MEANS
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BIOMEDICAL
IMPROVEMENT ENGINEERING
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QUALITY
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UDC 615.47.012
The past year, 1968, has been a significant one for workers in public health services and biomedical engineering industries. It was a year in which the whole country marked the completion of fifty years of Soviet health work. Further developments in public health and industries connected with health were discussed at a meeting of the Supreme Council of the USSR. The decisions reached for the improvement of public health have been received by the workers in this country with enormous satisfaction. Public health services and biomedical engineering industries are constantly aware of the very real interest of the Communist Party and the Soviet Government in their activities. It is due to this interest that, over the years of Soviet rule, a number of far-reaching measures have been put into operation and great advances have been made in the field of public health, with the result that our health services are now among the best in the world. Sovietmedical science has also made enormous strides, and considerable successes have been achieved in the treatment of pulmonary, cardiac, vascular, and rheumatic diseases. The advances made in medical science and public health work have been closely linked with the development of biomedical engineering industries. Medicinehas at its disposal all the latest advances in electronic technology and mechanics, cybernetics and polymer chemistry, physics and the d~mamics of gases, optics and phototechnology, nuclear physics and so on. The biomedical engineering industry is the branch which harnesses advances in science and technology to the service of public health. Biomedical engineering has been rightly termed the industry of health. The setting up of a separate Ministry for the biomedical engineering industries of the USSR marks a new stage in the development of the industries of health. It has assumed the enormous and responsible task of ensuring that the organs of public health have all the necessary therapeutic preparations and biomedical engineering equipment without which therapeutic and prophylactic institutions cannot operate successfully or fulfill their function in the safeguarding of the health of the Soviet people. The biomedical engineering industries are playing quite an important part in the accomplishment of all these tasks. Its task is to apply all the latest developments in science and technology in the creation, for each medical field, of ranges of modern appliances, apparatuses, equipment, and instruments in adequate quantities to satisfy the requirements of all medical institutions. This rapidly developing branch has undoubtedlyachieved considerable success. Recent years have seen the development and production of many new and original articles of equipment for diagnosis, treatment, and surgery, and particularly for the utilization of new medical methods and for the equipment of developing branches of medicine such as cardiology, thoracic surgery, anesthesiology. Manynew types of instruments and apparatuses have been developed for the diagnosis of ophthalmic diseases, for reanimation, physiotherapy, and for the treatment of diseases of children. The rates of increase in the gross production of this branch of industry have been fairly good, and they surpass the corresponding rates in a number of other State undertakings. Yet, looking beyond these successes, one cannot help but see certain serious deficiencies. By analyzing indices for the operation of undertakings it is possible to discover the factors militating against more rapid progress and to determine the measures required to mobilize reserves and achieve a better standard of work. There are great differences between different undertakings in the biomedical engineering industry in the technical level of production, and this is reflected in, for example, different production costs for similar
T r a n s l a t e d f r o m Meditsinskaya Tekhnika, No. 1, pp. 3-6, J a n u a r y - F e b r u a r y , 1969o
