Tags

Type your tag names separated by a space and hit enter

Proposal for a EN 149 acceptable reprocessing method for FFP2 respirators in times of severe shortage.
Antimicrob Resist Infect Control. 2020 06 17; 9(1):88.AR

Abstract

INTRODUCTION

Transmission of SARS-CoV-2 to health care workers (HCW) poses a major burden in the current COVID-19 pandemic. Unprotected exposure to a COVID-19 patient is a key risk factor for HCWs. Transmission mainly occurs by droplet transmission, or by aerosol generating procedures. Respirators such as filtering face piece masks (FFP2), also called respirators, are required to prevent transmission during aerosol generating procedures, as part of the personal protective equipment (PPE) for HCWs. However, many HCW were infected due to lack of PPE, or failure to use them. Therefore, the worldwide shortage of respirators triggered the development of reprocessing used FFP2 respirators or N95 respirators as standard in the US. Our proposal with H2O2 plasma sterilization for decontamination allows to reprocess FFP2, while they still meet the filtration efficiency required by EN 149. The protocol is simple, uses available resources in hospitals and can be rapidly implemented to decrease the shortage of respirators during this crisis. The goal of the study was the evaluate if respirators can be reprocessed and still fulfill the requirements for filtration efficiency outlined by EN 149.

METHODS

Used FFP2 respirators - Model 3 M Aura™ 1862+ - were sterilized using a low temperature process hydrogen peroxide (H2O2), V-PRO® maX Low Temperature, a FDA (Food and Drug Administration) approved method to decontaminate FFP2 respirators. Decontaminated respirators were further checked for residual peroxide by a single-gas detector for H2O2. The total inward leakage of the protective respirators was quantitatively tested with 10 test persons in an atmosphere charged with paraffin aerosol according to the European Standard EN 149. The fit factor was calculated as the inverse of the total inward leakage.

RESULTS

Ten new and ten decontaminated FFP2 respirators were tested for filtration efficiency. None of the respirators exceeded the maximum acceptable concentration of peroxide. More than 4000 respirators have been reprocessed so far, at cost of approximately 0.3 Euro/piece.

CONCLUSIONS

FFP2 respirators can be safely reprocessed once after decontamination with plasma peroxide sterilization, whereafter they still fulfill EN 149 requirements. This allows to almost double the current number of available FFP2 respirators.

Authors+Show Affiliations

University of Basel Hospitals, Division of infectious Diseases & Hospital Epidemiology and University of Basel, 4031, Basel, Switzerland. andreas.widmer@usb.ch.Federal Office for Civil Protection FOCP, Spiez Laboratory, Spiez, Switzerland.

Pub Type(s)

Journal Article
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

32552867

Citation

Widmer, Andreas F., and Gilles Richner. "Proposal for a EN 149 Acceptable Reprocessing Method for FFP2 Respirators in Times of Severe Shortage." Antimicrobial Resistance and Infection Control, vol. 9, no. 1, 2020, p. 88.
Widmer AF, Richner G. Proposal for a EN 149 acceptable reprocessing method for FFP2 respirators in times of severe shortage. Antimicrob Resist Infect Control. 2020;9(1):88.
Widmer, A. F., & Richner, G. (2020). Proposal for a EN 149 acceptable reprocessing method for FFP2 respirators in times of severe shortage. Antimicrobial Resistance and Infection Control, 9(1), 88. https://doi.org/10.1186/s13756-020-00744-3
Widmer AF, Richner G. Proposal for a EN 149 Acceptable Reprocessing Method for FFP2 Respirators in Times of Severe Shortage. Antimicrob Resist Infect Control. 2020 06 17;9(1):88. PubMed PMID: 32552867.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Proposal for a EN 149 acceptable reprocessing method for FFP2 respirators in times of severe shortage. AU - Widmer,Andreas F, AU - Richner,Gilles, Y1 - 2020/06/17/ PY - 2020/04/28/received PY - 2020/05/29/accepted PY - 2020/6/20/entrez PY - 2020/6/20/pubmed PY - 2020/7/1/medline KW - FFP2 KW - Infection control KW - Personal protection equipment KW - Reprocessing KW - Respirators KW - Sterilization SP - 88 EP - 88 JF - Antimicrobial resistance and infection control JO - Antimicrob Resist Infect Control VL - 9 IS - 1 N2 - INTRODUCTION: Transmission of SARS-CoV-2 to health care workers (HCW) poses a major burden in the current COVID-19 pandemic. Unprotected exposure to a COVID-19 patient is a key risk factor for HCWs. Transmission mainly occurs by droplet transmission, or by aerosol generating procedures. Respirators such as filtering face piece masks (FFP2), also called respirators, are required to prevent transmission during aerosol generating procedures, as part of the personal protective equipment (PPE) for HCWs. However, many HCW were infected due to lack of PPE, or failure to use them. Therefore, the worldwide shortage of respirators triggered the development of reprocessing used FFP2 respirators or N95 respirators as standard in the US. Our proposal with H2O2 plasma sterilization for decontamination allows to reprocess FFP2, while they still meet the filtration efficiency required by EN 149. The protocol is simple, uses available resources in hospitals and can be rapidly implemented to decrease the shortage of respirators during this crisis. The goal of the study was the evaluate if respirators can be reprocessed and still fulfill the requirements for filtration efficiency outlined by EN 149. METHODS: Used FFP2 respirators - Model 3 M Aura™ 1862+ - were sterilized using a low temperature process hydrogen peroxide (H2O2), V-PRO® maX Low Temperature, a FDA (Food and Drug Administration) approved method to decontaminate FFP2 respirators. Decontaminated respirators were further checked for residual peroxide by a single-gas detector for H2O2. The total inward leakage of the protective respirators was quantitatively tested with 10 test persons in an atmosphere charged with paraffin aerosol according to the European Standard EN 149. The fit factor was calculated as the inverse of the total inward leakage. RESULTS: Ten new and ten decontaminated FFP2 respirators were tested for filtration efficiency. None of the respirators exceeded the maximum acceptable concentration of peroxide. More than 4000 respirators have been reprocessed so far, at cost of approximately 0.3 Euro/piece. CONCLUSIONS: FFP2 respirators can be safely reprocessed once after decontamination with plasma peroxide sterilization, whereafter they still fulfill EN 149 requirements. This allows to almost double the current number of available FFP2 respirators. SN - 2047-2994 UR - https://www.unboundmedicine.com/medline/citation/32552867/Proposal_for_a_EN_149_acceptable_reprocessing_method_for_FFP2_respirators_in_times_of_severe_shortage_ L2 - https://aricjournal.biomedcentral.com/articles/10.1186/s13756-020-00744-3 DB - PRIME DP - Unbound Medicine ER -