体外膜氧合循环套包技术评价研究  

Research on the evaluation of circulatory kit technology in extracorporeal membrane oxygenation

作　　者：骆庆峰 黄敏菊[2] 蔡娜娜 王晶 杨鹏飞 Luo Qingfeng;Huang Minju;Cai Nana;Wang Jing;Yang Pengfei(Center for Medical Device Evaluationg,National Medical Products Administration,Beijing 100163,China)

机构地区：[1]国家药品监督管理局医疗器械技术审评中心,北京100163 [2]广东省医疗器械质量监督检验所医用电气安全室,国家药监局体外循环器械重点实验室,广州510663

出　　处：《中国体外循环杂志》2024年第5期420-422,共3页Chinese Journal of Extracorporeal Circulation

基　　金：国家重点研发计划(2020YFC0862900、2020YFC0862904);国家药品监督管理局体外循环器械重点实验室开放课题(2024YB01)。

摘　　要：体外膜氧合(ECMO)循环套包通过体外血气交换,部分替代人体器官,进行血液氧合、二氧化碳排除,减轻症状延续患者生命,在抗击新冠肺炎疫情中发挥了重要作用。目前ECMO产品没有对应的国家标准、行业标准、指南性评价文件。为满足临床治疗对该产品的需求,加速其上市,本文从性能研究、技术开发、检测等角度,对产品有效性和安全性的关键指标、风险控制、涂层研究、使用性能验证等提出要求。希望能够促进国内产品发展,更好地服务于临床。The extracorporeal membrane oxygenation(ECMO)circulatory kit can partially replace human organs through extracorporeal blood gas exchange,performing blood oxygenation and carbon dioxide removal to relieve symptoms and prolong the lives of patients with heart failure or respiratory failure patients,which has played an important role in the fight against the COVID-19 epidemic.At present,there are no corresponding national standards,industry standards or guide evaluation documents regarding ECMO circulatory kit.In order to meet the demand for this product in the clinical treatment and accelerate its clinical application,this paper focuses on the key indicators of product effectiveness and safety,testing methods,risk control measures,coating research,and applications from the perspectives of performance research,technological development,and testing.It aims to promote the development of domestic products and to better cater to clinical requirements.

关 键 词：体外膜氧合 有效性 安全性 涂层研究 技术评价 

分 类 号：R654.1[医药卫生—外科学]