Legal and ethical issues in the regulation and development ofengineering achievements in medical technology. I

The statutory and regulatory requirements governing medical device development and approval are reviewed. Some of the procedures that the US Food and Drug Administration has implemented to loosen the strictures that impede development and approval of new medical devices are discussed. Some of the ethical issues associated with these procedures are examined.     

Health care technical service in developing countries: Brazil

A comparison between the clinical engineering situation in Brazil and that found in some industrialized nations (including the US, Canada, and the UK) is drawn, highlighting possible future developments regarding health care technical service (HCTS) policy, human resources, and technology development. As a background, Brazil's economic development since 1960 is summarized. The Brazilian health care system is then described, and the characteristics of the Unified and Decentralized Health System (SUDS) established by the new constitution promulgated in 1988 are examined. HCTS development and medical products and standardization are described. Debt and policy considerations toward a clinical engineering model with SUDS are discussed. Short-term implementation of decentralized HCTS, as promoted by SUDS, is addressed. The role of appropriate technology and the potential impact of international policy supporting HCTS R&D are examined     

Testing MR Safety and Compatibility

Magnetic resonance (MR) safety and compatibility are important issues for all medical implants, surgical tools, and electronic or mechatronic equipment to be used within an MR environment. MR testing of medical devices is required for device approval by regulatory agencies, such as the Food and Drug Administration (FDA) and the European Union (EU) Notified Bodies. Different robotic and manipulator systems have been developed for use with MR imaging (MRI). This article provides the reader with a comprehensive overview of MR safety and compatibility issues and updates the discussion on existing MR testing methods with an overview on medical robotic and manipulator devices. These tests will increase the safety of the patient and provide MR operators and device manufacturers with important information and, thus, broaden the field of interventional MRI.     

虚拟电机技术应用前景和发展方向

随着高压大容量电力电子技术的迅速发展,越来越多的电力电子设备将投入运行,电力电子化已成为电力系统发展的必然趋势。但是,电力系统电力电子化程度的不断加深使系统相对惯量、阻尼下降,不利于电力系统的安全稳定运行。虚拟电机技术可以使电力电子设备模拟传统旋转电机惯量和阻尼特性,解决电力电子化电力系统所面临的安全稳定问题。文中主要介绍了虚拟同步电机和虚拟直流电机技术的基本原理,并描绘了虚拟电机技术在光伏和风力发电、电力电子式变压器、柔性交直流输电和负荷响应控制等方面的应用前景,最后对虚拟电机技术的发展方向进行了探讨。     

电力系统硬件在环仿真应用的现状及展望

硬件在环仿真(HILS)是提升现代大电网系统仿真准确性、支撑开展高压直流/新能源等装置可靠性验证的有效手段。首先,在介绍HILS基本架构和优势的基础上阐述了HILS在提升电网一次系统仿真准确性、支撑电网二次控制系统测试验证方面的技术及应用现状;然后分析了电力系统HILS平台构建面临的挑战,提出可接入多异构数据模型的灵活架构技术、有限仿真资源下新能源场站等值和大型二次系统等效技术、控制对象接入的通用接口技术等技术方向;最后,从传统技术深化和与新技术融合发展2个角度探讨了电力系统HILS的未来发展趋势,以期对相关平台研发和仿真实验工作提供一定参考。     

燃料电池车发展概况及展望

随着能源危机和环境恶化,利用可持续清洁能源和"零排放"的新能源车———燃料电池车经过多年发展,已取得了不少成绩。介绍了燃料电池车的优势、各国产业政策、国内外燃料电池车的发展概况等,对已研制出的一些燃料电池车的性能进行了介绍和比较。也对燃料电池车的发展,从质子交换膜燃料电池系统及其控制方面以及车载储氢技术方面进行了展望,探讨了未来燃料电池车发展急需解决的一些问题。     

The medical device industry and the biomedical engineer: currentstatus and future trends

The role of new and existing technology in the development of medical devices is examined. The impact of competition and economic and regulatory pressures is assessed. The identification of clinical needs is discussed. These include the needs to reduce liability, find less invasive alternatives to surgery, improve the quality of life, and prevent disease. Career opportunities are considered in some detail.     

