10 May 2025, Volume 40 Issue 5

    

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FEATURES
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  Competitive Landscape Analysis of Scientific Research in Tissue Engineering and Regenerative Medicine

  CHEN Juan, LONG Junyu, ZHANG Ting, LI Zhuoting, LU Yan, OUYANG Zhaolian

  China Medical Devices. 2025, 40(5): 1-8. https://doi.org/10.3969/j.issn.1674-1633.20241465

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  Objective To depict the competitive landscape of scientific research in the field of tissue engineering and regenerative medicine through scientific data. Methods Academic papers in this field were retrieved from the Web of Science database, and the number of publications, the number of highly cited papers, and their proportions were compared between different countries globally and different cities within China to assess China’s research strength in global competition and the research capabilities of various cities in China. Results From 2015 to 2024, a total of 128127 papers were published globally in the field of tissue engineering and regenerative medicine. From the perspective of global competition, China (41190 papers, 433 papers) and the United States (31044 papers, 411 papers) led the field in terms of publication volume and highly cited papers. China’s compound annual growth rate of publications reached 9.0%, while the United States showed a declining trend. A total of 19 institutions from China, including Shanghai Jiao Tong University, Chinese Academy of Sciences, and Sichuan University, ranked among the top 30 globally in terms of publication volume. From the perspective of domestic competition, Shanghai (6840 papers, 98 papers) and Beijing (6610 papers, 82 papers) significantly outperformed other cities in terms of both publication volume and highly cited papers. Both cities had multiple institutions and teams that accumulated substantial research achievements. Conclusion China’s research scale in the field of tissue engineering and regenerative medicine continues to expand, accumulating a large number of top-tier research results, with many institutions and teams ranking among the global leaders. Beijing and Shanghai demonstrate strong research output as national research hubs, while cities like Guangzhou, Chengdu, Hangzhou, Wuhan, Nanjing, Xi’an, and Shenzhen show notable activity as regional research centers.
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  Competitive Landscape Analysis of Technological Innovation in Tissue Engineering and Regenerative Medicine

  ZHANG Ting, XU Dongzi, CHEN Juan, LU Yan, YAN Shu, OUYANG Zhaolian

  China Medical Devices. 2025, 40(5): 9-16. https://doi.org/10.3969/j.issn.1674-1633.20241371

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  Objective To analyze the competitive landscape of technological innovation in the field of tissue engineering and regenerative medicine based on invention patents. Methods This study analyzed invention patents in the field of tissue engineering and regenerative medicine, and explored the time trend, hot spots, regions, and subjects of technological innovation to reveal the competitive landscape. Results There were 70030 invention patent applications worldwide, of which 32034 were authorized, and it had been in a stable development stage in recent years. Technological innovation focused on innovative biomaterials, stem cells and cell culture, tissue repair and regeneration, and surface modification technology. China and the United States were the most active, and the number of invention patent applications and authorizations was far ahead of other countries. Enterprises and universities/ research institutes were the most active subjects all over the world. The number of invention patent applications from Massachusetts Institute of Technology and Boston Scientific Corporation was the most prominent, and the universities such as Zhejiang University and Donghua University in China were relatively prominent. Conclusion This study analyzes invention patents in the field of tissue engineering and regenerative medicine, reveals the competitive landscape of technological innovation in a macro and comprehensive manner, and provides information support for the development of this field from the perspective of information science.
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  Competitive Landscape Analysis of Clinical Trials in Tissue Engineering and Regenerative Medicine

  LU Yan, WANG Jianbo, CHEN Juan, OUYANG Zhaolian

  China Medical Devices. 2025, 40(5): 17-23. https://doi.org/10.3969/j.issn.1674-1633.20241526

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  Objective To analyze clinical trial data in the field of tissue engineering and regenerative medicine from ClinicalTrials.gov and the Chinese Clinical Trial Registry (ChiCTR) to present the global and Chinese competitive landscape. Methods Data on clinical trials in the field of tissue engineering and regenerative medicine were collected from the two databases. A bibliometric analysis was conducted based on the number of registrations, countries or cities, clinical trial institutions, and sponsors. Results Based on ClinicalTrials.gov data, there were 582 registered clinical trials globally in the field of tissue engineering and regenerative medicine. Among 60 countries, the United States had 233 trials, China had 71, and all other countries had fewer than 30. Among more than 2000 clinical trial institutions, institutions such as Columbia University and University of California, Los Angeles in the United States stood out. Among 305 sponsors, 55.74% were universities/hospitals, and 27.54% were enterprises. 122 sponsors in the United States conducted 269 clinical trials, showing high activity. Based on ChiCTR data, China registered 97 clinical trials in this field. Among 29 cities, Shanghai registered 40 trials, Beijing registered 26, and other cities registered fewer than 10 trials. Among 76 clinical trial institutions and 45 sponsors, Beijing and Shanghai had the largest numbers, with institutions like Shanghai Ninth People’s Hospital, Shanghai Jiao Tong University School of Medicine and Peking University School and Hospital of Stomatology being highly involved. Conclusion The number of registered clinical trials in the field of tissue engineering and regenerative medicine is on the rise globally and in China. The United States is in the leading position. There is still a gap between China and the United States, and international multi-center cooperation needs to be strengthened.
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  Global Research Trends and Hotspot Analysis of Nanotechnology in Tissue Engineering and Regenerative Medicine

  WANG Jianbo, OUYANG Zhaolian

  China Medical Devices. 2025, 40(5): 24-33. https://doi.org/10.3969/j.issn.1674-1633.20241874

