Dataset Information

Rapid prototyping and clinical testing of a reusable face shield for health care workers responding to the COVID-19 pandemic.

ABSTRACT: Due to supply chain disruption, the COVID-19 pandemic has caused severe shortages in personal protective equipment (PPE) for health care professionals. Local fabrication based on 3D printing is one way to address this challenge, particularly in the case of simple products such as protective face shields. As a consequence, many public domain designs for face shields have become available. No clear path exists, however, for introducing a locally fabricated and unapproved product into a clinical setting. In a US health care setting, face shields are regulated by the Food and Drug Administration (FDA); similar policies exist in other countries. We describe a research protocol under which rapid iteration on an existing design, coupled with clinical feedback and real-world testing in an emergency department, allowed a face shield to be adopted by the incident command team at a major academic medical center. We describe our design and testing process and provide an overview of regulatory considerations associated with fabrication and testing of face shields and related products. All designs, materials used, testing protocols, and survey results are reported in full to facilitate the execution of similar face shield efforts in other clinical settings. Our work serves as a case study for development of a robust local response to pandemics and other health care emergencies, with implications for healthcare professionals, hospital administrators, regulatory agencies and concerned citizens.

SUBMITTER: Mostaghimi A

PROVIDER: S-EPMC7276039 | biostudies-literature | 2020 Apr

REPOSITORIES: biostudies-literature

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Rapid prototyping and clinical testing of a reusable face shield for health care workers responding to the COVID-19 pandemic.

Mostaghimi Arash A Antonini M-J MJ Plana Deborah D Anderson Philip D PD Beller Brandon B Boyer Edward W EW Fannin Amber A Freake Jacob J Oakley Richard R Sinha Michael S MS Smith Leanne L Van Christopher C Yang Helen H Sorger Peter K PK LeBoeuf Nicole R NR Yu Sherry H SH

medRxiv : the preprint server for health sciences 20200415

Due to supply chain disruption, the COVID-19 pandemic has caused severe shortages in personal protective equipment (PPE) for health care professionals. Local fabrication based on 3D printing is one way to address this challenge, particularly in the case of simple products such as protective face shields. As a consequence, many public domain designs for face shields have become available. No clear path exists, however, for introducing a locally fabricated and unapproved product into a clinical se ...[more]

PMID: 32511612

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Project description:During the coronavirus disease-19 pandemic, the demand for specific medical equipment such as personal protective equipment has rapidly exceeded the available supply around the world. Specifically, simple medical equipment such as medical gloves, aprons, goggles, surgery masks, and medical face shields have become highly in demand in the health-care sector in the face of this rapidly developing pandemic. This difficult period strengthens the social solidarity to an extent parallel to the escalation of this pandemic. Education and government institutions, commercial and noncommercial organizations and individual homemakers have produced specific medical equipment by means of additive manufacturing (AM) technology, which is the fastest way to create a product, providing their support for urgent demands within the health-care services. Medical face shields have become a popular item to produce, and many design variations and prototypes have been forthcoming. Although AM technology can be used to produce several types of noncommercial equipment, this rapid manufacturing approach is limited by its longer production time as compared to conventional serial/mass production and the high demand. However, most of the individual designer/maker-based face shields are designed with little appreciation of clinical needs and nonergonomic. They also lack of professional product design and are not designed according to AM (Design for AM [DfAM]) principles. Consequently, the production time of up to 4 - 5 h for some products of these designs is needed. Therefore, a lighter, more ergonomic, single frame medical face shield without extra components to assemble would be useful, especially for individual designers/makers and noncommercial producers to increase productivity in a shorter timeframe. In this study, a medical face shield that is competitively lighter, relatively more ergonomic, easy to use, and can be assembled without extra components (such as elastic bands, softening materials, and clips) was designed. The face shield was produced by AM with a relatively shorter production time. Subsequently, finite element analysis-based structural design verification was performed, and a three-dimensional (3D) prototype was produced by an original equipment manufacturer 3D printer (Fused Deposition Modeling). This study demonstrated that an original face shield design with <10 g material usage per single frame was produced in under 45 min of fabrication time. This research also provides a useful product DfAM of simple medical equipment such as face shields through advanced engineering design, simulation, and AM applications as an essential approach to battling coronavirus-like viral pandemics.

