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.     

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.     

Design of clinical trials for chronic diseases: implications for periodontal disease

In order to make effective use of the statistical theory of design of clinical trials for chronic diseases such as periodontal disease, certain issues must be considered. Any clinical trial requires that the disease definition be well-specified; that patient eligibility be explicit; that the observation times be explicit; that the duration and endpoint of therapy be specified; that the duration of subsequent followup observation be specified; and that the unit of observation (e.g., tooth, set of teeth, patient) be defined. In a chronic disease, the potential biases that can readily be introduced by self-selection of patients who enter the trial and/or who return for subsequent observation become more important, because subjects are required to remain on treatment and/or observation for prolonged periods. Further, the cyclical nature of some chronic diseases may require special attention to baseline definitions of active disease and disease outcome. These issues are illustrated with examples from clinical trials of hypertension, breast cancer screening, and Polycythemia Vera. Implications for periodontal disease are discussed.     

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。