生物医学工程医疗仪器论文中英文资料外文翻译文献

生物医学工程医疗仪器论文

中英文资料外文翻译文献

Present status and problems of domestic medical instrument engineering. Biomedical Engineehng

In recent years considerable progress has been achieved in domestic medical instrument engineering. Many plants and scientific-research organizations of machine-making and the defense industry have changed their profile toward production of medical equipment.

However, medical equipment often meets a reluctant market because of funding cuts in health services. Medical organizations often cannot satisfy even their basic requirements for diagnostic and therapeutic devices.

Also, health service organizations tend to buy foreign rather than domestic medical equipment because the former are easily available on the domestic market and prices for both are comparable because of inflation.

The transition to a market economy in Russia has had substantial impact on the relations between domestic manufactur- ers and consumers of medical devices. The spectrum and quality of available items has been significantly extended in recent

years. It should be also noted that available models of medical devices are continuously updated, which makes them sufficiently competitive.

Representative information on the updating dynamics of domestic medical equipment is summarized in Table 1. The data were provided by the VNIIMP-VITA Joint-Stock Company, which compiles a data bank of such information.

Generally, new items account for 37% of total production of medical devices. Routinely produced devices (duration of production, 2-5 years) account for 28%. Medical devices of long-term production (5-10 years) account for 17% and obsolete nomenclature (devices produced for more than 10 years) accounts for 18%.

It is seen from Table 1 that in recent years there has been considerable progress in the updating of production of medical equipment. For example, according to the VNIIMP-VITA Joint-Stock Company, the share of the items that have been produced for no longer than 5 years in 1988 did not exceed 35%, while now it is 65%. For the items that have been produced for more than 10 years such shares are 40 and 18%, respectively.

Updating of produced medical devices was encouraged by the increase in the number of designers and manufacturers, particularly those of former defense industry facilities. In collaboration with foreign partners they set up joint ventures for producing medical equipment.

Analysis of the updating of the various groups of medical equipment is of substantial

interest.

It is seen from Table 1 that detoxication devices contribute dominantly to the group of items that have been updated within the standard period of up to 5 years (100% of production, including modern devices for hemodialysis and hemosorption).

Comparatively high updating indices are observed for devices for functional diagnosis: 72% of these devices have been produced for no longer than 5 years, and obsolete devices account for only 9% of total production. However, it should be noted that although production of some obsolete devices has been terminated, equipment of similar functional capacity is still urgently needed.

Relatively low updating indices are observed among the devices for intensive care and resuscitation: 16% of new items and comparatively many obsolete devices (26%). Among new models apparatuses for artificial lung ventilation are worth mention. However, some apparatuses, which have been developed long ago are still on the market because they have good performance, are quite reliable, and still are in demand. This reduces the updating index of the group as a whole.

All-Russian Scientific-Research Institute for Medical Instrument Engineering, Rusaian Academy of Medical Sciences (VNIIMP-VITA Joint-Stock Company), Moscow. Translated from Meditsinskaya Tekhnika, No. 1, pp. 4-9, January-February, 1996. Original article submitted August 23, 1995.

0006-3398/96/3001-0001515.00 y Plenum Publishing Corporation

TABLE 1. Updating of Basic Groups of Medical Devices and Apparatuses (% of total nomenclature)

这里有个表

The lowest updating indices are observed for devices for examining a patient's body structures. These are: ophthalmological, otolaryngological, and anthropometric devices, endoscopes, etc. The share of obsolete devices is high (44%), while the devices which have been produced for no more than 5 years account for only 20% of total production.

It should be noted that these results on medical equipment updating are important general estimates, although they do not take into consideration specific achievements and shortcomings in the production of individual items. Therefore, some corresponding amendments are required.

Our survey of available information, including the VNIIMP-VITA Joint-Stock Company data bank, materials presented at various exhibitions, and recent literature, shows that domestic medical industry has developed a number of original medical devices and apparatuses which were designed to replace similar obsolete models. However, many types of important and necessary medical devices still do not meet contemporary requirements, and some types of devices are not produced at all.

