On not compensating for bad outcomes to biomedical innovations: a response and modest proposal.
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Biomedical Technology↗
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Results for “Technology Assessment, Biomedical”
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Outcomes research and the quality of health care: the beacon of an ethics of evidence.
Beyond the dazzling achievements of high-technology medicine, the spiraling cost of health care and lack of access for many have long been the subject of national debate. Driven by the interaction of powerful economic forces, managed care is now taking over the health care system, while there is growing popular interest in alternative medicine. But amid the changing structures and financial incentives, much uncertainty still remains concerning the safety and effectiveness of medical interventions. The author, a mathematical scientist engaged in medical research and education for more than 30 years, has proposed the "ethics of evidence" as an approach to medical uncertainty, to be adopted as a vital component of biomedical ethics. The ethics of evidence comprises two imperatives. The first imperative calls for the creation, dissemination, and use of the best possible scientific evidence as a basis for every phase of medical decision making. Complementing it, the second imperative focuses on the need to increase awareness of, and come to terms with, the extent and ultimately irreducible nature of uncertainty. After a brief sketch of the genesis of this concept, the ethics of evidence is further explored here in the context of current outcomes research, the focus on quality of health care, and related problems of contemporary medicine.
Biomedical Research↗
Analysis of a survey of 36 French research committees on intracytoplasmic sperm injection.
BACKGROUND: In France, when a new medical technology is to be applied experimentally to human beings, it must adhere to the principles stipulated by the Huriet-Sérusclat law on biomedical research. This law requires that the validation of a protocol applicable to human beings, with its corollary protection and information dimensions, is first submitted to a research committee, known as a Consultative Committee Protecting Persons in Biomedical Research (CCPPRB). We aimed to survey the competence of these committees in biotechnology, and whether or not intracytoplasmic sperm injection (ICSI) had been considered by the committees as being an innovative treatment. METHODS: We presented each of France's 48 CCPPRBs with a questionnaire to assess the choices and criteria for making decisions that arose at the time ICSI was implemented in the different centres in each region. FINDINGS: 36 committees took part. We found that ICSI had been largely introduced in settings outside the scope of the CCPPRBs and of the framework fixed by the law on biomedical research. Only three centres for medically assisted reproduction had submitted applications to a CCPPRB, although ICSI has been implemented in over 20 centres. 21 (58%) committees were of the opinion that the implementation of ICSI could have come under their supervision. 24 (67%) committees believed that, independently of their own involvement, evaluation procedures for ICSI should have been specified before centres decided to introduce it. INTERPRETATION: We observed important differences in the way CCPPRBs handled ICSI as being within or outside the medical research field. The status of the research committees is legally and identically defined. However, committees did not agree on the definition of the limits of their action, and, therefore, their handling of the same issue differed. An inquiry is needed to define how, now that ICSI is done in many centres, it should adhere to principles of evaluation and safety already in existence for other medical technologies.
Ethical Review↗
Biochips beyond DNA: technologies and applications.
Technological advances in miniaturization have found a niche in biology and signal the beginning of a new revolution. Most of the attention and advances have been made with DNA chips yet a lot of progress is being made in the use of other biomolecules and cells. A variety of reviews have covered only different aspects and technologies but leading to the shared terminology of "biochips." This review provides a basic introduction and an in-depth survey of the different technologies and applications involving the use of non-DNA molecules such as proteins and cells. The review focuses on microarrays and microfluidics, but also describes some cellular systems (studies involving patterning and sensor chips) and nanotechnology. The principles of each technology including parameters involved in biochip design and operation are outlined. A discussion of the different biological and biomedical applications illustrates the significance of biochips in biotechnology.
Biosensing Techniques↗
The global capacity for manufacturing vaccines. Prospects for competition and collaboration among producers in the next decade.
Can the world respond to the demands of the Children's Vaccine Initiative (CVI) to produce large quantities of affordable vaccines that have never been manufactured previously? Vaccines for the world's birth cohort of 150 million will continue to be produced in the countries that use the greatest part of the global vaccine supply. Thus, the CVI will rely on increased self sufficiency in vaccine production in the developing world and "shared development" of new and improved vaccines. The CVI's goal is to direct product development to meet the needs of immunization programs, but it must not neglect production. Thus, from the start, investment at the front end of the development and production sequence requires attention to the ultimate production capacity.
Child Welfare↗
The role of clinical engineering in the redesign of existing hospital patient monitoring systems.
Clinical engineering can have a key role in the redesign of existing hospital patient monitoring systems. This paper presents a systematic approach to the process of reinstrumenting highly specialized cardiovascular operating suites. A detailed definition of system requirements is presented for both basic and specialized instrument sets. Configuration flexibility was given the utmost attention. The method presented here suggests that system requirements should reflect information gathered from direct interviews of both the clinical and support personnel. Consideration is given to all applicable codes, standards, and practices. Special attention must also be focused on proper and efficient interfacing of the components of the new system to all components of the existing system. The project described here was conducted within and supported by the University of Alabama Hospital of the University of Alabama at Birmingham.
Alabama↗
The roles of biomedical maintenance branch, automation management & informatics departments throughout a clinical information systems's life cycle.
The introduction of new technology, such as a Clinical Information System (CIS), requires hospitals to re-evaluate the roles of the Biomedical Maintenance Branch, Automation Management, and Informatics departments. This paper describes the process a 400-bed hospital underwent to resolve role ambiguity among the three activities. The institution's goal was to reach an optimal solution to using the resources offered by each activity through redrawing lines of responsibilities. This experience demonstrated that relationships among departments are dynamic and vary depending on the stage of the CIS life cycle.
Biomedical Engineering↗
Emerging technologies and medical coverage.
