FDA updated information on respirator decontamination systems

Jan. 28, 2021

The U.S. 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 insufficient supply of new respirators resulting from the COVID-19 pandemic. 

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. Specifically, the reissued EUAs for certain decontamination systems are now only authorized to decontaminate each compatible N95 respirator a maximum of four or fewer times. 

When a decontamination system has been authorized for multiple-user reuse, healthcare facilities and applicable parties are also required to ensure that HCP receive the same model of decontaminated compatible N95 respirator for which they have been fit tested. If such model of respirator is unavailable, then healthcare facilities and applicable parties must provide HCP with fit testing prior to using an alternative model of decontaminated compatible N95 respirator. 

Please keep in mind that the decontamination systems are not authorized to decontaminate: 

·        respirators containing cellulose-based materials, unless specifically authorized for the decontamination system;

·         respirators containing antimicrobials, unless specifically authorized for the decontamination system;

·         duckbill respirators, unless specifically authorized for the decontamination system; and,

·         respirators with exhalation valves. 

The FDA recommends that HCP: 

·         Perform OSHA self-seal check to ensure an adequate seal is achieved each time a respirator is donned.

·         Review the updated Fact Sheets and Instructions associated with the EUA for the specific decontamination system being used. 

Decontamination systems are devices intended to decontaminate certain medical devices, such as filtering facepiece respirators (FFRs), so that they can be reused by healthcare personnel. The FDA has issued emergency use authorizations (EUAs) for some decontamination systems to decontaminate certain types of FFRs, recognizing that new FFRs are not sufficiently available during the Coronavirus Disease 2019 (COVID-19) pandemic. 

The FDA has issued EUAs for decontamination systems for decontaminating FFRs for reuse by healthcare personnel (HCP) to prevent exposure to pathogenic biological airborne particulates when there are insufficient supplies of FFRs resulting from the COVID-19 pandemic. In addition to authorizing some decontamination systems for emergency use, the FDA has also issued guidance to help sponsors requesting EUAs for decontamination and bioburden reduction systems for surgical masks and respirators.  

FDA has the FAQs. 

More COVID-19 coverage HERE.

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