For example, in recent years production of some sophisticated medical devices (apparatuses for intensive care, resuscitation, and anesthesiology; devices for artificial lung ventilation, respiratory narcosis devices, extracorporeal circulation) significantly rose, particularly at the former defense industry facilities, and their quality has been significantly improved. The functional performance of the devices is generally on par with foreign analogs.

Perfusion units have also been improved and their production has expanded. This allowed the demand of the health service organizations for such equipment to be satisfied completely. Modern domestic hemodialysis devices (Renart-10, Renan- 10RT, etc.) have been

developed and brought into wide clinical practice.

The development and production of diagnostic magnetic resonance imaging systems (Obraz-3, TOROS) are considerable breakthroughs in domestic medical industry. This substantially extends diagnostic capacities of many health service organizations and provides them with topical diagnosis previously unavailable domestically, although it is quite common in developed foreign countries.

Domestic medical industry has begun production of pulse oximeters; these are of particular use in surgery and resuscita-

tion. This bridged a substantial gap in the spectrum of available domestic medical devices.

The Bilitest bilirubin meter, which has been recently developed and produced in Russia, fully meets the requirements of maternity and children's hospitals in devices for diagnosing jaundice.

A high-standard radioimmunochemical laboratory was opened at the VNIIMP-VITA Joint-Stock Company to supply customers with necessary radioimmunochemical assay kits.

A number of high-quality medical devices and instruments have been developed at the electronic industry plants and

institutes. The following devices are particularly worthy of mention:

- artificial cardiac valves of the Emitron Plant, which are on par with the best foreign analogs;

- pH meters (Istok State Scientific-Manufacturing Association);

- Ikar long-term (up to 24 h) cardiomonitors with electronic memory (Kometa Central Scientific-Manufacturing Association);

- radiothermographs and racliothermoscopes for detecting deeply located thermal fields in the human body (Oktyabr' Manufacturing Association and Design Bureau for Ecological and Medical Equipment);

- original thermal imaging system (Institute of Radioelectronics and Automatics, Russian Academy of Sciences; OPTROS, Ltd.);

- original computer-assisted system Cardiac Rhythms for monitoring oatient condition and pulsimetry (Institute of Chemical Physics, Russian Academy of Sciences; Ekos, Ltd.);

- video system for endoscopic imaging (Zenit Scientific-Manufacturing A~sociation; Elektron Scientific-Research and Manufacturing Association);

- streamlined technology for producing disposable and reusable syringes, injection needles, and surgical threads.

A number of other problems of domestic medical instrument-making industry have been successfully solved in recent years.

For example, the number and quality of therapeutic devices, particularly for laser therapy, is quite sufficient. Research studies are carried out by many organizations including former defense industry facilities. Technologies which have been developed for other purposes give fruitful results in medical industry.

According to our data, more than 150 models of such medical devices have been developed over the last 5 years. Some 100 of them are commercially available. Although domestic medical devices are often superior ot foreign analogs in terms of working performance and they are definitely less expensive, many of them are not in short demand and are virtually not used.

However, this activity in many other areas of medical instrument engineering cannot be

considered as sufficiently successful and rational.

It should be noted that many newly developed models of domestic medical devices compare unfavorably with foreign analogs. This is particularly the case for X-ray and ultrasonic devices, electrocardiographic monitors, laboratory equipment, etc. Nevertheless, according to the VNIIMP-VITA Joint-Stock Company databank, certain positive trends have been observed in recent years even in these areas. However, most problems still remain unsettled and the conditions required to solve them have not yet been established.

It is important to note that the serially produced X-ray apparatus RUM-20 (Mosrentgen Joint-Stock Company) has been significantly updated. The updated model RUM-20M-SG312 is commercially available in combination with the Sapfir domestic image intensifier or an image intensifier of a French manufacturer. The Kruiz fiat image intensifier has been developed at the

All-Russian Scientific-Research Institute for Medical Instrument Engineering in collaboration with MELZ Manufacturing Association and Mosrentgen Joint-Stock Company. This device is designed to replace existing fluorescent screens in the X-ray diagnostic apparatuses RUM-10, RUM-20, RUM-20M, and others. The use of the Kruiz image intensifier significantly increases image information content and allows threefold decrease in the radiation load on patients and medical personnel.

