21 March 2025, Volume 40 Issue 3

    

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FEATURES
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  Analysis of Global Scientific Research Competition and Collaboration in Brain-Computer Interface

  Chen Juan, LONG Junyu, PAN Lizi, OUYANG Zhaolian

  China Medical Devices. 2025, 40(3): 1-7. https://doi.org/10.3969/j.issn.1674-1633.20241179

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  ObjectiveTo analyze the global research competition and cooperation landscape in the field of brain-computer interface (BCI), to provide reference for relevant practitioners. Methods BCI-related papers were retrieved from the Web of Science Core Collection. Bibliometric analysis and social network analysis methods were employed to analyze the global research competition and cooperation dynamics in the BCI field, identifying leading countries, institutions, and researchers. Results From 1990 to 2023, a total of 9037 SCI papers in the BCI field were produced globally, with 78.9% of these papers published between 2014 and 2023, showing a ten-year compound growth rate of 13.7%. The publication volume of China and the United States placed them in the leading tier globally. Although China started later, its growth rate was faster, with its publication volume in 2023 reaching three times that of the United States. In terms of cooperation, the United States surpassed China both in the number of collaborators (64) and the number of collaborations (1507). Other notable countries included Germany (968 papers) and the United Kingdom (725 papers) with relatively high publication volumes. In terms of institution and researcher, the University of Tübingen in Germany and Graz University of Technology in Austria were early leaders in BCI research, but their paper outputs significantly declined in recent years. In contrast, researchers from institutions such as Tsinghua University (GAO Xiaorong), Chinese Academy of Sciences (WANG Yijun), Tianjin University (MING Dong), East China University of Science and Technology (JIN Jing), and South China University of Technology (LI Yuanqing) produced many papers in recent years. Conclusion The BCI field has developed rapidly over the past decade, with the United States and China leading in global competition and cooperation. The United States had an early start but has experienced slower growth in recent years, while China started later but has seen rapid growth recently. Institutions such as Chinese Academy of Sciences, Tsinghua University, and Tianjin University have shown outstanding performance.
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  Patent Main Path Analysis in the Field of Brain-Computer Interface

  ZHANG Ting, XU Dongzi, CHEN Juan, LU Yan, YAN Shu, PAN Lizi, WANG Jianbo, OUYANG Zhaolian

  China Medical Devices. 2025, 40(3): 8-15. https://doi.org/10.3969/j.issn.1674-1633.20241466

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  ObjectiveTo explore the main path of technology development based on the patent citation network in the field of brain-computer interface (BCI). Methods The patent citation network in the field of brain-computer interface was constructed, and the traversal weights were calculated by the search path link count. The global main path, global key-route main path, local forward main path, local backward main path and local key-route main path were analyzed by two path search methods, global search and local search, so as to explore the technological development trajectory in this field of BCI. Results There were 15519 patent applications in the field of BCI, including 140691 patent citations, and the number of patent applications increased year by year. Technology development focused on neural stimulation and regulation technology, neural signal acquisition and processing technology, BCI hardware technology and other directions. The main path analysis showed that the technical theme was electrical stimulation as the core, emphasizing precise neural regulation and personalized treatment. The number of patents on the global main path was the largest (16), including 2 technical routes, and the global key-route main path was consistent with the global main path. There were 14 patents on the local forward main path, including 1 technical route, and the local key-route main path was consistent with the local forward main path. There were 10 patents on the local backward main path, including 1 technical route. Conclusion Through the main path analysis of patents in the field of BCI, this study identifies the technological development trajectory and provides information support for the research and development of BCI from the perspective of information science.
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  Analysis of Global Clinical Trial Registration Status for Brain-Computer Interface

  LU Yan, PAN Lizi, YAN Shu, CHEN Juan, OUYANG Zhaolian

  China Medical Devices. 2025, 40(3): 16-21. https://doi.org/10.3969/j.issn.1674-1633.20241660

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  ObjectiveTo analyze the global registration status of brain-computer interface (BCI) clinical trials and provide data to support further clinical research of this technology. Methods Based on the registration data of BCI related clinical trials in ClinicalTrials.gov, bibliometrics approach was applied to analyze the number and annual trend of registration, national distribution and international cooperation, sponsor type and country distribution, study type and recruitment, classification of indications and their characteristics. Results As of October 2024, a total of 194 BCI related clinical trials were registered worldwide, and the number of registrations was generally on the rise. Among all the countries that carried out clinical trials, the United States ranked first with 80 trials, while no other countries surpassed 20, and there were only 3 trials involved international collaboration. Sponsors were predominantly universities and research institutions (48.7%), with the United States having the largest number of sponsors. Of all the clinical trials, 88.1% were intervention studies, 38.1% were completed, 26.3% recruited fewer than 10 patients, and almost all of the trial subjects were recruited without gender restriction and included adults. BCI related clinical trials focused on rehabilitation and treatment of neurological diseases, the main indications included stroke, spinal cord injury, amyotrophic lateral sclerosis, and quadriplegia. Conclusion The global clinical research activity in BCI technology is steadily increasing, demonstrating significant application potential.
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  Analysis of Knowledge Composition and Trends in Brain-Computer Interface Research

  YAN Shu, CHEN Juan, LU Yan, OUYANG Zhaolian

  China Medical Devices. 2025, 40(3): 22-25. https://doi.org/10.3969/j.issn.1674-1633.20241713

