VEMERS UC:用于COVID-19和低资源社区大流行后临床验证的紧急机械呼吸机

IF 0.8 4区 医学 Q4 ENGINEERING, BIOMEDICAL Journal of Medical Devices-Transactions of the Asme Pub Date : 2021-09-01 DOI:10.1115/1.4051246
L. Chiang, Felipe A. Castro
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引用次数: 2

摘要

在这篇文章中,我们介绍了一种在智利开发的临床验证的有创紧急机械呼吸机,称为VEMERS UC。已在新冠肺炎插管患者中进行了临床试验和验证。当疫情在2020年3月袭击智利时,很明显,可用的机械呼吸机数量不够。就像在世界其他地方一样,出现了许多倡议,其中大多数都非常简单。智利的医学协会加入了工程专家,并在早期就有组织和规范的开放过程中达成一致,以验证紧急机械呼吸机,从而允许快速开发,但具有所需的功能、可靠性和安全性。VEMERS UC是少数几个成功完成验证过程所有阶段的公司之一,最后的测试是对5名危重患者进行插管,每人8小时。VEMERS UC基于电气动电路架构,其组件都是低成本的,现成的气动和电子产品,很容易在工业市场上获得。它在连续强制音量控制模式下工作。本文讨论了VEMERS UC的新技术特点以及在验证过程的每个阶段获得的结果。在智利进行的验证过程本身是值得注意的,它可以作为其他发展中国家的一个例子。此外,VEMERS UC也可以作为其他国家的指导性设计参考,因为这种设计已经在人类患者身上进行了彻底的测试,并被证明是成功的。
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VEMERS UC: A Clinically Validated Emergency Mechanical Ventilator for COVID-19 and Postpandemic Use in Low Resource Communities
In this article, we present a clinically validated invasive emergency mechanical ventilator developed in Chile called VEMERS UC. It has been clinically tested and validated in intubated Covid-19 patients. Once the pandemic hit Chilean soil in March 2020, it was quite clear that the number of mechanical ventilators available would not be enough. As in other parts of the world many initiatives sprung, most of them naively simple. Chilean medical societies joined engineering specialists and agreed early on in an organized and regulated open process for validating emergency mechanical ventilators, thus allowing for rapid development but with the required functionality, reliability, and safety features. VEMERS UC was one of a few that completed successfully all stages of the validating process, the final test being on five critically ill intubated Covid-19 patients for eight hours each. VEMERS UC is based on an electropneumatic circuit architecture, and its components are all low cost, off-the-shelf pneumatic, and electronic products easily obtained in industrial markets. It works in continuous mandatory volume control mode. The novel technical features of VEMERS UC are discussed here as well as the results obtained in each stage of the validating process. The validating process carried out in Chile is noteworthy by itself, and it could be used as an example in other developing countries. Furthermore, VEMERS UC can be used as a guiding design reference in other countries as well, since this design has already been thoroughly tested in human patients and has proven to work successfully.
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来源期刊
CiteScore
1.80
自引率
11.10%
发文量
56
审稿时长
6-12 weeks
期刊介绍: The Journal of Medical Devices presents papers on medical devices that improve diagnostic, interventional and therapeutic treatments focusing on applied research and the development of new medical devices or instrumentation. It provides special coverage of novel devices that allow new surgical strategies, new methods of drug delivery, or possible reductions in the complexity, cost, or adverse results of health care. The Design Innovation category features papers focusing on novel devices, including papers with limited clinical or engineering results. The Medical Device News section provides coverage of advances, trends, and events.
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