中国医疗器械杂志最新文献

{"title":"[Application and Future Prospects of Magnetic Resonance-Guided Adaptive Radiotherapy in Lung Cancer Treatment].","authors":"Longfu Tian, Jiping Wang, Guodong Yang, Zhiyong Yang, Xin Li","doi":"10.12455/j.issn.1671-7104.260102","DOIUrl":"10.12455/j.issn.1671-7104.260102","url":null,"abstract":"<p><p>Magnetic resonance-guided adaptive radiotherapy (MRgART) represents a significant advancement in the field of lung cancer treatment, integrating real-time magnetic resonance imaging (MRI) for monitoring and dynamic dose adjustment. This review provides a comprehensive analysis of the fundamental principles, technological advancements, clinical applications, and prospective developments of MRgART. It emphasizes the core benefits of MRgART in lung cancer therapy. Precise delineation of tumor boundaries is achieved based on the high soft-tissue resolution of MRI. This precision, coupled with online adaptive plan modifications, effectively addresses challenges posed by respiratory motion and tumor volume fluctuations, thereby improving target dose coverage and minimizing toxicity to surrounding healthy tissues.</p>","PeriodicalId":52535,"journal":{"name":"中国医疗器械杂志","volume":"50 5","pages":"498-504"},"PeriodicalIF":0.0,"publicationDate":"2026-09-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149169051","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":"[Progress in the Application of Mixed Reality-Assisted Surgical Navigation in Laparoscopic Nephrectomy].","authors":"Liqun Luo, Yaru Zhao, Xiulin Wen","doi":"10.12455/j.issn.1671-7104.250554","DOIUrl":"10.12455/j.issn.1671-7104.250554","url":null,"abstract":"<p><p>In laparoscopic nephrectomy, preserving as much renal function as possible while resecting complex renal tumors has long been a significant challenge for surgeons. In recent years, advancements in imaging visualization technology have led urologists to adopt various navigation systems to assist in preoperative planning and intraoperative procedures. The integration of mixed reality technology enables surgeons to overlay three-dimensional anatomical information onto the real-world visual field, thereby facilitating more intuitive assessment of tumor location and its relationship with critical structures. This review synthesizes recent domestic and international studies to summarize the characteristics of commonly used navigation systems and their application outcomes in laparoscopic partial nephrectomy. It also discusses their roles in improving surgical precision, reducing surgical time, and enhancing patient outcomes based on clinical reports, with the aim of providing a reference for the future promotion of mixed reality navigation in the field of urology.</p>","PeriodicalId":52535,"journal":{"name":"中国医疗器械杂志","volume":"50 5","pages":"505-512"},"PeriodicalIF":0.0,"publicationDate":"2026-09-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149169986","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":"[Risk Analysis of Adverse Events Associated with Implantable Left Ventricular Assist Devices].","authors":"Jianbing Yin, Yao Li, Xinxin Liu, Lan Zhang, Ningqing Chen, Zhixiang Xu, Zhilong Ruan, Yue Wang","doi":"10.12455/j.issn.1671-7104.260128","DOIUrl":"https://doi.org/10.12455/j.issn.1671-7104.260128","url":null,"abstract":"<p><strong>Objective: </strong>Based on multi-source monitoring data from both domestic and international sources, this study systematically analyzes the adverse events and recall characteristics associated with implantable left ventricular assist devices (LVADs) to provide a reference for clinical safety and regulatory optimization.</p><p><strong>Methods: </strong>The data were sourced from two fatality reports submitted in Zhejiang Province, registration and recall information from the National Medical Products Administration (2 cases), and the U.S. Food and Drug Administration's MAUDE (Manufacturer and User Facility Device Experience) database (36,581 reports) and recall database (23 cases). A strategy combining descriptive statistics, root cause analysis (RCA), the Delphi method, and a risk matrix was employed.