Why Washington matters in the silicon valley

Even though many US technological achievements are born elsewhere, decisions that affect the future viability of all types of engineering are made regularly on Capitol Hill (Washington, DC). In fact, public policy has an enormous impact on the direction of the careers of engineers. From the impact of research and development allocations to global competitiveness stemming from our national industrial policy, to the management of information-age resources, such as the radio spectrum, engineers often operate in an environment that is the cumulative product of years of political manipulation. The article looks at how political decisions can affect engineering and technology from innovation to manufacture. Currently, controversial legislative proposals have the potential to disrupt, misdirect, and channel the hard work of engineers towards more limited innovation. Rather than dream large, some engineers are more than willing to work within the confines of a given system. However, paying attention to the dynamics of public policy is important. Otherwise, engineers may find their lush rainforest of innovation shrinking at the edges until it just dots the horizon.     

Humanizing the Information Superhighway

We are rapidly moving toward an integration of two of the most powerful technologies shaping modern life: computers and communications. The telephone and television systems are merging with the computer to form an even more powerful and all-encompassing network of communication and information services, known formally as the National Information Infrastructure (NII), and informally as the Information Superhighway. The form this network finally takes will undoubtedly have an enormous impact on our individual lives, our businesses, and our society. The decisions that ultimately will determine it are even now being made. It is crucial that educators, engineers, business people, policy makers and citizens participate in shaping the technology and the institutions surrounding it. Some new ways of thinking about the NII are needed in order to achieve greater sensitivity to its social implications. Instead of regarding the network as a “superhighway”, which emphasizes the technical infrastructure, it can be viewed as a gathering place, like a village square or marketplace, which supports a rich variety of human interactions. This perspective suggests a framework for understanding and analyzing public policy issues related to the NII and some principles for addressing those issues     

How can energy storage catalyze GCC electricity policy? Issues and options

Saudi Arabia and other Gulf Cooperation Council (GCC) members have a parallel agenda of electricity market reforms together with ambitious goals of renewable energy deployment. The motivation for this agenda is multifaceted and extends beyond increasing economic efficiency. Renewable integration raises market and regulatory design issues for countries transitioning to markets and high levels of renewables though. This difficulty or perhaps even incompatibility may undercut both policies’ objectives. This paper analyses the implications of deploying new energy storage in this context. Although storage services would facilitate the integration of renewables and market restructuring policies, deploying this novel technology would raise additional regulatory issues in the electricity sector. Ignoring these regulatory challenges could not only lead to unnecessary costs of transition but also make it more difficult to obtain the full benefits of other economic policy objectives such as the removal of subsidies to relieve public finances and the release oil for sale in international markets.     

Medical technology and advocacy in Washington

A historical perspective on advocacy groups that influence US government actions is presented. The targets of these groups in the executive branch, legislative branch, and outside agencies and advisory groups are discussed. These targets include the Department of Health and Human Services, which includes the Health Care Financing Administration and the Public Health Service; the Office of the Secretary, which encompasses the Secretary's immediate staff, the General Counsel, and the Assistant Secretary for Planning and Evaluation; and the Office of Technology Assessment, which assists the Congress by providing it with objective analysis of major policy issues related to scientific and technological change. Six major keys to achieving effective advocacy are listed     

Lobbying for IEEE issues

An overview of the advocacy structure of IEEE-USA is presented. Some of its activities, including developing position papers on technology policy issues, conducting workshops, conferences, and briefings, issuing written comments to federal agencies on budgetary and regulatory issues, testifying before Congress and other regulatory bodies, conducting press briefings, and interacting with Washington policy officials, are discussed. A few examples of its activities in the areas of federal R&D funding, high-performance computing, an open-architecture modular approach for the design of high-resolution video systems, and electromagnetic fields are presented     

电磁发射用“锂电池-超级电容”混合储能技术研究综述

随着电磁发射系统(EMLS)应用场景的多样化发展,单一储能器件无法同时满足不同种类载荷发射过程中高功率密度和高能量密度的储能需求。为此,分析了EMLS短时间歇式运行模式下的储能需求,介绍了EMLS储能技术的研究现状及现有缺陷。在此基础上,对“锂电池-超级电容”混合储能应用于EMLS所需要攻克的储能器件选择、并联结构设计、容量配置和实时控制等关键技术进行了论述与总结,并对电磁发射混合储能技术的未来研究与发展方向提出了展望。     

FDA regulation of new devices-expedited review

The expedited review and approval of new medical devices by the US Food and Drug Administration (FDA) is described within the context of ethical issues in the regulation of new technologies. Current statutory provisions governing approval of medical devices, and the way in which the FDA has implemented these provisions are examined. Administrative efforts by the FDA to increase both the quality and efficiency of the new-product review process are then discussed     

