中国医疗器械杂志最新文献_第2页

[Exploration of Rational Use of DSA Equipment in IoT and Clinical Service]. [DSA设备在物联网与临床服务中的合理使用探讨]。

中国医疗器械杂志 Pub Date : 2025-03-30 DOI: 10.12455/j.issn.1671-7104.240316

Jie Yang, Xiaomin Ren, Jinning Zhang

{"title":"[Exploration of Rational Use of DSA Equipment in IoT and Clinical Service].","authors":"Jie Yang, Xiaomin Ren, Jinning Zhang","doi":"10.12455/j.issn.1671-7104.240316","DOIUrl":"https://doi.org/10.12455/j.issn.1671-7104.240316","url":null,"abstract":"Objective: This study aims to address the configuration and efficiency issues in the use of digital subtraction angiography (DSA) equipment through the practical implementation of a rationalization platform based on the Internet of Things (IoT).Methods: By employing IoT and data integration technologies, the deep integration of DSA equipment operational data with clinical data was achieved to construct a knowledge base for rational use of DSA equipment. Simultaneously, a knowledge base was developed using software engineering techniques to visually display data analysis results.Results: Through thorough data analysis, an imbalance in DSA usage between the southern and northern hospital campuses was identified. Addressing this issue, optimizations were implemented based on the data analysis results, which ultimately yielded significant effects. These adjustments not only effectively alleviated the pressure on DSA equipment usage in the southern campus, but also increased equipment utilization in the northern district (the average daily working hours have increased from 4.64 h to 7.19 h), shortened patient appointment wait time (the appointment duration in the southern campus decreased by 21.86% year-on-year, while the appointment duration in the northern campus decreased by 20.51% year-on-year).Conclusion: Through the practical implementation of a DSA rationalization platform based on IoT, this study not only successfully explored methods for rational DSA usage but also provided valuable reference for the rational management of medical equipment.","PeriodicalId":52535,"journal":{"name":"中国医疗器械杂志","volume":"49 2","pages":"186-190"},"PeriodicalIF":0.0,"publicationDate":"2025-03-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144040418","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

[Development of a Microstream End-Tidal Carbon Dioxide Monitoring System with Integrated Gas Circuit]. 集成气路的微流末潮二氧化碳监测系统的研制

中国医疗器械杂志 Pub Date : 2025-03-30 DOI: 10.12455/j.issn.1671-7104.240382

Yanan Liu, Xuedong Song, Qi Yin, Fuhao Kang, Yan Hang, Jilun Ye, Xu Zhang

引用次数: 0

[Brief Discussion on the General Requirements of Quality Management System of In Vitro Diagnostic Reagents Developed by Medical Institutions]. 浅谈医疗机构研制的体外诊断试剂质量管理体系的一般要求

中国医疗器械杂志 Pub Date : 2025-03-30 DOI: 10.12455/j.issn.1671-7104.240397

Ting He, Ru Bai, Neng Xie

{"title":"[Brief Discussion on the General Requirements of Quality Management System of In Vitro Diagnostic Reagents Developed by Medical Institutions].","authors":"Ting He, Ru Bai, Neng Xie","doi":"10.12455/j.issn.1671-7104.240397","DOIUrl":"https://doi.org/10.12455/j.issn.1671-7104.240397","url":null,"abstract":"On March 19, 2021, the National Medical Products Administration(NMPA) issued the Regulations on the Supervision and Administration of Medical Devices (Order No. 739 of the State Council of the People's Republic of China), which clearly stipulated in Article 53 the basic definition and scope of use of in vitro diagnostic reagents developed by medical institutions. It also pointed out that the relevant administrative measures shall be formulated by the Drug Regulatory Department of the State Council in conjunction with the Health Department of the State Council. This initiative marks the re-incorporation of in vitro diagnostic reagents developed by medical institutions into China's regulatory system. This study reviewed the development of regulatory policies for self-developed in vitro diagnostic reagents at home and abroad, combined with the Key Points of On-site Verification of Self-developed In Vitro Diagnostic Reagents in Shanghai Medical Institutions issued by the Shanghai Municipal Drug Administration, in conjunction with the Shanghai Municipal Health Commission, and the specific verification work of pre-record evaluation, and sorted out the general requirements for the quality management system of self-developed in vitro diagnostic reagents. The purpose is to provide some references for the further development of this pilot work and its nationwide promotion.","PeriodicalId":52535,"journal":{"name":"中国医疗器械杂志","volume":"49 2","pages":"219-223"},"PeriodicalIF":0.0,"publicationDate":"2025-03-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144018147","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

