來(lái)自中國(guó)的過(guò)濾式防護(hù)口罩FDA擔(dān)心可能不達(dá)標(biāo)竟從EUA附錄刪除了

本文摘譯自FDA 2020年5月7日

以下為詳文

美國(guó)食品藥品監(jiān)督管理局（FDA）擔(dān)心，根據(jù)美國(guó)國(guó)家職業(yè)安全與健康研究所（NIOSH）------美國(guó)疾病控制與預(yù)防中心（CDC）的國(guó)家個(gè)人防護(hù)技術(shù)實(shí)驗(yàn)室（NPPTL）（以下稱為NIOSH測(cè)試）進(jìn)行的額外過(guò)濾性能測(cè)試，部分來(lái)自中國(guó)的過(guò)濾式防護(hù)口罩（以下稱：防護(hù)口罩）可能無(wú)法為接觸COVID-19的醫(yī)護(hù)人員，提供一致性和充分性的呼吸保護(hù)。因此，F(xiàn)DA修訂并重新發(fā)布了2020年4月3日的EUA，如下所述。

2020年5月7日，F(xiàn)DA重新發(fā)布了中國(guó)制造的非NIOSH批準(zhǔn)的一次性過(guò)濾式防護(hù)口罩的緊急使用授權(quán)（EUA），修訂其中的一條適用條款------防護(hù)口罩的授權(quán)標(biāo)準(zhǔn)以制造商或進(jìn)口商提交給FDA的檢測(cè)評(píng)審報(bào)告為依據(jù)，該報(bào)告來(lái)自認(rèn)可獨(dú)立測(cè)試實(shí)驗(yàn)室-----據(jù)此，也從附錄A中刪除了根據(jù)該標(biāo)準(zhǔn)授權(quán)的防護(hù)口罩，無(wú)論它們是通過(guò)還是未通過(guò)NIOSH測(cè)試1。FDA之所以采取這種行動(dòng)，是因?yàn)樵S多此類(lèi)防護(hù)口罩在NIOSH進(jìn)行測(cè)試時(shí)，均未能證明其最低顆粒過(guò)濾效率達(dá)到95％。

從EUA附錄A中刪除的防護(hù)口罩，且不符合其標(biāo)注性能標(biāo)準(zhǔn)的（如下所列），不再具有資格；也不再被批準(zhǔn)在美國(guó)銷(xiāo)售或分銷(xiāo)。如果根據(jù)《口罩總則EUA》滿足了某些其他標(biāo)準(zhǔn)，它們還有機(jī)會(huì)重新貼上“口罩”的標(biāo)簽并獲得授權(quán)。其他相關(guān)信息，請(qǐng)參閱FDA關(guān)于口罩的實(shí)施政策，如在《2020年4月冠狀病毒疾?。–OVID-19）突發(fā)公共衛(wèi)生事件期間口罩及防護(hù)口罩的實(shí)施政策（修訂版）》中的指導(dǎo)意見(jiàn)所述。

在重新發(fā)布的《緊急使用授權(quán)》中，符合其他資格標(biāo)準(zhǔn)的非NIOSH批準(zhǔn)的防護(hù)口罩，F(xiàn)DA授權(quán)依然不變，可以在COVID-19大流行期間使用，且繼續(xù)在附錄A中列出。

注意事項(xiàng)

使用清單中這些防護(hù)口罩的醫(yī)療衛(wèi)生機(jī)構(gòu)應(yīng)該審閱下列注意事項(xiàng)。該事項(xiàng)專(zhuān)門(mén)針對(duì)防護(hù)口罩，旨在實(shí)現(xiàn)非常緊密地貼合面部并過(guò)濾空氣中的顆粒物。這些注意事項(xiàng)不適用于外科口罩，或?qū)捤尚涂谡?，它們可以在醫(yī)護(hù)人員的口鼻和周?chē)h(huán)境中的潛在污染物之間產(chǎn)生一道物理屏障。

▲? 不再出現(xiàn)在附錄A中的防護(hù)口罩，可能在提供95％的最低顆粒過(guò)濾效率方面不可靠。請(qǐng)參閱《NIOSH評(píng)估網(wǎng)頁(yè)》，以確定中國(guó)生產(chǎn)的非NIOSH批準(zhǔn)的防護(hù)口罩是否經(jīng)過(guò)檢測(cè)，并審查檢測(cè)結(jié)果。

▲?迄今為止，從附錄A刪除的產(chǎn)品中，有60多個(gè)產(chǎn)品未能在NIOSH進(jìn)行的檢測(cè)中證明最低顆粒過(guò)濾效率為95％：

?