a r t i c l e s p r o d u c e d in d i f f e r e n t f a c t o r i e s , s o m e t i m e s quite c o n s i d e r a b l e d i f f e r e n c e s . This i n d i c a t e s that t h e r e is not the r e g u l a r exchange of p r o g r e s s i v e e x p e r i e n c e t h a t t h e r e should be. The b a c k w a r d s e c t i o n s m u s t be b r o u g h t up to the l e v e l of the p r o g r e s s i v e s e c t i o n s by t r a n s f e r of p r o g r e s s i v e t e c h n o l o g i c a l e x p e r i ence and e x p e r i e n c e in p r o d u c t i o n o r g a n i z a t i o n f r o m the u n d e r t a k i n g s with good r e c o r d s . The group of f a c t o r i e s producing g e n e r a l m e d i c a l equipment has a low l e v e l of p r o d u c t i o n in c o m p a r i son with the o t h e r u n d e r t a k i n g s in the b i o m e d i c a l e n g i n e e r i n g i n d u s t r y and will r e q u i r e s p e c i a l attention. In addition, those u n d e r t a k i n g s which a r e s i t u a t e d in outlying a r e a s do not, as a r u l e , have adequate t e c h n i c a l s e r v i c e s and have to r e l y on the work of the " M e k h a n i z a t s i y a " TsKTB ( C e n t r a l T e c h n i c a l C o n s t r u c t i o n Office), which can no l o n g e r cope with the g r e a t l y i n c r e a s e d r e q u i r e m e n t s of u n d e r t a k i n g s in r e s p e c t of both m o d e r n i z a t i o n of p r o d u c t i o n and the d e v e l o p m e n t of the n e c e s s a r y equipment. S e r i o u s attention m u s t be given to the t a s k of i m p r o v i n g t e c h n o l o g i c a l l e v e l s in t h e s e h o s p i t a l equipment f a c t o r i e s , and t e c h n o l o g i c a l c o n s t r u c t i o n s e r v i c e s for t h e s e f a c t o r i e s m u s t be s t r e n g t h e n e d and expanded. On S e p t e m b e r 24, 1968 the C e n t r a l C o m m i t t e e of the C o m m u n i s t P a r t y of the Soviet Union and the Council of M i n i s t e r s of the USSR adopted a r e s o l u t i o n , " M e a s u r e s to i n c r e a s e the e f f e c t i v e n e s s of the w o r k of s c i e n t i f i c o r g a n i z a t i o n s and to a c c e l e r a t e u t i l i z a t i o n of s c i e n t i f i c and t e c h n i c a l a d v a n c e s in State u n d e r t a k i n g s . " This r e s o l u t i o n a p p l i e s in e v e r y way to b i o m e d i c a l e n g i n e e r i n g i n d u s t r i e s , and it p r o v i d e s m o r e p a r t i c u l a r l y for the s t r e n g t h e n i n g of t e c h n o l o g i c a l d e s i g n and c o n s t r u c t i o n s e r v i c e s and t e c h n o l o g i c a l re~ s e a r c h l a b o r a t o r i e s in i n d u s t r i a l u n d e r t a k i n g s . All the s e r v i c e s mentioned, and p a r t i c u l a r l y t e c h n o l o g i c a l s e r v i c e s , do undoubtedly r e q u i r e s t r e n g t h e n i n g . Main t e c h n o l o g i c a l l a b o r a t o r i e s , each c a p a b l e of c a r r y i n g out i n v e s t i g a t i o n s and planning the d e v e l o p m e n t of definite t e c h n o l o g i c a l p r o c e s s e s , m u s t be c r e a t e d , and a s y s t e m of l a b o r a t o r i e s of this kind m u s t be able to deal with a]l t y p e s of a c t i v i t y connected with the d e v e l opment of p r o g r e s s i v e p r o d u c t i o n technology in the b i o m e d i c a l e n g i n e e r i n g i n d u s t r y . These r e s e a r c h l a b o r a t o r i e s m a y with advantage be s e t up in the m o r e p r o g r e s s i v e u n d e r t a k i n g s . This r e s o l u t i o n of the C e n t r a l C o m m i t t e e and the Council of M i n i s t e r s w i l l a l s o c r e a t e conditions which a r e l i k e l y to a t t r a c t w e l l q u a l i f i e d s c i e n t i f i c and e n g i n e e r i n g staffs to w o r k on production. I m p l e m e n t a t i o n of the r e q u i r e m e n t s laid down in the r e s o l u t i o n m e a n s that e f f o r t s m u s t be r e s o l u t e l y d i r e c t e d to the t e c h n o l o g y of production and that s p e c i a l attention m u s t be given to s t r e n g t h e n i n g of t e c h n o l o g i c a l s e r v i c e s , as p r o g r e s s in any type of production depends on advance in production technology. It is e m p h a s i z e d in the r e s o l u t i o n that the main t a s k in r e l a t i o n to p r o d u c t i o n is to d e s i g n and i n t r o d u c e highly e f f i c i e n t t e c h n o l o g i c a l p r o c e s s e s which w i l l e n s u r e s o p h i s t i c a t e d u t i l i z a t i o n of r a w and o t h e r m a t e r i a l s , w i l l i m p