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

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.

When Scarcity Meets Disparity: "Resources Allocation and COVID-19 Patients with Diabetes".

The COVID-19 pandemic raised distinct challenges in the field of scarce resource allocation, a long-standing area of inquiry in the field of bioethics. Policymakers and states developed crisis guidelines for ventilator triage that incorporated such factors as immediate prognosis, long-term life expectancy, and current stage of life. Often these depend upon existing risk factors for severe illness, including diabetes. However, these algorithms generally failed to account for the underlying structural biases, including systematic racism and economic disparity, that rendered some patients more vulnerable to these conditions. This paper discusses this unique ethical challenge in resource allocation through the lens of care for patients with severe COVID-19 and diabetes.

ResUHUrge: A Low Cost and Fully Functional Ventilator Indicated for Application in COVID-19 Patients.

Although the cure for the SARS-CoV-2 virus (COVID-19) will come in the form of pharmaceutical solutions and/or a vaccine, one of the only ways to face it at present is to guarantee the best quality of health for patients, so that they can overcome the disease on their own. Therefore, and considering that COVID-19 generally causes damage to the respiratory system (in the form of lung infection), it is essential to ensure the best pulmonary ventilation for the patient. However, depending on the severity of the disease and the health condition of the patient, the situation can become critical when the patient has respiratory distress or becomes unable to breathe on his/her own. In that case, the ventilator becomes the lifeline of the patient. This device must keep patients stable until, on their own or with the help of medications, they manage to overcome the lung infection. However, with thousands or hundreds of thousands of infected patients, no country has enough ventilators. If this situation has become critical in the Global North, it has turned disastrous in developing countries, where ventilators are even more scarce. This article shows the race against time of a multidisciplinary research team at the University of Huelva, UHU, southwest of Spain, to develop an inexpensive, multifunctional, and easy-to-manufacture ventilator, which has been named ResUHUrge. The device meets all medical requirements and is developed with open-source hardware and software.

Increasing ventilator surge capacity in COVID 19 pandemic: design, manufacture and in vitro-in vivo testing in anaesthetized healthy pigs of a rapid prototyped mechanical ventilator.

OBJECTIVE: The advent of new technologies has made it possible to explore alternative ventilator manufacturing to meet the worldwide shortfall for mechanical ventilators especially in pandemics. We describe a method using rapid prototyping technologies to create an electro-mechanical ventilator in a cost effective, timely manner and provide results of testing using an in vitro-in vivo testing model. RESULTS: Rapid prototyping technologies (3D printing and 2D cutting) were used to create a modular ventilator. The artificial manual breathing unit (AMBU) bag connected to wall oxygen source using a flow meter was used as air reservoir. Controlled variables include respiratory rate, tidal volume and inspiratory: expiratory (I:E) ratio. In vitro testing and In vivo testing in the pig model demonstrated comparable mechanical efficiency of the test ventilator to that of standard ventilator but showed the material limits of 3D printed gears. Improved gear design resulted in better ventilator durability whilst reducing manufacturing time (< 2-h). The entire cost of manufacture of ventilator was estimated at 300 Australian dollars. A cost-effective novel rapid prototyped ventilator for use in patients with respiratory failure was developed in < 2-h and was effective in anesthetized, healthy pig model.

AmbuBox: A Fast-Deployable Low-Cost Ventilator for COVID-19 Emergent Care.

We present a low-cost clinically viable ventilator design, AmbuBox, using a controllable pneumatic enclosure and standard manual resuscitators that are readily available (AmbuBag), which can be rapidly deployed during pandemic and mass-casualty events with a minimal set of components to manufacture and assemble. The AmbuBox is designed to address the existing challenges presented in the existing low-cost ventilator designs by offering an easy-to-install and simple-to-operate apparatus while maintaining a long lifespan with high-precision flow control. As an outcome, a mass-producible prototype of the AmbuBox has been devised, characterized, and validated in a bench test setup using a lung simulator. This prototype will be further investigated through clinical testing. Given the potentially urgent need for inexpensive and rapidly deployable ventilators globally, the overall design, operational principle, and device characterization of the AmbuBox system have been described in detail with open access online. Moreover, the fabrication and assembly methods have been incorporated to enable short-term producibility by a generic local manufacturing facility. In addition, a full list of all components used in the AmbuBox has been included to reflect its low-cost nature.

Re-Examining the Race to Send Ventilators to Low-Resource Settings.

COVID-19 is devastating health systems globally and causing severe ventilator shortages. Since the beginning of the outbreak, the provision and use of ventilators has been a key focus of public discourse. Scientists and engineers from leading universities and companies have rushed to develop low-cost ventilators in hopes of supporting critically ill patients in developing countries. Philanthropists have invested millions in shipping ventilators to low-resource settings, and agencies such as the World Health Organization and the World Bank are prioritizing the purchase of ventilators. While we recognize the humanitarian nature of these efforts, merely shipping ventilators to low-resource environments may not improve outcomes of patients and could potentially cause harm. An ecosystem of considerable technological and human resources is required to support the usage of ventilators within intensive care settings. Medical-grade oxygen supplies, reliable electricity, bioengineering support, and consumables are all needed for ventilators to save lives. However, most ICUs in resource-poor settings do not have access to these resources. Patients on ventilators require continuous monitoring from physicians, nurses, and respiratory therapists skilled in critical care. Health care workers in many low-resource settings are already exceedingly overburdened, and pulling these essential human resources away from other critical patient needs could reduce the overall quality of patient care. When deploying medical devices, it is vital to align the technological intervention with the clinical reality. Low-income settings often will not benefit from resource-intensive equipment, but rather from contextually appropriate devices that meet the unique needs of their health systems.

Quick Thinking Turns out Low-Cost Ventilators.

As the number of coronavirus 2019 disease (COVID-19) cases in the United States began mounting in the early weeks of March, health care workers raised the alarm about a looming shortage of ventilators to treat patients. On March 30, 2020, Ford Motor Company announced plans to produce 50,000 ventilators in 100 days [1], and General Motors followed suit on April 8, stating that it would deliver out 6,000 ventilators by the end of May and another 24,000 by August [2].