Rapid prototyping and clinical testing of a reusable face shield for health care workers responding to the COVID-19 pandemic
Author(s)Mostaghimi, Arash; Antonini, Marc-Joseph; Plana, Deborah; Anderson, Philip D; Beller, Brandon; Boyer, Edward W; Fannin, Amber; Freake, Jacob; Oakley, Richard; Sinha, Michael S; Smith, Leanne; Van, Christopher; Yang, Helen; Sorger, Peter K; LeBoeuf, Nicole R; Yu, Sherry H; ... Show more Show less
Regulatory and Safety Considerations in Deploying a Locally Fabricated, Reusable Face Shield in a Hospital Responding to the COVID-19 Pandemic
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Due to supply chain disruption, the COVID-19 pandemic has caused severe shortages in personal protective equipment for health care professionals. Local fabrication based on 3D printing is one way to address this challenge, particularly in the case of products such as protective face shields. No clear path exists, however, for introducing a locally fabricated product into a clinical setting. Methods: We describe a research protocol under Institutional Review Board supervision that allowed clinicians to participate in an iterative design process followed by real-world testing in an emergency department. All designs, materials used, testing protocols, and survey results are reported in full to facilitate similar efforts in other clinical settings. Findings: Clinical testing allowed the incident command team at a major academic medical center to introduce the locally fabricated face shield into general use in a rapid but well-controlled manner. Unlike standard hospital face shields, the locally fabricated design was intended to be reusable. We discuss the design and testing process and provide an overview of regulatory considerations associated with fabrication and testing of personal protective equipment, such as face shields. Conclusions: Our work serves as a case study for robust, local responses to pandemic-related disruption of medical supply chains with implications for health care professionals, hospital administrators, regulatory agencies, and concerned citizens in the COVID-19 and future health care emergencies.
DepartmentMcGovern Institute for Brain Research at MIT; Harvard University--MIT Division of Health Sciences and Technology; Massachusetts Institute of Technology. Research Laboratory of Electronics
Mostaghimi, Arash et al. "Regulatory and Safety Considerations in Deploying a Locally Fabricated, Reusable Face Shield in a Hospital Responding to the COVID-19 Pandemic." Med 1, 1 (December 2020): P139-151.e4 © 2020 Elsevier Inc