Innovations to automate manual ventilation during Covid-19 pandemic and beyond.

ABSTRACT

Manual ventilation by compressing self-inflating bags is a life-saving option for respiratory support in many resource-limited settings. Previous efforts to automate manual ventilation using mechatronic systems were unsuccessful. The Covid-19 pandemic stimulated re-exploration of automating manual ventilation as an economically viable alternative to address the anticipated shortage of mechanical ventilators. Many devices have been developed and displayed in the lay press and social media platforms. However, most are unsuitable for clinical use for a variety of reasons. These include failure to understand the clinical needs, complex ventilatory requirements in Covid-19 patients, lack of technical specifications to guide innovators, technical challenges in delivering ventilation parameters in a physiological manner, absence of guidelines for bench testing of innovative devices and lack of clinical validation in patients. The insights gained during the design, development, laboratory testing and clinical validation of a novel device designated the 'Artificial Breathing Capability Device' are shared here to assist innovators in developing clinically usable devices. A detailed set of clinical requirements from such devices, technical specifications to meet these requirements and framework for bench testing are presented. In addition, regulatory and certification issues, as well as concerns related to the protection of intellectual property, are highlighted. These insights are designed to foster an innovation ecosystem whereby clinically useful automated manual ventilation devices can be developed and deployed to meet the needs associated with the Covid-19 pandemic and beyond.