, including nomenclature agencies, Member States, and UN bodies, is crucial for achieving this goal.