20 June 2025, Volume 40 Issue 6

    

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FEATURES
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  Research on the Current Situation of Usability Testing for Medical Surgical Robots

  ZHENG Yong, MENG Xiangfeng, LI Shu, ZHANG Chao, WANG Hao

  China Medical Devices. 2025, 40(6): 1-6. https://doi.org/10.3969/j.issn.1674-1633.20240869

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  Objective Based on the current status of usability testing of medical surgical robots in China, to explore the common perceptions of enterprises, clinical practitioners and testing agencies regarding the usability testing of surgical robots, and to compare the differences in their needs and concerns regarding usability testing, aiming to provide reference for the formulation of usability testing standards.Methods According to the general requirements of medical device regulation on usability, questionnaires were designed based on factors such as usability testing needs and experimental processes. Data were analyzed to explore the differences and consensus revealed by common questions among different respondents regarding the usability of different types of surgical robots.Results Analysis of the 60 collected questionnaires revealed that all respondents emphasized the fundamental role of surgical instruments and the necessity of simulating the surgical environment, identifying the completion rate of surgical tasks as a key objective indicator. There were significant differences in the usability testing of different types of surgical robots in terms of auxiliary equipment needs, the role of auxiliary equipment and key objective indicators, with variations in experimental design.Conclusion This study investigated the current status of usability testing of medical surgical robots in China and revealed the common perceptions of different respondents and the specific needs of various types of surgical robots in testing through multi-level analysis. It provides scientific evidence for the formulation of unified testing standards and helps promote the application and development of surgical robots in the medical field.
RESEARCH WORK
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  Interpretation on the Standard of Medical Electrical Equipment Employing Robotic Technology: Terminology, Definitions and Classification

  ZHANG Yanli, WANG Quan, MENG Xiangfeng

  China Medical Devices. 2025, 40(6): 7-10. https://doi.org/10.3969/j.issn.1674-1633.20241040

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  Objective With the implementation of the YY/T 1686-2020 standard and the continuous upgrading of artificial intelligence technologies, certain limitations have emerged in the content of YY/T 1686-2020. Specifically, the terminology within the standard can no longer comprehensively cover or accurately describe the structural components and characteristics of medical electrical equipment or systems utilizing robotic technologies currently available in the market. Consequently, there is a need for further refinement and supplementation of the terminology section. This article introduces the overview of the revised YY/T 1686 and the formulation of key technical indicators, aiming to address the inconsistent descriptions of critical technologies in the market and the misuse of terminology.Methods Through the analysis of key fundamental and technical terminology, a comparison of domestic and international standards, and a survey of existing products in China, the understanding and application of relevant terminology in medical electrical equipment or systems that employ robotic technologies were strengthened.Results To meet market demands and promote industrial development, the industry standard YY/T 1686-2020 has been revised. The revised standard added both basic general terminology and technical terminology, and incorporated performance-related terminology based on the functional characteristics of products in the market. In total, the revised standard included 98 terms, spanning four major categories: basic general terminology, technical terminology, structural components and performance.Conclusion The establishment of the relevant standard system is of great significance for the detailed classification and market promotion of medical robot products.
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  Study on the Evaluation of Patient Motion Tracking Performance of Surgical Robots

  MENG Xiangfeng, YANG Chenxu, WANG Hao, LI Shu

  China Medical Devices. 2025, 40(6): 11-15. https://doi.org/10.3969/j.issn.1674-1633.20241061

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  Objective To discuss the evaluation methods of patient tracking performance of surgical robots, analyze the sources of patient movement following deviation based on actual measurements, and solve the measurement problem of this index.Methods A linear motion generating unit was designed which can generate linear reciprocating motion to simulate patient movement. The non-contact spatial position measurement device was used to simultaneously collect the spatial coordinates of the motion generating unit and the robotic arm, and the movement following deviation of the robotic arm in different vector directions during the following process was analyzed.Results This research employed three methods to evaluate the robot’s following performance. The results indicated that maximum deviations often occurred at peak velocity moments; following motion was prone to jitter during movement reversals; the direction of following motion deviations primarily originated from the direction of motion. The measurement and analysis of patient follow-up performance were achieved.Conclusion The design of the experimental plan can fully simulate the clinical application status, and the measurement of this indicator can simultaneously pay attention to changes in the direction of movement, position of non-movement direction and posture.
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  Development of Intelligent Radiotherapy Patient Monitoring and Management System Based on Arduino

  GUO Mingrou, JIN Xiance

  China Medical Devices. 2025, 40(6): 16-22. https://doi.org/10.3969/j.issn.1674-1633.20242045

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  Objective To develop an intelligent radiotherapy patient monitoring and management system based on Arduino.Methods The system took Arduino Mega as the core and integrates multiple modules to achieve identity recognition and physiological parameter monitoring. The performance of the system was verified through experiments on healthy subjects, complex scene simulations of radiotherapy patients, and clinical questionnaires. The simple moving average model was used to analyze physiological parameters, and dynamic thresholds were set to assist in decision-making.Results The system achieved an (1.70±0.10) s of rapid identity recognition among healthy subjects compared with the traditional manual verification (P<0.001), and the recognition accuracy rate of radiotherapy patients in complex scenarios reached 97.66%. There was no statistically significant difference in physiological parameter monitoring compared with clinical equipment (P>0.05). Dynamic thresholds could be set through a simple moving average model to achieve personalized prediction of patients’ physiological parameters. Patients highly affirmed the system functions and treatment experience. Technicians believed that the system optimized the workflow and significantly improved the efficiency of identity verification, but the convenience of obtaining physiological information should be enhanced.Conclusion Through precise identity verification, dynamic physiological monitoring and personalized threshold setting, this system can effectively improve the safety and working efficiency of radiotherapy, provide a new solution for intelligent radiotherapy management.
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  Research and Development and Clinical Testing of PPG Near-Infrared Non-Invasive Blood Glucose Monitors for Pregnancy

