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PubMed2002

Safety of intraoperative transcranial electrical stimulation motor evoked potential monitoring.

This article reviews intraoperative transcranial electrical stimulation (TES) motor evoked potential (MEP) monitoring safety based on comparison with other clinical and experimental brain stimulation methods and clinical experience in more than 15000 cases. Comparative analysis indicates that brain damage and kindling are highly unlikely. There have been remarkably few adverse events. Pulse train TES-induced or coincidental seizures (n = 5) are rare, probably because of very brief (<0.03 second) stimuli, anesthesia, and the general absence of predisposing cerebral conditions. Soft bite blocks may prevent tongue or lip laceration (n = 29) or mandibular fracture (n = 1). Rare cardiac arrhythmia (n = 5) and intraoperative awareness (n = 1) may be coincidental. Minor scalp burns (n = 2) are rare. Although possible, no spinal epidural recording electrode complications or injuries resulting from TES-induced movement were found. There have been no recognized adverse neuropsychological effects, headaches, or endocrine disturbances. Comprehensive relative contraindications include epilepsy, cortical lesions, convexity skull defects, raised intracranial pressure, cardiac disease, proconvulsant medications or anesthetics, intracranial electrodes, vascular clips or shunts, and cardiac pacemakers or other implanted biomedical devices. Otherwise unexplained intraoperative seizures and possibly arrhythmias are indications to abort TES. With appropriate precautions in expert hands, the well-established benefits of TES MEP monitoring decidedly outweigh the associated risks.

Affect↗
PubMed1986

Extracorporeal shock wave lithotripsy: status of second generation lithotripters.

Since the Food and Drug Administration (FDA) approved the $2 million Dornier lithotripter for general distribution in December 1984, many hospitals and urology groups have expressed interest in acquiring this technology. In fact, more than 40 lithotripters were installed in the United States in 1985, and approximately 50 are scheduled for delivery in 1986. Although the Dornier lithotripter has wide appeal to urologists, many potential buyers cannot afford to purchase this technology. Even special interrelationships such as joint ventures among urologists, hospitals, and other third parties are not logistically or politically possible. As a result, a number of medical equipment firms have begun to develop so-called "second generation" lithotripters. These second generation units have generated a great deal of enthusiasm among those who are locked out of the Dornier market because of cost constraints. They are projected to cost less than one-half as much as the Dornier lithotripter, and may be capable of being used for a number of urological applications. As of March 1986, we have identified six firms in the United States and Europe that are developing second generation units. In the United States, International Biomedics, Inc., Medstone International, and Northgate Research, a Division of Monaghan Medical Corporation; and in France, Edap and Technomed International have all informed urologists and other interested parties in the U.S. about their research and development efforts. Several sources have also indicated that the Siemens Corporation in West Germany has begun to develop a second generation lithotripter.(ABSTRACT TRUNCATED AT 250 WORDS)

Equipment Design↗
PubMed2006

Research ethics: challenges in the Eastern Mediterranean Region.

The foundations of ethical principles in the Eastern Mediterranean Region can be found within the 3 major religions of the Region; Judaism, Christianity and Islam. Today, there are numerous ethical issues that have emerged as result of the technological advances of the 20th century and this paper addresses some of those related to biomedical research. The Islamic principles in relation to medicine and biomedical research are described, and in particular research involving human subjects. The paper also outlines the endeavours being made by the Islamic Organization for Medical Sciences to address such issues and draw up recommendations and rulings.

Abortion, Legal↗
PubMed2006

[An exploratory discussion on biological evaluation and risks for medical devices].

Biological evaluation of medical devices before clinical usage has become one of the necessary procedure. But many of medical devices which have already passed a series of biological safety evaluation do not mean that they are absolutely safe and harmless. And there are still application risks in these medical devices, because of the deficient knowledge about the interaction of biomedical materials and human tissue, limitation of the existent technology level, the indefiniteness of the evaluation system, the imperfections of present standards and so on. This essay is trying to analyze the relationship between the biological evaluation of medical devices and their application risks, and to discuss how to make a risk analysis related to biological evaluation in order to acquire a better and exact understanding of biological evaluation for medical devices.

Device Approval↗
PubMed2002

DNA microarrays in otolaryngology-head and neck surgery.

OBJECTIVES: Our goal was to review the technologies underlying DNA microarrays and to explore their use in otolaryngology-head and neck surgery. STUDY DESIGN: The current literature relating to microarray technology and methodology is reviewed, specifically the use of DNA microarrays to characterize gene expression. Bioinformatics involves computational and statistical methods to extract, organize, and analyze the huge amounts of data produced by microarray experiments. The means by which these techniques are being applied to otolaryngology-head and neck surgery are outlined. RESULTS: Microarray technologies are having a substantial impact on biomedical research, including many areas relevant to otolaryngology-head and neck surgery. CONCLUSIONS: DNA microarrays allow for the simultaneous investigation of thousands of individual genes in a single experiment. In the coming years, the application of these technologies to clinical medicine should allow for unprecedented methods of diagnosis and treatment. SIGNIFICANCE: These highly parallel experimental techniques promise to revolutionize gene discovery, disease characterization, and drug development.

Gene Expression Profiling↗
PubMed1992

The physician and the social contract.

Expenditures for health care are growing at a staggering rate, yet over 30 million Americans lack access to care. A growing population with needs, increasing administrative costs, expanding biomedical technology, and the ever-increasing expectations of patients are among the explanations for this cost. To resolve the problem, we must establish priorities, evaluate technology more carefully before application, reassess our fees as they relate to effort, and evaluate what we do for our patients as it relates to society generally. Many of the problems in health care are societal problems, but physicians as a particularly responsible and knowledgeable part of society must take the lead in finding and implementing the solutions.

Health Care Costs↗
PubMed2004

Decisions about critical events in device-related scenarios as a function of expertise.

This paper presents the perspectives of personnel involved in decision-making about devices in critical care. We use the concept of "sharp and blunt ends" of practice to describe the performance of health care professionals. The "sharp end" is physically and temporally close to the system; the "blunt end" is removed from the system in time and space and yet affects the system through indirect influence on the sharp end. In this study, the sharp end is represented by the clinicians (nurses and doctors) and the blunt end by the administrators and biomedical engineers. These subjects represent the professionals involved in the decision-making process for purchasing biomedical equipment for the hospital. They were asked to "think aloud" while evaluating three error scenarios based on real events. The responses were recorded and transcribed for analysis. The results show differences in interpretation of critical events as a function of professional expertise. The clinicians (sharp-end practitioners) focused on clinical and human aspect of errors while the biomedical engineers focused on device-related errors. The administrators focused on documentation and training. These different interpretations mean that the problems are represented differently by these groups of subjects, and these representations result in variable decisions about devices. These results are discussed within a systems approach framework to help us assess the completeness of the problem representations of the subjects, their awareness of critical events, and how these events would collectively contribute to the occurrence of error.

Decision Making↗
PubMed1988

Biomedical research councils. Their role and function in transferring information.

Biomedical research plays a great part in promoting not only advances in scientific knowledge but also in the continuous flow of technological innovations in health care. One of the first conditions for the successful transformation of research into an innovation is overcoming the divisions between science and technology, between the researchers and their partners in the innovation process. Biomedical Research Councils (BMRCs) have an important role in the transfer of information. To improve the chances of successful developments and transfers of scientific breakthroughs, the BMRCs must adopt new, comprehensive strategies for such transfer. They must learn to recognize as early as possible which new opportunities hold promise, at which stage of development information should be transferred to other areas of expertise, and which target groups in which fields should be made partners in the research.

Communication↗