Indonesia's Initiatives in Implementing Medical Device Nomenclature Standards: Current Gaps with Global Standards

Area of Science:

• Health Informatics
• Medical Device Regulation
• Health Systems Management

Background:

• Indonesia utilizes a hierarchical nomenclature system (KFA) for medical devices, facing standardization challenges.
• Existing national standards exhibit metadata gaps compared to global platforms like WHO's MeDevIS.
• Global standards incorporate crucial data points absent in Indonesia's current system.

Purpose of the Study:

• To compare Indonesia's national medical device nomenclature with WHO's MeDevIS platform.
• To identify discrepancies in metadata coverage between national and international standards.
• To advocate for a unified nomenclature system for improved medical device management.

Main Methods:

• A desk review methodology was employed.
• Analysis of Indonesia's Ministerial Health Decree and KFA dictionary.
• Comparison of metadata elements between Indonesian standards and WHO's MeDevIS (GMDN, EMDN).

Main Results:

• Significant discrepancies in metadata coverage were identified.
• WHO's MeDevIS includes richer metadata (e.g., knowledge level, reusability, population characteristics).
• Indonesia's national system lacks comprehensive data points essential for device lifecycle management.

Conclusions:

• Indonesia's current medical device nomenclature requires enhancement to align with global standards.
• A unified and standardized nomenclature system is crucial for effective medical device identification and management.
• Adopting a more comprehensive metadata framework will improve healthcare quality and safety.