Novel High-tech, Low-cost Ventilation for Military Use, Mass Casualty Incidents, Stockpiling, and Underserved Communities.

INTRODUCTION: Despite the significant need for mechanical ventilation in- and out-of-hospital, mechanical ventilators remain inaccessible in many instances because of cost or size constraints. Mechanical ventilation is especially critical in trauma scenarios, but the impractical size and weight of standard mechanical ventilators restrict first responders from carrying them in medical aid bags, leading to reliance on imprecise manual bag-mask ventilation. This is particularly important in combat-related injury, where airway compromise and respiratory failure are leading causes of preventable death, but medics are left without necessary mechanical ventilation. To address the serious gaps in mechanical ventilation accessibility, we are developing an Autonomous, Modular, and Portable Ventilation platform (AMP-Vent) suitable for austere environments, prolonged critical care, surgical applications, mass casualty incidents, and stockpiling. The core system is remarkably compact, weighing <2.3 kg, and can fit inside a shoebox (23.4 cm × 17.8 cm × 10.7 cm). Notably, this device is 65% lighter than standard transport ventilators and astoundingly 96% lighter than typical intensive care unit ventilators. Beyond its exceptional portability, AMP-Vent can be manufactured at less than one-tenth the cost of conventional ventilators. Despite its reduced size and cost, the system's functionality is uncompromised. The core system is equipped with closed-loop sensors and advanced modes of ventilation (pressure-control, volume-control, and synchronized intermittent mandatory ventilation), enabling quality care in a portable form factor. The current prototype has undergone preliminary preclinical testing and optimization through trials using a breathing simulator (ASL 5000) and in a large animal model (swine). This report aims to introduce a novel ventilation system and substantiate its promising performance through evidence gathered from preclinical studies. MATERIALS AND METHODS: Lung simulator testing was performed using the ASL 5000, in accordance with table 201.105 "pressure-control inflation-type testing" from ISO 80601-2-12:2020. Following simulations, AMP-Vent was tested in healthy 10-kg female domestic piglets. The Children's Hospital of Philadelphia Institutional Animal Care and Use Committee approved all animal procedures. Swine received 4-min blocks of alternating ventilation, where AMP-Vent and a conventional anesthesia ventilator (GE AISYS CS2) were used to titrate to varied end-tidal carbon dioxide (EtCO2) goals with the initial ventilator switching for each ascending target (35, 40, 45, 50, 55 mmHg). RESULTS: During ASL 5000 simulations, AMP-Vent exhibited consistent performance under varied conditions, maintaining a coefficient of variation of 2% or less within each test. In a large animal study, AMP-Vent maintained EtCO2 and SpO2 targets with comparable performance to a conventional anesthesia ventilator (GE AISYS CS2). Furthermore, the comparison of minute ventilation (Ve) distributions between the conventional anesthesia ventilator and AMP-Vent at several EtCO2 goals (35, 40, 45, 50, and 55 mmHg) revealed no statistically significant differences (p = 0.46 using the Kruskal-Wallis rank sum test). CONCLUSIONS: Preclinical results from this study highlight AMP-Vent's core functionality and consistent performance across varied scenarios. AMP-Vent sets a benchmark for portability with its remarkably compact design, positioning it to revolutionize trauma care in previously inaccessible medical scenarios.

Coping with drug shortages: A study of government-enterprise option cooperation stockpiling strategies for drugs in shortage considering API surrogate stockpiling subsidies.

