10 December 2025, Volume 40 Issue 12

    

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EXPERT CONSENSUS
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  Expert Consensus on Standardized Operation of High-Pressure Injection of Contrast Medium via Peripheral Vascular Access

  China Medical Devices. 2025, 40(12): 1-11. https://doi.org/10.3969/j.issn.1674-1633.20251061

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  Objective To standardize the operation of high-pressure injection of contrast medium, ensure the quality of radiological enhancement examinations, and reduce the incidence rate of adverse reactions such as extravasation. Methods By conducting a comprehensive search of domestic and foreign literature, and integrating research hotspots and clinical experience, the initial draft of the Expert consensus on standardized operation of high-pressure injection of contrast medium via peripheral cascular access was compiled. After two rounds of expert consultation and a demonstration meeting, each item was adjusted and revised in accordance with expert opinions, and the final consensus was formed. Results The consensus ultimately established 5 primary items, 17 secondary items, and 47 tertiary items across dimensions including nursing assessment, establishment of safe peripheral vascular access, management of peripheral vascular access during examination, management of peripheral vascular access after examination, and management of extravasation of peripheral vascular access. Conclusion The items of this consensus are clear and highly feasible. It supplements and improves existing norms to a certain extent, providing professional and scientific reference and guidance for the high-pressure injection operation of contrast medium via peripheral vascular access.
FEATURES
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  Development and Outlook of Flow Diverter Technology

  DONG Shuo, WU Ping, RONG Yao, WU Hang

  China Medical Devices. 2025, 40(12): 12-18. https://doi.org/10.3969/j.issn.1674-1633.20251599

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  Intracranial aneurysm refers to an abnormal bulging on the wall of intracranial arteries. Its rupture is the main cause of nontraumatic subarachnoid hemorrhage, with extremely high mortality and disability rates. Traditional treatment methods include craniotomy with clipping and endovascular interventional therapy. However, these conventional approaches often face significant challenges when dealing with large, giant, fusiform, or wide-necked aneurysms. The emergence of flow diverter (FD) represents a revolutionary shift in the treatment concept of intracranial aneurysms, moving from traditional endosaccular packing to the reconstruction of the parent artery. As a type of dense-mesh stent with high metal coverage and low porosity, FD is placed at the neck of the aneurysm to significantly alter the intraluminal hemodynamics of the aneurysm, promote blood flow stasis and intraneurysmal thrombosis. Meanwhile, acting as a scaffold, FD facilitates endothelial cell migration and proliferation, ultimately achieving complete occlusion of the aneurysm and physiological reconstruction of the parent artery. This article aimed to systematically review the development process of FD devices from the proposal of the concept to clinical practice, elaborate on their mechanism of action in detail, analyze its clinical effectiveness and safety, and provide an outlook on their future development directions.
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  Research on the Impact of Centralized Bulk Procurement on the Use of High-Value Consumables in Neurosurgical Interventional Procedures

  RONG Yao, CHENG Jiajia, LIU Yuan, YANG Bo, HUANG Yue, WU Hang

  China Medical Devices. 2025, 40(12): 19-24. https://doi.org/10.3969/j.issn.1674-1633.20251651

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  Objective To systematically evaluate the multidimensional impacts of the Beijing volume-based procurement (VBP) policy on the consumption of key high-value medical consumables, cost structure, clinical behaviors, and disciplinary development in neurosurgical interventional procedures, and to provide evidence-based basis for subsequent policy iteration. Methods All neurosurgical interventional cases using flow diverter (FD) in Xuanwu Hospital of Capital Medical University from January 2020 to March 2025 were enrolled. Taking the implementation of VBP on December 15, 2023 as the time node, the cases were divided into the pre-VBP group (1048 cases) and the post-VBP group (942 cases). Patient information, cost and consumable usage data were obtained through the hospital’s multiple data platforms to construct a three-level nested dataset of “case-surgery-consumable”, the various costs, consumable usage and the usage quantity of different types of FD before and after the implementation of VBP were compared, and explored the correlation between FD costs and other indicators. Results All research indicators did not follow a normal distribution. The number of patients undergoing FD implantation surgery increased year by year from 2020 to 2024, while the number of disease diagnosis categories showed no significant change. The average length of hospital stay of patients decreased from 6.34 d to 5.00 d after VBP (Z=6.484, P<0.05). All types of costs decreased significantly after the implementation of VBP (P<0.05), among which the consumable cost had the largest decrease (median decrease: 30860 yuan/case, Z=13.516, P<0.05), and the median total cost decreased by 33110 yuan/case (Z=13.116, P<0.05). The total consumption of consumables per case decreased by 8 units (Z=5.858, P<0.05), while the usage quantity of FD per case had no significant change (P>0.05), and the usage proportion of FD with surface treatment increased significantly (P<0.05). FD consumable cost was strongly positively correlated with consumable cost and total cost (Spearman correlation coefficients: 0.721 and 0.703, respectively, P<0.05), weakly positively correlated with the proportion of consumable cost in total cost, diagnosis and treatment cost, and surgical cost, and weakly correlated with other indicators. Conclusion Through the mechanism of “volume-based pricing+quality guarantee”, the VBP policy realized the intensive use of high-value medical consumables, optimization of cost structure and improvement of clinical efficiency in neurosurgical intervention, providing an empirical scheme for the implementation of “value-based healthcare” in the field of neurosurgery in China.
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  Study on the Influence of Different Materials of Flow Diverter on the Perioperative Safety of Intracranial Aneurysm Treatment

  CHENG Jiajia, LI Dong, RONG Yao, WU Ping, HUANG Yue, HU Peng, WU Hang

  China Medical Devices. 2025, 40(12): 25-30. https://doi.org/10.3969/j.issn.1674-1633.20251652

