15 November 2024, Volume 39 Issue 11

    

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RESEARCH WORK
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  Study on Tracheal Wall Thermal Injury of Lung Tumor Near Bronchus by Microwave Ablation

  WU Ning, LIU Huihui, SONG Xiaohua, NAN Qun

  China Medical Devices. 2024, 39(11): 1-6. https://doi.org/10.3969/j.issn.1674-1633.2024.11.001

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  Objective To simulate the 60 W, 300 s microwave ablation of lung tumor near the bronchus, to define the possible area of bronchial wall injury so as to provide data support for clinical safety treatment. Methods Based on the air flow conditions (respiratory rate of 1.0 m/s) and physiological parameters (tumor diameter of 1 cm), the lung model with three-stage bronchial branches and the different position models of the tumor were established, and the finite element analysis of electromagnetic field-temperature field-flow field coupling was carried out to study the volume of the tracheal wall injured under the premise of complete ablation of the tumor. Results Microwave ablation was safe and effective when the distance of the primary and secondary bronchi exceeded 5 and 4 mm respectively, and the tracheal wall was intact. When the distance was above 2.1 mm near the tertiary bronchus, it was safe to treat and there was no risk of injury. Conclusion When microwave ablation of lung tumor is adjacent to the bronchus, the degree of wall injury and the safe range of ablation are related to the central location of the tumor.
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  Comparative Study on SPECT System Performance Parameters Measured by Simple and Standard Modules

  HUI Jinzi, XU Zhezhen, QU Yang, LI Zhiwei, WU Peiyuan, TANG Yize, LI Yiyang, XU Jianlin

  China Medical Devices. 2024, 39(11): 7-11. https://doi.org/10.3969/j.issn.1674-1633.2024.11.002

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  Objective To test the system spatial resolution and system plane sensitivity of single-photon emission computed tomography (SPECT) equipment by self-made simple module and standard module, so as to analyze the difference of detection results between the two modules to evaluate the feasibility of simple module applied to SPECT system performance evaluation. Methods GE Discovery NM/CT 670 Pro imaging system was used, and according to the national standard WS 523-2019 and the National Electrical Appliance Manufacturers Association (NEMA) standard NU-1-2012, 99mTc planar source and dual-wire source were prepared by standard module and self-made simple module, respectively. The system plane sensitivity and system spatial resolution were measured by using the two modules under the standard detection conditions, and the measurement results were recorded. The distance from the source to the probe was changed, and other acquisition conditions remained unchanged, the standard and simple models were respectively used for detection under different source distances, and the difference and consistency of the measured data between the two models were analyzed. Results Under standard detection conditions, there was no significant difference in system spatial resolution between simple and standard dual-wire source modules (probe 1: Z=-1.184, P=0.854>0.05, probe 2: Z<0.001, P=1.000>0.05). There was no significant difference in the system plane sensitivity measured by simple and standard planar source modules (probe 1: Z=-1.826, P=0.068>0.05, probe 2: Z=-1.841, P=0.066>0.05). There was no significant difference in system spatial resolution (Z=-1.460, P=0.144>0.05) and system plane sensitivity (Z=-1.830, P=0.068>0.05) between the two groups measured by two different modules when the acquisition conditions were changed. Bland-Altman analysis showed that the system spatial resolution (difference 95%CI: -1.036~2.186) and the system plane sensitivity (difference 95%CI: 0.842~12.158) of the two models were both in good agreement. Conclusion The self-determination of SPECT system spatial resolution and system plane sensitivity can be realized under the basic condition of nuclear medicine, which provides an effective alternative for the rapid evaluation of equipment system performance.
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  Research on Safety and Effectiveness of Intelligent Anti-Epidemic Disinfection Robot

  SONG Yangyang, ZHANG Zaiai, FANG Liangyan, ZHAO Xu, SONG Ningning, CHEN Yiyi, WANG Rui, ZHANG Ke

  China Medical Devices. 2024, 39(11): 12-16. https://doi.org/10.3969/j.issn.1674-1633.2024.11.003

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  Objective To explore the research methods for the safety and effectiveness of disinfection robots, so as to provide a basis for the establishment of the evaluation method of disinfection robots. Methods By adjusting the position of obstacles and fixing the push-pull meter, the range of obstacles that could be recognized by the disinfection robot, the location of blind zones, and the physical collision force were tested. And the mobile safety of disinfection robots was analyzed. The electrical safety analyzers and withstand voltage testers were used to analyze the electrical safety of disinfection robots. A particle size analyzer was used to test the ultrasonic atomization volume and particle size distribution of the disinfection robot, and the spraying disinfection effect on the surface of object was evaluated by referring to the Technical Standard for Disinfection. Results The three obstacle avoidance methods of the disinfection robot differed significantly in their ability to recognize obstacles at different heights, and there were multiple blind zones. The physical touch sensor could effectively protect against collisions within its blind zone. The accessible voltage, current, and dielectric strength of the disinfection robot complied with the requirements of GB 4793.1-2007. The average atomization particle size of the disinfection robot was less than 5 μm, and the disinfection effect was greatly influenced by the relative position. The disinfection effect was better for surfaces at the same height as the spraying outlet of the disinfection robot, but less ideal for surfaces at lower positions. Conclusion The safety and effectiveness research methods proposed in this article are feasible and can provide a certain reference for the future establishment of evaluation methods for disinfection robot.
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  Establishment of Artificial Intelligence-Assisted System for Automatic Evaluation of Gastroesophageal Flap Valve Function Based on Hill Classification

  WANG Ganhong, XIA Kaijian, ZHOU Yanting, CHEN Jian, XU Lu

  China Medical Devices. 2024, 39(11): 17-26. https://doi.org/10.3969/j.issn.1674-1633.2024.11.004