Drug shortage is a global problem, and the development of government-enterprise cooperative stockpiles of drugs in shortage, combining physical and production capacity, has become one of the most important means of coping with drug shortages. However, existing studies have tended to overlook the fact that shortages of Active Pharmaceutical Ingredients (APIs) have become an important constraint on production capacity stockpiling and that the lack of incentives and provisions for coordination of benefits have led to a double marginal effect of joint stockpiling by government and enterprises of drugs in shortage. Accordingly, this study introduced the option contract to the drug supply system composed of government and pharmaceutical enterprises and used the subsidy of API storage in lieu as an important initiative to incentivize the reserve of APIs, to construct a model of shortage drug reserve under the government's leadership. This study aims to improve the effect of government-enterprise joint stockpiling of drugs in shortage, which is of great theoretical and practical significance. According to the classification of production license types of pharmaceutical enterprises, this study established a three-level supply chain decentralized decision-making model consisting of the government, formulation enterprises, and API enterprises, and a two-level supply chain centralized decision-making model consisting of the government and API Formulation (API-F) integrated enterprises, respectively. By solving the inverse order derivation, the government-enterprise option cooperation conditions and optimal decision-making strategy were derived. The study results showed that: (i) The addition of enterprise API stockpiling mode can help the government conventional reserves, and enterprise production capacity reserves, broaden the way of drug reserves, and improve the effect of government-enterprise option cooperation; (ii) when the probability of drug shortages is high, the government should prefer the cooperation of API-F integrated enterprises, which is conducive to reducing intermediate links and government costs and improving the supply responsiveness to shortages of medicines; (iii) Setting appropriate government subsidies for API storage can incentivize enterprises to stockpile APIs and improve drug production capacity and physical supply response capability. This study took the problem of socialized stockpiling of drugs in shortage as an entry point and explored the problems and solution strategies in the government-enterprise cooperative stockpiling of drugs in shortage, which not only made some theoretical contributions to the application of options contract in the government-enterprise cooperative stockpiling of drugs in shortage but also provided new ideas and theoretical basis for the improvement of the stockpiling work of drugs in shortage.

Use of Ebola Vaccines - Worldwide, 2021-2023.

Ebola virus disease (Ebola) is a rare but severe illness in humans, with an average case fatality rate of approximately 50%. Two licensed vaccines are currently available against Orthoebolavirus zairense, the virus that causes Ebola: the 1-dose rVSVΔG-ZEBOV-GP (ERVEBO [Merck]) and the 2-dose regimen of Ad26.ZEBOV and MVA-BN-Filo (Zabdeno/Mvabea [Johnson & Johnson]). The Strategic Advisory Group of Experts on Immunization recommends the use of 1-dose ERVEBO during Ebola outbreaks, and in 2021, a global stockpile of ERVEBO was established to ensure equitable, timely, and targeted access to vaccine doses for future Ebola outbreaks. This report describes the use of Ebola vaccines and the role of the stockpile developed and managed by the International Coordinating Group (ICG) on Vaccine Provision during 2021-2023. A total of 145,690 doses have been shipped from the ICG stockpile since 2021. However, because outbreaks since 2021 have been limited and rapidly contained, most doses (139,120; 95%) shipped from the ICG stockpile have been repurposed for preventive vaccination of high-risk groups, compared with 6,570 (5%) used for outbreak response. Repurposing doses for preventive vaccination could be prioritized in the absence of Ebola outbreaks to prevent transmission and maximize the cost-efficiency and benefits of the stockpile.

How Should Resources From National Stockpiles Be Managed?

The Strategic National Stockpile (SNS) is a national system maintained by the US federal government to deliver medical supplies during emergencies. In the past, the SNS has been used to mitigate public health consequences of tragedies, such as Hurricane Katrina and Ebola outbreaks. However, challenges in maintaining and utilizing the SNS for patient safety are prevalent. This article canvasses ways in which the SNS is accessed and suggests needed changes in the wake of the COVID-19 pandemic.

Predictors of Food and Water Stockpiling During the COVID-19 Pandemic Among Latinos and Non-Latino Black People.

