| Summary: | 碩士 === 國立清華大學 === 工業工程與工程管理學系碩士在職專班 === 103 === Abstract
With advances in medical devices and technology, adverse events caused by use errors have become an increasing cause for concern. Many of the medical devices developed without applying a usability evaluation are non-intuitive, difficult to learn and to use. As healthcare evolves, less skilled users including patients themselves are now using medical devices and medical devices are becoming more complicated. In simpler times, the user of a medical device might be able to cope with an ambiguous, difficult-to-use user interface. The design of a usable medical device is a challenging endeavor.
Therefore, in this study we focus from a perspective of human factors and risk management in medical device use, and also consider regulatory requirements for medical devices, to establish a systematic model of medical device usability evaluation. Medical device manufacturers can integrate this model into product design and development process, to reduce future risks associated with device use, and to improve the usability of products. Finally, the research utilizes home-use blood glucose meters as an empirical study to verify the validity of the model. The usability testing was performed, and we aggregated the results into blood sugar machine interface design principles. We hoped that this study may provide a reference for future study on medical device usability evaluation.
Keywords: Medical Device, Blood Glucose Meter, Risk Management, Usability Engineering, Usability Testing.
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