The G 202-5 system for lit-par-lit raster imaging of patients in lying position has been developed at the Mosrentgen Joint-Stock Company. This device is commercially available with the PURS power source. It allows both manual and automatic X-ray photography and organ-oriented X-ray examination.

The RTS-61 mobile X-ray video diagnostic apparatus has been developed at the Elektron Scientific-Research and Manufacturing Association. This device is designed to be used in surgery, orthopedics, and traumatology.

Among the defense industry facilities which have reoriented their production to medical market the Scientific-Research Institute for Electromechanics (Istra) is worth mention. In collaboration with Phillips (Germany) and borrowing their technology and circuitry, the Institute for Electromechanics developed the Mammodiagnost mammographic scanner, which meets international standards of operating performance.

The Rentgen-48 X-ray tomographic diagnostic systems with a rotary support table and the Rentgen-60 X-ray diagnostic systems with a remote control support table have been developed at the Sevkavrentgen Plant and received positive recognition by practicing physicians.

The models of X-ray diagnostic devices listed above are examples of achievements of domestic medical industry.

However, many important and significant problems of the development of domestic medical X-ray equipment remain unsettled, and it is unreasonable to expect that they will be solved in the foreseeable future unless special measures are taken.

For example, the most common RUM-20 X-ray apparatuses with the Sapfir image intensifier are equipped with the obsolete X-ray image converter REP-1. To replace the REP-1 image converter, the Moscow Plant for Electronic Tubes has developed the Buer image converter of improved design. This device offers better image contrast, reduced clark background noise, and has an output fiberoptic window of improved design. However, the Buer image converter is not yet commercially available.

Digital X-ray diagnostic devices are not yet commercially available from domestic

manufacturers either.

The Design Bureau for Medical Engineering in collaboration with Medtekh, Ltd. (Novosibirsk) have developed the Diaskan X-ray digital scanner. Serial production of this device is in progress at the Design Bureau for Medical Engineering.

However, devices of sufficient quality are not yet commercially available.

Domestic medical industry does not produce X-ray tomographs. Their production in Chelyabinsk has been suspended.

Electrocardiographic monitors are very important devices for functional diagnosis. However, domestic medical industry fails substantially behind leading foreign manufacturers and there is a disproportion in the development and production of necessary devices and apparatuses. Many automatic systems for ECG processing, including syndromal diagnosis, have been developed, but they trove not been tested and are of little demand. However, simple three-channel electrocardiographs of mass- scale application are not produced by domestic manufacturers.

Foreign manufacturers offer various ultrasonic scanners and sophisticated imaging systems. Domestic manufacturers produce only simple devices with manual sector-by-sector scanning and a few simplified models with linear electronic scanning.

Some positive results have been achieved in the development of endoscopic devices. These achievements are mainly due to the collaboration between LOMO and some companies from Japan. However, even these devices require further improvement of quality and reliability.

Although the level of production of domestic laboratory equipment has noticeably risen in recent years, it is still too little to meet the demand. The number of organizations involved in the development of such equipment has risen. However, the available devices are simple and have limited functional capacity. Many important devices (e.g., automatic analyzers and simple routine devices) are not produced at all.

Devices for blood transfusion and preparing blood substitute solutions are still in short supply (40 million items have been produced, while the demand is 200 million). The demand in dialyzers and polymer infusion systems reaches 100 and 150 million items, respectively, although such systems are not produced at all.

The correspondence between production and demand, quality and technical performance, and adequate testing of medical production are put in the forefront under conditions of a market economy. The problem of competition with foreign manufacturers is also quite important because of increasing import of medical equipment and reduced sale of the production of domestic manufacturers. In this connection, the following circumstances should be taken into consideration.