OBJECTIVE: The study examined factors associated with food and water stockpiling (FWS) during the COVID-19 pandemic. METHODS: A secondary analysis of online survey data collected in two waves: April 2020 (wave 1) and June/July 2020 (wave 2), was conducted through REDCap web application. A total of 2,271 Non-Latino Black and Latino adults (mean age: 36.8 years (SD = 16.0); 64.3% female) living in Illinois were recruited. Participants self-reported if they stockpiled food and/or water (FWS) seven days prior to survey completion because of the pandemic. Logistic regression was used to determine if each variable was associated with the odds of reporting FWS. RESULTS: Nearly a quarter (23.3%) of participants reported FWS. The adjusted model revealed that odds of FWS increase as the number of household members increased (OR: 1.21; 95% CI: 1.05-1.41). Odds of FWS were lower among participants who were not self-quarantining compared to those self-quarantining all the time (OR: 0.32; 95% CI: 0.17 - 0.62). Furthermore, individuals with lower levels of concern about COVID-19 had lower odds of FWS than those extremely concerned. CONCLUSIONS: Household size, self-quarantine status, and concern about COVID-19 were significantly associated with FWS. These findings highlight the need to address the concerns of marginalized individuals to promote healthy behaviors.

Ventaja de jugar en casa y el efecto de anotar primero en el fútbol profesional costarricense. Análisis de los campeonatos 2012/13 - 2018/19 / Home Advantage and Effects of Scoring First in the Costa Rican Professional Soccer. Analysis of Championships 2012/13 - 2018/19 / Vantagem de jogar em casa e o efeito de marcar primeiro no futebol profissional costa-riquenho. Análise dos campeonatos de 2012/13 - 2018/19

Resumen: Objetivo: analizar la ventaja de jugar en casa y la influencia de anotar primero sobre el resultado de los partidos en 14 campeonatos, desde el 2012/13 hasta el 2018/19, en el fútbol profesional costarricense. Metodología: se examinó un total de 1848 partidos, considerando el resultado del partido (ganador, empate o perdedor), la localización (local y visitante) y el orden de anotación (primero y segundo). Se aplicó estadística descriptiva y pruebas no paramétricas. Resultados: se evidenció que los equipos que jugaban de locales lograron mayor número de victorias (Z = -4,51; p < 0,01) y anotaron más goles (Z = -4,51; p < 0,01) que los visitantes. La ventaja de jugar en casa fue de 62,46 % y esta no difirió significativamente entre los campeonatos (H = 10,86; p = 0,62). La ventaja de anotar de primero fue de 78,86 % para equipos locales y de 72,26 % para los visitantes. Cuando el equipo local anotaba el primer gol, ganaba el 73,73 % de sus partidos, mientras que, los equipos visitantes terminaban ganando el 58,12 % de las veces (χ. = 53,674; p < 0,001; phi = 0,17, V = 0,17). Los 4 mejores equipos de la tabla de clasificación anotaron más goles y ganaron más partidos tanto en casa como de visita y presentaron una ventaja de anotar de primeros superior cuando jugaban de visita, en comparación con los que ocuparon las otras posiciones. Conclusión: jugar en casa y anotar el primer gol representaron una ventaja para que los equipos obtuvieran resultados positivos en los campeonatos de fútbol costarricense analizados. Implicaciones: estos resultados pueden orientar a los cuerpos técnicos a plantear estrategias para afrontar partidos que disputen tanto en casa como de visita.

Abstract: Objective: to analyze home advantage and the influence of scoring first on match outcomes in 14 Costa Rican professional soccer championships from 2012/13 to 2018/19. Methodology: a total of 1848 games were examined considering the match outcome (winner, draw or loser), the localization (home and away) and the order of scoring (first and second). Descriptive statistics and non-parametric tests were applied. Results: it was shown that local teams achieved a greater number of victories (Z = -4,51; p < 0,01) and scored more goals (Z = -4,51; p< 0,01) than the away ones. Home advantage was 62.46 % and this did not differ significantly among the championships (H = 10,86; p = 0,62). The advantage of scoring first was 78.86 % for home teams and 72.26 % for away ones. When the home team scored the first goal, they won 73.73 % of their matches, while the away ones ended up winning 58.12 % of their matches (χ. = 53,674; p < 0,001; phi = 0,17, V = 0,17). The top 4 teams in the ranking scored more goals and won more games both at home and away and had a superior scoring first advantage when played away compared to the teams than occupying the other positions. Conclusion: playing at home and scoring the first goal represented an advantage for teams to achieve positive results in the Costa Rican soccer championships analyzed. Implications: these results can guide the staff coach to propose strategies to front facing matches both at home and away.