  LU Heqing, CHENG Lirui, ZHANG Xiaofeng, LI Shuhan, ZHU Zhigang

  China Medical Devices. 2025, 40(6): 23-28. https://doi.org/10.3969/j.issn.1674-1633.20241432

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  Objective To solve the problems such as cumbersome operation, painful process and risk of wound infection in current invasive blood glucose monitors, design a non-invasive blood glucose monitor for pregnancy based on near-infrared technology.Methods The fusion algorithm of support vector machine, support vector machine regression and convolutional neural network was adopted. The blood glucose correlation parameters were extracted through the characteristics of dual-wavelength photoelectric volumetric pulse wave signals (such as waveform amplitude, slope, harmonic components) to construct a blood glucose prediction model. In the clinical trial, non-invasive data and traditional invasive data (whole blood and fingertip blood) of 50 pregnant women were collected simultaneously. The performance was evaluated through t-test analysis, and the blood glucose values of the subjects were calculated based on the artificial intelligence algorithm model.Results Through clinical verification, it was found that the P values of the differences between the non-invasive and invasive blood glucose levels of pregnant women aged 31-42 years detected by this non-invasive blood glucose monitor were 0.222 and 0.655, and the P values of the differences between the non-invasive and invasive blood glucose levels of pregnant women with a weight of 70-100 kg were 0.113 and 0.607, indicating that there was no statistically significant difference between the non-invasive and traditional blood glucose measurement methods, proving the feasibility and accuracy of non-invasive blood glucose monitor in measuring blood glucose.Conclusion The near-infrared non-invasive blood glucose monitor during pregnancy has accurate blood glucose detection results in some pregnant women. However, its scope of application is relatively limited and there is still room for improvement.
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  Design of Contact-DCT Experimental Device and Phantom Experiment

  YAN Wen, LIU Kai, SHANG Yu, ZHANG Xiaojuan

  China Medical Devices. 2025, 40(6): 29-36. https://doi.org/10.3969/j.issn.1674-1633.20241369

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  Objective To solve the problem of increased equipment cost caused by the need for large-scale source-detector (S-D) arrays to complete data acquisition in large-area contact diffuse correlation tomography (DCT) equipment.Methods An optical switch array was used to time-division multiplexing one group of S-D into eight groups, covering a total of 8 cm×8 cm target tissue. Each long and short distance S-D cross distribution formed a concentric circle structure. By taking advantage of its symmetry and equivalence, the balance of photons obtained by voxel was guaranteed, while the detection area and depth were expanded.Results By using this low-cost DCT equipment, the reconstructed position of the Phantom “cross-shaped” heterogeneous object was accurate, the shape was basically complete, and the contrast of the second layer (depth 0.5-1.0 cm) of the reconstructed image was 0.75. The contrast of the “tubular” heterogeneous substances showed a good linear relationship with the flow velocity, with precise reconstruction positions and complete morphology. The blood flow index in the natural state of the clinical cuff compression test experiment was approximately 10 times that in the pressurized state, and the 3D images and image standard deviations also showed that the blood supply in the natural state was more abundant.Conclusion This contact-type DCT equipment has a strong detection ability for heterogeneous substances of various shapes and can be used as a new detection method to detect diseases related to abnormal blood perfusion.
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  Design and Implementation of Delirium Prevention and Treatment Device

  CHEN Lu, TAO Huisun, ZHANG Shengzhao, WEI Dengrong, YIN Liang, LIANG Zhen

  China Medical Devices. 2025, 40(6): 37-43. https://doi.org/10.3969/j.issn.1674-1633.20241363

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  Objective To develop a delirium prevention and treatment device for preventing postoperative delirium based on the principle of remote ischemia preconditioning (RIPC).Methods The prototype was developed based on the relevant standards of medical devices and the principle of RIPC. The prototype was mainly composed of the main unit and the cuff. The cuff-type pressurization blocking device was formed by the cuff, together with the air pump and solenoid valve inside the main unit, to achieve the RIPC training function. The screen communicated with the main control module via serial port. Users controlled the start and stop of training, as well as query and save training information through the screen. After the prototype was fabricated, the pressure control performance, blood pressure accuracy, air tightness and electrical safety performance were tested and verified.Results The pressure error of the prototype was controlled within ±5 mmHg, and there was no statistically significant difference compared with the systolic and diastolic blood pressure data measured by the Panasonic blood pressure monitor (P>0.05). The prototype had a fast response speed, good air tightness, a noise level lower than 60 dB, and its electrical safety performance complied with the GB 9706.1-2020 standard.Conclusion The equipment developed in this paper is applicable to the preventive training of patients with delirious brain disorders, providing a new idea for the prevention of postoperative delirium.
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  Construction of Specific Disease Knowledge Graph Based on Electronic Medical Records and Public Medical Knowledge Graph

  XIE Zhongrang, WANG Muyu, FAN Shiyu, LI Yichen, CHEN Hui

  China Medical Devices. 2025, 40(6): 44-48. https://doi.org/10.3969/j.issn.1674-1633.20241314

