Application of System-Theoretic Process Analysis (STPA) for Enhancing Safety in a Ventilator System.

IF 1.7 3区医学 Q3 HEALTH CARE SCIENCES & SERVICES

Journal of Patient Safety Pub Date : 2025-09-19 DOI:10.1097/PTS.0000000000001421

Shinichi Yamaguchi, Tatsuo Yanagawa, Shuhei Iida, Mitsuo Shibagaki, Yoshinobu Sato

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引用次数: 0

Abstract

Background: In Japan, a significant number of ventilator-related medical accidents continue to be reported, with causes frequently linked to both equipment malfunctions and human errors. Conventional analytical methods often lack the methodological rigor needed for comprehensive safety analysis.

Objectives: This study explores the application of System-Theoretic Process Analysis (STPA) as a novel approach to ventilator safety analysis. The goal is to identify potential hazards arising from human errors and device failures and to establish system-level safety constraints.

Methods: STPA is employed to construct a control structure diagram of a ventilator system, offering a system-wide perspective to identify Unsafe Control Actions (UCAs) and resulting hazardous scenarios. This approach provides a structured analysis of system interactions to derive safety constraints aimed at reducing risks.

Results: STPA successfully identified UCAs and system-level interactions that could lead to hazardous outcomes. Compared with the Critical Incident Report (CIR) by the Japan Council for Quality Health Care (JCQHC), which provides retrospective insights into ventilator-related incidents, STPA demonstrates a systematic and comprehensive methodology. It analyzed the mechanisms by which incidents could arise within the system, considering both human and technical factors. The analysis identified hazardous interactions and provided a foundation for implementing preventive measures.

Conclusions: STPA offers a holistic framework for ventilator safety, surpassing traditional analysis methods by addressing complex human-technical interactions. The results contribute to enhanced ventilator safety, improved risk management, and a stronger safety culture across medical devices.

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系统理论过程分析（STPA）在提高通风系统安全性中的应用。

背景：在日本，继续报告大量与呼吸机有关的医疗事故，其原因往往与设备故障和人为错误有关。传统的分析方法往往缺乏全面安全分析所需的方法学严谨性。目的：本研究探讨系统理论过程分析（system - theoretical Process Analysis， STPA）在通风机安全性分析中的应用。目标是识别由人为错误和设备故障引起的潜在危险，并建立系统级安全约束。方法：采用STPA构建通风机系统的控制结构图，从全系统的角度识别不安全控制行为（UCAs）和由此产生的危险场景。该方法提供了系统交互的结构化分析，以派生出旨在降低风险的安全约束。结果：STPA成功识别出可能导致危险结果的uca和系统级相互作用。与日本卫生保健质量委员会（JCQHC）的重大事件报告（CIR）相比，STPA展示了一种系统而全面的方法，后者提供了对呼吸机相关事件的回顾性见解。它分析了系统内可能发生事件的机制，同时考虑到人为因素和技术因素。分析确定了危险的相互作用，并为实施预防措施提供了基础。结论：STPA提供了通风机安全性的整体框架，通过解决复杂的人机交互，超越了传统的分析方法。研究结果有助于提高呼吸机的安全性，改善风险管理，并加强医疗设备的安全文化。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Journal of Patient Safety HEALTH CARE SCIENCES & SERVICES-

CiteScore

4.60

自引率

13.60%

发文量

302

期刊介绍： Journal of Patient Safety (ISSN 1549-8417; online ISSN 1549-8425) is dedicated to presenting research advances and field applications in every area of patient safety. While Journal of Patient Safety has a research emphasis, it also publishes articles describing near-miss opportunities, system modifications that are barriers to error, and the impact of regulatory changes on healthcare delivery. This mix of research and real-world findings makes Journal of Patient Safety a valuable resource across the breadth of health professions and from bench to bedside.