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  Objective To systematically analyze the research literature on nanotechnology in the field of tissue engineering and regenerative medicine to reveal global research trends and hotspots in these areas, providing valuable reference information for researchers. Methods The Web of Science database was used as the data source, with the keyword combinations “nano” “nanotechnology” “nanomaterials” and “tissue engineering” “regenerative medicine”. A total of 4499 relevant papers published between 2010 and 2024 were retrieved. Data preprocessing and BERTopic topic modeling techniques were applied to perform topic clustering and analysis on the titles and abstracts of the papers. Results From 2010 to 2022, the number of papers published on nanotechnology in tissue engineering and regenerative medicine significantly increased. However, there were fluctuations in the annual publication volume, and since 2022, the number of papers published decreased. This study successfully identified 9 major research directions, including application of nanocomposite scaffold materials in bone tissue engineering; application of electrospinning technology in skin regeneration; application of nanotechnology in hydrogel materials; application of titanium and its oxides in tissue engineering; application of bacterial cellulose and chitosan in tissue engineering; application of nanomaterials in drug delivery; application of nanotechnology in cardiac tissue engineering; application of silk protein nanomaterials in tissue engineering; application of collagen-based scaffold materials in tendon and ligament repair. Conclusion Overall, nanotechnology has a broad research scope in tissue engineering and regenerative medicine, with most studies focusing on the optimization and functionalization of biomaterials. These studies have made significant progress in clinical fields such as orthopedics, dermatology, and cardiovascular surgery. In the future, multifunctional materials, personalized materials, and smart materials are expected to become the key research focus in this field.
RESEARCHWORK
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  Design and Implementation of Medical Portable Intelligent Incubator

  MENG Xueke

  China Medical Devices. 2025, 40(5): 34-41. https://doi.org/10.3969/j.issn.1674-1633.20240402

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  Objective To design a medical portable intelligent incubator to meet the demand for new types of medical portable intelligent incubator in the medical field. Methods The incubator body was built with acrylic sheets, and the temperature inside the incubator body was collected in real time through the DS18B20 temperature sensor. The collected temperature was input into the STC89C52 single-chip microcomputer controller, and the self-designed fuzzy proportion integration differentiation (PID) controller was used for operation. The output temperature control drive circuit HIP4082 full-bridge drive chip drived the H bridge, and the TEC1-12706 semiconductor refrigeration sheet temperature control element was used to control the temperature of the incubator. Results The medical portable intelligent incubator designed in this study could achieve precise temperature adjustment. Physical tests showed that when the set temperatures were 25.0℃ and 50.1℃, the temperature in the incubator at 30 min were (25.0±0.1) ℃ and (50.1±0.1) ℃ respectively. The design and construction of a portable incubator with a temperature control range of (4.0±0.2) to (48.0±0.2) ℃ was achieved. Conclusion The medical portable intelligent incubator designed in this study can meet clinical needs and has certain clinical promotion value.
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  Text Structuring of Electronic Medical Records Based on Large Language Model

  LI Jialin, GAO Binyu, CHEN Hui

  China Medical Devices. 2025, 40(5): 42-46. https://doi.org/10.3969/j.issn.1674-1633.20240857

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  Objective To conduct text structuring of electronic medical records using a large language model (LLM) and verify the superiority of LLM in text structuring. Methods Baidu’s ERNIE Bot was adopted. Based on the optimized prompt, the text of the electronic medical record was structured by calling the LLM application programming interface with Python, thereby obtaining structured features. The ratio of the number of accurately extracted features to all the extracted features was defined as the extraction accuracy, which was used to evaluate the performance of LLM in text structuring. Results Text structuring was performed on 100 electronic medical records of stroke patients. According to the statistics of the medical records, the average extraction accuracy of each electronic medical record text was 98.7%, the precision was 97.5%, and the recall rate was 98.9%. According to the statistics of feature words, the average extraction accuracy, precision, and recall of all feature words were 98.7%, 96.4%, and 98.6%, respectively. According to the statistics of major characteristic categories, the extraction accuracies of symptoms, past medical history, medication use and diagnostic results were 99.3%, 98.0%, 98.8% and 100% respectively. Conclusion It is feasible to use LLM for the structuring of electronic medical record texts. Baidu’s ERNIE Bot has superiority in the structuring of electronic medical record texts.
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  Research on Unexpected Ionizing Radiation Protection for the Cyberknife Accessory Accelerator

  ZHAO Rui, WANG Heping, ZHANG Jing, LI Junjie, GAO Xingxin

  China Medical Devices. 2025, 40(5): 47-52. https://doi.org/10.3969/j.issn.1674-1633.20240837

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  Objective To test the unexpected ionizing radiation level of the cyberknife accessory accelerator and provide a reference basis for the protection against unexpected ionizing radiation of the cyberknife accessory accelerator. Methods The assessment points around the cyberknife accessory accelerator and the permanent area of the cyberknife machine room were designed. Under the condition that the cyberknife accessory accelerator provided high voltage without emitting rays, the radiation monitoring detectors were used to measure the ambient dose equivalent rate of each assessment point respectively. The changes and distributions of the ambient dose equivalent rate of the cyberknife accessory accelerator and the permanent area of the cyberknife machine room around the assessment points were analyzed to put forward specific protective suggestions for radiotherapy patients and radiotherapy staff. Results The ambient dose equivalent rate of the assessment points around the cyberknife accessory accelerator was 33.15-86.77 µSv/h, and the unexpected ionizing radiation of the cyberknife accessory accelerator exceeded the standard of general medical electron accelerators by at least five times. The unexpected ionizing radiation of the cyberknife accessory accelerator was mainly concentrated in the middle and bottom of the accelerator, and the ambient dose equivalent rate range of it was 79.10-86.77 µSv/h. The ambient dose equivalent rate of the background of the machine room at the outer opening and midpoint of the labyrinth of the wave knife machine room were comparable, and the maximum did not exceed 0.28 µSv/h. During cyberknife radiotherapy, the unexpected ionizing radiation in the body area of the cyberknife accessory accelerator was the main factor causing additional radiation doses for patients. Conclusion Unexpected ionizing radiation protection against the cyberknife accessory accelerator should be given full attention in radiotherapy clinical practice. For radiotherapy patients, radiation protection should be carried out by reducing the planned treatment time and the patient positioning time under high pressure without reducing the quality of radiotherapy. When necessary, lead shielding protection should be provided for radiation-sensitive organs such as the lens, thyroid gland and sex gland. For radiotherapy staff, machine operation under high pressure should be avoided or reduced, and distance radiation protection measures should be adopted when necessary.
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  Research on Spatial Resolution Optimization of PET Images Based on Iterative Reconstruction

