中国医疗器械杂志最新文献

{"title":"[Development Status and Evaluation Strategy Considerations on <i>In Vitro</i> Alternative Methods for Skin Sensitization Testing of Medical Devices].","authors":"Likui Sun, Xiaoxia Sun, Xiaofei Wang, Chenghu Liu, Min Wan","doi":"10.12455/j.issn.1671-7104.250344","DOIUrl":"10.12455/j.issn.1671-7104.250344","url":null,"abstract":"<p><p>Tests for skin sensitization are commonly used methods for evaluating the sensitization of medical devices. With the development of animal welfare and scientific technology, various toxicology evaluation tools such as <i>in vitro</i> experiments and non-testing toxicity prediction methods are gradually used internationally to evaluate skin sensitization. The development and application of <i>in vitro</i> alternative methods for skin sensitization tests of medical devices has become an inevitable trend in the field of biological evaluation of medical devices. This article introduces the <i>in vitro</i> and genomic methods for identifying skin sensitization potential based on the adverse outcome pathway (AOP) of skin sensitization, which have been validated in the current <i>OECD 442 Trial Guidelines</i>. This article analyzes their respective experimental principles, scope of application, and limitations in their application to medical device testing. Based on the characteristics of medical devices themselves, it proposes a strategy for evaluating <i>in vitro</i> skin sensitization testing of medical devices.</p>","PeriodicalId":52535,"journal":{"name":"中国医疗器械杂志","volume":"50 2","pages":"217-224"},"PeriodicalIF":0.0,"publicationDate":"2026-03-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147693646","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":"[Study on Trajectory Tracking Control of a Flexibly-Driven Fracture Reduction Robot].","authors":"Qing Zhu, Di Jiang, Long Zhao, Deyu Tu","doi":"10.12455/j.issn.1671-7104.250396","DOIUrl":"10.12455/j.issn.1671-7104.250396","url":null,"abstract":"<p><strong>Objective: </strong>To reduce the risk of iatrogenic soft tissue injury and collision between fracture fragments, while maintaining a satisfactory reduction state to perform procedures such as intramedullary nail internal fixation, research on trajectory tracking control for fracture reduction robots was conducted.</p><p><strong>Methods: </strong>Firstly, considering the driving characteristics of the fracture reduction robot, a sliding mode variable structure controller was designed for the traction mechanism responsible for performing axial traction along the femur. For the rotation mechanism responsible for performing circumferential rotation around the femur and anteroposterior-lateral reduction of fracture fragments, a joint adaptive fuzzy PID controller was designed. Secondly, to ensure a smooth and shock-free reduction process, a quintic non-uniform B-spline curve was employed for reset trajectory planning of the robot. Finally, reduction simulation experiments were conducted on the robot under the same conditions of muscle contraction force and external disturbances.</p><p><strong>Results: </strong>After reduction, the maximum angular error was less than 2°, and the maximum translation residual was 2.3 mm, and the reduction accuracy met the clinical functional reduction criteria. When the robot was maintaining the reduction state and an interference signal was manually applied to the distal end of the fracture, the system recovered the lost reduction state and stabilized at the target value within 3.6 s.</p><p><strong>Conclusion: </strong>The experimental results confirm the flexibility and robustness of the robotic control system, which has a promising application prospect.</p>","PeriodicalId":52535,"journal":{"name":"中国医疗器械杂志","volume":"50 2","pages":"143-151"},"PeriodicalIF":0.0,"publicationDate":"2026-03-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147693676","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":"[Simulation Analysis and Radiation Protection Study of Induced Radioactivity in Carbon Ion Therapy Systems].","authors":"Siyang Liu, Chunying Jiao, Shibing Xie, Guotao Fu, Peichen Wang, Yulin Deng","doi":"10.12455/j.issn.1671-7104.250269","DOIUrl":"10.12455/j.issn.1671-7104.250269","url":null,"abstract":"<p><p><b>Objective</b> Addressing the issue of induced radioactivity in carbon ion therapy system operation, to systematically evaluate the impact of beam parameters on the distribution of induced radiation field in carbon ion therapy room and develop radiation protection strategies. <b>Methods</b> A geometric model integrating a multi-leaf collimator (MLC), compensator, patient phantom, and concrete shielding structure was developed using the FLUKA Monte Carlo simulation code. Systematic simulations were conducted to analyze residual dose rate decay kinetics and radionuclide activation profiles at critical components under 400 MeV/u carbon ion irradiation with beam intensities and irradiation durations. <b>Results</b> The induced radioactivity generated by components exhibited a linear response to beam intensity. The MLC surface exhibited a residual dose rate of 15.8 μSv/h at 1 min post-irradiation (1×10 ⁸ pps, 15-minute irradiation), requiring 45 min cooling for the safety threshold. The activation nuclides produced in patient phantoms were dominated by short-lived nuclides, with radiation dose decreased to acceptable level within 10 min post-irradiation. Occupational exposure assessments demonstrated annual effective doses of about 174 μSv (air immersion) and 0.31 μSv (inhalation). <b>Conclusion</b> The induced radioactivity dose produced by the carbon ion radiotherapy system is mainly generated by MLC and patient phantoms. Personnel should avoid direct contact within 10 minutes post-irradiation. Occupational exposure levels of the air activation remain compliant with occupational dose constraints.