医疗器械医学仪器工程中英文对照外文翻译文献

中英文对照翻译
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)
The lowest updating indices are observed for devices for examining a patient's body structures.These are: ophthalmological, otolaryngological, and anthropometric devices, endoscopes, etc. Theshare 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：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
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
设备是市售的的电源，有手动和自动两种，用于X射线摄影和器官型X射线检查。

该rts-61移动X射线视频诊断装置已在作电子科学制造业协会研究和开发。

该装置的设计是用于外科，骨科创伤。

国防工业设施已将其调整于生产医疗市场中。

机电（伊斯特拉）科学研究学院是值得一提的。

菲利普斯（德国）借助他们的技术和电路，机电研究所开发的mammodiagnost乳腺扫描仪，符合国际经营业绩的国际标准。

该rentgen-48层析X射线诊断系统的旋转支撑台和rentgen-60 X线诊断与远程控制系统已经在sevkavrentgen厂研制开发，收到了执业医师积极的响应。

上面X射线诊断设备列出的模型是国内医疗产业有成就的例子。

然而，我国医用X射线设备发展中许多重要问题仍然存在，这是个不合理的期望，除非采取特别措施，它们将在可预见未来的情况下得不到解决。

例如，在最常见的rum-20 X 射线设备配有类似sapfir图像增强器过时的X射线图像转换器REP-1。

为了能够更换REP-1图像转换器，莫斯科电子管厂开发了改进设计的唯一的图像转换器。

本装置提供更好的图像对比度，降低了克拉克的噪声背景，并改进设计的一项输出光纤窗口。

然而，在布尔图像转换器是尚未进入市场商业化。

数字X射线诊断设备尚未投入市场国产厂商是不会要的。

在与medtekh医学工程设计局合作下，公司（新西伯利亚）已经开发了diaskan X射线数字扫描仪。

本装置正处于在医学工程设计局连续生产状态。

然而，足够有质量的设备尚未投入市场。

国内医疗产业不生产X射线断层摄影。

心电图监测功能诊断的重要设备在车里雅宾斯克的生产已经暂停。

然而，国内医疗产业并未大幅落后领先的外国制造商，它们也在不均衡开发和生产必要的设备和装置。

许多的心电自动处理系统，包括syndromal诊断，已经处于发达状态，但是小的需求仍然没有测试发现。

然而，简单的三通道心电图机的质量应用规模国内厂家都是无法生产的。

外国制造商提供各种超声波扫描仪和先进的成像系统。

国内厂商通过扇形扫描和几个简单的模型与线性电子扫描也只能生产手工业简单的设备。

一些比较好的结果已经在内镜设备的开发中实现。

这些成绩的取得，主要是由于烙馍和一些日本公司之间的合作。

然而，即使这些设备需要进一步改进其质量和可靠性。

虽然国内实验室设备生产水平近年来有明显上升，还是很少能能满足需求的。

参与这类设备的开发组织的虽然数量上升了。

可是该可用的设备简单，具有有限的功能的能力。

许多重要的设备（例如，自动分析仪和简单常规设备）根本不能生产。

输血装置、血液替代品制备的解决方案仍然供不应求（40000000项）能够生产，而需求是200000000）。

透析器和聚合物注入系统的需求分别达到100和150百万的项目，这样的系统我们根本不能生产。

医药生产应该把生产和需求之间的对应关系，质量和技术性能，和足够的测试放在第一线，在市场经济条件下。

与国外的竞争问题，对于制造商也很重要，因为越来越多的进口医疗设备就会降低国内厂商生产销售。

在这方面，应考虑以下情况。

有些生产的医疗设备与群
体需要是有巨大失衡的。

如下：激光治疗设备和过度发展的巨大盈余。

综合征性心电图系统诊断，磁疗，与电刺激也过度供应。

然而，简单的心电图仪，常规实验室设备，和其他一些普通但必要的规模应用设备并非由国内制造商生产。

这些弊端造成重大的经济损失和目前健康的发展服务困难。

国内外的实践经验表明，这些问题可以通过适当的营销解决，但这是在在国内医疗产业的起步阶段。

应当指出，外国公司的重点放在市场营销和市场研究上。

他们对未决的需求以及消费者要求的实际评估，为消费者与厂商之间的反馈提供了有价值的在产品质量和工作绩效的改进信息。

在公司最领先的营销服务是最重要的。

一个新产品的开发往往从市场调查而不是从工程或设计研究开始的。

国内许多医疗器械工程组织需要提高营销水平的基本措施。

医疗器械检测也需要大量的改进。

相当多的国外医疗设备厂商生产的经验应予以考虑。

但值得一提的是这种经验经常被制造商忽略。

外国公司的医疗设备技术的性能检测和质量评估通常是由独立的实验室进行的。

实验室的专家也可以进一步提出改进测试设备的建议。

测试的基本目标是要检查的设备的性能规格是否符合，可用于医疗机构。

然而，实验室的专家通常超越这目标和问题比较了不同公司的产品。

这样的评论包含以下信息：
测试装置，描述其规格，价格；
技术测试结果，规格和实际性能之间的对应关系，优缺点，改进的建议（如果需要）；
分析比较，不同厂家生产的相似设备和仪器。

这样的分析通常能得出
一个最好的模型结论，并建议医疗机构在可靠性功能的基础上考虑经济原因。

在美国，测试实验室的活动是由政府与非政府控制的独立的非营利组织。

在俄罗斯，由国内厂家生产和进口是医疗设备在需求之间的平衡问题是起到相当重要的作用。

医疗行业的部门负责人认为，俄罗斯卫生和医疗工业部 F. doshchitsin每周一次的“meditsinskii图书”（No. 9，1995）发表强烈要求俄罗斯的国内的设备必须满足医疗市场包括高技术产品。

俄罗斯医学不应该单独依靠进口设备。

我们当然同意这个观点。

目前国内厂商几次从国外购买总体积更大的医疗设备。

这种情况绝对是不可以接受的。

红衣主教还必须采取经济措施刺激国内医疗设备制造商。

军事医学系统和设备是制造商的特别重要的生命支持。

然而，随着与外国制造商医疗设备联系，积极的方面不应该被忽视。

在国外的国际合作是很常见的，但它显然在俄罗斯是不够的。

在医药工业等领域的国际合作特别重要的是计算机技术，微处理器，与电子工程。

在先进的医疗设备和仪器缺乏足够的高质量的家用计算机和微处理器给制造商带来了相当大的的发展问题。