Aerosolized Hydrogen Peroxide Decontamination of N95 Respirators, with Fit-Testing and Virologic Confirmation of Suitability for Re-Use During the COVID-19 Pandemic

T. Hans Derr; Melissa A. James; Chad V. Kuny; Prem P. Kandel; Matthew D. Beckman; Kevin L. Hockett; Mark A. Bates; Moriah L Szpara

At present, respirator manufacturers have not approved protocols for respirator decontamination (2) . However to address imminent pandemic needs, healthcare settings are referencing U.S. Centers for Disease Control and Prevention guidelines on provisional N95 respirator decontamination and reuse (9). Battelle Memorial Institute of Columbus, Ohio, recently received U.S. Food and Drug Administration (FDA) emergency use authorization for an N95 decontamination protocol using H2O2 vapor, based on a prior study addressing the potential for respirator reuse in emergency scenarios (3, 10) . This prior Battelle decontamination study included evaluation of respirator structure, filtration and manikin fit-testing, and used bacterial spore-based biological indicators to demonstrate effective sterilization (3). It did not employ virologic testing, nor statistical evaluation of respirator fit on live subjects. Given that the current pandemic entails a respiratory viral pathogen, it is necessary to address these critical aspects of respirator safety for reuse. Due to the current urgency of COVID-19 pandemic, many . CC-BY-NC-ND 4.0 International license It is made available under a author/funder, who has granted medRxiv a license to display the preprint in perpetuity.