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De Novo Powered Air-Purifying Respirator Design and Fabrication for Pandemic Response.

ABSTRACT: The rapid spread of COVID-19 and disruption of normal supply chains has resulted in severe shortages of personal protective equipment (PPE), particularly devices with few suppliers such as powered air-purifying respirators (PAPRs). A scarcity of information describing design and performance criteria for PAPRs represents a substantial barrier to mitigating shortages. We sought to apply open-source product development (OSPD) to PAPRs to enable alternative sources of supply and further innovation. We describe the design, prototyping, validation, and user testing of locally manufactured, modular, PAPR components, including filter cartridges and blower units, developed by the Greater Boston Pandemic Fabrication Team (PanFab). Two designs, one with a fully custom-made filter and blower unit housing, and the other with commercially available variants (the "Custom" and "Commercial" designs, respectively) were developed; the components in the Custom design are interchangeable with those in Commercial design, although the form factor differs. The engineering performance of the prototypes was measured and safety validated using National Institutes for Occupational Safety and Health (NIOSH)-equivalent tests on apparatus available under pandemic conditions at university laboratories. Feedback was obtained from four individuals; two clinicians working in ambulatory clinical care and two research technical staff for whom PAPR use is standard occupational PPE; these individuals were asked to compare PanFab prototypes to commercial PAPRs from the perspective of usability and suggest areas for improvement. Respondents rated the PanFab Custom PAPR a 4 to 5 on a 5 Likert-scale 1) as compared to current PPE options, 2) for the sense of security with use in a clinical setting, and 3) for comfort compared to standard, commercially available PAPRs. The three other versions of the designs (with a Commercial blower unit, filter, or both) performed favorably, with survey responses consisting of scores ranging from 3 to 5. Engineering testing and clinical feedback demonstrate that the PanFab designs represent favorable alternatives to traditional PAPRs in terms of user comfort, mobility, and sense of security. A nonrestrictive license promotes innovation in respiratory protection for current and future medical emergencies.

SUBMITTER: Kothakonda A

PROVIDER: S-EPMC8450396 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BackgroundThe design of personal protective equipment (PPE) may affect well-being and clinical work. PPE as an integrated item may improve usability and increase adherence by healthcare professionals. Human factors design and safety may reduce occupational-acquired diseases. As an integrated PPE, a lightweight protective air-purifying respirator (L-PAPR) could be used during health procedures where healthcare professionals are exposed to airborne pathogens. The human factors affecting the implementation of alternative PPE such as L-PAPR have not been thoroughly studied. The population of interest is health care professionals, the intervention is the performance by PPE during tasks across the three PPE types 1.) N95 respirators and face shields, 2.)traditional powered air-purifying respirator(PAPR), and 3.) L-PAPR. The outcomes are user error, communications, safety, and end-user preferences.ObjectiveThis study will assess whether the L-PAPR improves health care professionals' comfort in terms of perceived workload and physical and psychological burden during direct patient care when compared with the traditional PAPR or N95 and face shield. This study also aims to evaluate human factors during the comparison of the use of L-PAPR with a combination of N95 respirators plus face shields or the traditional PAPRs.MethodsThis is an interventional randomized crossover quality improvement feasibility study consisting of a 3-site simulation phase with 10 participants per site and subsequent field testing in 2 sites with 30 participants at each site. The 3 types of respiratory PPE will be compared across medical tasks and while donning and doffing. We will evaluate the user's perceived workload, usability, usage errors, and heart rate. We will conduct semistructured interviews to identify barriers and enablers to implementation across each PPE type over a single continuous wear episode and observe interpersonal communications across conditions and PPE types.ResultsWe expect the research may highlight communication challenges and differences in usability and convenience across PPE types along with error frequency during PPE use across PPE types, tasks, and time.ConclusionsThe design of PPE may affect overall well-being and hinder or facilitate clinical work. Combining 2 pieces of PPE into a single integrated item may improve usability and reduce occupational-acquired diseases. The human factors affecting the implementation of an alternative PPE such as L-PAPR or PAPR have not been thoroughly studied.International registered report identifier (irrid)PRR1-10.2196/36549.

