ABSTRACT
Beyond an exceptional human toll, one of the most evident impacts of the ongoing COVID-19 pandemic is that of disrupted supply chain dynamics. Lessons learned here might help ameliorate the ability of frontline workers to secure personal protective equipment (PPE) such as N95 filtering facepiece respirators (FFRs) to prevent similar issues in future pandemics. A related concern is FFR waste streams, and the ability to recycle N95s using chemical or physical germicidal methods would greatly contribute to lessening PPE scarcity and providing relief to overall supply chains for all essential services. Early in 2020, the U.S. Food and Drug Administration (FDA) issued official guidance for sterilizers, disinfectant devices, and air purifiers with regards to the COVID-19 pandemic as a public health emergency bulletin. This guidance provided nonbinding recommendations for PPE and FFR decontamination processes, involving a wide spectrum of chemical and physical methods of sterilization. Many of the sterilization methods employ high heat or utilize polar chemical disinfectants that can compromise either the physical structure or the electrostatic properties of FFR fibers, thus attenuating the overall protection provided to the frontline worker. Ultraviolet germicidal irradiation (UVGI) has been employed for nearly a century to sterilize instruments and whole environments. UVGI offers numerous advantages as it is transitory by nature, leaving no chemical residue on the treated artifact. UVGI is also rapid, and depending on illumination sources, UVGI can easily scale to provide coverage to large areas. Here we provide an analysis of the regulatory aspect related to the use of UVC devices and describe our engineered design of a cost-efficient sterilization chamber that utilizes UVC for decontamination. Our design stresses a low-cost price point to facilitate easy manufacture for not only rapid deployment but also minimal impacts on supply chains. The device is intended to be easy to use, without any specialized training, and thus targets the general public for sanitizing non-washable materials, including PPE, FFR and other potential fomites, including electronic devices of daily use, that otherwise might harbor bacterial, viral and fungal pathogens. Copyright © 2022 by ASME.
ABSTRACT
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 health care professionals, hospital administrators, regulatory agencies, and concerned citizens in the COVID-19 and future health care emergencies. FUNDING: : 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.