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

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. 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. 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. 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. : This work was supported by the Harvard MIT Center for Regulatory Sciences, NIH/NCI grants U54-CA225088 and T32-GM007753, and the Harvard Ludwig Center. M.-J.A. is a Friends of McGovern Graduate Fellow. The COVID-19 pandemic has disrupted medical device supply chains and caused severe shortages in personal protective equipment needed for infection control. To mitigate these shortages, local companies and maker communities have come together to use 3D printing and public domain designs to fabricate protective equipment, such as face shields. However, using unapproved versions of regulated protective equipment in hospitals is problematic. The authors describe the use of a research protocol supervised by an ethical review panel to test a 3D-printed face shield in the emergency department of a major academic medical center and deploy the face shield widely. They make available designs, materials, testing protocols, and provider surveys so that others can reproduce their efforts