r o v e the q u a l i t y of production, r e d u c e l a b o r and m a t e r i a l c o s t s , i n c r e a s e p r o d u c t i v i t y , and i m p r o v e working conditions. This r e s o l u t i o n r e q u i r e s that we should make g r e a t e r e f f o r t s to i m p r o v e our o r g a n i z a t i o n for the m a n a g e m e n t of production, i m p r o v e the s c i e n t i f i c o r g a n i z a t i o n of l a b o r , d e s i g n and i n t r o d u c e a u t o m a t e d s y s t e m s of c o n t r o l and i n f o r m a t i o n p r o c e s s i n g in f a c t o r i e s , and c y b e r n e t i c p r o c e s s e s f o r the c o n t r o l of t e c h n o l o g i c a l p r o c e s s e s , b a s e d on the use of m a t h e m a t i c a l methods and e l e c t r o n i c c o m p u t e r s . W o r k s of this n a t u r e a r e now p r o c e e d i n g , and we m u s t do a l l that is r e q u i r e d of us to e n s u r e that t h e s e p r o b l e m s a r e solved r a p i d l y and at high level. Much s t i l l r e m a i n s to be done to i m p r o v e the q u a l i t y of production. In the c o u r s e of the l a s t t h r e e y e a r s quite a n u m b e r of m e a s u r e s have been put into o p e r a t i o n to i m p r o v e t e c h n o l o g i c a l p r o c e s s e s and to achieve m e c h a n i z a t i o n and a u t o m a t i o n of production. In c o n s e q u e n c e , the b i o m e d i c a l e n g i n e e r i n g i n d u s t r y has been able to a c h i e v e i m p r o v e m e n t in the t e c h n i c a l s t a n d a r d s and q u a l i t y of s o m e of its p r o d u c t s . Yet the r a t e at which this work is p r o c e e d i n g cannot be r e g a r d e d as s a t i s f a c t o r y . Q u e s t i o n s connected with i m p r o v e m e n t of the q u a l i t y of p r o d u c t i o n m u s t ahvays be u p p e r m o s t in the minds of f a c t o r y c o l l e c t i v e s as, in the w o r d s of the P a r t y P r o g r a m , " s y s t e m a t i c i m p r o v e m e n t in the q u a l i t y of p r o d u c t i o n is a m a n d a t o r y r e q u i r e m e n t for economic d e v e l o p m e n t . " At the s a m e t i m e , a n u m b e r of a r t i c l e s p r o d u c e d by the b i o m e d i c a l e n g i n e e r i n g i n d u s t r i e s do not m e a s u r e up to m o d e r n r e q u i r e m e n t s , while o t h e r s , p e r f e c t l y m o d e r n in t h e i r t e c h n i c a l c h a r a c t e r i s t i c s , a r e s o m e t i m e s the s u b j e c t of l e g i t i m a t e c o m p l a i n t by t h e i r u s e r s , b e c a u s e of d e f e c t s in m a n u f a c t u r e . While much is undoubtedly being done to i m p r o v e the t e c h n i c a l s t a n d a r d s and q u a l i t y of t h e s e p r o d u c t s , such m e a s u r e s a r e o b v i o u s l y not effective enough. C a s e s of d e v i a t i o n f r o m t e c h n o l o g i c a l s t a n d a r d s a r e known to o c c u r in s o m e f a c t o r i e s . Insufficient use is being made of methods to e n c o u r a g e all w o r k e r s in the i n d u s t r y to s t r i v e a c t i v e l y a f t e r high s t a n d a r d s
of quality, such as, for example, a system of contracting for complete, defect-free production processes, a system with enormous mobilizing potential. It must be mentioned that problems connected with specialization are being resolved somewhat slowly, although, in view of the long lists of articles and the great variety of technical processes and methods required, solution of the problem will have a decisive effect on the efficiency of production, its technological level, and the quality of the products. Questions of specialization must be decided at the time when undertakings are switching to new systems of planning and economic stimulation. Specialized production forms a basis for standardization of technological processes, stable technical standards, and consequently, constant quality. Carefully thought out, rational specialization of factories will contribute to the creation and strengthening of technological construction collectives and channel their efforts into more intensive development of the problems of technological design and construction to improve technical standards and qualities of products. There must also be decisions to ensure a rational degree of specialization in technological research institutions and design and construction offices, and