</p><p><strong>Results: </strong>There were a total of 18,772 post-market malfunction-related events involving LVAD products, primarily involving pump malfunction (14.25%), electrical issues (12.44%), flow path obstruction (12.10%), and alarm/control system issues (10.80%); There were a total of 29,509 reported cases of patient injury-related events, with deaths accounting for 29.77%, infections for 16.09%, organ failure/cerebrovascular accidents/strokes for 13.52%, bleeding for 9.77%, and thrombosis for 5.96%. Among the 25 recalls in China and the U.S., Class I recalls accounted for 52%. The root causes were primarily design defects and manufacturing process deviations, which together accounted for over 60%. One fatality in Zhejiang Province was related to an unexpected shutdown of the blood pump during a controller replacement; the risk matrix indicated that blood clots within the pump and flow path blockages, as well as pump malfunctions, were in the unacceptable zone.</p><p><strong>Conclusion: </strong>As a Class Ⅲ high-risk implantable medical device that saves the lives of patients with end-stage heart failure, the real-world risks associated with LVADs primarily involve device malfunctions (pump malfunction, electrical issues, and flow path obstruction) and serious adverse events (death, infection, organ failure/cerebrovascular accident/stroke, bleeding, and thrombosis); recalls are often attributed to design and manufacturing defects. It is recommended that registrants strengthen lifecycle management and incorporate redundant designs, that healthcare institutions standardize the reporting of adverse events, and that regulatory authorities enhance targeted monitoring.</p>","PeriodicalId":52535,"journal":{"name":"中国医疗器械杂志","volume":"50 5","pages":"563-570"},"PeriodicalIF":0.0,"publicationDate":"2026-09-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149167604","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":"[Mitigation Strategies and Evaluation Methods for Lipemia Interference in <i>In Vitro</i> Diagnostic Products].","authors":"Yurong Ji, Xiaofan Yin","doi":"10.12455/j.issn.1671-7104.250548","DOIUrl":"https://doi.org/10.12455/j.issn.1671-7104.250548","url":null,"abstract":"<p><p>Lipemia interference resistance constitutes a critical performance indicator in the design and development of <i>in vitro</i> diagnostic products. In this article, the causes of lipemic samples and their interference pathways are briefly introduced; currently available common strategies employed to counteract lipemia interference have been summarized, including widely accepted approaches such as ultracentrifugation and sample dilution, as well as recently implemented techniques like reagent formulation modification and measurement procedure optimization. Furthermore, based on the requirements outlined in the latest publication of the Clinical and Laboratory Standards Institute (CLSI) EP07 <i>Interference Testing in Clinical Chemistry</i> and the pharmaceutical industry standard of the People's Republic of China YY/T 1789.5 - 2023 <i>Performance Evaluation Methods for In Vitro Diagnostic Test Systems - Part 5: Analytical Specificity</i>, the standardized evaluation methods for lipemia interference are systematically discussed.</p>","PeriodicalId":52535,"journal":{"name":"中国医疗器械杂志","volume":"50 5","pages":"584-590"},"PeriodicalIF":0.0,"publicationDate":"2026-09-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149168741","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 Continuous Renal Replacement Therapy Devices].","authors":"Yicheng Wang, Yuan Yuan","doi":"10.12455/j.issn.1671-7104.250521","DOIUrl":"10.12455/j.issn.1671-7104.250521","url":null,"abstract":"<p><p>Continuous renal replacement therapy (CRRT) is one of the most commonly used treatments for patients with acute and chronic renal failure as well as end-stage chronic kidney disease, and is an important modality of renal replacement therapy. CRRT originated in the 1990s, initially focusing on a single dialysis mode. With the advancement of technology, treatment modes have gradually diversified, treatment effectiveness and safety have been optimized, and treatment efficiency has also been significantly improved. This article surveys the development history of CRRT devices and their clinical applications in acute and chronic kidney injury, chronic renal failure, sepsis, and other diseases. The development of CRRT devices toward intelligent and portable designs is reviewed, and the future clinical applications of CRRT devices are predicted.