REVIEW

PROBLEMS IN DEVELOPMENT OF MEDICAL TECHNOLOGY UNDER CONDITIONS

OF THE SCIENTIFIC-TECHNOLOGICAL REVOLUTION

V. F. Rusyaev UDC 615.47:008(47+57)

Science and technology have a pronounced effect on the acquisition of basic medical- biological knowledge, the development of clinical medicine, and clinical thinking; achiev- ments in physics and engineering have a decisive significance for increasing the quality of prophylaxis, diagnosis, and treatment [36]. Expenses for public health are quite large, ~nd in many contries their growth exceeds the rate of growth of the gross national product [20]. Decreasing expenditures is associated with the use of highly efficient equipment and new methods. Thus economic factors and a number of other conditions stimulate research, de- sign developments, and the production of new medical technology.

As a result of the economic crisis a tendency toward the decentralization and tech- nologization of medical services and the elaboration of its primary components has developed [32]. Taking these tendencies into account, O. Jusinski [25] gives priority in his re- search programs to the development of equipment and precise inexpensive methods of diagnosis for small medical establishments and individual physicians. In the opinion of Sakurai Yasu- hisa [i], medical technology has a decisive significance in the care of invalids and the elderly, the improvement of medical services with the aid of computers and telecommunica- tions networks, and consultation and the obtaining of primary recommendations for the selec- tion of treatment methods. The increase in the significance of bioengineering in the Directory of Scientific References is characterized by the fact that, since 1984, works devoted to these problems appeared in the upper fifth level of quotability [17].

The resources of medical technology may be classified into groups as a function of the problems they address.

i. Laboratory equipment for the analysis of biological substrates and metabolic products isolated from the organism.

2. Diagnostic technology for investigating the structural and functional characteristics of the organism;

3. Apparatus for prophylaxis, therapy, and rehabilitation.

4. Monitoring systems for the prolonged monitoring of the functional parameters of the organism.

5. Biotechnical systems to monitor the condition of the organism, to correct pathological changes, and to provide functional prosthesis.

Like any other classification, this division is somewhat arbitrary.

The laboratory equipment includes a set of measurement instruments to record the physical properties of biological substrates. Along with the usual technical-economic indicators - cost efficiency, accuracy, reliability, and energy efficiency [24] - these devices should satisfy special requirements associated with their medical application: high output and the capacity to perform rapid diagnoses and microanalyses.

Diagnostic technology is represented by a broad class of specialized medical apparatus. It should be noted that the morphological conception which predominates in modern medicine determines the priority development of methods and devices to detect structural disturbances in the organism (endoscopy, roentgenology, ultrasound examination methods, NMR tomography et al.). But this strategy in principle may not serve as the basis for the development of prophylactic medicine. The problems of prophylaxis and earlypreclinical diagnosis of patho- physiological changes may be solved by the development of technical systems recording bio- physical parameters which determine the dynamics of the functional state of the organism. Sekiya Tomio and Kikuti Makoto [2] propose to classify the methods of diagnostic research

Crimean Medical Institute, Simferopol. Translated from Medistinskaya Tekhnika, No. pp. 33-39, July-August, 1988. Original article submitted November I0, 1987.

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as a function of measurable quantities: electrical potentials, forces, pressures, oscilla- tions, acoustic signals, hydrodynamic quantities, temperatures, heat transfers, etc. Along with the traditional electrodes and sensors a new class of biological transducers is under- going intensive development at the present time: biosensors. In V. M. Owen's [35] defini- tion, a biosensor is an analytical device with a biological substrate and an element which con- verts a biochemical signal into an electrical one. Enzymes, antibodies, tissues, and entire organisms are used as the substrate [8, 34, 42]. As a function of the converting element V. M. Owen distinguishes five types of biosensors: electrode, field-effect transistor, fiber- optic, thermistor, and piezoelectric. The Subcomission of Scientific Research in Medical Clinical Engineering of Great Britain has noted the possibilities of such devices to record p02, pH, pCO2, pK+, pN20, anesthetizing gases, blood pressure, EKG, temperature, and respira- tory parameters [31]. Increase in the accuracy and reliability of instruments (electronic endoscopes, ultrasound diagnostic instruments, NMR tomographs, EKG analyzers, etc.) and the expansion of their diagnostic possibilities are achieved as a result of the introduction of programmed methods of analysis [3].