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  Objective To develop an artificial intelligence model based on Hill classification using deep learning technology, to enhance the efficiency and accuracy of endoscopists in classifying the morphology of the esophagogastric junction. Methods Four datasets were collected, comprising a total of 1143 gastroesophageal flap valve (GEFV) images and 17 gastroscopic videos, covering GEFV images of Hill grades Ⅰ, Ⅱ, Ⅲ and Ⅳ. The images were preprocessed and enhanced, then transfer learning was performed using pretrained models based on convolutional neural network (CNN) and Transformer architectures. When evaluating model performance, metrics such as accuracy, precision, recall, and F1 score were considered, and the predictive accuracy of endoscopists at different thresholds was compared. To enhance model transparency, various interpretable analysis techniques were employed, including t-SNE, Grad-CAM, and SHAP. Finally, the model was converted to ONNX format and deployed to multiple device endpoints to achieve real-time Hill grading of GEFV morphology. Results The EfficientNet-Hill model outperformed the other six CNN and Transformer models, achieving an accuracy of 83.32% on the external test set, slightly lower than that of senior endoscopists (86.51%), but higher than that of junior endoscopists (75.82%). Moreover, the model achieved precision, recall, and F1 scores of 84.81%, 83.32%, and 83.95%, respectively. Following deployment on multi-terminal devices, the model achieved real-time automatic Hill grading at over 50 fps. Conclusion The development of the EfficientNet-Hill artificial intelligence model using deep learning, has realized automatic Hill grading of GEFV morphology. It can assist endoscopists in enhancing the diagnostic efficiency and accuracy of endoscopic grading, promoting the inclusion of Hill grading in routine endoscopic reports and gastroesophageal reflux disease assessment.
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  Self-Supervised Deep-Learning Cardiac Magnetic Resonance Image Registration Algorithm

  LIU Zixing, LIAN Yu, LI Hanjun, TANG Xiaoying

  China Medical Devices. 2024, 39(11): 27-32. https://doi.org/10.3969/j.issn.1674-1633.2024.11.005

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  Objective To address the lack of a gold standard in registration by employing synthetic images, and to perform the the registration of cardiac T1 map by deep learning algorithms. Methods Firstly, the motion-free reference images was synthesized by using prior information from T1-weighted images. Subsequently, a DeepIPMCNet convolutional neural network was utilized to learn and register in-plane motion. Another network DeepTPMDNet was employed for the detection and elimination of throughplane motion. The STONE sequence T1 mapping dataset collected under free-breathing conditions was used for training, validation, and testing, so as to validate the effectiveness of the proposed method. Performance was evaluated by T1 standard deviation and SD map standard deviation. Results After registration, the Dice coefficient, T1 standard deviation and SD map standard deviation of left ventricle and ventricular septum were improved (Using DeepIPMCNet, Dice coefficient of the left ventricle increased from 0.88 to 0.90, T1 standard deviation of the interventricular septum decreased from 121.91 ms to 86.99 ms, and SD map standard deviation decreased from 46.49 ms to 36.53 ms; Using DeepTPMCNet, Dice coefficient of the left ventricle increased from 0.74 to 0.93, T1standard deviation of the interventricular septum decreased from 192.02 ms to 114.37 ms, and SD map standard deviation decreased from 93.41 ms to 50.53 ms). These differences were statistically significant (P<0.001). Conclusion The deep learning approach proposed in this study effectively alleviates the effects of cardiac and respiratory motion on cardiac T1 quantitative mapping images.
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  Design and Implementation of Therapy Iso-Center Calculation Program Based on CT-Simulator

  LV Dongxia, SHI Feiyue, FU Lin, QIN Wei, WANG Min, ZHUANG Jieying, JIANG Hongbing

  China Medical Devices. 2024, 39(11): 33-38. https://doi.org/10.3969/j.issn.1674-1633.2024.11.006

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  Objective To design a calculation program for positions of movable lasers and CT scanning bed, to determine the radiotherapy isocenter for patients. Methods The therapy iso-center calculation program (TICP) was designed by using Spring Boot system structure. With inputting the initial position data of the movable lasers light and CT scanning bed, and planned displacement data, TICP automatically calculated the final position of the laser light and CT scanning bed corresponding to the radiotherapy isocenter. Then 36 groups of random displacement data was selected to test the accuracy of program by using phantom. Results TICP realized the functions of automatic calculation of radiotherapy isocenter position, historical records query, report printing, and power and responsibility division. The test results showed that the deviation ∆x (left and right, X direction) and ∆z (front and back, Z direction) were 0.4 and 0.3 mm. The deviation ∆y (head and foot, Y direction) was less than 1 mm. There were a total of 65 groups in the range of Ra deviation grade in the three directions, 35 groups in the range of Rb deviation grade, and 8 groups in the range of Rc deviation grade. There was a significant difference in the grade of transverse error between different directions (P＜0.05). Conclusion By using the TICP, it can assist the work of determining the radiotherapy isocenter under the CT-simulator effectively, and improve the related radiotherapy work efficiency.
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  Application Value of Free Breathing DCE-VIBE Sequence Based on Compressed Sensing Technology in Enhanced MR Examination of Gastric Cancer

  YUAN Lei, WANG Chuanbing, LI Qiong, XU Weiyue, LI Bowen, LIU Xisheng

  China Medical Devices. 2024, 39(11): 39-43. https://doi.org/10.3969/j.issn.1674-1633.2024.11.007