</p>","PeriodicalId":52535,"journal":{"name":"中国医疗器械杂志","volume":"50 2","pages":"160-166"},"PeriodicalIF":0.0,"publicationDate":"2026-03-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147693669","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":"[Development and Application of Digital Surgery Video Cloud-Based Management Platform].","authors":"Zheng Gu, Yonghua Chu, Cancan Xu, Ye Xu, Zhenjie Liu","doi":"10.12455/j.issn.1671-7104.250326","DOIUrl":"10.12455/j.issn.1671-7104.250326","url":null,"abstract":"<p><p>In response to bottlenecks such as multi-source data integration and large-volume video data processing in traditional operating rooms, this paper proposes and develops a cloud-based digital surgical video management platform. By integrating cloud architecture with intelligent technologies, it has established a comprehensive digital surgical data ecosystem covering scientific research, education, and quality control throughout the entire workflow. The platform features interfaces with all hospital surgical systems and achieves normalized audio-visual signal processing through unified client deployment in operating rooms, supporting parallel processing of 8-channel high-definition videos per case. Implementing a tiered storage strategy for surgical video data, it overcomes limitations of traditional local storage capacity. Innovatively incorporating cross-platform collaboration capabilities, the system enables scientific data mining. Built-in video editing tools including timeline synchronization, dynamic layout switching, and subtitle annotation significantly reduce operational complexity for medical staff. Clinical applications demonstrate that the platform achieves 85.3% online video storage rate post-implementation, with 72.8% of stored videos undergoing online editing. Surgeons can efficiently create educational videos, while postoperative video reviews dynamically correlate intraoperative field visuals with monitoring data, optimizing procedural workflows and strengthening surgical quality control systems. This platform development provides a replicable technical template for smart hospital construction, and this platform serves as a critical infrastructure for promoting healthcare resource homogenization and digital transformation.</p>","PeriodicalId":52535,"journal":{"name":"中国医疗器械杂志","volume":"50 1","pages":"70-75"},"PeriodicalIF":0.0,"publicationDate":"2026-01-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146167899","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":"[Review of Progress of Optical Brain-Computer Interface Technology and Prospects for Medical Device Testing Technology].","authors":"Yiqiao Wang, Yunping Mi, Xinyan Zhang, Bin Zhao, Hao Li, Xun Liu","doi":"10.12455/j.issn.1671-7104.250262","DOIUrl":"10.12455/j.issn.1671-7104.250262","url":null,"abstract":"<p><p>Optical brain-computer interface (OBCI) technology is a new cross-cutting frontier technology that achieves information interaction between the human brain and external devices through neuroengineering based on optical methods. Among them, brain-computer interface (BCI) devices based on functional near-infrared spectroscopy (fNIRS) have been successively developed and applied, and this type of technology has become one of the main development directions of non-invasive optical brain-computer interface medical device technology. At the same time, OBCI technology based on optogenetics and optical calcium imaging technology has also been proposed as a research hotspot in recent years, and will serve as a new direction for the future development of OBCI medical device testing technology. This paper mainly reviews the basic principles and research progress of functional near-infrared spectroscopy brain-computer interface (fNIRS-BCI), and introduces the research frontiers of BCI based on optogenetics and optical calcium imaging technology. Finally, it presents prospects for the further development of OBCI medical device testing technology, providing certain guidance and ideas for the development, testing, and supervision of the BCI industry.