2.The proposed principles by GHTF of the classification and assessment for in vitro diagnostic (IVD) medical devices.
Shuang LI ; Bao-ai CHEN ; Zi-ming PENG
Chinese Journal of Medical Instrumentation 2009;33(6):438-440
The IVD (In Vitro Diagnostic)Medical Devices are various and develop rapidly. This paper introduces briefly the principles of classification and conformity assessment for IVD medical that proposed by GHTF (Global Harmonization Task Force).
Diagnostic Techniques and Procedures
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instrumentation
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Equipment and Supplies, Hospital
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classification
3.Recent advance in diagnostic telepathology.
Chinese Journal of Pathology 2006;35(3):176-178
4.Site inspection procedures and methods for evaluation of the quality management system of in vitro diagnostic regents.
Chinese Journal of Medical Instrumentation 2010;34(2):129-132
In this paper, the procedures, logos, methods, essentials as well as notable problems for inspecting the qualification management system of in vitro diagnostic regent manufactures are discussed, with aims of promoting inspector's practical level and consequentially ensuring the quality, standard and efficacy of the inspection.
Diagnostic Techniques and Procedures
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instrumentation
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Indicators and Reagents
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standards
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Quality Assurance, Health Care
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Quality Control
5.Study on the supervision of in-vitro diagnostic reagents.
Haining LI ; Ruihong MU ; Haiping REN ; Dondting BAI
Chinese Journal of Medical Instrumentation 2011;35(1):68-70
The regulatory history and status of in vitro diagnostic reagents (IVD) at home and abroad are introduced. Suggestions are also provided on the administration of IVD.
Diagnostic Techniques and Procedures
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instrumentation
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Health Services Administration
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Indicators and Reagents
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standards
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Product Surveillance, Postmarketing
6.Analysis on renving and cunkou pulse diagnostic methods in Internal Classic and Pulse Classic.
Chinese Acupuncture & Moxibustion 2015;35(5):493-496
Renying and cunkou pulse diagnostic methods have been recorded in Neijing Unternal Classic) and Maijing (Pulse Classic) and these two pulse diagnostic methods are very different. Through the analysis and inference on the relevant statements in Internal Classic and Pulse Classic, as well as those of medical scholars in later generations, it is discovered that the pulse of excess type, the pulse of deficiency type, the tense pulse, the regular missed-beat pulse, etc. could be detected and be used to judge the disorders of meridians and zangfu organs by the comparison between the pulse of excess type and the pulse of deficiency type with renying and cunkou pulse diagnostic methods recorded in Internal Classic. The substance of renying and cunkou pulse diagnostic methods in Pulse Classic is consistent with the methods in later generations, meaning that they can be applied to judge the disorders of meridians and zangfu organs through detecting the excess or the deficiency in every region of cun, guan and chi.
China
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Diagnostic Techniques and Procedures
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history
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instrumentation
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Heart Rate
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History, Ancient
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Humans
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Medicine in Literature
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Meridians
7.Consanguinity between meridian theory and Bianque's pulse theory.
Chinese Acupuncture & Moxibustion 2015;35(5):517-523
The integral meridian theory is composed of five parts, including meridian course, syndrome, diagnostic method, treating principle and treatment, and the core of it is meridian syndrome. It has been proved by multiple evidences that the meridian syndrome induced by the pathological change in meridian and the death syndrome of pulse penetrating or attaching to the syndrome are all originated from Bianque' s facial color and pulse diagnosis. And regarding the pulse syndrome,there are many different interpretations based on the theory of yin-yang in four seasons before the Han Dynasty. The emerging of Biaoben diagnostic method in Bianque's pulse method and its extensive clinical application promote a new theoretic interpretation the connection of meridians interpreting pulse syndrome directly. Besides, along with the new development of blood-pulse theory of Bianque's medicine, the revolution on meridian theory is aroused as well its theoretical paradigm turning from "tree" type to "ring" type. In other words, Bianque's medicine not only gives birth to meridian theory, but also decides its final development.
Acupuncture Therapy
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history
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China
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Diagnostic Techniques and Procedures
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history
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instrumentation
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Heart Rate
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History, Ancient
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Humans
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Medicine in Literature
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Meridians
8.Intrusion of overerupted maxillary molars with miniscrew implant anchorage: a radiographic evaluation.