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  Objective By comparing and analyzing the image quality of conventional three-dimensional volumetric interpolated breath-hold examination (VIBE) sequences and dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) VIBE sequences based on compressed sensing (CS) technology (hereinafter referred to as CS-DCE-VIBE) in gastric cancer MR enhancement examinations, to explore the application value of CS-DCE-VIBE sequences in gastric cancer MR enhancement scanning. Methods A total of 120 patients with gastric cancer who underwent gastric MR scanning were selected as the study objects. Based on pre examination breathing training, patients were divided into a good breath holding group and a poor breath holding group, with 60 cases in each group. The scanning sequences included routine VIBE and CS-DCE-VIBE sequence. After obtaining the images, the region of interest of measurable lesions on these two types of images were delineated, and the signal-to-noise ratio (SNR) and contrast to noise ratio (CNR) were calculated by two experienced radiologists. The intraclass correlation coefficient and paired sample t-test were used for consistency evaluation and difference analysis. Next, a double-blind method was used to subjectively score the two sequences of images by two radiologists, and consistency evaluation and difference analysis were conducted by using Kappa test and Wilcoxon rank sum test. Results The consistency between the measurement and calculation of SNR, CNR, and subjective scores calculated by two radiologists was good. The SNR and CNR of the CS-DCE-VIBE sequence images in good breath holding group and a poor breath holding group were higher than those in the conventional VIBE sequence, and the differences between them were statistically significant (P<0.001). For the group with good breath holding, the subjective evaluation score of CS-DCE-VIBE sequence images was lower than that of conventional VIBE sequences, and the difference between the two was statistically significant (P<0.001). For the group with poor breath holding, the subjective score of CS-DCE-VIBE sequence images was higher than that of conventional VIBE sequences, and the difference between the two was statistically significant (P<0.001). Conclusion The CS-DCE-VIBE sequence can provide a reliable scanning scheme for preoperative imaging evaluation of gastric cancer patients, especially for better clinical diagnostic methods for gastric cancer patients with poor respiratory coordination.
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  Study on Deviation of Position Between Intensity-Modulated Radiotherapy Planning Centerand Target Area Center for Esophageal Cancer

  WANG Hao, GUO Feng, CHE Ya, REN Yinghong, DING Qi, YANG Yunyi, LI Yi

  China Medical Devices. 2024, 39(11): 44-50. https://doi.org/10.3969/j.issn.1674-1633.2024.11.008

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  Objective To explore the change of planning center and its effect on the quality of radiotherapy plan when the deviation between the esophageal cancer positioning center and the target area center in the X(left-right), Y(head-foot), Z(up-down) threedimensional direction is less than ±15 mm in the planning stage. Methods A total of 40 patients receiving dynamic intensity modulated radiotherapy in Shangluo Central Hospital were selected as the study objects. Firstly, The planning target volume (PTV) center was used to design the radiotherapy plan. After the plan optimization was completed, the new radiotherapy plan was designed by shifting the planning center ±5, ±10 and ±15 mm in three directions towards X, Y, Z, and this point was used as the planning center. The feasibility of the plan was assessed using statistical dosimetric parameters. Results There was no statistical significance in target area, organ at risk and plan execution efficiency (P>0.05). Compared with PTV center plan, the variations in maximum dose (Dmax), minimum dose, average dose (Dmean), homogeneity index and conformity index in other groups ranged from -0.15%~0.12%, -0.05%~0.05%, -0.07%~0.09%, -0.09%~0.28%, and -0.36%~0.48%. The maximum deviation of lung doses at V5 (percentage of the volume of the organ receiving 500 cGy dose, and so on), V10, V20, V30 and Dmean were 0.68%, 0.29%, 0.40%, -0.14% and 7.75 cGy. The maximum deviation of heart doses at V10, V20, V30, V40 and Dmean were 0.66%, -0.30%, -0.47%, 0.54% and -14.08 cGy. Maximum deviation of spinal-cord Dmax was 28.98 cGy. The maximum deviations of monitor unit, delivery time and planned optimization time were -34.01 MU, 5.33 s and -6.09 s. Conclusion When the positioning center and the PTV center in the X, Y, Z, direction is less than ±15 mm, the positioning center can be directly used as the planning center to design the radiotherapy plan, so as to reduce the patient’s reset time and the positioning error.
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  Application Analysis of ArcCheck 3D Dose Verification in Intensity Modulated Radiotherapy for Rectal Cancer and Cervical Cancer

  ZHENG Chao, ZHONG Qingsong

  China Medical Devices. 2024, 39(11): 51-55. https://doi.org/10.3969/j.issn.1674-1633.2024.11.009

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  Objective To explore the 3D dose validation effect of ArcCheck-3DVH on intensity modulated radiotherapy for rectal cancer and cervical cancer, and to explore the difference of the results for ArcCheck-3DVH on planned dose validation for two groups. Methods A total of 19 cases of rectal cancer and 21 cases of cervical cancer were retrospectively collected based on the Monaco 6.1 planning system. SNC Patient was used to calculate and compare the γ passing rates measured by treatment planning system (TPS) and ArcCheck model under the conditions of diff/Dist=3 mm/3%, Threshold=10. Then 3DVH system was used to reconstruct the three-dimensional dose distribution of target and organs at risk, and the difference between it and TPS was compared under D98% (the minimum dose received at 98% target area volume), D2% (the minimum dose received at 2% target area volume) and Dmean (the average dose) parameters. Results The average γ passing rate of 19 rectal cancer plans calculated on SNC Patient was 99.46%±0.7%, which was higher than 98.88%±0.46% in 3DVH, and the dose difference was statistically significant (P<0.05). The γ passage rates in clinical target were all greater than 94%, and there were significant differences in D2% (P<0.05). The γ passing rates of the organs at risk were all greater than 95% and there was no significant difference in the parameters of other organs at risk except small intestine V40 (the volume percentage of organs receiving 40 Gy dose) and spinal cord Dmean (P>0.05). The γ passing rate of 21 cervical cancer plans calculated on SNC Patient was 99.67%[99.35%, 99.95%], which was higher than 98.49%[98.05%, 98.95]% of 3DVH, and the difference between the two was statistically significant (P<0.05). The γ passage rates in clinical target areas were all greater than 93.70%, and there were significant differences in Dmean and D2% (P<0.05). The γ passing rates of the organs at risk were all greater than 91%, and the dose differences in the parameters of other organs except the V30 (the volume percentage of organs receiving 30 Gy dose) and the Dmean of the spinal cord were statistically significant (P<0.05). Conclusion The ArcCheck-3DVH system can not only evaluate the dose validation results of the VMAT program for rectal and cervical cancer as a whole, but also further provide the difference between the measured reconstruction dose and the calculated dose of TPS for the target area and the organ at risk.
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  Construction and Application of Internet Multi-Disciplinary Team Information Platform Based on Cloud Clinic

