中国医疗器械杂志Pub Date : 2025-03-30DOI: 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":"<p><strong>Objective: </strong>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).</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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).</p><p><strong>Conclusion: </strong>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.</p>","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}
中国医疗器械杂志Pub Date : 2025-03-30DOI: 10.12455/j.issn.1671-7104.240382
Yanan Liu, Xuedong Song, Qi Yin, Fuhao Kang, Yan Hang, Jilun Ye, Xu Zhang
{"title":"[Development of a Microstream End-Tidal Carbon Dioxide Monitoring System with Integrated Gas Circuit].","authors":"Yanan Liu, Xuedong Song, Qi Yin, Fuhao Kang, Yan Hang, Jilun Ye, Xu Zhang","doi":"10.12455/j.issn.1671-7104.240382","DOIUrl":"https://doi.org/10.12455/j.issn.1671-7104.240382","url":null,"abstract":"<p><p>End-tidal carbon dioxide monitoring is an important means of evaluating human lung function and is widely used in fields such as clinical emergency treatment and cardiopulmonary resuscitation. This paper develops a microstream end-tidal carbon dioxide monitoring system. It adopts an integrated gas circuit design to further reduce the size of the equipment. The system uses the method of calculating the root mean square (RMS) of differential pressure signals to regulate the gas circuit flow, enabling the system to stably operate at a flow state of 30 mL/min. In addition, by simultaneously detecting multiple environmental parameters such as temperature and pressure, the system realizes system state monitoring and gas parameter compensation. The test results show that various indicators of the system meet the requirements of relevant standards, laying a good foundation for subsequent engineering applications.</p>","PeriodicalId":52535,"journal":{"name":"中国医疗器械杂志","volume":"49 2","pages":"204-211"},"PeriodicalIF":0.0,"publicationDate":"2025-03-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144038933","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}
中国医疗器械杂志Pub Date : 2025-03-30DOI: 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 <i>In Vitro</i> 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":"<p><p>On March 19, 2021, the National Medical Products Administration(NMPA) issued the <i>Regulations on the Supervision and Administration of Medical Devices</i> (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 <i>in vitro</i> 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 <i>in vitro</i> diagnostic reagents developed by medical institutions into China's regulatory system. This study reviewed the development of regulatory policies for self-developed <i>in vitro</i> diagnostic reagents at home and abroad, combined with the <i>Key Points of On-site Verification of Self-developed In Vitro Diagnostic Reagents in Shanghai Medical Institutions</i> 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 <i>in vitro</i> diagnostic reagents. The purpose is to provide some references for the further development of this pilot work and its nationwide promotion.</p>","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}
{"title":"[Three-Dimensional Reconstruction Technique and Its Application of Binocular Endoscopic Images Based on Deep Learning].","authors":"Lina Huang, Shenglin Liu, Qingmin Feng, Haolong Jin, Qiang Zhang","doi":"10.12455/j.issn.1671-7104.240293","DOIUrl":"https://doi.org/10.12455/j.issn.1671-7104.240293","url":null,"abstract":"<p><p>The clinical application of binocular endoscope relies primarily on the visual system of physicians to create a three-dimensional effect, but it cannot provide accurate depth information. The utilization of 3D reconstruction technology in binocular endoscopy can facilitate the recovery of image depth information, and the application of deep learning-based 3D reconstruction technology can significantly improve the accuracy and real-time performance of reconstruction results, making it widely applicable in the realm of minimally invasive surgery. This paper aims to explore the key technologies and implementation methods of deep learning based 3D reconstruction for binocular endoscopic images, and seeks to outline strategies for enhancing the quality of 3D reconstruction in endoscopic images, providing guidance for sustainable development of binocular endoscopic image reconstruction technology in clinical settings. This will assist in the application of minimally invasive surgery and contribute to meeting the demands of precision medicine.</p>","PeriodicalId":52535,"journal":{"name":"中国医疗器械杂志","volume":"49 2","pages":"161-168"},"PeriodicalIF":0.0,"publicationDate":"2025-03-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144050817","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}
中国医疗器械杂志Pub Date : 2025-03-30DOI: 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":"<p><p>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.</p>","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}
中国医疗器械杂志Pub Date : 2025-03-30DOI: 10.12455/j.issn.1671-7104.240326
Mingyang Li
