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Medical technology horizon scanning.

Horizon scanning is becoming particularly important in the medical industry, in the identification and evaluation of emerging technologies. This paper examines the role biomedical engineers may have in horizon scanning new medical technologies and considers whether this is a useful activity for biomedical engineers. A horizon scanning methodology for conducting studies of emerging medical technologies is introduced, consisting of the three main phases of (a) a systematic literature review, in which a set approach is taken to the gathering of information; (b) scanning for publications across a range of different sources; and (c) consideration of the literature in relation to fixed benchmarks to indicate the quality of published information and reported achievements. This methodology has been successfully applied by the authors in a horizon scanning study for the purpose of advising a Government agency on the status of remote patient monitoring technology.

Australia↗

A standard approach to measurement uncertainties for scientists and engineers in medicine.

The critical nature of health care demands high performance levels from medical equipment. To ensure these performance levels are maintained, medical physicists and biomedical engineers conduct a range of measurements on equipment during acceptance testing and on-going quality assurance programs. Wherever there are measurements, there are measurement uncertainties with potential conflicts between the measurements made by installers, owners and occasionally regulators. Prior to 1993, various methods were used to calculate and report measurement uncertainties. In 1993, the International Organization for Standardization published the Guide to the Expression of Uncertainty in Measurement (GUM). The document was jointly published with six international organizations principally involved in measurements and standards. The GUM is regarded as an international benchmark on how measurement uncertainty should be calculated and reported. Despite the critical nature of these measurements, there has not been widespread use of the GUM by medical physicists and biomedical engineers. This may be due to the complexity of the GUM. Some organisations have published guidance on the GUM tailored to specific measurement disciplines. This paper presents the philosophy behind the GUM, and demonstrates, with a medical physics measurement example, how the GUM recommends uncertainties be calculated and reported.

Algorithms↗

Centralized maintenance responsibilities: a case study.

This paper reviews a total equipment management program that has been documented since 1983. One department was given responsibility for all maintenance activities needed for the hospital's electronic equipment, including many items that were, at the time, not maintained by most biomedical engineering departments. The department combined customer satisfaction and cost-effectiveness into a single goal and produced excellent results. Costs decreased, customers were satisfied, and effectiveness increased. The program has saved over $1,000/bed/year for the last seven years, and total documented savings are over $5,000,000. The cost/unit was almost 30% below the average values for many other biomedical engineering departments.

Arizona↗

The hip status: a telemedical application.

Biomedical informatics and biomedical engineering are interdisciplinary sciences that are growing fast and have a significant impact on healthcare delivery. The University Medical Centre in Ljubljana and the Medical Faculty through its institutes have initiated the building of their own telemedicine systems. These systems concern only the medical informatics field. However, in this work a telemedical application that uses a combination of biomedical engineering methods and methods of biomedical informatics is presented. This telemedical application was built at the Department of Surgery and it was named "The Hip Status Application". Its aims are to provide services of preventive medicine and health promotion for people with potential problems with the hip-joint, guidance for people that have already underwent an operation of implantation of hip endoprosthesis, or have in any other way affected hip-joints, remote system consultation for diagnostic purposes, etc. The application is still under evaluation, and it is meant as a start of a new era of engineering-powered telemedical applications at the Department of Surgery following the trends in the most developed countries of the World.

Arthroplasty, Replacement, Hip↗

Tissue regeneration based on tissue engineering technology.

Recent development of biomedical engineering as well as basic biology and medicine has enabled us to induce cell-based regeneration of body tissue to self-repair defective tissue or substitute biological functions of damaged organs. For successful tissue regeneration, it is indispensable to give cells an environment suitable for regeneration induction. Tissue engineering is a newly emerging biomedical technology for creating an environment for tissue regeneration with various biomaterials. The paper presented here overviews recent research data on tissue regeneration based on tissue engineering, and briefly explains the key technology of tissue engineering.

Adipose Tissue↗

Applying technology to operator requirements in medical equipment design.

The methodology used by the author consists of the following elements: Expose the design team to the user environment, followed by question and answer periods with users while still in the use environment. Place biomedical engineers in the leading teaching institutions where they will have day-to-day exposure to the use of products similar to the one being designed. Bring biomedical engineers back into the company as part of the design team. Expose concepts to focus groups while the product is in the definition stage. Bring a select group of users into the design review process. Evaluate the ease of use of the device as part of clinical trials. Establish a means of monitoring product performance after the product has been released. How well such a methodology will work in any particular environment is a function of management's recognition of the concept that ease of operator use is a vital element to the overall success of the product.

Biomedical Engineering↗

[The research progress of using electroporation therapy in treatment of tumor].

In these years, the electrical technology is widely applied in the study of biomedical engineering. Using electroporation therapy (EPT) to treat tumor is associated with biomedical engineering, electrical new technology, computer technology and microelectronic technology, which is a new marginal subject. Many experts have studied the mechanism and clinical treatment of the cell membrane electroporation phenomenon under electrical fields. These researches have shown that the membrane electroporation can stimulate the transport and intake of various drugs, which improves the tumoricidal effect of these drugs. The researchers have also been exploring the phenomenon that irreversible electrical breakdown (IREB) of cell membrane under high electrical fields and steep pulses leads to the death of tumor.