In modern medicine a broad spectrum of physical effects is used: electromagnetic fields, optical, ultrasound, and ionizing radiation, hyperthermia, cryotechnology etc. The prophylac- tic, therapeutic, surgical, and rehabilitative application of physical factors requires pro- found investigation of primary biophysical mechanisms and integral biological reactions, well- founded selection of parameters, and the development of the appropriate reliable and safe ap- paratus [24].

The need for observation with the aid of monitoring systems arises in those cases in which the patient is in a borderline state or in which the probability of the sudden occurrence of such a life-threatening state is high. Therefore monitoring systems are most often used in reanimation tents. However, successes in the area of microelectronics, the development of biosensors, and the use of microprocessors already allow consideration of the creation of individualized information systems which monitor the state of the organism of practically healthy persons in a natural living environment. For example, a device has been proposed which records over a long period (30 days) the motor activity of a human being while he is working under field conditions [41]. The wide use of personal computers significantly ex- pands the capabilities of monitors in the individual evaluation of the dynamic state of the organism and the elucidation of its chronotype, reactivity, limits of adaptation, etc. The combination of polyfunctional monitors with microcomputers makes it possible to obtain pri- mary diagnostic information and to make the necessary recomendations. This opinion is shared by D. H. Wallace [50], who, considering the trend to decentralized medicine, connects the progress of public health with the use of new technologies and personal computers. He reports on the creation of programs for such forms of self-help as the planning of rational nutrition and diet, the self-monitoring of the physical and mental state of the organism, and consultative systems permitting the diagnosis of certain illnesses. This approach decreases the burden of medical personnel and facilitates the acquisition of an adequate volume of pri- mary information permitting individualized prophylactic, therapeutic, and rehabilitative mea- sures. The organization of centralized information banks and networks makes it possible to evaluate on an on-going basis the state of health of large groups of the population and to plan long-term programs in public health.

The development of multipurpose autonomic monitors allows the question to be posed of the creation of biotechnical systems, integrated with the organism, which monitor the param- eters controlling the state and duplicating the functions of its biological structures. These devices are capable of increasing the reliability of the functioning of organs and tis- sues, and, if necessary, providing functional prosthesis. The importance of the problem of adaptive control of biological functions and the creation of artificial organs and tissues (heart, kidneys, liver, lungs, pancreas, blood etc.) is evident and therefore attracts the attention of specialists in the field of clinical bioengineering [21, 22, 26, 40]. The primary task in this regard is the development of specialized biosensors, small, powerful power supplies [39], systems of physical, pharmacological, and combined control [27, 48], biocompatible materials [19, 37], and methods of integrating technical systems with the organism.

An increasing role in the medical intrumentation is played by computers, which are used to increase ther effectiveness of public health [47], to integrate with measurement devices [7], to acquire and interpret diagnostic data [3, 45], to select doses of pharmacological preparations [4], and to train medical personnel [5, 38]. Analyzing the experience of the past 25 years, H. W. Gottinger [18] examines the organizational problems to the solution of

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which computers can be successfully applied: the creation of data base control systems, the automation of diagnosis and the planning of the treatment process, and the development and application of expert decision-making systems with the aid of artificial-intelligence sys- tems. E. R. Gabrieli [16] isolates the basic tasks of medical informatics in the USA deter- mining the interaction of the human-computer system: the creation of a common national iden- tification code, the guaranteeing of data secrecy, the development of interfaces for the input- ing and outputing of information in ordinary language, the development of facilities for the representation and accumulation of medial knowledge, and the storage of genealogical data.

The biotechnologization of medicine at its current stage requires a new interaction be- tween the physical-technical and medico-biological disciplines. The tendency to the formation of biotechnical (medico-technical) centers is quite evident. An example of such a center in the USSR is the "Eye Microsurgery" Interdisciplinary Scientific-Research Complex. In France the biomedical technical service is occupied with training and raising the qualifica- tions of various categories of hospital and medical personnel, their technical and technolog- ical refitting and the development of new types of medical instrumentation [30]. At the New Jersey State Technical Institute (USA) combined efforts in the area of bioengineering are being carried out: hemorheology research, the development of new recording methods and of electrodiagnostic apparatus, the development of methods of identifying visual-reception param- eters, methods of blood circulation diagnosis, and the use of hyperthermy and cryotechnology [28]. In the state of New York (USA) a center of progressive technology has been organized to coordinate the activity of a number of technical, engineering, and medical-biological in- stitutes, industrial firms and treatment facilities. In particular, the scientific programs of a university in Buffalo are directed toward research in the area of rehabilitation engineer- ing, laser surgery, and the design of medical instruments and devices, biosensors, biomaterials, and implantable devices.