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  Objective To systematically analyze the perioperative safety and surgical efficiency of implanting flow diverters (FD) of different materials in patients with intracranial aneurysms, and to provide empirical evidence for the clinical selection of safer and more effective treatment methods. Methods This study was a single-center retrospective study. A total of 1316 patients who were treated with FD from January 1, 2022 to March 31, 2025 were selected as the research subjects. The enrolled patients were divided into the nickel-titanium alloy group (118 cases) and the cobalt-chromium alloy group (1198 cases) based on the implantation of FD. The following core indicators were compared and analyzed: operation time, intraoperative blood loss, postoperative hospital stay, the frequency of postoperative anti-inflammatory/anti-edema medication, and the usage quantities of FDS, support catheters, microcatheters, and microguidewires. Results The cobalt-chromium alloy group was significantly superior to the nickel-titanium alloy group in terms of postoperative hospital stay and operation time, and the differences were statistically significant (P<0.05). However, there was no statistically significant difference between the two groups in terms of intraoperative blood loss and the frequency of anti-inflammatory/anti-edema medication (P>0.05). In terms of the number of microcatheters used, the nitinol group was significantly lower than the cobalt-chromium alloy group, and the difference was statistically significant (P<0.05). Additionally, the number of microcatheters used in the cobalt-chromium alloy group increased year by year, while the proportion used in the nickel-titanium alloy group decreased significantly. Conclusion Cobalt-chromium alloy FD is superior to nickel-titanium alloy FD in terms of surgical efficiency and patient recovery speed, while there is no difference between the two in terms of surgical trauma and postoperative inflammation control. This study can provide a basis for the clinical selection of safer and more effective FD.
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  Exploration of Cost Influencing Factors of Flow Diverter Based on Different Surface Treatment Processes in the Treatment of Intracranial Aneurysms

  WU Ping, HUA Cheng, LI Dong, RONG Yao, GUO Shuang, DONG Shuo, WU Hang

  China Medical Devices. 2025, 40(12): 31-35. https://doi.org/10.3969/j.issn.1674-1633.20251649

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  Objective To investigate the changes in surgical patient costs and utilization of flow diverter (FD) (designed based on different surface technologies) in the treatment of intracranial aneurysms, and to analyze the economic impact of this consumable in clinical practice. Methods The FD consumable utilization catalog of Xuanwu Hospital, Capital Medical University was established. Stents were categorized into 2 groups by whether surface treatment technology was applied (yes/no), and into 3 groups by the type of surface treatment (no surface treatment, surface coating treatment, surface polishing treatment). Statistical analysis was performed on the hospital’s consumable utilization data (from January 2020 to March 2025) by calculating parameters including the average number (amount) of consumables per case, average number of FDs per case, average proportion of FD quantity per case, and average proportion of FD amount per case. Results From 2020 to 2025, the average number of consumables per case decreased year by year, with a statistically significant difference (H=260.870, P<0.001); the average amount of consumables per case also decreased, with a statistically significant difference (H=412.300, P<0.001). Under different surface treatment technologies, the differences in the average number and amount of consumables per case were statistically significant (P<0.05); there was no significant difference in consumable quantity, but the total consumable amount for stents using coating technology increased significantly (P<0.05). Conclusion When FDs with different surface treatment technologies are used for intracranial aneurysm treatment, there are significant differences in the total quantity/amount of consumables used by patients and the unit price of stents. Studying its impact on treatment costs can provide a data basis for standardized/refined consumable management and hospital cost control.
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  Impact of Surface Treatment Techniques of Flow Diverter on Perioperative Safety: A Real-World Study

  LI Dong, QIAO Lei, CHENG Jiajia, WU Ping, LIU Yuan, WU Hang, DONG Shuo

  China Medical Devices. 2025, 40(12): 36-41. https://doi.org/10.3969/j.issn.1674-1633.20251645

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  Objective To investigate the effects of various surface treatment techniques on the perioperative bleeding risk, surgical efficiency, postoperative recovery, and antiplatelet medication burden in patients with intracranial aneurysms undergoing flow diverter (FD) stenting. The goal is to provide evidence-based guidance for clinical decision-making. Methods A retrospective analysis was conducted on 1972 patients who underwent FD implantation in Xuanwu Hospital, Capital Medical University. The patients were divided into three groups according to the surface treatment type of the stents they received: polishing group, coating group and nonsurface treatment group. A total of 1217 cases without special comorbidities were selected for focused comparison, with the operative duration, intraoperative blood loss, postoperative length of hospital stay and frequency of postoperative antiplatelet medication administration as the key outcome measures. Results No statistically significant difference was found in intraoperative blood loss among the three groups (H=3.749, P=0.153), with the median blood loss of 10 mL in each group, suggesting that different surface treatment methods did not increase the immediate bleeding risk. There was a significant difference in operative duration among the three groups (H=24.312, P<0.05), and the operative duration in both the polishing group and the coating group was significantly shorter than that in the non-surface treatment group (P<0.05). The postoperative length of hospital stay differed significantly among the three groups (H=76.899, P<0.05), the median length of hospital stay was the shortest in the polishing group (1.85 d), followed by the coating group (1.95 d) and the non-surface treatment group (2.58 d), with statistically significant differences observed in all pairwise comparisons (P<0.05). There was a significant overall difference in the frequency of antiplatelet medication use among the three groups (H=10.461, P<0.05). Multiple comparisons showed that a significant difference was detected only between the polishing group and the non-surface treatment group (P<0.05), while no statistically significant differences were identified between the other groups (P>0.05). Conclusion In the scenario of FD implantation with low bleeding risk, both polishing and coating surface treatments do not increase the incidence of immediate bleeding events, and can significantly shorten the operative duration and postoperative length of hospital stay. In addition, polishing can reduce the burden of antiplatelet medication, thus demonstrating favorable safety and advantages in clinical efficiency.
SUPERVISION AND REGULATIONS
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  Registration Status and Development Trends of Medical Electrical Equipment/System Employing Robotic Technology

  ZHANG Yanli, TANG Qiaohong, WANG Quan, WANG Hao, YANG Chenxu, LI Shu, MENG Xiangfeng

  China Medical Devices. 2025, 40(12): 42-47. https://doi.org/10.3969/j.issn.1674-1633.20251392

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  Objective To analyze the registration data of medical robot products in China, clarify the current development status and trends of the industry, and provide data support and reference for policy improvement, industrial upgrading, and the healthy development of the intelligent cutting-edge medical industry in this field. Methods Taking the domestic and imported medical device registration information before March 31, 2025, from the Medical Device Data Query Platform of the National Medical Products Administration as the data source, six key fields including “navigation and positioning” and “endoscope” were screened to obtain the registration information of medical robot products. The included registration data of medical robot products were analyzed from six dimensions: registration quantity, product type, registration category, registrant situation, product composition, and intended use. Results As of the first quarter of 2025, the total number of registered medical robot products in China reached 135. The number of registrations has surged since 2021, with 44 registrations in 2024. In terms of product types, surgical robots dominated (88.15%), among which navigation and positioning products accounted for 71.11%, and rehabilitation robots accounted for 11.85%. In terms of registration categories, domestic products accounted for 93.33%, with most surgical robots being Class Ⅲ medical devices and all rehabilitation robots being Class Ⅱ medical devices. Registrants were mainly concentrated in the Yangtze River Delta, Beijing-Tianjin-Hebei, and Pearl River Delta regions. Only 20.74% of the product compositions clearly indicated the inclusion of software, and “robotic arm” was a frequently mentioned component. In terms of intended use, surgical robots were mainly applied in departments such as orthopedics and stomatology, while rehabilitation robots were primarily used for rehabilitation training of patients with lower limb motor dysfunction, and the intended use of various products reflected their core technical characteristics. Conclusion China’s medical robot industry is in a critical stage of technological innovation and market expansion. The number of product registrations will continue to grow, and the integration with new technologies will drive the diversification of product types and the expansion of application scenarios. However, the industry is also faced with problems such as non-standard product naming, increased difficulty in quality evaluation, uneven regional distribution of technologies, and lack of regulatory standards. In the future, it is necessary to improve the regulatory framework for medical robots, standardize naming rules, and fill the gaps in evaluation standards and methods to promote the healthy development of the industry.
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  Analysis of the Trend of Innovation of Deep Brain Stimulation Products in China and USA from the Perspective of Intellectual Patents