Cell Membrane↗

Clinical engineering in Romania. The coming of age.

Biomedical engineering (BME) includes clinical engineering and bioengineering. Bioengineering is academically oriented towards theory and research in biology using the methods of exact sciences such as maths and physics, while clinical engineering (CE) has a rather practical orientation focusing on the general management of clinic/hospital equipment and providing aid to the medical staff in the use of advanced technologies for diagnosis and therapy purposes. The Romanian physiological community has been closely involved in the growth of BME that has now come of age in this country. Radu Vrâncianu's great intuition in opening the door to this science and its practical application in an institution created by Daniel Danielopolu definitely represented a good chance for Romanian public health. Recently, both clinical engineering and medical bioengineering have been introduced into the Romanian Classification of Occupations.

Biomedical Engineering↗

Teaching biomedical applications to secondary students.

Certain aspects of biomedical engineering applications lend themselves well to experimentation that can be done by high school students. This paper describes two experiments done during a six-week summer internship program in which two high school students used electrodes, circuit boards, and computers to mimic a sophisticated heart monitor and also to control a robotic car. Our experience suggests that simple illustrations of complex instrumentation can be effective in introducing adolescents to the biomedical engineering field.

Adolescent↗

Guidelines for clinical engineering programs--Part I: guidelines for electrical isolation; Part II: performance evaluation of clinical engineering programs.

This series presents guidelines for: electrically isolated inputs and outputs; measuring the performance of hospital biomedical engineering programs; evaluating the risk of electric shock in hospitals; and for isolated power in anesthetizing locations. In Part I, specific recommendations are given for the use of insulated approach, battery-powered monitors in surgery, and for isolation requirements for devices connected to cardiac leads. In Part II, checklists are provided for the self-evaluation of an in-house, biomedical engineering staff. Parts III and IV, in future issues of this Journal, will include discussion of the theoretical electrical hazard potential in reference to the use of isolated power systems. The question of whether isolated power should be required in all anesthetizing locations will be discussed in Part IV.

Accident Prevention↗

Profile of a BMET (biomedical equipment technician) in small hospitals.

A survey was done of biomedical engineering programs in hospitals of under 100 beds. A random sampling of 400 hospitals was selected from the American Hospital Association Guidebook. Questions were asked with regard to the size, educational background and experience of the biomedical engineering staff. The organizational location of the program was surveyed, and most programs were part of facility engineering. Programs are discussed as full-time, part-time and outside service contracts. An in-depth analysis of the educational and training background of BMETs has been done. This part of the study covered the type of training and what additional training they felt they required.

Adult↗

Bioelectrical impedance analysis in body composition measurement: National Institutes of Health Technology Assessment Conference Statement.

The objective of this conference was to provide physicians with a responsible assessment of bioelectrical impedance analysis (BIA) technology for body composition measurement. Participants were 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. The literature was searched through Medline and an extensive bibliography of references 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. 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 the conference. The panel concluded that 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 instrument manufacturers be formed with the goal of setting instrument standards and procedural methods.

Body Composition↗

Problem-based learning biotechnology courses in chemical engineering.

We have developed a series of upper undergraduate/graduate lecture and laboratory courses on biotechnological topics to supplement existing biochemical engineering, bioseparations, and biomedical engineering lecture courses. The laboratory courses are based on problem-based learning techniques, featuring two- and three-person teams, journaling, and performance rubrics for guidance and assessment. Participants initially have found them to be difficult, since they had little experience with problem-based learning. To increase enrollment, we are combining the laboratory courses into 2-credit groupings and allowing students to substitute one of them for the second of our 2-credit chemical engineering unit operations laboratory courses.

Biotechnology↗

Basic philosophy utilized in development of the intensive-care unit--coronary-care unit concept.

One of the major developments in health care has been the evolution of critical-care medicine. This concept* encompasses total care of patients from the initiation of an illness or injury, through all their sophisticated care, until the patient has either recovered or succumbed. The concept of critical-care medicine has actually evolved only over the past decade. Because of its complexity, broad-based planning is imperative. This paper focuses on the steps necessary in planning for critical care or in the intensive-care units, as a part of critical-care medicine. A multidisciplinary unit is described as one of four alternative approaches. Participants in such planning for this area of patient care must include physicians, nurses and technologists, architects, biomedical and clinical engineers, biomedical technologists, and all hospital department heads who might not necessarily be directly involved in this kind of patient care, but who do, in fact, participate in some fashion. Our obligation is obvious, and the need to familiarize all involved with this concept of patient care and its urgency are discussed.

Coronary Care Units↗

Design and development of a computer-assisted retinal laser surgery system.

Since the mid-1980s, the development of a therapeutic, computer-assisted laser photocoagulation system to treat retinal disorders has progressed under the guidance of Dr. Welch, the Marion E. Forsman Centennial Professor of Engineering, Department of Biomedical Engineering, the University of Texas at Austin. This paper reviews the development of the system, related research in eye movement and laser-tissue interaction, and system implementation and testing. While subsets of these topics have been reported in prior publications, this paper brings the entire evolutionary design of the system together. We also discuss other recent "spinoff" uses of the system technology that have not been reported elsewhere and describe the impact of the latest technical advances on the overall system design.

Animals↗