美国食品药品监督管理局对ECMO用离心泵设备的审评变迁  

FDA approval history of centrifugal pump device in ECMO system

作　　者：董士勇 申华 任明仕 王嵘[2] DONG Shi-yong;SHEN Hua;REN Mingshi(Department of Cardiovascular Surgery,The 1st Medical Centre,Chinese PLA General Hospital,Beijing 100853,China)

机构地区：[1]解放军总医院第一医学中心心脏大血管外科,北京100853 [2]解放军总医院第六医学中心成人心脏外科,北京100048 [3]解放军医学院,北京100853

出　　处：《中国医学装备》2022年第4期194-199,共6页China Medical Equipment

摘　　要：体外膜肺氧合(ECMO)技术是对危重患者进行生命支持的有效手段,离心泵是驱动ECMO装置运转的关键设备。目前,国内尚缺乏对ECMO用离心泵设备进行上市前评估的成熟体系。经全面查阅美国联邦政府相应法案、历年美国联邦政府公告及食品药品监督管理局(FDA)网站上相关的电子公告内容,梳理40年来美国卫生行政管理部门对ECMO用离心泵设备的管控历史及其变迁,进一步探讨影响管控措施变化的社会因素,在此基础上借鉴他国经验,为我国有关卫生行政部门对ECMO用离心泵设备的上市前审评提出相应建议。Extracorporeal membrane oxygenation(ECMO)is an effective life-supporting method for critical patients.Centrifugal pump drives blood in ECMO circuit,which makes that to be crucial device in ECMO system.However,there is no developed domestic premarket assessment system for centrifugal pump device that used in ECMO system until now.After comprehensively reviewed the relevant sections of the United States Code,Federal Register,and electronic bulletin board on the FDA official websites,we summarized the approval and regulatory history of centrifugal pump device in ECMO system in the sanitation administrative service department of the United States during last 4 decades,and further discussed the social factors that push the changes of regulatory methods in progress.Furthermore,we provided corresponding suggestions on the premarket approval process of centrifugal pump device in ECMO system for relevant health administration in China refer to U.S.experiences on above basis.

关 键 词：体外膜肺氧合(ECMO) 离心泵 上市前审批 上市前通知 医疗器械分类 

分 类 号：R318.6[医药卫生—生物医学工程]