  ZHANG Xinyan, LI Mingyang, LIU Xun, XIAO Jiahao, LI Yaohua

  China Medical Devices. 2025, 40(12): 48-53. https://doi.org/10.3969/j.issn.1674-1633.20251299

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  Deep brain stimulation (DBS) is an invasive neuromodulation technique. After decades of advancement, DBS has been approved by regulatory authorities for the treatment of various neurological disorders, including Parkinson’s disease, essential tremor, epilepsy, and obsessive-compulsive disorder. In recent years, with the rapid development of brain science and brain-computer interface technology, novel DBS modulation techniques such as directional stimulation electrodes and closed-loop modulation have continued to emerge, providing technical support for achieving more precise and personalized neuromodulation. This study retrieved data from the patent database of the China National Intellectual Property Administration and integrated publicly available data on innovative DBS products from the US Food and Drug Administration and the National Medical Products Administration of China. It systematically analyzed the filing status of patents related to DBS medical devices, as well as the characteristics of the application and approval of innovative DBS products. Additionally, this paper discussed the similarities and differences between the innovative medical device approval systems in China and the United States, aiming to provide references for the innovation research and development guidance, technical review, and regulatory decision-making of DBS products.
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  Analysis and Discussion on Standards for High-Frequency Surgical Equipment

  ZHANG Yanli, WANG Hao, LI Ning, LI Shu, ZHANG Chao, MENG Xiangfeng, WANG Quan

  China Medical Devices. 2025, 40(12): 54-58. https://doi.org/10.3969/j.issn.1674-1633.20251394

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  In 2021, the National Medical Products Administration issued the national standard GB 9706.202-2021 “Medical electrical equipment - part 2-2: special requirements for basic safety and basic performance of high-frequency surgical equipment and highfrequency accessories”, which clearly defined the scope of application and covers high-frequency surgical equipment and accessories. Basic safety and performance requirements were highlighted in this update, risk analysis was strengthened, and key contents, such as high-current mode control, high-frequency leakage current, and leakage capacity limits of surgical accessories were added. To enhance the understanding of the standard and analyze its key contents, based on the practice of medical device inspection and testing and the understanding of the standard, the core content of the standard was dissected, and the hierarchical relationship between this standard, general standards, and parallel standards was clarified in this article. Safety requirements covered multiple dimensions of measures, including electric shock protection (e.g., neutral electrode monitoring, neuromuscular stimulation prevention and control, leakage current limits), mechanical and radiation protection, as well as over-temperature and liquid immersion protection. Performance requirements focused on the accuracy of the controller (e.g., output power deviation, monotonicity, voltage control) and the protection mechanisms for special scenarios such as high-current mode and excessive output. Through systematic analysis, standardized guidance was provided for the research and development, inspection, and clinical safe application of high-frequency surgical equipment, which helped strengthen product quality control and promoted the high-quality development of the industry.
RESEARCH WORK
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  Study on the Clinical Gain Effect of 3D Printing Combined with Mimics Software to Create Navigation Templates in TPF Internal Fixation

  YANG Zhangquan, GE Wenjie, WANG Xingzheng, ZHANG Yin, LIAO Jiaxin

  China Medical Devices. 2025, 40(12): 59-65. https://doi.org/10.3969/j.issn.1674-1633.20250123

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  Objective To explore the clinical benefit effect of 3D printing combined with Mimics software to create navigation templates for the assisted treatment of patients with tibial plateau fracture (TPF). Methods A total of 126 patients with TPF in Wuxi Hospital of Traditional Chinese Medicine from January 2021 to December 2023 were selected and divided into the study group and the control group by random number table method, with 63 cases in each group. The control group was treated with conventional open reduction plate internal fixation, and the study group was treated with 3D printing combined with Mimics software to make navigation template to assist open reduction plate internal fixation. The difference in perioperative indicators, excellent and good rate of fracture reduction, inflammation-stress factors [norepinephrine (NE), angiotensin Ⅱ (AT-Ⅱ), C-reactive protein (CRP), interleukin-8 (IL-8)], knee joint function [hospital for special surgery (HSS) knee joint score], motor function [fugl-meyer assessment (FMA) scale], difference in lower extremity force line indicators between the affected and healthy knee joints [posterior slope angle (PSA), femora tibial angle (FTA), tibial plateau angle (TPA), plateau collapse and gap width], and complications were compared between the two groups. Results The average preoperative planning time was shortened by more than 2 h by 3D printing combined with Mimics software to create navigation templates. The results of three-dimensional registration by CT examination after the operation and the preoperative 3D model showed that the average deviation of the positioning points of the measured navigation template from the predetermined anatomical landmarks was all less than 1.5 mm. Compared with the control group, the study group had fewer fluoroscopy sessions and less bleeding, and shorter surgery, fracture reduction and hospital stay. The excellent and good rate of fracture reduction in the study group (92.06%) was higher than that in the control group (74.60%). On the third day after the operation, the levels of serum CRP, IL-8, NE and AT-Ⅱ in the study group were lower than those in the control group. At the 6th month after the operation, the HSS and FMA scores of the study group were higher than those of the control group, and the differences in the above comparisons were statistically significant (P<0.05). At the 6th month after the operation, there was no statistically significant difference in the differences of FTA, TPA, PSA, plateau collapse and knee joint space width between the affected and healthy knee joints in the study group compared with the control group (P>0.05). The incidence of postoperative complications in the study group (3.17%) was lower than that in the control group (12.70%), and the difference was statistically significant (P<0.05). Conclusion 3D printing combined with Mimics software to create navigation templates for assisted open reduction and plate internal fixation in the treatment of TPF can reduce surgical trauma and postoperative complications, has a good reduction effect, and can significantly improve knee joint function and lower extremity motor ability.
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  Research on the Construction of an Intelligent Triage and Grading Model for Pediatric Emergency Departments

