Based upon the increased knowledge of the performance and design of respirators, the Federal Drug Administration (FDA) has reissued the emergency use authorizations (EUAs) specifying which respirators can be decontaminated for reuse. This reissuance of EUAs resulted from the FDA being made aware by the Centers for Disease Control and Prevention’s (CDC) National Institute for Occupational Safety and Health (NIOSH) testing that raised concerns about authorized respirators made in China. The testing indicated that those respirators may vary in their design and performance, and information is not available to support their ability to be decontaminated for reuse. Additionally, the FDA revised relevant EUAs to stop authorizing decontamination or the reuse of respirators having exhalation valves.
Based on CDC’s recommendations, decontaminated respirators should only be used when new FDA-cleared N95 respirators, NIOSH-approved N95 respirators, or other FDA authorized respirators are not available. The decontamination systems are only authorized to decontaminate non-cellulose compatible N95 respirators. As such, healthcare personnel should not reuse a respirator that is incompatible with an authorized decontamination system, but has nonetheless been decontaminated. Users of any respirator (whether or not decontaminated) should always assess for proper fit after placement. Respirators with poor fit, visible soiling, or damage should not be used.
For more information, check out these websites:
https://www.cdc.gov/niosh/npptl/respirators/testing/NonNIOSHresults.html
https://www.fda.gov/media/136664/download
https://www.fda.gov/media/136403/download
Compliance Perspective
Issue
Failure to be aware of FDA changes in EUAs regarding decontamination of respirators, particularly those made in China, may contribute to a breakdown in infection control regarding COVID-19 and place residents and staff in greater danger of contracting the Coronavirus, which might result in provision of substandard quality of care, in violation of state and federal regulations.
Discussion Points
- Review policies and procedures regarding FDA reissuance of EUAs and CDC testing regarding unauthorized Chinese respirators and having an authorized decontamination system.
- Train staff regarding FDA guidelines for decontamination of respirators and the need to ensure that respirators, whether or not they have been decontaminated, continue to fit properly, are not soiled, and not damaged.
- Periodically determine if staff are reusing respirators that are not compatible with an authorized decontamination system.