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  ObjectiveTo analyze the disciplinary and knowledge composition as well as the trends in brain-computer interface (BCI) research to provide insights for team development, talent cultivation, and cross-disciplinary collaboration in the field. Methods Citation analysis from bibliometrics was applied to calculate interdisciplinary indices within the field, and trend assessments were conducted through statistical analysis. Results The disciplinary diversity in BCI research continued to grow, with varying levels of knowledge concentration across disciplines. Medicine, computer science, psychology, engineering, and physiology were the primary contributing fields. Among them, the shares of medicine and psychology decreased, while computer science significantly increased in proportion, with humanities and social sciences contributing less frequently. Conclusion Driven by advancements in areas such as artificial intelligence, BCI research has shifted from fundamental mechanistic studies to a focus on technology development and algorithmic iteration. At this stage, computer science and engineering have emerged as key pillars in the interdisciplinary knowledge framework. In the future, as technology progresses toward clinical transformation and commercialization, clinical sciences and sociology may receive greater attention.
RESEARCHWORK
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  Research on Incontinence Behavior Detection Technology Based on Wireless Energy Harvesting

  CHEN Xingyong, ZHAO Hanbin, CHENG Gaojie, LOU Liangliang, WU Xiaomai

  China Medical Devices. 2025, 40(3): 26-30. https://doi.org/10.3969/j.issn.1674-1633.20240367

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  ObjectiveTo solve the problems such as low safety and poor sense of acquisition of battery-powered humidity sensor in incontinence patients, to design an incontinence behavior detection technology based on spatial wireless energy self-capture. Methods A flexible temperature and humidity sensor with wireless energy collection was implanted in underwear, and an incontinence behavior detection algorithm based on temperature and humidity data characteristics was constructed to provide digital support for high-quality monitoring of incontinence personnel. Results The detection range of the algorithm built in this paper reached 2.8 m, the detection accuracy was up to 100% in specific scenes, and the average alarm delay was 1 s. Conclusion The incontinence behavior detection technology based on spatial wireless energy self-capture designed in this paper can meet the incontinence monitoring needs of medical and nursing institutions, and has strong application value.
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  Design and Animal Experiment of the Magnetic Totally Implantable Venous Access Port

  ZHANG Li, ZHANG Miaomiao, WAN Jiahui, ZHAN Qirui, LV Xin, LV Yi, YAN Xiaopeng

  China Medical Devices. 2025, 40(3): 31-34. https://doi.org/10.3969/j.issn.1674-1633.20241249

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  ObjectiveIn order to improve the success rate of Huber needle puncture, to design a magnetic totally implantable venous access port (MTIVAP), and to verify its feasibility by animal experiments. Methods According to the principle of magnetic anchor technology, the magnetic positioning device was designed by embedding magnetic ring in the port body of the intravenous infusion port, and the product prototype of the MTIVAP was designed. A total of four beagle dogs were used as animal models to implant a MTIVAP in their necks, and five experimenters performed ten times piercings in each experimental dog, respectively. The success rate of one-time insertion was calculated to verify the feasibility of MTIVAP in positioning puncture. Results The prototype of the MTIVAP was successfully prepared using 3D printing technology. All four beagle dogs were successfully implanted with MTIVAP in their necks. After using the magnetic positioning device, the one-time insertion success rate of the Huber needle reached 99.5% in the course of 200 piercings, and the operating experience was significantly improved. Conclusion The design scheme of magnetic anchoring for MTIVAP can simplify and significantly improve the puncture operation of the Huber needle.
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  Application of Tissue Adaptive Control Technology Based on Tool Head Temperature Estimation in Ultrasonic Knife

  LIU Yujia, MA Jialin, YU Jia, CAO Dawei

  China Medical Devices. 2025, 40(3): 35-40. https://doi.org/10.3969/j.issn.1674-1633.20241730

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  ObjectiveTo study a new technology with the effect of benchmarking the tissue adaptive control function of American Johnson & Johnson in order to improve the performance level of domestic ultrasonic knives. Methods By analyzing the factors affecting the resonant frequency of the electromechanical system composed of ultrasonic tool bar and transducer, a method was designed to observe the resonant frequency change, and a set of mathematical formula with the resonant frequency change as the main parameter was fitted through a large number of test data, which was used to estimate the tool head temperature. Then a method of adjusting the output of ultrasonic knife based on estimated cutter head temperature was proposed to realize the tissue adaptive control function. Results It was proved by thermal simulation that the temperature rise was limited to the part of the cutter head, and the reproducibility of resonant frequency change when the cutter head cuts the simulated tissue was good. The temperature estimation algorithm based on resonant frequency change was applied to a domestic ultrasonic host, and the difference between the estimated tool head temperature and the actual tool head temperature was less than ±10℃. Finally, animal experiments verified that clinical effect of the tissue adaptive control method proposed in this study had no statistical significance compared with that of American Johnson & Johnson GEN11CN ultrasonic knife host in terms of cutting closure efficiency and soft tissue thermal damage distance(P>0.05). Conclusion The tissue adaptive control method based on tool head temperature estimation has practical application value, which can improve the technical level of domestic ultrasonic knives and shorten the gap with international first-class products.
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  Application of Medical Big Data Combined with Artificial Intelligence Algorithm in Ventilator Fault Identification and Preventive Maintenance

  GONG Xinchen, WEN Lin

  China Medical Devices. 2025, 40(3): 41-48. https://doi.org/10.3969/j.issn.1674-1633.20240844