▲?NIOSH將定期更新其測(cè)試結(jié)果列表。以下為5月8日前103個(gè)中國(guó)防護(hù)口罩PFE(顆粒物過(guò)濾效率）測(cè)試結(jié)果清單

生產(chǎn)廠	型號(hào)規(guī)格	采納標(biāo)準(zhǔn)	PFE （max)	PFE （min)
Shanghai Dasheng Health Products Manufacture ?Co., Ltd.	DTC3B-1	GB2626	99.92	99.83
Shanghai Dasheng Health Products Manufacture ?Co., Ltd.	DTC3B	USA (claimed, 42 CFR 84)	99.76	99.67
Anhui Hongqiaosi Hometextile Co., Ltd.	KN95 Disposable Protective Face Mask	UNKNOWN	99.8	99.64
Shanghai Dasheng Health Products Manufacture ?Co., Ltd.	DTC3X	USA (claimed, 42 CFR 84)	99.95	99.58
Shanghai Dasheng Health Products Manufacture ?Co., Ltd.	DTC3X	USA (claimed, 42 CFR 84)	99.84	99.45
Shanghai Dasheng Health Products Manufacture ?Co., Ltd.	DTC3X (Sample Group 3 of 3)	USA (claimed, 42 CFR 84)	99.76	99.34
Xiamen Lixia Medical Technology Co., Ltd.	Lixia Medical Respirator	GB2626	99.96	99.31
Shanghai Dasheng Health Products Manufacture ?Co., Ltd.	DTC3X (Sample Group 2 of 3)	USA (claimed, 42 CFR 84)	99.63	99.31
Qingdao Maysheng Medical Devices Co., Ltd	KN95 Protective Mask(Self Suction Filter Respirator FFP2)	GB2626	99.59	99.3
Guangzhou Baoweikang (Powecom) Personal ?Protection Equipment Co., Ltd.	KN95 Protective Mask	GB2626	99.4	99.21
Guangzhou Harley Commodity Co., Ltd.	L-103V KN95	GB2626	99.49	99.02
Te Yin	TY0929 FFP2 NR	EN149	99.7	98.89
Shenzhen Kawang Network Technology Co., Ltd.	FFP3	EN149	99.17	98.77
Jiande Chaomei Daily Chemicals Co. Ltd.	Jan-05	GB2626	99.19	98.73
Anhui Jinling Plastics Company Limited	Protective Mask	EN149	99.66	98.67
Zhandjiagang Meijie Commodity Co., Ltd	MJ-N02A (Particulate Respirator)	GB2626	99.47	98.55
Jiangmen Huayue Industrial Co., Ltd.	HY9501 Folding Mask – KN95	GB2626	99.55	98.48
Honeywell Safety Products (Shanghai) Co., Ltd.	H801 Particulate Respirator	GB2626	99.32	98.4
Shanghai Dasheng Health Products Manufacture ?Co., Ltd.	DTC3X (Sample Group 1 of 3)	USA (claimed, 42 CFR 84)	99.66	98.32
Gaomi City Hancheng Personal Protective ?Products Co., Ltd.	Baokangjie 9001	GB2626	99.15	98.19
UNKNOWN	UNKNOWN	GB2626	99.6	98.14
Shanghai Gangkai Purifying Products Co., Ltd.	8012	GB2626	99.13	98.11
Qingdao Hainuo Bioengineering Co., Ltd.	Hynaut KN95 Protective Face Mask	GB2626	98.37	97.98
Zhangjiagang Zhiyi Medical Materials Co.	Self-Priming Filter Respirator KN95	GB19083	99.26	97.93
Guangdong Medical Technology Co., Ltd.	KN95 Stereo Protective Mask	EN149	99.18	97.91
Suzhou Jinruida Protective Equipment Co, Inc.	KN95 Three Dimensional Respirator	GB2626	99.31	97.87
Jiande Chaomei Daily Chemicals Co., Ltd.	CM 9527	GB19083	99.29	97.87
Laianzhi	KLT01	GB2626	99.68	97.83
Jiande Chaomei Daily Chemicals Co. Ltd.	F-Y3-A Medical Protective Masks	GB19083	99.68	97.75
Xiamen Luan’an Protective Equipment Co., Ltd.	Eversafe KN95 Self-Priming Filter Respirator	GB2626	98.16	97.56
Chunyu	Chunyu FFP2	EN149	99.03	97.54
