Comprehensive evaluation of practical application of domestic surgical microscope
Relevant evaluation units: 1. Sichuan Provincial People's Hospital, Sichuan Academy of Medical Sciences; 2. Sichuan Food and Drug Inspection and Testing Institute; 3. Urology Department of the Second Affiliated Hospital of Chengdu University of Traditional Chinese Medicine; 4. Cixi Hospital of Traditional Chinese Medicine, Department of Hand and Foot Surgery
purpose
The domestic CORDER brand ASOM-4 surgical microscope was re-evaluated after the market.Methods: According to the requirements of GB 9706.1-2007 and GB 11239.1-2005, CORDER surgical microscope was compared with similar foreign products. In addition to the product access evaluation, the evaluation focused on reliability, operability, economy and after-sales service.Results: The CORDER operating microscope can meet the requirements of relevant industry standards, and its reliability, operability and after-sales service can meet the clinical needs, while its economy is good.Conclusion: CORDER operating microscope is effective and available in various microsurgeries, and is more economical than imported products. It is worth recommending as a domestic advanced medical device.
introduction
The operating microscope is mainly used for microsurgery such as ophthalmology, orthopedics, brain surgery, neurology and otolaryngology, and is the necessary medical equipment for microsurgery [1-6]. At present, the price of such equipment imported from abroad is more than 500000 yuan, and there are high operating costs and maintenance costs. Only a few large hospitals in China are able to purchase such equipment, which affects the development of microsurgery in China. Therefore, domestic surgical microscopes with similar performance and higher cost performance came into being. As the first batch of innovative medical device demonstration products in Sichuan Province, the ASOM-4 operating microscope of CORDER brand is an independently developed operating microscope for orthopedics, thoracic surgery, hand surgery, plastic surgery and other microsurgical operations [7]. However, some domestic users are always skeptical of domestic products, which limits the popularity of microsurgery. This study intends to conduct a multi-center post-marketing re-evaluation of ASOM-4 surgical microscope of CORDER brand. In addition to the product access evaluation of technical parameters, optical performance, safety and other products, it will also focus on its reliability, operability, economy and after-sales service.
1 Object and method
1.1 Research object
The experimental group used ASOM-4 surgical microscope of CORDER brand, which was provided by domestic Chengdu CORDER Optics&Electronics Co.; The control group selected the purchased foreign surgical microscope (OPMI VAR10700, Carl Zeiss). All equipment was delivered and put into use before January 2015. During the evaluation period, the equipment in the experimental group and the control group were used alternately, as shown in Figure 1.
1.2 research center
Select one Class III Class A hospital (Sichuan Provincial People's Hospital, Sichuan Academy of Medical Sciences, ≥ 10 microsurgeries per week) in Sichuan Province that has carried out microsurgery for many years and two Class II Class A hospitals in China that have carried out microsurgery for many years (the Second Affiliated Hospital of Chengdu University of Traditional Chinese Medicine and Cixi Hospital of Traditional Chinese Medicine, ≥ 5 microsurgeries per week). The technical indicators are determined by Sichuan Medical Device Testing Center.
1.3 research method
1.3.1 Access evaluation
The safety is evaluated according to GB 9706.1-2007 Medical Electrical Equipment Part 1: General Requirements for Safety [8], and the main optical performance indicators of the operating microscope are compared and evaluated according to the requirements of GB 11239.1-2005 [9].
1.3.2 Reliability evaluation
Record the number of operating tables and the number of failures of the equipment from the time of equipment delivery to July 2017, and compare and evaluate the failure rate. In addition, the data of the National Center for Clinical Adverse Reaction Detection in recent three years were queried to record the incidence of adverse events of the equipment in the experimental group and the control group.
1.3.3 Operational evaluation
The equipment operator, that is, the clinician, gives a subjective score on the ease of operation of the product, the comfort of the operator and the guidance of the instructions, and gives a score on the overall satisfaction. In addition, the number of failed operations due to equipment reasons shall be recorded separately.
1.3.4 Economic evaluation
Compare the equipment purchase cost (host machine cost) and consumables cost, record and compare the total equipment maintenance cost between the experimental group and the control group during the evaluation period.