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  ObjectiveTo propose a ventilator fault identification and preventive maintenance strategy based on particle swarm optimization (PSO) algorithm and back propagation (BP) neural network model, aiming at improving the management and maintenance level of ventilator equipment, and providing reference for preventive maintenance of ventilator. Methods The daily quality control data, clinical use data, environmental data and other multi-modal data of ventilators used in our hospital from 2017 to 2023 were selected as the research objects to introduce the PSO algorithm and establish the PSO-optimized BP neural network model (PSO-BP). At the same time, K-nearest neighbor classification (KNN) model, support vector machine (SVM) model and eXtreme gradient boosting (XGBoost) were introduced and used as the comparison model, and accuracy (ACC), precision (PRE), recall rate, F1 score and area under curve (AUC) were selected to evaluate the model. Results ACC, PRE, recall rate, F1 score and AUC values of the trained PSO-BP model were 90.05%, 91.00%, 89.30%, 0.90 and 0.88, respectively. Compared with KNN, SVM, XGBoost and BP models, the recognition ACC of PSO-BP model was improved by 6.64%, 4.50%, 3.32% and 7.35%, respectively. Recall rates, F1 scores and AUC values had also improved to some extent. The optimal threshold of the model was 0.6768, and the safe area, stable area, danger area and high-risk area were [0, 0.3384], (0.3384, 0.6768], (0.6768, 0.8384] and (0.8384, 1.0000], respectively. Conclusion The establishment of PSO-BP model through high-throughput medical big data can effectively identify ventilator faults, and can provide reference for preventive maintenance of ventilator with quantitative data, which has certain theoretical and practical significance.
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  Comparative Analysis of Periodic Quality Control Results of Various Medical Electron Linear Accelerators

  ZHANG Jin, XIONG Yi, NIE Xin

  China Medical Devices. 2025, 40(3): 49-56. https://doi.org/10.3969/j.issn.1674-1633.20231992

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  ObjectiveBy statistical analysis of the weekly test results of 4 medical electron linear accelerators in the past 3 years, to find and summarize the regularity and characteristics of periodic quality control of accelerators, so as to provide recommendations for the rational maintenance of accelerators and radiotherapy for cancer patients. Methods According to the quality control content recommended by domestic and foreign reports and literatures, five items such as output dose stability, laser lamp position, image center and mechanical center coincidence test, optical distance scale accuracy and optical field size were selected to carry out periodic inspection work. Results The four accelerators were American Varian Trilogy (old), Swedish Elekta Precise, American Varian Unique and American Varian Trilogy (new) in order of service time. The passing rates of the output dose test were 97.5%, 93.2%, 96.3% and 100%, respectively. The average maximum deviation of laser lamp position was 0.84, 0.76, 0.82 and 0.64 mm, respectively. The average maximum deviation of the coincidence degree between image center and mechanical center was 1.19, 1.05, 0.83 and 0.81 mm, respectively. The average maximum deviation was 1.05, 0.72, 1.72 and 0.91 mm, respectively. The average maximum deviation of optical field size was 0.91, 0.82, 0.79 and 0.60 mm, respectively. Varian Trilogy (new), the shortest-serving and highest-configuration accelerator, ranked in the top two for each of the four accelerators in the horizontal rankings, while all the others ranked in the bottom for at least one test. Conclusion The shorter the service time of the medical electron linear accelerator weekly inspection project, the higher the comprehensive standard rate, more suitable for the implementation of more complex treatment plans, to undertake more radiotherapy tasks. In addition, the higher the accelerator configuration produced by the same company, the higher the output dose stability and the accuracy of the optical gauge. The position of laser light in the horizontal direction of each accelerator is more prone to deviation. The more C-arm accelerators participate in image guidance, the greater the probability of image center deviation. The greater the difference from 100 cm, the greater the probability of deviation.
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  Discussion on the Practice Method of Quality Control Testing for Neonatal Blue Light Therapy Instrument

  MAI Dacheng, CHEN Weiye, XIAO Xiang, CHEN Yuanpeng, ZHANG Xuewen, CHEN Guangyuan

  China Medical Devices. 2025, 40(3): 57-63. https://doi.org/10.3969/j.issn.1674-1633.20240899

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  ObjectiveTo solve the problem of the lack of effective and feasible quality control testing methods for neonatal blue light therapy instrument, especially the lack of radiation performance quality control testing standards, to study a quality control testing method for neonatal blue light therapy instrument to ensure its therapeutic effect. Methods According to the treatment principle and design principle of the neonatal blue light therapy instrument, the quality control testing method was developed from the three aspects such as equipment appearance and daily management, running state and irradiation performance. Among them, irradiation performance included irradiation area and distance, irradiation intensity. In addition, the vertical ruler and level ruler were used as the control group to compare with the developed blue ray radiation auxiliary measuring device (observation group 1) and manual quality control (observation group 2) to verify the importance of standard quality control. Results The maximum, minimum and average values of the upper and lower blue light irradiation intensity were all within the permissible range of YY 9706.250-2021 Medical Electrical Equipment Part 2-50 and Expert Consensus on Diagnosis and Treatment of Neonatal Hyperbilirubinemia, and all differences were statistically significant ((P<0.001)). The study clearly suggested that the mobile blue light therapy device should be more than 25 cm away from the infant incubator during intense light therapy. In the comparison experiment between blue light radiation auxiliary measuring device and human hand quality control, the measurement results of observation group 2 were more discrete than those of observation group 1, with statistical significance ((P<0.001)), and the measurement results of observation group 1 were close to those of control group. Conclusion The quality control test method of neonatal blue light therapy instrument is feasible and in line with the relevant provisions of YY 9706.250-2021 Medical Electrical Equipment Part 2-50 and Expert Consensus on Diagnosis and Treatment of Neonatal Hyperbilirubinemia.
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  Construction and Application of Extraction and Docking Platform for Clinical Diagnosis and Treatment Data Based on Specialized Disease Database Construction