Shanghai Huaxiang Woolen Dressing Co., Ltd.	Disposable Mask	GB2626	98.51	97.48
Zhejiang Lv Mei Biotech Co.	BeBetty Particulate Respirator	GB2626	98.71	97.1
Rizhao Sanqi Medical & Health Articles Co., ?Ltd.	3Q 9505	GB2626	99.39	96.95
CSIC Pacli (Nanjng) Tech Co. Ltd.	Filtered Protective Mask KN95	GB2626	97.72	96.74
Liaoning Shengjingtang Biotechnology Co., Ltd.	Medical Protective Mask N95	GB19083	98.74	96.71
Scotics Science & Technology Co.	SKSS Sterile N95	GB19083	97.36	96.65
Guangdong Energy Fortress Pharmaceutical Co., ?Ltd.	KN95 Protective Respirator	GB2626	100	95.36
Lanshan Shendun Technology Co., Ltd.	SD-KN95	GB2626	98.14	94.91
Anhui Changli Environmental Protection ?Technology Co., Ltd	KN95 Protective Mask	EN149	95.74	94.73
Baoji Taidakang Medical Technology Co., Ltd	Medical Protective Mask	GB19083	99.27	94.3
Zhejiang Allta Industrial Co., LTD	ALLTA Respirator 9591	GB2626	98.08	93.61
Delta Plus	CA 38.504	ABNT/NBR 13698	99.43	93.09
Senke Pharmaceutical (Chengdu) Co., Ltd.	KN95 Non-Powered Air-Purifying Particulate Respirator	EN149, GB2626	98.36	92.19
Anhui Kangweijia Labor Protection Articles Co., ?Ltd.	9501 Protective Mask	EN149, GB2626	98.92	92.05
Jiangsu Jiton Clothing Corporation	JT-KN95 Reusable and Sterilizable Nano-mask KN95	EN149	96.74	91.61
UNKNOWN	KN95 Ear Face Mask	EN149, GB2626	93.6	91.55
Daddybaby Co., Ltd.	KN95 4-PLY	EN149	93.45	91.15
Zhejiang Xingxin Medical Techology Co., Ltd.	KN95 Protective Face Masks	GB2626	98.81	90.93
Huizhou Huinuo Technology Co., Ltd.	HV-N White KN95	GB2626	94.98	90.58
Dongguan Oukangda Medical Technology Co., Ltd.	Kangerda KN95 Particulate Respirator	EN149, GB2626	93.68	90.28
Flyhorse Industrial Co., Ltd.	FL 0616	EN149	92.58	90.18
Kindly Care Products Co., Ltd.	Y-9500	GB2626	91.64	89.8
Lamdown	SD-KN95	GB2626	99.22	89.6
Huizhou Huinuo Technology Co., Ltd.	HV-N 9501B (Non-Sterile Mask)	GB2626	96.55	88.81
Changshu City Hengyun Nonwoven Products Co., ?Ltd.	KN95 Respirator Masks	GB2626	97.29	88.53
Kindly Care Products Co., Ltd.	Y-9500	GB2626	90.71	88.2
Guangzhou Tianyi Zhongliang Biotechnology Group ?Co., Ltd.	KN95 Disposable Protective Mask	GB2626	97.29	87.2
CTT Co., Ltd.	KN95 (8410)	EN149, GB2626	98.83	85.7
UNKNOWN	KN95 Daily Protective Mask	GB2626	97.08	84.8
Nantong Gold-Sufang Weaving Co. Ltd.	KN95 Face Mask	GB2626	93.39	84.2
King Year and Packaging Co., Ltd.	Self-Breathing Filtration Particle-Preventive Respirator	EN149, GB2626	91.12	83.4
King Year and Packaging Co., Ltd.	Self-Breathing Filtration Particle-Preventive Respirator	EN149, GB2626	90.03	82.7
San Jiao	JS95-01	EN149	89	82.4
Hangzhou Senrunqing Technology Co., Ltd.	KN95 Mask-C	EN149, GB2626	85.9	78.7
UNKNOWN	Haze Mask KN95	EN149, GB2626	81.2	78.1
Anhui Jinling Plastics Co., Ltd.	UNKNOWN	GB2626	96.13	77.6
Huizhou Zhongna Medical Technology Co., Ltd	Anysound KN95 Self-Priming Filter & Anti-Particle Respirator	EN149, ?GB2626	83.41	77.3