  LIU Qiong, LI Chaofan, ZHU Zhenyu, DONG Anding

  China Medical Devices. 2025, 40(5): 53-57. https://doi.org/10.3969/j.issn.1674-1633.20240965

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  Objective Through experimental research on the self-made miniature Derenzo phantom, to explore the influence of different imaging conditions (the number of iterations, the number of subsets) in the iterative reconstruction algorithm on the image quality of positron emission tomography (PET). Methods The spatial resolution measurement experiment of the preclinical MadicLab Ultra PET/CT equipment was conducted using the miniature Derenzo phantom (list-mode mode, with a acquisition time of 20 min). Image reconstruction was carried out using the iterative reconstruction algorithm. The iterative range was 1 to 40, the subset was 5 to 30 with an interval of 5, the voxel size was 0.314 mm, the matrix size was 257×257, and the full width at half maximum (FWHM) of the Gaussian post-filter was 1.57 mm. Through visual evaluation, signal-to-noise ratio (SNR), contrast, coefficient of variation (CV), and contrast-to-noise ratio (CNR) were used to evaluate the image quality of the 0.8 mm hot rod in the 8 slices at the center of the reconstructed phantom PET image. Finally, through an experiment on healthy mouse, the influence of the optimal reconstruction parameters was empirically studied. Results In the study of the miniature Derenzo phantom, an image resolution of 0.6 mm could be clearly identified. When the 3D-maximum likelihood expectation maximized (3D-MLEM) algorithm was adopted, the SNR of the image reached the peak in 15 iterations and tended to converge after 25 iterations. When the 3D-ordered subset expectation maximized (3D-OSEM) algorithm (with 5 subsets) was adopted, the differences in image changes from 8 to 12 iterations were relatively small. The SNR tended to converge after approximately 7 iterations, and the contrast, CNR and CV values all showed an upward trend. In animal experiments, 3D-MLEM (30 iterations) and 3D-OSEM (5 subsets, 6 iterations) were used for image reconstruction, and the local tissue structures such as the brain, heart and kidneys of mice could be clearly observed. Conclusion The optimal reconstruction parameters are crucial for obtaining high-resolution images and quantitative accuracy. By using 30 to 40 iterative update times (subset×iteration), 0.314 mm reconstructed voxels and 1.57 mm Gaussian post-filter FWHM for image reconstruction, high SNR and high-resolution PET image quality can be obtained. In animal empirical studies, this reconstruction parameter is suitable for high-precision identification and imaging of tiny lesions.
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  Effect Analysis of Flux Smoothness on the Radiotherapy Dose of Cervical Cancer Based on VIKOR Method

  SUN Yu, ZHANG Wu, LIU Hao, WU Manli, HAO Yuanxiang

  China Medical Devices. 2025, 40(5): 58-64. https://doi.org/10.3969/j.issn.1674-1633.20240687

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  Objective To analyze and compare the effects of four flux smoothness levels of the Monaco planning system on radiotherapy planning for cervical cancer using vise kriterijumska optimizacija i kompromisno resenje (VIKOR). Methods Forty patients with cervical cancer in our hospital were selected as the research subjects. According to the prescribed dose of 50.4 Gy/28 times for PTV, four groups of radiotherapy plans were designed using four flux smoothing modes (OFF, LOW, MEDIUM and HIGH) respectively. After reducing the prescribed dose to 95% of the target area volume, One-way ANOVA was performed using SPSS 27.0 software to compare the differences among the groups, and VIKOR analysis was used for comprehensive evaluation. Results The four groups planned at D98% (the minimum dose received by 98% of the target area volume, and so on for the others), D2%, Dmean (average dose), homogeneity index, conformal index, and bladder V50 (the volume percentage of the organ receiving at least 50 Gy dose, and so on for the others), the Dmean of the bladder, and the probability of normal tissue complication probability (NTCP) of the bladder, small intestine V30, small intestine Dmean, small intestine NTCP, rectal V50, rectal Dmean, rectal NTCP, left femoral head V20, left femoral head Dmean, right femoral head V20, and right femoral head Dmean were no statistically significant differences (P>0.05). The difference in the number of monitor unit (MU) was statistically significant (P<0.05), and MU showed a decreasing trend with the increase of flux smoothness. The VIKOR analysis results showed that the LOW group was the optimal scheme. Conclusion For the design of clinical radiotherapy plans for cervical cancer, all four flux smoothing modes of the Monaco planning system can meet the clinical treatment requirements. With the improvement of flux smoothness, MU shows a gradually decreasing trend. The VIKOR results suggest that the LOW mode can be selected to achieve the optimal dose results.
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  Research on the Prediction of Radiation Pneumonitis After Radiotherapy for Lung Cancer Based on Machine Learning

  YANG Rui, QUE Dan, YANG Dingyi, FAN Xun, SHI Xuejun, LIU Lei

  China Medical Devices. 2025, 40(5): 65-71. https://doi.org/10.3969/j.issn.1674-1633.20240876

