NASA呼吸机获FDA紧急使用授权,使用寿命3-4个月

2020-05-05 张静 澎湃新闻

由美国国家航空航天局(NASA)开发的呼吸机日前获美国食品和药物管理局(FDA)紧急使用授权,可用于治疗新冠肺炎患者。FDA局长斯蒂芬·哈恩说,“在适当情况下,FDA将继续增

由美国国家航空航天局(NASA)开发的呼吸机日前获美国食品和药物管理局(FDA)紧急使用授权,可用于治疗新冠肺炎患者。FDA局长斯蒂芬·哈恩说,“在适当情况下,FDA将继续增加紧急使用授权,在这次新冠肺炎大流行期间帮助增加呼吸机储备。”

NASA喷气推进实验室(JPL)的工程师用时37天开发了一种名为VITAL (Ventilator Intervention Technology Accessible Locally)的新型高压呼吸机,可缓解传统呼吸机供应不足的问题。

早在FDA审查前,4月21日,VITAL原型机在纽约西奈山伊坎医学院通过了关键测试。和传统呼吸机一样,VITAL也要求患者服用镇静剂,并在呼吸道中插入氧气管进行呼吸。

但与传统呼吸机不同的是,VITAL的制造速度更快,维护更简单,而且组成部件更少,其中许多部件是潜在制造商可以从现有供应链中采购到的。

NASA在一份声明中表示,VITAL的灵活设计意味着它可以改良用于世界各地的野战医院中。它的设计使用寿命只有3-4个月,不会取代目前医院里可使用数年的呼吸机。

NASA局长吉姆·布里登斯廷觉得这台呼吸机是NASA将纳税人在太空探索上的投资转化成改善地球生命的先进技术的案例之一,而FDA的批准体现了政府在危机时期所能做的最好的事情。

“我们专攻航天器研发而不是医疗设备制造。”但喷气推进实验室主任Michael Watkins说,卓越的工程、严密的测试、快速的原型机制造也是他们的专长。

不过,眼下更重要的是找到制造商生产这些新设备。为NASA管理喷气推进实验室的加州理工学院技术转让和企业合作办公室,正在接触商业医疗行业。

“现在我们有了这个设计,我们正努力把接力棒传递给医学界,最终传递给患者。”加州理工学院首席创新和企业合作官Fred Farina说,“为了达到这个目的,在新冠肺炎大流行期间,我们在免费版税的基础上提供呼吸机的设计许可。”

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    2020-10-14 lvygwyt2781
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    2020-05-07 Boyinsh
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