There is a considerable disproportion between production and demand of some groups of medical devices. For example, there is :~ huge surplus of laser therapeutic devices and their excessive development. Systems for syndromal electrocardiographic diagnosis, magnetotherapy, and electrostimulation are also in excessive supply. However, simple electrocardiographs, routine laboratory equipment, and some other ordinary but necessary devices of mass-scale application are not produced by domestic manufacturers. These disadvantages cause significant economic losses and present difficulties in the development of health service. Domestic and foreign experience show that these problems can be solved by adequate marketing, but this is in its infancy in the domestic medical industry.

It should be noted that foreign companies place special emphasis on marketing and market research. They evaluate actual and pending demand as well as consumer requirements. The

feedback between consumer and manufacturer gives valuable information on the improvement of the product quality and working performance. The marketing service in most leading companies is of paramount importance. The development of a new product often starts from marketing survey rather than from engineering or design research. Many domestic organizations of medical instrument engineering require cardinal measures for increasing the level of marketing.

Testing of medical devices also requires substantial improvement. Considerable experience of foreign manufacturers of medical equipment should be taken into account. It should be noted, however, that this experience is often neglected by domestic manufacturers. Technical testing of medical equipment in foreign companies is usually carried out by independent laboratories which assess performance and quality. The specialists of the laboratories may also give recommendations for further improvement of the tested equipment. The basic goal of the testing is to check if the performance of the device matches its specifications and to conclude if the device can be used in medical organizations. However, the specialists of the laboratories usually go beyond this goal and issue comparative reviews of products of different companies. Such reviews contain the following information:

- description of tested device, its specifications, and price;

- results of technical testing, correspondence between specifications and actual performance, advantages and disadvan- tages, recommendations for improvement (if necessary);

- comparative analysis of similar devices and apparatuses produced by different manufacturers. Such analysis is usually concluded by a most preferable model, which is recommended to medical organizations on the basis of functional capacity, reliability, and economic reasons.

In the USA, activity of testing laboratories is controlled by governmental, nongovernmental, and independent nonprofit organizations.

In Russia, the problem of balance between the demand in medical devices, their production by domestic manufacturers, and import is of considerable importance.

The opinion of the Head of the Department of Medical Industry, Russian Ministry of Health and Medical Industry, Yu. F. Doshchitsin, which was published in the weekly "Meditsinskii Biznes" (No. 9, 1995), is that the requirements of Russian medical market must be met by domestic devices, including products of high technology. Russian medicine should not rely on imported devices alone. We certainly agree with this opinion.

The total volume of medical equipment purchased from abroad is presently several times greater than purchases from domestic manufacturers. This situation is definitely unacceptable. Cardinal measures are required to boost and stimulate economically domestic manufacturers of medical equipment. This is particularly important for manufacturers of life support systems and devices for military medicine.

However, positive aspects of contacts with foreign manufacturers of medical equipment should not be disregarded. International cooperation is very common in foreign practice, but it is clearly insufficient in Russia.

International cooperation in medical industry is particularly vital in such areas as computer technology, microprocessors, and electronic engineering. Lack of sufficiently high-quality domestic computers and microprocessors presents considerable problems in the development of sophisticated medical devices and apparatuses.

In recent years a number of domestic organizations established joint ventures with

leading foreign manufacturers of medical devices. These joint ventures produce high-technology devices on the basis of imported circuitry, modules, and individual finished units. For example, VNIIMP-VITA produces ultrasonic doppler scanners, Kursk Manufacturing Association Pribor in collaboration with Frezenius (Germany) produces mobile apparatuses for hemodialysis and hemosorption, LOMO and some companies from Japan established a joint venture for manufacturing flexible endoscopes of improved design, Moscow Manufac- turing Association EMA produces ultrasonic diagnostic devices, etc.

It seems reasonable to continue and extend mutually profitable contacts between domestic and foreign manufacturers of medical equipment.

Active participation and patronage of the Russian Ministry of Health and Medical Industry as well as the Russian Government and local authorities are needed to solve the problems of medical industry listed above and to implement programs of development and production of high-quality domestic medical devices.

References

[1] V. A. Viktorov，V. P. gundarov，A. P. yurkevich. Present status and problems of domestic medical instrument engineering. Biomedical Engineehng~ V oL 30, No. 1, 1996.

