Academic Journal
Application of System-Theoretic Process Analysis for Enhancing Safety in a Ventilator System.
| Τίτλος: | Application of System-Theoretic Process Analysis for Enhancing Safety in a Ventilator System. |
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| Συγγραφείς: | Yamaguchi S; Faculty of IT and Business, Cyber University, Minato, Tokyo, Japan., Yanagawa T; Nerima General Hospital, Nerima, Tokyo, Japan.; Institute for Healthcare Quality Improvement, Nerima, Tokyo, Japan., Iida S; Nerima General Hospital, Nerima, Tokyo, Japan.; Institute for Healthcare Quality Improvement, Nerima, Tokyo, Japan., Shibagaki M; Reliability Engineering Association of Japan, Safety Science Study Group, Suginami, Tokyo, Japan., Sato Y; Institute for Healthcare Quality Improvement, Nerima, Tokyo, Japan. |
| Πηγή: | Journal of patient safety [J Patient Saf] 2026 Jan 01; Vol. 22 (1), pp. e1-e9. Date of Electronic Publication: 2025 Sep 19. |
| Τύπος έκδοσης: | Journal Article |
| Γλώσσα: | English |
| Στοιχεία περιοδικού: | Publisher: Lippincott Williams & Wilkins Country of Publication: United States NLM ID: 101233393 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1549-8425 (Electronic) Linking ISSN: 15498417 NLM ISO Abbreviation: J Patient Saf Subsets: MEDLINE |
| Imprint Name(s): | Original Publication: Philadelphia, Pa. : Lippincott Williams & Wilkins, c2005- |
| Ιατρικοί όροι (MeSH): | Ventilators, Mechanical*/standards , Safety Management*/methods , Patient Safety* , Systems Analysis* , Systems Theory*, Medical Errors/prevention & control ; Humans ; Japan |
| Περίληψη: | 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. (Copyright © 2025 Wolters Kluwer Health, Inc. All rights reserved.) |
| Competing Interests: | The authors disclose no conflict of interest. |
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| Contributed Indexing: | Keywords: STPA; hazard analysis; human error; medical device safety; system safety; ventilator |
| Entry Date(s): | Date Created: 20250919 Date Completed: 20251219 Latest Revision: 20260105 |
| Update Code: | 20260130 |
| DOI: | 10.1097/PTS.0000000000001421 |
| PMID: | 40970497 |
| Βάση Δεδομένων: | MEDLINE |
| ISSN: | 1549-8425 |
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| DOI: | 10.1097/PTS.0000000000001421 |