Tissue engineering and Eucomed news in brief

This study emphasizes the importance of multicellular cultures in providing appropriate signals for vascular organization of skeletal tissues. Eucomed, the European Medical Technology Industry Association, represents directly and indirectly more than 3,500 business entities in Europe and beyond. The Eucomed mission is to create and maintain a suitable framework by enabling the manufacturers of medical technology and other related economic actors to operate, innovate, and market in an open and competitive marketplace, with the ultimate objective to improve the access of patients and clinicians to modern and reliable medical technology products. The paper shows a recent example of the role of Eucomed on the tissue engineering industry as illustrated in its response to the proposal of a regulation launched by the European Commission on 4 May 2005. The proposal covers human-tissue-engineered products, bringing them under the scope of medicinal products. Eucomed's position is that since human-tissue-engineering products are not medicinal products, they cannot be regulated by the existing, unchanged rules for medicinal products. Existing requirements for clinical investigation and for good manufacturing practices for medicinal products should be appropriately adapted from the technical point of view, while maintaining their general ethical requirements. Eucomed has also put forward suggestions to address the specificity of combination products, in particular hybrid products made of human-tissue-engineered products and medical devices.     

Ethical considerations in engineering design processes

Engineering ethics involves a broad range of (ethical) issues. In this article, we focus on the specific area of engineering ethics pertaining to engineering design. We believe that engineering design constitutes an interesting starting point for ethical issues in engineering, both for educational and research purposes. So far, there has not been much systematic research on ethical aspects in engineering design and on how engineers deal with such aspects. Engineering design is also an interesting topic to research from the point of view of engineering ethics because design is one of the main activities in which engineers are involved. Moreover, technology has social and ethical implications, mainly because of the kinds of products produced, which are the eventual outcomes of design processes. We focus on two ethical aspects of design processes: the formulation of design requirements and criteria, and the acceptance of tradeoffs between different design criteria. When calling an aspect of the design process “ethical”, we have used the following criteria: the aspect of the design process is connected to, or brings about possible negative consequences, for people other than the designers involved; more or less generally accepted values or norms are at stake; and the norms and values of the different engineers involved in the design clash with each other     

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     

Regulatory and other public policy issues

Regulatory and other public policy issues in the future of biomedical engineering, as they relate to the development and use of medical devices, are discussed. At the federal level, agencies that directly influence the application of medical technology include the Food and Drug Administration (FDA), with its clinical trials and premarket and regulatory authority, and the Health Care Financing Administration (HCFA), with its reimbursement policy. The Occupational Safety and Health Administration (OSHA), the Environmental Protection Agency (EPA), and the Department of Commerce can have a considerable impact on corporate profitability, which is a driving force for most new technology and new product introductions. Another area of public policy that has been cited as significantly influencing health care and medical device development, namely, civil litigation, is also considered. To illustrate the issues, the impact of the regulatory environment on the application of computer software to a wide variety of medical products is examined. The humanistic and ethical problems brought about by technological advances are discussed. Ten key technologies that are likely to have the greatest importance in the next few years and ten external influences on the future of the medical device technology industry that have been identified by the Health Industry Manufacturers Association are described.     

基于多智能体的用户分时电价响应模型

科学制定峰谷分时电价政策,有利于提高系统可靠性与经济性。基于多智能体技术,提出了智能体系统(multi-agent system,MAS)总体框图,阐述了供电智能体、用户智能体和政府部门智能体的学习过程及其相互影响,结合电量电价弹性矩阵,考虑了不同用户的用电和响应特点以及用户智能体内部的相互影响。仿真过程可以动态显示供电智能体的调整动作、用户智能体的响应行为和负荷越限情况,以及政府部门智能体的干预行为。仿真结果表明:根据文中模型获得的峰谷分时电价策略具有更好的"移峰填谷"效果,兼顾供需双方的经济利益和用户用电习惯,供电、用户、政府智能体间实现信息共享。     

Assessing Reliability as the Electric Power Industry Restructures

Current criteria and methods for reliability assessment and provision do not provide the quality of service requested by regulators on behalf of consumers. Although some improvements can be envisioned, a new paradigm may be necessary in which reliability responsibilities are clearly assigned to suppliers and wire companies, with understanding of verifiable reliability-related products seen by the customer.     

