系统理论过程分析的应用,以提高风扇系统的安全性
Shinichi Yamaguchi1, Tatsuo Yanagawa2,3, Shuhei Iida2,3
1Faculty of IT and Business, Cyber University, Minato, Tokyo, Japan.
Journal of patient safety
|September 19, 2025
概括
系统理论过程分析 (STPA) 通过系统地识别人为错误和设备故障的危险,提高了医疗器械的风险管理,从而提高了通风器的安全性.
科学领域:
- 生物医学工程 生物医学工程
- 医疗保健安全 医疗保健安全
- 系统工程 系统工程
背景情况:
- 与呼吸机相关的医疗事故在日本是一个持续的问题,源于设备故障和人为错误.
- 医疗器械安全现有的分析方法往往缺乏对综合分析所需的严谨性.
研究的目的:
- 探索系统理论过程分析 (STPA) 对通风器安全的应用.
- 识别来自人为错误和设备故障的潜在危险.
- 为通风机建立系统级的安全约束.
主要方法:
- 使用STPA构建一个通风系统的控制结构图.
- 从全系统的角度来看,确定了不安全的控制行动 (UCA) 和危险场景.
- 分析系统相互作用,以推导降低风险的安全约束.
主要成果:
- STPA成功地确定了UCAs和导致危险结果的系统级相互作用.
- 该STPA方法证明是系统和全面的,超过了回顾性关键事件报告 (CIR).
- 确定了事故因果关系的机制,考虑了人类和技术因素,并为预防措施提供了基础.
结论:
- STPA为通风器安全提供了一个整体的框架,有效地解决了复杂的人与技术的互动.
- 这种方法提高了通风器的安全性,改善了风险管理,并促进了医疗器械更强大的安全文化.
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