Objective To develop and test a new reusable, sterilisable N95 filtering facepiece respirator (FFR)-comparable face mask, known as the Injection Molded Autoclavable, Scalable, Conformable (iMASC) system, given the dire need for personal protective equipment within healthcare settings during the COVID-19 pandemic.
Design Single-arm feasibility study.
Setting Emergency department and outpatient oncology clinic.
Participants Healthcare workers who have previously undergone N95 fit testing.
Interventions Fit testing of new iMASC system.
Primary and secondary outcome measures Primary outcome is success of fit testing using an Occupational Safety and Health Administration (OSHA)-approved testing method, and secondary outcomes are user experience with fit, breathability and filter replacement.
Results Twenty-four subjects were recruited to undergo fit testing, and the average age of subjects was 41 years (range of 21–65 years) with an average body mass index of 26.5 kg/m2. The breakdown of participants by profession was 46% nurses (n=11), 21% attending physicians (n=5), 21% resident physicians (n=5) and 12% technicians (n=3). Of these participants, four did not perform the fit testing due to the inability to detect saccharin solution on premask placement sensitivity test, lack of time and inability to place mask over hair. All participants (n=20) who performed the fit test were successfully fitted for the iMASC system using an OSHA-approved testing method. User experience with the iMASC system, as evaluated using a Likert scale with a score of 1 indicating excellent and a score of 5 indicating very poor, demonstrated an average fit score of 1.75, breathability of 1.6, and ease of replacing the filter on the mask was scored on average as 2.05.
Conclusions The iMASC system was shown to successfully fit multiple different face sizes and shapes using an OSHA-approved testing method. These data support further certification testing needed for use in the healthcare setting.
- public health
- respiratory medicine (see thoracic medicine)
- respiratory infections
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JDB, AJW, PRC and H-WH contributed equally.
Contributors JDB and AJW designed and fabricated the iMASC system, assisted with the clinical trial, analysed and interpreted data, and wrote the manuscript. PRC performed the clinical trial, analysed and interpreted data, and wrote the manuscript. H-WH and SB designed the face scanning and performed FE analysis modelling, analysed data and wrote the manuscript. SB, CT and SM analysed data and designed prototypes. GT supervised, reviewed the data and edited the manuscript.
Funding This work was supported in part by the Prostate Cancer Foundation. JDB was supported by the Prostate Cancer Foundation Young Investigator Award. GT was supported in part by the Department of Mechanical Engineering, MIT, and Brigham and Women’s Hospital. PRC was supported by NIHK23DA044874, and investigator-initiated research grants from e-ink, Gilead Sciences, Philips Biosensing and the Hans and Mavis Lopater Psychosocial Foundation. Support for the materials and supplies was from discretionary funds to GT from Brigham and Women’s Hospital and the Department of Mechanical Engineering, MIT.
Competing interests None declared.
Patient and public involvement Patients and/or the public were not involved in the design, conduct, reporting or dissemination plans of this research.
Patient consent for publication Not required.
Ethics approval Partners Healthcare Institutional Review Board (IRB) approval was obtained prior to any human testing of the iMASC system (Partners IRB 2020P000852).
Provenance and peer review Not commissioned; externally peer reviewed.
Data availability statement Data are available in a public, open access repository. The authors declare that the data supporting the findings of this study are available within the paper and its supplementary information files.
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