Assessing Use Errors Related to the Interface Design of Electrosurgical Units

Area of Science:

• Medical device safety
• Human factors engineering
• Clinical engineering

Background:

• Medical device use errors, particularly with electrosurgical units (ESUs), pose risks for adverse events.
• Current healthcare facility procurement processes lack proactive use-error risk assessment for devices.
• Instrument connection errors are a significant concern in the use of ESUs.

Purpose of the Study:

• To identify electrosurgical unit (ESU) user interface design features that can prevent or mitigate instrument connection errors.
• To evaluate the impact of user interface design on ESU instrument connection accuracy, efficiency, and user acceptance.
• To inform the development of a decision-support tool for pre-purchase ESU risk assessment.

Main Methods:

• A randomized crossover study involving 36 current electrosurgical unit (ESU) users.
• Participants used two ESU models with varying user interface designs in a simulated operating room scenario.
• Comparison of instrument connection accuracy, task efficiency, and subjective user feedback between ESU models.

Main Results:

• The ESU model incorporating more user interface design principles demonstrated superior performance.
• Participants exhibited higher instrument connection accuracy and efficiency with the improved ESU model.
• The user interface with enhanced design principles received greater user acceptance.

Conclusions:

• User interface design is critical for preventing electrosurgical unit (ESU) instrument connection errors.
• ESU models with better human-centered design lead to improved user performance and acceptance.
• A decision-support tool was developed to aid in assessing ESU instrument connection error risk prior to acquisition.