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.

Diseño de un dispositivo de asistencia ventilatoria temporal de lazo cerrado basado en bolsa válvula-mascarilla / Design of a closed-loop temporary ventilation assistance device based on bag valve mask

Desde inicios del 2020, el mundo se ha visto afectado por la COVID-19 causada por el SARS-CoV-2, que en agosto lo padecen más de 31 millones de pacientes, algunos de los cuales presentan el síndrome de distrés respiratorio, que requiere de ventilación mecánica. Por el alto número de contagios, la disponibilidad de ventiladores para el tratamiento es escasa. Se presenta la descripción de un prototipo de un dispositivo de asistencia ventilatoria temporal de lazo cerrado de bajo costo; el AR_CODEX, basado en una bolsa válvula-mascarilla (BVM), que contribuye al mantenimiento ventilatorio mínimo del paciente durante un tiempo corto en casos donde no hay disponibilidad de ventiladores mecánicos. Para esto, se diseñó y construyó un sistema mecánico ajustable que compresiona la bolsa de ventilación, el cual cuenta con sensores de flujo y presión. Además, se elaboró una interfaz gráfica para un adecuado monitoreo del paciente y un sistema de control para variables como volumen, presión máxima, frecuencia respiratoria y relación inspiración: espiración. Por otro lado, existe un problema de sensibilidad en el sensor de flujo debido a varios factores, como la variación del voltaje en los motores. Adicionalmente, la implementación de un lazo cerrado es importante para compensar variaciones aleatorias en el funcionamiento del dispositivo. Es necesario realizar pruebas en animales para evaluar el correcto funcionamiento de AR_CODEX en seres vivos.

In early 2020, the world has been affected from Covid-19 caused by SARS-CoV-2. By August there were more than 31 million patients, some of them suffering from respiratory distress that requires mechanical ventilation. Due to the rise of infection rates there is no ventilator availability for the treatment. In this work we describe a reduced cost closed loop temporal assisted ventilation device prototype, AR_CODEX. It is based on mask valve bag (BVM from its Spanish initials), contributing to the minimum ventilation maintenance for the patient du-ring a short period of time when there is no mechanical ventilation availability. For this purpose an adjustable mechanical system was designed and built to pressurize the ventilation bag that is equipped with flux and pres-sure sensors. Additionally a graphical interface was developed to include adequate monitoring and controlling system for volume, maximum pressure, respiratory frequency and inhalation/exhalation rate. In addition there is a sensibility issue on the flux sensor due to engine voltage variation. A closed loop implementation is important to overcome aleatory variations during the device operation. It is needed to run AR_CODEX device performance test on animals to evaluate prior to use it directly on human patients.

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.

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.

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.

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].

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.

The design and evaluation of a novel low-cost portable ventilator.

Modern mechanical ventilator technologies broadly consist of digitally-controlled electronic devices and analogue systems driven by compressed gas sources. Drawbacks such as high cost, complex maintenance and the need for cumbersome sources of compressed driving gas hinder adoption in pre-hospital and low-resource environments. We describe the evaluation and testing of a simple, low-cost alternative ventilator that uses a novel pressure-sensing approach and control algorithm. This is designed to provide portable positive-pressure mechanical ventilation at a reduced cost, while autonomously monitoring patient condition and important safety parameters. A prototype ventilator was constructed and evaluated using an anaesthetic test-lung as a patient surrogate. Using a modifiable test-lung and digital pressure sensor, we investigated ventilation pressure waveform circuit leak detection, and compliance and resistance change detection. During intermittent positive-pressure ventilation to the test-lung, the prototype system showed acceptable pressure waveform parameters: all simulated circuit leaks ≥ 6 mm2 in size were detected; compliance changes were detected between 10 ml.cmH2 O-1 , 20 ml.cmH2 O-1 and 50 ml.cmH2 O-1 ; and resistance changes were detected across the available simulated range. These results show this prototype technology has the potential to provide safe emergency ventilation without the use of any complex digital sensors or software while its construction and design enables significant reductions in cost and complexity. The study suggests further work is now justified in progressing the technology to clinical trials.