[Three-Dimensional Reconstruction Technique and Its Application of Binocular Endoscopic Images Based on Deep Learning]. [基于深度学习的双目内窥镜图像三维重建技术及其应用]。

中国医疗器械杂志 Pub Date : 2025-03-30 DOI: 10.12455/j.issn.1671-7104.240293

Lina Huang, Shenglin Liu, Qingmin Feng, Haolong Jin, Qiang Zhang

引用次数: 0

[Finite Element Simulation Analysis of a Nickel-Titanium Alloy Patent Foramen Ovale Occluder]. 镍钛合金卵圆孔闭锁器的有限元模拟分析

中国医疗器械杂志 Pub Date : 2025-03-30 DOI: 10.12455/j.issn.1671-7104.240458

Juan Shen, Wei Liu

{"title":"[Finite Element Simulation Analysis of a Nickel-Titanium Alloy Patent Foramen Ovale Occluder].","authors":"Juan Shen, Wei Liu","doi":"10.12455/j.issn.1671-7104.240458","DOIUrl":"https://doi.org/10.12455/j.issn.1671-7104.240458","url":null,"abstract":"In this paper, a preliminary stress/strain analysis of the design structure of a nickel-titanium alloy patent foramen ovale occluder is conducted with the finite element simulation analysis method. In the analysis, solid structure modeling is carried out on three different specifications of domestic patent foramen ovale occluders. Referring to the test method of fatigue performance in inspection standard YY/T 1553-2017, an initial installation deformation is applied to the model, and then the fatigue displacement of 2 mm is applied to the sample to make the model fatigue deformation. The fatigue safety factors of each type of occluder are obtained by strain simulation analysis. The results indicate that the minimum fatigue safety factors of the three specifications of domestic patent foramen ovale occluders are 2.09, 2.35 and 2.06 respectively, which all meet the design of fatigue safety factor greater than 1. Among them, 1818 and 3030 specifications of patent foramen ovale occluders have close values in minimum fatigue safety factors, and both are lower than that of 1825 model. Therefore, it is recommended to carry out physical fatigue tests on both 1818 and 3030 specifications to further verify the fatigue performance of the products.","PeriodicalId":52535,"journal":{"name":"中国医疗器械杂志","volume":"49 2","pages":"119-124"},"PeriodicalIF":0.0,"publicationDate":"2025-03-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144057118","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

[Current Situation and Development Trends Analysis of Innovative Medical Devices for Heart Valve Intervention]. 心脏瓣膜介入创新医疗器械现状及发展趋势分析

中国医疗器械杂志 Pub Date : 2025-03-30 DOI: 10.12455/j.issn.1671-7104.240326

Mingyang Li

引用次数: 0

[Torso Simulation Research on Electromagnetic Compatibility of Implantable Neurostimulator]. [植入式神经刺激器电磁兼容性的躯干仿真研究]。

中国医疗器械杂志 Pub Date : 2025-03-30 DOI: 10.12455/j.issn.1671-7104.230726

Qifei Li, Weiming Wang, Weiqiang Zhang, Linzhi Dai, Jiawei Liu

引用次数: 0

[Analysis of the Influence of Different Scanning Conditions of Medical Linear Accelerator CBCT on Image Quality]. [医用直线加速器CBCT不同扫描条件对图像质量的影响分析]。

中国医疗器械杂志 Pub Date : 2025-03-30 DOI: 10.12455/j.issn.1671-7104.240480

Li Liu, Chengwei Ye, Jianjun Yuan, Yingui Luo, Zhiyao Luo, Wei Zeng, Ling Li, Huan Liu, Yan Liu