  SI Chaozeng, HU Yu, ZHANG Sheng, TIAN Yanbin, ZHANG Weishuo, LI Lin, XIA Jiefeng

  China Medical Devices. 2025, 40(3): 64-69. https://doi.org/10.3969/j.issn.1674-1633.20240651

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  ObjectiveTo develop an efficient and stable method for the extraction and docking of heterogeneous multi-source clinical data, to realize the data integration and application of specialized disease databases. Methods The clinical data resources were obtained by data extraction algorithms such as incremental accumulation model and self-zipper model. The data engine technology was applied to realize the data docking and integration with the specialized disease database, and the standardized data quality and data security management system was established. Results By the end of 2023, the data extraction and docking platform successfully facilitated the docking of clinical data from 31 specialized disease databases. After the application of the platform, the number of functional modules, average construction period, enrollment sample size, number of included indicators and missing indicators of the special disease database were significantly improved compared with those before the application of the platform (P<0.05). Conclusion The docking method of clinical diagnosis and treatment data realizes the accurate extraction, transformation and integration of data content in the construction of specialized disease database, improves the construction efficiency and data quality of specialized disease database, provides data support for clinical scientific research. Consequently, it promotes the transformation of clinical scientific research results.
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  Development and Application of Medical Equipment Technical Parameter Management System Based on Java

  KE Xiaopo, PAN Guobing, LIN Cheng, NI Jilong, CHEN Dapeng, YUAN Chang

  China Medical Devices. 2025, 40(3): 70-76. https://doi.org/10.3969/j.issn.1674-1633.20240281

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  ObjectiveTo design and develop a hospital medical equipment technical parameter management system, to realize the market research and bidding technical parameters demonstration of hospital medical equipment procurement. Methods The medical equipment technical parameter management system integrating equipment bidding process was designed and implemented, which was adopted on MyElipse 6.5 as the development tool, used Java and B/S architecture, and used MySQL as the background data management software. The functions were realized including login management, user management, equipment information management, parameter demonstration management, bidding parameter management and classification directory management. Results By determining the system module test scenario and the gradient increasing concurrent users to test gradientally, the pass rate of system performance test results was 100%. Through the system management, the efficiency of parameter response, market research, parameter compilation and parameter demonstration was significantly improved compared with that before management, and the time consumption was reduced by 43.33%, 60.66%, 53.90% and 57.77% respectively, and the differences were statistically significant (P<0.001). Conclusion The technical parameter management system of medical equipment saves the procurement cycle of hospital procurement institutions and demonstration institutions, optimizes the parameter demonstration and research process, and improves the management efficiency and economic benefits of medical and health institutions.
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  Design and Practice of Security Protection and Monitoring and Early Warning Platform for Large-Scale Medical Equipment

  PENG Yuan, LIU Yun, XU Sai, KOU Jianqiu

  China Medical Devices. 2025, 40(3): 77-82. https://doi.org/10.3969/j.issn.1674-1633.20241121

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  ObjectiveTo take effective security protection and monitoring measures against the network security risks of large-scale networked medical equipment. Methods Combined with the requirements of cybersecurity classified protection compliance, the large-scale medical equipment private network and compliance network system were built. The information technologies such as software defined network, AI, Internet of Things and log analysis were used to deploy network security protection platforms and equipment monitoring and early warning platforms. And the network security and operation state of equipment were visible, manageable and controllable. Results Through the deployment and application of 23 pieces of large-scale medical equipment and related terminal equipment, the number of network security incidents and equipment failure time were significantly lower than those before the launch, with a decrease of more than 90% and 80%, respectively, and the differences were statistically significant (P<0.05). Conclusion The construction of large-scale medical equipment security protection platform and monitoring and early warning platform achieves centralized management and real-time monitoring of large-scale medical equipment, guarantees the safe, stable and efficient operation of large-scale medical equipment, improves the level of protection management, which can provide effective support for the whole life cycle security management of medical equipment.
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  Design and Practice of Hospital Information Procurement Management System

  XU Minglei, WEN Zhilin, XU Lijun

  China Medical Devices. 2025, 40(3): 83-90. https://doi.org/10.3969/j.issn.1674-1633.20240447

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  ObjectiveIn view of the current situation and existing problems of procurement management, to realize the whole cycle information management of hospital procurement by applying big data and “Internet +” method. Methods Through literature research and demand research, combined with multiple data sources and actual needs of hospital procurement, the procurement management system was constructed by using Java open source platform and MySQL 8.0 cloud database to achieve one-stop electronic management of the whole process of hospital procurement. The functions of data board, project browsing, budget management, research management, recruitment management, contract management, appointment management, supplier management and so on were realized. Results The procurement management system could realize the tracking and recording of the whole procurement process, optimize the procurement work mode and improve the procurement work efficiency. Compared with before the system was launched, the pre-procurement research time, procurement-related table production time, procurement progress update time and procurement data access time of procurement projects using the procurement management system were shortened by 37.17%, 57.49%, 54.90% and 59.05%, respectively, and the efficiency of recruitment information management was increased by 58.64%, and all differences were statistically significant (P<0.001). Conclusion By promoting the informatization of hospital procurement management, it can reduce the cost of procurement management, improve the efficiency and quality of procurement management, help hospital procurement personnel realize the informatization management of the whole process of procurement, which can enhance the compliance of procurement, and reduce procurement risks.
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  Design and Implementation of Vital Signs Acquisition System Based on PDA Image Recognition