Resumo: Objetivo: analisar a vantagem de jogar em casa e a influência do primeiro gol no resultado dos jogos em 14 campeonatos, de 2012/13 a 2018/19, no futebol profissional costarriquenho. Metodologia: um total de 1848 jogos foi analisado considerando seus resultados (vencedor, empate ou perdedor), localização (em casa e fora) e ordem de pontuação (primeiro e segundo). Foram aplicadas estatísticas descritivas e testes não paramétricos. Resultados: ficou evidente que as equipes da casa conseguiram um número maior de vitórias (Z= -4,51; p< 0,01), e marcaram mais gols (Z= -4,51; p< 0,01) que as equipes visitantes. A vantagem doméstica foi de 62,46% e não diferiu significativamente entre os campeonatos (H= 10,86; p= 0,62). A vantagem de marcar primeiro foi 78,86% para as equipes da casa e 72,26% para as equipes visitantes. Quando a equipe da casa marcou o primeiro gol, ele ganhou 73,73% de seus jogos; enquanto as equipes visitants, eles acabaram ganhando 58,12% do tempo (χ2= 53,674; p< 0,001; phi= 0,17, V= 0,17). As quatro melhores equipes da tabela do campeonato marcaram mais gols e ganharam mais jogos tanto em casa quanto fora e tiveram uma maior vantagem no primeiro gol quando jogaram fora em comparação com as equipes nas outras posições. Conclusão: Jogar em casa e marcar o primeiro gol representou uma vantagem para as equipes obterem resultados positivos nos campeonatos de futebol costarriquenhos analisados. Implicações: estes resultados podem orientar o pessoal de coaching no planejamento de estratégias para enfrentar jogos em casa e fora.

The Role of Public Health Emergency Management in Biodefense: A COVID-19 Case Study.

INTRODUCTION: The emergence of the COVID-19 pandemic has had significant impact on human lives as well as economic and social stability. The United States has a complicated history with biosecurity as policy making, biodefense activities, and government transparency have historically been in contention. The terror attacks of September 11, 2001 uncovered various weaknesses in the national public health infrastructure that have persisted into the current pandemic. METHODS: This study explores the biodefense and public health preparedness landscape for trends in federal support and capacity building. It also investigates the applicability of public health emergency management principles to the biodefense structure. A mixed method was utilized in this study to investigate the qualitative and quantitative factors of the research inquiry. Braun and Clarke's six phase framework for thematic analysis will assist with defining the important information from a review of the literature. The concurrent triangulation design permits that use of qualitative and quantitative data to more accurately define and analyze the relationship among the variables of interest. RESULTS: The results included the identification of 8 common themes of failure during the COVID-19 response: (1) accountable leadership, (2) statutory authorities and policies, (3) inter-agency coordination, (4) coherent data system for situational awareness, (5) strategic national stockpile and supply chain, (6) testing and surveillance, (7) health care system surge capacity and resilience, and (8) federal funds and the role of public health emergency management in the evolving landscape of biothreats, both intentional and natural. DISCUSSION: To counter the increasing biothreats, the United States must invest in revamping the biodefense infrastructure to mimic and support public health emergency preparedness initiatives which will increase our resilience to various biothreats.

Create a COVID-19 commission.

We need a definitive public reference for the history of events.

