Reissued EUAs for N95 Decontamination Systems Authorized for Maximum of Four Decontaminations

The Food and Drug Administration (FDA) is reissuing the Emergency Use Authorizations (EUAs) for decontamination systems that are authorized to decontaminate compatible N95 respirators for use by healthcare personnel (HCP) to prevent exposure to pathogenic biological airborne particulates when there is an insufficient supply of new respirators resulting from the Coronavirus Disease 2019 (COVID-19) pandemic. 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.

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.

Source: FDA

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