摘要
突发公共卫生事件如新冠肺炎疫情,对公众健康造成巨大威胁,引起国家经济和社会发展的不可估量损失。以体外膜肺氧合(ECMO)设备为代表的呼吸支持高端医疗设备成为全球研发的热点领域,无泵体外二氧化碳清除系统、便携ECMO系统、呼吸透析平台和可植入式人工肺等技术不断问世并进入临床。为提高我国创新高端医疗器械的公众可及性,建议采取探索高效、敏捷的上市前临床研究模式以及建立多方协作的器械导向临床研究队列等监管策略,鼓励新型政策支持和投融资机制,促进技术的长远发展,参与未来高端制造业的国际竞争。
Public health crisis such as COVID-19 pandemic, has posed great threat on public health and caused immeasurable losses to national economic and social development. Ever since then, ECMO-representative respiratory-support advanced medical device has become a hot field of global research and development. Technologies such as carbon dioxide removal, portable ECMO, respiratory dialysis and implantable artificial lung have been continuously developed and entered the clinic. In order to improve the public accessibility of innovative advanced medical devices in China, it is suggested that regulatory strategies such as efficient and agile pre-market clinical research mode and multi-collaborated device-oriented clinical research sequence, should be adopted, and new policy support and investment and financing mechanisms should be encouraged, which promotes the long-term development of technology, and make enterprises to participate in the international competitions of high-end manufacturing industry in the future.
作者
焦国慧
陈静瑜
JIAO Guo-hui;CHEN Jing-yu(Wuxi People's Hospital affiliated to Nanjing Medical University,Lung Transplantation Center in Jiangsu Province)
出处
《中国食品药品监管》
2022年第8期58-67,共10页
China Food & Drug Administration Magazine
基金
无锡市新型冠状病毒感染应急防治科技专项项目(N2020X002)。
关键词
疫情
体外膜肺氧合
呼吸支持
临床研究
监管
pandemic
extracorporeal membrane oxygenation(ECMO)
respiratory-support
clinical research
regulation
