UC Davis

Respiratory failure has been a common cause of death in patients infected by SARS-CoV-2 during the time of worldwide ventilator shortage. In early 2020, our team have introduced a fast-deployable and low-cost emergency resuscitator system, AmbuBox, in response to the rising demand of ventilators. The AmbuBox system uses a controllable pneumatic enclosure in conjunction with a standard manual resuscitator (or AmbuBag) to achieve the basic functionalities of a modern ventilator. It is a modularized system integrated with off-the-shelf components for ramp-up production capability at a competitive cost. However, the regulatory requirements for emergency use have not been considered. My project focuses on improving the AmbuBox system in accordance with regulatory consensus and documenting the design process in detail. As part of the initial effort to make AmbuBox publicly available, this project further studies the general process and requirements of FDA Emergency Use Authorization for ventilators. Through this project, I am able to implement key functionalities on the AmbuBox system and understand the expectations from FDA for emergency use approval.