Abstract

The Battelle Critical Care Decontamination System™ (CCDS™) decontaminates N95 filtering facepiece respirators (FFRs) using vapor phase hydrogen peroxide (VPHP) for reuse when there is a critical supply shortage. The Battelle CCDS received an Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) in March 2020. This research focused on evaluating the mechanical properties of the straps as an indicator of respirator fit. The objective was to characterize the load generated by the straps following up to 20 don/doff and decontamination cycles in Battelle’s CCDS. In general, the measured loads at 50 and 100% strains after 20 cycles were similar (±15%) to the as-received controls. Qualitatively, reductions in the load may be associated with loss of elasticity in the straps, potentially reducing the ability to obtain a proper fit. However, small changes in strap elasticity may not affect the ability to obtain a proper fit given the potential for variation in strap length and positioning on the head. Regardless, prior to reusing a N95 respirator, it is important to complete a visual inspection to ensure it is not damaged, malformed, or soiled. If so, it is recommended to discard the respirator and use a different one. Similarly, the respirator should be discarded if the wearer cannot obtain a proper fit during the user seal check.

Highlights

  • The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic drove an increase in the demand for N95 filtering facepiece respirators (FFRs)

  • Reductions in the load may be associated with loss of elasticity in the straps, potentially reducing the ability to obtain a proper fit

  • Small changes in strap elasticity may not affect the ability to obtain a proper fit given the potential for variation in strap length and positioning on the head

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Summary

Introduction

The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic drove an increase in the demand for N95 filtering facepiece respirators (FFRs). EUAs have been issued for several decontamination systems based on vaporous hydrogen peroxide as well as other methods based on supercritical carbon dioxide, ozone, and moist heat [2]. NIOSH research indicates ultraviolet germicidal irradiation (UVGI), vaporous hydrogen peroxide, and moist heat showed the most promise to decontaminate FFRs [1,3,4]. This research focused on evaluating the mechanical properties of the straps as an indicator of respirator fit following decontamination using the Battelle CCDS. The objective was to characterize the load generated by the straps from a sampling of ten N95 FFR models following up to 20 decontamination cycles in Battelle’s CCDS. The research presented in this paper is specific to strap testing, but Battelle has demonstrated the aerosol collection efficiency of these 10 models of N95 FFRs is maintained (i.e., ≥95%) after up to 20 VPHP decontamination cycles

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