  YUAN Junyi, PENG Hong

  China Medical Devices. 2024, 39(11): 56-61. https://doi.org/10.3969/j.issn.1674-1633.2024.11.010

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  Objective To explore the use of the internet to achieve multi-disciplinary team (MDT) services, and expand the channels for patients with difficult diseases. Methods Based on the cloud clinic software of the internet hospital, the MDT information platform was built. The platform realized remote application, video consultation, doctor-patient communication and other functions through real-time interaction with electronic medical record, inspection and other heterogeneous systems. The application effect after implementation was empirically analyzed. Results After the platform was put into use, a total of 227 patients were provided with appointment and application services, of which 146 patients completed treatment. After the application of the platform, the speed of sorting medical records and writing diagnostic conclusions was significantly improved compared with that before the application (P<0.001), and the waiting time for patients was significantly shortened (P<0.001), which improved the diagnosis and treatment efficiency of the medical team and optimized the link of business processes. Conclusion Internet medicine brings more efficient and humanized service experience, which is conducive to enhancing the brand influence of hospitals.
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  Design and Implementation of Medical Record Download Service Platform Based on WeChat Official Account

  MA Qunsheng, YUAN Junyi, RONG Wenwen, CEN Xingxing

  China Medical Devices. 2024, 39(11): 62-68. https://doi.org/10.3969/j.issn.1674-1633.2024.11.011

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  Objective To build a medical record download service platform based on the hospital’s WeChat official account, to further optimize the medical record service process, and improve service efficiency and patient service experience. Methods Using internet technology, based on the hospital’s WeChat official account, the medical record download service platform was designed and implemented by adopting Vue+WebAPI+ESB front-end separation technology, using Microsoft Visual Studio15.0 and .Net framework 4.5 as the development tools, and using Microsoft SQL Server 2016 as database storage. The number of medical record download platform applicants from August to November 2023 was selected as the observation group (n=712). In the same period, an equal number of online medical record copying applicants were selected as the control group (n=712). The time of the two groups of modes was compared and analyzed to evaluate the impact of the platform on work efficiency. By comparing and analyzing the economic costs of medical record download mode and medical record copying mode for the year 2023, the impact of medical record download mode on economic costs was evaluated. Results The observation group had significantly lower time consumption than the control group, and the difference between the two groups was statistically significant (P<0.05). According to the user satisfaction survey, users had a high degree of satisfaction with the platform. The economic cost of the medical record download mode was much lower than that of the medical record copying mode. Conclusion By establishing a medical record download service platform based on WeChat official account, it effectively meets the patients’ demand for medical record download, reduces their burden of traveling to and from the hospital, and saves time and economic costs. At the same time, the platform has also improved the efficiency of hospital staff and provided patients with better quality services.
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  Construction and Application of Hospital Offensive Network Security Defense System from the Perspective of Actual Combat

  SUN Baofeng, GE Xiaowei, YANG Yang, LI Yuhong

  China Medical Devices. 2024, 39(11): 69-74. https://doi.org/10.3969/j.issn.1674-1633.2024.11.012

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  Objective To address the security situation of unquantifiable cybersecurity efforts, passive defense system and professional and technical personnel shortage, to explore the construction of hospital offensive network security defense system. Methods By setting up a situational awareness platform, combining and implementing technical measures such as internet exposure control, port management, penetration testing, network zoning, endpoint threat detection and response, and security training, the hospital offensive network security defense system was constructed. Results After implementing the hospital offensive network security defense system, there was a significantly higher number of proactive detection and automatic interception of network security incidents compared to before (P<0.05), and the platform exhibited superior handing capabilities and stability. Conclusion The hospital offensive network security defense system can enhance the current passive network defense status in the healthcare sector, significantly bolster the overall network protection capabilities of hospital.
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  Construction and Application of Pre-Processing System for Surgical Pathological Specimens Based on Automatic Perfusion System

  SUN Bihai, ZHANG Ying, ZHONG Lintao, PANG Lei

  China Medical Devices. 2024, 39(11): 75-81. https://doi.org/10.3969/j.issn.1674-1633.2024.11.013

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  Objective To explore the standardized, practical and efficient managerial approach, to effectively solve the problems existing in the management of pre-processing of surgical pathological specimens. Methods By referring to the requirements of domestic and foreign standards, relying on mobile nursing PDA, barcode tracing technology, Wi-Fi coverage, automatic perfusion system and multi-interface technology, the closed-loop management of acquisition, registration, fixation, temporary storage, transportation, signing and other processes for surgical pathological specimens was realized. Results After the scheme implementation, the time consuming of specimens pre-processing, adverse event occurrence rate and formalin dosage were significantly lower than before the implementation; the satisfaction of operating room and pathology department personnel was higher than before the use, and the differences were statistically significant (P<0.05). Conclusion The information management approach for the pre-processing procedure for surgical pathological specimens based on the automatic perfusion system, realizes the standardization and normalization management of pathological specimens, effectively reduces the formalin dosage and occupational exposure, and effectively protects the health of medical personnel. The approach is practical, efficient, and safe, and has popularization value.
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  Study on the Evaluation of Mainstream Micro-Syringe Infusion Pump Based on Multi Index Analysis

  XIONG Wei, YUAN Xin, NIE Tao, PAN Jin, ZHENG Jun, FENG Jingyi

  China Medical Devices. 2024, 39(11): 82-86. https://doi.org/10.3969/j.issn.1674-1633.2024.11.014