their links with production must be strengthened. Very serious attention must be given to the training of groups of specialists within technological construction collectives. We already have some excellent specialists who have given much effort and energy to the building up and advancement of biomedical engineering. The heads of industrial undertakings must have constant care of these groups, provide them with good working and living conditions, and help them to train additional personnel and worthy successors. Plastic materials are being increasingly used in the construction of articles of medical equipment. Here, the outlook for the biomedical engineering industries is good as they have at their disposal considerable quantities of the production equipment required. The lists of parts now being made from plastics in a number of factories can be counted in anything from tens to hundreds. The extended use of plastics will improve the appearance of articles and reduce production costs. Another important way in which the quality and reliability of articles can be improved is by more extensive standardization of parts and units for both apparatus and equipment° Some progress has already been made in this field, in which the change was initiated by the All-Union Research Institute of Medical Instrument Construction and the mechanization section of the Central Design and Construction Office. In these institutions the development of new designs for any group of apparatuses or equipment is always preceded by preliminary standardization of types and the development of standard components. The development of standard types of apparatus for anesthesia, artificial respiration, physiotherapeutic and light apparatus, disinfection chambers, autoclaves, operating tables, etc., is now an accomplished fact. The work of the All-Union Research Institute of Medical Instrument Construction in conjunction with the ~Krasnogvardeets ~ Combine on standardization of units in combined anesthesia and artificial lung apparatuses, cardiographic instruments, and laboratory instrument merits attention. There is still much to be done, however, in the field of standardization, and the work must be extended both in the Institute and in the factories of the industry. Standardization is one of the effective means for improvement in the reliability of biomedical engineering products, and careful designing of standardized parts will reduce the time required for the creation and production of new types of apparatus and for the constant improvement of others. More extensive standardization of parts and units for apparatuses and equipment will make it possible to increase the standardization of technological processes. Standardization of articles produced by the biomedical engineering industry must be brought to the level prevailing in the basic industries. It will then be possible to coordinate activities within the industry and to arrange for the specialized production of a number of standardized parts and units. The combined scientific and technological conferences which were held in the second half of 1968 discussed the entire range of problems connected with technological progress in our industry and noted practical measures for its acceleration. Put into practice, these would raise the level of production and improve the quality of the products. The same purpose will be served by the All-Union the direction of the Central Committee of the trade union cal Engineering and which will deal with the introduction technological standards in production, and improving the
public review which will be carried out in 1969 at of medical workers and the Ministry of Biomediof new technological processes, means of raising quality of the products.
This All-Union review will mark the c e n t e n a r y of the birth of V. I. Lenin. The purpose of the review is to encourage the scientific and engineering communities, w o r k e r s , and production experts to cooperate actively in o r d e r to a c c e l e r a t e scientific and technical p r o g r e s s in the biomedical engineering industry and to improve the quality, reliability, and durability of the articles produced. The collectives in the factories and in the organization of the biomedical engineering industry will undoubtedly m a r k the c e n t e n a r y of the birth of the founder of the Soviet State, V. I. Lenin, in a fitting manner.