FDA guides on selecting respirators for healthcare facilities

Aug. 19, 2020

The U.S. Food and Drug Administration (FDA) has authorized the emergency use of certain filtering facepiece respirators (FFRs) for use in healthcare settings by healthcare personnel (HCP) in accordance with the Centers for Disease Control and Prevention (CDC) recommendations to prevent HCP exposure to pathogenic biological airborne particulates during FFR shortages resulting from the COVID-19 outbreak, according to guidance on the FDA website.

In accordance with CDC Strategies for Optimizing the Supply of N95 Respirators, this flowchart and the information below illustrates which Emergency Use Authorization (EUA) applies to specific respirator types and provides links to information on performance factors for each type to consider when selecting respirators for use in health care facilities in the United States.

The FDA, in conjunction with the CDC and the National Institute for Occupational Safety and Health (NIOSH), continues to evaluate respirator performance.

What to use: National Institute for Occupational Safety and Health (NIOSH) Approved Air Purifying Respirators (includes those that are FDA-cleared and authorized under the EUA such as disposable filtering facepiece respirators (FFRs) (such as N95s) and reusable respirators such as elastomeric and powered air purifying respirators (PAPRs).

How to identify a respirator to use: Search the NIOSH certified equipment list (CEL) that shows both disposable and reusable air purifying respirators of different types from different manufacturers.

Use the shortcut links below to search for specific types of respirators.

Search for non-powered air purifiers (such as N95 or elastomeric).

Search for powered air purifying respirators (such as PAPRs).

Review the CEL list to choose a particular manufacturer or to do a unique search. As a reminder, non-powered general respirators can be found under Schedule 84A and the powered air purifying respirators are found under Schedule 21C.

Before selecting a respirator, review the NIOSH Counterfeit Respirators list to identify if NIOSH-approval has been misrepresented.

If you are unable to obtain NIOSH-approved respirators: Consider the use of imported FDA EUA authorized non-NIOSH-approved respirators NOT manufactured in China and follow these steps:

How to identify a respirator to use: Review the FDA EUA for Respirators including Exhibit 1: Authorized Imported, Non-NIOSH Disposable Filtering Facepiece Respirators (FFR) to identify respirators authorized by FDA for use by health care providers.

Before selecting a respirator, review these:

CDC’s Factors to Consider When Planning to Purchase Respirators from Another Country.

CDC’s National Personal Protective Technology Laboratory (NPPTL) Respirator Assessments to Support the COVID-19 Response International Assessment Filtration Results - Not NIOSH-approved to determine if filtration levels are adequate for your use.

If you are unable to purchase an imported NIOSH-approved respirator not manufactured in China: Consider the use of FDA EUA authorized non-NIOSH-approved respirators manufactured in China, including KN95s, and follow these steps:

How to identify a respirator to use: Review the FDA EUA for Respirators, including Appendix A: Authorized Imported, Non-NIOSH Approved Respirators Manufactured in China to identify respirators authorized by FDA for use by health care providers.

Before selecting a respirator, review these:

CDC's NPPTL Respirator International Assessments Filtration Results for not NIOSH-approved to determine if filtration levels are adequate for your use.

CDC’s Factors to Consider When Planning to Purchase Respirators from Another Country.

FDA has the guidance.

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