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This article briefly describes the imaging performance standards of the kilovolt X-ray image guidance system used in radiotherapy, analyzes the main aspects that should be considered in the image quality of X-IGRT system, and focuses on parameters that should be considered in the imaging performance evaluation criteria of the CBCT X-IGRT. The purpose is to sort out the imaging performance evaluation standards of kilovolt X-IGRT system, clarify the image quality requirements of X-IGRT equipment, and reach a consensus when evaluating the imaging performance of X-IGRT system.
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Radiotherapy Planning, Computer-Assisted/methods , Cone-Beam Computed Tomography/methods , Spiral Cone-Beam Computed Tomography , Radiotherapy, Intensity-Modulated/methods , Radiotherapy, Image-Guided/methodsABSTRACT
The anterior cruciate ligament (ACL) injury is a common sports injury that has a significant impact on knee function and patients′ mobility. With the popularity of national fitness campaign in China, the incidence of ACL injury is increasing year by year. Currently, there still lacks clinical standards or guidelines on how to choose appropriate treatment methods, surgical plans and rehabilitation protocols for ACL injury. In order to timely reflect the new treatment concept of ACL injury, standardize its diagnosis and treatment and improve the curative effect, the Sports Medicine Society of Chinese Research Hospital Association and the Editorial Board of Chinese Journal of Trauma organized domestic orthopedic and sports medicine experts to formulate the "clinical evidence-based guideline for the diagnosis and treatment of anterior cruciate ligament injury (2022 version)" based on the level of evidence-based medicine and in compliance with the principle of scientificity, practicability and advancement. The present guideline includes 12 recommendations for the diagnosis, treatment and rehabilitation of ACL injury in order to provide guidance and assistance for the clinical diagnosis and treatment of ACL injury in China.
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OBJECTIVE@#This paper puts forward suggestions on the development of in vitro diagnostic reagents and supervision measures for the post-marketing products, so as to further improve the quality of in vitro diagnostic reagents and ensure the safety use of medical device.@*METHODS@#This paper summarizes the quality of in vitro diagnostic reagents and analyzes the causes of the problems, according to the results of the national medical device supervision and inspection in 2020.@*RESULTS@#The overall quality of in vitro diagnostic reagents for national medical device supervision and inspection in 2020 is stable and the unqualified detection rate is 1.6%. However, there are some problems. For example, the management of raw materials is unscientific, the faultiness in the preparation of reference materials, the understanding of standards is unthorough, and the management of instructions is unimportance.@*CONCLUSIONS@#It is suggested that manufacturers of in vitro diagnostic reagents should improve the binding force of the quality management system, strengthen the awareness of risk management, attach importance to communicate with regulatory authorities, study standards sufficiently and strengthen the management of instructions. It is also suggested that the regulatory authorities should strengthen supervision and inspection, and further complete the evaluation guidance and standard publicity and implementation.
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Indicators and Reagents , Marketing , Reference StandardsABSTRACT
Summarize the quality status and variety quality change characteristics of the sampling products through the Summary and analysis, according to the results of the national medical device supervision and inspection in 2019. Put forward suggestions on the development of the medical device industry and supervisory measures. Thereby, further improve the level of the medical device and ensure the safety use of medical device.
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Equipment and Supplies , Industry , Reference StandardsABSTRACT
This article introduces the process and principles of variety selection for medical device supervision and inspection, and it analyzes the reason and consideration of the variety selection data of national medical device supervision and inspection from 2017 to 2019, it also put forward a collection of selected varieties for reference in the future by sorting out the classified catalogue of medical devices and diagnostic reagents.
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Equipment SafetyABSTRACT
This paper reviews the quality and safety risk points of medical devices found in the sampling inspection of national medical device supervision in recent years. These risk points are summarized into quality management system, product technical requirements, national standards and industry standards, etc. Several specific risk scenarios are further summarized. Based on the above efforts, a more comprehensive risk point system is constructed. Then it is illustrated with typical examples. In view of the existing problems, the corresponding suggestions are put forward to the production enterprises and supervision departments respectively.
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Equipment Safety , Equipment and Supplies , Industry , Reference StandardsABSTRACT
This paper introduces the sampling scheme and the inspection scheme paradigm followed in organizing the sampling inspection of medical devices. The sampling scheme paradigm includes the definition and operation guidelines for sampling products, the regulations for individual sampling batches and related model specifications, accessory data, validity period, storage conditions, etc., the requirements for sampling areas, places and quantities, and the requirements for samples to be sent to inspection institutions. The inspection scheme paradigm includes the provisions for inspection basis, inspection items and determination principles.
