Abstract

The ongoing COVID-19 pandemic has revealed alarming shortages of personal protective equipment for frontline healthcare professionals and the general public. Therefore, a 3D-printable mask frame was developed, and its air seal performance was evaluated and compared. Personalized masks (PM) based on individual face scans (n = 8) and a statistically shaped mask (SSM) based on a standardized facial soft tissue shape computed from 190 face scans were designed. Subsequently, the masks were additively manufactured, and in a second step, the PM and SSM were compared to surgical masks (SM) and FFP2 masks (FFP2) in terms of air seal performance. 3D-printed face models allowed for air leakage evaluation by measuring the pressure inside the mask in sealed and unsealed conditions during a breathing simulation. The PM demonstrated the lowest leak flow (p < 0.01) of inspired or expired unfiltered air of approximately 10.4 ± 16.4%, whereas the SM showed the highest (p < 0.01) leakage with 84.9 ± 7.7%. The FFP2 and SSM had similar values of 34.9 ± 18.5% leakage (p > 0.68). The developed framework allows for the time- and resource-efficient, on-demand, and in-house production of masks. For the best seal performance, an individually personalized mask design might be recommended.

Highlights

  • The ongoing COVID-19 pandemic has revealed alarming shortages of personal protective equipment for frontline healthcare professionals and the general public

  • The ongoing COVID-19 pandemic continues to spread around the world, and healthcare systems still face an associated increased need for personal protective equipment (PPE)

  • The Personalized masks (PM) revealed the best seal performance, with a leak flow of inspired or expired unfiltered air of approximately 10.4 ± 16.4% (p < 0.01)

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Summary

Introduction

The ongoing COVID-19 pandemic has revealed alarming shortages of personal protective equipment for frontline healthcare professionals and the general public. The ongoing COVID-19 pandemic continues to spread around the world, and healthcare systems still face an associated increased need for personal protective equipment (PPE). Both healthcare professionals and the general public are faced with a critical shortage of PPE, face m­ asks[1,2]. While FFP2/N95 respirators use melt-blown fabric and inserts to improve the fit around the nose, their elastic straps result in a tighter face seal and an improved fit and filtering p­ erformance[9]. The protection level of respirators is assessed by evaluating the filtration efficiency, face seal leakage and fit factors as well as additional national standards defined by the ASTM. N95 respirators (corresponding to the FFP2 standard) and N99 respirators (corresponding to the FFP3 standard) meet the standards required for protection against aerosol and droplet ­transmission[14]

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