  SONG Han, GUO Linying, WANG Hui, FAN Jingrong, LI Dan, YAN Xue

  China Medical Devices. 2025, 40(12): 66-71. https://doi.org/10.3969/j.issn.1674-1633.20250754

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  Objective To address the core issues in pediatric emergency triage, such as strong disease dynamics, high symptom concealment, high concurrent resources leading to high rates of missed diagnosis of severe cases, imbalance in resource allocation, and low clinical trust. Methods The double actor module was used to improve the proximal strategy optimization algorithm, and the time series data processing ability was improved by dynamically adjusting the triage strategy. Combined with the non-dominated sorting genetic algorithm, an efficient and accurate intelligent triage grading model was constructed. Results The research results showed that when the number of environmental interactions was 50, the average return rates of the near end strategy optimization improvement algorithm with the introduction of the dual actor module on the DMControl dataset and Atari 2600 dataset were 82.6% and 88.5%, respectively. In addition, the lowest missed diagnosis rate and excessive triage rate of the intelligent triage and grading model for pediatric emergency proposed in the study were 2.8% and 1.5% respectively. After adding noise, the area under curve of the precision-recall rate of this triage model only decreased by 0.041. Conclusion Through the collaboration of dual algorithms, this model significantly enhances the efficiency and accuracy of pediatric emergency triage, effectively addressing the issues of missed diagnosis of severe cases and resource misallocation, and providing a practical solution for intelligent emergency systems.
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  Research on the Influence of Typical Electromagnetic Interference Sources in Hospitals on the Environmental Magnetic Field of MCG

  WANG Yun, YU Jing

  China Medical Devices. 2025, 40(12): 72-78. https://doi.org/10.3969/j.issn.1674-1633.20251315

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  Objective To evaluate the consistency of the benchmark measurement of environmental magnetic field, analyze the influence of typical electromagnetic interference sources in hospitals (color Doppler ultrasound diagnostic equipment, CT equipment, magnetic resonance imaging equipment and distribution stations) on the environmental magnetic field of magnetocardiography (MCG), and determine the minimum coincidence point of the environmental magnetic field. Methods The consistency was evaluated by Bland-Altman analysis and intraclass correlation coefficient (ICC), and the distance-field strength relationship was established based on polynomial fitting. The minimum environmental magnetic field coincidence points for different interference sources (magnetic field variation <5000 nT, spectral peak <0.1 nT, noise <15 pT) were calculated. The superimposed effect of multiple CT devices in operation was tested under a triple shielding system (μ metal, active compensation, and environmental control). Results The variation trend of the environmental magnetic field measured by the fluxgate gradient meter had a good consistency with the MCG monitoring data (ICC>0.75). The minimum environmental magnetic field coincidence points of the color Doppler ultrasound diagnostic instrument, CT equipment (single unit), magnetic resonance imaging equipment and distribution station were 0.53, 4.70, 9.15 and 16.57 m respectively. When multiple CTS operate simultaneously, superimposed interference would occur, but triple shielding could effectively suppress it. Conclusion Fluxgate gradient meters can serve as an effective supplement to MCG. This study provides key data support for the site selection, equipment layout, and shielding design of MCG testing rooms, promoting MCG to move from traditional shielded rooms to broader clinical scenarios.
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  Study on the in Vitro Evaluation Method for the Shedding Performance of Drug-Coated Balloon Insoluble Particles

  CHEN Tian, NIE Jiaqi, LU Wenbo, SHI Kai, LI Kanyuan, GUO Linlin, FANG Yuan

  China Medical Devices. 2025, 40(12): 79-86. https://doi.org/10.3969/j.issn.1674-1633.20250411

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  Objective To reduce the risk of acute vascular embolism caused by the massive release of drug-coated particles as insoluble particles in a short period of time, so as to study a method for evaluating the shedding performance of insoluble particles in drug-coated balloons (DCB) using a standard vascular model in vitro. Methods A vascular model system was established using a standard vascular model, guiding catheters and guiding wires to simulate the release process of DCB in vitro. The particle shedding performance of DCB in the three stages of transport, release and withdrawal, as well as in the simulated blood flow at different flow rates, was evaluated using a particle analyzer, an ultra-depth-of-field microscope and a particle size and shape analyzer. Results By comparing the test results of two different evaluation methods, among the six test samples, the number of particles shed by DCB in the simulated blood flow (based on 50 mL/min) in four samples was higher than the total number of particles shed in the staged test. Compared with the transportation and withdrawal processes, the particle shedding of DCB mainly occurred during the release process in the vascular model, and the number of shed particles accounted for the highest proportion in the entire process: among the 6 test samples, the particle shedding distribution of 5 samples was similar. For the particle range of ≥10 μm, this proportion reached 48% to 84%. For the particle range of ≥25 μm, this proportion reached 55% to 93%. For the particle range of ≥50 μm, this proportion reached 77% to 100%. The above proportions were significantly higher than the proportion of particle shedding during the transportation and withdrawal of the balloon. When evaluating the particle shedding performance by simulating blood flow, it was recommended to use a circulating water flow rate of 100 mL/min to meet the requirements of particle recovery rate. The morphological characteristics of the shed particles were analyzed. Most of the particles existed in a plate-like form, while a small number existed in a rod-like or fibrous form. In addition, the roundness and sphericity of the shed particles were relatively low, and their length-to-diameter ratio was high. Therefore, the assessment of the particle size of the shed particles by the light blocking method was rather one-sided. Conclusion This study establishes a vascular model system, which can evaluate the particle shedding performance of DCB by collecting particles from different release stages or using the method of simulating blood flow.
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  Research on Surgical Instrument Recognition Method Based on Improved YOLOv8n

  LI Xiaozhen, LV Dongbo, TAO Guanghong

  China Medical Devices. 2025, 40(12): 87-92. https://doi.org/10.3969/j.issn.1674-1633.20241560