</p>","PeriodicalId":52535,"journal":{"name":"中国医疗器械杂志","volume":"50 1","pages":"54-63"},"PeriodicalIF":0.0,"publicationDate":"2026-01-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146167942","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":"[Regulatory Requirements and Considerations of Aesthetic Injection Medical Devices in China, the USA and the European Union].","authors":"Shan Dong, Xiangmei Zhang","doi":"10.12455/j.issn.1671-7104.250110","DOIUrl":"10.12455/j.issn.1671-7104.250110","url":null,"abstract":"<p><p>This study summarizes the marketing access and regulatory requirements of aesthetic injection medical devices in China, the USA, and the European Union (EU), and conducts a comparative analysis of the regulatory similarities and differences among these regions. There are differences in the supervision of aesthetic injection medical devices in China, the USA, and the EU, but they are essentially converging. It is recommended that Chinese medical device authorities improve the formulation of relevant guidelines, strengthen the management of product labeling and post-market surveillance, establish an electronic information management system for the total product life cycle, enhance the supervision level and capability of aesthetic injection medical devices in China, and promote the healthy development of the aesthetic industry.</p>","PeriodicalId":52535,"journal":{"name":"中国医疗器械杂志","volume":"50 1","pages":"93-99"},"PeriodicalIF":0.0,"publicationDate":"2026-01-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146167904","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":"[Deep Learning-Based Automated Segmentation Algorithms of Brain and Vertebral Substructures for Radiotherapy in Pediatric Medulloblastoma].","authors":"Wei Wang, Shuxian Chen, Mawei Jiang","doi":"10.12455/j.issn.1671-7104.250219","DOIUrl":"10.12455/j.issn.1671-7104.250219","url":null,"abstract":"<p><p>To evaluate the application feasibility of nnU-Net and FuseNet for automatic segmentation of pediatric medulloblastoma substructures, 60 pediatric patients who received radiotherapy and grouped by 5-year age (≤5 and >5 years) were retrospectively analyzed. Brain substructures were delineated on CT-MRI fusion images, and vertebral substructures were delineated on CT images. The three convolutional neural network models of U-Net, nnU-Net and FuseNet were trained (24 cases/group) and tested/validated (6 cases/group), with 20 external cases verifying generalization. The three models and Atlas-based methods were compared using DSC; nnU-Net/FuseNet's HD95, RAVD and manual correction time were evaluated. Results showed that FuseNet performed best in brain segmentation, outperforming Atlas and U-Net in vertebral substructures for both age groups ( <i>P</i>=0.028/0.005 and 0.005/0.005) but not differing from nnU-Net ( <i>P</i>=0.107/0.236). Its DSC exceeded 0.8 for most substructures (except cerebellar anterior lobe/hippocampus in group≤5 years; hippocampus in group>5 years), with shortest correction time in both age groups. This study has demonstrated that nnU-Net can achieve good segmentation; FuseNet can improve brain segmentation accuracy <i>via</i> dynamic multimodal feature fusion, with the highest correction efficiency.</p>","PeriodicalId":52535,"journal":{"name":"中国医疗器械杂志","volume":"50 1","pages":"15-23"},"PeriodicalIF":0.0,"publicationDate":"2026-01-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146167911","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":"[Design of Single-Use Duodenoscope Image Processing System].","authors":"Xukai Wang","doi":"10.12455/j.issn.1671-7104.250496","DOIUrl":"10.12455/j.issn.1671-7104.250496","url":null,"abstract":"<p><strong>Objective: </strong>To design a single-use duodenoscope image processing system that reduces the cost of duodenoscopes while ensuring high-definition (HD) imaging. After use, the system eliminates the need to clean and sterilize the duodenoscope, thereby effectively eliminating the risk of cross-infection.</p><p><strong>Methods: </strong>A single-use duodenoscope image processing system was designed, comprising a single-use duodenoscope, single-use optical fiber, and image processor. The single-use duodenoscope consists of a sequentially connected HD camera module, emission light path preprocessing module, light path emission module, and key module. The HD camera module is used to acquire HD image data, the emission light path preprocessing module converts the image data into electrical signals, and the light path emission module transforms the image electrical signals into optical signals and transmits them to the image processor <i>via</i> a single-use optical fiber. The single-use duodenoscope is made of low-cost medical plastic; key components such as the camera module adopt low-cost CMOS image sensors, the illumination at the scope tip uses ultra-microscopic, ultra-low-power, low-cost LEDs, and HD images are transmitted <i>via</i> low-cost single-use optical fibers instead of expensive amplification circuits, significantly reducing the duodenoscope cost. The reusable image processor consists of sequentially connected light path receiving module, receiving light path preprocessing module, HD image processing module, control module, and display module. The light path receiving module receives image optical signals and converts them into electrical signals, the receiving light path preprocessing module converts the image electrical signals into data signals, the HD image processing module processes the HD images, the control module coordinates and controls system operation, and the display module displays the HD images. The system was subjected to <i>in vitro</i> tests and prototype tests.