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  Objective To establish a prediction model of radiation pneumonitis based on the clinical dosimetric data of lung cancer patients before radiotherapy, and to explore the weights of characteristic factors affecting radiation pneumonitis. Methods The clinical dosimetric data of 126 lung cancer patients before radiotherapy were selected. Three machine learning methods, namely logistic regression analysis, support vector machine and random forest, were used as base classifiers. Radiation pneumonia ensemble learning (RPE) prediction model was established through the voting method. Results The accuracy of the RPE model in predicting radiation pneumonitis was 71.16%, the sensitivity was 68.31%, and the specificity was 73.98%. The receiver operating characteristic curve and the area under curve of RPE reached up to 0.798±0.082. In the weight analysis of the influencing factors of radiation pneumonitis, the weight of bilateral lung V20 (the volume percentage of organs receiving at least 20 Gy dose, and so on for others) was the highest at 0.2423, followed by the weight of bilateral lung V40 at 0.1624. Conclusion The RPE model established based on the clinical dosimetric dataset of radiotherapy patients can effectively improve the prediction accuracy of radiation pneumonitis compared with three traditional base classifiers. Moreover, this model can provide a guiding basis in the design of radiotherapy plans and improve the quality of life of patients.
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  Construction and Application of Ward Warehouse Management System for Low-Value Medical Consumables Based on Material Management System

  LI Xueqin, YANG Dongming, LI Xi

  China Medical Devices. 2025, 40(5): 72-78. https://doi.org/10.3969/j.issn.1674-1633.20241304

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  Objective To address the current issues in the management of low-value medical consumables in hospitals, to establish a ward warehouse management system for low-value medical consumables, so as to improve the fine management level of low-value medical consumables. Methods Based on the Windows operating system, the multi-layer architecture was adopted, and the .NET MVC Framework and other frameworks were introduced. Java was used as the main development language, with Oracle 11g as the database. Under the B/S architecture, user interaction was completed to implement functions such as material requisition, intelligent reminder, inventory threshold management and statistical analysis of ward warehouse. The data of the requisition and charging of 6 types of general low-value medical consumables in 5 departments of our hospital before the application of the system (from May 2022 to April 2023) and after the application of the system (from May 2023 to April 2024) was selected as research data to verify the effectiveness of the application of the system. Results After the application of the system, the number of low-value medical consumables requisitions decreased by 42.10% when the total number of discharged patients increased by 23.78%, and the difference was statistically significant (P<0.001). The per capita cost of low-value medical consumables in discharged patients decreased by 38.16% year-on-year, and the decreases of drug syringes, indwelling needles and vacuum blood collection tubes were significant, and the differences were statistically significant (P<0.05). The weekly requisition time, weekly check time and monthly inventory time of the warehouse administrator were significantly shortened, and the differences were statistically significant (P<0.001). Conclusion The construction and promotion of the ward warehouse management system for low-value medical consumables greatly improves the efficiency and accuracy of warehouse management, further reduces operating costs, and ensures the efficient and stable operation of medical services.
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  Application Exploration of Hospital Monitor Based on NearLink

  ZHOU Yu, ZHU Xinyi, WANG Wenming

  China Medical Devices. 2025, 40(5): 79-85. https://doi.org/10.3969/j.issn.1674-1633.20241350

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  Objective To solve the problems of complicated wiring and poor mobility of traditional wired monitor, to improve the efficiency of medical care and patient satisfaction. Methods In this paper, the interoperability of hospital monitors was realized based on NearLink. The NearLink module was connected to the monitor, and then deployed it in the ward. The NearLink transmission data was analyzed. The management and interconnection of hospital monitors were realized, and the monitoring indicators of patients could be viewed remotely. Results A total of 20 stroboscopic base stations was deployed in the hospital, which could support multiple bandwidths such as 1/2/4/12 M. The average data delay of flash technology was 3.2 ms, and the packet loss rate was less than 1% in high interference environment. It showed good characteristics in terms of real-time performance, concurrent number, anti-interference and security. After the application of wireless monitor based on NearLink, the patient’s activity range and time were significantly improved; the bedside monitoring time and response time of medical staffwere significantly shortened, and the number of task processing was significantly increased, and the differences were statistically significant (P<0.05). Conclusion The application of NearLink in monitor can solve the limitations of monitor, which is of great significance to improve the efficiency and quality of medical monitoring.
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  Application and Effect Evaluation of Internet of Things Technology in the Construction of Smart Wards in Hospitals

  GE Xiaowei, SUN Baofeng, SU Yabo, YANG Yang

  China Medical Devices. 2025, 40(5): 86-91. https://doi.org/10.3969/j.issn.1674-1633.20240804

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  Objective To explore the practical process and application effect of Internet of Things technology in the construction of smart wards in hospitals. Methods With hospital information platform as the center of information integration and coordination, combined with Internet of Things, micro-service and other technologies, the Internet of Things interaction and management platform of intelligent ward was constructed to realize full-scene closed-loop management of ward nursing and efficient intercommunication of information. The application effect was discussed by comparing the nursing quality management evaluation, operation efficiency and personnel satisfaction before and after the application of a ward system. Results After the application of the system, the overall score of nursing quality management evaluation in the disease area was (90.30±4.32) points, which was significantly higher than that before the application of the system (81.60±7.88) points; the hospitalization days, hospitalization expenses, hospitalization improvement rate and bed utilization rate of patients were significantly improved; nursing staffand patient satisfaction were significantly improved, and the differences were statistically significant (P<0.05). Conclusion On the basis of integrating various information resources, the application of smart ward can effectively improve the quality of nursing, enhance patient satisfaction, and address issues such as insufficient efficiency and safety in traditional model, which can provide reference for the construction of a new era of smart ward.
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  Application Value of Internet of Things Intelligent Management Mode in Hospital Medical Consumables Management

  DUAN Legang, ZHANG Yue, CAO Kun

  China Medical Devices. 2025, 40(5): 92-97. https://doi.org/10.3969/j.issn.1674-1633.20240218