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  Objective To propose a surgical instrument recognition method based on the improved YOLOv8n model, which aims to reduce the errors prone to in the traditional manual counting method and further protect the safety of patients. Methods The squeeze-and-excitation (SE) network attention mechanism was introduced into the backbone of the network to enhance the ability of the model to use feature information. Secondly, the model was integrated into the bi-directional feature pyramid network (BiFPN) structure to integrate multi-scale features more effectively. Finally, the weighted intersection over union (WIoU) loss function was adopted to optimize the loss function of the original network, thereby improving the model accuracy. Results The results of the ablation experiment showed that the YOLOv8n model, which incorporated the SE network attention mechanism, BiFPN structure, and WIoU loss function, had a mAP50 (mean average precision with 50% intersection over union threshold) of 98.7% in the surgical instrument recognition task. The average precision of MAP50-95 (mean average precision with 50%-95% intersection over union threshold) was 95.6%. Compared with the original YOLOv8n model, mAP50 and MAP50-95 have improved by 6.8% and 8.0% respectively. Compared with other mainstream algorithms, the improved YOLOv8n model has improved mAP50 and MAP50-95 by 11.58% and 18.30% respectively compared with the SSD algorithm. Compared with the Faster R-CNN algorithm, it has increased by 3.43% and 9.10% respectively; Compared with the YOLOv4 algorithm, it has been improved by 5.97% and 7.00% respectively. Compared with the IYOLO algorithm, it has been improved by 2.22% and 8.00% respectively. Conclusion The improved model is superior to common algorithms such as YOLOv4 in terms of accuracy. It can effectively reduce the phenomenon of missed detection of surgical instruments and significantly improve the reliability and accuracy of surgical instrument recognition.
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  Research on Electronic Medical Record Text Data Based on Information Extraction Algorithm and Multi-Task Learning

  CHEN Shuo, ZHOU Quan

  China Medical Devices. 2025, 40(12): 93-99. https://doi.org/10.3969/j.issn.1674-1633.20250282

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  Objective To solve the problem of low efficiency in extracting key clinical information from electronic medical record text data, support precision medical decision-making and disease research, so as to develope an efficient joint information extraction algorithm to achieve the automatic extraction of entities and relationships in medical record texts. Methods Based on the differences in unstructured features of medical record texts, a joint extraction model integrating multi-task learning was proposed. Firstly, bidirectional long short-term memory (BiLSTM)-conditional random field (CRF) baseline model (BiLSTM-CRF) was constructed. Entity recognition was accomplished by combining bidirectional encoders with CRF. Secondly, a multi-head attention mechanism was introduced to capture the remote dependencies between entities. Finally, the multi-task learning framework was adopted to handle the problem of entity relationship overlap, obtaining the bidirectional encoder representations from transformers (BERT)- BiLSTM-CRF of the joint model. Results Training and validation were conducted on the Chinese electronic medical record dataset to evaluate the extraction performance in the field of cerebrovascular diseases. The results showed that the entity recognition accuracy of the text information of the BERT-BiLSTM-CRF model on the dataset exceeded 80.00%, and the extraction error results of entity relationships did not exceed 0.2, which was superior to other algorithm models. The recognition accuracy of the BERT-BiLSTM-CRF algorithm in instance dataset of cerebrovascular diseases reached 91.18%, and it performed relationship recognition on medical text data quite well. Conclusion The BERT-BiLSTM-CRF model can effectively break through the technical bottleneck of overlapping entity relationships, provide a new method for the in-depth mining of electronic medical records, and offer research ideas for clinical medical decision-making and disease diagnosis.
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  Evaluation of the Advantages of E-VMAT Technology in Postoperative Radiotherapy for Breast Cancer in Optical Surface-Guided Simulated Respiratory Movement Scenarios

  ZHANG Peng, BAO Jie, WU Ailin, LIU Haowu, ZHOU Jieping, WU Aidong

  China Medical Devices. 2025, 40(12): 100-105. https://doi.org/10.3969/j.issn.1674-1633.20250586

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  Objective To explore the dosimetric effects of respiratory movement on volumetric modulated arc therapy (VMAT) and the external VAMT (E-VMAT) plan in the field of radiotherapy after breast cancer surgery. Methods Thirty postoperative patients with left breast cancer were selected as the research subjects. VMAT and E-VMAT plans were designed respectively. The displacement of 2~8 mm respiratory amplitude was simulated by moving the isocenter point, and the dose changes of the clinical target volume for chest wall (CTVcw)/planning target volume for chest wall (PTVcw) of the breast chest wall and organs at risk were analyzed. Results When the breathing amplitude increased from 0 mm to 8 mm, the target dose indicators of both the VMAT group and the E-VMAT group showed a downward trend. The V43.5 of CTVcw in the VMAT group decreased from 96.49%±1.87% to 73.51%±7.57%. The E-VMAT group decreased from 95.75%±2.00% to 81.31%±6.66%. The V43.5 of PTVcw in the VMAT group decreased from 96.02%±1.14% to 79.23%±4.61%, and that in the E-VMAT group decreased from 96.01%±1.08% to 84.23%±4.08%. It was worth noting that when the breathing amplitude increased to 4 mm, the dose coverage of CTVcw and PTVcw in the E-VMAT group was significantly higher than that in the VMAT group, the difference was statistically significant (P<0.05). Linear regression analysis further confirmed that the rate of dose reduction in the target area in the E-VMAT group was significantly slower than that in the VMAT group (CTVcw slope: -1.8101 vs. -2.8509; PTVcw slope: -1.5169 vs. -2.1267). In addition, in terms of protection of organs at risk, the protective effect of E-VMAT on the lungs was superior to that of VMAT, while there was no significant difference in the protective effect of E-VMAT on the heart compared with VMAT (P<0.05). Conclusion The E-VMAT technique can effectively alleviate the dose deficiency in the target area caused by respiratory movement through the boundary externalization method. It is recommended to give priority to the use of E-VMAT for patients with a large respiratory amplitude.
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  Design and Implementation of an AI Quality Control System for Medical Imaging Reports Based on Large Language Models

  DU Weinan, LI Xiaocui, MA Jian, MA Jun, FENG Zhiwen, ZHOU Jun

  China Medical Devices. 2025, 40(12): 106-112. https://doi.org/10.3969/j.issn.1674-1633.20251232

