麻醉机不良事件相关数据分析

目的:分析麻醉机不良事件相关数据,探讨影响麻醉机安全性的相关因素,为临床合理及安全使用麻醉机提供有效信息。方法:检索美国食品药品监督管理局(FDA)医疗器械制造商和用户设施设备体验(MAUDE)数据库,从MAUDE数据库中2018年8-12月麻醉机225例不良事件报告中整理归纳出221例有效报告数据,对不良事件报告来源、不良事件类型以及不良事件主要表现和原因进行统计分析。结果:麻醉机不良事件主要表现为患者死亡、患者受伤和仅设备故障未对患者造成伤害3类,其中患者死亡3例,占1.36%;患者受伤(包含轻伤及重伤)9例,占4.07%;设备故障209例,占94.57%,设备故障为不良事件多发区。结论:麻醉机生产单位应提高生产技术,加强故障检测及自动报警功能;使用单位应严格按照诊疗规范操作,提高临床医务人员和维修人员的风险意识,加强设备日常维护和保养,为医疗器械安全有效使用提供保障。

Analysis on the related data of adverse events of anesthesia machine

Objective:To analyze the related data of adverse events of anesthesia machine,and explore the relevant factor that affected safety of anesthesia machine so as to provide effective information for reasonable and safe using anesthesia machine.Methods:Through searched Manufacturer and User Facility Device Experience Database(MAUDE)of U.S.food and drug administration(FDA)to get 221 valid reports of adverse events of anesthesia machine which was produced by General Electric Company(GE)of American and Dr ger Company of Germany from August 1,2018 to December 31,2018.The statistical analysis was implemented from the source of adverse event reports,the types of adverse events,and the main performance and reason of adverse events.Results:The main performances of adverse events of anesthesia machine included 3 kinds of events that were death of patients,injury of patients,and just equipment failure but not injury for patients.Among them,3 patients died(accounting for 1.36%),and 9 patients were injured(including minor wound and serious injuries)(accounting for 4.07%).And 209 cases existed equipment failure(accounting for 94.57%).Conclusion:The manufactories of anesthesia machine should improve the production technique,and strengthen the function of fault detection and automatic alarm.The used institute should be strictly in accordance with the diagnosis and treatment standards to operate machine,and improve the risks awareness of clinical medical personnel and maintenance personnel,and strengthen the daily maintenance to provide guarantee for the safety of using device of the public.