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  Objective To construct a clinical specific disease knowledge graph of stroke based on the public medical knowledge graph and electronic medical records.Methods The biomedical information ontology system and the structured electronic medical records of stroke patients were used as knowledge sources, the basic terminology list of stroke, the characteristic word list of patients, the concept dictionary of stroke, the triplet set of stroke relationships and the concept terminology set of stroke were constructed successively. The relational triplet set and the conceptual term set were imported into the Neo4j database to complete the construction of the knowledge graph of stroke specific diseases. The knowledge graph representation was obtained through the knowledge graph embedding model. Experiments were designed to take link prediction and triple classification as evaluation tasks to compare the performance differences of the graph embeddings obtained by the graph through models such as TransE, RotatE, and Analogy. In addition, two prediction tasks were designed for whether the patient’s hospitalization exceeded 7 and 14 d. The embedding of the knowledge graph with the optimal performance was fused with the original feature patient representation based on the Skip-gram algorithm to construct a machine learning model to complete the prediction task and evaluate its performance. F1 score, area under curve (AUC) of receiver operating characteristic (ROC), and AUC of precision-recall rate were adopted as the evaluation indicators.Results The constructed knowledge graph for stroke specific diseases had 215090 entities and 550976 relationships, and the optimal graph embedding was obtained based on the RotatE model. The experimental results showed that, compared to the P-vector, the KGP-vector achieved improvements in the tasks of predicting whether a patient’s hospitalization exceeds 7 and 14 d. Specifically, the F1 score, ROC AUC, and precision-recall AUC increased by 0.039, 0.061, 0.047 and 0.089, 0.081, 0.103, respectively.Conclusion By using the public medical knowledge graph combined with patient data, a high-quality specific disease knowledge graph can be rapidly constructed, which is expected to provide support for clinical decision-making, disease diagnosis and personalized medical treatment of stroke diseases.
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  Biocompatibility of Vascular Endothelial Cells with Hemodialysis Circulation Pipeline Materials

  ZHOU Lianzeng, GUO Bina

  China Medical Devices. 2025, 40(6): 49-54. https://doi.org/10.3969/j.issn.1674-1633.20240365

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  Objective To explore the biocompatibility of hemodialysis circulation pipeline materials, with a focus on evaluating their interaction with human umbilical vein endothelial cells (HUVECs).Methods Through the CCK8 experiment and staining of live and dead cells, the adhesion, growth and cytotoxic reactions of dialysis tubing materials in different parts to HUVECs were observed.Results HUVECs were cultured and proliferated in different pipeline materials, and cells in different groups could adhere well after 24 h, the proliferation rate could all reach more than 94% after 48 h. After culturing for 72 h, a high cell adhesion rate could be observed under a bright-field microscope. The adhesion rates of the six different pipeline materials to HUVECs all reached more than 90%, and the pipeline materials had no significant effect on the proliferation of cells. The six experimental groups were respectively compared with the negative control group. There was no statistically difference between the experimental group and the control group (P>0.05), indicating that the proliferation rate and adhesion rate of cells in the experimental group were consistent with those in the control group. It can be known from the staining results of live and dead cells that the cell survival rate exceeds 90%, with no cytotoxicity, indicating good biocompatibility.Conclusion This study can provide a scientific basis for the optimization of hemodialysis pipeline materials and the development of new materials, and offer theoretical support for improving the therapeutic effect of dialysis and reducing complications.
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  A Detection Method for Image Delay and Stereoscopic Image Disparity of 3D Endoscope System

  ZHAO Rongjiao

  China Medical Devices. 2025, 40(6): 55-60. https://doi.org/10.3969/j.issn.1674-1633.20240911

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  Objective To propose an objective, accurate and convenient detection method for image delay and stereoscopic image disparity of three-dimensional endoscope systems.Methods The three-dimensional endoscope system was taken as the overall measured object. In the white light mode and fluorescence mode, the step signals of the light source and screen brightness changes were collected respectively by the photoelectric sensor. The time difference between different step signals was measured by the oscilloscope, thereby obtaining the image delay and stereoscopic image disparity in the two modes. Statistical analysis was carried out to verify whether there was statistically significant difference between the two groups.Results The image delay in the white light mode was (67.76±5.17) ms, and that in the fluorescence mode was (71.52±4.30) ms. The time difference of stereoscopic image in white light mode was (0.27±0.07) ms and that in fluorescence mode was (0.38±0.08) ms. The time difference of stereoscopic image in fluorescence mode was higher than that in white light mode, and P=0.006<0.05, the difference between the two was statistically significant.Conclusion By analyzing the imaging link of the three-dimensional endoscopy system, the image delay and stereoscopic image disparity of the entire endoscopy system are detected, providing a reference for the clinical selection of three-dimensional endoscopy systems. The image delay in pure white light mode is smaller, the image consistency is better, and the follow-up and smoothness of the video stream are better. Therefore, in actual clinical practice, it is recommended to mainly use white light mode and supplement with fluorescence mode, which is helpful to reduce the impact of image delay and stereoscopic image disparity on clinical operators and ensure surgical safety.
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  Construction and Application of Cardiovascular Disease Specialized Database Based on Multimodal Data Model

  LUO Hao, LI Huakang, WANG Fei

  China Medical Devices. 2025, 40(6): 61-68. https://doi.org/10.3969/j.issn.1674-1633.20240978

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  Objective To construct a specialized disease database for cardiovascular diseases based on multimodal diagnosis and treatment data, to improve the efficiency of clinical data utilization and assist the analysis and application of specialized disease data in Cardiovascular Medicine Department. Methods By utilizing Hadoop based big data and artificial intelligence technologies such as natural language processing and computer vision, multimodal data of more than 1.2 million patients in Cardiovascular Medicine Department were aggregated and managed, and the specialized disease database function was developed to provide data support services. Results The cardiovascular disease specialized database was designed with 730 structured fields, included data from 445004 patients, integrated 11939686 outpatient records, and correlated and aggregated 12 types of imaging data including ECG, ultrasound, CT, endoscopy and so on. After using the specialized disease database, the average number of patients and fields in each project were significantly higher than those without using the special disease database; and the time for patient enrollment, data cleaning and governance, field data governance and statistical analysis were all significantly shorter than those without using the special disease database, with all differences being statistically significant (P<0.05). The application efficiency of clinical data has been significantly improved. Conclusion The cardiovascular disease specialized database based on multimodal diagnosis and treatment data has improved the diagnosis and treatment level and scientific research output of the department, which plays a positive role in its application.
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  Construction and Clinical Application of Comprehensive Digital Intelligent Management System for Pulmonary Function Examination

