Engineering and the law-products liability for medical devices:federal preemption of state lawsuits

The basis of product liability lawsuits and a trend in the law that can protect medical device manufacturers from these lawsuits are discussed. Section 402(A) of the Restatement of Torts, the basis for liability laws in most states, is reviewed. The King vs. Collagen Corp. case, in which King, diagnosed with an autoimmune disease, claimed that the disease was caused by Zyderm, a modified cow protein that is injected under the skin to correct wrinkles, is also reviewed. King sued Collagen Corp. for selling a defective product and for failure to properly warn her and her physician of the risks of using the product and lost the suit     

Product liability and malpractice

The expanded definition of liability, which includes the liability of those who design, manufacture, and sell products, is discussed. Also examined is malpractice, in which the engineer may be subjected to liability on an individual basis. It is noted that liability under both products liability and malpractice doctrines has also expanded beyond the physical limits of the state in which the corporate principal place of business is located to encompass any state in which a company sells products, not just that in which an engineer is employed. The significance of these developments for the individual engineer is examined     

The Vitrifix process

The Vitrifix process solves the problems of nonbiodegradability and the legal liability for asbestos in a landfill by totally destroying the asbestos and converting it into a safe, useful product-glass. The process uses well-established glass technology in a unique fashion. The use of an existing technology gives great reliability, and the way it is applied makes the process intrinsically safe. The successful demonstration of the process to the US Environmental Protection Agency and its commercial operation in the UK are described. Comprehensive testing of the glass product using transmission electron microscopy and X-ray diffraction confirmed that the product is totally amorphous glass. No trace of asbestos or any crystalline structure was detected     

A Multilevel Collision Mitigation Approach—Its Situation Assessment, Decision Making, and Performance Tradeoffs

This paper deals with the problem of decision making in the context of forward collision mitigation system design. The authors present a multilevel collision mitigation (CM) approach that allows a flexible tradeoff between potential benefit and the risk associated with driver acceptability and product liability. Due to its practical relevance, algorithms that allow for an efficient incorporation of both sensor and prediction uncertainties are further outlined. The performance tradeoffs that come along with different parameterizations are investigated by means of stochastic simulations on three dangerous traffic situations, namely 1) rear-end collisions due to an unexpected braking, 2) cutting-in vehicles, and 3) crossing traffic at intersections. The results show that an overly conservative CM system sacrifices much of its potential benefit. However, it is pointed out that the vision of accident-free driving can be achieved only through cooperative driving strategies     

Reliability of Power Transmission and Transformation Facilities in 2010

Through the reliability analysis on transmission and transformation facilities with 220 kV or above voltage level in China in 2010, particularly by investigating the planned and unplanned outage of transformers, circuit breakers and overhead transmission lines with 220 kV, 330 kV and 500 kV level, the weak parts that may influence the operational reliabilities are figured out from technical and liability causes. Moreover, through the research on the device models and comparison of performance indices between domestic and imported devices, the trend of the reliability changes are identified so that the references can be provided for power enterprises to determine corresponding effective reliability measures during planning, design, implementation and production stages.     

火电厂设备管理五级责任体系的应用

详细介绍了设备管理五级责任体系的内涵与使用方法。五级责任体系的创新点就是从设备的设计、制造、安装运行、检修维护、报废等实行全员、全方位、全过程的设备管理。五级责任体系之间相互独立又相互关联,每级都有各自的设备管理任务,在遇到重大问题时可通过专业组技术攻关组来协调运行、维护、点检及技术支持体系的工作,达到解决问题的目的,对同行有一借鉴作用。     

火电厂设备管理五级责任体系的应用

详细介绍了设备管理五级责任体系的内涵与使用方法。五级责任体系的创新点就是从设备的设计、制造、安装运行、检修维护、报废等实行全员、全方位、全过程的设备管理。五级责任体系之间相互独立又相互关联，每级都有各自的设备管理任务．在遇到重大问题时可通过专业组技术攻关组来协调运行、维护、点检及技术支持体系的工作，达到解决问题的目的，对同行有一借鉴作用。     