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  Objective To address core issues in traditional manual quality control of medical imaging reports, such as inefficiency, missed/misdiagnoses, logical errors, and delays in critical value alerts, to develop an intelligent quality control system based on the Qwen2.5:72B Large Language Model, in order to enhance medical quality management and ensure patient safety. Methods The system deeply integrated with the picture archiving and communication system via Application Programming Interface, and established a three-dimensional intelligent analysis framework for quality control covering report completeness, accuracy, and timeliness. It employed a dual-end architecture design, combined with a floating interactive interface and Tencent WeCom (Enterprise WeChat) notification mechanisms and formed a closed-loop quality control workflow. Imaging data that underwent manual quality control by the Quality Control Team of the Department of Medical Imaging, Yuxi People’s Hospital from June to December 2024 were retrospectively selected, with a total of 120 samples. The study used the results of manual quality control by the hospital’s quality control team as a reference standard to evaluate and compare the performance of the AI model. Results The time for AI quality control was (4.56±1.31) s, and the time for manual analysis and diagnosis was (5.00±1.02) min. The time for AI quality control image reporting was significantly shorter than that of manual quality control (t=52.018, P<0.05), achieving 100% full coverage and zero omission rate of critical values. Conclusion This study demonstrates that the AI quality control system based on a large language model holds significant application value in medical quality management. It overcomes the limitations of traditional rule-based engines and provides a key solution for the intelligent advancement of healthcare quality and safety.
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  Research on the Automated Analysis Model of Comprehensive Performance of Medical Equipment in the Big Data Environment

  QIN Yi, GU Yuhua, GE Sili, WANG Lei, GU Xinmei, ZHANG Yaju

  China Medical Devices. 2025, 40(12): 113-121. https://doi.org/10.3969/j.issn.1674-1633.20241620

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  Objective To develop an automatic analysis model for the comprehensive performance of medical equipment based on a data platform, explore the realization methods and application value of all-round evaluation of equipment performance, and improve the efficiency of equipment management. Methods Power BI series big data analysis and management tools were used, and highconfiguration virtual servers were used to collect data from multi-service systems through interfaces. Social benefit data calculated by fuzzy analytic hierarchy process was integrated to establish an efficient data platform in line with data quality management standards. Based on the data platform, 205 measurement values and 68 visual reports in 8 sections were designed to complete data analysis and equipment performance evaluation. In this study, a structured questionnaire was used to systematically compare the comprehensive performance of the two types of systems from 10 key technical dimensions such as functionality, user interface, and user experience. Results With the aid of RPA software, the model in this study has achieved the process automation of equipment performance evaluation from data collection to visual reports, realizing multi-angle evaluation and analysis of equipment performance as well as real-time early warning monitoring. After the system was implemented, the performance indicators gradually increased from 4 to nearly 50, and the accuracy rate of the source data after cleaning approached 100%. The results showed that the big data model significantly outperformed the traditional software in eight evaluation dimensions (P<0.001). Among them, the improvements in accessibility, functionality and scalability are the most significant. There was no statistically significant difference between Group 2 in terms of compatibility (P=0.184) and maintainability (P=0.734), indicating that traditional software still had certain advantages in system integration and operation and maintenance maturity, reflecting that users had a higher comprehensive recognition of big data models. Conclusion This model can effectively transform the analysis of equipment performance from theoretical research to practical application, providing new tools and methods for hospital equipment management and economic operation, and enhancing the management efficiency and risk perception ability of medical equipment.
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  Construction of the Sentence Quality Evaluation Index System for Continuous Renal Replacement Therapy Devices Based on the Three-Dimensional Quality Evaluation Model

  WANG Mingxia, YANG Ling, HU Lanping, LUO Qing, JIAO Hong

  China Medical Devices. 2025, 40(12): 122-128. https://doi.org/10.3969/j.issn.1674-1633.20241658

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  Objective To construct a scientific and standardized maintenance quality evaluation index system for continuous renal replacement therapy (CRRT) devices, and to provide a reliable basis for the systematic assessment of the whole-cycle maintenance quality of CRRT devices. Methods Based on Donabedian’s “structure-process-outcome” model as the theoretical framework, evidence-based methods were used to systematically search Chinese and English databases (search period: October 2017 to October 2024). Evidence was screened by combining industry standards and clinical practice to initially establish a draft index system. Two rounds of expert consultation were conducted using the Delphi method to evaluate the enthusiasm, authority, and consistency of expert opinions. Finally, the entries at all levels of the index system were determined, and the analytic hierarchy process was adopted to clarify the index weights. Results A total of 24 experts were selected for consultation. The effective recovery rates of the two rounds of Delphi expert consultation were 85.71% and 100%, respectively, the expert authority coefficients (Cr) were 0.871 and 0.900. The Kendall’s concordance coefficients of indicators at all levels were 0.160 and 0.166, indicating good expert enthusiasm, authority, and opinion consistency. Through index screening (7 items deleted, 10 items modified, and 6 items added), a CRRT device maintenance quality evaluation index system consisting of 3 first-level indicators, 12 second-level indicators, and 52 third-level indicators was finally formed. The analytic hierarchy process was used to determine the weight of each indicator, and the consistency test results all met CR<0.1, indicating a reasonable weight distribution. Conclusion The constructed CRRT device maintenance quality evaluation index system has good scientificity, reliability, and practicality, and can provide a scientific basis for the standardized assessment and continuous improvement of the whole-cycle maintenance quality of CRRT devices. Subsequent multi-center large-sample clinical validation is required to further optimize the applicability and effectiveness of the index system.
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  Research on the Performance Evaluation Indicators System for High-end Medical Equipment in Public Hospitals Based on AHP Analysis

  LU Yun, YANG Yinghua, CHU Chengchen, YU Jinjuan, LUO Li, SONG Yuanjun, ZHENG Yunxin

  China Medical Devices. 2025, 40(12): 129-136. https://doi.org/10.3969/j.issn.1674-1633.20242034

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  Objective To construct a performance evaluation index system for high-end medical equipment in public hospitals, aiming to establish evaluation standards for the use of medical equipment and provide support for the decision-making of high-end medical equipment allocation. Methods Taking Shanghai Sixth People’s Hospital as the research object, the literature research method was adopted to search relevant literatures in the Wanfang Database in the past 10 years and screen high-frequency performance evaluation indexes. The expert interview method was used to supplement and optimize the indexes to form a preliminary index system. Two rounds of expert consultation were carried out by the Delphi method to screen and determine the core indexes. Finally, the analytic hierarchy process was used to determine the weight of each index and construct a comprehensive performance evaluation index system. Results The response rates of the two rounds of expert consultation were 90.0% and 87.5%, respectively. The expert authority coefficients were 0.91 and 0.92, and the Kendall’s concordance coefficients were 0.658 and 0.403, with statistically significant differences (P<0.05). A performance evaluation index system for high-end medical equipment was constructed, distinguishing between diagnostic and therapeutic equipment. Specifically, the system for diagnostic equipment included 4 first-level indicators (clinical effect, discipline construction, scientific research achievement, and economic benefit), 12 second-level indicators, and 28 third-level indicators; the system for therapeutic equipment consisted of 4 first-level indicators, 12 second-level indicators, and 29 third-level indicators (with the new third-level indicator “number of grade Ⅲ/Ⅳ surgeries increased by equipment utilization” added). Among the first-level indicators, “clinical effect” had the highest weight (0.58 for diagnostic equipment and 0.54 for therapeutic equipment), and “discipline construction” was incorporated as a new first-level indicator with weights of 0.20 for diagnostic equipment and 0.23 for therapeutic equipment, respectively. The consistency ratio (CR) of all judgment matrices was less than 0.1, indicating reasonable weight allocation. Conclusion This study classified high-end medical equipment into two categories (diagnostic and therapeutic) and established two corresponding performance evaluation index systems, which have strong applicability. The selection of indexes and weight scoring are scientific and reasonable, and they can provide scientific reference for the improvement of the comprehensive quality of medical treatment, teaching and research as well as the enhancement of economic benefits in public hospitals.
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  Research on the Implementation Effect of Coronary Stent Concentrated Volume Procurement Policy Based on Interruption Time Series Analysis