{"title":"[Analysis of the Influence of Different Scanning Conditions of Medical Linear Accelerator CBCT on Image Quality].","authors":"Li Liu, Chengwei Ye, Jianjun Yuan, Yingui Luo, Zhiyao Luo, Wei Zeng, Ling Li, Huan Liu, Yan Liu","doi":"10.12455/j.issn.1671-7104.240480","DOIUrl":"https://doi.org/10.12455/j.issn.1671-7104.240480","url":null,"abstract":"Objective: To investigate the influence of different scanning conditions on the image quality of medical electron accelerator cone-beam computed tomography (CBCT) and provide a reference for the selection of scanning conditions for different body parts. Methods Set different scanning conditions, the Catphan 503 phantom was scanned using CBCT parameters to analyze the influence of spatial resolution, noise, uniformity, spatial geometric accuracy, and low-contrast resolution on the image quality of CBCT.Results: For the head, chest, and abdomen, with the increase in scanning parameter values, the noise value decreased by 47.4%, 26.1%, and 51.3% respectively, and the uniformity values decreased by 30.2%, 26.6%, and 47.9% respectively. The low-contrast resolution values decreased by 50.6%, 34.2%, and 12.0%. The influence of different scanning conditions on spatial geometric accuracy and spatial resolution is not significant.Conclusion: Different scanning parameters have a certain influence on the image quality of medical electron accelerator CBCT. Lower scanning parameters can be selected based on individual patients to reduce the additional radiation dose, providing a reference for the safe application of CBCT image guidance in radiotherapy.","PeriodicalId":52535,"journal":{"name":"中国医疗器械杂志","volume":"49 2","pages":"176-180"},"PeriodicalIF":0.0,"publicationDate":"2025-03-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143998978","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

[Study on Vibration Characteristics of Deep Brain Stimulator Induced by Magnetic Resonance Gradient Magnetic Field]. [磁共振梯度磁场诱导深部脑刺激器振动特性研究]。

中国医疗器械杂志 Pub Date : 2025-01-30 DOI: 10.12455/j.issn.1671-7104.240229

Ya Chen, Peng Cao, Sheng Hu, Kai Zheng, Xun Liu

{"title":"[Study on Vibration Characteristics of Deep Brain Stimulator Induced by Magnetic Resonance Gradient Magnetic Field].","authors":"Ya Chen, Peng Cao, Sheng Hu, Kai Zheng, Xun Liu","doi":"10.12455/j.issn.1671-7104.240229","DOIUrl":"10.12455/j.issn.1671-7104.240229","url":null,"abstract":"The gradient coils of MRI equipment can induce vibrations in implantable medical devices, causing periodic vibrations of implantable medical devices with respect to the surrounding tissue. This not only results in instrument failure but also causes discomfort to the patient. Therefore, studying the vibration characteristics of implantable devices under different scanning sequences and the orientation of the device relative to the magnetic field is crucial for comprehending vibration performance. This study observed the vibration spectra of a full cranial bone-implanted neurostimulator by using laser vibrometry under typical rapid imaging sequences and explored the impact of different magnetic field orientations on vibration. The results demonstrated that the rapid echo sequences induced diverse and rich vibration components, whereas the planar echo sequences caused relatively simple vibrations. Additionally, the strongest vibrations normally occurred in the maximum conductive surface parallel to the phase-coded direction. It revealed the factors influencing the vibrations of skull fixation active implantable devices and provided guidance for enhancing device safety and protecting patient well-being during MR examinations.","PeriodicalId":52535,"journal":{"name":"中国医疗器械杂志","volume":"49 1","pages":"8-14"},"PeriodicalIF":0.0,"publicationDate":"2025-01-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143494805","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

[Design and Reliability Research of Spherical Radiotherapy Accelerator Motion System]. 球形放疗加速器运动系统设计与可靠性研究

中国医疗器械杂志 Pub Date : 2025-01-30 DOI: 10.12455/j.issn.1671-7104.240288

Shuming Xu, Yongxin Che, Haipeng Liang, Guoyong Zhao, Yanjie Li

引用次数: 0