根本原因分析法在医疗器械不良事件分析中的应用

摘要

本文在介绍根本原因分析法（Root Cause Analysis，RCA）的基础上，应用RCA对一例医疗器械不良事件进行分析，确定事件发生的根本原因，制定改进措施和防范对策，提高了工作质量和安全管理意识。%Based on the introduction of the Root Cause Analysis, this paper analyzes the adverse events involving misapplication of medical devices through the implementation of the Root Cause Analysis to determine the fundamental causes of the adverse events. The paper also proposed the counter measures for improvement and strategies to prevent more adverse events from happening again so as to improve the working quality and the safety management awareness.