各國醫材上市前「審查醫療器材人因工程可用性」之評估比較【醫法新論】 試閱
Comparison of International Pre-market Review on Human Factors Engineering Usability Evaluation for Medical Devices
在設計開發初期時採取有效的人因可用性評估，可消除或降低因使用者介面設計不良，導致使用者無法進行正確感知、操作所引發醫療器材傷害事件發生的機率。目前將人因可用性評估列為醫療器材上市前需審查文件，已成為各國主管機關管理的方向。本文擬以現行醫療器材管理之體例勾勒臺灣目前醫療器材人因／可用性工程評估原則，再以相關國際通用標準對醫療器材設計開發須考量醫材設計原則，以期降低對使用者所造成的風險，並比較先進國家美國、歐盟、日本、韓國、中國及國際組織，對醫療器材人因工程／可用性文獻查詢管理及在上市前審查制度要求，俾對提供未來醫療器材於人因可用性工程之管理原則一完整之輪廓。以建立國際調和的審查制度，強化醫材產業國際競爭力，加速國內醫療器材產品發展與產業升級。
Effective human factors and usability engineering assessment in the initial phase of medical device design can eliminate or reduce the likelihood of injury incidents caused by users’ inability to correctly perceive and operate the device because of poor user interface designs. Currently, relevant authorities worldwide are attaching greater importance to the management of documents required for reviews before medical device becomes commercially available. Therefore, this study analyzed the existing medical device management system to clarify the principles associated with medical device human factors and usability engineering assessment currently employed in Taiwan. Relevant international standards are referenced to clarify the principles of medical device design and development to reduce user risks. Moreover, the inquiries and management of human factors and usability engineering studies and the reviews and requirements for production commercialization in the United States, the European Union, Japan, South Korea, China, and various international organizations were compared to provide a comprehensive outline of management principles in human factors and usability engineering for future medical device. Accordingly, a globally standardized review system can be established to accelerate the product development and upgrade of the medical device industry in Taiwan, thereby reinforcing its international competitiveness.
123-152