  REN Bin, SU Yucheng, LOU Miaomiao, JIANG Kun

  China Medical Devices. 2025, 40(3): 91-95. https://doi.org/10.3969/j.issn.1674-1633.20231760

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  ObjectiveTo design a vital signs acquisition system, to realize the automatic identification and recording of measurement data of non-networked vital signs acquisition equipment. Methods The personal digital assistant (PDA) was used as hardware carrier, the image recognition function was developed based on convolutional neural networks algorithm and combined with YOLOv5 target detection algorithm. And the vital signs acquisition system was designed. Through PDA, the rapid identification of measurement equipment signs date such as body temperature, blood pressure, blood oxygen and blood glucose was realized, and automatically recorded to the medical system according to the nursing management rules. Results After the application of vital signs acquisition system, the accuracy of vital signs data collection increased from 99.67% to 100.00%, the average acquisition time was shortened by 29.21%, and the medical satisfaction was increased by 5.74%, and all differences were statistically significant (P<0.05). Conclusion The system ensures effective diagnosis with real vital signs data, further improves the efficiency of ward nursing work, and improves the level and correctness of nursing quality.
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  Study on Hospital Discharge Risk Prediction Model of DRG Low-Risk Group Patients Based on the Home Page of Medical Records

  YUAN Xiaoqi, GAO Wei

  China Medical Devices. 2025, 40(3): 96-101. https://doi.org/10.3969/j.issn.1674-1633.20240663

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  ObjectiveTo investigate the independent risk factors of death in the low-risk group of diagnosis related group (DRG), and construct a risk prediction model by using the radial basis neural network model, in order to reduce the death rate of patients in the low-risk group of DRG and improve the quality of medical safety of patients in hospital. Methods A total of 50344 pieces of home page data of medical records in a grade Ⅲ-A hospital in Shanghai from January to August 2023 were selected and divided into cured group, non-cured group and death group according to discharge conditions. Important risk factors were screened out through single factor analysis and used as analysis variables of radial basis neural network to build a risk prediction model. The area under curve (AUC) and the accuracy, sensitivity and specificity of the model were used to evaluate the prediction efficiency of the model. Results The overall prediction accuracy of radial basis function neural network model was 98.69%. Among them, for cured group, the AUC 0.829, 95%CI: 0.826-0.832, the maximum Jorden index was 0.5823, the sensitivity was 76.29%, and the specificity was 82.06%. For non-cured group, the AUC was 0.825, 95%CI: 0.822-0.828, the maximum Jorden index was 0.5779, the sensitivity was 76.84%, and the specificity was 80.95%. For death group, the AUC was 0.600, 95%CI: 0.596-0.605, the maximum Jorden index was 0.2009, the sensitivity was 44.99%, and the specificity was 75.10%. Conclusion For the risk objective prediction of DRG low-risk patients, the radial basis function neural network model of the cure model has better predictive performance. Blood transfusion response, patient age, length of stay and total hospitalization cost are important independent risk factors affecting the discharge status of DRG low-risk group. The model of this study can provide theoretical basis for the deterioration of discharge status and intervention of DRG low-risk group.
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  Efficiency Analysis of Medical Equipment Allocation in Chongqing Based on Data Envelopment Analysis and Malmquist Index Model

  KOU Yueqin, ZHU Xiaobing, LI Shikang, WEI Anhai, NIE Rui, ZHANG Hehua

  China Medical Devices. 2025, 40(3): 102-108. https://doi.org/10.3969/j.issn.1674-1633.20240922

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  ObjectiveTo analyze the current situation of medical equipment allocation in Chongqing’s medical and health institutions, evaluate its allocation efficiency, and promote the scientific and rational allocation of medical equipment. Methods Data envelopment analysis (DEA) and Malmquist index model were used to comprehensively analyze the static and dynamic efficiency of medical equipment allocation in Chongqing medical and health institutions during 2017-2022. Results The distribution proportion of low-value medical equipment in hospitals, primary medical and health institutions and professional public health institutions was relatively stable, while the distribution proportion of medium and high-value medical equipment in professional public health institutions and primary medical and health institutions showed a wave rising trend. From the static evaluation results, the equipment allocation efficiency of hospitals and other institutions was DEA weakly effective, the allocation efficiency of primary medical and health institutions was DEA effective, and the allocation efficiency of professional public health institutions was DEA ineffective. From the dynamic evaluation results, the allocation efficiency of medical equipment in all medical and health institutions showed an overall decreasing trend during 2017-2022. Conclusion Medical and health institutions in Chongqing have achieved continuous optimization in the allocation structure of medical equipment, and the overall allocation efficiency is high. In order to further improve the allocation efficiency, it is necessary to pay attention to the technical update of medical equipment and the optimization of configuration and use management. The results of this study can provide scientific and reasonable decision-making reference for medical and health institutions in the allocation and management of medical equipment, promote the scientific and rationalization of medical equipment allocation decision-making, and improve the overall efficiency of medical services.
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  Research on the Application of Prospective Quality Management Concept in Medical Device Treatment

