Decontaminating Compatible N95 Respirators Reauthorized

The US Food and Drug Administration (FDA) reissued its Emergency Use Authorizations (EUAs) for decontamination systems that are authorized to decontaminate compatible N95 respirators used by healthcare personnel.

N95 respirators and surgical masks are examples of personal protective equipment (PPE) that are used to protect the wearer from airborne particles and from liquid contaminating the face.

Among other things, the reissued EUAs for certain decontamination systems are now only authorized to decontaminate each compatible N95 respirator a maximum of four or fewer times, announced the FDA on January 22, 2021.

Based on the FDA’s review of real-world use of these systems and evidence from adverse events and scientific literature, including studies regarding N95 respirator failures from simulated and real-world use, the FDA has determined that it is appropriate to protect the public health or safety to revise certain decontamination system EUAs to limit the number of decontamination cycles and respirator reuses permitted under each authorization.

N95 respirators help prevent exposure to pathogenic biological airborne particulates when there is an insufficient supply of new respirators resulting from the COVID-19 pandemic.

It is important to recognize that the optimal way to prevent airborne transmission is to use a combination of interventions from across the hierarchy of controls, not just PPE alone.

The US Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health, and the Occupational Safety and Health Administration also regulate N95 respirators.

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