  SI Chaozeng, HU Yu, XIA Qinfang, YIN Tingyu, LI Yong, ZHANG Weishuo, XIA Jiefeng

  China Medical Devices. 2025, 40(6): 69-74. https://doi.org/10.3969/j.issn.1674-1633.20241559

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  Objective To construct a comprehensive digital intelligent management system for pulmonary function examination, aiming to optimize patient examination processes, reduce manual data entry time, enhance the efficiency of clinical diagnostic and treatment and achieve data resource sharing and equipment efficiency optimization. Methods In this study, the existing issues in the pulmonary function examination workflow were analyzed in depth, and the informatization technology and artificial intelligence technology were comprehensively utilized. Combined with clinical business needs and patient diagnosis and treatment needs, the pulmonary function examination system was developed using Java language and Oracle database based on B/S architecture with Tomcat and Nginx, which realized the digital and intelligent management of pulmonary function examination. Through the statistical analysis of patients’ appointment waiting time, examination waiting time, examination time, number of examination equipment, annual operation cost of equipment, annual return rate of equipment and equipment utilization rate before and after the system was launched, the application effect of pulmonary function examination system was comprehensively evaluated. Results After the system was launched, the examination appointment waiting time, examination waiting time and examination time were shortened by 60.22%, 54.97% and 41.08%, respectively. In the case of the same total number of equipment (9 units), the annual operation cost of the equipment was reduced by 24700 yuan, the annual return rate of the equipment was increased by 71.06%, and the utilization rate of the equipment was increased by 9.34%, and the differences were statistically significant (P<0.05). Conclusion The comprehensive digital intelligent management system for pulmonary function examination significantly optimizes the examination process, enhances equipment efficiency, and facilitates the sharing of examination results and clinical data application, which is of great importance for improving the quality and efficiency of medical services.
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  Construction and Application of Multi-Center and Multi-User Biobank Information Management System

  WANG Yueqiao, LIU Yanhong, SU Yifei, LENG Jifeng, DING Jie

  China Medical Devices. 2025, 40(6): 75-81. https://doi.org/10.3969/j.issn.1674-1633.20241452

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  Objective To construct a biobank information management system involving multi-center and multi-user, to provide innovative ideas and methods for the future development of biobank. Methods In accordance with the relevant standards and regulations of the biobank, the system adopted the technical architecture including the foundation layer, data layer, application layer and user layer. It interfaced with multiple hospital information systems to achieve information interoperability. The multiple functional modules including authority control, sample management, “boutique queue” management, storage space management, reagent consumables management, instrument and equipment monitoring, document management, follow-up management, data statistics, shared display platform, mobile application were deployed to ensure the convenience, efficiency, integrity, safety and traceability of sample information management and application. Results After the application of the system, the time required for the intake of non-tissue samples, tissue samples and the recording of informed consent was reduced by 35.08%, 29.70% and 62.50%, respectively, all of which were statistically significant (P<0.05). Furthermore, the number of sample increased by 22.35%, and the efficiency and scope of sample sharing were also significantly enhanced. Conclusion The establishment and application of the biobank information management system not only improves the efficiency and quality of sample management, but also promotes the sharing and utilization of sample resources, which provides strong support for biomedical research.
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  Exploration and Implementation of Intelligent Admission and Discharge Service Platform Under the Background of Digital Transformation

  SHANG Shi, CHEN Hui, MI Linhui

  China Medical Devices. 2025, 40(6): 82-86. https://doi.org/10.3969/j.issn.1674-1633.20240483

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  Objective Taking online self-service as the starting point, to promote a new model of hospital services under the background of digital transformation, to explore the optimization methods for admission and discharge processing. Methods Through four-layer architecture data transmission of software layer, service layer, function layer and scene layer, the patients unique identification was used to obtain the hospitalization status. And the intelligent admission and discharge service platform based on WeChat public number was constructed to realize the functions of self-service admission, payment of prepayment and self-service discharge settlement. Taking the patients in the day surgery ward of Shanghai Chest Hospital as the research object, the average time of each link and patient satisfaction before and after the platform’s launch were selected, and the application effect of the platform was empirically analyzed. Results The intelligent admission and discharge service platform was launched for 7 months, the admission process data of 1133 patients and the discharge settlement data of 416 patients were recorded. After the launch of the platform, the average time of admission, prepayment and discharge was significantly shorter than that before the launch of the platform, and the differences were statistically significant (P<0.001). The whole process operation of patients could decrease 59.6 min, and the patient satisfaction increased from 96.19% to 98.96%. Conclusion The intelligent admission and discharge service platform realizes the digital and intelligent admission and discharge service, makes the medical process “subtraction”, effectively improves the patient’s medical experience, provides reference experience for strengthening the convenience service measures, and further promotes the coordination and intelligence of hospital process management.
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  Application of the Whole-Process Medical Technology Appointment Platform in "Daily Clearance" of Imaging Department Examination

  LIAN Wei, LIU Haixia, JIANG Liyan, QIU Jiyu, ZHANG Guowei

  China Medical Devices. 2025, 40(6): 87-92. https://doi.org/10.3969/j.issn.1674-1633.20241694