Challenges facing technology assessment in modern health care

Clearly, a precise tool does not now exist for making technological assessments. Yet, however imperfect the process might be, technology assessment is a valuable tool for use by doctors, health-care providers, and hospital administrators to control the increasing cost of health care. Technological assessment allows hospitals to evaluate the safety, efficacy, and cost-effectiveness before the commitment to purchase new equipment. As advancements in medical technology continue, the concerns associated with moral and ethical issues related to quality of life become increasingly difficult to assess. Hospitals must place the needs of the community and the quality of patient care ahead of profits and the purchase of new technologies. Stuart Poston, administrator of Murray-Calloway County Hospital, best concludes the authors' discussion with his view on the importance of technology assessment: "If you keep up with technology and buy quality equipment, you can enhance your medical staff and maintain a solid financial base. Then you can afford new equipment"     

浅谈我国LED医疗照明的应用与发展

LED医疗照明产品可以满足各种诊治的需要,光源和被观察组织以及周围色彩能相适应,提高诊断的准确性,可以正确观察和处理病情。病房既是医疗场所,又是病人生活和休息场所,功能要求不同,光照要求在诊疗、生活、休息时各不相同,采用LED可以满足相同场所在不同时期光环境的变化,给患者和医生提供舒适的环境。     

Development of an Environmentally Safe Process for Medical Waste Disposal Based on Pyrolysis

Upon analyzing the methods for processing epidemiologically hazardous medical waste (MW), it has been shown that the problem of safe disposal of MW with respect to the formation of polychlorinated dibenzo-para-dioxins and dibenzofurans (dioxins and furans) is acute and requires scientifically sound solutions. The typical morphological and elemental composition of the MW classes B and C and their thermal properties were determined, and the modern literature on the processes of thermal detoxification of dangerous MW was analyzed. It has been found that the process of pyrolysis is the most adaptive to various types of solid waste. Currently, pyrolysis attracts special attention due to its flexibility in treating various combinations of wastes only by changing the operating parameters of the process, such as temperature and heating rate. Pyrolysis is particularly important in connection with the growing amount of polymers in the waste of medical institutions, including those containing chlorine. In this case, the pyrolysis method presents the possibility of using a number of circuit solutions to prevent the formation of dioxins and furans. It has been shown that the use of the pyrolysis method ensures, along with full satisfaction of the requirements of sanitary and hygienic standards, the environmental safety of the MW detoxification process as compared to other high temperature methods (combustion and gasification). Next, possible directions of utilization of secondary resources received in the process under consideration were analyzed. In the proposed scheme of the installation for safe disposal of medical waste on the basis of the pyrolysis process, its products (excess gas, heat of the products of combustion, etc.) are expected to be used to generate electrical and thermal energy; semicoke as a solid residue of the process will be converted to activated carbon.     

Designing ethical phishing experiments

While fraud has been part of human society for as long as we know, the automated type of fraud that is known as phishing is a relatively recent phenomenon. It is becoming clear to society that phishing is a problem of quite catastrophic dimensions. Phishing is a multifaceted techno-social problem for which there is no known single silver bullet. As a result of these insights, an increasing number of researchers and practitioners are attempting to quantify risks and degrees of vulnerabilities in order to understand where to focus protective measures. When academic researchers plan phishing studies, they are faced with the reality that such studies must not only be conducted in an ethical manner, but they also must be reviewed and approved by their Institutional Review Board (IRB). This article provides an overview of the review process used by IRBs, an outline of the section of the federal regulations, 45 CFR 46, 116(d)(14), that provide the circumstances where aspects of the informed consent process can be waived. Moreover, it contains a discussion of the controversial ethical issues inherent in phishing studies that request a waiver of aspects of the informed consent requirement. Finally, this paper outlines the process of designing and analyzing phishing experiments in an ethical manner, and in accordance with the principles and regulations guiding IRBs     

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.     

基于ARM的四路锂电池充电器设计

随着便携式电子产品的迅速发展,锂电池的使用也越来越广泛。为解决多种锂电池电子产品快速充电的问题,应用STM32单片机设计制作了一种智能化四路锂电池充电器。设计集成了四路充电回路,各个回路独立控制,互不影响。通过模拟开关来分别选通充电回路,利用按键来选择初始化充电参数,采用PWM波来调节锂电池的充电过程。经过实验验证,在保证充电时间的前提下,此设计能有效实现多路同时充电,而且通过按键选择,可以选择为3．7 V和7．4V2种大小的锂电池充电。     