Commercializing Successful Biomedical Technologies: Basic Principles in the Development of Drugs, Diagnostics, and Devices (S.S. Mehta; 2008) [Book Review]

This textbook is a nicely laid out logical road map to the development of drugs, devices, and diagnostics in the United States. Some of the topics covered include: an overview of the industry; market research; intellectual property law as practiced in the United States; new product development; an overview of Title 21 Code of Federal Regulations and the Food and Drug Administration operations; manufacturing; marketing and sales; and product liability. Each chapter begins with a bullet listing of the learning points involved in the chapter. Each chapter concludes with an overall summary, exercises as appropriate, a reference listing, and appendices as necessary. The book is a well-written introduction to the field of drug and device development and commercialization in the United States.     

Investigating the Impact of Familiarity and Product Conditions on The Ease of Use of a Product

Ease of use is one of the main criteria that customers consider when making a purchase decision. To provide a pleasant experience to the customers, offering products or services consisting of advanced features and functions is no longer enough, due to the existing competition in the global market. In reality, the ease of use of any product is influenced by the conditions of the product and the familiarity of the user. This study examines the influence of the familiarity and the product conditions on the ease of use of a product. This only explains how the conditions of the product and the fa-miliarity of the user, influence on the ease of use of a product when the usage hours of a product increases. A case study would be conducted to validate the results. The results of this study indicate that in the case where both the product conditions and the familiarity has been varied, the ease of use of the product has been increased from 0.229 to 0.380 gradually within the 10 weeks period. Through these results valuable guidance could be obtained by the manufacturers to identify how the ease of use level of a product deviates from the standard level when the usage hours of the product would increase.     

通信用阀控式铅酸蓄电池供电可靠性的讨论

阀控式铅酸蓄电池（VRLA）是目前支持通信系统工作的主要备用电源。VRLA电池在浮充条件下的缺点已在国际会议上经过多次专题讨论。国内用户的反映是,当市电发生故障时,电池单体放电容量往往达不到设计要求。本文分析了一些影响电池可靠性的重要因素,提议在使用维护过程中改变充电方式,并在选购产品时要注重电池的基本性质。     

并网异步风电场短路特性的仿真分析

风速的随机性与间隙性使风电场经常处于不同的运行方式,合理的保护配置是保证风电场及接入系统稳定运行的卫士。短路特性是保护配置的前提和依据,针对恒速异步风力发电机组,讨论了其数学模型,分析了异步机组的电磁暂态过程,建立了风电场联络线路接地故障时,风电场提供的短路电流各序分量表达式,对影响风电场故障特性的主要因素进行了分析,并以PSCAD/EMTDC为平台建立风电场并网运行的仿真模型,研究了风电场投入系统容量、风速、故障类型、X/R对故障特性的影响,仿真结果与理论分析相吻合。研究结果表明风电场继电保护整定时应考虑这些影响因素,以提高风电场继电保护动作的有效性和可靠性。     

适应配电自动化的馈线接地保护研究

传统的基于零序电流基波、高次谐波的故障选线方法,测量复杂,可靠性不高。文中对负序电流馈线接地保护及负序电流与零序电流比较式接地保护进行了分析,讨论了保护判据,分析了保护精度,介绍了实现方法。该保护方法适用于各种中性点接地方式,便于在馈线保护中实现和在FTU上安装。仿真分析及模拟实验表明,该方法能对弧光接地故障正确选线,抗过渡电阻能力强,可靠性高。     

基于动态特性的继电器仿真分析

从动态特性出发,才能揭示继电器实际的工作过程与状态变化,仿真分析才接近实际产品.本文以印刷电路板继电器为例,采用新版JDQCAD2.0系统软件进行动态特性分析,剖析其真实的工作特性,分析影响特性的参数,以提高产品质量,特别是提高批量生产的产品质量与效率.     

