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Correctly fitting N95 filtering facepiece respirators (FFRs) have become increasingly important in health care throughout the COVID-19 pandemic. We evaluated the hypothesis that personalized 3D-printed frames could improve N95 FFRs quantitative fit test pass rates and test scores in health care workers (HCWs). HCWs were recruited at a tertiary hospital in Adelaide, Australia (ACTRN 12622000388718). A mobile iPhone camera + app was used to produce 3D scans of volunteers’ faces, which were then imported into a software program to produce personalized virtual scaffolds suited to each user’s face and their unique anatomical features. These virtual scaffolds were printed on a commercially available 3D printer, producing plastic (and then silicone-coated, biocompatible) frames that can be fitted inside existing hospital supply N95 FFR. The primary endpoint was improved pass rates on quantitative fit testing, comparing participants wearing an N95 FFR alone (control 1) with participants wearing the frame + N95 FFR (intervention 1). The secondary endpoint was the fit factor (FF) in these groups, and R-COMFI respirator comfort and tolerability survey scores.  N  = 66 HCWs were recruited. The use of intervention 1 increased overall fit test pass rates to 62/66 (93.8%), compared to 27/66 (40.9%) for control s . (OR for pFF pass 20.89 (95%CI: 6.77, 64.48,  p  &lt; 0.001.) Average FF increased, with the use of intervention 1–179.0 (95%CI: 164.3,193.7), compared to 85.2 (95%CI: 70.4,100.0) with control 1. Pass rates and FF were improved with intervention 1 compared to control 1 for all stages of the fit-test: bending, talking, side-to-side, and up-down motion. ( p  &lt; 0.001 all stages). Tolerability and comfort of the frame were evaluated with the validated R-COMFI respirator comfort score, showing improvement with the frame compared to N95 FFR alone ( p  = 0.006). Personalized 3D-printed face frames decrease leakage, improve fit testing pass rates and FF, and provide improved comfort compared to the N95 FFR alone. Personalized 3D-printed face frames represent a rapidly scalable new technology to decrease FFR leakage in HCW and potentially the wider population.

Personalized 3D-printed frames to reduce leak from N95 filtering facepiece respirators: A prospective crossover trial in health care workers