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<section data-color="rgb(182, 228, 253)" data-custom="rgb(182, 228, 253)"><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section data-color="rgb(182, 228, 253)" data-custom="rgb(182, 228, 253)"><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><p><p><img src="image/20201014/86b79d371e9862b01189f0252a03b2cd_1.jpg" /></p></p></section><section><section><span><strong></strong></span></section><p><span>医疗器械媒体报道先锋</span></p><p><span>分享专业医疗器械知识</span></p></section><section><section><section><span>关注</span></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section><section data-role="paragraph"><section data-tplid="89781" data-tools="gulangu"><section data-tools="gulangu" data-id="95298"><section><section><section><br /></section><section data-mpa-powered-by="gulangu"><section><p><span>近日,国家卫生健康委网站发布了《体外膜氧合(ECMO)技术临床应用管理规范》(下文简称《规范》),这是国家卫健委首次就呼吸支持技术制定规范。<br /></span></p><p><span><br /></span></p><p><br /></p></section></section><section><section><p><img src="image/20201014/db1783fe854a02c04e7e7f23af46d035_2.png" /></p></section><section><br /></section></section><section><section><p><br /></p><p><span><strong><span>一、《规范》为ECMO技术的使用,设定了入门的门槛<br /></span></strong></span></p><p><span><br /></span></p><p><br /></p></section></section><section><section><p><span>中华医学会呼吸病学分会呼吸治疗学组组长、危重症学组顾问解立新教授曾参加「规范」的修稿。谈到体外膜肺氧合(ECMO)技术,他感触颇深:关于ECMO的相关规范和共识,我们在2016年就写过。在此次新冠疫情后,一些地区医院,甚至一些县级医院都开始开展该项技术。</span></p><p><span><br /></span></p><p><br /></p><p><span>解教授强调,ECMO技术被称为ICU皇冠上的明珠,但ICU是一个团队的技术,是整个一个团队在作战。如果适应证把握不好,如果没有丰富的经验,很容易会好事变坏事,甚至危及生命。这项技术的并发症发生率是很高的,尤其是出血、导管相关感染等一系列的问题。</span></p><p><span><br /></span></p><p><br /></p><p><span>解教授说,此次规范的出台是国家层面首次为一项呼吸支持技术制定规范,就是要对这一技术的使用设定一个入门的门槛,让大家在购置设备的时候,有一个清醒的认知,它能干什么?最关键的是对机构、对人员能力的要求,包括技术开展的时候,是否到上一级单位进行培训,这些都要有严格的规范。</span></p><p><span><br /></span></p><p><br /></p></section></section><section><p><p><img src="image/20201014/b5da91ce18d18f3819825905f0886408_3.jpg" /></p></p></section><section><p><p><img src="image/20201014/8d4631581713c44c748dfc7c9f78a49e_4.jpg" /></p></p></section><section><p><p><img src="image/20201014/33cadc19be972ff4dd70fa5d9df28c22_5.jpg" /></p></p></section><section><p><p><img src="image/20201014/6a4cdc01ee9a7cb02029bcc176871c52_6.jpg" /></p></p></section><section><p><p><img src="image/20201014/be6293b39a57bc8108b9df63d065603e_7.jpg" /></p></p><p><br /></p><p><br /></p><p><span><strong><span>二、卫健委官方解读</span></strong></span></p></section><section><section><p><br /></p></section></section><p><p><img src="image/20201014/148b31b1be6bfef7601e5c14d372ca6c_8.png" /></p></p><section><section><section><section><p><br /></p><p><span>体外膜肺氧合技术(以下简称ECMO技术)对救治心肺功能衰竭、心跳骤停等重症患者具有重要意义,尤其在新冠肺炎危重症患者救治工作中发挥了巨大的作用。</span></p><p><span>近年来,我国ECMO技术临床应用迅速增长,但该技术操作复杂,管理难度大,对医疗机构的专业水平和管理水平要求高。为规范ECMO技术临床应用,保障医疗质量和医疗安全,根据《医疗技术临床应用管理办法》等相关规定,我委组织制定了《体外膜肺氧合(ECMO)技术临床应用管理规范》,为各级各类医疗机构开展ECMO技术临床应用管理工作提供基本遵循。?</span></p><p><span><br /></span></p><p><br /></p></section></section></section></section><section><section><p><p><img src="image/20201014/69cb907b4f3fa9f8509f03e57aa90370_9.png" /></p></p><p><br /></p><p><span>本规范对医疗机构开展ECMO技术临床应用应当具备的诊疗科目、设备设施、人员资质、技术能力、实施流程和管理制度等方面提出了具体要求,是医疗机构及其医务人员开展ECMO技术临床应用的最低要求。</span></p><p><span><br /></span></p><p><br /></p><p><p><img src="image/20201014/e033112932f09711d7e7d1175fbe3db9_10.png" /></p></p><p><br /></p><p><span>各省级卫生健康行政部门应当加强辖区内ECMO技术临床应用的管理和质量控制,做好相关数据信息的收集、分析和反馈,指导医疗机构规范开展ECMO技术临床应用。鼓励各省级卫生健康行政部门结合实际情况,将ECMO技术纳入省级限制类技术管理。</span></p><p><span><br /></span></p><p><br /></p><p><span>开展ECMO技术临床应用的医疗机构应当按照本规范的要求成立ECMO技术临床应用专家组,对ECMO技术临床应用实施统筹管理;将ECMO技术纳入医师手术授权并实行动态管理,制定本机构标准化操作流程,建立健全ECMO技术临床应用监测和评估制度,定期就ECMO技术临床应用的病例选择、并发症、医疗不良事件、术后患者管理、患者生存质量等情况开展评估,并接受卫生健康行政部门和相关质控中心对ECMO技术临床应用的质量控制。</span></p><section><br /></section><section><span>文章来源:呼吸界</span></section></section></section><section powered-by="gulangu"><section><section powered-by="gulangu"><section><section powered-by="gulangu"><p><br /></p></section></section></section></section></section></section></section></section></section></section><section><section 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