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  Objective To investigate the application effect of the whole-process medical technology appointment platform in the “daily clearance” of patient examinations in the Imaging Department. Methods The platform design used Java, JavaScript and other development languages. Based on SpringCloud microservices architecture and Vue front-end framework, a whole-process medical technology appointment platform integrating appointment, queuing, inspection and reporting was constructed. By collecting the key indicators such as the waiting time of patients, the completion rate of the examination on the day, and patient satisfaction in the Imaging Department, the application effect of the whole process medical technology appointment platform was comprehensively evaluated. Results After the application of the whole process medical technology appointment platform, the waiting time of patients was shortened from (59.6±15.8) min to (21.7±6.2) min, the completion rate of the examination on the day was increased from 61.36%±12.15% to 85.28%±11.98%, the patient satisfaction was increased from (5.5±1.9) points to (8.5±1.2) points, the complaint rate of patient visit time was decreased from 0.53%±0.06% to 0.12%±0.01%, and the complaint rate of patient visit satisfaction was decreased from 0.33%±0.06% to 0.08%±0.01%, and the differences were statistically significant (P<0.05). Conclusion The whole process medical technology appointment platform plays an important role in “daily clearance” of patient examinations in the Imaging Department, effectively improves medical service quality and patient experience, which is worthy of promotion.
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  Research on Hospital Cybersecurity Management under the Integrated Online and Offline Medical Service Model

  WANG Zhaolai

  China Medical Devices. 2025, 40(6): 93-99. https://doi.org/10.3969/j.issn.1674-1633.20241556

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  Objective To establish a safe, reliable, and efficient hospital cybersecurity management system under the integrated online and offline medical service model, ensuring the continuity of medical services, the security of medical and health data, and the confidentiality of patient information. Methods By analyzing the characteristics of the integrated online and offline medical service model and the cybersecurity risks and challenges it brought, cybersecurity management strategies were formulated and a cybersecurity management system was established, based on laws, regulations, rules and measures, drawing on existing cybersecurity theories and best practices, and in combination with the current development trends of cybersecurity technologies. Results By establishing a hospital cybersecurity management system that integrated technology, management and operation into a multi-layer defense system, a comprehensive prevention and control pattern featuring the coordination of the four major systems of protection, monitoring, handling and guarantee was formed. The ability to detect active security incidents was enhanced by 100% and the comprehensive cybersecurity score remained at a high level (dynamic 100 points). Conclusion Through scientific planning and construction, this study has established a solid “cybersecurity barrier” to ensure the continuity of medical services and the security of patient information, providing a high-speed, stable, reliable and secure network environment for smart hospitals to achieve integrated online and offline medical services and high-quality hospital development.
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  Role of the "3444" Management Mode in the Construction of Compact Urban Medical Group in Improving the Service Level of Primary Medical Institutions

  LIU Dan

  China Medical Devices. 2025, 40(6): 100-105. https://doi.org/10.3969/j.issn.1674-1633.20241732

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  Objective To explore the positive role of adopting the “3444” management mode in optimizing resource allocation and improving the efficiency of medical services in the construction of compact urban medical group. Methods The “3444” management mode was constructed to guide the management work in the construction of compact urban medical group. Its core lay in relying on three major platforms, establishing four major systems, focusing on four major diseases, and enhancing four major capabilities to form a full-process closed-loop management of all work within the medical group. Results In the practice of constructing the compact urban medical group with Beijing Anzhen Hospital, Capital Medical University (hereinafter referred to as “Anzhen Hospital”) as the core hospital, under the “3444” management mode, Anzhen Hospital provided multiple professional skills training to primary medical institutions and promoted the continuing education and on-the-job training of primary medical staff. Meanwhile, Anzhen Hospital dispatched responsible directors and on-duty experts to primary medical institutions. The total number of patients served reached 2317, with a cumulative service duration of 1123 h. In the first three quarters of 2024, the number of referrals between Anzhen Hospital and primary medical institutions was 22971, 24429 and 23448 respectively. The service quality of primary medical institutions was evaluated. After adopting the “3444” management mode, the evaluation score increased significantly (P<0.05). Conclusion Under the “3444” management mode, the allocation of medical resources among the members within the compact urban medical group has been optimized, the quality and efficiency of medical services have been improved, and the service capabilities of primary medical institutions have been strengthened. This management model plays a positive role in the construction of the compact urban medical group.
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  Application of PDCA Cycle in the Management of Medical Consumables in Secondary Warehouse of the Department

  QIAO Yuanhui, GUO Xiaowei

  China Medical Devices. 2025, 40(6): 106-111. https://doi.org/10.3969/j.issn.1674-1633.20250106

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  Objective To solve the problems of inconsistent accounts and inflated inventory by carrying out the spot check and inventory of the secondary warehouse of medical consumables, so as to further promote the rational use of medical consumables in the department and improve the inventory turnover. Methods A total of 8 secondary medical consumables warehouses with large inventory amount in our hospital were selected as the research objects, and the Plan-Do-Check-Act (PDCA) cycle management mode was used. In the Plan stage, on-site inventory and comparative analysis of outbound data were carried out. In the Do stage, By improving the inventory management system, simplifying the operation process, strengthening staff training, optimizing supplier cooperation, and establishing a regular inventory and supervision mechanism, the inventory of consumables was regulated and controlled. In the Check stage, the relevant indicators of the department were checked in the next month. In the Act stage, the accounting compliance and inventory of the secondary warehouse of the department were managed and controlled. Results After conducting an inventory check of the secondary medical consumables warehouse in our hospital, it was found that there were some problems such the inconsistent accounts and inflated inventory in secondary medical consumables warehouse. After the improvement of the PDCA cycle management model, the four departments (Department A, B, C, and D) whose original account-physical consistency rate was less than 80% all improved to varying degrees in the following month. The account-physical consistency rates all increased to 86.10%-92.23%, and the overall difference was statistically significant (P=0.045). Among the four departments (Departments E, F, G, and H) whose original account-physical consistency rate was more than 80%, the inventory amounts of Departments E, G, and H decreased by 25.00%, 37.15%, and 56.20%, respectively, the inventory of Department F slightly increased due to temporary fluctuations in demand. The rectification effects of typical consumables were all relatively significant (P<0.001). Conclusion The adoption of the PDCA cycle management model can effectively solve the problems such as the inconsistent accounts and inflated inventory of medical consumables in the department, which is conducive to the standardized, refined and scientific management of medical consumables.
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  Impact of Centralized Volume-Based Procurement of Orthopedic Implant Consumables on Surgery Based on Real-World Evidence

