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Subject validation of reusable N95 stop-gap filtering facepiece respirators in COVID-19 pandemic.
PLoS One. 2020; 15(11):e0242304.Plos

Abstract

INTRODUCTION

The COVID-19 pandemic has unveiled widespread shortages of personal protective equipment including N95 respirators. Several centers are developing reusable stop-gap respirators as alternatives to disposable N95 respirators during public health emergencies, using techniques such as 3D-printing, silicone moulding and plastic extrusion. Effective sealing of the mask, combined with respiratory filters should achieve 95% or greater filtration of particles less than 1um. Quantitative fit-testing (QNFT) data from these stop-gap devices has not been published to date. Our team developed one such device, the "SSM", and evaluated it using QNFT.

METHODS

Device prototypes were iteratively evaluated for comfort, breathability and communication, by team members wearing them for 15-30min. The fit and seal were assessed by positive and negative pressure user seal checks. The final design was then formally tested by QNFT, according to CSA standard Z94.4-18 in 40 volunteer healthcare providers. An overall fit-factor >100 is the passing threshold. Volunteers were also tested by QNFT on disposable N95 masks which had passed qualitative fit testing (QLFT) by institutional Occupational Health and Safety Department.

RESULTS

The SSM scored 3.5/5 and 4/5 for comfort and breathability. The median overall harmonic mean fit-factors of disposable N95 and SSM were 137.9 and 6316.7 respectively. SSM scored significantly higher than disposable respirators in fit-test runs and overall fit-factors (p <0.0001). Overall passing rates in disposable and SSM respirators on QNFT were 65% and 100%. During dynamic runs, passing rates in disposable and SSM respirators were 68.1% and 99.4%; harmonic means were 73.7 and 1643.

CONCLUSIONS

We present the design and validation of a reusable N95 stop-gap filtering facepiece respirator that can match existent commercial respirators. This sets a precedence for adoption of novel stop-gap N95 respirators in emergency situations.

Authors+Show Affiliations

Department of Anesthesiology and Pain Management, Toronto General Hospital, University Health Network, Toronto, Ontario, Canada. Department of Anesthesiology and Pain Medicine, University of Toronto, Toronto, Ontario, Canada. Department of Anesthesiology and Pain Management, Cardiac Division, Hospital for Sick Children, Toronto, Ontario, Canada.Department of Anesthesiology and Pain Management, Toronto General Hospital, University Health Network, Toronto, Ontario, Canada.Department of Anesthesiology and Pain Management, Toronto General Hospital, University Health Network, Toronto, Ontario, Canada.Department of Anesthesiology and Pain Management, Toronto General Hospital, University Health Network, Toronto, Ontario, Canada.Division of Respirology and Lung Transplantation, Toronto General Hospital Research Institute, University Health Network, Toronto, Ontario, Canada. Department of Medicine, University of Toronto, Toronto, Ontario, Canada.Faculty of Medicine, University of Alberta, Edmonton, Alberta, Canada.Joint Department of Medical Imaging, Toronto General Hospital, University Health Network, Toronto, Ontario, Canada.Department of Medicine, University of Toronto, Toronto, Ontario, Canada.Department of Anesthesiology and Pain Management, Toronto General Hospital, University Health Network, Toronto, Ontario, Canada. Department of Anesthesiology and Pain Medicine, University of Toronto, Toronto, Ontario, Canada.

Pub Type(s)

Journal Article
Validation Study

Language

eng

PubMed ID

33186406

Citation

Ng, William C K., et al. "Subject Validation of Reusable N95 Stop-gap Filtering Facepiece Respirators in COVID-19 Pandemic." PloS One, vol. 15, no. 11, 2020, pp. e0242304.
Ng WCK, Mbadjeu Hondjeu AR, Syrett A, et al. Subject validation of reusable N95 stop-gap filtering facepiece respirators in COVID-19 pandemic. PLoS One. 2020;15(11):e0242304.
Ng, W. C. K., Mbadjeu Hondjeu, A. R., Syrett, A., Caragata, R., Rozenberg, D., Xiao, Z., Anwari, V., Trac, J., & Mashari, A. (2020). Subject validation of reusable N95 stop-gap filtering facepiece respirators in COVID-19 pandemic. PloS One, 15(11), e0242304. https://doi.org/10.1371/journal.pone.0242304
Ng WCK, et al. Subject Validation of Reusable N95 Stop-gap Filtering Facepiece Respirators in COVID-19 Pandemic. PLoS One. 2020;15(11):e0242304. PubMed PMID: 33186406.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Subject validation of reusable N95 stop-gap filtering facepiece respirators in COVID-19 pandemic. AU - Ng,William C K, AU - Mbadjeu Hondjeu,Arnaud Romeo, AU - Syrett,Andrew, AU - Caragata,Rebecca, AU - Rozenberg,Dmitry, AU - Xiao,Zixuan, AU - Anwari,Vahid, AU - Trac,Jessica, AU - Mashari,Azad, Y1 - 2020/11/13/ PY - 2020/06/18/received PY - 2020/11/01/accepted PY - 2020/11/13/entrez PY - 2020/11/14/pubmed PY - 2020/11/24/medline SP - e0242304 EP - e0242304 JF - PloS one JO - PLoS One VL - 15 IS - 11 N2 - INTRODUCTION: The COVID-19 pandemic has unveiled widespread shortages of personal protective equipment including N95 respirators. Several centers are developing reusable stop-gap respirators as alternatives to disposable N95 respirators during public health emergencies, using techniques such as 3D-printing, silicone moulding and plastic extrusion. Effective sealing of the mask, combined with respiratory filters should achieve 95% or greater filtration of particles less than 1um. Quantitative fit-testing (QNFT) data from these stop-gap devices has not been published to date. Our team developed one such device, the "SSM", and evaluated it using QNFT. METHODS: Device prototypes were iteratively evaluated for comfort, breathability and communication, by team members wearing them for 15-30min. The fit and seal were assessed by positive and negative pressure user seal checks. The final design was then formally tested by QNFT, according to CSA standard Z94.4-18 in 40 volunteer healthcare providers. An overall fit-factor >100 is the passing threshold. Volunteers were also tested by QNFT on disposable N95 masks which had passed qualitative fit testing (QLFT) by institutional Occupational Health and Safety Department. RESULTS: The SSM scored 3.5/5 and 4/5 for comfort and breathability. The median overall harmonic mean fit-factors of disposable N95 and SSM were 137.9 and 6316.7 respectively. SSM scored significantly higher than disposable respirators in fit-test runs and overall fit-factors (p <0.0001). Overall passing rates in disposable and SSM respirators on QNFT were 65% and 100%. During dynamic runs, passing rates in disposable and SSM respirators were 68.1% and 99.4%; harmonic means were 73.7 and 1643. CONCLUSIONS: We present the design and validation of a reusable N95 stop-gap filtering facepiece respirator that can match existent commercial respirators. This sets a precedence for adoption of novel stop-gap N95 respirators in emergency situations. SN - 1932-6203 UR - https://www.unboundmedicine.com/medline/citation/33186406/Subject_validation_of_reusable_N95_stop_gap_filtering_facepiece_respirators_in_COVID_19_pandemic_ L2 - https://dx.plos.org/10.1371/journal.pone.0242304 DB - PRIME DP - Unbound Medicine ER -