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Equipment Safety , Methods , Guidelines as TopicABSTRACT
The types and the reasons of changing the original test result after retesting in national medical device sampling and testing from 2013 to 2016, are summarized and analyzed. Firstly, collecting data of "standards not complied" and retesting. Then, giving specific examples when summarizing five types of changing the original test result after retesting. Meanwhile, analyzing the relevant reasons, discovering the deep problems. Finally, giving suggestions for the above problems.
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Equipment and Supplies , Reference Standards , Quality ControlABSTRACT
The standard of YY/T 0481-2004 Medical diagnostic X-ray equipment-Radiation conditions for use in the determination and characteristics has been revised and replaced in 2012. This paper first introduces the key technical problems to be solved in establishing standard radiation quality and radiation conditions by comparing the main changes of the two versions standards, including the expression of radiation quality and radiation conditions, the measurement of X-ray tube voltage, and the measuring of the practical peak voltage. Then it introduces a procedure for establishing standard radiation quality and radiation conditions.
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Radiation Dosage , Radiography , Reference StandardsABSTRACT
Objective To explore the efficacy of quantitative susceptibility mapping (QSM) in the assessment of osteoporosis and the impact factors on the QSM values.Methods A total of 105 volunteers (35 males and 70 females) were recruited in this study.The height,weight,waistline and hipline were measured,and the body mass index was calculated.All the subjects underwent MRI-based QSM and quantitative computed tomography (QCT).The measurement of QSM and QCT values was performed on L3 vertebrae body.According to QCT value,the subjects were divided into three groups (normal,osteopenia and osteoporosis).According to age,the subjects were divided into group I (21-30 years old),group 2 (31-40 years old),group 3 (41-50 years old),group 4 (51-60 years old),and group 5 (＞60 years old).Differences among all groups were compared using one-way ANOVA or Kruskal-Wallis.Results According to QCT value,54 subjects were normal,22 osteopenic and 29 osteoporotic.The QSM value for the subjects with osteoporosis [148.60(109.42,188.81)ppb] was significantly higher than that of normal (P＜0.001)and the osteopenia (P＜0.001).The QSM value for the subjects with osteopenia was significantly higher than the normal (P＜0.001).The coefficient of QSM and BMD was-0.749 (P＜0.001).Multiple linear regression showed age was the independent influence factor for QSM value (r=0.72,P＜0.001),whereas the gender,BMI,waistline and hipline showed no significant difference (P＞0.05).With the increasing of age,the QSM value showed a gradual increasing trend.And there were significant differences of QSM values among the different age groups (P＜0.001).The QSM value of 138.98 (100.37,183.84)ppb for group 5 (＞60 years old) was significantly higher than that of group 1,group 2,and group 3 (P＜0.001).There is no difference between group 5 and group 4 (P＞0.05).The QSM value of 96.62(28.62,143.99)ppb for group 4 (51-60 years old) was significantly higher than that of group 1 and group 2 (P＜0.001).And there was no difference between group 4 and group 3 (P＞0.05).The QSM value of group 1,group 2,and group 3 showed no significant difference (P＞0.05).Conclusions The QSM of bone is feasible in the assessment of osteoporosis and has the potential to be a biomarker providing new insights into osteoporosis.And age is the critical factor affecting QSM value.
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<p><b>OBJECTIVE</b>To compare the image quality of isotropic 3-dimensional fast spin echo (3D-FSE), 3D fast field echo (3D-FFE), and 2D fast spin echo (2D-FSE) sequences in magnetic resonance imaging (MRI) of the anatomical structure of the ankle joint.</p><p><b>METHODS</b>The ankle joints of 10 healthy volunteers were examined with isotropic 3D-FSE, 3D-FFE and 2D-FSE sequences using a 1.5T MR scanner and 3D reconstruction. The signal-to-noise ratio (SNR) and contrast-to-noise ratio (CNR) of the tissues were measured. Two radiologists evaluated the image quality of the 3 sequences using a 5-point Likert scale in a double-blinded manner.</p><p><b>RESULTS</b>The 3D-FSE sequences resulted in the highest SNRs for all the tissues and the highest CNRs for differentiation between cartilage and marrow, between muscle and tendon, and between tendon and fluid. In the estimation of image quality for cartilages, 3D-FFE had the highest score followed by 3D-FSE, and the latter had the highest score among the 3 sequences in displaying the tendon.</p><p><b>CONCLUSION</b>3D-FSE sequence has a high performance in displaying the anatomical structures of complex joints especially for cartilage, ligament, and tendon tissues.</p>
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Humans , Ankle Joint , Imaging, Three-Dimensional , Magnetic Resonance ImagingABSTRACT
This paper focuses on issues needed to be clear towards the product quality supervision of medical devices in use. The life circle of medical devices, the supervision regarding its boundary, target, emphasis, basis and standards have been analyzed in turn. A clear and creative idea is also provided for theoretical exploration of the supervision on medical devices in use.
