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FDA regulation of technology and surgical devices in the operating room.

Federal regulation of medical devices began in 1976 with the signing of the Medical Device Amendments to the Food, Drug and Cosmetic Act. For the purpose of regulating medical devices, the Food and Drug Administration is divided into various divisions and branches, including the Office of Device Evaluation. The evolution of the Food and Drug Administration's regulations of laparoscopic devices is described. Also described is the technology of laparoscopic surgical devices and how they are regulated by the Office of Device Evaluation. Trends towards the future of laparoscopic devices, and their regulation, are reviewed.

Biomedical Technology↗

The use of technologies to decrease peri-operative allogenic blood transfusion: results of practice variation in Israel.

BACKGROUND: Concern about the side effects of allogeneic blood transfusion has led to increased interest in methods of minimizing peri-operative transfusion. Technologies to minimize allogeneic transfusion include drugs such as aprotinin, desmopressin, tranexamic acid and erythropoietin, and techniques such as acute normovolemic hemodilution, cell salvage and autologous pre-donation. OBJECTIVE: To survey the current use in Israel of these seven technologies to minimize allogeneic blood transfusion. METHODS: Our survey was conducted in 1996-97 in all hospitals in Israel with more than 50 beds and at least one of the following departments: cardiac or vascular surgery, orthopedics, or urology. All departments surveyed were asked: a) whether the technologies were currently being used or not, b) the degree of use, and c) the factors influencing their use and non-use. The survey was targeted at the heads of these departments. RESULTS: Pharmaceuticals to reduce allogeneic blood transfusion were used in a much higher proportion in cardiac surgery departments than in the other three departments. Pre-operative blood donation was used in few of the cardiac, urologic and vascular surgery departments compared to its moderate use in orthopedic departments. The use of acute normovolemic hemodilution was reported in a majority of the cardiac departments only. Moderate use of cell salvage was reported in all departments except urology where it was not used at all. CONCLUSION: There is considerable practice variation in the use of technologies to minimize exposure to peri-operative allogeneic blood transfusion in Israel.

Aprotinin↗

Developing the European core curriculum in renal technology.

Working within the multi-professional team, renal technicians play a greater part in the functioning of renal units than in other less technical areas of care. The role of the renal technician has been changing and, is now one that often combines technical, scientific and clinical knowledge in utilizing technology so that the long-term outcomes of the patient are optimised and complications reduced. Therefore a sound knowledge base is vital in ensuring patients' safety. Whilst still centered on the traditional engineering functions such as equipment repair and maintenance, the curriculum is structured to give a broad overview of renal related physiology, chemistry, treatment modalities and technology. The inclusion of these more clinical aspects in the curriculum reflects the change in the technician's role to a more science-based approach.

Allied Health Personnel↗

Neurology, technology, and the diagnostic imperative.

Advancements in diagnostic technologies have revolutionized the field of neurology. The use of these tools in the course of neurological evaluations is driven by a strong version of the diagnostic imperative, with the goal of precisely identifying the locus and extent of disease processes. Because of the discrepancy between the sophistication of these technologies and the availability of therapeutic interventions, there is active debate regarding the appropriate use of these tools when the diagnosis is clear, or when no change is made to the therapeutic management. A narrow view of management that is bounded by the availability of pharmacological or surgical interventions results in a more rigid dichotomy between the needs of doctors and patients. A broader view that relaxes the constraint between diagnostic procedures and interventions is more in keeping with the observation that many acts are performed for the benefit of doctors and patients alike. An historical and ethical analysis of the diagnostic imperative, with attention to the rise of innovative medical technologies and current concepts of therapeutic intervention, can help clarify the principles of medical paternalism and beneficence that guide current models of decision making in the neurological sciences.

Biomedical Technology↗

How place matters: unpacking technology and power in health and social care.

The devolution of care into nontraditional community-based settings has led to a proliferation of sites for health and social care. Despite recent (re)formulations of 'evidence-based' approaches that stress the importance of optimizing interventions to best practice by taking into account the uniqueness of place, there is relatively little guidance in the literature and few attempts to systematically 'unpack' key dimensions of settings most relevant to policy, practice and research. In this paper, we explore how place matters for health and social care. In effect, we propose making place the lens through which to view practice, and not simply an interesting sideline focus. We focus specifically on (a) the emplacement of power relations in health and social care in and across settings; and (b) the pervasive (and often unrecognised) influence of technology on and in place (both 'mundane' and more visible 'high' technologies) as arguably among the most significant and pervasive (and often overlooked) dimensions of place pertinent to health and social care in both traditional (institutional) and nontraditional (community) settings. Drawing on diverse disciplinary literatures, we seek to make visible certain issues and bodies of work that health professionals may not be aware of, and which often remain inaccessible to practitioners and applied researchers on account of their density, complexity, and specialised terminology. In particular, drawing on the rich tradition of cultural studies, we advance the culture of place as a rubric for understanding the complex interrelationship between power, technology, culture, and place. Several fruitful avenues for place-sensitive research of health and social care practice (and its effects) are suggested.

Benchmarking↗

Healthwear: medical technology becomes wearable.

Widespread adoption of sensors that monitor the wearer's vital signs and other indicators promises to improve care for the aged and chronically ill while amassing a database that can enhance treatment and reduce medical costs.

Biomedical Technology↗

Cross-national comparisons of health systems using OECD data, 1999.

