Regulatory and safety considerations in deploying a locally fabricated, reusable, face shield in a hospital responding to the COVID-19 pandemic

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.

Summary Background 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 healthcare professionals, hospital administrators, regulatory agencies and concerned citizens in the COVID-19 and future healthcare emergencies.