</p><p><strong>Results: </strong><i>In vitro</i> test results showed that the single-use duodenoscope image processing system meets the requirements for clinical application. Clinical trial results demonstrated that the HD images of the pharyngeal, gastric, and duodenal models are clear with realistic color reproduction.</p><p><strong>Conclusion: </strong>The single-use duodenoscope image processing system can overcome the shortcomings of existing reusable duodenoscopes, which are difficult to sterilize and clean and more prone to cross-infection. Its image quality can also achieve the HD standard of reusable duodenoscope systems.</p>","PeriodicalId":52535,"journal":{"name":"中国医疗器械杂志","volume":"50 1","pages":"82-87"},"PeriodicalIF":0.0,"publicationDate":"2026-01-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146167926","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":"[Advances in Application of Artificial Intelligence for Breast Cancer Radiotherapy].","authors":"Rongyao Chen, Yuting Liang, Junyue Shi","doi":"10.12455/j.issn.1671-7104.250421","DOIUrl":"10.12455/j.issn.1671-7104.250421","url":null,"abstract":"<p><p>Breast cancer is a highly prevalent malignant tumor among women worldwide, posing a serious threat to women's health, and radiotherapy plays a key role in its comprehensive treatment process. With the rapid development of artificial intelligence (AI) technology, its application in the field of breast cancer radiotherapy has been expanding, especially with deep learning as the representative technical means, which has brought new opportunities for enhancing radiotherapy accuracy and optimizing radiotherapy plans. Existing researches demonstrate that AI technology plays a crucial role in medical image processing and automated radiotherapy planning for breast cancer radiotherapy. By systematically reviewing relevant research findings and practical advancements while identifying key technical challenges, this paper will provide effective support for the deep integration and development of AI and breast cancer radiotherapy.</p>","PeriodicalId":52535,"journal":{"name":"中国医疗器械杂志","volume":"50 1","pages":"7-14"},"PeriodicalIF":0.0,"publicationDate":"2026-01-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146167868","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":"[Research on Automatic Detection Technology of Radioactive Source Position Accuracy of Brachytherapy Machine Based on Machine Vision and Image Feature Recognition].","authors":"Shouyu Wang, Xiaochun Wang, Nan Hu, Jianyu Yang, Jun Yang","doi":"10.12455/j.issn.1671-7104.250375","DOIUrl":"10.12455/j.issn.1671-7104.250375","url":null,"abstract":"<p><strong>Objective: </strong>To realize the integration of radioactive source position accuracy detection technology for clinical brachytherapy machines with artificial intelligence.</p><p><strong>Methods: </strong>Based on multiple machine vision algorithms, including video angle correction using affine transformation function, line segment detector (LSD) algorithm, Canny edge detection operator, and identification of moving radioactive source targets <i>via</i> findContours function, automatic identification of radioactive source position was achieved for detecting the position accuracy of radioactive sources in brachytherapy machines, with a comparative analysis with traditional manual detection methods conducted.</p><p><strong>Results: </strong>Compared with the actual set reference values, the accuracy of the radioactive source repeated positioning error measured by the visual observation method and machine vision analysis method was (0.70±0.48) mm and (0.20±0.42) mm, respectively; the accuracy of the repeated timing error was (0.32±0.12) s and (0.03±0.00) s, respectively; and the accuracy of the cumulative positioning error was (0.55±0.42) mm and (0.28±0.47) mm, respectively. The detection accuracy of the machine vision analysis method was higher than that of the visual observation method, with a statistically significant difference ( <i>P</i><0.05). In terms of time spent on result analysis, for the three parameters (radioactive source positioning error, repeated positioning error, and cumulative positioning error), the time consumed by the visual observation method and the machine vision analysis method was approximately 1, 10, 20 minutes and 1, 6, 10 minutes, respectively, indicating that the machine vision analysis method was more time-efficient.</p><p><strong>Conclusion: </strong>The automatic detection technology for radioactive source position accuracy based on machine vision analysis can meet the requirements of brachytherapy machine quality control guidelines as well as the needs of basic and complex quality control items. It has the advantages of time-saving, high stability, and high automation, and serves as a practical technology integrating artificial intelligence with clinical medicine.</p>","PeriodicalId":52535,"journal":{"name":"中国医疗器械杂志","volume":"50 1","pages":"76-81"},"PeriodicalIF":0.0,"publicationDate":"2026-01-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146167909","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}