{"title":"[Current Situation and Development Trends Analysis of Innovative Medical Devices for Heart Valve Intervention].","authors":"Mingyang Li","doi":"10.12455/j.issn.1671-7104.240326","DOIUrl":"https://doi.org/10.12455/j.issn.1671-7104.240326","url":null,"abstract":"<p><p>In recent years, the field of heart valve interventional treatment has developed rapidly, and various new technologies have been continuously applied. The study provides a comprehensive review and analysis of the research progress and challenges related to interventional treatment products for the aortic valve, pulmonary valve, mitral valve, and tricuspid valve both domestically and internationally. The study also summarizes the status of heart valve interventional devices entering Special Review of Innovative Medical Device of National Medical Products Administration (NMPA). The results show that the field of valve interventional treatment is developing rapidly, but there is still room for improvement in terms of valve durability, operational suitability, and complication reduction. Lastly, the study looks forward to the future development trend of new technologies for heart valve interventional therapy, and puts forward suggestions for the promotion and application of new technologies of valve interventional therapy from the perspective of supervision.</p>","PeriodicalId":52535,"journal":{"name":"中国医疗器械杂志","volume":"49 2","pages":"148-153"},"PeriodicalIF":0.0,"publicationDate":"2025-03-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144032836","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}
中国医疗器械杂志Pub Date : 2025-03-30DOI: 10.12455/j.issn.1671-7104.230726
Qifei Li, Weiming Wang, Weiqiang Zhang, Linzhi Dai, Jiawei Liu
{"title":"[Torso Simulation Research on Electromagnetic Compatibility of Implantable Neurostimulator].","authors":"Qifei Li, Weiming Wang, Weiqiang Zhang, Linzhi Dai, Jiawei Liu","doi":"10.12455/j.issn.1671-7104.230726","DOIUrl":"https://doi.org/10.12455/j.issn.1671-7104.230726","url":null,"abstract":"<p><p>In the YY 0989.3-2023 standard, clause 27.106 specifies the protection test against electromagnetic interference, but it only briefly describes the test level for electromagnetic exposure, and does not detail the parameters of the torso. This study aims to explore the internal field distribution for different torso parameters under electromagnetic exposure, and explore the patterns of field distribution through modeling and simulation. The results indicate that the parameters of the torso significantly affect the internal field distribution. The findings of this study provide a basis and reference for the electromagnetic compatibility test for implantable neurostimulator products.</p>","PeriodicalId":52535,"journal":{"name":"中国医疗器械杂志","volume":"49 2","pages":"212-218"},"PeriodicalIF":0.0,"publicationDate":"2025-03-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144008296","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}
中国医疗器械杂志Pub Date : 2025-03-30DOI: 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":"<p><strong>Objective: </strong>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. <b>Methods</b> 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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusion: </strong>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.</p>","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}
中国医疗器械杂志Pub Date : 2025-01-30DOI: 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":"<p><p>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.</p>","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}
中国医疗器械杂志Pub Date : 2025-01-30DOI: 10.12455/j.issn.1671-7104.240288
Shuming Xu, Yongxin Che, Haipeng Liang, Guoyong Zhao, Yanjie Li
{"title":"[Design and Reliability Research of Spherical Radiotherapy Accelerator Motion System].","authors":"Shuming Xu, Yongxin Che, Haipeng Liang, Guoyong Zhao, Yanjie Li","doi":"10.12455/j.issn.1671-7104.240288","DOIUrl":"10.12455/j.issn.1671-7104.240288","url":null,"abstract":"<p><p>At present, the C-arm structure accelerators commonly used in radiotherapy equipment are complex in operation and have potential safety hazards when realizing non-coplanar treatment. By combining with medical robotic arm technology, a spherical radiotherapy accelerator motion system is designed. The beam module is clamped by the medical robotic arm structure to achieve three-dimensional multi-angle irradiation treatment within the non-coplanar angle range. Firstly, the rotating mechanism, beam module, and MLC module of the spherical radiotherapy equipment are designed. Then, the double-plane counterweight method is used to calculate the dynamic balance of the equipment, ensuring that the beam center point does not rotate during the treatment process. Finally, the strength check and reliability analysis of the transmission component gear are conducted. The results show that the designed spherical radiotherapy accelerator motion system can meet the requirements of stable, accurate, and fast precision radiotherapy, which is conducive to improving the treatment efficiency.</p>","PeriodicalId":52535,"journal":{"name":"中国医疗器械杂志","volume":"49 1","pages":"48-54"},"PeriodicalIF":0.0,"publicationDate":"2025-01-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143494701","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}