Avaliação da qualidade na gestão de estoque em laboratório clínico no município de Fortaleza, Ceará / Quality assessment in stock management in a clinical laboratory in Fortaleza Municipality, Ceará

Objetivo: Este trabalho visa discutir sobre a correta gestão de insumos em um laboratório de análises clínicas. Nesse tipo de atividade, o Sistema de Gestão da Qualidade embasa uma série de processos visando garantir a fidedignidade dos resultados, pautados em processos bem estabelecidos. A gestão de insumos e estoque é uma atividade integrada entre os diversos setores existentes na empresa, fundamental para a garantia da qualidade do exame. Dessa forma, falhas na política de qualidade podem desencadear prejuízos materiais, institucionais e humanos. Métodos: Para tanto, realizou-se análise em um laboratório clínico privado de Fortaleza, Ceará, de modo observacional, prospectivo e descritivo, desenvolvido como estudo de caso. Resultados: Verificou-se que, apesar de sistemas de gestão de estoque serem adotados, não há treinamento efetivo e documentação detalhada que norteie todos os processos do setor. Conclusão: A ausência de processos bem definidos de gestão de estoque pode ser interferente importante na correta liberação dos laudos de exames, gerando prejuízos importantes à organização e ao cliente.

Objective: This paper aims to discuss the correct management of inputs in a clinical analysis laboratory. In this type of activity, the Quality Management System is based on a series of processes aimed at guaranteeing the reliability of results, based on well-established processes. The management of inputs and stock is an integrated activity among the various sectors existing in the company, essential for ensuring the quality of the exam. Thus, failures in quality policy can trigger material, institutional and human losses. Methods: For this purpose, an analysis was carried out in a private clinical laboratory in Fortaleza, Ceará, in an observational, prospective and descriptive manner, developed as a case study. Results: It was found that, although inventory management systems are adopted, there is no effective training and detailed documentation to guide all processes in the sector. Conclusion: The absence of well-defined inventory management processes can be an important interferer in the correct release of examination reports, generating significant losses to the organization and the customer.

Vaccine nationalism and the dynamics and control of SARS-CoV-2.

Vaccines provide powerful tools to mitigate the enormous public health and economic costs that the ongoing severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic continues to exert globally, yet vaccine distribution remains unequal among countries. To examine the potential epidemiological and evolutionary impacts of "vaccine nationalism," we extend previous models to include simple scenarios of stockpiling between two regions. In general, when vaccines are widely available and the immunity they confer is robust, sharing doses minimizes total cases across regions. A number of subtleties arise when the populations and transmission rates in each region differ, depending on evolutionary assumptions and vaccine availability. When the waning of natural immunity contributes most to evolutionary potential, sustained transmission in low-access regions results in an increased potential for antigenic evolution, which may result in the emergence of novel variants that affect epidemiological characteristics globally. Overall, our results stress the importance of rapid, equitable vaccine distribution for global control of the pandemic.

Recomendação nº 007, de 07 de abril de 2021: recomenda ações para aquisição, distribuição e monitoramento público dos medicamentos contemplados no kit intubação e outras medidas / Recommendation No. 007, of April 7, 2021: recommends actions for the acquisition, distribution and public monitoring of the medications included in the intubation kit and other measures

Que estabeleçam, em parceria com os gestores da saúde, nas respectivas instâncias de gestão do SUS, procedimentos para acompanhamento e monitoramento da situação de abastecimento dos medicamentos para intubação e oferta de oxigênio nos hospitais públicos e privados, monitorando prioritariamente aqueles beneficiados a partir da distribuição centralizada destes produtos pelo Ministério da Saúde, bem como por aquisições diretamente realizadas pelos gestores estaduais, municipais e do Distrito Federal.

Healthcare risk management during the SARS-CoV-2 virus pandemic in the European Union: The guaranteed access to medicines.

