FDA Tightens Up Emergency Use Conditions for N95 Respirator Decontaminators
The FDA has reissued its Emergency Use Authorizations (EUA) for decontamination devices authorized to decontaminate N95 respirators used by healthcare personnel, lowering the number of times certain systems may be used for each respirator.
The agency’s EUAs now authorize the decontamination systems to clean each compatible N95 respirator no more than four times. The decision, which impacts 10 different devices, was based on real-world use of the systems and evidence from adverse events and scientific literature, including studies on N95 respirator failures both in simulations and real-world settings.
“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,” the agency said.