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  Objective To explore the application value of Internet of Things intelligent management model in hospital medical consumables management. Methods The Internet of Things intelligent management model was based on the establishment of the intelligent management system and intelligent cabinet of the Internet of Things, which realized the intelligent management of consumables in the central logistics warehouse and operating room of the hospital. The traceability management of consumables was optimized by strengthening label management and increasing personnel in the central warehouse, and the fine and standardized management of the “whole process, all elements, all perspectives and all data” of medical consumables after admission was realized. Taking the interventional operating room as an example, the allocation efficiency of consumables, the inventory amount and management quantity of the department, the abnormal labeling of consumables, the abnormal billing of consumables, the efficiency of traceability information of consumables and the loss rate of consumables before and after the application of Internet of Things intelligent management mode were selected to explore the effectiveness of the mode. Results After the application of Internet of Things intelligent management mode, the collection time of medical consumables in the operating room was significantly shorter than that before the application; the monthly consumables inventory amount and management quantity, consumables label missing rate and error paste rate, name error rate and missing billing rate, and monthly average consumables loss rate were all lower than those before application; the effective rate of traceability information of manufacturer, logistics, warehousing and application was higher than that before application, and all the differences were statistically significant (P<0.05). Conclusion The Internet of Things intelligent management model has high application value in the management of medical consumables in hospitals, which can significantly improve the efficiency of consumables allocation and the management level of consumables.
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  Construction and Practice of Evaluation Index System for Digital Pathological Slice Scanner

  LU Ruyi, SUN Jing, ZHANG Qian, JIN Yile, WANG Zhichen, FENG Jingyi

  China Medical Devices. 2025, 40(5): 98-101. https://doi.org/10.3969/j.issn.1674-1633.20241705

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  Objective To construct a multidimensional, subjective and objective evaluation index system for digital pathological slice scanner, to provide theoretical basis for the evaluation of digital pathological slice scanner by medical institution users and managers. Methods The draft of the evaluation index system for the digital pathological slice scanner was drafted through methods such as literature analysis, enterprise symposiums, group discussions, and clinical research. The Delphi method was used to determine the indicators at all levels, and the analytic hierarchy process was utilized to obtain the normalized weights of the indicators at all levels and the combined weights of the secondary indicators. Results Through the consistency test of single ranking and overall ranking at each level of indicators, the evaluation index system of the digital pathological slice scanner was finally constructed, including 5 first-level indicators and 22 second-level indicators. Conclusion The evaluation index system of digital pathological slice scanner constructed in this study has shown good enthusiasm, strong participation and high authority among experts. It can provide a scientific theoretical basis for medical institutions to regularly conduct clinical application evaluations of digital pathological slice scanner at home and abroad.
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  Research on the Clinical Use Evaluation Model of Medical Anesthesia Machine

  HUANG Hao, ZHU Yi, CHEN Jun, ZHANG Bin, LI Wei, PAN Zongwei, YANG Dongming

  China Medical Devices. 2025, 40(5): 102-106. https://doi.org/10.3969/j.issn.1674-1633.20241130

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  Objective To establish a scientific evaluation system for the use of medical anesthesia machines based on the investigation and analysis of the usage of medical anesthesia machines in the hospital, to provide a theoretical basis for procurement and management decisions for scientific management. Methods Two rounds of expert consultations were conducted using the Delphi expert consultation method. Through discussions in the group, 4 first-level indicators, 11 second-level indicators and 35 third-level indicators were obtained. The indicators were designed into research questionnaires, and consulting experts were invited specifically to fill them out. The results were statistically analyzed. Results After two rounds of expert consultation and research, it was shown that the first-level indicators were technical performance (35.23%), clinical application effect (32.79%), economic benefit (17.41%), and after-sales service (14.56%) in sequence. Among the corresponding secondary indicators, the ones with relatively high attention were: safety, stability, reliability, manufacturer service capability, maintainability, procurement cost and return on investment. The average scores of the third-level indicators ranged from 3.99 to 4.75 points. The standard deviations of 34 indicators were less than 1, and the coefficient of variation were less than 0.25. Conclusion Based on the full life cycle management of medical anesthesia machines, this study has established a relatively comprehensive evaluation system from multiple dimensions such as technical characteristics, clinical applications, economic management, and usage behaviors, which can provide a reference basis for the procurement and management of medical anesthesia machines.
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  Refinement Establishment and Empirical Application Effect Analysis of PIVAS Full Process Audit and Control System

  ZHAO Siting, FENG Yonghong, CHEN Jiawen, CHEN Guixiang

  China Medical Devices. 2025, 40(5): 107-113. https://doi.org/10.3969/j.issn.1674-1633.20241538

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  Objective To establish a full process audit and control system for pharmacy intravenous admixture services (PIVAS), and to comprehensively evaluate the actual impact of this system on the antitumor drug dispensing work in the hospital. Methods In accordance with the latest released relevant guidelines, laws and regulations, and in combination with cross-departmental collaboration, the PIVAS full process audit and control system was officially implemented in our hospital since July 2022, which included formulating unified antitumor drug prescription review standards, upgrading the intelligent prescription review system, strengthening professional training for clinical pharmacists and physicians, and establishing an effective clinical feedback mechanism. A longitudinal comparative analysis method was adopted to systematically analyze the changes in the efficiency of antitumor drug dispensing in PIVAS before and after the system construction (from July 2021 to June 2023). The main observation indicators included physician order review time, drug scheduling time, drug dispensing time, medication cycle, incidences of irrational drug dispensing, error rates, as well as the comprehensive competence and satisfaction of the staff. Results After the implementation of the PIVAS full process audit and control system, the physician order review time, drug scheduling time, drug dispensing time and medication cycle in our hospital were shortened significantly. The incidences of irrational drug dispensing and error rate were decreased significantly. The comprehensive competence indicators such as the enthusiasm, ability value, sense of responsibility, communication and coordination ability, self-confidence and team cohesion score of PIVAS staff increased significantly. The satisfaction of the staff also increased significantly, and all the differences were statistically significant (P<0.05). Conclusion Our hospital has successfully established and implemented the PIVAS full process audit and control system, which not only greatly improves the efficiency of antitumor drug dispensing in the hospital, but also significantly reduces the occurrence of unreasonable dispensing and error events, strongly proving the effectiveness of this system in optimizing the rationality and accuracy of the dispensing process.
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  Research on the Management Mode of Anesthetic and Psychotropic Drugs Based on Two-Dimensional Code Technology Combined with Intelligent Cabinet