</p>","PeriodicalId":52535,"journal":{"name":"中国医疗器械杂志","volume":"50 5","pages":"521-525"},"PeriodicalIF":0.0,"publicationDate":"2026-09-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149167195","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":"[A Brief Analysis of the Regulatory Model for In-House Development and Use of <i>In Vitro</i> Diagnostic Reagents by Medical Institutions in Shanghai].","authors":"Anting Wang, Shuang Liang","doi":"10.12455/j.issn.1671-7104.260074","DOIUrl":"10.12455/j.issn.1671-7104.260074","url":null,"abstract":"<p><p>At the end of 2022, China initiated a pilot program for in-house development and use of <i>in vitro</i> diagnostic reagents by medical institutions. This study compares the evolution of laboratory developed tests（LDTs） regulation in the United States and the requirements for \"in-house devices\" under the EU IVDR with China's pilot policies, systematically summarizes Shanghai's \"national selected varieties+provincial filing+joint supervision\" practice model, and identifies challenges such as difficulties in unifying technical evaluation standards, insufficient clinical evidence, and difficulties in implementing primary responsibility. Recommendations are proposed, including establishing a tiered evaluation system, exploring real-world data applications, and strengthening full-life-cycle supervision, aiming to provide insights for improving the national regulatory framework for in-house reagents.</p>","PeriodicalId":52535,"journal":{"name":"中国医疗器械杂志","volume":"50 5","pages":"558-562"},"PeriodicalIF":0.0,"publicationDate":"2026-09-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149167761","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":"[A Proof-of-Concept Study of Intelligent Chinese Medicine Splint for Distal Radius Fracture].","authors":"Yuebin Cheng, Yunong Li, Xiliang Liu, Baojian Wang, Yufeng Ma","doi":"10.12455/j.issn.1671-7104.260153","DOIUrl":"https://doi.org/10.12455/j.issn.1671-7104.260153","url":null,"abstract":"<p><p>Distal radius fracture (DRF) usually adopts static fixation method, which often leads to complications such as abnormal fracture healing and pressure injury. The reason lies in the lack of real-time regulation of fixed pressure and biomechanical feedback, which affects the functional recovery. Our team designed an intelligent and adaptive orthopedic equipment. Based on the patient's personalized three-dimensional (3D) printing architecture, the equipment system realizes light and accurate adaptation, and embeds a series of thin film pressure sensors in key anatomical parts to continuously quantify biomechanical values. Relevant data are uploaded to the cloud platform through the Internet of Things module for real-time remote monitoring by clinicians. The innovation of the system is to construct a closed-loop feedback controller by using interval type Ⅱ fuzzy logic (IT2-FLC) algorithm, which can automatically adjust the servo drive belt and dynamically adjust the pressure to adapt to the changes of limb swelling. Preliminary clinical evaluation showed that the patients in the treatment group who received intelligent splint of traditional Chinese medicine performed better in anatomical reduction and functional recovery, with a higher Cooney score (91.65 <i>vs</i>. 83.15) and a lower visual analogue scale pain score (VAS) (1.15 <i>vs</i>. 1.88). This proof-of-concept study provides a new technical paradigm for adaptive orthopedic equipment and shows a good clinical transformation prospect.</p>","PeriodicalId":52535,"journal":{"name":"中国医疗器械杂志","volume":"50 5","pages":"541-548"},"PeriodicalIF":0.0,"publicationDate":"2026-09-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149165779","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 a Smartphone-Based Portable Corneal Topography Device].","authors":"Xiaojie Zhou, Man Chen, Jialin Shen, Peiming Zhang, Li Wang","doi":"10.12455/j.issn.1671-7104.260178","DOIUrl":"https://doi.org/10.12455/j.issn.1671-7104.260178","url":null,"abstract":"<p><strong>Objective: </strong>Aiming at the problems of large size, high cost, and poor mobility of traditional corneal topographers, a smartphone-based portable corneal topography device was designed to provide a low-cost and convenient tool for large-scale preliminary screening of corneal diseases.</p><p><strong>Methods: </strong>A small conical Placido disk was used as the core optical component. Its ring distribution was optimized by Matlab and verified by OptisWorks optical simulation, and the miniaturized processing of the Placido disk was realized by laser printing and a PMMA support structure. The device shell was modeled based on SolidWorks and fabricated by 3D printing technology. A red light-emitting diode (LED) lighting system was then designed, arranged in parallel along the angle of the Placido cone and powered by a smartphone to achieve precise adaptation between the device and the smartphone.