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

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.

Gravity steam reprocessing in healthcare facilities for the reuse of N95 respirators.

BACKGROUND: Coronavirus disease 2019 (COVID-19) has significantly impacted the health of millions of people around the world. The shortage of personal protective equipment, including N95 respirators, in hospital facilities has put frontline healthcare professionals at high risk for contracting this virus. AIM: To develop a reproducible and safe N95 respirator reprocessing method that satisfies all presented regulatory standards and that can be directly implemented by hospitals using existing available equipment. METHODS: A non-toxic gravity steam reprocessing method has been developed for the reuse of N95 respirators consisting of 30 min of steam treatment at 121°C followed by 30 min of heat drying. Samples of model number 1860, 1860s, 1870+, and 9105 N95 respirators were either collected from hospitals (for microbiology testing) or purchased new (for functionality testing), with all functionality tests (i.e. filter efficiency, fit evaluation, and strap integrity) performed at the Centers for Disease Control and Prevention using standard procedures established by the National Institute for Occupational Safety and Health. FINDINGS: All tested models passed the minimum filter efficiency of 95% after three cycles of gravity steam reprocessing. The 1870+ N95 respirator model is the most promising model for reprocessing based on its efficient bacterial inactivation coupled with the maintenance of all other key functional respirator properties after multiple reprocessing steps. CONCLUSIONS: The gravity steam method can effectively reprocess N95 respirators over at least three reprocessing cycles without negatively impacting the functionality requirements set out by regulators. Enabling the reuse of N95 respirators is a crucial tool for managing both the current pandemic and future healthcare crises.