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Medical device registration system comparison between China and U.S.A.

Chinese Journal of Medical Instrumentation.2009;33(1):51-58.

The paper compares the medical device registration system between China and FDA in U.S.A., with the main focus on the problems of design default of supervision and management in Chinese system. It analyzes the primary elements of substantial equivalence approval in medical device registration, and points out the design defaults of our medical device registration system and the basic points which need to be handled.
China ; Device Approval ; Equipment Safety ; United States

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Discussions on the regulatory requirements for medical device risk management in China.

Lan-ming WANG

Chinese Journal of Medical Instrumentation.2009;33(1):46-50.

The requirements for risk management in current medical device regulations in China were reviewed, and some suggestions for the future were given.
China ; Device Approval ; legislation & jurisprudence ; Risk Management ; legislation & jurisprudence

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The status and prospect of total body irradiation technique.

Xiao-lei LIN ; Hai-Rong XU

Chinese Journal of Medical Instrumentation.2009;33(1):40-45.

This paper describes the development of TBI technique about fractionated TBI and the relationship between irradiation dose rate and complication; IMRT for TBI and lung compensation technique.
Dose-Response Relationship, Radiation ; Humans ; Radiation Dosage ; Whole-Body Irradiation ; methods

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Present status and future challenges of direct cardiac assist devices.

Yi LIU ; Ming YANG

Chinese Journal of Medical Instrumentation.2009;33(1):36-39.

Compression cardiac assist devices (CCAD) wrap around the epicardial surfaces or the aorta, assisting the weakened heart to restore its function. The advantage of avoiding the contact with patient bloods makes them a kind of important cardiac assist devices. This article reviews the current status and future challenges of compression cardiac assist devices.
Heart-Assist Devices ; trends

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Development of the remote hydraulic pressure control injection.

Di-le WANG ; Ming-jie LI ; Tao HE ; Zhi ZHENG ; Xin DUAN ; Ying-jian ZHENG

Chinese Journal of Medical Instrumentation.2009;33(1):34-35.

This paper introduced the work principle, execution, use and major characteristics of the remote hydraulic pressure control injection. Using Pascal principle, it is more accurate, convenient, cheap and safe. It could be used in all the fields of the medicine.
Equipment Design ; Injections ; Telemedicine ; instrumentation

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The practiced experiences of a PACS.

Ge CHEN

Chinese Journal of Medical Instrumentation.2009;33(1):31-33.

PACS is a long-term and complex systematic project. The system needs support of hardwares and softwares. The functions of the PACS and the context of integration between PACS and other systems must be specified in details. This paper introduces experiences of a PACS on sides of system environment, system technology and system relationships.
Hospital Information Systems ; Radiology Information Systems ; Systems Integration

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Design and application of medical knowledge model on SAGE.

Yan YANG ; Bin-fei WU ; Feng YE ; Xu-dong LV

Chinese Journal of Medical Instrumentation.2009;33(1):27-30.

As an methodology for promoting the quality and efficiency of health care, clinical decision support systems (CDSSs) have gained much improvement. The knowledge base (KB) plays an important role in DSS. For CDSSs, the construction of KB means modeling the medical knowledge based on a suitable model. This study analyzes the SAGE model, then implements it on knowledge of diagnosis and treatment of Metabolic Syndrome (MS), and improves the SAGE to enhance its expression ability. The model is constructed as the KB in CDSS, and be applied in hospital. The evaluation result of CDSS reveals that the SAGE model should be useful in clinical application. Finally, this study propounds some points yet to be improved in the SAGE.
Decision Support Systems, Clinical ; Knowledge Bases ; Models, Theoretical ; Research Design

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K-space undersampling algorithm based on PROPELLER MRI technique.

Le LUO ; Wen-long XU

Chinese Journal of Medical Instrumentation.2009;33(1):23-26.

PROPELLER (periodically rotated overlapping parallel lines with enhanced reconstruction) is a new method of MRI data collection and reconstruction technique for reducing motion artifact. However, the minimum imaging time in PROPELLER is markedly longer than in conventional fast MRI. Through the current research of K-Space Undersampling algorithm based on PROPELLER technique, a proper undersampling method is conducted and then proved by simulation. The new data collection method can shorten the PROPELLER time without causing more image artifacts, which improves the value of PROPELLER technique.
Algorithms ; Image Enhancement ; methods ; Image Processing, Computer-Assisted ; methods ; Magnetic Resonance Imaging ; methods

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Preliminary study on immunosuppressive effects evaluation of biomaterial.

Yang XUE ; Ting-ting DING ; Jiao SUN

Chinese Journal of Medical Instrumentation.2009;33(1):20-22.

In this paper, an immunosuppression model of immunotoxicity built through applying immunosuppressive agent-cyclophosphamide. Subsequently the changes of some assessment indexes including total amount of lymphocytes and concentration of cytokine TNF-alpha in peripheral blood were observed and were used to evaluate immunotoxicity induced by Medical Heat Vulcanizing Silicone Rubber. The final results showed no immunosuppressive effect caused by this material. The study provide effective and sensitive detection technique for evaluation of medical devices and biomaterials' immunotoxicity.
Animals ; Biocompatible Materials ; toxicity ; Elastomers ; toxicity ; Female ; Immunosuppressive Agents ; Lymphocytes ; immunology ; Male ; Materials Testing ; Mice ; Rubber ; toxicity ; Silicones ; toxicity ; Tumor Necrosis Factor-alpha ; blood

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Battery and power management of portable telemonitoring system.

Wei-jiao LI ; Da-kun LAI ; Xiao-mei WU ; Zu-xiang FANG

Chinese Journal of Medical Instrumentation.2009;33(1):15-19.

Biomedical Engineering of Electronic Engineering Deparment, Fudan University Shanghai, 200433 Based on the pulse-coded transmitting and wide-band receiving system, this paper describes a research of phase design a special power management circuit according to the particular demands of a real-time and continuously monitor system is essential. Combined with the requirement of voltage and current in separated module, three aspect must be considered, that is, how to select the functional component, how to accomplish voltage converting and how to carry on battery management. The test at last shows that, using this circuit and the 4400 mAh battery the energy utilization is more than 88%, and the work time is more than 20 hours.
Electric Power Supplies ; Equipment Design ; Monitoring, Ambulatory ; instrumentation ; Monitoring, Physiologic ; instrumentation ; Telemedicine ; instrumentation

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