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对负压吸引装置便携方式的研究一直是急救医学追求的目标之一,因为它能够极大地促进急救成功率。文章基于这种需要,研制了一套便携式负压吸引装置,并根据实际应用效果,选择优化的制造材料。研制的便携式负压吸引装置主要由特殊设计的储液罐及罐盖、负压产生装置、过渡接头等部分组成,关键部件采用特殊材料制作,体积小,质量轻,操作简单,易于携带,完全能满足临床抢救及治疗的需要。作为一种急救中必不可少的器械,便携式负压吸引装置在急救伤病员运输、转运,家庭急救,及无动力源环境等情况下,对于抢救患者及提高救治效果,具有极大的竞争优势和应用前景。 相似文献
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FDA’S Perspectives on Cardiovascular Devices 总被引:1,自引:0,他引:1
Eric A. Chen Sonna M. Patel-Raman Kathryn O’Callaghan Matthew G. Hillebrenner 《Journal of cardiovascular translational research》2009,2(2):143-146
The Food and Drug Administration (FDA) decision process for approving or clearing medical devices is often determined by a
review of robust clinical data and extensive preclinical testing of the device. The mission statement for the Center for Devices
and Radiological Health (CDRH) is to review the information provided by manufacturers so that it can promote and protect the
health of the public by ensuring the safety and effectiveness of medical devices deemed appropriate for human use (Food, Drug
& Cosmetic Act, §903(b)(1, 2(C)), December 31, 2004; accessed December 17, 2008 ). For high-risk devices, such as ventricular assist devices (VADs), mechanical heart valves, stents, cardiac resynchronization
therapy (CRT) devices, pacemakers, and defibrillators, the determination is based on FDA’s review of extensive preclinical
bench and animal testing followed by use of the device in a clinical trial in humans. These clinical trials allow the manufacturer
to evaluate a device in the intended use population. FDA reviews the data from the clinical trial to determine if the device
performed as predicted and the clinical benefits outweigh the risks. This article reviews the regulatory framework for different
marketing applications related to cardiovascular devices and describes the process of obtaining approval to study a cardiovascular
device in a U.S. clinical trial. 相似文献
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Few cases in the history of epidemiology and public health are more famous than John Snow's investigation of a neighborhood cholera outbreak in the St. James, Westminster, area of London in 1854. In this study Snow is assumed to have proven that cholera was water rather than airborne through a methodology that became, and to a great extent remains, central to the science and social science of disease studies. And yet, Snow's work did not satisfy most of his contemporaries who considered his proof of a solely waterborne cholera interesting but unconvincing. Uniquely, this paper asks whether the caution of Snow's contemporaries was reasonable, and secondly, whether Snow might have been more convincing within the science of the day. The answers significantly alter our understanding of this paradigmatic case. It does so in a manner offering insights both into the origins of nineteenth century disease analysis and more generally, the relation of mapping in the investigation of an outbreak of uncertain origin. The result has general relevance—pedagogically and practically—in epidemiology, medical geography, and public health. 相似文献
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The choice of therapies for Crohn's disease has expanded greatly over the past 30 years. Increasingly it is important that we attempt to identify subgroups of patients who will benefit most from each type of therapy. This article reviews the therapeutic options currently available, organized by the goal the practitioner hopes to achieve. Imaging is one critical way of aiding the classification of Crohn's disease by attempting to accurately determine the location, extent and, most importantly, the nature of the disease. 相似文献
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This paper examines the uses of evidence-based medicine (EBM) in post-Soviet Russia through the use of semi-structured interviews. It asks what it means to talk about practicing evidence-based medicine in a setting where the context of practice presents considerable barriers to the implementation of EBM principles. Drawing on interviews with Russian physicians, medical students and users of the healthcare system, the paper argues that in post-Soviet Russia EBM serves as a strategic discourse for segments of the medical profession. With the collapse of the U.S.S.R. the healthcare system has been going through a period of crisis, and Russian physicians are finding that they have to redefine their professional identity with respect to the domestic and the international context and have to seek new sources for legitimating their professional position. The western origins of EBM endow this rhetoric with considerable power in the Russian context and render it a very useful tool in the project of redefinition. 相似文献
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The goals of this report are: 1) to review the number needed to treat (NNT) concept, which, although well established in many sectors of medicine, is still relatively new to the radiotherapy community; 2) to discuss several clinical radiotherapy examples illustrating the inherent advantages of the NNT approach; and 3) to discuss potential future roles of the NNT concept within radiotherapy. 相似文献