FDA’s Emergency Use Authorizations for PPE

Beginning in March of this year, the FDA has issued several Emergency Use Authorizations (EUAs) to help healthcare personnel and facilities in their fight against the COVID-19 epidemic. Over the next several blogs we will explore some of the more significant EUAs in order to provide you with a greater understanding of them and their impact on you and your facility. On August 5, 2020, the FDA issued an EUA for several types of single use, disposable surgical masks. This EUA was issued in response to public concerns relating to the availability and potential lack of adequate supply for such masks. According to the FDA, “This EUA authorizes the emergency use of surgical masks that meet certain performance requirements for use in healthcare settings by health care personnel as personal protective equipment to provide a physical barrier to fluids and particulate materials to prevent HCP exposure to respiratory droplets and large particles during surgical mask shortages resulting from the COVID-19 pandemic.”¹ Surgical masks that have been confirmed by the FDA as of August 31, 2020 to meet the criteria under the EUA include: Date of Addition:          Manufacturer:             Authorized Product Name: 08/18/2020                  Venus Group, Inc.       Venus Medical Grade Disposable Surgical Mask 08/08/2020                 Outdoor Research      Outdoor Research Surgical Mask (Model #OR2159)²   In addition to surgical masks, N95 and other commercially available respirators have also been authorized by the FDA for emergency use by healthcare personnel during the COVID-19 pandemic. Here’s a link to a complete list³ of N95 and other respirators that are included in the FDA’s current (as of September 4, 2020) EUA: Complete List of N95 and Other Respirators

In the next few blogs, we will be providing EUA information on Non-NIOSH-Approved Disposable Filtering Facepiece Respirators (FFRs), Non-NIOSH-Approved Respirators along with a list of respirators that have been removed from the EUA list.

  Your personal safety, along with the safety of your co-workers and patients is greatly impacted by the efficacy and effectiveness of the PPE products that you use in your healthcare facility.  

1. https://www2a.cdc.gov/drds/cel/cel_results.asp?startrecord=1&Search=cel_form&maxrecords=50&schedule=84A&appdatefrom=&appdateto=&facepiecetype=Filtering+Facepiece&facepiecetype=Full+Facepiece&facepiecetype=Half+Ma
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