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  Objective To establish a scientific micro-syringe infusion pump evaluation index system and carry out evaluation, provide a basis for medical staff to select high-quality products, provide constructive suggestions for product improvement and optimization, and provide patients with more accurate and guaranteed medical services. Methods Through expert group discussion, 10 parameters including flow relative indication error, flow indication repeatability, output accuracy, blocking pressure alarm relative indication error, grounding resistance, identification syringe capacity completeness, display interface availability, battery full charge working time, internal structure stability and operation convenience were determined as the evaluation index system of micro-syringe infusion pump. The weights of each index were assigned by the subjective and Objective weighting method. The decision scheme set and decision matrix corresponding to brand A~D micro-syringe infusion pump were established, and the evaluation target model was constructed to comprehensively evaluate and rank the advantages and disadvantages of each brand micro-syringe infusion pump. Results Under the comprehensive comparative evaluation of the above 10 main indicators, the evaluation target value matrix of each brand micro-syringe infusion pump di=(0.32, 0.84, 0.57, 0.56), the product was sorted as brand B>brand C>brand D>brand A. Conclusion The evaluation index system and evaluation method of micro-syringe infusion pump established in this paper has certain applicability, which is helpful for medical institutions to choose the most suitable products, and provides ideas for the establishment of medical device evaluation index system and the research of evaluation methods.
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  Research on Mining Evaluation of Ventilators and Related Adverse Events in Shandong Province in Recent Five Years

  MA Jipeng, ZHAO Yujuan, ZHOU Pengchao, ZONG Ran, JIANG Xinchang

  China Medical Devices. 2024, 39(11): 87-92. https://doi.org/10.3969/j.issn.1674-1633.2024.11.015

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  Objective To determine the factors leading to ventilators and related adverse events and their influence weights. Methods Based on the data of ventilators and related adverse events provided by Shandong Adverse Event Monitoring Center from December 2018 to December 2023, the factors leading to ventilators and related adverse events were determined using Delphi method, and then the weights of different factor indicators were calculated through the analytic hierarchy process. Results The factors and weight tables leading to ventilator and related adverse events were obtained, including 4 primary indexes, 19 secondary indexes and 33 tertiary indexes. In addition to use time, the important factors leading to ventilator and related adverse events were product quality (primary index), flow sensor failure (secondary index), tidal volume alarm (tertiary index). The factors at all levels were analyzed horizontally and vertically, and the corresponding improvement plan was put forward. Besides, the accuracy, cost performance, functionality and stability of the flow sensor were compared, and the causes of adverse events caused by the flow sensor were analyzed and the improvement measures were proposed. Conclusion Through quantitative analysis and research on the weight of factors leading to the ventilator and related adverse events, the weight values of various factors leading to adverse events are determined when considering the incidence rate, influence degree to patients, timeliness of failure relief and treatment cost, which provides certain technical evaluation standards for the mining of adverse events of ventilator. It provides guidance basis for ventilator manufacturers to improve the technology of their products and the maintenance of ventilators in hospitals, so that hospitals can take specific measures to reduce the incidence of adverse events of ventilators and improve the quality of clinical services.
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  Application of Non-Equilibrium Measurement Method in Mining Risk Signals and Analysis of Adverse Events Report of Disposable Venous Blood Collection Needle

  XIAO Yuhua, CAI Quanzhou, FU Yuanfeng, WANG Hong

  China Medical Devices. 2024, 39(11): 93-97. https://doi.org/10.3969/j.issn.1674-1633.2024.11.016

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  Objective To promptly identify the risks associated with disposable venous blood collection needles and leverage the real-time monitoring effectiveness of the medical device adverse event monitoring system. Methods Using the reporting odds ratio (ROR) method and the proportional reporting ratio (PRR) method in the non-equilibrium measurement approach, a real-world report of 234 cases of adverse events related to disposable venous blood collection needles reported by medical institutions in Guangdong Province was analyzed to explore risk signals, investigate, and analyze the reasons for the occurrence of events. Results Monitoring revealed an imbalance in the number and proportion of adverse event reports related to the connecting component loosening of disposable venous blood collection needles among different holders, meeting the risk signal determination criteria. Through analysis and research, the risk signal was confirmed, with the main cause being attributed to product-related issues, including incomplete instructions, production process problems, and design defects. Conclusion The ROR and PRR methods in the non-equilibrium measurement approach effectively explore and identify the risk of adverse events related to disposable venous blood collection needles among different holders. They have a certain reference and promotional value in the mining, identification, and analysis of risk signals for adverse events in active, passive, and in vitro diagnostic reagent medical devices.
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  ITSA for the Cost Control Effect of Centralized Procurement of High-Value Medical Consumables──Taking Drug-Coated Coronary Balloon Catheters as an Example

  FAN Linlin, JIA Zhiguo, ZHOU Pengchao

  China Medical Devices. 2024, 39(11): 98-104. https://doi.org/10.3969/j.issn.1674-1633.2024.11.017

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  Objective To analyze the changes of hospitalization expenses and cost structure before and after two rounds of price reduction in centralized procurement of drug-coated coronary balloon catheter, and to explore the implementation effect. Methods The interruption time series analysis method was used to obtain the cost data of the first page of 1468 patients’ medical records and the purchase data of high-value consumables from January 2021 to September 2023. The data change trend was described, and the influence of two rounds of price reduction on the hospitalization cost and cost structure of patients was analyzed. Results Before the implementation of the centralized procurement policy, the comprehensive medical cost showed an upward trend. In the first round of price reduction, the cost decreased instantaneously, among which the total hospitalization cost and medical materials cost decreased by 1.1094 million yuan and 0.7804 million yuan. After the first round of price reduction, the total cost of hospitalization increased by 105200 yuan per month. The cost of treatment, diagnosis and medicine increased rapidly. The proportion of treatment costs and the proportion of consumption only changed significantly instantaneously, and the proportion of drugs increased slowly in the long term. In the second round of price reduction, the instantaneous changes of all costs were not significant (P>0.05), and the long-term trend changed from rising to falling (P<0.01). The total cost of hospitalization decreased rapidly at a rate of 325100 yuan per month, and the cost of medical materials decreased by 186700 yuan per month. The proportion of medical cost and the proportion of drugs increased, and the proportion of diagnosis fees decreased. Conclusion After the implementation of the centralized procurement policy, the patients’ medical burden is reduced. The cost structure needs to be further optimized, the proportion of consumption remains high, the technical labor value of medical staff is not fully reflected, and the comprehensive reform of medical consumables has a long way to go. In order to form a policy synergy, we should give full play to the guiding role of the “three medical linkage”mechanism in the governance of high-value medical consumables.
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  Study on the Application Effect of Sub-Specialty Joint Optimization Quality Traceability System in the Management for Instruments of Orthopaedic Day Surgery in CSSD

