Considerations for Medical Device Usability Evaluation Focused on Use Errors

Medical devices play an important role in the diagnosis, treatment, and management of diseases, but they can cause use errors that can harm users (patients or medical staff) due to various contexts of use. To solve these use errors, usability evaluation of medical devices is emerging as an essential process to identify use errors and ensure safety. Regulatory agencies around the world are also focusing on usability evaluation and human factors engineering in the design and certification process of medical devices. In this study, we aimed to derive the factors that should be considered during the usability evaluation to identify and prevent use errors of medical devices. In this study, we used a comprehensive literature review methodology to review the literature on existing studies, regulations, and case studies related to usability and use errors of medical devices over the past 10 years (2014-2024). Various factors can cause use errors in medical devices, including device complexity, time pressure, environmental stress factors, and poor user interface design. These factors causing use errors were classified into four root causes: inappropriate device feedback, complex medical device configuration and usage procedures, interface design defects, and environmental stress factors. In addition, for each of these four root causes, the main factors that should be considered in the usability evaluation were derived for each of the Perception, Cognition, and Action stages of the interaction between the medical device and the user. The results of this study can be utilized as a guide for conducting usability evaluations to find use errors, hazardous situations