Regulatory and Safety Considerations in Deploying a Locally Fabricated, Reusable Face Shield in a Hospital Responding to the COVID-19 Pandemic

Abstract

In response to pandemic-related shortages in medical supplies, the authors use an institutional review board-supervised research protocol to clinically test a 3Dprinted face shield in a hospital emergency department. This allowed a major academic medical center to incorporate locally manufactured personal protective equipment into the care of COVID-19 patients.

An overview of filtration efficiency through the masks: Mechanisms of the aerosols penetration

“…The transparent part is made in most cases by Polycarbonate (PC). It functions as a shield to protect the face parts from the direct contact of the liquid splashes from the Infectious when speaking, sneezing, and coughing [ 28 , 29 ]. The schematic of full-length face shield is shown in Fig.…”

The Importance of Personal Protective Equipment Design and Donning and Doffing Technique in Mitigating Infectious Disease Spread: A Technical Report

“…When considering face shield models as an example, there are multiple factors to consider when trying to optimize the utility of this protective equipment. First, the fit must effectively limit exposure to aerosols and be resistant to fogging [ 11 ]. It must also allow for adequate vision for users, and be comfortable enough to be worn for extended periods of time and in high-stress situations.…”

“…As an example, the utility of face shields has been emphasized during the COVID-19 pandemic [ 10 ]. The use of face shields is mandated when healthcare professionals are in close proximity with patients during aerosol-generating procedures to mitigate potential for inoculation onto mucous membranes of the eyes, nose and mouth [ 11 ]. In order for a face shield to be effective, it must limit exposure to aerosols and other bodily fluids while also being resistant to fogging.…”

A Crisis-Responsive Framework for Medical Device Development during the COVID-19 Pandemic

“…In the case of prosthetics 26 and orthotics 27 , tools for surgical planning 28 , and dental and surgical equipment 27,29,30 additive manufacturing has opened new possibilities for designing products with complex geometries and allowed manufacturers to move away from standardized products in a few pre-specified sizes toward patient-matched products. During the COVID-19 pandemic, additive manufacturing has been widely used to make face shields, 27,31,32 nasopharyngeal swabs [33][34][35] , face mask brackets 18 , components for portable-air purifying respirators (PAPRs) 35 , and ventilator splitters 36 . In response, the FDA has released relevant guidance in its "FAQs for 3D printing medical devices, accessories, and components during the COVID-19 pandemic."…”

“…We have found that the use of research protocols for product testing increases buy-in from healthcare leadership, in part because it is a familiar process. In the case of a non-traditional face shield described below (Box 2) it was possible to perform IRB protocol review and product specification, validation, and testing in a clinical setting in a period of roughly three weeks 32 .…”