Emergency Use Authorizations
Industry Hotline: Coronavirus COVID-19 Diagnostic Tests and Shortages For Industry Questions: COVID-19 Diagnostic Tests, and COVID-19 device shortages, including all Personal Protective Equipment for
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｜originally written by Pei-Chi Lo
■確有此事，這是住在Ohio的Laurie和Kevin的故事：
①經兩人晚餐對話啟發，工程師Kevin在其公司「Battelle」研發Critical Care Decontamination System(CCDS)系統，藉由濃縮的氣態過氧化氫，消毒已使用、可能已被COVID-19的病毒汙染過的N95口罩。
②Battelle的此產品在3月29日取得美國FDA緊急使用授權、4月13日與美國國防部簽訂60台共$415百萬的合約，承諾每台設備每天可清潔8萬個N95口罩。
③但亦須留意，美國CDC有提醒此方式僅適用於一次性過濾式口罩急缺的危機情形。
■至於「全球就不用受中共掌控」則屬轉傳訊息者個人詮釋。
①經兩人晚餐對話啟發，工程師Kevin在其公司「Battelle」研發Critical Care Decontamination System(CCDS)系統，藉由濃縮的氣態過氧化氫，消毒已使用、可能已被COVID-19的病毒汙染過的N95口罩。
②Battelle的此產品在3月29日取得美國FDA緊急使用授權、4月13日與美國國防部簽訂60台共$415百萬的合約，承諾每台設備每天可清潔8萬個N95口罩。
③但亦須留意，美國CDC有提醒此方式僅適用於一次性過濾式口罩急缺的危機情形。
■至於「全球就不用受中共掌控」則屬轉傳訊息者個人詮釋。
References
美國FDA官網-可見「Battelle Decontamination System」列在緊急使用授權清單中：https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations
美國國防部官網-公告與Battelle公司的簽約資訊：
https://www.defense.gov/Newsroom/Releases/Release/Article/2148352/dod-contract-for-60-n95-critical-care-decontamination-units-415m-contract-each/
美國CDC官網-強調Battelle公司提供的清潔方式僅用於危機情形：
https://www.cdc.gov/coronavirus/2019-ncov/hcp/ppe-strategy/decontamination-reuse-respirators.html
2020年4月15日NBCnews報導-介紹Laurie和Kevin發想此設備的過程：
https://www.nbcnews.com/health/health-news/dinner-table-chat-between-husband-wife-may-help-solve-coronavirus-n1183716
https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations
DOD Contract for 60 N95 Critical Care Decontamination Units: $415M Con
Statement attributed to Lt. Col. Mike Andrews, Department of Defense spokesman: "The Department of Defense's Defense Logistics Agency, on behalf of the Department of Health & Human Services (HHS), h
Coronavirus Disease 2019 (COVID-19)
Disposable filtering facepiece respirators (FFRs) are not approved for routine decontamination and reuse as standard of care. However, FFR decontamination and reuse may need to be considered as a cris
A husband and wife may have helped solve the hospital mask shortage
Late Monday, the Pentagon announced a $415 million contract to commission 60 decontamination systems that will allow millions of highly protective N95 face masks to be reused.The system, which can pro
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