Reducing Leak and Increasing Comfort of an N95 Filtering Facepiece Respirator for Aged-Care Workers Using a Customized, Soft, and Compliant Mask Frame

This prospective cohort study examines the quantitative fit-factor and tolerability impact of a novel custom frame designed to fit beneath N95 filtering facepiece respirators (FFRs) in a healthcare setting. Conducted at a medium-sized metropolitan residential aged care facility (RACF) in South Australia, sixty participants underwent quantitative fit testing while wearing institutional-provided N95 FFRs. Utilizing three-dimensional (3D) face scanning with a proprietary iPhone app, personalized frames were created using flexible silicone foam with a rigid plastic interior “backbone” to ensure compliance and comfort. Following the fitting of custom frames, participants underwent repeat quantitative fit testing using the same style and size of N95 FFRs. Results indicate a remarkable improvement, with 81.5% of participants achieving a pass on quantitative fit testing when using their custom frame in conjunction with the N95 FFRs, compared to a baseline pass rate of only 21.7% (odds ratio (OR) 20.9, 95% confidence interval (CI): 8.26, 58.50, p < 0.001 via logistic regression). Additionally, participants reported a 2.4 times higher level of tolerability when wearing the custom frame with their N95 FFRs compared to using FFRs alone (p < 0.001). In conclusion, the study demonstrates that wearing a customized frame device under an N95 FFR significantly enhances the likelihood of achieving a pass on quantitative fitting and offers a substantially more tolerable experience for wearers. These findings highlight the potential of personalized frame devices to improve respiratory protection efficacy and wearer comfort in healthcare settings.