Cost-effectiveness analysis of N95 respirators and medical masks to protect healthcare workers in China from respiratory infections.

BACKGROUND: There are substantial differences between the costs of medical masks and N95 respirators. Cost-effectiveness analysis is required to assist decision-makers evaluating alternative healthcare worker (HCW) mask/respirator strategies. This study aims to compare the cost-effectiveness of N95 respirators and medical masks for protecting HCWs in Beijing, China. METHODS: We developed a cost-effectiveness analysis model utilising efficacy and resource use data from two cluster randomised clinical trials assessing various mask/respirator strategies conducted in HCWs in Level 2 and 3 Beijing hospitals for the 2008-09 and 2009-10 influenza seasons. The main outcome measure was the incremental cost-effectiveness ratio (ICER) per clinical respiratory illness (CRI) case prevented. We used a societal perspective which included intervention costs, the healthcare costs of CRI in HCWs and absenteeism costs. RESULTS: The incremental cost to prevent a CRI case with continuous use of N95 respirators when compared to medical masks ranged from US $490-$1230 (approx. 3000-7600 RMB). One-way sensitivity analysis indicated that the CRI attack rate and intervention effectiveness had the greatest impact on cost-effectiveness. CONCLUSIONS: The determination of cost-effectiveness for mask/respirator strategies will depend on the willingness to pay to prevent a CRI case in a HCW, which will vary between countries. In the case of a highly pathogenic pandemic, respirator use in HCWs would likely be a cost-effective intervention.

Challenges of Anesthesia in Low- and Middle-Income Countries: A Cross-Sectional Survey of Access to Safe Obstetric Anesthesia in East Africa.

BACKGROUND: The United Nations 2015 Millennium Development Goals targeted a 75% reduction in maternal mortality. However, in spite of this goal, the number of maternal deaths per 100,000 live births remains unacceptably high across Sub-Saharan Africa. Because many of these deaths could likely be averted with access to safe surgery, including cesarean delivery, we set out to assess the capacity to provide safe anesthetic care for mothers in the main referral hospitals in East Africa. METHODS: A cross-sectional survey was conducted at 5 main referral hospitals in East Africa: Uganda, Kenya, Tanzania, Rwanda, and Burundi. Using a questionnaire based on the World Federation of the Societies of Anesthesiologists (WFSA) international guidelines for safe anesthesia, we interviewed anesthetists in these hospitals, key informants from the Ministry of Health and National Anesthesia Society of each country (Supplemental Digital Content, http://links.lww.com/AA/B561). RESULTS: Using the WFSA checklist as a guide, none of respondents had all the necessary requirements available to provide safe obstetric anesthesia, and only 7% reported adequate anesthesia staffing. Availability of monitors was limited, and those that were available were often nonfunctional. The paucity of local protocols, and lack of intensive care unit services, also contributed significantly to poor maternal outcomes. For a population of 142.9 million in the East African community, there were only 237 anesthesiologists, with a workforce density of 0.08 in Uganda, 0.39 in Kenya, 0.05 in Tanzania, 0.13 in Rwanda, and 0.02 anesthesiologists in Burundi per 100,000 population in each country. CONCLUSIONS: We identified significant shortages of both the personnel and equipment needed to provide safe anesthetic care for obstetric surgical cases across East Africa. There is a need to increase the number of physician anesthetists, to improve the training of nonphysician anesthesia providers, and to develop management protocols for obstetric patients requiring anesthesia. This will strengthen health systems and improve surgical outcomes in developing countries. More funding is required for training physician anesthetists if developing countries are to reach the targeted specialist workforce density of the Lancet Commission on Global Surgery of 20 surgical, anesthetic, and obstetric physicians per 100,000 population by 2030.

Review of economic evaluations of mask and respirator use for protection against respiratory infection transmission.