  ZHOU Fangfang, LIU Xia, ZHOU Chunyan, WANG Ending, CUI Li

  China Medical Devices. 2024, 39(11): 105-111. https://doi.org/10.3969/j.issn.1674-1633.2024.11.018

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  Objective To explore the construction of supply quality management model for instruments of orthopedic day surgery in central sterile supply department (CSSD) based on sub-specialty joint optimization quality traceability system. Methods On the basis of the traditional information tracing system in CSSD, a sub-specialty system was constructed and optimized for management to achieve data analysis and traceability, feedback and alerting. A total of 5018 aseptic kits for orthopedic day surgery with routine quality traceability management from January to June 2022 were selected as the control group. In comparison, 5107 aseptic kits used for orthopedic day surgery with sub-specialty joint optimization quality traceability management from July to December 2022 were selected as the experimental group. The management quality, supply quality defects, traceability management quality defects, and overall satisfaction of surgical staff were compared between the two groups under the two models. Results The quality of the management processes for instrument retrieval, cleaning, packaging, sterilization, and distribution in the experimental group was significantly higher than that in the control group. The timeliness of urgent instrument disposal and the occurrence of defects in aseptic package distribution was significantly lower in the experimental group compared to the control group. The unqualified rate and the occurrence rate of adverse warning events during the whole process of aseptic packs in the experimental group were significantly lower than those in the control group. The comprehensive satisfaction of surgical staff in the experimental group was significantly higher than that in the control group, The differences were statistically significant (P<0.05). Conclusion The subspecialty joint optimization quality traceability system shows significant effects in the management for instruments of orthopedic day surgery in CSSD. It improves the quality of instrument management in CSSD, enhances supply efficiency, avoids the occurrence of supply-related adverse events, expands information warning prompts, reduces surgical medical risks, and maintains a good collaborative atmosphere between the operating room and CSSD.
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  Analysis of Maintenance Strategies for Large-Scale Medical Equipment Based on Whole Process Management

  WANG Yongrong, WANG Xiangang, HU Qiaofu, MAO Qing

  China Medical Devices. 2024, 39(11): 112-119. https://doi.org/10.3969/j.issn.1674-1633.2024.11.019

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  Objective To analyze the problems in the whole process management of large-scale medical equipment maintenance, and establish an evaluation index system for large-scale medical equipment maintenance, to provide reference for the formulation of maintenance strategies for large-scale medical equipment. Methods A total of 26 representative public hospitals of different levels in central and southern Sichuan were selected to carry out a survey on the status quo of large-scale medical equipment maintenance management, and the existing maintenance management problems in the whole process of demand demonstration, procurement, maintenance implementation and after-effect evaluation of large-scale medical equipment in current hospitals were analyzed through comprehensive literature research. Based on this, the index of large-scale medical equipment maintenance evaluation system was determined, the weight of each index was obtained by analytic hierarchy process and Delphi expert consultation method, and the evaluation index system of large-scale medical equipment maintenance was constructed and applied to the configuration management of 8 large-scale medical equipment in a new hospital area. Results The final evaluation index system of large-scale medical equipment maintenance included 5 first-level indexes and 27 second-level indexes. The first-level indexes included demand demonstration, maintenance procurement, maintenance implementation, acceptance evaluation, and maintenance management, among which the weight of maintenance implementation was the highest (0.247). Among the second-level indexes corresponding to each first-level index, the most weighted ones were market research (0.051), the nature of the maintenance party (0.044), repair time and engineer technology (0.034), service acceptance (0.038) and regular inspection (0.045). Conclusion The maintenance evaluation index system established in this study can provide guidance and reference for the scientific configuration, rational maintenance strategies, and efficient maintenance service evaluation of large-scale medical equipment. It is of great significance for improving the operational efficiency of large-scale medical equipment and promoting the modernization and high-quality development of hospitals.
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  Visual Analysis for the Affects of Mobile Health to the Health Behavior of Domestic Users Based on CiteSpace

  LI Jiale, CHEN Weiqiang, YANG Yiling

  China Medical Devices. 2024, 39(11): 120-127. https://doi.org/10.3969/j.issn.1674-1633.2024.11.020

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  Objective To comprehensively assess the research landscape, key trends, and hot spots of mHealth’s impact on domestic users’ health behaviors, and to deliver targeted recommendations for enhancing mHealth’s role in health management services. Methods Taking the literature of CNKI database spanning from 2012 to 2022 as the research object, visual analysis for the publishing institutions, authors and keywords was conducted using CiteSpace 6.2R4 software. Results A total of 1048 literature was included, and the field went through three stages of publication: growth period (2012-2016), mature period (2017-2020), and breakthrough period (2021-2022). Central South University and Huazhong University of Science and Technology had higher publication outputs with 20 and 19 papers respectively, with less close collaboration between institutions. Jin Xinzheng, Zhang Min and Han Xiaodan were the top three contributors in terms of publications. Keywords were divided into9 clusters, covering research hotspots and frontiers in areas such as health management, telemedicine and Internet+. Conclusion mHealth that integrates behavior change technologies shows tremendous potential in the field of health management for domestic users, but there still exist issues such as a lack of high-quality clinical research and collaboration between teams and institutions. In the future, mHealth interventions should be user-centered, focus on user needs and experiences, based on theoretical framework, strengthen collaboration and communication between authors and institutions, meet the diverse health needs of the population, and maximize health promotion effects.
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  Visual Analysis for the Current Research Status and Hotspots in the Application of Quantitative MRI in Intervertebral Disc Degeneration

