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.     

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。     

青年人原发性肝癌的治疗与预后分析

目的:探讨青年人原发性肝癌手术切除率低及术后复发率较高的原因.方法:将1985年1月～2000年1月收治的原发性肝癌173例患者分为青年组(≤35岁)83例和中老年组(≥36岁)90例,对其临床资料、手术切除率、术后复发率及生存率等进行比较分析.结果:青年组原发性肝癌手术切除率、术后1年复发率分别为26.51%(22/83)和68.18%(15/22),术后1、3、5年生存率分别为59.09%(13/22)、22.73%(5/22)和9.09%(2/22).中老年组原发性肝癌手术切除率、术后1年复发率分别为53.33%(48/90)和37.50%(18/48),术后1、3、5年生存率分别为81.25%(39/48)、47.92%(23/48)和39.58%(19/48).青年组各项生存率指标均较中老年组低(P＜0.01).结论:青年组原发性肝癌具有肿瘤生长迅速、侵袭力强、门静脉癌栓发生率高、多表现为巨块型及弥漫型等特点,导致手术切除率较低及术后复发率较高.     

实习医生临床技能操作短期集中培训的可行性分析

探索临床技能培训和提高学生临床实践能力的有效方法.通过培训前考核、观看教学片、指导教师示范、模拟练习、现场点评、培训后考核等方式,比较培训前后考核成绩.通过短期集中培训,使实习生在临床技能方面快速提高.学生们很快掌握了临床基本技能操作规范,为更好地投入到临床实习打下了良好的基础.     

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.