Project description:BackgroundHealthcare workers (HCWs) are at particular risk during pandemics and epidemics of highly virulent diseases with significant morbidity and case fatality rate. These diseases include severe acute respiratory syndrome coronaviruses, SARS-CoV-1 and SARS-CoV-2, Middle Eastern Respiratory Syndrome (MERS), and Ebola. With the current (SARS-CoV-2) global pandemic, it is critical to delineate appropriate contextual respiratory protection for HCWs. The aim of this systematic review was to evaluate the effect of powered air-purifying respirators (PAPRs) as part of respiratory protection versus another device (egN95/FFP2) on HCW infection rates and contamination.MethodsOur primary outcomes included HCW infection rates with SARS-CoV-2, SARS-CoV-1, Ebola, or MERS when utilizing PAPR. We included randomized controlled trials, non-randomized controlled trials, and observational studies. We searched the following databases: MEDLINE, EMBASE, and Cochrane Library (Cochrane Database of Systematic Reviews and CENTRAL). Two reviewers independently screened all citations, full-text articles, and abstracted data. Due to clinical and methodological heterogeneity, we did not conduct a meta-analysis. Where applicable, we constructed evidence profile (EP) tables for each individual outcome. Confidence in cumulative evidence for each outcome was classified according to the GRADE system.ResultsWe identified 689 studies during literature searches. We included 10 full-text studies. A narrative synthesis was provided. Two on-field studies reported no difference in the rates of healthcare workers performing airway procedures during the care of critical patients with SARS-CoV-2. A single simulation trial reported a lower level of cross-contamination of participants using PAPR compared to alternative respiratory protection. There is moderate quality evidence that PAPR use is associated with greater heat tolerance but lower scores for mobility and communication ability. We identified a trend towards greater self-reported wearer comfort with PAPR technology in low-quality observational simulation studies.ConclusionField observational studies do not indicate a difference in healthcare worker infection utilizing PAPR devices versus other compliant respiratory equipment. Greater heat tolerance accompanied by lower scores of mobility and audibility in PAPR was identified. Further pragmatic studies are needed in order to delineate actual effectiveness and provider satisfaction with PAPR technology.Systematic review registrationThe protocol for this review was prospectively registered with the International Register of Systematic Reviews identification number CRD42020184724 .

Project description:An ASTM International subcommittee on Respiratory Protection, F23.65 is currently developing a consensus standard for assessing respirator fit capability (RFC) criteria of half-facepiece air-purifying particulate respirators. The objective of this study was to evaluate if the test methods being developed for half-facepiece respirators can reasonably be applied to nonpowered full-facepiece-air-purifying respirators (FF-APR). Benchmark RFC test data were collected for three families of FF-APRs (a one-size-only family, a two-size family, and a three-size family). All respirators were equipped with P100 class particulate filters. Respirators were outfitted with a sampling probe to collect an in-mask particle concentration sample in the breathing zone of the wearer. Each of the six respirator facepieces was tested on the National Institute for Occupational Safety and Health 25-subject Bivariate Panel. The RFC test assessed face seal leakage using a PortaCount fit test. Subjects followed the corresponding Occupational Safety and Health Administration-accepted fit test protocol. Two donnings per subject/respirator model combination were performed. The panel passing rate (PPR) (number or percentage of subjects in the panel achieving acceptable fit on at least one of two donnings) was determined for each respirator family at specified fit factor passing levels of 500, 1,000, and 2,000. As a reasonable expectation based on a previous analysis of alpha and beta fit test errors for various panel sizes, the selected PPR benchmark for our study was >75%. At the fit factor passing level of 500 obtained on at least one of two donnings, the PPRs for three-, two-, and one-size families were 100, 79, and 88%, respectively. As the fit factor passing criterion increased from 500 to 1,000 or 2,000, PPRs followed a decreasing trend. Each of the three tested families of FF-APRs are capable of fitting ?75% of the intended user population at the 500 fit factor passing level obtained on at least one of two donnings. The methods presented here can be used as a reference for standards development organizations considering developing RFC test requirements.

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De Novo Powered Air-Purifying Respirator Design and Fabrication for Pandemic Response.

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