Guangzhou Kangbang Medical Equipment Co., Ltd.	KN95 Mask	EN149	98.86	72
Purvigor	KN95 Antibacterial Mask	GB2626	74.2	69.8
Guangdong Qian Jing Testing Co., LTD.	DNW Protective Mask	EN149, GB2626	76.5	69.2
Huabai	9501	GB2626	97.07	69
Lanshan Shendun Technology Co., Ltd.	SD-KN95	GB2626	99.71	66.8
UNKNOWN	PLOW KN95	GB2626	91.05	66.4
Guangdong Fei Fan Mstar Technology LTD	Purvigor KN95	EN149, GB2626	68.83	61.6
Jining Jianda Medical Device Technology Co., ?Ltd.	PM2.5 KN95	EN149, GB2626	64.8	59.6
Shenzhen Meili Medical Devices Co., Ltd.	KN95 Protective Mask	EN149, GB2626	98.29	58.4
Shenzhen Hangsen Star Technology Co., Ltd.	Alchemy KN95 Face Mask A1	EN149, GB2626	92.77	56
Ningbo YiXin Intelligentized Science and ?Technology Co. Ltd.	KN95 (Non-medical)	GB2626	59.5	53.2
Henan Kang Medical Devices Co., Ltd.	KN95 Protective Mask – KS16	GB2626	97.5	52.1
Sinpup Health (Shenzhen) Co., Ltd.	Face Mask KN95	EN149, GB2626	74.3	43.1
LitezAll	Wanning Protective Mask	GB2626	98.14	43
Guanyang Yuhan Textile Co., Ltd.	KN95 Protective Face Mask	GB2626	56.59	42.15
Zhongshan Cassiey Biotechnology Co., Ltd.	N95 Masks + Particulate Protection Respirator	EN149, GB2626	49.5	41.5
Garry Galaxy Biotechnology Co., Ltd.	Respirator Mask With TruTone Technology	GB/T 32610	44.3	35.2
Guangdong Shantou Machinery	KN95 Mask	EN149, GB2626	49	34.7
UNKNOWN	KN95	UNKNOWN	90.5	34.6
Changning Lingjiakang Protective Products ?Factory	KN95 Stereo Protective Mask	EN149	50.74	33.75
Ningbo Green Health Science & Technology ?Co., Ltd.	KN95 Protective Mask	GB2626	45.8	33.2
Tongcheng Chengfeng Protective Equipment Co., ?Ltd.	Wanhuizhong Anti-Dust Respirator	GB2626	59.2	32.5
An Hui Su Bo Lun Clothing Co., Ltd.	SU KN95	GB2626	95.1	28.45
Zhejiang Kanghao Medical Instruments Co., Ltd.	KN95 Respirator	GB2626	50.2	28.3
Guangzhou Huashan Biotechnology Co., Ltd.	GF-Mask KN95 Mask	GB2626	74.9	27.1
Anhui RYZUR Medical Equipment Manufacturing ?Co., Ltd.	KN95B	EN149, GB2626	33.9	27
Guangdong Nuokang Medical Technology Co., Ltd.	KN95-Certified Particulate Respirator	GB2626	98.73	24.22
Dongguan Xianda Medical Equipment Co., Ltd.	KN95 Protective Mask	EN149, GB2626	35	24.1
Dongguan Oukangda Medical Technology Co., Ltd.	Self-Priming Filter Respirator	GB2626	93.76	20
Jiangsu Homcan Medical Technology Co., Ltd.	HC-NP95A Self-Priming Filter	EN149	51.8	17.2
UNKNOWN	KN95 Protective Mask	GB2626	68.9	14.8
Guangdong Nafei Industrial Holding Co., Ltd.	NAFY Protective Mask	EN149	20.4	13.9
Kuangye (Dongguan) Technology Co., Ltd.	Geyou KN95 Environmental Protective Respirator	GB2626	97.1	13.6
Ningbo Green Health Science & Technology ?Co., Ltd.	Disposable Protective Mask (Non-Medical)	GB2626	23.9	11.2
Guangdong Nafei Industrial Holding Co., Ltd.	Efficient Nursing Protective Mask	EN149, GB2626	10.5	1.1