1.3.5 After-sales service evaluation
The equipment management principals of three medical institutions will give subjective scores on installation, personnel training and maintenance.
1.4 Quantitative scoring method
Each item of the above evaluation content shall be scored quantitatively with a total score of 100 points. The details are shown in Table 1. According to the average score of the three medical institutions, if the difference between the scores of the products in the experimental group and the products in the control group is ≤ 5 points, the evaluation products are deemed to be equivalent to the control products, and the products in the experimental group (CORDER surgical microscope) can replace the products in the control group (imported surgical microscope).
2 result
A total of 2613 operations were included in this study, including 1302 domestic equipment and 1311 imported equipment. Ten orthopedic associate senior and above doctors, 13 urological male associate senior and above doctors, 7 neurosurgical associate senior and above doctors, and a total of 30 associate senior and above doctors participated in the evaluation. The scores of the three hospitals are counted, and the specific scores are shown in Table 2. The overall index score of ASOM-4 operating microscope of CORDER brand is 1.8 points less than that of imported operating microscope. See Figure 2 for the comprehensive score comparison between the equipment in the experimental group and the equipment in the control group.
3 discuss
The overall index score of ASOM-4 surgical microscope of CORDER brand is 1.8 points less than that of the imported surgical microscope of the control, and the difference between the score of the control product and ASOM-4 is ≤ 5 points. Therefore, the results of this study suggest that ASOM-4 surgical microscope of CORDER brand can replace the imported products of foreign countries and is worth promoting as an advanced domestic equipment.
The radar chart clearly shows the difference between domestic equipment and imported equipment (Figure 2). In terms of technical indicators, stability and after-sales support, the two are equivalent; In terms of comprehensive application, imported equipment is slightly superior, indicating that domestic equipment still has room for continuous improvement; In terms of economic indicators, CORDER brand ASOM-4 domestic equipment has obvious advantages.
In the admittance evaluation, the key performance indicators of domestic and imported surgical microscopes meet the requirements of GB11239.1-2005 standard. The key safety indicators of both machines meet the requirements of GB 9706.1-2007. Therefore, both meet the requirements of national standards, and there is no obvious difference in safety; In terms of performance, imported products have some advantages over domestic medical devices in terms of lighting light characteristics, while other optical imaging performance has no obvious difference; In terms of reliability, during the evaluation period, the failure rate of this type of equipment was less than 20%, and most of the failures were caused by the bulb need to be replaced, and a few were caused by the improper adjustment of the counterweight. There was no serious failure or equipment shutdown.
CORDER brand ASOM-4 surgical microscope host price is only about 1/10 of the control group (imported) equipment. At the same time, because it does not need to protect the handle, it requires less consumables and is more conducive to the sterile principle of surgery. In addition, this type of operating microscope uses domestic LED lamp, which is also cheaper than the control group, and the total maintenance cost is lower. Therefore, CORDER brand ASOM-4 surgical microscope has obvious economy. In terms of after-sales support, the equipment in the experimental group and the control group are very satisfactory. Of course, as the market share of imported equipment is higher, the maintenance response speed is faster. I believe that with the gradual popularization of domestic equipment, the gap between the two will gradually narrow.
As the first batch of innovative medical device demonstration products in Sichuan Province, the CORDER brand ASOM-4 surgical microscope produced by Chengdu CORDER Optics&Electronics Co. is at the international advanced and domestic leading level. It has been installed and used in many hospitals in China, and exported to Southeast Asia, the Middle East, Africa and other regions, which is favored by users. CORDER brand ASOM-4 surgical microscope has a high-resolution, high-definition optical system, strong stereoscopic sense, large depth of field, cold light source dual optical fiber coaxial lighting, good field brightness, foot control automatic micro-focus, electric continuous zoom, and has visual, television and video photography functions, multi-function rack, complete functions, especially suitable for microsurgery and teaching demonstration.
In conclusion, the CORDER brand ASOM-4 surgical microscope used in this study can meet the relevant industry standards, meet the clinical needs, be effective and available, and is more economical than the control equipment. It is a domestic advanced medical device worthy of recommendation.
[reference]
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Post time: Jan-30-2023
