1.The Preliminary Study on the Construction of Medical Device Naming System in China.
Wanjuan YANG ; Jun LI ; Jingli LI
Chinese Journal of Medical Instrumentation 2015;39(6):442-444
The article has summarized the situation related to medical device naming, analyzed the problems of medical device naming in our country, put forward some new thinking in building the naming system of medical device in our country provided some reference on technical study of medical device naming.
China
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Durable Medical Equipment
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classification
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Terminology as Topic
2.The Analysis on Application of Global Medical Device Nomenclature(GMDN).
Wanjuan YANG ; Jun LI ; Jingli LI
Chinese Journal of Medical Instrumentation 2015;39(4):275-278
The article has reviewed the administration technical structure and global application of the global medical device nomenclature(GMDN), analyzed the coordination between GMDN and the industry status of medical device in our country, put forward some suggestions on the applicaition of GMDN, provided some reference on raising the management level of medical device in our country.
Equipment and Supplies
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standards
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Terminology as Topic
3.Progress in FDA UDI System for Medical Devices and its Revelation for Coding of our Country
Wanjuan YANG ; Jun LI ; Jingli LI
China Pharmacist 2015;(1):142-144,145
USA is the first country implementing the UDI program at national level,and the UDI rules and GUDID guidance have been issued by FDA recently to officially launch the implementation of UDI. The paper reviewed the advancement of UDI program,dis-cussed the framework of UDI system,analyzed the approaches of UDI implementation such as accredited issuing agencies and GUDID et al, and made some suggestions on the development of medical device coding system in our country.
4.Comparision of Different Methods of Area Measurement in Irregular Scar
Dan RAN ; Wanjuan LI ; Quangang SUN ; Jianqiu LI ; Qing XIA
Journal of Forensic Medicine 2016;32(5):338-341
ObjectiveTo determine a measurement standard of irregular scar area by comparing the ad-vantages and disadvantages of different measurement methods in measuring same irregular scar area. MethodsIrregular scar area was scanned by digital scanning and measured by coordinate reading method, AutoCAD pixel method, Photoshop lasso pixel method, Photoshop magic bar filled pixel method and Foxit PDF reading software, and some aspects of these methods such as measurement time, repeata-bility, whether could be recorded and whether could be traced were compared and analyzed.Results There was no significant difference in the scar areas by the measurement methods above. However, there was statistical difference in the measurement time and repeatability by one or multi performers and only Foxit PDF reading software could be traced back.ConclusionThe methods above can be used for measuring scar area, but each one has its advantages and disadvantages. It is necessary to develop new measurement software for forensic identification.
5.The Feasibility Study on the Application of Global Medical Device Nomenclature(GMDN).
Wanjuan YANG ; Jian ZHENG ; Jun LI ; Ying HUANG ; Chunqing ZHANG ; Jingli LI
Chinese Journal of Medical Instrumentation 2015;39(5):349-352
The article has analyzed the policy co-ordination, Industry coverage and technical experience of the global medical device nomenclature (GMDN) to our country, argued the feasibility on the application of GMDN in our medical device administration system, provided some reference on building the naming system of medical device in our country.
Equipment and Supplies
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Feasibility Studies
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Industry
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Terminology as Topic
6.International progress of unique device identification for medical devices.
Wanjuan YANG ; Jun LI ; Jingli LI
Chinese Journal of Medical Instrumentation 2014;38(5):353-356
Unique Device Identification (UDI) is a hot spot research area in the medical device administration. It comes a breakthrough from International Medical Device Regulators Forum (IMDRF) and government implementation recently. The article reviewed the advancement of IMDRF UDI program, discussed the framework for UDI system, analyzed the implementation of UDI in other countries, put forward some suggestions on the development of medical device coding system in our country.
Equipment and Supplies
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standards
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Product Labeling
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standards
7.Expression of TNF-?,MMP-9 and TIMP-1 in the lesions of psoriasis vulgaris
Wanjuan WANG ; Li CHEN ; Xiaopeng WANG ; Hongmin LI ; Yingjuan WANG ; Xiuying WANG
Journal of Xi'an Jiaotong University(Medical Sciences) 1981;0(03):-
Objective To study the role of TNF-?,MMP-9 and TIMP-1 in the lesions of psoriasis vulgaris.Methods SABC immunohistochemical technique was used to examine the expression of TNF-?,MMP-9 and TIMP-1 in lesional skin of 40 cases and uninvolved skin of 20 cases of psoriasis and in skin of 20 cases normal controls.Results The expression of TNF-? and MMP-9 was significantly higher in the lesional skin than that in nonlesional skin and normal controls(P0.05).There was a positive correlation between the expression of TNF-? and MMP-9(r=0.471,P
8.Analysis and thinking on the post marketing quality of the disposable sterilized syringe.
Jingli LI ; Wanjuan YANG ; Qing HAO ; Yuan JI ; Bijun ZHU
Chinese Journal of Medical Instrumentation 2012;36(6):441-443
By scattered-sampling testing the disposable sterilized syringe according to legal inspection and explorative research methods of vitro cytotoxicity and easy oxide etc. testing, this article comprehensively evaluated and analyzed the product quality and found the potential risk. The results will help to improve the work process and product quality.
Disposable Equipment
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Product Surveillance, Postmarketing
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Quality Control
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Syringes
9.Internatinal Progress of Unique Device Identiifcation for Medical Devices
Wanjuan YANG ; Jun LI ; Jingli LI
Chinese Journal of Medical Instrumentation 2014;(5):353-356
Unique Device Identification(UDI) is a hot spot research area in the medical device administration. It comes a breakthrough from International Medical Device Regulators Forum(IMDRF) and government implementation recently. The article reviewed the advancement of IMDRF UDI program, discussed the framework for UDI system, analyzed the implementationof UDI in other countries, put forward some suggestions on the development of medical device coding system in our country.
10.The Analysis on Application of Global Medical Device Nomenclature(GMDN)
Wanjuan YANG ; Jun LI ; Jingli LI
Chinese Journal of Medical Instrumentation 2015;(4):275-278
The article has reviewed the administration、technical structure and global application of the global medical device nomenclature(GMDN), analyzed the coordination between GMDN and the industry status of medical device in our country, put forward some suggestions on the applicaition of GMDN, provided some reference on raising the management level of medical device in our country.