  WU Siyu, GU Wei, LI Yanian

  China Medical Devices. 2025, 40(12): 137-144. https://doi.org/10.3969/j.issn.1674-1633.20241980

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  Objective To evaluate the implementation effect of the centralized volume-based procurement policy for high-value medical consumables at Shanghai Chest Hospital using coronary stents as an example, compare and analyze changes in coronary stent utilization and patients’ hospitalization expenses before and after the policy implementation, identify problems in policy execution, and propose targeted countermeasures to provide references for optimizing the centralized volume-based procurement policy for high-value medical consumables. Methods Based on the Horn-Mitchell model, detailed hospitalization expense data of 11707 inpatients who underwent percutaneous coronary intervention (PCI) between 2019 and 2024 were collected. Interrupted time series (ITS) analysis was used to examine changes in coronary stent utilization before and after the implementation of the centralized volume-based procurement policy. Results After the policy was implemented in 2021, the annual number of inpatients decreased by 12.40% on average, and the annual utilization of coronary stents dropped by 20.33% on average. The average annual reduction in per capita surgical consumable expenses was 8.66%, and the proportion of surgical consumable expenses in total hospitalization expenses decreased by 16.66% annually. The total hospitalization expenses increased by 9.16% annually with a small fluctuation range. ITS analysis showed that the monthly average utilization of coronary stents showed an upward trend after the policy implementation (β1+β3=0.757, P>0.05), while the number of surgeries showed a slight downward trend (β1+β3=2.679, P>0.05). Conclusion The centralized volume-based procurement policy for coronary stents has achieved remarkable results in reducing consumable expenses, optimizing the structure of medical expenses, alleviating patients’ economic burden, and promoting the efficient allocation of medical resources. To ensure the steady advancement of the national centralized procurement policy, medical institutions should continue to demonstrate a proactive attitude of cooperation. Meanwhile, relevant departments should strictly control product quality, closely monitor supply stability and adaptability to clinical needs, and continuously improve the scientificity, rationality, and sustainability of centralized procurement for high-value medical consumables, so as to facilitate the high-quality development of the medical security system.
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  Establishment of Early Warning Mechanism for Medical Consumables Under the Background of Normalized Collective Procurement of Orthopedic Medical Consumables

  LU Ming, YU Yang, WU Guoan, SONG Kai, HAN Hongna

  China Medical Devices. 2025, 40(12): 145-150. https://doi.org/10.3969/j.issn.1674-1633.20241613

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  Objective To establish an early warning mechanism for the use of medical consumables, helping medical institutions better adapt to the centralized procurement policy, providing data support for managers to facilitate the timely implementation of management measures and guide the rational use of medical consumables. Methods This study systematically analyzed the difficulties and risk points in medical consumables management after the normalization of centralized procurement of orthopedic medical consumables. Based on information technology, an early warning mechanism for the use of medical consumables was established, which only focused on monitoring and analyzing indicators such as the usage quantity, costs, and benefits of medical consumables. Multi-dimensional comprehensive monitoring was adopted to fully reflect the usage of various consumables, and big data analysis was used to issue early warnings for abnormal data and irrational use. Results Through the establishment of the early warning mechanism, the hospital improved its management system for the use of medical consumables and achieved effective control over orthopedic consumables. In 2024 compared with 2023, the proportion of 18 categories of key monitored consumables decreased by 10.46% year-on-year, and the completion rate of the joint centralized procurement task reached 100%. In addition, the total usage of orthopedic consumables in the hospital decreased by 31.76% cumulatively from 2021 to 2024, effectively eliminating long-unused “zombie consumables” and significantly improving the efficiency and overall level of consumables management. Conclusion The establishment of the early warning mechanism for orthopedic medical consumables provided a scientific management approach for usage monitoring after the centralized procurement of orthopedic consumables, and helped large public hospitals achieve preventive monitoring and source control. This mechanism could be promoted and applied to strengthen the hospital’s consumables monitoring system, assisting managers in making scientific decisions by promptly identifying and continuously improving problems.
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  Reproducibility of Radiomic Features in T2-Weighted Prostate Images with Different Levels of Deep Learning-Based Reconstruction

  CHEN Jingwen, FANG Xiangming, WAN Hongyan, CHEN Lihua, DUAN Shaofeng, TANG Ran, ZHU Zongming

  China Medical Devices. 2025, 40(12): 151-158. https://doi.org/10.3969/j.issn.1674-1633.20251579

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  Objective To evaluate the reproducibility of radiomics features extracted from prostate magnetic resonance imaging (MRI) images without deep learning-based reconstruction (DLR) and with different levels of DLR. Methods T2-weighted images of 57 patients suspected of prostate cancer were included, reconstructed using conventional reconstruction and three levels of DLR (low, medium, and high). Radiomics features were extracted from original images, Laplacian of Gaussian (LoG)-filtered images, and wavelet-transformed images. The intra-class coefficient (ICC) was used to quantify the reproducibility of radiomics features, and the effect of feature correction on mitigating reconstruction-related impacts was assessed. Results With the increase of DLR level, the overall reproducibility of features significantly decreased (P<0.05). Among texture features, gray-level size zone matrix indices were most sensitive to reconstruction levels, with 5 features showing ICC<0.75; while first-order features remained stable, with a mean ICC of 0.99. In filtered image correlation analysis, LoG filtering exhibited the optimal stability, with all LoG-filtered radiomics features having ICC>0.96; in contrast, features extracted from wavelet-transformed high-frequency images showed a significant downward trend in reproducibility as the proportion of high-frequency components increased. Additionally, feature correction effectively improved the reproducibility of radiomics features. Conclusion DLR affects the reproducibility of prostate MRI radiomics features. When performing radiomics feature analysis based on DLR images, first-order features or LoG-filtered features should be preferred, and feature correction should be applied to reduce deviations.
REVIEW
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  Advances in the Application of Artificial Intelligence-Based Raman Spectroscopy in Cancer Diagnosis

