中国医学装备2026，Vol.23Issue(3)：119-122,133,5.DOI:10.3969/j.issn.1672-8270.2026.03.022
基于失效模式与影响分析的麻醉机风险管理研究
Risk management based on FMEA for anesthesia machine
李艳春 1李庚 1王宇坤 1齐得州 2张楷 1董硕 1白玫1
作者信息
- 1. 首都医科大学宣武医院医学工程处 北京 100053
- 2. 首都医科大学宣武医院麻醉手术科 北京 100053
- 折叠
摘要
Abstract
Objective:To identify potential failure risks of anesthesia machines using Failure Mode and Effects Analysis(FMEA),and evaluate risk levels of them,so as to assess risk levels and formulate targeted control measures for enhancing safety and reliability of anesthesia machines in clinical application.Methods:Maintenance records and operational data of 14 Avance CS2 anesthesia machines in clinical use at Xuanwu Hospital,Capital Medical University from 2022 to 2024 were collected.A expert panel of evaluating risk management for anesthesia machine was established to conduct quantitative assessment for risks of 15 types of failure modes during operation of anesthesia machine from three dimensions:severity(S),occurrence(O),and detectability(D).Risk Priority Numbers(RPN)were calculated,and Action Priority(AP)levels were determined.The reasons and effects of failure modes with high-risk were specially analyzed,and targeted strategies for risk control were formulated.Results:In 15 types of failure modes of anesthesia machines,the risk of the bladder of the bellows was highest(RPN=240),and the AP grades of batteries,boards of measuring gas,and sealing cap of sodium lime canister,etc.were moderate.The main failure modes were 8 items included battery,oxygen cell,paramagnetic oxygen unit,board of measuring gas,conversion switch of manual and machine control,bladder of bellows,sealing cap of sodium lime canister,and sealing gasket of sodium lime canister.The reasons of failure mainly were component aging,mechanical wear,and seal failure.The risks of the faults of equipment can be reduced through personnel training,establishment of the system of reserving component,and optimization of preventive maintenance.Conclusion:The FMEA method can effectively identify failure components with high-risk of anesthesia machines,and assess risk levels of them,and rationally allocate resources through priority ranking of risk.The special attention should be paid on failure mode with high-risk,so as to improve the efficiency and effectiveness of risk management,and provide basis of risk management for medical equipment.关键词
失效模式与影响分析(FMEA)/麻醉机/风险管理/预防性维护Key words
Failure mode and effects analysis(FMEA)/Anesthesia machine/Risk management/Preventive maintenance分类
医药卫生引用本文复制引用
李艳春,李庚,王宇坤,齐得州,张楷,董硕,白玫..基于失效模式与影响分析的麻醉机风险管理研究[J].中国医学装备,2026,23(3):119-122,133,5.