  LI Na, YU Yao, LIU Shangkun, DAI Hengmao

  China Medical Devices. 2025, 40(5): 114-119. https://doi.org/10.3969/j.issn.1674-1633.20241513

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  Objective To explore the establishment of information, intelligent, traceable management mode, to effectively solve the problems in the management of anesthetic and psychotropic drugs. Methods By leveraging two-dimensional code technology and through process reconstruction and information integration, with intelligent cabinet as the information medium, intelligent management terminals for anesthetic and psychotropic drugs were comprehensively deployed in drug warehouses, pharmacies, and operating rooms. The information connection among the anesthesiology department, hospital information system, surgical anesthesia system, medical technology workstations, and pharmacy workstations was completed, achieving full-process traceable closed-loop management of anesthetic and psychotropic drugs. Results After the implementation of the program, the time for anesthesiologists to collect/return drugs, the time for anesthesia nurse to write offempty bottles and manage inventory, and the traceability time of a single drug were all significantly lower than those in the traditional mode group, and the differences were statistically significant (P<0.05).The satisfaction score of anesthesiologists increased from (86.47±6.34) points to (94.11±5.65) points, and the difference was statistically significant (P<0.05). Conclusion The management mode of anesthetic and psychotropic drugs based on two-dimensional code technology combined with intelligent cabinet is convenient and efficient. It improves the refined management and safe medication level of anesthetic and psychotropic drugs, enhances the satisfaction of anesthesiologists with the management of anesthetic and psychotropic drugs, and has certain promotion value.
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  Fine Management of Orthopedic Consumables Under the Model of Volume-Based Procurement

  LI Longfei, XU Ting, WEI Li, ZHANG Shu

  China Medical Devices. 2025, 40(5): 120-127. https://doi.org/10.3969/j.issn.1674-1633.20241546

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  Objective To improve the in-hospital procurement process of orthopedic consumables, to better complete the sequential tasks of volume-based procurement, to achieve fine management of orthopedic consumables, and to promote the high-quality development of public hospitals. Methods Relying on the SPD system, the information silos among various departments were broken down, process reengineering was promoted, an integrated full-process management of orthopedics was formed, and the task of volume-based contract signing and package formation was completed using information tools. The period when the system was stably operating in our hospital from July to September 2023 was selected as the experimental group, and the period from July to September 2022 was selected as the control group. The occurrence of problems in the management process, patients’ satisfaction with the surgical use process of orthopedic implants, the accuracy of the disinfection process, and the time spent on national centralized procurement volume-based statistics were compared between the two groups to verify the effect of fine management of orthopedic consumables under the volume-based procurement model. Results After the implementation of the system, the incidence of problems in the management process of orthopedic implant consumables and patients’ dissatisfaction with the orthopedic implant process were significantly reduced, the accuracy of the disinfection process in the disinfection supply room was significantly improved, and the time for statistical measurement of the kit type was significantly shortened. All the differences were statistically significant (P<0.05). Conclusion The fine management of orthopedic consumables can enhance the management efficiency of hospitals, reduce operating costs, ensure the smooth implementation of volumebased procurement, and provide data support for hospital managers to make scientific decisions.
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  Impact and Analysis of Centralized Procurement of Medical Consumables on the Cost of Surgical Patients

  WANG Qian, QIAN Bangfu

  China Medical Devices. 2025, 40(5): 128-134. https://doi.org/10.3969/j.issn.1674-1633.20240805

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  Objective To explore the impact of the centralized procurement policy of medical consumables on the cost structure of inpatient surgical patients. Methods Based on the data of inpatient surgical patients in a certain grade-Ⅲ A hospital from July 2020 to June 2022, a statistical analysis was conducted on the basic situation of patients, total costs, the proportion of various costs, and the distribution of consumable costs in different levels of surgeries before and after the implementation of the centralized procurement policy for medical consumables. Results After the implementation of the centralized procurement policy for medical consumables, the out-of-pocket amount of surgical patients decreased significantly. The average daily hospitalization cost increased significantly, the average daily consumable cost, treatment cost and diagnosis cost increased significantly, and the average daily drug cost decreased significantly. The proportion of comprehensive medical service fees and the proportion of drug fees decreased significantly, while the proportion of treatment fees increased significantly. The proportion of consumable costs in patients undergoing grade one and two surgeries decreased significantly, and all the above differences were statistically significant (P<0.001). The probability of high proportion of consumable costs among patients undergoing grade three and four surgeries decreased. Conclusion The centralized procurement policy for medical consumables optimizes the cost structure of surgical patients. Hospitals can further improve the layout of specialized departments, enhance the refined management level of consumables, give full play to the guiding role of the policy, and reduce the overall cost burden of patients.
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  Application Value of Multi-Delay Arterial Spin-Labeling in Evaluating Oxygen Extraction Fraction in Aging

  LIU Xiaoyi, YIN Yayan, SHAN Yi, LU Jie

  China Medical Devices. 2025, 40(5): 135-140. https://doi.org/10.3969/j.issn.1674-1633.20241002

