Human-centered risk management for medical devices - new methods and tools

Area of Science:

• Medical device usability engineering
• Human-centered risk management
• Human-machine interface (HMI) design

Background:

• Non-usable interfaces in medical devices lead to use deficiencies and patient harm.
• Lack of integrated methods for usability engineering and human-centered risk management hinders error identification and control.
• Need for robust support for medical device manufacturers in designing reliable and error-tolerant HMIs.

Purpose of the Study:

• To develop and evaluate a model-based human risk analysis methodology (HiFEM) and a software tool (mAIXuse).
• To implement and assess a systematic human risk control method (mAIXcontrol) for medical devices.
• To compare the effectiveness of new methods against traditional approaches like Failure Mode and Effects Analysis (FMEA).

Main Methods:

• Developed the HiFEM methodology with task-type-sensitive modeling and temporal relations for detailed use process analysis.
• Created the mAIXuse software tool for model-based human risk analysis.
• Implemented mAIXcontrol with a knowledge base and a matrix of 41 countermeasure principles for systematic risk control.

Main Results:

• Comparative study showed HiFEM significantly outperforms classical Failure Mode and Effects Analysis (FMEA).
• The mAIXcontrol method demonstrated substantial benefits in risk control and countermeasure selection compared to conventional approaches.
• Blind expert evaluation confirmed the effectiveness of the new risk control matrix and reassessment of risk priority numbers.

Conclusions:

• The HiFEM methodology provides a superior approach to human risk analysis in medical device development.
• mAIXcontrol offers an effective system for identifying and implementing suitable countermeasures for human-induced risks.
• These integrated methods enhance the safety and reliability of medical device human-machine interfaces.