Respirators in Healthcare: Material, Design, Regulatory, Environmental, and Economic Considerations for Clinical Efficacy.

Maintaining an ample supply of personal protective equipment continues to be a challenge for the healthcare industry, especially during emergency situations and times of strain on the supply chain. Most critically, healthcare workers exposed to potential airborne hazards require sufficient respiratory protection. Respirators are the only type of personal protective equipment able to provide adequate respiratory protection. However, their ability to shield hazards depends on design, material, proper fit, and environmental conditions. As a result, not all respirators may be adequate for all scenarios. Additionally, factors including user comfort, ease of use, and cost contribute to respirator effectiveness. Therefore, a careful consideration of these parameters is essential for ensuring respiratory protection for those working in the healthcare industry. Here respirator design and material characteristics are reviewed, as well as properties of airborne hazards and potential filtration mechanisms, regulatory standards of governmental agencies, respirator efficacy in the clinical setting, attitude of healthcare personnel toward respiratory protection, and environmental and economic considerations of respirator manufacturing and distribution.

Patient and Health Care Worker Perceptions of Communication and Ability to Identify Emotion When Wearing Standard and Transparent Masks.

Importance: Adoption of mask wearing in response to the COVID-19 pandemic alters daily communication. Objective: To assess communication barriers associated with mask wearing in patient-clinician interactions and individuals who are deaf and hard of hearing. Design, Setting, and Participants: This pilot cross-sectional survey study included the general population, health care workers, and health care workers who are deaf or hard of hearing in the United States. Volunteers were sampled via an opt-in survey panel and nonrandomized convenience sampling. The general population survey was conducted between January 5 and January 8, 2021. The health care worker surveys were conducted between December 3, 2020, and January 3, 2021. Respondents viewed 2 short videos of a study author wearing both a standard and transparent N95 mask and answered questions regarding mask use, communication, preference, and fit. Surveys took 15 to 20 minutes to complete. Main Outcomes and Measures: Participants' perceptions were assessed surrounding the use of both mask types related to communication and the ability to express emotions. Results: The national survey consisted of 1000 participants (mean [SD] age, 48.7 [18.5] years; 496 [49.6%] women) with a response rate of 92.25%. The survey of general health care workers consisted of 123 participants (mean [SD] age, 49.5 [9.0] years; 84 [68.3%] women), with a response rate of 11.14%. The survey of health care workers who are deaf or hard of hearing consisted of 45 participants (mean [SD] age, 54.5 [9.0] years; 30 [66.7%] women) with a response rate of 23.95%. After viewing a video demonstrating a study author wearing a transparent N95 mask, 781 (78.1%) in the general population, 109 general health care workers (88.6%), and 38 health care workers who are deaf or hard of hearing (84.4%) were able to identify the emotion being expressed, in contrast with 201 (20.1%), 25 (20.5%), and 11 (24.4%) for the standard opaque N95 mask. In the general population, 450 (45.0%) felt positively about interacting with a health care worker wearing a transparent mask; 76 general health care workers (61.8%) and 37 health care workers who are deaf or hard of hearing (82.2%) felt positively about wearing a transparent mask to communicate with patients. Conclusions and Relevance: The findings of this study suggest that transparent masks could help improve communication during the COVID-19 pandemic, particularly for individuals who are deaf and hard of hearing.

Thinking green: modelling respirator reuse strategies to reduce cost and waste.

OBJECTIVES: To compare the impact of respirator extended use and reuse strategies with regard to cost and sustainability during the COVID-19 pandemic. DESIGN: Cost analysis. SETTING: USA. PARTICIPANTS: All healthcare workers within the USA. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: A model was developed to estimate usage, costs and waste incurred by several respirator usage strategies over the first 6 months of the pandemic in the USA. This model assumed universal masking of all healthcare workers. Estimates were taken from the literature, government databases and commercially available data from approved vendors. RESULTS: A new N95 respirator per patient encounter would require 7.41 billion respirators, cost $6.38 billion and generate 84.0 million kg of waste in the USA over 6 months. One respirator per day per healthcare worker would require 3.29 billion respirators, cost $2.83 billion and generate 37.22 million kg of waste. Decontamination by ultraviolet germicidal irradiation would require 1.64 billion respirators, cost $1.41 billion and accumulate 18.61 million kg of waste. H2O2 vapour decontamination would require 1.15 billion respirators, cost $1.65 billion and produce 13.03 million kg of waste. One reusable respirator with daily disposable filters would require 18 million respirators, cost $1.24 billion and generate 15.73 million kg of waste. Pairing a reusable respirator with H2O2 vapour-decontaminated filters would reduce cost to $831 million and generate 1.58 million kg of waste. The use of one surgical mask per healthcare worker per day would require 3.29 billion masks, cost $460 million and generate 27.92 million kg of waste. CONCLUSIONS: Decontamination and reusable respirator-based strategies decreased the number of respirators used, costs and waste generated compared with single-use or daily extended-use of disposable respirators. Future development of low-cost,simple technologies to enable respirator and/or filter decontamination is needed to further minimise the economic and environmental costs of masks.

Prospective Evaluation of the Transparent, Elastomeric, Adaptable, Long-Lasting (TEAL) Respirator.

N95 filtering facepiece respirators (FFR) and surgical masks are essential in reducing airborne disease transmission, particularly during the COVID-19 pandemic. However, currently available FFR's and masks have major limitations, including masking facial features, waste, and integrity after decontamination. In a multi-institutional trial, we evaluated a transparent, elastomeric, adaptable, long-lasting (TEAL) respirator to evaluate success of qualitative fit test with user experience and biometric evaluation of temperature, respiratory rate, and fit of respirator using a novel sensor. There was a 100% successful fit test among participants, with feedback demonstrating excellent or good fit (90% of participants), breathability (77.5%), and filter exchange (95%). Biometric testing demonstrated significant differences between exhalation and inhalation pressures among a poorly fitting respirator, well-fitting respirator, and the occlusion of one filter of the respirator. We have designed and evaluated a transparent elastomeric respirator and a novel biometric feedback system that could be implemented in the hospital setting.

Injection Molded Autoclavable, Scalable, Conformable (iMASC) system for aerosol-based protection: a prospective single-arm feasibility study.

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.