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Materials Management, Hospital , Quality Assurance, Health CareABSTRACT
This article analyzes the status quo of sales supervision on medical devices through some aspects, including the relevant regulation system, the standards of sales admittance, the supervision team and the approval of business license. According to the exiting problems, some improving countermeasures are proposed for reference.
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Materials Management, HospitalABSTRACT
The paper introduces supervision situation of enterprises of medical devices from the aspects of supervision team of medical devices, construction of credit system and implementation of regulation of quality management of medical devices, and raises supervision difficulties and puts forwards corresponding proposals.
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China , Equipment and Supplies , Reference Standards , Quality ControlABSTRACT
This paper focused on the revision of national administrative provisions for the sampling and testing of quality supervision on medical devices, according to the practice, it introduced the scope of application, Chinese system of sampling and testing on medical devices, the methods of sampling, inspection standards, re-inspection institutes and the other issues should be taken into consider and discussed The current situation of these issues, main idea of the revision and influences of the provisions were also analyzed to provide theoretical exploration for the revision.
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Constitution and Bylaws , Equipment and Supplies , Reference Standards , Quality ControlABSTRACT
Objective To study the treatment of acute renal failure induced by uretericobstruction . Methods Twenty-five cases of acute renal failure induced by uretericobstruction were emergent managed with ureteroscope pneumatic lithotripsy .Results All the renal function resumed well , BUN,Cr in serum was natural or near natural .Conclusion Ureteroscope pneumatic lithotripsy should be used for acute renal failure induced by uretericobstruction as first-line.
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Objective To investigate clinical efficacy and safety and complications of transurethral plasmakinetic resection of prostate ( PKRP) for benign prostatic hyperplasia ( BPH) .Methods Totally 186 BPH patients were underwent PKRP .Comparison of clinical parameters before and after operation .Results Following-up at 3 and 6 months after the operation showed that international prostate symptom score ( IP-SS),quality of life(QQL),residual urine volume(RUV) scores increased and maximal urinary flow rate ( Qmax) scores decreased .The incidence of complications was 8.2%.Conclusion PKRP have efficacy in the treatment of BPH , and PKRP is safer and less complications .
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BACKGROUND: Using color Doppler ultrasonography, renal graft size, appearance, structure, and blood flow distribution can be observed. Through the use of blood flow display technique, blood flow perfusion of renal graft can be accurately observed to assist diagnosis and differential diagnosis of complications following renal transplantation. OBJECTIVE: To observe the hemodynamic characteristics during different periods of acute renal transplant rejection, summarize its specific manifestations through analyzing different reaction of two dimensional and color Doppler flow imaging (CDFI) during renal transplantation in order to get valuable index on acute rejection of renal transplantation.DESIGN, TIME AND SETTING: Comparative observation was performed at the Jinan University and First Hospital of Shenzhen University between January 2003 and January 2007.PARTICIPANTS: A total of 299 patients undergoing renal transplantation were divided into normal allograft group (n=236) and acute rejection group (n=63) according to renal allograft function.METHODS: The systolic peak flow rate, end-diastolic flow rate, mean flow rate, pulsatility index and resistance index of main renal artery and arcuate artery in patients of two groups were compared. MAIN OUTCOME MEASURES: Renal allograft arterial inner diameter and hemodynamics of two groups.RESULTS: Compared with normal allograft group, the blood flow perfusion was reduced at acute rejection, which could not reach cortex margin, blood velocity was decreased at the diastolic phase, pulsatility index and resistance index were increased (P < 0.05). CONCLUSION: Color Doppler ultrasound, as a convenient, economical and noninvasive technique, provides the reliable evidences for the renal artery pulsatility index and resistance index in clinic, and also is valuable for the acute rejection early diagnosis of renal allograft.
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OBJECTIVE:To strengthen the implementation of Drug Recall Administration(DRA).METHODS:Based on the study of "DRA" and the analysis of the current drug recall status both in China and abroad,effective measures for the enforcement of the regulation was presented.RESULTS & CONCLUSIONS:In the initial enforcement stage of "DRA",some relative effective measures should be taken from the aspects of drug manufacturing enterprises,consumers and the related supporting regulations to ensure the effective enforcement of the regulation.
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Objective To investigate the clinical value of perforin and granzyme B expression in peripheral blood lymphocytes and diagnosis of acute rejection in renal transplantation. Methods Sixty-seven recipients of renal allograft were included in the study. The expression of perforin and granzyme B of peripheral blood lymphocytes was studied by quantitative reverse transcription polymerase chain reaction (RT-PCR). The recipients were divided into four groups, including 7 cases of acute rejection as group 1, 8 cases of delayed graft function as group 2, 27 cases of stable function as group 3, 25 cases of long-term survival as group 4. Results The expression of perforin and granzyme B in group 1 was significantly higher than that of the other three groups (P