FDA’S Perspectives on Cardiovascular Devices

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.     

Gerontology in the developing Brazil: Achievements and challenges in public policies

Aim:   In the last three decades, the segment of population aged 60 years and older has more than doubled in Brazil. People aged 80 years and older are expected to be the fastest-growing segment in the near future. This aim of this study was to analyze the legal structures currently in place in Brazil and to provide a framework for care policies and practices towards older-adults.
Methods:   This article focuses on past and present major socioeconomic burdens on this segment of the Brazilian population as well as on public achievements to overcome inequities.
Results:   Both the public health and the social security systems have been directed to provide preferential assistance to the aged. Nonetheless, the elderly remain the most impoverished segment of Brazil and carry the burden of an overall lack of specialized services. Moreover, socioeconomic inequalities and population diversity in Brazil affects elderly care, adding complexity to this unique scenario.
Conclusion:   Brazil has adopted legal hallmarks that substantially shifted public practices towards the elderly segment from a philanthropic status to a legitimate right for care and assistance. The demographic transition that took place provides an opportunity for innovative solutions in public policies for older adults in a developing economic environment.     

Crediting his critics' concerns: Remaking John Snow's map of Broad Street cholera, 1854

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.     

医学文献检索课中期刊论文分类标引的教学

针对当前的医学文献检索课中忽略期刊论文分类标引教学的问题,总结了几点教学实践,分别从期刊论文分类标引准确的重要性、期刊论文分类标引的步骤及原则、医学期刊论文分类标引的注意事项几个方面进行阐述.     

加强行业管理规范人体器官移植技术

人体器官移植技术历经近半个世纪的发展历程．在上个世纪70年代我国逐步开展对肝脏、心脏和肾脏等器官移植技术的研究工作。近5年来，随着国际医学研究交流频繁，国内一些大型医疗机构加大了对器官移植技术上的投入．使人体器官移植技术发展迅猛。但同时也伴随着一些医疗费用过高、买卖供体等问题的出现。因此，如何规范人体器官移植技术．是当前的一个重要研究课题。     

引入PDCA循环规范医疗废物管理

目的采用PDCA循环法,规范医院医疗废物管理。方法通过计划、实施、检查、处理4个阶段具体实施。结果医疗废物要达到规范化管理,建立有效的组织管理体系,制定切实可行的规章制度是重要保证;加强培训与宣传教育,提高全员管理意识是重要环节;完善医疗废物处置过程中的配套设施是重要基础;制定管理质量标准认真督促检查考核是重要手段。结论PDCA循环法是加强完善医疗废物管理的一种科学的管理方式。     

清代名医的医德（二）

用生动事例介绍清代名医的医德，以供后人效法和学习。     

Medical management of Crohn's disease: A guide for radiologists

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.