  QIAO Yuanhui, BAI Xiaodong

  China Medical Devices. 2025, 40(6): 112-117. https://doi.org/10.3969/j.issn.1674-1633.20250518

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  Objective To analyze the impact of centralized volume-based procurement of trauma orthopedic surgical implants on osteoporotic proximal humerus fracture (OPHF) surgery based on real-world evidence. Methods Key informants were interviewed to collect data on the impact of centralized volume-based procurement of trauma orthopedic surgical implants on OPHF surgery before and after the procurement. An assessment model for OPHF surgery was constructed based on literature reviews and interviews with key informants. Using the implementation of centralized volume-based procurement of trauma orthopedic surgical implants in our hospital in April 2023 as the cutoffpoint, patients with OPHF who visited the Trauma Orthopedics Department and were admitted for open reduction and plate and screw internal fixation surgery from April 2021 to March 2024 were included in the study. Patients from April 2021 to March 2023 were assigned to the control group, while those from April 2023 to March 2024 were assigned to the volume-based procurement study group. Data on surgical time, surgical blood loss, surgical efficiency, hospital stay duration, surgical complications, preoperative and postoperative 1-year upper limb function scores [disabilities of arm, shoulder and hand (DASH), hospitalization costs (implant costs, examination and testing fees, medication costs, treatment and other fees, total hospitalization costs], costeffectiveness ratio (CER), incremental cost-effectiveness ratio (ICER) and surgical satisfaction were collected and analyzed between 2 groups. Results There were no statistically significant differences between the two groups in terms of surgical time, surgical blood loss, intraoperative fluoroscopy frequency, intraoperative adjustment rate of implants, hospital stay duration, surgical complications, examination and testing fees, medication costs, treatment and other fees, preoperative and postoperative DASH scores (P>0.05). Compared with before surgery, the DASH of the two groups were significantly reduced at 1 year postoperatively (P<0.05).Compared with the control group, the study group had significantly lower implant costs, total hospitalization costs and CER (P<0.05). The ICER for both groups was -32.18 thousand yuan/point. Surgical satisfaction was significantly higher in the study group compared to the control group (P<0.05). Conclusion Based on real-world evidence, under the premise of effective quality of diagnosis and treatment, centralized volume-based procurement of trauma orthopedic surgical implants has a significant impact on OPHF surgery, with a marked reduction in patient medical costs and optimization of the overall diagnostic and treatment cost structure.
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  Refined Management of Cost in Laboratory Department Based on LTCT Model

  DING Siji, HAN Zhaojin, LI Kangrui, WANG Zhengyang, LI Jun, WANG Hui, ZHONG Jianping

  China Medical Devices. 2025, 40(6): 118-122. https://doi.org/10.3969/j.issn.1674-1633.20241353

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  Objective To analyze the operational costs of the clinical laboratory department by establishing a cost accounting model, with the aim of achieving more effective cost control and resource optimization. Methods Operational data from the immunology and biochemistry groups of the laboratory were collected, including the revenue and reagent costs of each testing item. The total revenue, theoretical cost rate, actual cost rate, non-testing cost rate, and the deviation between theoretical and actual cost rates were calculated. The cost composition of the two groups of testing items was analyzed through the correlation between the deviation and non-testing cost rate. Results Both the actual and theoretical cost rates of the biochemistry group were significantly lower than 40%. The actual cost rate of the immunology group was higher than 40%, but there was no statistically significant difference between the theoretical cost rate and 40% (P>0.05). In the biochemistry group, there was a significant correlation between the cost rate deviation and non-testing cost rate (P<0.05). There was no significant correlation between these two indicators in the immunology group (P>0.05). Conclusion The application of the cost accounting model not only helps identify and analyze the cost structure of the laboratory department, but also provides important references for further optimizing resource allocation and improving operational efficiency.
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  Research Status Analysis of Domestic Medical Consumables Management Based on CiteSpace and VOSviewer

  ZENG Haiyan, DENG Xinqi

  China Medical Devices. 2025, 40(6): 123-128. https://doi.org/10.3969/j.issn.1674-1633.20241156

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  Objective To analyze the research status and hotspots in the field of domestic medical consumables management by using knowledge graph, and to reveal the main research directions and trends through multi-dimensional data statistics. Methods The CiteSpace and VOSviewer software were adopted to conduct visual analysis of the current situation of domestic medical consumables management in terms of the annual number of published papers, keyword clustering, keyword emergent, keyword central relevance, authors and institutions of the published papers, etc. Results The analysis of the annual number of published papers showed that the overall trend of published papers in this field was on the rise from 2014 to 2023, but it began to decline in 2021. Keyword clustering analysis revealed multiple major clusters, covering a wide range of topics from fine management, high-value consumables management to information application and cost control. The analysis of keyword frequency showed that keywords such as “fine management” “public hospitals” and “high-value medical consumables” had relatively high occurrence frequencies. The keyword emergent analysis showed that the research field of medical consumables management presented a development trend of gradually transitioning from the management of specific technologies and specific types of medical consumables to a more macroscopic level of policy influence and practical application. The keyword central relevance analysis showed that keywords such as “fine management” and “high-value consumables” were of great significance in the optimization and efficiency improvement of consumables management. The analysis of the authors of the published papers indicated that there was less cooperation among researchers but a core cooperation network existed, while the institutional analysis showed that a close cooperation network had been formed centered on Shanghai General Hospital. Conclusion This study analyzed the current research status in the field of domestic medical consumables management based on CiteSpace and VOSviewer software, comprehensively revealing the research dynamics and trends in this field, and providing theoretical support for the formulation of future research directions.
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  Diagnostic Value of 18F-D3FSP PET/CT in Patients with Subjective Cognitive Decline in Preclinical Alzheimer’s Disease