BACKGROUND: The disease caused by the novel coronavirus SARS-CoV-2 has rapidly spread escalating the situation to an international pandemic. The absence of a vaccine or an efficient treatment with enough scientific evidence against the virus has generated a healthcare crisis of great magnitude. The precautionary principle justifies the selection of the recommended medicines, whose demand has increased dramatically. METHODS: we carried out an analysis of the healthcare risk management and the main measures taken by the state healthcare authorities to a possible shortage of medicines in the most affected countries of the European Union: Spain, France, Italy and Germany. RESULTS: the healthcare risk management in the European Union countries is carried out based on the precautionary principle, as we do not have enough scientific evidence to recommend a specific treatment against the new virus. Some measures aimed to guarantee the access to medicines for the population has been adopted in the most affected countries by the novel coronavirus. CONCLUSIONS: in Spain, Italy and Germany, some rules based on the precautionary principle were pronounced in order to guarantee the supply of medicines, while in France, besides that, the competences of pharmacists in pharmacy offices have been extended to guarantee the access to medicines for the population.

The Strategic National Stockpile: identification, support, and acquisition of medical countermeasures for CBRN incidents.

The Strategic National Stockpile (SNS) serves as a repository of materiel, including medical countermeasures (MCMs), that would be used to support the national health security response to a chemical, biological, radiological, or nuclear (CBRN) incident, either natural or terrorism-related. To support and advance the SNS, the National Institutes of Health (NIH) manages targeted investigatory research portfolios, such as Countermeasures Against Chemical Terrorism (CounterACT) for chemical agents, that coordinate projects covering basic research, drug discovery, and preclinical studies. Project BioShield, managed by the Biomedical Advanced Research and Development Agency (BARDA), guides and supports academia and industry with potential MCMs through the Food & Drug Administration's approval process and ultimately supports the acquisition of successful products into the SNS. Public health emergencies such as the COVID-19 pandemic and the ever-increasing number of MCMs in the SNS present logistical and financial challenges to its maintenance. While MCMs for biological agents have been readily adopted, those for chemical agents have required sustained investments. This paper reviews the methods by which MCMs are identified and supported for inclusion in the SNS, the current status of MCMs for CBRN threats, and challenges with SNS maintenance as well as identifies persistent obstacles for MCM development and acquisition, particularly for ones focused on chemical weapons.

The US Strategic National Stockpile Ventilators in Coronavirus Disease 2019: A Comparison of Functionality and Analysis Regarding the Emergency Purchase of 200,000 Devices.

BACKGROUND: Early in the coronavirus disease 2019 (COVID-19) pandemic, there was serious concern that the United States would encounter a shortfall of mechanical ventilators. In response, the US government, using the Defense Production Act, ordered the development of 200,000 ventilators from 11 different manufacturers. These ventilators have different capabilities, and whether all are able to support COVID-19 patients is not evident. RESEARCH QUESTION: Evaluate ventilator requirements for affected COVID-19 patients, assess the clinical performance of current US Strategic National Stockpile (SNS) ventilators employed during the pandemic, and finally, compare ordered ventilators' functionality based on COVID-19 patient needs. STUDY DESIGN AND METHODS: Current published literature, publicly available documents, and lay press articles were reviewed by a diverse team of disaster experts. Data were assembled into tabular format, which formed the basis for analysis and future recommendations. RESULTS: COVID-19 patients often develop severe hypoxemic acute respiratory failure and adult respiratory defense syndrome (ARDS), requiring high levels of ventilator support. Current SNS ventilators were unable to fully support all COVID-19 patients, and only approximately half of newly ordered ventilators have the capacity to support the most severely affected patients; ventilators with less capacity for providing high-level support are still of significant value in caring for many patients. INTERPRETATION: Current SNS ventilators and those on order are capable of supporting most but not all COVID-19 patients. Technologic, logistic, and educational challenges encountered from current SNS ventilators are summarized, with potential next-generation SNS ventilator updates offered.