August 21, 2020
The following quote is attributed to Binita Ashar, M.D., Director, Office of Surgical and Infection Control Devices, FDA’s Center for Devices and Radiological Health:
“The FDA is revoking the umbrella emergency use authorization (EUA) for passive protective barrier enclosures (those without negative pressure.) We have carefully reviewed and considered preliminary evidence showing that there is a potential for adverse events or complications when using these devices while treating patients who are known or suspected to have COVID-19.
“It is important to note that the FDA has not received any adverse event reports related to the use of these devices so far, but we are taking this action to protect patients and health care providers from potential harm from using these devices. This is based on the conclusion that the criteria for issuance of an EUA is no longer met and that revocation of the EUA is appropriate to protect the public health or safety.
“We will continue to take action when there is a need to do so to protect health care providers, patients and the public.”
- Today the U.S. Food and Drug Administration revoked the umbrella emergency use authorization (EUA) for passive protective barrier enclosures (without negative pressure).
- On May 1, 2020, the FDA issued the umbrella EUA for protective barrier enclosures that do not use fans, air filters or other features and are not intended to generate negative pressure for use by health care providers (HCP) when caring for or performing medical procedures on patients who are known or suspected to have COVID-19 in health care settings.
- The authorized use of these enclosures was to prevent HCP exposure to pathogenic biological airborne particulates by providing an extra layer of barrier protection in addition to personal protective equipment (PPE).
- Based on available scientific evidence at that time, the FDA concluded that the protective barrier enclosures may be an effective barrier device when used in addition to PPE during the pandemic. The FDA has since become aware of information about the potential for adverse events and complications with use of these devices.
- The FDA concluded it is no longer reasonable to believe that these authorized passive protective barrier enclosures may be effective at preventing HCP exposure to pathogenic biological airborne particulates by providing an extra layer of barrier protection in addition to PPE when caring for or performing medical procedures on patients who are known or suspected to have COVID-19 in healthcare settings, and FDA can no longer conclude that the known and potential benefits of passive protective barrier enclosures, for such use, outweigh the known and potential risks of such products.
- With revocation of the umbrella EUA, the FDA instead will review individual EUA requests for passive protective barrier enclosures to assess each device’s safety and performance under the statutory criteria for issuance of an EUA.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.