  MENG Fansheng, WU Dongxue, PAN Deng, XIONG Liang, JIANG Haizhuang, YU Lijuan

  China Medical Devices. 2025, 40(6): 129-133. https://doi.org/10.3969/j.issn.1674-1633.20241048

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  Objective To investigate the value of \(^{18}\)F-D3FSP positron emission tomography/computed tomography (PET/CT) in diagnosing preclinical subjective cognitive decline (SCD) in Alzheimer’s disease. Methods A total of 19 normal control (NC) subjects (NC group) and 42 SCD patients (SCD group) who underwent \(^{18}\)F-D3FSP PET/CT imaging at Hainan Cancer Hospital from January 2021 to December 2022 were enrolled. Clinical characteristics including gender, age and years of education were collected. The standard uptake value ratio (SUVR) of the whole brain was measured. The receiver operating characteristic (ROC) curve was used to analyze the optimal cutoff value of whole brain SUVR for diagnosing SCD. The scale scores and SUVR were compared between the NC group and the SCD group, and the ROC curve was applied to evaluate the predictive value of positive indicators for SCD. Results Compared with the NC group, the whole brain SUVR was higher in the SCD group, and the difference was statistically significant (\(P<0.001\)). There were no statistically significant differences in years of education, gender, age and scale scores between the two groups (\(P>0.05\)). The ROC curve showed that the optimal cutoffvalue of SUVR for diagnosing SCD was 1.122, with an area under the curve of 0.806, a sensitivity of 100.00%, and a specificity of 47.37%. Conclusion \(^{18}\)F-D3FSP PET/CT is a sensitive and reliable detection tool, which can serve as a potential biomarker for the diagnosis of SCD and the assessment of disease progression in future clinical practice.
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  Research on the Application of Quasi-3D CT Imaging Technology in Percutaneous Balloon Compression for Trigeminal Neuralgia

  DONG Ao, GUO Liangdong, FU Xianhua, CHEN Honglin

  China Medical Devices. 2025, 40(6): 134-138. https://doi.org/10.3969/j.issn.1674-1633.20250402

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  Objective To evaluate the utility of quasi-3D CT imaging technology in the treatment of trigeminal neuralgia (TN) using percutaneous balloon compression (PBC). Methods A retrospective analysis was conducted on 47 patients who underwent PBC for TN from June 2019 to April 2024 at our hospital. The quasi-3D CT group (\(n=26\)) utilized quasi-3D CT imaging technology, while the control group (\(n=21\)) employed 2D-digital subtraction angiography technology. At the GE AW4.7 post-processing workstation, skull volume rendering reconstruction was conducted, the distance of the puncture needle from the foramen ovale was measured, the angle of the puncture needle entering the foramen ovale was adjusted, and the position of the balloon tip within Meckel’s cavity was confirmed using quasi-3D CT. The balloon shape was documented on the lateral view. Postoperatively, the operation time, X-ray dose, exposure times, and the frequency of quasi-3D CT use were documented. Results The quasi-3D CT group had lower X-ray exposure times and operation time compared to the control group, but the total X-ray dose was higher than the control group, with statistically significant differences (\(P<0.05\)). There was no significant difference in the dose of contrast medium in the balloon (\(P>0.05\)). The success rate of the balloon shape being “pear-shaped” was higher in the quasi-3D CT group, with statistically significant differences (\(P<0.05\)). Conclusion Quasi-3D CT imaging technology for PBC treatment of TN can reduce operation time, X-ray exposure times, angle adjustment times, surgical complications, etc., and improve the success rate of the surgery.
REVIEW
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  Technological Advancements and Clinical Applications of Ultra-High-Definition Surgical Microscopes

  LI Jin, LI Bin, SHAN Haojie, FAN Boya, ZHENG Yilun, GAO Xiumin, YU Xiaowei

  China Medical Devices. 2025, 40(6): 139-145. https://doi.org/10.3969/j.issn.1674-1633.20250449

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  The ultra-high-definition surgical microscope plays a critical role in modern surgical procedures. Compared to traditional microscopes, the ultra-high-definition surgical microscope provides surgeons with clearer and more detailed views due to its high-resolution imaging technology. This assists in accurately identifying tissue structures and enhances both surgical safety and success rates. This article focused on the technological advancements of ultra-high-definition surgical microscopes, including core technologies such as optical systems, lighting systems, visualization systems, and multi-modal imaging. It also analyzed their applications in various types of surgeries and explores the integration of intelligent assistive technologies such as augmented reality and artificial intelligence. Additionally, the article summarized the challenges faced by current technologies, such as the large size of equipment, lighting control issues, and data transmission limitations, aiming to provide reference for researchers and clinicians, promoting innovative applications of ultra-high-definition surgical microscopes in the medical field.
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  Advances in Automated Segmentation of Regions of Interest in PET Images Based on Deep Learning

  LI Fengqi, LU Jie

  China Medical Devices. 2025, 40(6): 146-151. https://doi.org/10.3969/j.issn.1674-1633.20241237

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  Positron emission tomography (PET) imaging is of great significance in clinical applications. The automated segmentation of its images is crucial for disease diagnosis and treatment. In recent years, remarkable progress has been made in the research of automated PET image segmentation, especially in the application of deep learning methods. PET image segmentation can accurately isolate and label regions of interest, such as tumors, organs, and other structures, which is of great importance for disease diagnosis, treatment planning, and research. This paper provided an overview of the latest research achievements in PET image segmentation based on neural network systems, analyzed the existing limitations and future development trends, aiming to facilitate the optimization of PET image segmentation algorithms and provide new ideas and references for medical research.
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  Research Progress and Prospects of Nitric Oxide Therapeutic Device

