醫療器材可用性評估模式之研究

A Study on Usability Evaluation Model for Medical Devices

李俊賢(Lee, Jonathan)

指導教授 ： 王明揚

國立清華大學/工學院/工業工程與工程管理學系碩士在職專班/碩士(2015年)

https://doi.org/10.6843/NTHU.2015.00585

摘要

摘要

隨著醫療器材與技術的進步，由醫療器材使用錯誤所引起的傷害事件，也逐漸受到重視。在許多醫療器材於設計開發過程中未進行可用性評估，使器材設計不符合人的直覺習慣，難於學習和使用。隨著醫療的發展，如今包括患者自身在內的使用者使用醫療器材的技能較低，但醫療器材卻越來越複雜，很少情況下醫療器材使用者能夠處理難以使用的使用者介面。設計具備良好可用性的醫療器材面臨很大挑戰。

因此，本研究以人因工程及風險管理之觀點，並考量醫療器材法規要求，建立一套有系統的醫療器材可用性評估模式。醫療器材製造業者可於產品設計開發過程即導入本研究之可用性評估模式，以降低器材使用風險，提昇產品可用性。最後以家用血糖機做為個案評估之醫療器材，執行醫療器材可用性測試，以驗證本研究可用性評估模式之成效，並將評估結果彙整成為血糖機介面設計原則，提供後續研究參考。

關鍵字：醫療器材、血糖機、風險管理、可用性工程、可用性測試

關鍵字

醫療器材 ； 血糖機 ； 風險管理 ； 可用性工程 ； 可用性測試

並列摘要

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.

並列關鍵字

Medical Device ； Blood Glucose Meter ； Risk Management ； Usability Engineering ； Usability Testing

參考文獻

梁秀美（2012）。市面上血糖機之比較. 中華民國糖尿病衛教學會會訊, 8(4), 41-45.

International Organization for Standardization. (2003).ISO 13485, Medical devices-Quality management systems-Requirements for regulatory purposes.

American National Standards Institute. (2001). INCITS 354-2001. Common Industry Format for Usability Test Reports.

American National Standards Institute. (2007). HFES-100. Human Factors Engineering of Computer Workstations.

American National Standards Institute. (2008). HFES-200. Human Factors Engineering of Software User Interfaces.