美国FDA MAUDE数据库呼吸机致死不良事件分析  

Analysis of ventilator fatal adverse events in FDA MAUDE database

作　　者：方志杰 陈岗 周文光 FANG Zhi-jie;CHEN Gang;ZHOU Wen-guang(The 73rd Army Hospital,Xiamen 361001,Fujian Province,China)

机构地区：[1]陆军第七十三集团军医院,福建厦门361001

出　　处：《医疗卫生装备》2023年第10期86-90,共5页Chinese Medical Equipment Journal

摘　　要：检索了美国食品药品监督管理局(Food and Drug Administration,FDA)医疗器械制造商和用户设施设备体验(Manufacturer and User Facility Device Experience,MAUDE)数据库中2022年1月1日至2022年12月31日呼吸机不良事件的报告数据,利用Python提取了呼吸机不良事件中致人死亡的数据并进行了统计分析,指出了消音泡沫降解、使用不当、呼吸机故障等为呼吸机致人死亡的主要原因,从用料、生产商、使用方、设备维护维修方、监管部门等5个方面提出了相关建议,为其他医疗设备的使用管理和不良事件控制提供了参考。The data on reported adverse events of ventilators in the U.S.Food and Drug Administration(FDA)Medical Device Manufacturer and User Facility Device Experience(MAUDE)database were searched from January 1,2022 to December 31,2022,of which the data on ventilator fatal adverse events were extracted and statistically analyzed with Python.The main causes for ventilator fatal adverse events were pointed out including degradation of noise-reducing foams,improper use and ventilator malfunction,and some suggestions were put forward accordingly from the aspects of material,manufacturer,user,maintainer and supervisor.References were provided for utilization management and adverse events control for other medical devices.

关 键 词：美国FDA MAUDE数据库 呼吸机 不良事件 致死因素 

分 类 号：R318.6[医药卫生—生物医学工程] TH777[医药卫生—基础医学]