Evaluating the safety and effectiveness of novel personal protective equipment during the COVID-19 pandemic

As health services worldwide respond to the coronavirus disease of 2019 (COVID-19) pandemic, rapid integration of innovative technology-based manufacturing solutions is a priority. In response to threatened supply chains, health services have been forced to exploring novel sources personal protective equipment (PPE). Given these challenges with PPE supply chains, companies and community members worldwide have progressed the design and manufacturing of face shields, often without any healthcare experience or conformity assessment, and with limited or no understanding of the regulation of medical devices in their jurisdiction. For the purposes of this article, “novel” sources of PPE are defined as non-traditional sources of PPE, including three-dimensional (3D) printing and obtaining PPE from non-traditional suppliers e.g. hardware stores and industrial suppliers. This paper provides an evaluation framework to make evidence-based decisions on how to evaluate the safety of novel PPE before distribution to clinicians, using the May 2020 case study of a locally manufactured 3D printed face shield.