Project description:IntroductionThe COVID-19 pandemic has led to widespread shortages of N95 respirators and other personal protective equipment (PPE). An effective, reusable, locally-manufactured respirator can mitigate this problem. We describe the development, manufacture, and preliminary testing of an open-hardware-licensed device, the "simple silicone mask" (SSM).MethodsA multidisciplinary team developed a reusable silicone half facepiece respirator over 9 prototype iterations. The manufacturing process consisted of 3D printing and silicone casting. Prototypes were assessed for comfort and breathability. Filtration was assessed by user seal checks and quantitative fit-testing according to CSA Z94.4-18.ResultsThe respirator originally included a cartridge for holding filter material; this was modified to connect to standard heat-moisture exchange (HME) filters (N95 or greater) after the cartridge showed poor filtration performance due to flow acceleration around the filter edges, which was exacerbated by high filter resistance. All 8 HME-based iterations provided an adequate seal by user seal checks and achieved a pass rate of 87.5% (N = 8) on quantitative testing, with all failures occurring in the first iteration. The overall median fit-factor was 1662 (100 = pass). Estimated unit cost for a production run of 1000 using distributed manufacturing techniques is CAD $15 in materials and 20 minutes of labor.ConclusionSmall-scale manufacturing of an effective, reusable N95 respirator during a pandemic is feasible and cost-effective. Required quantities of reusables are more predictable and less vulnerable to supply chain disruption than disposables. With further evaluation, such devices may be an alternative to disposable respirators during public health emergencies. The respirator described above is an investigational device and requires further evaluation and regulatory requirements before clinical deployment. The authors and affiliates do not endorse the use of this device at present.

Project description:BackgroundThe ability of individuals to use HIV self-tests correctly is debated. To inform the 2016 WHO recommendation on HIV self-testing, we assessed the reliability and performance of HIV rapid diagnostic tests when used by self-testers.MethodsIn this systematic review and meta-analysis, we searched PubMed, PopLine, and Embase, conference abstracts, and additional grey literature between Jan 1, 1995, and April 30, 2016, for observational and experimental studies reporting on HIV self-testing performance. We excluded studies evaluating home specimen collection because patients did not interpret their own test results. We extracted data independently, using standardised extraction forms. Outcomes of interest were agreement between self-testers and health-care workers, sensitivity, and specificity. We calculated κ to establish the level of agreement and pooled κ estimates using a random-effects model, by approach (directly assisted or unassisted) and type of specimen (blood or oral fluid). We examined heterogeneity with the I2 statistic.Findings25 studies met inclusion criteria (22 to 5662 participants). Quality assessment with QUADAS-2 showed studies had low risk of bias and incomplete reporting in accordance with the STARD checklist. Raw proportion of agreement ranged from 85·4% to 100%, and reported κ ranged from fair (κ 0·277, p<0·001) to almost perfect (κ 0·99, n=25). Pooled κ suggested almost perfect agreement for both types of approaches (directly assisted 0·98, 95% CI 0·96-0·99 and unassisted 0·97, 0·96-0·98; I2=34·5%, 0-97·8). Excluding two outliers, sensitivity and specificity was higher for blood-based rapid diagnostic tests (4/16) compared with oral fluid rapid diagnostic tests (13/16). The most common error that affected test performance was incorrect specimen collection (oral swab or finger prick). Study limitations included the use of different reference standards and no disaggregation of results by individuals taking antiretrovirals.InterpretationSelf-testers can reliably and accurately do HIV rapid diagnostic tests, as compared with trained health-care workers. Errors in performance might be reduced through the improvement of rapid diagnostic tests for self-testing, particularly to make sample collection easier and to simplify instructions for use.FundingThe Bill & Melinda Gates Foundation and Unitaid.

Dataset Information

Rapid prototyping and clinical testing of a reusable face shield for health care workers responding to the COVID-19 pandemic.

Publications

Rapid prototyping and clinical testing of a reusable face shield for health care workers responding to the COVID-19 pandemic.

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