? ??■??已經(jīng)過(guò)NIOSH檢測(cè)但未能證明最低顆粒過(guò)濾效率為95％的防護(hù)口罩，可考慮改用作源頭控制的口罩，幫助減緩人在講話，咳嗽或打噴嚏時(shí)的感染傳播。醫(yī)療衛(wèi)生機(jī)構(gòu)應(yīng)意識(shí)到，這種口罩的功能有別于醫(yī)護(hù)人員的個(gè)人防護(hù)設(shè)備。

? ??■??使用這些防護(hù)口罩的醫(yī)療衛(wèi)生機(jī)構(gòu)，如未通過(guò)NOISH檢測(cè)，在決定用這些產(chǎn)品作口罩時(shí)，不妨考慮一些因素，包括當(dāng)前需求、庫(kù)存、設(shè)備操作和可接受的用途。

▲?FDA認(rèn)為，在COVID-19大流行期間，不再出現(xiàn)在附錄A中的防護(hù)口罩，可能無(wú)法在任何已授權(quán)使用的凈化空間中可靠地使用。

▲?如果您持有從附錄A中刪除的防護(hù)口罩，而且您想讓NIOSH檢測(cè)其過(guò)濾效率，您可以通過(guò)提交《國(guó)際防護(hù)口罩評(píng)估申請(qǐng)》來(lái)要求NIOSH進(jìn)行檢測(cè)。

附加信息

醫(yī)療衛(wèi)生機(jī)構(gòu)在考慮購(gòu)買(mǎi)或使用N95和KN95等防護(hù)口罩時(shí)，可能會(huì)發(fā)現(xiàn)以下有用信息：?

▲?標(biāo)有“respirators（防護(hù)口罩）”的產(chǎn)品必須符合FDA的適用要求，或者獲得在美國(guó)進(jìn)口和分銷(xiāo)的緊急使用授權(quán)。但是，標(biāo)有“face masks（口罩）”而不是“respirators（防護(hù)口罩）”的產(chǎn)品有不同的要求，它們進(jìn)口美國(guó)和分銷(xiāo)不需要出現(xiàn)在重新發(fā)布的EUA的附錄A中，不需要出現(xiàn)在2020年3月28日的附件1中，不需要出現(xiàn)在進(jìn)口防護(hù)口罩的EUA中。有關(guān)更多信息，請(qǐng)參見(jiàn)《口罩總則EUA》以及《2020年4月冠狀病毒疾?。–OVID-19）突發(fā)公共衛(wèi)生事件期間口罩及防護(hù)口罩的實(shí)施政策（修訂版）》，《口罩總則EUA》授權(quán)了符合某些標(biāo)準(zhǔn)的口罩。

▲?使用FDA批準(zhǔn)或NIOSH批準(zhǔn)的防護(hù)口罩。在COVID-19突發(fā)公共衛(wèi)生事件期間，F(xiàn)DA授權(quán)緊急使用NIOSH批準(zhǔn)的用于醫(yī)療機(jī)構(gòu)的所有空氣凈化防護(hù)口罩。CDC提供了NIOSH批準(zhǔn)的顆粒物過(guò)濾式防護(hù)口罩和電動(dòng)凈化空氣防護(hù)口罩的列表。

▲?如果FDA批準(zhǔn)的或NIOSH批準(zhǔn)的防護(hù)口罩不可用，請(qǐng)考慮使用其他FDA防護(hù)口罩緊急使用授權(quán)中所涉及的任一項(xiàng)。根據(jù)FDA全部的科學(xué)證據(jù)和其他信息，有理由相信授權(quán)的防護(hù)口罩可能會(huì)有效地防止接觸某些顆粒，以防止COVID-19擴(kuò)散。這些防護(hù)口罩列于《2020年3月28日進(jìn)口、其他國(guó)家制造的非NIOSH批準(zhǔn)的一次性防護(hù)口罩緊急使用授權(quán)》的附件1中，或《中國(guó)制造的非NIOSH批準(zhǔn)的一次性防護(hù)口罩緊急使用授權(quán)》附錄A中。附錄A中的清單由FDA定期更新。

▲?遵循盡職調(diào)查做法，例如詢問(wèn)賣(mài)方問(wèn)題，對(duì)產(chǎn)品進(jìn)行物理評(píng)估和適合性測(cè)試，以做出關(guān)于使用防護(hù)口罩的最明智的收益風(fēng)險(xiǎn)決策。

