[Usability first. Model-based approach for the use-oriented risk analysis of medical devices]

Area of Science:

• Medical Engineering
• Human-Computer Interaction
• Risk Management

Context:

• Increasing automation in medical devices leads to complex user interfaces and potential human-induced risks.
• Existing risk analysis methods may not fully address the complexities of modern medical technology.

Purpose:

• To introduce a formal-analytical methodology and software tool for prospective human-risk analysis and model-based usability evaluation.
• To identify and assess use-related risks associated with human-machine interaction in medical devices.

Summary:

• Developed the HiFEM (human-function effect modeling) methodology, employing a twofold approach: high-level task analysis and cognitive low-level task analysis.
• HiFEM models user-interactive processes and assesses risks based on human error taxonomies, applicable to diverse interfaces from computer-based to mechanical.
• Comparative studies show HiFEM is more effective, efficient, and satisfactory than traditional Failure Modes and Effects Analysis (FMEA).

Impact:

• Provides medical device manufacturers, especially SMEs, with a robust tool for risk management (ISO 14971) and usability engineering (IEC 62366, IEC 60601-1-6, EN ISO 9241).
• Enhances the safety and efficiency of medical devices by proactively identifying and mitigating human-related risks.
• Improves user satisfaction and reduces the potential for errors in clinical and home care settings.