Chun-Lei XUN ; Hong ZHAO ; Xiang-Long ZENG ; Xing WANG
Journal of Huazhong University of Science and Technology (Medical Sciences) 2013;33(5):780-785
The aim of this retrospective study was to quantitatively evaluate the treatment effects of intrusion of overerupted maxillary molars using miniscrew implant anchorage and to investigate the apical root resorption after molar intrusion. The subjects included 30 patients whose average ages were 35.5±9.0 years. All patients had received intrusion treatments for overerupted maxillary molars with miniscrew anchorage. There were 38 maxillary first molars and 26 maxillary second molars to be intruded. Two miniscrews were inserted in the buccal and palatal alveolar bone mesial to the overerupted molar. Force of 100-150 g was applied by the elastic chains between screw head and attachment on each side. Lateral cephalograms and panoramic radiographs taken before and after intrusion were used to evaluate dental changes and root resorption of molars. Only 6 of the 128 miniscrews failed. The first and second molars were significantly intruded by averages of 3.4 mm and 3.1 mm respectively (P<0.001). The average intrusion time was more than 6 months. The crown of the molars mesially tilted by averages of 3.1 degrees and 3.3 degrees (P<0.001) for first and second molars. The amounts of root resorption were 0.2-0.4 mm on average. The intrusion treatment of overerupted molars with miniscrew anchorages could be used as an efficient and reliable method to recover lost restoration space for prosthesis. Radiographically speaking, root resorption of molars was not clinically significant after application of intrusive forces of 200 to 300 g.
Adult
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Bone Screws
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Cephalometry
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Dental Implantation
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Female
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Humans
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Male
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Maxilla
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Middle Aged
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Molar
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diagnostic imaging
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surgery
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Orthodontic Anchorage Procedures
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instrumentation
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methods
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Radiography, Dental
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methods
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Retrospective Studies
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Root Resorption
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diagnostic imaging
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surgery
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Tooth Movement Techniques
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instrumentation
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methods
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Young Adult
9.Current Status of External Quality Assessment of Fecal Occult Blood Test.
Soo Jin YOO ; Young Joo CHA ; Won Ki MIN ; You Kyoung LEE ; Seok Lae CHAE ; Bo Moon SHIN ; Hwan Sub LIM
The Korean Journal of Laboratory Medicine 2010;30(6):726-733
BACKGROUND: Nationwide external quality assessment (EQA) of the fecal occult blood test (FOBT) in Korea was first introduced in 2007-2009. The EQA results were analyzed to assess the current status of FOBT and to plan the continuation of the EQA program. METHODS: The surveys included 40 hospitals in the preliminary survey conducted in 2007, 249 general hospitals in 2008, and 389 hospitals in 2009. In the surveys, the participating hospitals provided the results of the distributed materials and replies to the questionnaire on the FOBT test procedures and quality controls. RESULTS: In the surveys conducted between 2007 and 2009, a total of 650 institutes submitted 653 test system results; 3 institutes used 2 kinds of methods. All of the institutes used immunologic methods; 107 institutes (16.5%) used quantitative equipments and 546 institutes (84.0%) used qualitative kits. Most quantitative tests yielded consistent positive or negative results; however, their cut-off and measured values differed according to the equipments used. A low-level material tested in 2007 was negative in the quantitative methods but positive in some qualitative methods because of lower detection limits. The discordance rates among quantitative tests were 3.2% in 2007, 4.4% in 2008, and 0% in 2009 and the rates among qualitative tests were 13.8% in 2008 and 2.6% in 2009. Semi-solid EQA materials showed the ability to evaluate the overall test procedures with acceptable stability. CONCLUSIONS: In the first Korean FOBT EQA, commercially available EQA materials were proven to be stable. Continuation of the EQA program and further education of laboratory personnel are needed to reduce inconsistency in results. Further, the test kit, procedures, and result reports must be standardized.
Colorectal Neoplasms/diagnosis
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Data Collection
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Hemoglobins/analysis/immunology/standards
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Humans
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Laboratory Techniques and Procedures/instrumentation/standards
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*Occult Blood
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Quality Control
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Questionnaires
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Reagent Kits, Diagnostic
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Temperature