Infection control, decontamination, and the clinical engineer.
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OBJECTIVE: To provide physicians with a responsible assessment of bioelectrical impedance analysis (BIA) technology for body composition measurement. PARTICIPANTS: A non-Federal, nonadvocate, 13-member panel representing the fields of nutrition, pediatrics, surgery, public health, biomedical engineering, epidemiology, and biostatistics. In addition, 20 experts in nutrition, pediatrics, metabolism, biomedical engineering, physiology, and epidemiology presented data to the panel and a conference audience of 220. EVIDENCE: The literature was searched through Medline and an extensive bibliography of reference was provided to the panel and the conference audience. Experts prepared abstracts with relevant citations from the literature. Scientific evidence was given precedence over clinical anecdotal experience. ASSESSMENT PROCESS: The panel, answering predefined questions, developed their conclusions based on the scientific evidence presented in open forum and the scientific literature. The panel composed a draft statement that was read in its entirety and circulated to the experts and the audience for comment. Thereafter, the panel resolved conflicting recommendations and released a revised statement at the end of the conference. The panel finalized the revisions within a few weeks after conference. CONCLUSIONS: BIA provides a reliable estimate of total body water under most conditions. It can be a useful technique for body composition analysis in healthy individuals and in those with a number of chronic conditions such as mild-to-moderate obesity, diabetes mellitus, and other medical conditions in which major disturbances of water distribution are not prominent. BIA values are affected by numerous variables including body position, hydration status, consumption of food and beverages, ambient air and skin temperature, recent physical activity, and conductance of the examining table. Reliable BIA requires standardization and control of these variables. A specific, well-defined procedure for performing routine BIA measurements is not practiced. Therefore, the panel recommends that a committee of appropriate scientific experts and instruments manufacturers be formed with the goal of setting instruments standards and procedural methods.
Northern California Kaiser Foundation Hospitals' Biomedical Engineering developed a regional rental medical equipment management program in response to the revised 1989 Joint Commission's Health Care Organization Accreditation Standards. The program shifts the operational and safety responsibility for the equipment from the hospitals to the rental vendor. Rental vendors who agreed to Biomedical Engineering's performance standards became preferred vendors from which Kaiser Foundation Hospitals rented their equipment. This program has become a standard adopted by other hospitals that are members of BAMMI (Bay Area Managers of Medical Instrumentation).
It is recommended to standardize the biomedical engineering terminology by making use of greek latin terminological elements. The designations of biomedical engineering products should include terms featuring the fundamental functions of their technical arrangements, viz. the type of action, the method of examination, the surgical manipulation, the kind of treatment, by retaining the already established clinical terms. The second part in the designation of the technical arrangement should carry the name of the organ, cavity, region and system of the organism, of the tissue, etc, for whose handling the instrument or apparatus is intended.
With growing dependence on picture archiving and communication systems for viewing images, a quality assurance program to monitor the condition of workstation displays has become increasingly important. At present there is no universally accepted program for PACS, but there are groups such as DICOM Working Group 11 of the ACR-NEMA and AAPM Task Group 18 that are working on image quality guidelines for interpretation from soft-copy displays. Texas Children's Hospital (TCH) is developing our own quality assurance program. Data is being collected to determine the appropriate frequency of calibration, the useful life of the displays, appropriate manufacturers, and model-dependent limits on maximum and minimum luminance (black level), symptoms of degradation, and monitor cleanliness. Our system includes a variety of monitors manufactured by Sun, AFP, Siemens, Image Systems, Barco, and Orwin. We are presently collecting data on individual monitor luminance functions but have not yet initiated service calls based on deviation from the DICOM Part 14 Grayscale Display Function (GSDF). The GSDF was intended to produce a grayscale in which driving levels produce changes in luminance that are perceptually equivalent throughout the entire luminance range for a specific test target. Our data is based on measurements of luminance from a digital Society of Motion Picture and Television Engineers (SMPTE) test pattern, which is a standard used by many other institutions. TCH's biomedical engineer measures luminance data each month from the display of the SMPTE pattern and record the results in a spreadsheet. The engineer also makes subjective evaluations of sharpness, geometric distortion, and artifacts. When a monitor's luminance falls outside of arbitrary 10% limits of maximum or minimum luminance, then a service call is placed to the vendor. The luminance check by the biomedical engineer is used to verify both routine and unscheduled calibrations. In addition to the monthly monitor checks, the vendor calibrates the monitor every three months. The vendor checks the following: width and height of display, focus and position of image, SMPTE test pattern, and a graph of the GSDF Index produced by an automatic calibration software by the video driver card. Monitors are also cleaned occasionally for dust, fingerprints, ink, and pencil marks, which accumulate with routine use. This paper reports data collected to date on luminance drift, as well as conclusions on appropriate frequency of test and calibration, and our experience with monitor useful life.
