Decontamination of filtering facepiece respirators using a low-temperature-steam–2%-formaldehyde sterilization process during a pandemic: a safe alternative for re-use

Abstract

Background The coronavirus disease 2019 pandemic has caused problems with respirator supplies. Re-use may minimize the impact of the shortage, but requires the availability of an efficient and safe decontamination method.

Aim To determine whether low-temperature-steam–2%-formaldehyde (LTSF) sterilization is effective, preserves the properties of filtering facepiece (FFP) respirators and allows safe re-use.

Methods Fourteen unused FFP2, FFP3 and N95 respirator models were subjected to two cycles of decontamination cycles. After the second cycle, each model was inspected visually and accumulated residual formaldehyde levels were analysed according to EN 14180. After one and two decontamination cycles, the fit factor (FF) of each model was tested, and penetration tests with sodium chloride aerosols were performed on five models.

Findings Decontamination physically altered three of the 14 models. All of the residual formaldehyde values were below the permissible threshold. Irregular decreases and increases in FF were observed after each decontamination cycle. In the sodium chloride aerosol penetration test, three models obtained equivalent or superior results to those of the FFP classification with which they were marketed, both at baseline and after one and two cycles of decontamination, and two models had lower filtering capacity.

Conclusion One and two decontamination cycles using LTSF did not alter the structure of most (11/14) respirators tested, and did not degrade the fit or filtration capacity of any of the analysed respirators. The residual formaldehyde levels complied with EN 14180. This reprocessing method could be used in times of shortage of personal protective equipment.