  XU Jie, GAO Jingying

  China Medical Devices. 2025, 40(3): 109-114. https://doi.org/10.3969/j.issn.1674-1633.20240944

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  ObjectiveTo explore the application effect of prospective quality management concept intervention scheme in the management of central sterilized supply department (CSSD). Methods A total of 500 packages of medical devices from January to June 2022 (before the implementation of prospective quality management) were randomly selected to be included in the control group, and another 500 packages of medical devices from July to December 2022 (after the implementation of prospective quality management) were selected to be included in the study group. The control group adopted the traditional device quality management mode, while the research group adopted the prospective quality management mode. The application effect of the prospective quality management mode were verified by comparing the medical device disinfection management situation, adverse events of device quality management, device quality management quality and medical staff satisfaction in clinical departments of the two groups. Results The qualified rates of cleaning, packaging and distribution in the study group were significantly higher than those in the control group, and the sterilizing return rate was lower than that in the control group. The incidence of adverse events of device quality management was significantly lower than that of control group. The score of instrument quality management was significantly higher than that of control group. The satisfaction of medical staff in clinical departments was significantly higher than that in control group, and the above differences were statistically significant (P<0.05). Conclusion The introduction of prospective quality management concept enables CSSD to operate better, and further improves the CSSD device quality management system, which is conducive to the improvement of the pass rate of each process.
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  Application Research on Improving Medical Equipment Measurement and Testing Coverage Based on Quality Control Circle Activities

  WANG Xiaomei, ZHANG Xiaobin

  China Medical Devices. 2025, 40(3): 115-119. https://doi.org/10.3969/j.issn.1674-1633.20241123

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  ObjectiveTo improve the medical equipment measurement and testing coverage through quality control circle activity. Methods The quality control circle group of the Equipment Department was established, and “To improve the medical equipment measurement and testing coverage” was determined as the activity theme. A total of 357 medical devices from the measurement equipment testing catalog of our hospital in 2023 were selected as the control group, and 474 measurement and testing devices based on the improvement strategy of quality control circle activity were selected as the observation group in 2024. By analyzing the reasons for the low medical equipment measurement and testing coverage in our hospital, the circle members proposed solutions to the problems one by one, established the standardized process of measurement and testing in our hospital, improved the dynamic management function of measurement management in the medical equipment management system, and regularly carried out equipment quality control and maintenance work. After improvement, the differences in medical equipment measurement and testing coverage of the two groups of equipment were compared. Results After optimization, the medical equipment measurement and testing coverage reached 96.62%, which was significantly higher than that before optimization (87.11%), the difference was statistically significant (P<0.05), and higher than the target value (95.34%). Conclusion Through this quality control circle activity, the medical equipment measurement and testing coverage in our hospital has been improved, the quality of equipment management has been improved, the occurrence of non-inspection has been greatly reduced, and the satisfaction of clinical staff has been improved.
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  Evaluation of Clinical Application of Polyurethane PICC Catheter After Volume-Based Procurement Based on Real-World Evidence

  LIU Wei, GENG Jiaojiao, YANG Wenyong, DENG Gang

  China Medical Devices. 2025, 40(3): 120-125. https://doi.org/10.3969/j.issn.1674-1633.20240987

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  ObjectiveTo compare the clinical use and the cost of patient treatment before and after the volume-based procurement of peripherally inserted central catheter (PICC), to provide a reference for optimizing clinical decision-making and improving the policy of volume-based procurement for medical consumables. Methods The clinical use data of PICC before and after volume-based procurement was collected through interviews with key insiders. The overall cost model of PICC was constructed based on literature review and interviews with key insiders. Kruskal-Wallis test was used to analyze the overall treatment cost of patients. Results According to the interviews with nurses, the actual mean retention time of PICC after volume-based procurement was reduced by 10.77%, the puncture time was increased by 14.21%, and the incidence of complications or adverse reactions caused by catheterization after volume-based procurement was increased to varying degrees compared with that before the volume-based procurement. There were statistically significant differences in hospitalization cost and eisai cost before and after the volume-based procurement of PICC ((P<0.05)). The unit price of PICC and the total cost of average catheterization after volume-based procurement decreased significantly, but the average cost of complications after volume-based procurement showed an increasing trend, with all the differences were statistically significant (P<0.05). Conclusion The quality and clinical use of PICC were not very satisfactory after the volume-based procurement. It is suggested that all medical entities strengthen the construction of quality evaluation system and clinical use monitoring before, during and after the volume-based procurement of medical consumables, systematically analyze the treatment costs of patients, gradually establish the quality and overall cost evaluation standards for the volume-based procurement of medical consumables, and further improve the volume-based procurement system of medical consumables.
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  Visual Analysis for Application of Functional Near-Infrared Spectroscopy in Rehabilitation Medicine Field over the Past Decade

  LI Sihui, LENG Jun, CHEN Yiting, YANG Rong, LIANG Chunting, CHENG Xiaofei

  China Medical Devices. 2025, 40(3): 126-133. https://doi.org/10.3969/j.issn.1674-1633.20241250

