美國FDA緊急授權(quán)使用包括N95在內(nèi)的呼吸器具

美國FDA緊急授權(quán)使用包括N95在內(nèi)的呼吸器具

On March 2, 2020, in a joint effort, the U.S.Food and Drug Administration and the Centers for Disease Control and Preventiontook action to make more respirators, including certain N95s, available tohealth care personnel. Currently, the majority of respirators on the market areindicated for use in industrial settings. Today’s action allows certainNational Institute for Occupational Safety and Health (NIOSH) approvedrespirators not regulated by the FDA to be used in a health care setting duringthe coronavirus (COVID-19) outbreak, thereby maximizing the number ofrespirators available to meet the needs of the U.S. health care system.

2020年3月2日，經(jīng)過美國食品藥品管理局（簡稱FDA）和疾病控制和預(yù)防咨詢中心(簡稱CDC)的共同努力，以確保包括N95在內(nèi)的更多呼吸器具可供醫(yī)護(hù)人員使用。目前，市面上絕大多數(shù)的呼吸器具均作工業(yè)用途使用。當(dāng)前的行動，準(zhǔn)許某些僅獲得了美國國家職業(yè)與健康研究所（簡稱NIOSH）批準(zhǔn)，但未獲得FDA許可的呼吸器具器械，在新型冠狀病毒（COVID-19）爆發(fā)期間，用于衛(wèi)生保障措施使用。

In the meantime, the FDA issued an Emergency UseAuthorization (EUA) for emergency use of, (1) all disposable filteringfacepiece respirators (FFRs) approved by the National Institute forOccupational Safety and Health (NIOSH), in accordance with 42 CFR Part 84, asnon-powered air-purifying particulate FFRs, and (2) FFRs that wereNIOSH-approved but have since passed the manufacturers' recommended shelf-life,for use in healthcare settings by healthcare personnel (HCP) to prevent wearerexposure to pathogenic biological airborne particulates during FFR shortagesresulting from the Coronavirus Disease 2019 (COVID-19) outbreak.
與此同時，F(xiàn)DA發(fā)布了關(guān)于緊急授權(quán)使用聲明（簡稱EUA），并宣布以下類別器械可供醫(yī)護(hù)人員在醫(yī)療環(huán)境條件下用作緊急授權(quán)使用。以防止佩戴者由于防護(hù)器具的短缺，在新型冠狀病毒（COVID-19）爆發(fā)期間，暴露在致病性病毒環(huán)境下：
（1）所有根據(jù)美國聯(lián)邦法規(guī)42 CFR Part 84，并經(jīng)美國國家職業(yè)與健康研究所（簡稱NIOSH）批準(zhǔn)，作為無動力空氣顆粒物凈化裝置使用的一次性過濾式面罩呼吸器具（FFRs）
（2）獲得美國國家職業(yè)與健康研究所（簡稱NIOSH）批準(zhǔn)，但是超過了制造商規(guī)定的貨架壽命/有效期的一次性過濾式面罩呼吸器具（FFRs），

U.S. FDA has provided a list for approved holder as below:

美國FDA提供了一份持有此類器械的公司名單，如下：

3M Company
Moldex-Metric, Inc.
Honeywell International Inc.
Louis M. Gerson Company, Inc.
Honeywell Int’l. Inc.
Mine Safety Appliances Company
Kimberly-Clark Corporation
O&M Halyard, Inc.
Prestige Ameritech
Dentec Safety Specialists Corp.
Alpha Pro-Tech
Makrite Industries, Inc.
Dr?ger Safety AG & Co. KGaA
Jahan Company t/a IREMA Ireland
Industrias Saver
KOS Protección S.A.S
Japan Vilene
Koken, Ltd.
San M Package Co., Ltd.
Shigematsu Works Co., Ltd.
M/s. Magnum Health & Safety Pvt. Ltd.
Venus Safety & Health Pvt., Ltd.
Dobu Life Tech Co. Ltd.
Ever Green Co., Ltd.
Profit Royal Pharmaceutical Ltd.
Aero Pro Co., Ltd
AOK Tooling Limited
Aswan International Corp.
Champak Enterprise Co., Ltd.
Fido Mask Company
Guangzhou Harley Commodity Company Limited
Innonix Technologies Limited
Jinfuyu Industrial Co., Ltd.
Master & Frank Ent. Co. Ltd.
Rizhao Sanqi Medical & Health Articles Co.,  Ltd.
San Huei United Company, Ltd.
Shanghai Dasheng Health Products Manufacture  Co., Ltd.
Shanghai Gangkai Purifying Products Co., Ltd.
Shining Star Electronic Technology Co., Ltd
Suzhou Fangtian Industries Co., Ltd.
Suzhou Sanical Protective Product Manufacturing  Co., Ltd.
XiantaoZhongyi Safety Protection Products Co.,  Ltd.
Paul Boye, Inc
Global Safety First
NITTA Corp. S.A.