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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 \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
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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~ VoL 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.
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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
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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：ophthalmologiCal，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并为他们提供了以前国内无法在国外医疗仪器成熟的普通国家的局部诊断。
国内医药行业已开始生产的脉搏血氧仪；这些都是在外科手术中经常使用的特定人工康复手段。双碘苯酚丙酸胆红素测定仪在国内医疗设备的可用频谱存在较大的差距。，但它最
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近已开发和生产在俄罗斯产品是完全符合要求的诊断黄疸是用在孕妇和儿童医院的设备。
高标准的放射免疫化学实验室是由vniimp-vita联合股份公司敞开供应给必要的放射免疫检测试剂盒的客户。
一批高素质的医疗设备和仪器已在植物电子工厂和高校中发展。下列设备是特别值得一提的：
光电厂生产的人工心脏瓣膜，这是类似国外最好的并与之能相相媲美的； pH计（伊斯托克国家科学制造协会）；
IKAR长期（24小时）的电子存储cardiomonitors（kometa中央科学制造协会）； 为检测在人体radiothermographs和racliothermoscopes深部热领域；
原有的热成像系统（俄罗斯科学院无线电电子学和自动化研究所；optros，公司）； 为oatient条件和pulsimetry监测心脏节律（原始的计算机辅助系统物理化学研究所，俄罗斯科学院；EKOS，公司）；
用于内窥镜成像视频系统（泽尼特的制造~科学协会；电子科学研究制造业协会）生产一次性和可重复使用的注射器，注射针精简技术，和缝线。
其他一些国内医疗仪器制造业存在的问题已经在最近成功解决。 例如，治疗设备的质量和数量，特别是激光治疗，是相当足够了。
这些研究是由许多组织这其中就包括前国防工业的设施下进行的。这其他目的是已被技术开发的丰硕成果用于医疗行业。
根据我们的数据，这样的150多个型号医疗设备已经过去5年投入研究了。其中100已经进入市场。虽然国内医疗设备往往类似于OT国外条款下优越的工作性能但它们确定是不太昂贵的，但是他们不仅仅是不足，而是几乎没有用。
然而，这一活动在医疗仪器工程其他区不能被认为是足够成功的，合理的。
应当指出的是，许多新开发的新型国内医疗器械是比不上国外类似医疗设备的。特别是X射线和超声波装置，例心电图监测，实验室设备，等等。
然而，根据vniimp-vita联合股份公司数据库，即使在这些领域，最近几年某些有利的趋势已被我们观察到。
然而，大多数的问题仍然没有解决，需要解决他们的条件尚未建立。
需要注意的是，一直连续生产的X射线装置rum-20重要（mosrentgen联合股份公司已 更新。更新的模型rum-20m-sg312与sapfir国内组合图像增强器或法国生产的图像增强器是已经进入市场的。
菲亚特的kruiz图像增强器已在所有在梅尔斯的俄罗斯科学研究院研究，协同制造医疗仪器工程协会和mosrentgen联合股份公司。这个装置是设计用来取代现有的X射线荧光屏 rum-10诊断设备，rum-20，rum-20m，和其他人。kruiz图像增强器的使用显著增加图像信息的内容，保证患者和医务人员的辐射量减少三倍。
G 202-5系统PAR点亮卧位患者光栅成像已在mosrentgen发达联合股份公司研究。此