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  ObjectiveTo analyze the current situation, hotspot and evolution trend of functional near-infrared spectroscopy (fNIRS) in the field of rehabilitation medicine over the past decade. Methods Literature related to the application of fNIRS technology in the field of rehabilitation medicine from January 2013 to June 2024 were retrieved from Web of Science, and visual analysis was performed by CiteSpace 6.3.R1 software. Results A total of 1036 literatures were finally included, and the number of published literatures showed an increasing trend year by year. LI Zengyong was the most prolific author in this field. China was the country with the highest number of articles. Beihang University was the most prolific institution. Research focused on cortical activation, stroke, functional connectivity, transcranial magnetic stimulation, neuroimaging, motor imagery, brain-computer interface and cognitive impairment. Conclusion The application of fNIRS technology in the field of rehabilitation medicine is in the development stage, and domestic institutions should strengthen cooperation and exchanges. In recent years, research in this field has begun to integrate multimodal monitoring of brain activation and connection-related features to learn more about motor behavior and neurophysiological mechanisms. In the future, we will continue to focus on the application of fNIRS technology in patients with stroke, spinal cord injury, Parkinson’s disease and Alzheimer’s disease.
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  Study on the Diagnostic Efficacy of Two Parameter Calibration Techniques in CT Myocardial Static Perfusion Imaging for Ischemic Cardiomyopathy

  PAN Yingjie, CHEN Yan, QIN Bin, ZHANG Xiang, GAO Xifa

  China Medical Devices. 2025, 40(3): 134-139. https://doi.org/10.3969/j.issn.1674-1633.20240868

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  ObjectiveTo evaluate the diagnostic value and correlation of two CT static perfusion parameters, namely myocardial perfusion index (MPI) and corrected myocardial perfusion (C-MP) for ischemic cardiomyopathy, with cardiac magnetic resonance (CMR) imaging as the reference standard. Methods A total of 42 patients who underwent coronary CT angiography (CCTA) and resting CMR within one week at our hospital from January 2022 to December 2023 were retrospectively enrolled. Among them, 21 patients with normal myocardium were included as the threshold reference group, and the remaining 21 patients were assigned to the experimental group. The 17-segment method recommended by the American Heart Association was used to measure the myocardial attenuation density (AD) of 16 segments excluding the apex. MPI and C-MP were obtained by correcting with the average AD of the intracavitary and aortic segments. The correlation and diagnostic performance consistency of MPI and C-MP were analyzed. Results There was no statistically significant difference in the data between MPI and C-MP (P>0.05), and they exhibited a positive correlation. Compared with CMR, the sensitivity of MPI was 79.5%, specificity was 97.9%, positive predictive value was 72.9%, negative predictive value was 98.6%, and accuracy was 96.7%. For C-MP, the sensitivity was 70.5%, specificity was 96.8%, positive predictive value was 60.8%, negative predictive value was 97.9%, and accuracy was 92.5%. The diagnostic efficacy of MPI and C-MP for ischemic myocardial segments was comparable to that of CMR (P>0.05) Conclusion The diagnostic efficacy of MPI for myocardial ischemia is better than that of C-MP. MPI can be used as a supplement to CCTA, providing a convenient method for clinical detection of myocardial ischemia.
REVIEW
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  Application Status of Intelligent Equipment Assisting Traditional Chinese Medicine Rehabilitation Therapy

  WANG Binhan, LIU Jiayu, WU Minmin, ZHU Luwen

  China Medical Devices. 2025, 40(3): 140-145. https://doi.org/10.3969/j.issn.1674-1633.20240772

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  Traditional Chinese medicine rehabilitation is a new specialty that combines China’s national conditions and adapts to the needs of rehabilitation development. With the emergence of forward-looking technologies such as artificial intelligence, machine learning, and deep learning, the cross-integration of multiple disciplines and intelligent applications have also achieved good results in facilitating the development of traditional Chinese medicine rehabilitation. To promote the modernization of traditional Chinese medicine, fully integrate traditional Chinese medicine rehabilitation with artificial intelligence, and enable the field of traditional Chinese medicine to reach a new height based on modern science and technology, this paper discussed the combination of traditional Chinese medicine rehabilitation and artificial intelligence technology from the two perspectives of traditional Chinese medicine rehabilitation assessment and treatment, aiming to provide a frontier direction and theoretical support for the further development of intelligent traditional Chinese medicine rehabilitation.
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  Advances in Biological Scaffolding and Cell Transplantation in Spinal Cord Injury Repair

  WANG Chunqing

  China Medical Devices. 2025, 40(3): 146-153. https://doi.org/10.3969/j.issn.1674-1633.20232172

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  Spinal cord injury is a serious complication of spinal fracture. It is a trauma-induced neurological disorder, which can cause motor, sensory, sphincter and autonomic nerve dysfunction below the injury site, leading to severe disability. At present, although the technology of spinal internal fixation is very mature, the treatment methods for the recovery of spinal cord injury are limited and the efficacy is not exact. Research has found that cell transplantation can, to a certain extent, increase the regenerative potential of the nerve and promote the recovery of the nervous system, and the combination of transplanted cells loaded on a biological scaffold and transplanted together at the injury site can significantly increase the survival rate of the cells after transplantation and promote the recovery of spinal cord injury. However, there are differences in the degree of repair of spinal cord injury between different combination treatments, and the selection of an appropriate combination treatment is of great value in promoting the recovery of spinal cord function after injury. This article provided a review of the role of biological scaffold and cell transplantation in the repair of spinal cord injury, and summarized the current research progress of the combination of bioengineering technology and cell transplantation, aiming to provide literature information for clinical research and further basic research, and offering new ideas for the development and application of these approaches in the repair of spinal cord injury.
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  Development and Prospect of Liquid Chromatography-Tandem Mass Spectrometry in Clinical Examination