This paper presents selected components of the most recent (1999) Organization for Economic Cooperation and Development (OECD) Health Data. Previous trends in spending for health care, supply and use of health care resources, and health status are updated for the thirty industrialized countries in the OECD. In 1999 the United States spent 53 percent more on health care than any other OECD country spent. The paper reviews two possible reasons for the difference: economic development and population aging. It discusses spending, supply, and utilization for specific categories of health care services: pharmaceuticals, physicians, hospitals, and high-technology services. The paper concludes with a consideration of the strengths and weaknesses of using OECD data to compare health systems.

Actuarial Analysis↗

Emotion and cardiac technology: an interpretive study.

This paper presents a frequently overlooked aspect of advanced technological care--that of the human dimension and emotions. Emotionality is defined as the emotional ways that a client experiences their embodied experience as a recipient of a cardiac pacemaker. One individual's story from a larger interpretive study of clients who received pacemakers is presented and interpreted. Kev's story encapsulates the difficulties of dealing with and understanding cardiac technology. When Kev's heart malfunctions he confronts a new reality; an experience where the 'technological body' is linked confusingly with emotion. This complex interplay between technology, the body and emotionality is discussed to demonstrate the importance of the mediating role that nurses can and should play in clients' adaptation and recovery.

Aged↗

Motion aware clothing for the personal health assistant.

This paper sketches the vision and first results of a 'Personal Health Assistant' PHA, opening up new vistas in patient centred healthcare. The PHA is comprised of a wearable sensing and communicating system, seamlessly embedded in daily clothing. Several on-body sensors monitor the biometric and contextual status of the wearer continuously. The embedded computer fuses the vital and physiological data with activity patterns of the wearer and with the social environment; based on these data the on-body computer generates the 'Life Balance Factor' LBF as an individual feedback to the user and to the surroundings afford-ing effective disease prevention, management and rehabilitation, the last also involving telemedicine. The state-of-the-art enabling technologies: smart textile technology and miniaturization of electronics combined with wireless communication, along with recent developments in wearable computing are presented and assessed in the context of multiparameter health monitoring.

Biomedical Technology↗

Review of technology: planning for the development of telesonography.

Teleradiology allows contemporaneous interpretation of imaging exams performed at some distance from the interpreting radiologist. The transmitted images are usually static. However, there is benefit to real-time review of full-motion ultrasound (US) exams as they are performed. Telesonography is transmission of full-motion sonographic data to a remote site. We hypothesize that US exams, read after having been compressed utilizing Motion Picture Experts Group version 4 (MPEG-4) compression scheme, transmitted over the Internet as streaming multimedia, decompressed, and displayed, are equivalent in diagnostic accuracy to reading the examinations locally. MPEG-4 uses variable compression on each image frame to achieve a constant output bit rate. With less compression, the bit rate rises, and the only way the encoder can contain bit rate within the set bandwidth is by lowering frame rate or reducing image quality. We review the relevant technologies and industry standard components that will enable low-cost telesonography.

Biomedical Technology↗

Population health technologies: emerging innovations for the health of the public.

At the beginning of the 21st century, we are at the dawn of a possibly unprecedented era of scientific discovery and promise. Emerging technologies, including information and communication technologies, genomics, microelectromechanical systems, robotics, sensors, and nanotechnologies, provide enormous opportunities for population health improvement. Population health technology refers to the application of an emerging technology to improve the health of populations. Emerging technologies present an opportunity for addressing global health challenges-in both developed and developing countries. Health issues ripe for the application of new technologies include disease surveillance and control, environmental monitoring and pollution prevention, food safety, health behavior change, self-care, population screening, and chronic disease and injury prevention and control. If appropriately applied, population health technologies may greatly enhance existing health intervention models. However, potential adverse consequences could arise related to privacy, confidentiality, and security; quality and effectiveness; sustainability; and the technology divide. To ensure the optimal development and diffusion of population health technologies will require balancing these risks and benefits while simultaneously adopting new mechanisms of public and private support for research and development in this potentially important new domain of public health.

Biomedical Technology↗

Platform technologies to support brain-computer interfaces.

There is a lack of adequate and cost-effective treatment options for many neurodegenerative diseases. The number of affected patients is in the millions, and this number will only increase as the population ages. The developing areas of neuromimetics and stimulative implants provide hope for treatment, as evidenced by the currently available, but limited, implants. New technologies are emerging that are leading to the development of highly intelligent, implantable sensors, activators, and mobile robots that will provide in vivo diagnosis, therapeutic interventions, and functional replacement. Two key platform technologies that are required to facilitate the development of these neuromimetic and stimulative implants are data communication channels and the devices' power supplies. In the research reported in this paper, investigators have examined the use of novel concepts that address these two needs. These concepts are based on ionic volume conduction (VC) to provide a natural communication channel to support the functioning of these devices, and on biofuel cells to provide a continuously rechargeable power supply that obtains electrons from the natural metabolic pathways. The fundamental principles of the VC communication channels, including novel antenna design, are demonstrated. These principles include the basic mechanisms, device sensitivity, bidirectionality of communication, and signal recovery. The demonstrations are conducted using mathematical and finite element analysis, physical experiments, and animal experiments. The fundamental concepts of the biofuel cells are presented, and three versions of the cells that have been studied are discussed, including bacteria-based cells and two white cell-based experiments. In this paper the authors summarize the proof or principal experiments for both a biomimetic data channel communication method and a biofuel cell approach, which promise to provide innovative platform technologies to support complex devices that will be ready for implantation in the human nervous system in the next decade.

Animals↗