面向错峰潜力分析的典型用户筛选

错峰潜力估计是精细化有序用电管理的基础。基于用户电量峰谷特征,采用模糊C-均值聚类对同行业用户进行灵活分类,再从聚类结果中依据同类用户峰谷重心和电量水平特征,筛选出该行业各类典型用户,建立了一套可用于错峰潜力分析的典型用户筛选方法。经某地36个行业实例分析,共得出146个典型用户,因篇幅所限只给出了通用及专用设备制造业的3个典型用户的筛选过程以及该行业的错峰潜力分析,结果验证了所提筛选方法的可行性与有效性。     

Balancing technical and social issues: a new first-year designcourse

The new ABET EC2000 accreditation guidelines call for greater emphasis on social and ethical issues in the education of engineering students. Universities are responding in varied ways - generally through increased liberal arts content and, in a few instances, through design activities, but generally, design education focuses primarily on the technical and process aspects. This is especially true in the new first-year engineering design courses that have evolved in the 1990s. A first-year “Introduction to Engineering Design” course has been developed at the University of Dayton that seeks to achieve a balance between technical, social and ethical issues throughout the design process to help ground the education of engineering students with the ideals of social and ethical responsibility as part of their profession. This grounding has been achieved through interdisciplinary projects, which teach students, through self-discovery, the relevance of social, environmental, cultural, political and ethical factors to their normal engineering functions     

基于聚类分析和层次分析法的电力客户信用评价研究

对于市场化运营的电力公司,有效的信用管理是一项非常必要的工作。事先预知电力客户的信用等级,是电力公司防范欠费风险、实施差异化客户服务的重要前提。在建立电力客户信用评价指标体系的基础上,使用聚类分析算法,对已经预处理的大量电力客户样本指标数据进行快速地、客观地信用分类;然后利用层次分析法灵活确定指标权重;最后根据每一类客户样本的中心点计算信用分值,并以此代表该类用户的信用水平,进而进行等级评定。同时,根据某供电公司的数据,对信用评价做了算例分析。计算结果表明了所使用的方法具有快速、准确且有效的特点。     

Engineering and the law. Public policy and the preemption of statetort claims against medical device manufacturers

As the settlement of breast implant cases illustrate, the dynamics of the tort system are such that safe products can still be driven from the market by emotional pleas to juries. Given the importance of medical devices in modern medicine, it is critical that the legal system limit tort claims against medical device manufacturers. While it may ultimately be necessary for Congress to create a statutory compensation system for medical device injuries, the best short-term chance for relief of the pre-emption of tort claims is found in the MDA     

Ethical issues in managed care

"Within the next ten years almost all insured Americans will obtain medical services through managed care" (Dallek and Geraldine, press release, 1995). The emergence and expected dominance of managed care has transformed every dimension of health care and created new ethical and policy questions. In particular, it has reshaped the physician-patient relationship and threatens the physician's role as a patient advocate. The author's aim in this article is to set out some of the major ethical issues in these two areas. This review only discusses some of the most obvious and pressing ethical problems in managed care.     

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

For pt.I see ibid., vol.9, no.2, p.79-81 (1990). The ethical issues raised by the fact that patients/subjects are less protected in non-investigational-device-exemption (non-IDE) use of unapproved medical devices than in IDE use are examined. Practice, research, and nonvalidated practice, an intervention that falls into the region between pure practice and pure research, are defined and examined with respect to non-IDE use of unapproved medical devices. Two types of non-IDE use are considered: that which would be permitted under the feasibility studies mechanism, and emergency use. Ethical issues in both cases are discussed. It is concluded that the Food and Drug Administration (FDA) must not only expand the freedom of scientific investigators to develop new medical devices, allowing flexibility in defined non-IDE contexts that will not jeopardize the safety or welfare of patients, but also clearly and concisely define the procedures which outline this expanded freedom.     

配合医疗市场发展趋势的安森美医疗半导体解决方案

安森美半导体多款医疗半导体产品居于领先地位。通过提供完整的医疗半导体解决方案,帮助创新型医疗电子产品实现更高的集成度、高能效、便携性等特性,配合医疗设备智能化、移动化等趋势的发展。     

配电网重要电力用户停电损失及应急策略

重要电力用户的停电损失占配电网总体停电损失的绝大部分。建立了重要电力用户的配电网负荷模型、系统模型和费用损失模型,对系统可靠性和经济性进行了分析。从设计用户调查表入手,建模确定生产过程复杂、损失巨大的大工业类用户及其它类用户的停电损失函数,从而建立负荷模型。采用故障模式后果分析法选取正确的配电系统可靠性指标对负荷点可靠...