▲?繼續(xù)確保與醫(yī)護(hù)人員一道進(jìn)行防護(hù)口罩的仔細(xì)檢測(cè)或“合適性檢測(cè)”，從而實(shí)現(xiàn)非常緊密的面部貼合。中國(guó)制造的許多防護(hù)口罩都有耳環(huán)設(shè)計(jì)。根據(jù)CDC的說(shuō)法，對(duì)耳環(huán)設(shè)計(jì)的有限評(píng)估表明，可能難以實(shí)現(xiàn)適當(dāng)?shù)馁N合度。請(qǐng)遵循您的醫(yī)療衛(wèi)生機(jī)構(gòu)的指導(dǎo)方針進(jìn)行適合性檢測(cè)。

▲?如果先前FDA批準(zhǔn)或NIOSH批準(zhǔn)的防護(hù)口罩可用，而一種新的防護(hù)口罩在FDA防護(hù)口罩緊急使用授權(quán)中所涉及到的任一項(xiàng)卻不可用，您可以考慮使用FDA緊急使用授權(quán)的消毒設(shè)備，受污防護(hù)口罩可得到重新利用。請(qǐng)同時(shí)注意，如果您使用的是從附錄A中刪除的防護(hù)口罩，那么，這些防護(hù)口罩不再由FDA授權(quán)一次性使用或由FDA授權(quán)的凈化系統(tǒng)進(jìn)行重復(fù)使用。

▲?如果您對(duì)防護(hù)口罩有任何疑問(wèn)，或者對(duì)防護(hù)口罩的包裝，標(biāo)簽或質(zhì)量有任何疑問(wèn)，請(qǐng)考慮更換、丟棄、或?qū)⒎雷o(hù)口罩退還給分銷(xiāo)商（如適用）。

有關(guān)更多信息，請(qǐng)參閱有關(guān)非NIOSH批準(zhǔn)的過(guò)濾式防護(hù)口罩的常見(jiàn)問(wèn)題（FAQ）。

FDA行動(dòng)

如果有其他可用信息表明防護(hù)口罩沒(méi)有資格被授權(quán)，則將其從附錄A中刪除，并將在FDA的“緊急使用授權(quán)”頁(yè)面上公開(kāi)通報(bào)。

向FDA報(bào)告問(wèn)題

FDA鼓勵(lì)醫(yī)療供應(yīng)商報(bào)告與防護(hù)口罩相關(guān)的任何不良事件或疑似不良事件。

▲?自愿報(bào)告可以通過(guò)MedWatch，F(xiàn)DA安全信息和不良事件報(bào)告程序提交。

▲?設(shè)備制造商和用戶設(shè)施必須遵守適用的《醫(yī)療器械報(bào)告（MDR）》條例。

▲?受FDA用戶設(shè)施報(bào)告要求約束的設(shè)施雇用的醫(yī)療供應(yīng)商，應(yīng)遵循其設(shè)施規(guī)定的報(bào)告程序。

▲?欺詐性COVID-19產(chǎn)品對(duì)公共健康構(gòu)成嚴(yán)重風(fēng)險(xiǎn)。我們鼓勵(lì)把任何涉及到潛在性的假冒偽劣產(chǎn)品發(fā)送至FDA-COVID-19-Fraudulent-Products@fda.hhs.gov。如有可能，請(qǐng)附上產(chǎn)品說(shuō)明和產(chǎn)品標(biāo)簽圖片。

及時(shí)報(bào)告不良事件有助于FDA識(shí)別和更好地了解與醫(yī)療器械相關(guān)的風(fēng)險(xiǎn)。

注釋1：但是，如果防護(hù)口罩通過(guò)NIOSH的檢測(cè)，（即，根據(jù)NIOSH標(biāo)準(zhǔn)檢測(cè)程序（STP）TEB-APR-STP-0059的修改版本，證明大于或等于95％的過(guò)濾效率），請(qǐng)?jiān)L問(wèn)https：// www.cdc.gov/niosh/npptl/stps/pdfs/TEB-APR-STP-0059-508.pdf，并且，在滿足最初的第三個(gè)標(biāo)準(zhǔn)的基礎(chǔ)上，之前已列于附錄A中，防護(hù)口罩仍然是授權(quán)的，并根據(jù)修訂后的第三項(xiàng)標(biāo)準(zhǔn)列于附錄A中。

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原文：

Certain Filtering Facepiece Respirators from China May Not Provide Adequate Respiratory Protection - Letter to Health Care Providers

The U.S. Food and Drug Administration (FDA) is concerned that certain filtering facepiece respirators (respirators) from China may not provide consistent and adequate respiratory protection to health care personnel exposed to COVID-19 based on additional filtration performance testing conducted by the National Institute for Occupational Safety and Health (NIOSH) - National Personal Protective Technology Laboratory (NPPTL) of the Centers for Disease Control and Prevention (CDC) (referred to below as the NIOSH testing). As such, FDA has revised and reissued the April 3, 2020 EUA as explained below.