</p><p><strong>Results: </strong>The processing errors of the key dimensions of the acrylic cone were small, all less than 0.2 mm. The LED lighting system had a uniform irradiance distribution, and the photobiological safety verification showed that it met the non-hazardous standards. The standard deviation for corneal topography detection was 0.034, which complied with the specifications.</p><p><strong>Conclusion: </strong>The portable corneal topography device designed in this study meets the measurement standards, achieves miniaturization, low cost, and high adaptability, with uniform and safe lighting, laying a foundation for the practical application of portable corneal topography devices.</p>","PeriodicalId":52535,"journal":{"name":"中国医疗器械杂志","volume":"50 5","pages":"549-557"},"PeriodicalIF":0.0,"publicationDate":"2026-09-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149169604","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":"[Application of Intelligent Management in the Cost Control of Hospital Medical Consumables].","authors":"Weihong Ye, Yonghua Chu","doi":"10.12455/j.issn.1671-7104.260210","DOIUrl":"https://doi.org/10.12455/j.issn.1671-7104.260210","url":null,"abstract":"<p><p>As the informatization of the healthcare industry advances, the management of medical consumable costs is gaining increasing attention. The deep integration of healthcare informatization and intelligence has made intelligent management a key factor in reducing consumable costs. This paper reviews the application of intelligent management in the fields of hospital medical consumables, introducing its application scenarios, technical approaches, and cost control effectiveness. It also analyzes, in the context of DRG payment reform and volume-based procurement, existing problems and technical challenges, such as poor technical interoperability, uneven data quality, and poor compatibility between personnel and systems. Furthermore, suggestions are put forward for future algorithm optimization, full-process integrated management, and risk management, aiming to help hospitals better achieve fine-grained management of consumables through intelligent means.</p>","PeriodicalId":52535,"journal":{"name":"中国医疗器械杂志","volume":"50 5","pages":"526-531"},"PeriodicalIF":0.0,"publicationDate":"2026-09-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149171621","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 Opportunistic Maintenance Strategy for Hospital Diagnostic Equipment Considering Mixed Time Windows Based on INSGA-Ⅱ].","authors":"Chenjie Guo, Qinming Liu","doi":"10.12455/j.issn.1671-7104.260260","DOIUrl":"https://doi.org/10.12455/j.issn.1671-7104.260260","url":null,"abstract":"<p><strong>Objective: </strong>To address the issues of high maintenance costs, patient care disruption due to equipment downtime, and low maintenance efficiency in large-scale hospital diagnostic equipment, this study aims to develop a maintenance strategy that is more aligned with actual clinical practices.</p><p><strong>Methods: </strong>First, the specific characteristics of diagnostic equipment maintenance in terms of patient safety, equipment quality control, and downtime impact are analyzed, and a single-component failure rate evolution model that accounts for equipment performance degradation is constructed. Second, a mixed time window mechanism consisting of soft and hard time windows is introduced to simulate the flexibility of clinical maintenance scheduling and the risks and costs associated with maintenance node deviations. On this basis, a multi-objective opportunistic maintenance optimization model is established, aiming to minimize preventive maintenance costs and opportunistic maintenance costs, while maximizing the improvement in effective age.</p><p><strong>Results: </strong>An improved non-dominated sorting genetic algorithm Ⅱ (INSGA-Ⅱ) is employed to solve the model. Compared with traditional methods, the proposed model can effectively reduce the frequency of equipment downtime, extend the average maintenance interval in the optimized scheme, and theoretically increase equipment availability.</p><p><strong>Conclusion: </strong>The proposed model can ensure equipment reliability while balancing economic efficiency and clinical applicability, providing decision-making support for hospital medical engineering departments to formulate scientific equipment maintenance plans.</p>","PeriodicalId":52535,"journal":{"name":"中国医疗器械杂志","volume":"50 5","pages":"532-540"},"PeriodicalIF":0.0,"publicationDate":"2026-09-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149169975","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}