Progress in the development of medical technology under the conditions of the scientific- technological revolution raises the question of the interaction of medical and engineering personnel. New conditions in the development of medicine require the rethinking of tradi- tional concepts, the improvement of higher education, and inclusion of future physicians in scientific research in the area of medical technology, and the acquisition of work skills with modern equipment. Analysis of the efficiency of the use of medical technology shows that user errors are at a level of from 7 to 18% [6]. Thus H. I. Bassen considers it neces- sary to create an "adaptive security monitor" which can be used in working with various types of medical apparatus to increase the reliability of standardized control. Errors occur most frequently in working with blood pressure monitors, anesthesiological apparatus, transcuta- neous gas measurement devices, et al. [33]. Practice shows that the apprenticing of develop- ers in the clinic is less effective than raising the qualification of users and their in- volvement in the process of developing new instruments [34]. This conclusion focuses atten- tion on the organization of the educational process in medical institutes and acquainting fu- ture physicians with the problems and possibilities of medical technology. Inasmuch as the development of medical technology requires trained personnel, it is expedient to study the ex- perience of a number of countries in the training of engineers for clinics and their use in therapeutic and prophylactic facilities.

In the German Democratic Republic a polytechnical institute (the llmenau) specializing in "Electromedical and Radiological Technology" has conducted, since 1953, interdisciplinary training of engineers for work in clinics and participation in the creating of new medical technology [14]. Success in the training of such specialists depends on the optimal coordi- nation of educational programs in physico-technical and medico-biological disciplines: phys- ics, electrotechnology, electronics, engineering cybernetics, informatics, and the theory of measurement instruments, as well as clinical dosimetry, laboratory techniques, and the funda- mentals of medico-biological knowledge. In Canada scientific research, the development of medical equipment, and the training of clinical engineers have been carried out by a number of universities for several decades [13]. M. Frize [15], in considering questions of an or- ganizational character, proposes the unification of the status of the clinical engineer with the strategy of the medical equipping of clinics, to define his rights and duties precisely. In France clinical engineers received official status in 1973. These specialists work pri- marily in major hospitals and are trained in four technical schools and nine universities [ii, 12]. Economic analysis shows that the efficient use of the resources of medical tech- nology is associated with improved use of engineering personnel and with increased reliabil- ity and expanded possibilities of medical technology [i]. The shortage of bioengineers in

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the FRG makes it necessary for complex medical equipment to be serviced by representatives of the manufacturing firms [23]. J. D. Bronzino [9] considers that the need to train clinical engineers in the USA appeared in the 1970's as a result of the growth of the cost of medical services and an increased demand to guarantee patients' safety. In his opinion, the education of bioengineers differs from traditional technical education in that it requires knowledge of the operation of the entire public health system. Believing that the education of clinical engineers should include internship-type training, J. D. Brozino [i0] has described a standard plan for a two-year internship of this sort. According to data for 1984, in the USA approxi- mately i0,000 engineers were employed in biology and medicine [43]. Population increase and aging and the negative consequences of scientific and technical progress increase the re- quirements on the development of medicine. M. J. Shaffer [44] believes that clinical engi- neering is one of the specialities in biomedical technology which furthers the optimization of public health, and that clinical engineers play a key role in making equipment reliable, safe, and effective. It should be emphasized that bioengineers should in all cases combine knowledge of the technical, biological, and medical aspects of instrument engineering [46]. At the beginning of the 1980's in Japan a combined committee of medicotechnical societies came to the conclusion that it is necessary to train and give official status to clinical engineers since approximately 3500 specialists in medical technology are employed in the country [49]. In Australia groups of biomedical engineers service, utilize, replace, and test equipment. The need for such groups is dictated by economic considerations, since a typical 800-bed hospital is equipped with more than 20 million dollars worth of medical technology [29].

The results of this survey of information from foreign sources permits the conclusion that under the conditions of the scientific and technological revolutions the expanding use of modern technology in medicine requires integral interaction with the physical and tech- nical sciences in basic research, increasing the effectiveness of prophylactic, therapeu- tic-diagnostic, and rehabilitative measures.

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