On May 7, 2020, the FDA reissued the Emergency Use Authorization (EUA) for Non-NIOSH-Approved Disposable Filtering Facepiece Respirators Manufactured in China to revise one of the eligibility criteria –? the criterion for authorization of respirators based on review of test reports from recognized independent test laboratories submitted to the FDA by the manufacturer or importer – and accordingly removed from Appendix A the respirators that had been authorized under that criterion, regardless of whether they passed or failed the NIOSH testing.1 The FDA is taking this public health action because a number of these respirators failed to demonstrate a minimum particulate filtration efficiency of 95 percent in testing conducted at NIOSH.

Respirators that were removed from Appendix A of the EUA and that did not meet their labeled performance standard (listed below) are no longer eligible and are no longer authorized to be marketed or distributed in the United States as respirators. They may be re-labeled as face masks and authorized if certain criteria are met under the Face Mask umbrella EUA . For other information, please see FDA’s enforcement policy on face masks,? as described in the April 2020 Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency (Revised)” Guidance.

Non-NIOSH-approved respirators that meet the other eligibility criteria in the reissued Emergency Use Authorization remain authorized by the FDA for use during the COVID-19 pandemic and continue to be listed in Appendix A.

Considerations

Health care facilities with these respirators in inventory should review the considerations listed below.? The information is specific to respirators that are designed to achieve a very close facial fit and to filter airborne particles.? These considerations are not applicable to surgical masks or face masks that are loose-fitting and create a physical barrier between the health care personnel’s mouth and nose and potential contaminants in the immediate environment.

Respirators that no longer appear in Appendix A may not reliably provide a minimum percent particulate filtration efficiency of 95 percent.? Refer to the NIOSH assessment webpage to determine whether non-NIOSH-approved respirators manufactured in China have been tested and to review the testing results.?

Among products removed from Appendix A to date, the following failed to demonstrate a minimum percent particulate filtration efficiency of 95 percent in testing conducted by NIOSH:?

CTT Co. Ltd

Daddybaby Co. Ltd

Dongguan Xianda Medical Equipment Co., Ltd.

Guangdong Fei Fan Mstar Technology LTD

Guangdong Nuokang Medical Technology Co., Ltd.

Huizhou Huinuo Technology Co., Ltd.

Lanshan Shendun Technology Co

NIOSH regularly updates its list of testing results.

Respirators that have been tested by NIOSH and failed to demonstrate a Minimum Particulate Filtration Efficiency of 95 percent may be considered for use as face masks for source control, to help slow the spread of infection when a person speaks, coughs, or sneezes. Health care facilities should be aware that this use of face masks is different from personal protective equipment for health care personnel.

Health care facilities with these respirators that failed the NOISH testing may wish to consider a number of factors in deciding to use these products as face masks, including current need, inventory, facility practices, and acceptable uses.

The FDA believes respirators that no longer appear in Appendix A may not be reliably decontaminated in any decontamination system authorized for use during the COVID-19 pandemic.

If you have respirators that were removed from Appendix A and you want NIOSH to test their filtration efficiency, you can request NIOSH testing by submitting the International Respirator Assessment Request.

Additional Information

Health care facilities may find the following information useful when considering the purchase or use of respirators such as N95s and KN95s:?

Products labeled as “respirators” must meet the applicable FDA requirements or receive an Emergency Use Authorization to be imported and distributed in the United States. However, products labeled as “face masks” and not as “respirators” are subject to different requirements.? They do not need to be on Appendix A to the reissued EUA, or on Exhibit 1 to the March 28, 2020, EUA for imported respirators, to be imported and distributed in the United States.? For more information, please see the Face Mask umbrella EUA which authorizes face masks that meet certain criteria, as well as the April 2020 Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency (Revised).?