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Biomedical Technology↗
The evolution of medical uncertainty.
Modern developments of scientific medicine have uncovered and created uncertainties and risks that were previously not known or experienced; the stakes have become very much higher. The rise in public expectation, however, is paralleled by a lowered tolerance of uncertainty. Metaphors of "deliverance" and "disaster" abound in discussions of scientific discovery, reflecting differing conceptions and philosophies about errors and mistakes, and the role they play in the physical universe, the biosphere, and human affairs. These concerns highlight the difficulties and dilemmas of finding scientifically adequate, culturally appropriate, and socially effective ways of appraising and controlling risk.
Adult↗
A perspective on medical infrared imaging.
Since the early days of thermography in the 1950s, image processing techniques, sensitivity of thermal sensors and spatial resolution have progressed greatly, holding out fresh promise for infrared (IR) imaging techniques. Applications in civil, industrial and healthcare fields are thus reaching a high level of technical performance. The relationship between body temperature and disease was documented since 400 bc. In many diseases there are variations in blood flow, and these in turn affect the skin temperature. IR imaging offers a useful and non-invasive approach to the diagnosis and treatment (as therapeutic aids) of many disorders, in particular in the areas of rheumatology, dermatology, orthopaedics and circulatory abnormalities. This paper reviews many usages (and hence the limitations) of thermography in biomedical fields.
Diagnostic Imaging↗
Reengineering the biomedical-equipment procurement process through an integrated management information system.
The design of each new hospital site is typically preceded by decisions on the most appropriate level of biomedical equipment which significantly influences the layout of the hospital departments which are under construction. The most appropriate biomedical equipment should ideally be decided upon considering a series of demographic and social parameters of the hospital and international regulations and standards. This information should ultimately be distilled to proper technical specifications. This paper proposes a streamlined management process related to the procurement of biomedical equipment for new hospital sites or for those under expansion. The new management process aims to increase the efficiency of the experts involved in the definition of the most appropriate level of equipment and its technical specifications. It also addresses all aspects of the biomedical equipment-selection cycle, including the evaluation of the bids submitted by the equipment suppliers. The proposed process is assisted by a management information system, which integrates all related data-handling operations. It provides extensive decision-support facilities to the expert and a platform for the support of knowledge re-use in the field of biomedical-equipment selection.
Competitive Bidding↗
If there's a will, is there a way?
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Advisory Committees↗
Surface-enhanced Raman scattering studies on immunoassay.
Surface-enhanced Raman scattering (SERS) has recently been a matter of keen interest from the points of both basic science and applications because by using the SERS effect one can obtain Raman signals even from a single molecule. Immunoassay is one of the most promising fields in the applications of SERS, and the purpose of this review paper is to discuss the potential of SERS in immunoassay. This paper consists of four parts work on the indirect and direct methods of immunoassay via SERS. These methods provide the laboratorial attempts on biomedical diagnostic applications of SERS.
Biosensing Techniques↗
Creating tissue microarrays by cutting-edge matrix assembly.
Tissue microarrays have become widely adopted for effective parallel in situ analysis of hundreds of tissues placed onto single slides. Traditionally, tissue core punches are transferred into predrilled holes within a scaffold block of paraffin or other material, and sectioned transversely by a microtome to generate array sections. While core-based arraying has greatly advanced tissue analyses, some of the limitations include restricted feature sizes and numbers, variable core depths of unpredictable tissue quality and inability to array thin-walled, stratified tissue samples such as intestines, vessels or skin. Overcoming these limitations, the authors have developed a practical arraying method that combines serial cutting and edge-to-edge bonding of samples to assemble a scaffold-free array matrix -- cutting-edge matrix assembly. Using cutting-edge matrix assembly, the authors have successfully placed more than 10,000 individual tissue pieces on a single histology glass slide. The potential biomedical utility and ongoing efforts to further develop the assembly technology and analysis of high-density cutting-edge matrix assembly tissue microarrays is discussed.
Equipment Design↗
Health services technology: Part 2, Policy and managerial considerations.
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American Hospital Association↗
Ethics and evidence.
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Biomedical Technology↗
Focus on: Washington Hospital Center, Biomedical Engineering Department.
The Biomedical Engineering Department of the Washington Hospital Center provides clinical engineering services to an urban 907-bed, tertiary care teaching hospital and a variety of associated healthcare facilities. With an annual budget of over $3,000,000, the 24-person department provides cradle-to-grave support for a host of sophisticated medical devices and imaging systems such as lasers, CT scanners, and linear accelerators as well as traditional patient care instrumentation. Hallmarks of the department include its commitment to customer service and patient care, close collaboration with clinicians and quality assurance teams throughout the hospital system, proactive involvement in all phases of the technology management process, and shared leadership in safety standards with the hospital's risk management group. Through this interactive process, the department has assisted the Center not only in the acquisition of 11,000 active devices with a value of more than $64 million, but also in becoming one of the leading providers of high technology healthcare in the Washington, DC metropolitan area.
Biomedical Engineering↗
A study on the current situation in the biomedical technology and clinical engineering sector in Bulgaria--advances, trends and needs.
A survey of the clinical engineering sector in Bulgaria was carried out, within the context of the 1996 Phare Partnership Program, with the aim to provide a reflection of the current situation concerning the management of biomedical technology and investigate the relevant needs in hospitals. The survey was initiated by the Institute of Biomedical Technology (INBIT) in Patras, Greece, with the active support of national organizations, educational institutions and other parties that share involvement in the overall management of medical devices in Bulgaria. This paper summarizes the results of the survey, giving an insight into the situation in the field and providing the basis for a more thorough study on the Biomedical Technology and Clinical Engineering sectors in Bulgaria.
Biomedical Engineering↗