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  Objective To investigate the effects of single-delay arterial spin-labeling (ASL) and multi-delay ASL data acquisition methods on oxygen extraction fraction (OEF) quantification in different ages based on quantitative susceptibility mapping (QSM) and quantitative blood oxygen level-dependent (qBOLD) (QSM+qBOLD, QQ) model. Methods A total of 65 healthy participants were prospectively collected, and data of multi-delay pseudo-continuous ASL sequence, QSM sequence and T1 structural imaging were acquired. The differences in the OEF values of the whole brain, gray matter, white matter, and different brain regions were analyzed by using paired t tests and Wilcoxon rank-sum tests. The Mann-Whitney U test was used to compare the OEF bias between different age groups. Spearman correlation was used to explore the relationship between OEF bias and cerebral blood flow (CBF) bias with age. Results The quantification of OEF by the QQ-multi-delay ASL method was significantly higher than that by the QQ-single-delay ASL method in both the whole brain and various brain regions of the middle-aged and elderly group (P<0.05), while there was no significant difference between the two methods in the young group except for the occipital lobe. The whole brain quantification differences by the two methods of OEF (r= 0.310, P= 0.013) and CBF (r=0.480, P<0.001) both increased significantly with the growth of age. Conclusion The QQ-multi-delay ASL method may help improve the quantification bias of OEF caused by prolonged arterial arrival time in middle-aged and elderly populations, which has the potential to explore the physiological mechanisms of cerebral oxygen metabolism in patients with hemodynamic abnormalities in the future.
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  Application Study of Reduced Field of View Diffusion Weighted Imaging in the Diagnosis of Nasopharyngeal Carcinoma

  YI Siqi, WANG Min, HE Yakun, REN Jing, DENG Heping

  China Medical Devices. 2025, 40(5): 141-146. https://doi.org/10.3969/j.issn.1674-1633.20241086

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  Objective To compare the application value of reduced field of view diffusion weighted imaging (rFOV DWI) and full field of view diffusion weighted imaging (fFOV DWI) in nasopharyngeal carcinoma. Methods The data of 104 patients with nasopharyngeal carcinoma were retrospectively analyzed. All patients underwent rFOV DWI and fFOV DWI examinations before treatment. Two radiologists subjectively scored the overall image quality, lesion edge clarity, visual distortion, magnetic susceptibility artifacts and lesion saliency of the DWI images using the double-blind method. The signal to noise ratio (SNR) and contrast to noise ratio (CNR) of the DWI images in the two groups were calculated and compared. The differences between two groups of apparent diffusion coefficient (ADC) in different pathological grades and clinical classifications were analyzed. Taking the transverse T2WI images as the reference, the objective indicators reflecting the alignment accuracy [maximum diameter (Dmax), minimum diameter (Dmin), Area, distortion rate (DR)] of the lesions in the DWI images were measured and compared. Results Each subjective scores and data measurements showed good consistency (ICC>0.7). In the subjective evaluation, except that there was no significant difference in the score of lesion edge clarity (P>0.05), the scores of rFOV DWI in the overall image quality, visual distortion, magnetic susceptibility artifacts and lesion saliency were all significantly higher than those of fFOV DWI (P<0.05). The SNR and CNR of the rFOV DWI images were both significantly higher than those of the fFOV DWI images (P<0.05). In the pathological grades and clinical staging (stages Ⅱ, Ⅲ, and Ⅳ), the ADC values measured on rFOV DWI were all significantly lower than those on fFOV DWI (P<0.05), and there was no significant difference in stage Ⅰ (P>0.05). The alignment accuracy of the lesion matching between the rFOV DWI and T2WI images was significantly better than that of fFOV DWI, and the differences in Dmax, Dmin, Area, and DR were all statistically significant (P<0.05). Conclusion In the DWI examination of nasopharyngeal carcinoma, rFOV DWI can improve the quality of images and clearly display lesions, which can provide more reliable imaging data for clinical diagnosis.
REVIEW
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  Progress and Clinical Practices of Immobilization Cushions in Radiotherapy

  HE Xuwei, SUN Hangbiao, ZHANG Xinlei, HUANG Wenzheng, LIN Haitao, HU Qunchao

  China Medical Devices. 2025, 40(5): 147-151. https://doi.org/10.3969/j.issn.1674-1633.20241163

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  Intensity modulated radiation therapy technology, which is centered around precise positioning, precise treatment planning, and precise treatment, has been widely applied in clinical practice. It has improved the conformality of the tumor target volume and the dose gradient, enabling accurate irradiation of the target area while effectively protecting the organs at risk. “Precise positioning” places higher demands on the patient’s body position fixation. Reasonably selecting a body position fixation scheme can effectively enhance the stability and reproducibility. Common body position fixation devices include fixed body frames, thermoplastic membranes, vacuum cushions, foams, and shaping pads, etc., each with its own characteristics. Among them, the shaping pad has multiple advantages, and its application in the body position fixation for radiotherapy has gradually become more widespread in recent years. This article mainly reviewed the clinical applications and progress of shaping pads in the body position fixation for radiotherapy, aiming to provide a reference for the rational selection of body position fixation schemes and to promote precise positioning in radiotherapy.
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  Applications and Prospects of Artificial Intelligence in Pulmonary Hypertension

  PAN Siyu, YU Miao, CHEN Yujing, ZHAO Fanrong, ZHU Tiantian

  China Medical Devices. 2025, 40(5): 152-158. https://doi.org/10.3969/j.issn.1674-1633.20241300

