Simulation and Usability Lab to Analyse the Safety and Performance of Medical Devices

Area of Science:

• Medical device safety
• Human-computer interaction
• Usability engineering

Background:

• Investigating hazardous human-machine interaction and use-related risks in medical devices is crucial.
• Traditional methods may not fully capture risks in critical care environments.
• Simulation offers a potential solution for risk assessment.

Purpose of the Study:

• To evaluate the effectiveness of combining simulation and usability testing for medical device risk investigation.
• To assess the suitability of a simulation lab for replicating critical emergency and intensive care scenarios.
• To identify practical considerations for implementing simulation-based usability testing.

Main Methods:

• Utilized a simulation lab to replicate realistic emergency and intensive care environments.
• Simulated critical situations and high-stress conditions.
• Conducted usability testing within the simulated environment to identify human-machine interaction risks.

Main Results:

• The simulation and usability testing approach effectively identified potential hazards in human-machine interaction.
• The simulation lab successfully recreated critical scenarios without endangering patients.
• The methodology proved suitable for investigating use-related risks of medical devices.

Conclusions:

• Combining simulation and usability testing is a viable and safe method for evaluating medical device risks.
• Simulation labs provide a realistic platform for assessing device performance under stress.
• Financial and organizational management are key to successful implementation of this approach.