  ZHANG Xiaosi, XIANG Siwei, LIN Zhongkuan, ZHENG Kun

  China Medical Devices. 2025, 40(6): 152-158. https://doi.org/10.3969/j.issn.1674-1633.20250353

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  Nitric oxide (NO), as a signaling molecule with critical biological functions, is involved in various physiological processes such as vasodilation, neurotransmission, and immune regulation. As a key device for NO delivery, NO therapeutic devices have demonstrated unique advantages in the treatment of respiratory diseases, cardiovascular diseases, and tumors by precisely controlling gas concentration and release patterns. However, challenges in technical design and clinical application arise from NO’s extremely short half-life, strong concentration dependence, and potential toxicity. This paper reviewed the development history of NO therapeutic devices, covering research progress at home and abroad, technical structures, classification methods, and explored current dilemmas and future development trends, aiming to provide a reference for in-depth research in this field and facilitate broader applications of NO therapeutic devices in medicine.
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  Progress in the Application of UDI in the Fine Management of Medical Consumables

  ZHOU Lianzeng

  China Medical Devices. 2025, 40(6): 159-163. https://doi.org/10.3969/j.issn.1674-1633.20250675

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  With the increasing demand for hospital informatization management, problems such as low efficiency of manual entry, difficult traceability, and data silos in traditional medical consumables management have become more and more prominent. The unique device identification (UDI) of medical devices, as a core technology for achieving “one item, one code” whole-life cycle management, has become the key to breaking through the bottleneck of refined hospital management. This paper reviewed the relevant regulations and application status of UDI at home and abroad, as well as the applications of UDI in the refined qualification management, order management, inventory management, usage management, and traceability management of medical consumables in hospitals, aiming to provide references for the informatization and refined management of hospitals, as well as the whole-life cycle management and development of medical consumables.
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  Applications and Prospects of CT Extracellular Volume Fraction in Abdominal Diseases

  MIAO Yuyu, WU Zhifeng

  China Medical Devices. 2025, 40(6): 164-169. https://doi.org/10.3969/j.issn.1674-1633.20241016

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  The extracellular matrix (ECM), a pericellular network composed of various proteins, polysaccharides, and other components, is essential for maintaining the function of normal tissues and organs. Abnormal deposition and modification of ECM may lead to pathological conditions, such as the occurrence and progression of fibrosis and tumors. As a novel non-invasive parameter for quantifying ECM, the extracellular volume fraction (ECV) can reflect the microenvironment of tumors and evaluate the degree of tissue fibrosis. It holds significant clinical value for clinicians in assessing the severity of abdominal organ fibrosis, predicting the differentiation of abdominal tumor tissues, differentiating tumor types, and evaluating treatment efficacy. This article reviewed the measurement of CT-ECV and its applications in abdominal diseases, aiming to provide new technologies and perspectives for the diagnosis and treatment of abdominal diseases and improve the level of clinical management.
DEVICE MAINTENANCE
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  Current Situation Analysis and Countermeasures of Hard Mirror Related Damage Based on FTA

  QIAO Zhongquan, LIU Sheng, JI Cuie

  China Medical Devices. 2025, 40(6): 170-175. https://doi.org/10.3969/j.issn.1674-1633.20240575

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  Objective To explore the effect of fault tree analysis (FTA) on hard mirror fault analysis. Methods Retrospectively analyzed the repair order of hard mirror fault in our hospital from 2019-2021 and 2022-2023. After statistical summary of 47 cases, the hard mirror fault tree model was established by FTA, and its qualitative and quantitative analysis was conducted. Results The function T was determined by hard mirror fault tree model, 28 minimum cut sets were obtained by qualitative analysis, the probability \(P(T)=0.22568116\) was calculated by quantitative analysis, and the importance coefficient of each basic event was calculated. The ten basic events that had the greatest impact on the top event were analyzed and the quality management plan for medical devices was formulated. The failure rate was reduced from 22.57% to 5.87%. Conclusion FTA can be effectively applied to hard mirror fault diagnosis, which can improve the basic events, reduce the failure rate, reduce the maintenance cost, and significantly extend the service life of hard mirror.
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  Practice and Discussion of Hemodialysis Machine Maintenance System

  YANG Kai, YI Zhengyang, DAI Xijuan, WANG Yanmei

  China Medical Devices. 2025, 40(6): 176-182. https://doi.org/10.3969/j.issn.1674-1633.20241701

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  Objective Hemodialysis machines generally have a long service life and frequent malfunctions. In order to effectively reduce the failure rate of our hemodialysis machines, reduce hospital expenses, this research aim to form a new maintenance system for hemodialysis machines, namely the three-level maintenance system. Methods By using the hemodialysis information management system of our hospital, the number of faults, maintenance costs and maintenance data of the hemodialysis machines from 2022 to 2024 were statistically analyzed to identify the commonalities and patterns of equipment faults. From daily maintenance to offline maintenance, on-machine maintenance, and then to quality control, a more reasonable three-level maintenance system suitable for the hemodialysis machines of our hospital was gradually formulated. The maintenance and upkeep of hemodialysis machines throughout their entire life cycle were carried out by integrating information technology means. Results The formulation and implementation of the new maintenance system reduced the failure rate of our hospital’s hemodialysis machines by 9.69% in 2024 compared to 2022, and saved 50.33% in total annual maintenance costs. Conclusion The newly established three-level maintenance system for hemodialysis machines includes daily maintenance, offline maintenance, on machine maintenance, and quality control, which is in line with the actual situation of hemodialysis machines in our hospital. It can significantly reduce the failure rate of hemodialysis machines, reduce expenses, and ensure the safe and stable operation of hemodialysis treatment, simultaneously assist clinical engineers in transitioning from passive maintenance to active maintenance.