The demand for disposable respiratory protective devices needed to protect health care personnel may exceed supply during large outbreaks of respiratory infectious diseases.1,2 Concerns are growing over global shortages of respiratory protective devices during the novel coronavirus disease 2019 (COVID-19) pandemic.3 A reusable alternative to N95 respirators for which health care personnel can be rapidly assessed for fit (fit testing) and trained for use is needed. Elastomeric half-mask respirators (EHMRs), which provide the same level of respiratory protection as N95 respirators, are one alternative4 (eFigure in Supplement 1). These reusable respirators are used in construction and manufacturing, but not widely used in health care4 because of uncertainty about disinfection methods and upfront costs.5 The goal of this demonstration study was to test the feasibility of rapidly training and fit testing health care workers to EHMRs.
In 2019, 2 US health care organizations (Emory University and University of Texas Health [UTHealth] Science Center at Houston) conducted an outbreak simulation in which health care personnel, who were randomized to EHMR (80%) or N95 (20%) groups, were rapidly fit tested and trained. The institutional review boards at UTHealth, Baylor College of Medicine, and Emory University approved this study. Written informed consent was obtained at recruitment. Fit testing was performed to assess respirator fit to face, checking for leaks, using an Occupational Safety and Health Administration qualitative fit testing process.6 The number of fit testing attempts and testing time were recorded. Both groups were trained using a 9-minute video. The EHMR group was assessed 3 times consecutively for 26 performance indicators in the following 6 key areas: (1) inspection, (2) donning, (3) positive-pressure user seal check, (4) negative-pressure user seal check, (5) doffing, and (6) disinfection. Trainers scored participants based on the degree of assistance needed to complete each step (1 indicated physical assistance; 2, verbal assistance; 3, no assistance). A total score for each area consisted of a sum of 4 or 6 individual performance indicators (3 points each) ranging from 12 or 18, with a possible overall score of 78 points. Mean differences for time to completion of fit testing between groups was calculated using t tests, differences in the number of attempts to achieve proper fit were calculated using χ2 tests, and ANOVA with post hoc and 2-sided pairwise comparisons were used to compare EHMR performance scores by attempts with α = .05. No sample size calculation was performed. Additional details are available in the protocol (Supplement 2). Analyses were conducted using SPSS, version 25.
Of 193 health care personnel randomized, 153 (79%) participated in the study (124 in the EHMR group and 29 in the N95 group) (Table 1). The majority of participants were women (77%), with a mean age of 38 years. Overall, 87% of participants had at least 1 year of experience wearing a respiratory protective device; 9.7% of participants in the EHMR group vs 27.6% in the N95 group had no prior experience. Few participants (1.3%) had prior experience using an EHMR.
In the EHMR group, 92.2% passed fit testing during the first attempt compared with 88.5% in the N95 group (P = .76); all participants passed by the third attempt. The mean time to complete fit testing for the EHMR group, including total number of attempts (6 min 47 s), was not significantly different than the N95 group (6 min 29 s) (difference, 0 min 18 s [95% CI, −0 min 31 s to 1 min 6 s]; P = .48). Participants’ performance scores for EHMR use significantly improved from the first to second attempts overall and in all areas, with a significant improvement from the second to third attempt in 1 area (Table 2).
This study found that health care personnel can be rapidly fit tested and trained to use the reusable EHMR. Time to achieve fit with EHMRs was not significantly different than with N95 respirators. High EHMR performance was demonstrated. EHMR participants had prior experience using other forms of respiratory protection, which may have influenced their high performance. Limitations include the simulated emergency, small number of participants, and lack of data on actual use of EHMRs. No information was available to inform sample size calculations; P values may not be meaningful. Better understanding about the efficacy and feasibility of disinfection methods are key. Combined with an Occupational Safety and Health Administration respiratory protection program,6 the EHMR may serve as a suitable alternative to disposable N95 respirators during public health emergencies.
Corresponding Author: Lisa A. Pompeii, PhD, Department of Pediatrics, Center for Epidemiology & Population Health, Baylor College of Medicine, 1 Baylor Plaza, BCM 622, Houston, TX 77030-3411 (firstname.lastname@example.org)
Published Online: March 25, 2020. doi:10.1001/jama.2020.4806
Author Contributions: Dr Radonovich had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.
Concept and design: Pompeii, Kraft, Brownsword, Rios, Radonovich.
Acquisition, analysis, or interpretation of data: All authors.
Drafting of the manuscript: Pompeii, Kraft, Brownsword, Lane, Rios, Radonovich.
Critical revision of the manuscript for important intellectual content: Pompeii, Kraft, Brownsword, Benavides, Rios, Radonovich.
Statistical analysis: Kraft, Brownsword, Lane, Benavides.
Obtained funding: Pompeii, Brownsword, Radonovich.
Administrative, technical, or material support: Pompeii, Kraft, Brownsword, Rios, Radonovich.
Supervision: Pompeii, Brownsword, Rios, Radonovich.
Conflict of Interest Disclosures: Dr Pompeii reported receiving grants from the Centers for Disease Control and Prevention during the conduct of the study. Dr Kraft reported receiving grants from the National Institute for Occupational Safety and Health during the conduct of the study and serving on a scientific advisory board for Rebiotix outside the submitted work. Dr Lane reported receiving grants from the Centers for Disease Control and Prevention during the conduct of the study. Dr Benavides reported receiving grants from the Centers for Disease Control and Prevention during the conduct of the study. No other disclosures were reported.
Funding/Support: This study was funded by the Centers for Disease Control and Prevention’s National Personal Protective Technology Laboratory (contract numbers 75D30118C02646 and 75D30118C02645).
Role of the Funder/Sponsor: Members of the study team employed by the National Institute of Occupational Safety and Health at the Centers for Disease Control and Prevention (the funding organization) contributed to the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication. Scientists at the Centers for Disease Control and Prevention (the funding organization) who were not members of the study team reviewed and approved the manuscript for publication. The funding organization did not participate in data collection or management of the study.
Disclaimer: The findings and conclusions in this report are those of the author(s) and do not necessarily represent the official position of the National Institute for Occupational Safety and Health, Centers for Disease Control and Prevention. Mention of specific products does not imply endorsement.
Additional Contributions: Patrick L. Yorio, PhD, provided statistical support for these analyses. He is affiliated with and funded by the National Personal Protective Technology Laboratory, National Institute for Occupational Safety and Health, Centers for Disease Control and Prevention.
Additional Information: This study was registered with ClinicalTrials.gov (NCT03888898). Institutional review board approval was provided by the University of Texas Health Science Center (HSC-18-0834), Baylor College of Medicine (H-46459), and Emory University (109854).
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