Improving Medical Risk Management Using Automotive Standards

Area of Science:

• Biomedical Engineering
• Systems Safety Engineering
• Medical Device Regulation

Background:

• Medical electrical (ME) equipment and systems require robust safety assessments.
• Current risk assessment and development for safety-relevant medical devices can be complex.
• Cross-sectoral learning offers potential for improved methodologies.

Purpose of the Study:

• To present a strategy for assessing ME EQUIPMENT and ME SYSTEMS.
• To leverage techniques from the ISO 26262:2018 automotive functional safety standard.
• To improve and simplify risk assessment and development for safety-relevant medical devices.

Main Methods:

• Adaptation of techniques from the ISO 26262:2018 standard.
• Systems-focused approach applicable to devices under IEC 60601-1.
• Application of cross-sectoral learning principles.

Main Results:

• A simplified and improved strategy for assessing ME EQUIPMENT and ME SYSTEMS.
• Demonstration of the advantages of applying automotive safety standards to medical devices.
• Identification of efficiencies gained through interdisciplinary safety approaches.

Conclusions:

• The proposed strategy effectively enhances the safety assessment of medical electrical equipment.
• Cross-sectoral learning from automotive functional safety provides significant benefits.
• This approach streamlines development and risk management for safety-critical medical devices.