Recent developments in the field of Biomedical Engineering have led to considerable improvement in health care delivery, but also impose continuous change and improvement in education and training schemes of its professionals, in order to assure appropriate front-line knowledge, competencies and skills. Open and distance learning provides a very effective means for continuous education and training purposes. Image processing may be used as an attractive case for exploring the Collaborative Learning Model (CLM) paradigm in Open Distance Learning (ODL). An on-line course on Medical Image Processing, following the principles of collaborative learning, has been developed and evaluated. Each concept of the course is available in three levels of complexity. The first level shows only a very general description, actually the main idea. If the user is interested to continue, a second level is accessible, where the concept is explained in a more detailed manner. Moreover, for some concepts requiring complicated mathematical proofs, a third level is available. The course has been used at the European Course on Biomedical Engineering organized by the Department of Medical Physics, University of Patras, Greece, and was positively evaluated by the students.
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.
PURPOSE OF REVIEW: Regenerative medicine holds promise for the restoration of tissues and organs damaged by wear, trauma, neoplasm, or congenital deformity. Tissue engineering combines the disciplines of cell biology and biomedical engineering to effect the design and maturation of various tissues. Despite progress in some areas of tissue regeneration, there has not been significant translation to clinical practice. This article reviews the present understanding of and advances in regenerative medicine, as well as describing limitations in current techniques and areas that need further development. A discussion of the state of the art in the regeneration of skin, cartilage, bone, adipose tissue, and neural tissue is included. RECENT FINDINGS: Differences between extracorporeal and in-vitro tissue engineering are discussed, as well as tissue engineering principles, including the use of bioactive scaffolds, progenitor cells and stem cells, the need for cellular and tissue patterning, microcirculation development, and the use of external stimuli for differentiation. Much needs to be learned about progenitor cell biology, cell-cell interactions, cellular interactions with the extracellular matrix, and about the cues needed for differentiation of functional tissues. SUMMARY: The current limitations in regenerative medicine techniques and the gaps in current knowledge of cellular biology and tissue development represent significant research opportunities in tissue engineering.
The beneficial therapeutic effects of selected low-energy, time-varying magnetic fields, called PEMFs, have been documented with increasing frequency since 1973. Initially, this form of athermal energy was used mainly as a salvage for patients with long-standing juvenile and adult nonunions. Many of these individuals were candidates for amputation. Their clearly documented resistance to the usual forms of surgical treatment, including bone grafting, served as a reasonable control in judging the efficacy of this new therapeutic method, particularly when PEMFs were the sole change in patient management. More recently, the biological effectiveness of this approach in augmenting bone healing has been confirmed by several highly significant double-blind and controlled prospective studies in less challenging clinical circumstances. Furthermore, double-blind evidence of therapeutic effects in other clinical disorders has emerged. These data, coupled with well-controlled laboratory findings on pertinent mechanisms of action, have begun to place PEMFs on a therapeutic par with surgically invasive methods but at considerably less risk and cost. As a result of these clinical observations and concerns about electromagnetic "pollution", interactions of nonionizing electromagnetic fields with biological processes have been the subject of increasing investigational activity. Over the past decade, the number of publications on these topics has risen exponentially. They now include textbooks, speciality journals, regular reviews by government agencies, in addition to individual articles, appearing in the wide spectrum of peer-reviewed, scientific sources. In a recent editorial in Current Contents, the editor reviews the frontiers of biomedical engineering focusing on Science Citation Index methods for identifying core research endeavors. Dr. Garfield chose PEMFs from among other biomedical engineering efforts as an example of a rapidly emerging discipline. Three new societies in the bioelectromagnetics, bioelectrochemistry, and bioelectrical growth and repair have been organized during this time, along with a number of national and international committees and conferences. These activities augment a continuing interest by the IEEE in the U.S. and the IEE in the U.K. This review focuses on the principles and practice behind the therapeutic use of "PEMFs". This term is restricted to time-varying magnetic field characteristics that induce voltage waveform patterns in bone similar to those resulting from mechanical deformation. These asymmetric, broad-band pulses affect a number of biologic processes athermally. Many of these processes appear to have the ability to modify selected pathologic states in the musculoskeletal and other systems.(ABSTRACT TRUNCATED AT 400 WORDS)
Tissue engineering is a new field in biomedical engineering. In this review, progress in the field of tissue engineering is presented in detail, including a general introduction, design and fabrication principles, key technologies, various applications, new directions, as well as related market and R&D issues.
Biomedical engineering approaches used to develop controlled-release delivery systems for hormones are here reviewed regarding system design and therapeutic applications. The biomedical engineering approach uses a system of non-drug components to control the rate and duration of hormone delivery. The non-drug components vary from system to system, but generally include: a reservoir for the hormone; a barrier or regulator to contain the hormone within the reservoir and to control its release; an energy source to remove the hormone from the reservoir; and a pathway for egress of the hormone from the system. Controlled-release delivery systems for hormones discussed in this review include mechanical and osmotic pumps; intraocular, intravaginal and intrauterine platform devices; biodegradable and non-biodegradable subcutaneous implants; and small particulate systems including microcapsules, microspheres and liposomes. Examples of the therapeutic application of the various systems are given along with a discussion of design factors and pharmacological aspects relevant to their clinical use.