  ZHAO Yanfu, CUI Zhiming, LIU Jingxin

  China Medical Devices. 2025, 40(12): 159-164. https://doi.org/10.3969/j.issn.1674-1633.20242008

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  Cancer poses a severe threat to human health, and its early and rapid diagnosis can significantly improve patient prognosis. Raman spectroscopy enables the rapid and accurate detection of biochemical changes in cancer tissues at the molecular level, offering unique advantages in cancer diagnosis. However, Raman spectral data are large-scale and complex, making direct analysis by researchers infeasible. Artificial intelligence algorithms, with their rapid and precise data processing and analysis capabilities, provide an effective solution to this challenge. Studies have shown that combining Raman spectroscopy with artificial intelligence has significantly improved diagnostic accuracy and efficiency, while facilitating the discovery of novel tumor biomarkers. This article reviewed the current application status of artificial intelligence-assisted Raman spectroscopy technology in the field of cancer diagnosis, systematically expounded its technical principles and core advantages, deeply analyzed the key challenges currently faced, and looked forward to the future development trends, aiming to provide references for promoting the clinical transformation and application development of intelligent Raman spectroscopy technology in the rapid, accurate, early and non-invasive diagnosis of cancer.
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  Research Progress and Prospects of Novel Foreign Lymphedema Pressure Sleeves

  CHENG Haifeng, GONG Jianmei

  China Medical Devices. 2025, 40(12): 165-171. https://doi.org/10.3969/j.issn.1674-1633.20250120

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  Breast cancer-related lymphedema is a high-incidence complication following breast cancer surgery that severely impacts patients’ daily lives. Complete decongestive therapy (CDT) is currently the “gold standard” for lymphedema treatment, and pressure therapy is one of the cornerstones of CDT. Among pressure therapy devices, pressure sleeves, as wearable medical devices, offer advantages of portability, non-invasiveness, and continuous pressure control, making them an important tool for home-based management of lymphedema. In recent years, with the emergence of various novel foreign pressure sleeves for lymphedema, new developments have been witnessed in lymphedema treatment. This paper reviewed the research status of foreign novel lymphedema pressure sleeves in terms of design, materials, functions, therapeutic mechanisms, and clinical applications, analyzed and concluded their characteristics, aiming to provide references for the research and development of lymphedema pressure therapy devices in China, and promote the synergistic improvement of lymphedema treatment efficacy and patient adherence.
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  Application Status of Central Sterile Supply Department Information Tracing System from the Perspective of Smart Hospital

  LIANG Lele, ZHANG Jieqiong, CAI Minmin, ZHANG Ting, CAO Ling, CHEN Ke, ZHANG Chun

  China Medical Devices. 2025, 40(12): 172-178. https://doi.org/10.3969/j.issn.1674-1633.20250559

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  With the continuous promotion and deepening of hospital informatization management construction in China, the application of information technology to achieve intelligent management of the central sterile supply department (CSSD) has become an inevitable trend in the development of hospital CSSDs. The CSSD information-based quality traceability system is an intelligent system that can record and track the entire process of reusable instruments, devices, and items from CSSD processing to clinical department use. Through the application of this traceability system, dynamic monitoring and accurate tracking of all links in the disinfection and sterilization process can be realized, with responsibilities assigned to specific individuals. This not only enhances the sense of responsibility among staff but also ensures the safety of sterile supply, making it a key component of quality control management in hospital CSSDs. Based on a literature review, this article elaborated on the current development status of informationbased quality traceability systems in CSSDs, and specifically analyzed their advantages and shortcomings during application, aiming to provide new insights for the development of more professional and intelligent CSSD quality traceability management systems, further improve the quality of hospital instrument management, and promote the construction of intelligent CSSDs in hospitals.
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  Applications and Prospects of Digital Medical Devices in Remote Monitoring and Smart Healthcare

  DING Wei, LI Yiming

  China Medical Devices. 2025, 40(12): 179-186. https://doi.org/10.3969/j.issn.1674-1633.20250346

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  With the rapid development of information technology, digital medical devices are profoundly transforming traditional medical models by virtue of their advantages in real-time monitoring, aided diagnosis, and data-driven decision-making. However, existing literature has mostly focused on single devices or specific application scenarios, lacking systematic integration and indepth analysis of their technical implementation paths and clinical application processes. This review summarized the core concepts and technical frameworks of digital medical devices, systematically sorted out key implementation approaches such as sensors, algorithms, and wireless communication, and concluded the typical application processes and practical cases of wearable devices and implantable devices in remote monitoring and smart healthcare. From the perspectives of standardized interconnection, data privacy and security, operational usability, and doctor-patient acceptance, this paper conducted an in-depth analysis of the main challenges encountered in the current promotion process and looked forward to the future development trends of digital medical devices, aiming to reveal the coupling mechanism between technologies and application scenarios, thereby providing theoretical and practical references for device R&D, standard formulation, and clinical implementation.
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  Advances in the Application of SPECT/CT in the Diagnosis of Myocardial Ischemia in Coronary Artery Disease

  REN Qingyu, MENG Qingle, ZHANG Yanhua, WU Xing, HE Yuhong, CHEN Tiantian

  China Medical Devices. 2025, 40(12): 187-192. https://doi.org/10.3969/j.issn.1674-1633.20250543

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  Single-photon emission computed tomography/computed tomography (SPECT/CT) is a crucial modality for detecting myocardial perfusion in patients at rest and under stress. It can accurately assess myocardial ischemia in patients with coronary artery disease and exhibits excellent sensitivity and specificity, thus holding significant value in the diagnosis, risk stratification, and prognosis assessment of coronary artery disease. In recent years, SPECT/CT technology has achieved rapid advancement, and its application in the diagnosis of coronary artery disease-related myocardial ischemia has become increasingly widespread with universal recognition. However, insufficient understanding among some medical professionals has hindered its further development. This review summarized the main types and characteristics of SPECT/CT radiotracers, the progress and optimization of imaging methods, as well as their applications in the diagnosis of coronary artery disease-related myocardial ischemia. Additionally, it provided an outlook on future development directions, aiming to enhance medical professionals’ understanding of this field and promote the broader application of SPECT/CT in the management of coronary artery disease-related myocardial ischemia.