  LI Ziou, MAO Zhenni, WANG Bin, ZHANG Xiuping

  China Medical Devices. 2024, 39(11): 128-136. https://doi.org/10.3969/j.issn.1674-1633.2024.11.021

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  Objective To explore the research status and hotspots of the application of quantitative magnetic resonance imaging (MRI) in intervertebral disc degeneration by bibliometrics. Methods Literatures on the application of quantitative MRI in the field of intervertebral disc degeneration published from 2012 to 2022 were searched in the Web of Science (WOS) core database. Bibliometrix in the R language environment, Microsoft Excel 2016, VOSviewer 1.6.2, CiteSpace 6.1 Advanced Edition, Scimago Graphica and other bibliometric softwares were used for bibliometrics and knowledge map visual analysis. Results A total of 434 articles from the WOS core database were included for visual analysis. With the passage of time, the number of publications in this field has gradually increased. China and the United States were the top two countries in the number of publications and citations, but Chinese literature lacked international cooperation and exchange. Schleich C, Mueller-Lutz A, Antoch G and Trattnig S were the top authors who have made important contributions to the research in this field. European Spine Journal and Spine were the most authoritative journals in this field. Keyword co-occurrence, clustering, timeline view and burst analysis revealed that recent studies in this field had focused on quantifying the biochemical components of degenerative intervertebral discs. Conclusion This study provides a knowledge map of quantitative MRI research on degenerative disc diseases, covers aspects such as countries, institutions, journals, authors, and keywords through bibliometric analysis. It systematically presents the current status and hot topics in this field, aiming to provide reasonable suggestions for future research.
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  Effect of Genistein Based on PPARγ Target on Angiogenesis and Macrophage Polarization in Nude Mice with Osteosarcoma

  LIU Huanru, LI Xianfeng, ZHANG Yi, ZHU Lunqing

  China Medical Devices. 2024, 39(11): 137-142. https://doi.org/10.3969/j.issn.1674-1633.2024.11.022

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  Objective To investigate the effect of genistein based on peroxisome proliferators-activated receptor γ (PPARγ) target on angiogenesis and macrophage polarization in nude mice with osteosarcoma. Methods A total of 35 nude mice were selected to establish the osteosarcoma nude mouse model. After successful modeling, the nude mice were randomly divided into model group, low-dose genistein group, medium-dose genistein group, high-dose genistein group and cisplatin group, with 6 mice in each group. The low, medium, and high-dose genistein groups were orally gavaged with 50, 100, and 200 mg/kg of genistein, respectively; the cisplatin group received intraperitoneal injection of 2 mL/kg cisplatin solution; the model group was gavaged with an equivalent volume of 0.9% NaCl solution. The tumor mass was weighed using an electronic balance and the tumor inhibition rate was calculated; HE staining was used to observe the pathological morphology of tumor tissue; immunohistochemistry was performed to detect vascular endothelial growth factor A (VEGFA) expression and tumor microvessel density (MVD); immunostaining was used to detect inducible nitric oxide synthase (iNOS), recombinant cluster of differentiation 163 (CD163), PPARγ, rabbit anti-human protein kinase B (AKT), and glycogen synthase kinase 3β (GSK-3β) proteins. Results Compared with the model group, the tumor weight of low, medium and high dose genistein groups and cisplatin groups were decreased and the tumor inhibitory rate was increased (P<0.05); there were no differences between high dose genistein group and cisplatin group (P>0.05). The number of VEGFA-MVD in model group, low, medium and high dose genistein group and cisplatin group were (17.25±2.05), (14.10±1.72), (13.56±1.67), (6.35±0.52) and (6.14±0.47), respectively, with statistically significant difference (F=71.340, P<0.05). Compared with model group, iNOS and PPARγ proteins were increased in low, medium and high dose genistein groups and cisplatin groups, while proteins of CD163, AKT and GSK-3β were decreased (P<0.05); there were no statistically significant differences between high-dose genistein group and cisplatin group (P>0.05). Conclusion Genistein can inhibit the growth of osteosarcoma tumors in nude mice, reduce the transformation of M1-type macrophages to M2-type, exert anti-tumor effects, and its mechanism of action may be related to upregulating PPARγ expression.Key words: osteosarcoma; genistein; angiogenesis; macrophage polarization; peroxisome proliferator activated receptor
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  Current Advances in Superficial Radiotherapy for Skin Lesions

  ZHANG Hui, LIU Junyi, TAO Li, WANG Haiyang, CHEN Zhi, WU Aidong, QIAN Dong, XU Xie

  China Medical Devices. 2024, 39(11): 143-148. https://doi.org/10.3969/j.issn.1674-1633.2024.11.023

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  Superficial radiotherapy plays an important role in the treatment of skin lesions for more than a century. Several innovative techniques, methods and devices have been developed in this area of radiation therapy (Hereinafter referred to as radiotherapy) for treating various benign or malignant skin lesions such as keloid and skin cancer. Electron beam therapy, brachytherapy, Beta radiotherapy and superficial X-ray therapy are the established methods that are currently used on skin lesions patients. The purpose of this paper is to overview these techniques and discuss the advantages, disadvantages and applicability of these methods in practices. Additionally, the paper summarized the emerging needs and challenges of superficial radiotherapy, as well as providing the future directions.Key words: skin cancer; keloid; radiation therapy; electron beam therapy; superficial X-ray therapy
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  Research Progress in Detecting Urinary Biomarkers of Alzheimer’s Disease by Enzyme-Linked Immunosorbent Assay

  HUANG Xiaohui, LIU Zheng, JIN He

  China Medical Devices. 2024, 39(11): 149-152. https://doi.org/10.3969/j.issn.1674-1633.2024.11.024