Use an FDA-cleared or NIOSH-approved respirator. The FDA authorized the emergency use of all NIOSH-approved air purifying respirators for use in healthcare settings during the COVID-19 public health emergency. The CDC provides a list of NIOSH-Approved Particulate Filtering Facepiece Respirators and powered air purifying respirators.

If FDA-cleared or NIOSH-approved respirators are not available, consider using respirators covered under one of the other FDA Emergency Use Authorizations for respirators. Based on the totality of scientific evidence and other information from the FDA, it is reasonable to believe the authorized respirators may be effective at preventing exposure to certain particulates to prevent the spread of COVID-19.? These respirators are listed in Exhibit 1 of the March, 28, 2020, Imported, Non-NIOSH Approved Disposable Respirators Emergency Use Authorization for respirators manufactured in other countries, or Appendix A of the Emergency Use Authorization for Non-NIOSH Approved Disposable Respirators manufactured in China. The list in Appendix A is updated by the FDA regularly.?

Follow due diligence practices, such as asking questions of the seller, conducting a physical assessment of the product and fit testing, to make the most informed benefit-risk decision about respirator use.

Continue to ensure that careful testing or “fit testing” of respirators is conducted with health care personnel so that a very close facial fit is achieved. Many respirators manufactured in China have an ear loop design. According to the CDC, limited assessment of ear loop designs indicate there may be difficulty achieving a proper fit. Follow your health care facility’s guidelines for conducting fit testing.

If a previously used FDA-cleared or NIOSH-approved respirator is available and a new respirator covered under one of the FDA Emergency Use Authorizations for respirators is not available, you may consider using an FDA Emergency Use Authorization decontamination device for reuse of a compatible contaminated respirator.? Please also note that if your facility is using respirators that have been subsequently removed from Appendix A, these respirators are no longer authorized by FDA for single use or reuse by an FDA authorized decontamination system.

If you have concerns about respirators or questions about the packaging, labeling, or quality of the respirators, consider replacing, discarding, or returning the respirators to the distributor, if appropriate.

See Frequently Asked Questions (FAQs) about Non-NIOSH-Approved Filtering Facepiece Respirators for more information.

FDA Actions

The FDA continues to actively monitor and mitigate any potential shortages in the supply chain, including the medical device supply chain.? This includes taking action to help assure health care personnel on the front lines have the necessary supplies of personal protective equipment to meet the demand.

The FDA continues to collaborate with the CDC to increase the availability and ensure the integrity of respirators during the COVID-19 public health emergency.?

The FDA will continue to keep health care providers and the public informed if new or additional information becomes available.

If additional information becomes available that indicates respirators are not eligible to be authorized, they will be removed from Appendix A and this removal will be publicly communicated on the FDA’s Emergency Use Authorization? page.

Reporting Problems to the FDA

The FDA encourages health care providers to report any adverse events or suspected adverse events experienced with respirators.

Voluntary reports can be submitted through MedWatch, the FDA Safety Information and Adverse Event Reporting program.

Device manufacturers and user facilities must comply with the applicable Medical Device Reporting (MDR) regulations.

Health care providers employed by facilities that are subject to the FDA's user facility reporting requirements should follow the reporting procedures established by their facilities.

Fraudulent COVID-19 products pose a serious risk to public health.? We encourage any concerns about potential counterfeit or fraudulent product be sent to FDA-COVID-19-Fraudulent-Products@fda.hhs.gov.? ?If possible, please include a description of the product along with a picture of the product’s labeling.

Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices.

Contact Information

If you have questions about this letter, contact the Division of Industry and Consumer Education (DICE).

Additional Resources:

Personal Protective Equipment Emergency Use Authorizations

The FDA’s Video "What is an Emergency Use Authorization?"External Link Disclaimer

NIOSH’s Healthcare Respiratory Protection Resources Fit Testing

The Occupational Safety and Health Administration’s video about Respiratory Protection Fit Testing

The CDC’s Counterfeit Respirators/Misrepresentation of NIOSH-Approval provides information about recognizing counterfeit respirators and recommended best practices for proper respirator use.

However, if a respirator has passed testing by NIOSH (i.e., it demonstrated greater than or equal to 95 percent filtration efficiency per a modified version of NIOSH Standard Test Procedure (STP) TEB-APR-STP-0059), //www.cdc.gov/niosh/npptl/stps/pdfs/TEB-APR-STP-0059-508.pdf, and was previously listed in Appendix A based on meeting the original third criterion, that respirator remains authorized and listed in Appendix A under the revised third criterion.