Simulation-Based Rapid Development and Implementation of a Novel Barrier Enclosure for Use in COVID-19 Patients: The SplashGuard CG

Abstract

Background. The current COVID-19 pandemic has resulted in over 54,800,000 SARS-CoV-2 infections worldwide with a mortality rate of around 2.5%. As observed in other airborne viral infections such as influenza and SARS-CoV-1, healthcare workers are at high risk for infection when performing aerosol-generating medical procedures (AGMP). Additionally, the threats of a global shortage of standard personal protective equipment (PPE) prompted many healthcare workers to explore alternative protective enclosures, such as the "aerosol box"invented by a Taiwanese anesthetist. Our study includes the design process of a protective barrier enclosure and its subsequent clinical implementation in the management of critically ill adults and children infected with SARS-CoV-2. Methods and Results. The barrier enclosure was designed for use in our tertiary care facility and named "SplashGuard CG"(CG for Care Givers). The device has been adapted using a multi- A nd interdisciplinary approach, with collaboration between physicians, respiratory therapists, nurses, and biomechanical engineers. Computer-aided design and simulation sessions throughout the entire process facilitated the rapid and safe implementation of the SplashGuard CG in different settings (intensive care unit, emergency department, and the operating room) during AGMPs such as bag-valve-mask ventilation, nasopharyngeal suctioning, intubation and extubation, and noninvasive ventilation. Indications for use and anticipatory precautions were communicated to all healthcare workers using the SplashGuard CG. The entire process was completed within one month. Conclusion. The rapid design, development, and clinical implementation of a new barrier enclosure, the "SplashGuard CG,"was feasible in this time of crisis thanks to close collaboration between medical and engineering teams and the use of recurring simulation sessions to test and improve the initial prototypes. Following this accelerated process, it is necessary to maintain team skills, monitor any undesirable effects, and evaluate and continuously improve this new device.