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  Alzheimer’s disease (AD) is the main type of dementia, and the number of AD patients is increasing rapidly as the population ages. Considering the irreversible nature of AD progression, early screening and diagnosis of AD are essential for timely interventions. Urine sample detection has the advantages of convenience, non-invasive, high patient acceptance and suitable for screening, and has been paid more attention to in the field of biomarker development and application in recent years. This paper summarized the latest research progress in detecting urinary biomarkers of AD by enzyme-linked immunosorbent assay, aiming to provide new ideas for the development and clinical application AD biomarkers.
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  Research Progress of Transducer for Ultrasonic Surgical Cutting Equipment

  HU Fuji, WANG Haibo, FENG Gengchao

  China Medical Devices. 2024, 39(11): 153-158. https://doi.org/10.3969/j.issn.1674-1633.2024.11.025

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  The ultrasonic surgical cutting equipment is playing an increasing important role in surgery, and the transducer is a critical component in ultrasonic surgical cutting equipment. This paper reviewed the latest research on transducers in ultrasonic surgical cutting equipment, categorized these transducers and analyzed the design and result of these transducers, and summarized the advantages and disadvantages and development trends of these new transducers, aiming to provide a reference for the research on ultrasonic surgical cutting equipment.
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  Advance in the Application of Isokinetic Technology for Anterior Cruciate Ligament Injury

  XU Yongyi, JIANG Cai, ZONG Huachen, XU Pan, LIN Zhonghua

  China Medical Devices. 2024, 39(11): 159-164. https://doi.org/10.3969/j.issn.1674-1633.2024.11.026

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  Anterior cruciate ligament (ACL) is a special connective tissue band in the knee joint connecting the tibia and femur. It maintains the stability of the tibia and prevents increased internal rotation and anterior translation. ACL injury can have negative psychological and physical effects on patients. Therefore, accurate assessment of the strength of the muscle groups around the knee joint in patients with ACL injury and early training of the muscle groups around the knee joint in patients with ACL injury are very important to return to sports and prevent secondary injuries. Isokinetic technique has been widely used in patients with ACL injury due to its simple, safe and effective characteristics. This paper summarized the development of isokinetic techniques at home and abroad, and the application and progress of isokinetic techniques in patients with ACL injury from the two aspects of isokinetic muscle strength testing and isokinetic muscle strength training, in order to provide a reference for clinical medical staff in the rehabilitation treatment of patients with ACL injury.
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  Current Status and Prospect of Neonatal Pulmonary Ultrasound Application

  JIA Xinying, MA Jiaojiao, ZHENG Yujin, SUN Zhe, ZHANG Bo

  China Medical Devices. 2024, 39(11): 165-169. https://doi.org/10.3969/j.issn.1674-1633.2024.11.027

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  The accurate assessment of lung physiology and pathological conditions is vital for evaluating the health of neonates. Ultrasound, as a safe, non-invasive, real-time, and convenient imaging examination technology, has made significant progress in the field of neonatal lung applications in recent years. This paper reviewed the process of establishing the correspondence between the identification of pulmonary ultrasound artifacts and diseases, as well as the application process of qualitative diagnosis of neonatal lung diseases and discussed the standardization of neonatal lung ultrasound and the application value of semi-quantitative lung ultrasound scoring in improving lung ventilation therapy. Additionally, this paper explored the research prospects of AI-assisted diagnosis, elastography, and contrast-enhanced ultrasound in neonatal lung diseases, while analyzing their limitations and potential safety issues. Lastly, this paper discussed the future application scenarios of portable ultrasound in neonatal lung assessment, including bedside intensive care and non-medical settings, aiming to provide insights for further research and technological improvements in neonatal lung ultrasound, ultimately enhancing the overall diagnostic capabilities and benefiting a larger number of neonates.
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  Current Research Status and Clinical Application of Lower Extremity Rehabilitation Robot

  HUANG Cheng, LIU Fen, JIANG Haibo

  China Medical Devices. 2024, 39(11): 170-177. https://doi.org/10.3969/j.issn.1674-1633.2024.11.028

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  As the transportation facilities expand, the incidence of stroke and various accidents leading to patient cases has also increased. Postoperative rehabilitation training is one of the important guarantees for patients to recover their quality of life. Rehabilitation robots, utilizing robotic technology to assist physicians in patient training, are increasingly being adopted. Future developments in lower extremity exoskeleton rehabilitation robots should primarily focus on enhancing human-machine collaboration, improving control algorithms, optimizing rehabilitation outcome assessment, enhancing equipment portability and reconfigurability, and addressing economic considerations. This paper systematically reviewed and examined the research and clinical applications of lower extremity rehabilitation robots from the past decade at home and abroad, sorting out, analyzing key technologies and summarizing advancements in this field. Additionally, a feasibility analysis of the development trends in lower extremity rehabilitation robot technology was carried out.
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  Application of In Vitro Alternative Method in Biocompatibility Evaluation of Medical Devices

  HAN Ying, TIAN Linqi, ZHOU Jing, LIU Kangbo, LIU Xiaojun, MENG Xing

  China Medical Devices. 2024, 39(11): 178-182. https://doi.org/10.3969/j.issn.1674-1633.2024.11.029

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  With the rapid development and continuous innovation of the medical device industry, the safety problem of medical devices in clinical use has become increasingly noticeable. Good biocompatibility is a prerequisite for the safe and effective clinical application of medical devices, while animal testing is one of the important means to evaluate the biocompatibility of medical devices. However, driven by the 3R principles of replacing, reducing and optimizing animal use, it is a global trend to carry out in vitro alternative methods. However, compared with chemicals and cosmetics, research on in vitro alternatives for biocompatibility evaluation in the field of medical devices has progressed slowly. This paper analyzed the importance of conducting in vitro alternatives from a regulatory perspective, introduced in vitro substitution methods that had been and could be used for biocompatibility evaluation of medical devices, and provided a reference for subsequent in vitro alternatives of medical devices.