Angela S. Andrews, MS, is a Physical Scientist; John R. Powers, Jr. is a Supervisory General Engineer; and Christopher C. Coffey, PhD, is the former Associate Director for Science (retired); all at the National Personal Protective Technology Laboratory (NPPTL), National Institute for Occupational Safety and Health (NIOSH), Centers for Disease Control and Prevention (CDC), Morgantown, WV. Jaclyn K. Cichowicz, MA, and Marisa L. Fries are Health Communications Specialists; Patrick L. Yorio, PhD, is a Health Statistician; and Maryann M. D'Alessandro, PhD, is Director; all at the NPPTL, NIOSH, CDC, Pittsburgh, PA. The findings and conclusions in this report are those of the authors and do not necessarily represent the official position of NIOSH or CDC. Product and company names are provided for identification purposes only and do not imply endorsement by the CDC.
Health Secur. 2021 Jul-Aug;19(4):379-385. doi: 10.1089/hs.2020.0173. Epub 2021 Jan 11.
National Institute for Occupational Safety and Health (NIOSH)-approved respirators are required by the Occupational Safety and Health Administration (OSHA) when personal respiratory protection is used in US occupational settings. During the COVID-19 pandemic, the demand for NIOSH-approved N95 filtering facepiece respirators overwhelmed the available supply. To supplement the national inventory of N95 respirators, contingency and crisis capacity strategies were implemented and incorporated a component that endorsed the use of non-NIOSH-approved respiratory protective devices that conformed to select international standards. The development and execution of this strategy required the collaborative effort of numerous agencies. The Food and Drug Administration temporarily authorized non-NIOSH-approved international respiratory protective devices through an emergency use authorization, OSHA relaxed their enforcement guidance concerning their use in US workplaces, and NIOSH initiated a supplemental performance assessment process to verify the quality of international devices. NIOSH testing revealed that many of the non-NIOSH-approved respiratory protective devices had filtration efficiencies below 95% and substantial inconsistencies in filtration performance. This article reports the results of the NIOSH testing to date and discusses how it has contributed to continuous improvement of the crisis strategy of temporarily permitting the use of non-NIOSH-approved respirators in US occupational settings during the COVID-19 pandemic.
美国职业安全与健康管理局（OSHA）要求在使用个人呼吸防护设备的美国职业场所，必须使用美国国家职业安全与健康研究所（NIOSH）批准的呼吸器。在 COVID-19 大流行期间，NIOSH 批准的 N95 过滤式面罩呼吸器的需求超过了可用供应。为了补充 N95 呼吸器的国家库存，实施了应急和危机能力策略，并纳入了一项认可符合某些国际标准的非 NIOSH 批准的呼吸防护设备使用的组件。这项策略的制定和执行需要许多机构的协作努力。食品和药物管理局通过紧急使用授权临时授权非 NIOSH 批准的国际呼吸防护设备，OSHA 放宽了其在美工作场所使用这些设备的执法指导意见，NIOSH 启动了补充性能评估程序，以验证国际设备的质量。NIOSH 的测试表明，许多非 NIOSH 批准的呼吸防护设备的过滤效率低于 95%，过滤性能存在实质性差异。本文报告了截至目前的 NIOSH 测试结果，并讨论了它如何有助于不断改进在 COVID-19 大流行期间临时允许在美国职业场所使用非 NIOSH 批准的呼吸器的危机策略。
