美国再出招 口罩消毒设备获批EUA-奥咨达

美国再出招 口罩消毒设备获批EUA

2020-04-14 10:08  阅读数:52 标签:FDA注册,CE注册
2020年4月12日,美国食品和药物管理局(U.S.Food and Drug Administration)发布了一项紧急使用授权(EUA),该授权有可能对美国每天约400万个N95或当量防护口罩进行净化,供医院环境中的医护人员重复使用。


FDA局长Stephen M.Hahn说:“我们国家的医护人员是这一流行病的众多英雄之一,我们必须尽一切努力增加供给他们所需的关键医疗设备,比如N95防护口罩。FDA工作人员继续全天候、跨政府和与私营部门合作,以寻求解决办法。这项授权将有助于提供数百万的防护口罩,使我们前线的医护人员得到更好的保护,从而为COVID-19患者提供最好的护理。”

FDA批准紧急使用授权(EUA)给Advanced Sterilization Products (ASP)公司的STERRAD Sterilization Cycle系列产品(STERRAD 100S Cycle, STERRAD NX Standard Cycle, or STERRAD 100NX Express Cycle),这些产品均使用汽化过氧化氢气体等离子气体灭菌。

在美国将近6300家医院中,大约有9930套STERRAD消毒系统。STERRAD 100S Cycle, STERRAD NX Standard Cycle, or STERRAD 100NX Express Cycle的再处理时间从55分钟到28分钟和24分钟不等。每人每天可以重新处理大约480个防护口罩。




原文:



The U。S。 Food and Drug Administration issued an emergency use authorization (EUA) that has the potential to decontaminate approximately 4 million N95 or N95-equivalent respirators per day in the U。S。 for reuse by health care workers in hospital settings。


“Our nation’s health care workers are among the many heroes of this pandemic and we need to do everything we can to increase the availability of the critical medical devices they need, like N95 respirators,” said FDA Commissioner Stephen M. Hahn, M.D. “FDA staff continue to work around the clock, across government and with the private sector to find solutions. This authorization will help provide access to millions of respirators so our health care workers on the front lines can be better protected and provide the best care to patients with COVID-19.”


The FDA granted the EUA to Advanced Sterilization Products (ASP) for the STERRAD Sterilization Cycles (STERRAD 100S Cycle, STERRAD NX Standard Cycle, or STERRAD 100NX Express Cycle), which uses vaporized hydrogen peroxide gas plasma sterilization. There are approximately 9,930 STERRAD Sterilization systems in approximately 6,300 hospitals across the U.S. STERRAD 100S Cycle, STERRAD NX Standard Cycle and STERRAD 100NX Express Cycle vary in reprocessing times from 55 minutes, to 28 minutes, and 24 minutes. Each can reprocess approximately 480 respirators per day.


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