美國監管機構和國家官員發現大量的進口N95口罩的認證標準缺失，這使得對冠狀病毒的反應更加複雜化，也潛在的讓一些前線的工人處於更大風險中。最近由國家國家職業安全和健康研究所的測試發現大約67種不同的進口口罩中有60%可以穿透的顆粒物比美國標準正常允許的量多。NOISH說一種由Niosh測試的帶包裝的售賣的口罩，帶著未經授權的食品和藥物管理局標誌，過濾掉的顆粒物只有35%。KN95和N95都是指可以抵擋95%的細小顆粒物的口罩。
另外一種，中國標準的KN95口罩，試樣測試度低於15%，遠低於廣告中的95%。U.S. regulators and state officials are finding a significant number of imported N95-style masks fall short of certification standards, complicating the response to the coronavirus crisis and potentially putting some front-line workers at greater risk.Recent tests by the NationalInstitute for Occupational Safety and Health found that about 60% of 67 different types of imported maskstested allowed in more tiny particles than U.S. standards normally permit.One mask that Niosh tested,sold in packaging bearing unauthorized Food and Drug Administration logos, filtered out as little as 35% of particles.Another, marked KN95, a Chinese standard similar to N95,had one sample test below15%, far short of the 95% it advertised, Niosh said. KN95 and N95 both refer to standards that call for masks to block 95% of very small particles.
Niosh 測試，和其他多個州的召回和額外測試，表明上百萬低於標準從中國和其他國家進口的用於滿足工人的防護需求對抗冠狀病毒的口罩突飛猛漲。這個機構表示，Niosh現在很關心該事件，部分聯邦疾病控制和預防中心，用67種口罩中的10個樣品做了測試。由於國內的生產和庫存遠低於需求，測試說明醫院，地方政府和公司面臨很高的風險，經常支付了很高的價格購買了低於標準出處不明的醫療防護品，另外一個由Noish發現的問題是，67種經測試的進口口罩樣品大部分使用了掛耳繩，用於把口罩固定到頭部，然而NOISH批准的口罩帶有綁頭繃帶用於確保緊密貼合。把細小的可能包含病毒的顆粒獨擋在外很重要，尤其是N95是專用於醫護人員避免直接接觸病毒。FDA,在緊急應對疫情的行動中，允許進口和使用N95-式樣的口罩，這類口罩由國外的標準包括中國的標準認證過。許多的國外口罩被允許使用耳掛。Lawrence General Hospital in Massachusetts說在他們看見NOISH對不符合美國N95的口罩品牌的警示之前，已經把一部分中國製造的帶著耳掛的口罩從倉庫中分發出去了。醫院的護士林恩·裡瑟說，她和她所在單位的同事40名護士中的大約四分之三在過去的三個星期裡在某個時候戴了口罩。 “我們我們沒有受到保護，“她說。 到4月24日，在瑞瑟女士穿著有毛病的衣服四天後她說她感到精疲力竭，呼吸急促，乾咳還有疼痛。 她對冠狀病毒
檢測結果為陰性，但認為檢測結果可能產生假陰性。 Risacher女士說，她已經接受了自我隔離，而且還沒有再次接受測試。
The Niosh tests, combined with recalls and additional testing from multiple states, show that millions of substandard masks have been imported from China and other countries as the need for protective gear for workers confronting the pandemic has skyrocketed.“Niosh is very concerned about this issue,” the institute said. Niosh, part of the federal Centers for Disease Control and Prevention, used 10 samples from each of the 67 mask types in its tests.With domestic production and stockpiles falling far short of demand, the tests suggest a high risk that hospitals, local authorities and companies are in many cases paying steep prices for substandard medical gear of uncertain provenance.Another issue identified by Niosh: Most of the 67 imported mask samples it tested used ear loops to secure them to the head, while all Niosh-approved masks have headbands to ensure a tight fit isimportant to keep out tiny droplets that may contain the coronavirus, especially because N95sare typically used by health-care workers facing direct exposure.The FDA, in an emergencymove in response to the pandemic, has allowed the import and use of N95-style masks that are certified under some foreign standards including China’s.Many of these foreign masks are allowed to use ear loops.Lawrence General Hospital in Massachusetts said it had distributed part of a batch of Chinese-made masks using ear loops from its stock, before seeing a Niosh alert that the masks weren’t up to the U.S. N95 standard their label suggested.Lynn Risacher, a nurse at the hospital, said she and about three-quarters of the 40colleagues in her unit had worn the masks at some point over the previous three weeks. “Weweren’t protected,” she said. By April 24, four days after Ms. Risacher wore the faultymask, she said she felt exhausted, experiencing shortness of breath, a dry coughand aches. She tested negative for the coronavirus but believes the test may have generated a false negative. Ms. Risacher said she self-quarantined and hasn’t gotten tested again.
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