1.Spermatic vein detection by color doppler ultrasound for minimally trauma varicocelectomy
Wei ZHONG ; Lijuan ZHOU ; Tiejun MAI ; Zhizhen ZHU ; Zhe LI
Chinese Journal of Primary Medicine and Pharmacy 2009;16(10):1773-1774
Objective In order to choose the best surgical approach for minimally trauma varicocelectomy color Doppler ultrasound(CDU) was used to detect the anatomic relationships of spermatic vein in groin. Methods Sixty varicocele patients were randomly selected. Their spermatic veins were examined by CDU which beginning from superficial inguinal ring,passing the crossing point of spermatic vein and femoral artery ,and ending at the 3cm above the deep inguinal ring. The depths from skin to spennatic vein were measured and the relationships between spermatic vein and femoral artery were recorded. Results The average length of incision is 2.1cm and the average duration of operation is 22 minutes. The average depth from skin to spermatic vein was 1.1cm,1.55cm and 3.56cm respectively at the site of the superficial inguinal ring,the crossing point of spermatic vein and femoral artery,and the deep ingui-nal ring. Conclusion The best approach for minimally trauma varicocelectomy is at the crossing point of spermatic vein and femoral artery because here the spermatic vein is relative superficial and has merged into two or three vessels and the femoral artery can be easily touched by fingers.
2.High performance liquid chromatography for determining the isofraxidin content in Feitai Capsule
Zongyang YU ; Xuenong OUYANG ; Quanshan HE ; Xihu DAI ; Guixiang ZHONG ; Jia YAN ; Zhizhen LIU
Journal of Medical Postgraduates 2004;0(01):-
Objective Feitai Capsule,a compound of traditional Chinese herbal medicine,has been screened and refined repeatedly for many years and shown to have a good anti-tumor effect.Strict quality control and further screening of the efficacious components of the compound are of great clinical significance.The purpose of this study was to establish the methods for determining the isofraxidin content in Feitai Capsule.Methods We determined the content of isofraxidin in Feitai Capsule by high performance liquid chromatography (HPLC),using the chromatographic column Hypersil ODS-C18 (4.6 mm?150 mm,5 ?m),with the mobile phase as acetonitrile 0.2% phosphoric acid solution (21∶79),the flow rate of 1.0 ml/min,the detective wavelength of 344 nm and the column temperature at 30℃.Results Isofraxidin showed a good linearity,within the range of 2.00-10.80 ?g/ml (y=69 427x+15961,r = 0.999 9),with the average recovery of 97.89% and RSD of 1.64% (n = 6).Conclusion HPLC,accurate and reproducible,is suitable for the determination of the isofraxidin content in Feitai Capsule.
3.Instruction of the technical evaluation for medical devices kits.
Zhizhen ZHONG ; Hong QIAN ; Yungao CHU ; Siwei DAI ; Ze WANG ; Yingfeng ZHU ; Xuying SUN
Chinese Journal of Medical Instrumentation 2013;37(3):213-217
Recent years, the development of medical devices kits is rapid. How to make the technical evaluation of medical devices kits more perfect bases on the two major principles of safe and effective, and to make kits in the market more normative and orderly, these issues for technical evaluation have to be considered. This article makes a study on current situation of production, classification of management and registration status, combined with existing regulations and related standards, and discusses technical evaluation related issues.
Equipment and Supplies
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standards
4.Status Analysis and Improvement Suggestions on the Renew Registration of Passive Medical Devices.
Dandan HOU ; Yungao CHU ; Zhizhen ZHONG
Chinese Journal of Medical Instrumentation 2018;42(5):375-377
The article collected 250 renew registration of domestic Class Ⅱ passive medical devices from Jan. 2016 to Aug. 2017 in Shanghai. It summarized the common problems listed in the correction notifications of the technical evaluation, and then provides some relevant countermeasures or suggestions. So that we can further speed up the evaluation and approval of medical devices.
5.Approval Status and Suggestions on Supervision of Class II Innovative Medical Device.
Chinese Journal of Medical Instrumentation 2023;47(1):80-82
Based on the current situation of approval and publicity of class II innovative medical devices in various provinces and cities, especially after analyzing the problems found in the review of class II innovative medical devices in Shanghai and the factors affecting the listing process of innovative medical devices, this study puts forward some thoughts on supervision for reference in establishing and perfecting systems and regulations, changing the review and approval thinking, extending services to the development of innovative medical devices and the formulation of clinical trial schemes.
Device Approval
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China
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Equipment and Supplies
6.Regulation Considerations of Medical Devices with Wireless Technology.
Xiaoling WANG ; Shuai NIU ; Zhizhen ZHONG
Chinese Journal of Medical Instrumentation 2020;44(3):258-262
Wireless technology has been widely used in medical devices and has brought convenience to medical care. However, wireless medical devices face risks such as data security and radio frequency interference. This study highlights safety and effectiveness evaluation of wireless medical devices, and discusses technical characteristics and regulation requirements, providing references for industry development and regulation.
Computer Security
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Wireless Technology