  CHEN Ningqing, JIANG Hongqiang, XIA Jiansong, HUANG Qiaoqiao, YAN Guofei, YAO Luyu

  China Medical Devices. 2025, 40(3): 154-159. https://doi.org/10.3969/j.issn.1674-1633.20240582

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  Mass spectrometry technology has gradually assumed a significant position in the field of clinical testing. This is due to its characteristics such as high sensitivity, high specificity, good reproducibility, high throughput and high efficiency. In particular, liquid chromatography-tandem mass spectrometry (LC-MS/MS) technology, which embodies these qualities, has been widely applied in clinical testing. This paper commenced with a concise elucidation of the principal structural components and technical characteristics of LC-MS/MS. Subsequently, it comprehensively elaborated on four key aspects, namely, its application scenarios, regulatory aspects, development trends, and innovation frontiers. Moreover, it meticulously identified the opportunities and challenges encountered in the advancement of LC-MS/MS technology. Finally, the future development trajectory of mass spectrometry was forecasted. It was expounded that with the in-depth and extensive progression of research, the salutary development of mass spectrometry could be further propelled.
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  Application and Development Trends of Digital Therapeutics in Lumbar Disc Herniation

  LONG Juncheng, HE Hui, HU Donghui, LU Zheng, XIAN Huifeng, ZHANG Yazhong

  China Medical Devices. 2025, 40(3): 160-163. https://doi.org/10.3969/j.issn.1674-1633.20240398

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  With the continuous development of network informatization, digital therapeutics has been deeply integrated into the medical field. As a means of digital health management, digital therapeutics has been widely used in the management of various diseases in European and American countries. In recent years, corresponding clinical studies have also been carried out in China, and digital therapeutics is widely applied in the diagnosis and treatment of lumbar disc herniation. This article reviewed the origin of the concept and current situation of digital therapeutics, as well as its application effects and value in the treatment of lumbar disc herniation, and pointed out the current challenges, aiming to provide a reference for the development of digital therapeutics - related research in China.
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  Application Progress of FFR, CT-FFR and QFR in Coronary Artery Revascularization

  TIAN Yang, LIU Xiaolin

  China Medical Devices. 2025, 40(3): 164-168. https://doi.org/10.3969/j.issn.1674-1633.20240761

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  Coronary revascularization is an effective method for the treatment of coronary heart disease. Fractional flow reserve (FFR) is the gold standard for the invasive assessment of ischemia caused by coronary artery lesions. However, it requires additional guidewires and vasodilation, which limits its widespread clinical application. In recent years, new technologies such as FFR derived from coronary CT angiography (CT-FFR) and quantitative flow fraction (QFR) have developed rapidly. These technologies can further evaluate the situation of myocardial ischemia and the degree of coronary artery stenosis while avoiding the use of additional guidewires and vasodilation. This paper reviewed the principles, application values, and limitations of FFR, CT-FFR, and QFR from multiple aspects, aiming to provide a reference for clinicians to select reasonable technologies in the diagnosis and treatment of coronary heart disease.
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  Application Progress of Ultrasonic Elastography Technology

  CHEN Zhaotao, LIU Peipei, QIAN Linlin, LIU Ruguo, WANG Shengxue, ZHENG Weilei, YOU Xiaogong

  China Medical Devices. 2025, 40(3): 169-175. https://doi.org/10.3969/j.issn.1674-1633.20240414

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  In recent years, the application of ultrasonic elastography technology for detecting the mechanical properties of tissues and organs has stepped into a stage of rapid clinical popularization. Users should first understand its technical advantages and master its operation methods skillfully. At the same time, they should also be clear about its limitations, so as to achieve standardized and correct clinical use and maximize its value. In this paper, the classification of ultrasonic elastography was briefly described first. Then, the wide application value of ultrasonic elastography in the diagnosis of four typical diseases, namely breast tumors, liver fibrosis, prostate cancer, and thyroid nodules, was emphasized. The characteristics of traditional clinical diagnosis methods, the technical advantages and limitations of different ultrasonic elastography methods, and ultrasonic elastography methods’ important role in promoting the development of medical imaging were discussed.
DEVICEMAINTENANCE
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  Circuit Structure Principle and Fault Maintenance of ERBE VIO200S Electrosurgical System Based on Classification Analysis

  KONG Kanghui, ZHAO Dongsheng, GUO Mingzhou, WANG Shuai, LI Huili, XU Bo

  China Medical Devices. 2025, 40(3): 176-180. https://doi.org/10.3969/j.issn.1674-1633.20241108

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  In this paper, ERBE VIO200S electrosurgery system circuit structure is divided into energy channel, control signal channel, power channel three categories, through the circuit diagram of related categories, quickly lock the fault point. Two cases of C48 and C30 fault alarm occurred in ERBE VIO200S electrosurgery system were reported, and the fault was quickly locked through circuit analysis of energy channel, signal channel and power channel. The reason for C48 fault was max4429 chip continued to output high level signals, resulting in the model 35N60 field effect tube burning out. The C30 failure was caused by the failure of the DCDC power module of the current detection circuit of the MCU control board and the failure of the secondary output control relay of the transformer of the inverter board. By replacing the DC-DC module of the specification model E1K15A15-15/2 and the relay of the model 894H-2AC2-F-C 24 V, The ERBE VIO200S electrosurgical system was repaired. Through the classification and analysis of maintenance cases, a kind of high frequency electrotome maintenance idea is provided for medical equipment maintenance peers.