FDA:口罩消毒設備獲批EUA

2020年4月12日,美國食品和藥物管理局(U.S.Food and Drug Administration)發佈了一項緊急使用授權(EUA),該授權有可能對美國每天約400萬個N95或當量防護口罩進行淨化,供醫院環境中的醫護人員重複使用。


FDA:口罩消毒設備獲批EUA


FDA局長Stephen M.Hahn說:“我們國家的醫護人員是這一流行病的眾多英雄之一,我們必須盡一切努力增加供給他們所需的關鍵醫療設備,比如N95防護口罩。FDA工作人員繼續全天候、跨政府和與私營部門合作,以尋求解決辦法。這項授權將有助於提供數百萬的防護口罩,使我們前線的醫護人員得到更好的保護,從而為COVID-19患者提供最好的護理。”

FDA批准緊急使用授權(EUA)給Advanced Sterilization Products (ASP)公司的STERRAD Sterilization Cycle系列產品(STERRAD 100S Cycle, STERRAD NX Standard Cycle, or STERRAD 100NX Express Cycle),這些產品均使用汽化過氧化氫氣體等離子氣體滅菌。

在美國將近6300家醫院中,大約有9930套STERRAD消毒系統。STERRAD 100S Cycle, STERRAD NX Standard Cycle, or STERRAD 100NX Express Cycle的再處理時間從55分鐘到28分鐘和24分鐘不等。每人每天可以重新處理大約480個防護口罩。


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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