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  Artificial intelligence (AI) is a cutting-edge interdisciplinary subject that integrates the essence of multiple disciplines such as computer science, mathematics, and statistics. It is dedicated to simulating, expanding, and enhancing human intelligence. In recent years, AI technology has been increasingly applied in the medical field, especially demonstrating great potential and application value in the diagnosis, formulation of treatment strategies, and prognosis assessment of pulmonary hypertension (PH). PH is a progressive cardiorespiratory disease characterized by pulmonary vascular remodeling. Its course is often accompanied by severe consequences such as decreased exercise tolerance, aggravated dyspnea, and right heart failure, which may ultimately lead to the death of patients. This review aimed to systematically explore the current application status of AI technology in the field of PH, including its specific practices in disease diagnosis, prognosis assessment, and monitoring of treatment effects, among other aspects. At the same time, it pointed out the existing limitations and challenges in the current applications. In addition, this paper also conducted a forwardlooking discussion on the potential opportunities and challenges that AI technology may face in the future precision medicine for PH, aiming to provide new ideas for researchers and clinical workers in related fields.
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  Application and Prospects of Brain Computer Interface Technology in Field of Mental Disorders

  XU Meng, HUANG Xin, WU Donglian, WANG Zhiyin, LIANG Jie, WANG Shaofu

  China Medical Devices. 2025, 40(5): 159-164. https://doi.org/10.3969/j.issn.1674-1633.20240339

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  With the increasing annual incidence of mental disorders, research integrating brain computer interface (BCI) technology into the field of mental health has gained growing attention. This paper presented an overview of the current status of BCI applications in mental disorders at home and abroad, focusing on four representative conditions: major depressive disorder, autism spectrum disorder, schizophrenia, and attention deficit hyperactivity disorder. By summarizing and analyzing a substantial number of typical experimental studies, the paper elaborated on the mechanisms of disease monitoring and treatment using BCI technology, discussed the risks and challenges in its clinical application, and explored future prospects for technological innovation in this domain, aiming to provide a reference for advancing BCI-based research and clinical practices in mental disorder management.
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  Application Value of Imaging Examination Combined with SCC-Ag in Early Detection of Cervical Cancer Recurrence

  ZHANG Qin, ZHOU Maorong, ZHAO Zilong, LIU Mingyue, BAO Lijie

  China Medical Devices. 2025, 40(5): 165-170. https://doi.org/10.3969/j.issn.1674-1633.20241115

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  Cervical cancer is the most common malignant tumor of the female genital tract, affecting the psychological and physical health of female patients. It has a high incidence and mortality rate among all malignant tumors in women globally. Current treatment approaches for cervical cancer primarily include radical surgery for early-stage patients and concurrent chemoradiotherapy for advanced-stage patients. However, even after standardized treatment, recurrence remains a major factor impacting the long-term survival of cervical cancer patients, and early and accurate detection of recurrence may improve their overall survival rate. This paper provided a comprehensive review of the application value of imaging examinations, including ultrasound, computed tomography, magnetic resonance imaging, and positron emission tomography/computed tomography, combined with squamous cell carcinoma antigen in the early diagnosis of cervical cancer recurrence. The review aimed to offer references for the early precise diagnosis of cervical cancer recurrence and promote the clinical implementation of the combined detection model using multimodal imaging and biomarkers, thereby contributing to more effective recurrence assessment and management strategies in clinical practice.
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  Research Status on the Extent of Lesion Damage Caused by Microwave Ablation of Malignant Tumors

  ZHENG Ling, YU Dedong

  China Medical Devices. 2025, 40(5): 171-177. https://doi.org/10.3969/j.issn.1674-1633.20240822

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  In recent years, the incidence of malignant tumors continues to rise, and has become a major public health problem that endangers human health. In view of the serious situation of cancer prevention and treatment, clinical treatment methods are also improving with each passing day. The treatment methods mainly include surgery, radiotherapy, chemotherapy, targeting, etc., but some patients can not perform conventional treatment due to physical and other reasons. In this context, thermal ablation emerged as a new minimally invasive interventional therapy for cancer. This technology directly acts heat energy on tumor tissue to make it coagulative and necrotic, so as to achieve the purpose of treatment. It has the39 advantages of less trauma, faster recovery and fewer complications, and has gradually been recognized by the clinic, and is used in the treatment of various malignant tumors. This paper briefly described the application of microwave ablation in malignant tumors, analyzed the relationship between ablation power, ablation time and ablation range, and discussed the safety boundary of microwave ablation range. Through literature review and data analysis, this paper provided theoretical basis for the establishment of standardized and standardized programs for microwave ablation of malignant tumors, thus promoting the scientific application and further development of this technology in clinical practice. Meanwhile, it also forecasted the future development of microwave ablation technology, aiming to provide reference for further research in the field of minimally invasive tumor therapy.
DEVICEMAINTENANCE
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  Analysis of Faults in Ultrasound Power Supply Topology and Optimization of BUCK Circuit

  SHAN Changzheng, LI Aolin, LI Yunlei, BIAN Zhaofeng

  China Medical Devices. 2025, 40(5): 178-182. https://doi.org/10.3969/j.issn.1674-1633.20240700

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  Objective To solve the fault points in the portable color ultrasound DC-AC and DC-DC circuits as well as make an optimization scheme for the BUCK circuit controlled by TPS40055, by analyzing the power topology principle of pulse width modulation (PWM) chip control. Methods The fault points were determined by circuit diagram analysis and oscilloscope measurement. After analyzing the DC bias characteristic of the ceramic capacitor and calculating the formula, the BUCK circuit was optimized. It was concluded that when the parallel output capacitance was about 28 μF, it could not only meet the requirement of output voltage regulation, but also reduce the output ripple voltage ΔVO to 0.07 V theoretically, which greatly improved the stability of the whole machine. Results The damaged KIA494 chip was replaced and the CCFL backlight driver board was repaired. The power module was repaired by replacing the TPS40055 chip and DC12 V filter capacitor. Conclusion For this kind of circuit, medical engineers should use professional knowledge and professional testing tools to analyze the circuit, which can solve the fault and make a reasonable optimization plan for the corresponding circuit through scientific calculation.