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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.
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Subject validation of reusable N95 stop-gap filtering facepiece respirators in COVID-19 pandemic
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