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FDA丨关于非手术口罩EUA常见问答汇编

FDA 问答 EUA

25

本文摘译自FDA 2020年4月26日答疑
以下为详文


为什么FDA会重新发布普通口罩的紧急使用授权(EUA)?

Why did the FDA re-issue the Emergency Use Authorization (EUA) for face masks?


FDA收到了2020年4月18日发布的关于最初的普通口罩EUA的问题。在2020年4月24日,FDA更新并重新发布了EUA,以澄清经EUA授权的包括布面口罩在内的普通口罩,仅被授权用于普通公众和医护人员作为源头的控制。
这些口罩没有被授权为个人防护用品,意味着它们不能替代过滤式防护口罩或外科口罩。


The FDA received questions about the original face mask EUA posted on April 18, 2020. On April 24, 2020, the FDA updated and re-issued the EUA to clarify that face masks, including cloth face coverings, that are authorized by the EUA are only authorized for use by the general public and health care personnel as source control.
These face masks are not authorized to be personal protective equipment, meaning they are not a substitute for filtering face piece respirators or for surgical face masks.



戴普通口罩进行源头控制是什么意思?

What does wearing a face mask for source control mean?

源头控制是指防止通过人在说话、咳嗽或打喷嚏时产生的呼吸分泌物传播感染。可能有或可能没有COVID-19症状的个体可能通过呼吸道分泌物传播COVID-19。普通口罩(包括布面口罩)可遮盖佩戴者的嘴和鼻子,有助于进行源头控制。
关于源头控制的更多信息,请参阅美国疾病预防控制中心(CDC)发布的《疑似或确诊2019冠状病毒病(COVID-19)患者临时感染预防和控制建议》。
由普通易取材料制成的布面口罩是另外一种自愿的公共卫生手段,有助于减缓COVID-19的传播。CDC有一个布面口罩常见问题解答清单,供公众使用。


Source control means preventing the transmission of infection through a person’s respiratory secretions which are produced when speaking, coughing, or sneezing. Face masks, including cloth face coverings, help with source control by covering the wearer’s mouth and nose. COVID-19 may be spread through respiratory secretions by individuals who may or may not have symptoms of COVID-19.
For more information on source control, see the CDC’s Interim Infection Prevention and Control Recommendations for Patients with Suspected or Confirmed Coronavirus Disease 2019 (COVID-19) in Healthcare Settings.
Cloth face coverings made from common, easily accessible materials are an additional, voluntary public health approach to help slow the spread of COVID-19. The CDC has a list of FAQs about Cloth Face Coverings for use by the general public.



在COVID-19突发公共卫生事件中,医护人员什么时候应该戴普通口罩?

During the COVID-19 public health emergency, when should health care personnel wear face masks?

普通口罩不是个人防护用品。医疗机构不应购买或提供此类口罩作为外科口罩或过滤式防护口罩的替代品。普通口罩(包括布面口罩)用作源头控制时,可能有助于防止或减缓COVID-19的传播。根据EUA的规定,这种口罩只能用于包括医疗场所在内的源头控制。
正如《CDC优化普通口罩供应策略》中提出的,个人防护用品(即外科口罩和过滤式防护口罩)是必须持续供给医护人员和其他医疗急救人员的关键物资。
不得使用普通口罩代替外科口罩或过滤式防护口罩,提供以下防护:


•液体屏障保护
•抗菌或抗病毒保护,预防或减少
•呼吸防护
•微粒过滤
•高风险气溶胶生成过程中的保护


Face masks are not personal protective equipment. Health care facilities should not purchase or offer these masks as substitutes for surgical masks or filtering facepiece respirators. Face masks, including cloth facial coverings, when used as source control, may help in preventing or slowing the spread of COVID-19. Face masks are authorized under this EUA to be worn for source control only, including in the healthcare setting.
Personal protective equipment (i.e., surgical masks and filtering facepiece respirators) are critical supplies that must continue to be reserved for health care personnel and other medical first responders, as recommended in the CDC’s Strategies for Optimizing the Supply of Facemasks.
Face masks should NOT be used in place of surgical masks or filtering facepiece respirators to provide protections such as:


•Liquid barrier protection
•Antimicrobial or antiviral protection, prevention, or reduction
•Respiratory protection
•Particulate filtration
•Protection in high-risk aerosol generating procedures



疑似或确诊的COVID-19的病人应该佩戴哪种类型的普通口罩?

What type of face mask should someone who is suspected or confirmed with COVID-19 wear?

如果你生病了该怎么办?CDC建议你戴一个布面口罩,以控制病毒传播给他人。CDC还提出了防止感染者传播的建议。

In What to Do if You Are Sick, the CDC recommends wearing a cloth face covering to control the spread of the virus to others. The CDC also provides recommendations to prevent transmission from infected individuals.



医疗机构应如何优先使用口罩?

How should health care facilities prioritize the use of masks?

当普通口罩供应有限时,CDC会提出优化普通口罩供应的策略部署,FDA也会提供普通口罩的保护对策。

The CDC provides strategies for optimizing the supply of face masks when there is limited supply. The FDA also provides information about conservation strategies for face masks.



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