BACKGROUND: There has been increasing debate surrounding mask and respirator interventions to control respiratory infection transmission in both healthcare and community settings. As decision makers are considering the recommendations they should evaluate how to provide the most efficient protection strategies with minimum costs. The aim of this review is to identify and evaluate the existing economic evaluation literature in this area and to offer advice on how future evaluations on this topic should be conducted. METHODS: We searched the Scopus database for all literature on economic evaluation of mask or respirator use to control respiratory infection transmission. Reference lists from the identified studies were also manually searched. Seven studies met our inclusion criteria from the initial 806 studies identified by the search strategy and our manual search. RESULTS: Five studies considered interventions for seasonal and/or pandemic influenza, with one also considering SARS (Severe Acute Respiratory Syndrome). The other two studies focussed on tuberculosis transmission control interventions. The settings and methodologies of the studies varied greatly. No low-middle income settings were identified. Only one of the reviewed studies cited clinical evidence to inform their mask/respirator intervention effectiveness parameters. Mask and respirator interventions were generally reported by the study authors to be cost saving or cost-effective when compared to no intervention or other control measures, however the evaluations had important limitations. CONCLUSIONS: Given the large cost differential between masks and respirators, there is a need for more comprehensive economic evaluations to compare the relative costs and benefits of these interventions in situations and settings where alternative options are potentially applicable. There are at present insufficient well conducted cost-effectiveness studies to inform decision-makers on the value for money of alternative mask/respirator options.

Where do we go from here? A small scale observation of transfer results from chronic to skilled ventilator facilities.

PURPOSE: Skilled nursing facility ventilator units (SNF) are a recent attempt to reduce the costs of an increasing number of patients who are in acute intensive care units and are not able to be liberated from ventilators. Transfers of such patients from long-term care chronic vent units (LTCVs) to SNFs in Maryland began in 2006. The safety of these transfers needs to be assessed. METHODS: We retrospectively followed up all patients designated as eligible by their insurance for transfer from our LTCV units to SNF from July 1, 2008 through June 30, 2010 looking only at survival. Those patients who refused transfer and appealed and remained in our LTCV were compared to those who were transferred to SNF ventilator units. The analysis was by Kaplan-Meier statistics. RESULTS: There was an increased mortality (P=.025) of those transferred to SNF ventilator facilities as compared to those remaining in the LTCV. CONCLUSION: We recognize that bias may occur in patients choosing to remain in our LTCV compared to those accepting transfers, the magnitude of the difference in mortality indicates the need for more comprehensive well designed analysis investigating the outcome of all transfers occurring to and from LTCVs.

The environmental impact of the Glostavent® anesthetic machine.

Because anesthetic machines have become more complex and more expensive, they have become less suitable for use in the many isolated hospitals in the poorest countries in the world. In these situations, they are frequently unable to function at all because of interruptions in the supply of oxygen or electricity and the absence of skilled technicians for maintenance and servicing. Despite these disadvantages, these machines are still delivered in large numbers, thereby expending precious resources without any benefit to patients. The Glostavent was introduced primarily to enable an anesthetic service to be delivered in these difficult circumstances. It is smaller and less complex than standard anesthetic machines and much less expensive to produce. It combines a drawover anesthetic system with an oxygen concentrator and a gas-driven ventilator. It greatly reduces the need for the purchase and transport of cylinders of compressed gases, reduces the impact on the environment, and enables considerable savings. Cylinder oxygen is expensive to produce and difficult to transport over long distances on poor roads. Consequently, the supply may run out. However, when using the Glostavent, oxygen is normally produced at a fraction of the cost of cylinders by the oxygen concentrator, which is an integral part of the Glostavent. This enables great savings in the purchase and transport cost of oxygen cylinders. If the electricity fails and the oxygen concentrator ceases to function, oxygen from a reserve cylinder automatically provides the pressure to drive the ventilator and oxygen for the breathing circuit. Consequently, economy is achieved because the ventilator has been designed to minimize the amount of driving gas required to one-seventh of the patient's tidal volume. Additional economies are achieved by completely eliminating spillage of oxygen from the breathing system and by recycling the driving gas into the breathing system to increase the Fraction of Inspired Oxygen (FIO2) at no extra cost. Savings also are accrued when using the drawover breathing system as the need for nitrous oxide, compressed air, and soda lime are eliminated. The Glostavent enables the administration of safe anesthesia to be continued when standard machines are unable to function and can do so with minimal harm to the environment.