Human Health Care System of Systems

In this paper, we describe a human health management system scheme and its practical applications. Specifically, it focuses on health management, medical diagnosis, and surgical support system of systems engineering (SoSE). The application domains discussed here are broad and essential in health management and clinical practice. Firstly, we describe a system of systems (SoS) in human health management. Within it, a notion of health management is introduced and discussed from the viewpoint of SoS. Human health management is the first level of daily monitoring for a healthy human. Sensing and control technology during sleep are espectially focused on because the quality and quantity of sleep has considerable impact on health. Secondly, an SoS in medical diagnostic imaging is discussed. This section introduces a clinical usage of a magnetic resonance imaging (MRI) scanner for the diagnosis of certain diseases. In it, there is a new system that consists of image processing system and expert medical knowledge system described by fuzzy logic. To demonstrate the effectiveness of the new system, applications to human brain magnetic resonance images and orthopedic kinematic analyses are introduced. Thirdly, we describe an SoS in medical ultrasonic surgery support device. This section introduces a novel ultrasonic support system for supporting crash bone orthopedic surgery.      

A biointelligence system for identifying potential disease outbreaks

The development of public health surveillance systems requires multidisciplinary knowledge and advanced technologies. Scientific Technologies Corp. has developed the NH Pharmaceutical Sales Surveillance (NHPSS) for the New Hampshire Department of Health and Human Services (NH DHHS). The NHPSS was developed as a distributed information system. In addition to the database server, enterprise application servers and the Web-browser-based user interface, its architecture features knowledgebase technology, a new dynamic system model with rule systems, and automated data analysis in supporting public health surveillance. Internet mapping was also embedded in the system to provide for spatial analysis. Since its pilot application, started in December of 2002 in the Bureau of Communicable Disease Control and Surveillance, NH DHHS, the NHPSS has assisted NH DHHS in successful detections of gastrointestinal and respiratory events. This article first introduces the methodology and the technology in the NHPSS development. Next, the system functionalities are introduced. Then, a new dynamic system model with a rule system for public health surveillance is described in detail. Finally its application and preliminary results are summarized.     

美国加州地区提高山火灾害下电网弹性的公共安全停电政策和措施

美国加州公共安全停电政策是为了预防山火灾害而采取的一种新型主动停电措施,如何保证电力系统在公共安全停电政策下的安全运行以及提升系统运行的弹性是亟待解决的问题.对加州地区公共安全停电政策进行综述分析,并对电网在公共安全停电政策下的安全运行基本流程进行报道,进而对当前加州公共安全停电政策下安全控制存在的难题和未来可能的研究...     

Healthcare technology, economics, and policy: an evolving balance

Economic and policy issues increasingly influence healthcare technology solutions as we wrestle with keeping healthcare quality high while keeping costs under control. The healthcare system is also undergoing rapid change brought about by managed care, shifting care to team providers in an outpatient or home environment. The development of health technologies under new market arrangements needs to be examined so that quality of care and cost are not at cross roads. As these issues continue to evolve in the public forum, it is critical for engineers and contributors to technology in healthcare to understand the dynamics that influence technology need and and adoption in the healthcare market. We hope that this special issue will provide a basis for initial understanding of these issues and stimulate further involvement by the bioengineering community at large, for the improvement of healthcare across all of society.     

我国生物质能-碳捕集与封存技术应用潜力分析

生物质能-碳捕集与封存(BECCS)技术有望通过实现负排放,使全球温室气体穗定在较低甚至近零排放水平.为了评估BECCS在我国的应用及减排潜力,本文梳理了BECCS技术的发展现状,系统阐述了生物质资源量、技术成熟度、经济性和政府政策等因素对BECCS技术部署的影响,评估了基于农林废弃物燃烧发电、燃煤耦合生物质发电和生物...     

面向电力电子化电网的宽频测量技术探讨

高压直流输电、柔性交流输电系统(FACTS)的应用以及新能源大规模并网为电网引入了大量电力电子设备,给电网注入了大量的间谐波和高次谐波等宽频信号,使得电网逐步呈现电力电子化的发展趋势。现有的测量设备重点关注工频信号测量,无法应对宽频信号测量所提出的挑战。文中分别从现有测量设备的局限、相量测量单元(PMU)升级改进的局限和高频信号测量的局限三个方面分析了现有测量技术的现状,针对性地提出了宽频测量技术总体方案,设计了总体架构,并讨论了具体实现所涉及的宽频信号范围限定、采样频率选择、数据处理机制设计、数据传输协议和同步对时等关键问题,研发了原型装置并在变电站试点应用,验证了宽频测量技术的可行性。文中研究能够为电力电子化电网提供新的监测手段,保障电网安全稳定、推动新能源大规模应用,同时进一步推动二次设备集成整合,降低变电站建设成本。