[2]All-Russian Scientific-Research Institute for Medical Instrument Engineering, Rusaian Academy of Medical Sciences (VNIIMP-VITA Joint-Stock Company), Moscow. Translated from Meditsinskaya Tekhnika, No. 1, pp. 4-9, January-February, 1996. Original article submitted August 23, 1995.

国内医学仪器工程的现状和存在的问题

近年来，国内在工程医疗器械实现取得了很大进展。许多植物和机械制造和国防工业科研机构已经改变了他们对医疗设备生产型材。

然而，医疗设备往往遇到一个景气的市场，因为随着卫生服务经费削减。医学组织诊断和治疗设备往往是不能满足他们的基本要求。

同时，卫生服务机构倾向于购买国外而不是国内的医疗设备，因为前者可以在国内市场和价格都比较有利。

俄罗斯向市场经济转型的过程中，ERS和医疗设备的消费者已经对国内制造业之间的关系有着实质的影响。频谱和可用的项目的质量在最近年大幅延长。还应当指出，医疗设备的可用模型的也在不断更新，行业就充满了竞争。

对国内医疗设备的更新动态信息表1数据总结。此类信息由vniimp-vita联合股份公司提供，并编写银行数据。

一般来说，医疗器械生产总数中有37%个新项目帐户。常规生产设备（持续时间

生产，2-5年）占28%。长期生产医疗器械（5-10年）17%和命名过时的（10年以上生产设备）占18%。

从表1看出，医疗设备在最近几年有了长足的进步，生产有了更新。例如，根据vniimp-vita 联合股份公司项目的份额:在1988的时间不超过5年的生产不超过35%，而现在是65%。对于已经产生10年以上的物品股票分别是40和18%。

由设计师和制造商的数目增加的鼓励，特别是那些前国防工业设施，医疗器械也在更新。现在中国公司与外国企业办理合资公司来生产医疗器械。

从表1看出各种群体对医疗设备的更新分析是有极大的兴趣。解毒装置明显有助于已更新的项目组

在长达5年的标准周期（100%的生产，包括血液透析和hemosorption现代设备）。

观察更新指标比较高的是功能性诊断设备中：不超过5年的生产装置有72%，而过时的设备只占总产量的9%。然而，值得注意的是虽然一些陈旧的设备生产已终止，类似的功能设备仍然迫切需要。

观察到的更新指标相对较低的重症监护和复苏设备中：16%

新项目，许多比较陈旧的设备占26%。

设备间人工肺通气新模式的价值同时也被提到了。然而，很久以前已开发的一些设备，在市场上他们依然有良好的性能体现相当可靠，也有需求。作为一个整体这降低了集团的更新索引。

表1 更新的基本医疗设备和仪器（总名称%）

更新最低用来观察病人的身体结构的指标是：ophthalmolog—

iCal，耳鼻咽喉，和人体测量设备，内窥镜，及陈旧的设备等，他们的比例高（44%），而

设备已不超过5年的设备只占总产量的20%。

值得注意的是，这些结果对医疗设备的更新只是一般重要的估计，虽然他们做的不考虑具体的成就和在个别项目的生产不足。但是，一些相应的修改是必需的。我们提供的信息调查，包括vniimp-vita联合股份公司资料库，在各种展览中的资料和最近的文献等都表明国内医疗行业已经开发出的一些原始医学设备和仪器，只是取代了过时设计的相似模型。并且，许多重要的医疗模型及一些必要的医疗设备，还不适应时代的要求，仍然根本不能生产。

例如，尤其是在前国防工业设施质量有了明显的提高的情况下，在一些近几年生产先进的医疗设备（重症监护设备，复苏和麻醉；人工肺通气装置，呼吸麻醉设备，体外循环）显著上涨。功能上设备性能一般也会低于国外类似设备。

由于灌注单位也进行了改进，其产量有所增加。这种设备能够完全满足服务内允许的健康需求组织。现代家庭血液透析设备（renart-10，安10rt，等）已被开发并纳入广泛的临床实践。开发和生产（obraz-3，公牛）的磁共振成像诊断系统在国内医疗产业的突破的相当大的。这大大扩展了许多卫生服务机构的诊断能力