框架式断路器机构系统动态仿真与试验研究

研究产品仿真建模与分析的方法。对于复杂产品系统的仿真,可采用系统分解的方法进行,也可将实验结果作为系统模型的组成部分。利用多体动力学仿真分析软件ADAMS,对断路器机构系统进行动态仿真建模与分析,获得其分闸过程的动态特性。分析了断路器主要结构参数对其运动特性的影响。通过实验方法验证仿真模型及仿真结果的正确性。研究结果表明,仿真与实验结果吻合较好,仿真方法为断路器产品提供了可视化开发环境,是产品创新的有效手段。     

基于电气剖分方法的阻塞费用分摊

分析指出以传输容量价值最大化为目标的跨区域阻塞管理是一种有效的阻塞管理方法,基于该方法可以计算出跨区域阻塞联络线上的阻塞费用.然而,如何将阻塞费用进行合理分摊是一个需要解决的问题.文中基于"论责分摊"的思想,提出了一种基于电气剖分方法计算阻塞影响因子的方法,根据该方法可将联络线上的阻塞费用根据交易参与者的定量阻塞责任大小进行分摊.最后用改进的IEEE 30节点算例对该方法进行了验证.     

智能电能表可靠性及其评价方法分析

介绍智能电能表可靠性评价体系,分析智能电能表可靠性的主要影响指标和评价方法,提出进行可靠性设计、利用高可靠性材料、采用先进工艺3种提高智能电能表可靠性的对策。     

输电线路OPGW接地方式的分析研究

为了减少光纤复合架空地线(OPGW)中的电能损耗,针对目前普遍采用的OPGW逐基接地方式,分析和计算了逐基接地带来的电能损耗;试验说明了这种接地方式会使OPGW遭雷击的概率增大。根据OPGW逐基接地产生的问题,提出了OPGW经导弧间隙的接地方式,分析了导弧间隙应满足的技术要求及对线路运行的影响。研究结果表明,用导弧间隙接地方式代替逐基接地方式可有效解决OPGW的环流损耗和易遭雷击断股问题。     

基于信息熵的多谐波源定位研究

针对复杂配电网中缺少有效划分非线性负荷谐波污染责任和不能准确确定主谐波源位置的状况,提出了一种基于信息熵的多谐波源定位方法。通过支持向量机进行谐波分离,获得测量量的各次谐波数据。接着利用B样条法对测量数据进行概率密度估计,从而计算出母线电压与各支路电流的互信息值,根据互信息值的大小来确定主谐波源位置。通过对典型配电系统在ATP(选择性暂态程序)软件中仿真分析,所提方法具有定位准确、能够进行实际谐波责任区分的优点。     

一种综合的电器质量监控方法

燃弧时间是开关电器的一个重要参数,电器的可靠性和寿命直接受燃弧时间的影响.根据燃弧时间可将电器分级,而燃弧时间取决于材料、设计、运行和环境等诸多因素的影响.本文介绍了一种综合的电器质量监控方法,取燃弧时间的影响因素为样本属性,以燃弧时间确定样本类别,在同类别样本中利用FICSEM方法提取关键影响因素,并获得达到相同燃弧时间的影响因素组合.提高关键影响因素以提高产品质量,利用最优影响因素组合降低产品成本,规避生产风险,提高经济效益.     

格式合同下电站主机设备性能违约的风睑管控

电站主机设备的采购多采用买方的格式合同，其违约责任越来越偏袒买方而苛刻于卖方。卖方在招投标过程中为了争取项目，极少偏标，导致合同谈判过程中双方较大分歧。本文基于此，对电站主机设备常见的性能保证指标分析讨论，提出确定性能违约责任的三种分析方法，以期合理确定电站主机设备性能违约责任，并结合违约赔偿的法律解读，为合同谈判过程中的风险管控提供参考建议。