20 December 2024, Volume 39 Issue 12

    

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FEATURES
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  Discussion on the Construction Method of Clinical Application Evaluation Platform for Multi-Center Medical Imaging Equipment

  RONG Yao, HUA Cheng, DONG Shuo, WU Ping, LI Dong, ZHANG Wenlong, WU Hang

  China Medical Devices. 2024, 39(12): 1-7. https://doi.org/10.3969/j.issn.1674-1633.2024.12.001

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  Objective To establish a clinical application evaluation platform for multi-center medical imaging equipment by building primary and secondary information centers. Methods The clinical application data of medical imaging equipment was obtained through a secondary information center. The raw data was desensitized using methods such as data collection, data governance, and indicator design. Through data space management and data space testing verification techniques, the desensitized data was transmitted to the primary information center. The primary information center designed analysis algorithms based on the clinical application evaluation criteria for medical imaging equipment to evaluate the clinical application of the equipment. Results A number of secondary information centers transmitted standardized data listed to the primary information center through data space management technology, and was able to analyze and evaluate the reliability, availability, functional effect, equipment performance and operating efficiency of medical imaging equipment. Users could intuitively understand the clinical applicability evaluation results of various medical imaging equipment brands through the results displayed on the primary information platform. Taking PET/MR as an example, from the perspective of individual ratings, the reliability evaluation of A brand equipment was 99.69%, and the reliability evaluation of B brand equipment was 98.37%, the reliability of A brand equipment was slightly higher than that of B brand equipment. Taking MRI as an example, the advanced function application rates among the three brands in August 2024 was 61%, 47%, and 38%, respectively. According to the rank sum test, there was no significant difference in the advanced function application rates among the three brands of MRI (P=0.53). Conclusion The construction of clinical application evaluation platform for multicenter medical imaging equipment can provide systematic technical solutions and platform-wise support for medical institutions to select and verify medical imaging equipment, can provide data support for promoting the quality improvement of domestic-made medical imaging equipment, and can provide research data and basic sharing service platform-wise support for establishing and improving standards and standardized systems on the reliability, clinical application verification and maintenance of domestic-made medical imaging equipment.
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  Reliability Data Analysis of CT in the Early Stage of Use

  LI Dong, WU Ping, ZHANG Wenlong, DONG Shuo, HUA Cheng, RONG Yao, WU Hang

  China Medical Devices. 2024, 39(12): 8-11. https://doi.org/10.3969/j.issn.1674-1633.2024.12.002

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  Objective To analyze the reliability data of CT equipment in use, improve the theoretical framework of equipment reliability analysis and evaluation indicators, explore practical methods for equipment reliability evaluation, to provide practical reference solutions for performance comparison between different CT equipment. Methods Based on the data of the first two years of the newly commissioned CT equipment, the performance comparison framework was constructed according to the reliability theory. According to the maintenance records provided by the equipment manufacturer, the data related to the reliability, maintainability and supportability parameters in the work order of the first year, the second year and the first two years after the installation of a single CT equipment were statistically compared. And the maintenance time, fault time and maintenance interval of the first year and the second year after the installation were compared. Results The reliability parameters of the equipment in the first year, the second year, and the first two years after the installation showed excellent performance in the following order: the first year, the first two years, and second year. The maintenance time and fault time in the second year were longer than those in the first year, and the maintenance interval was shorter than that in the first year, but the difference was not statistically significant (P>0.05). The overall operation status of CT equipment was relatively stable in the first two years after installation, and decreased slightly in the second year. Conclusion The maintenance data analysis and evaluation system established in this study can provide reference information for improving equipment reliability, provide reference solutions for performance comparison between different CT equipment, which can promote the continuous progress of CT technology and industry standardization.
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  Reliability Analysis and Research of Digital Radiography Equipment

  HUA Cheng, DONG Shuo, ZHANG Wenlong, LI Dong, HOU Yiwei, WU Hang

  China Medical Devices. 2024, 39(12): 12-15. https://doi.org/10.3969/j.issn.1674-1633.2024.12.003

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  Objective To study and analyze the reliability level of imported and domestic high-end digital radiography (DR) equipment in clinical application using a reliability verification scheme. Methods Data such as maintenance and work logs of three DR equipment (one imported and two domestic) within a certain period were extracted. The image performance parameters, core component status, reliability parameters, maintainability parameters and supportability parameters of the equipment were analyzed, and the performance test data and reliability level of the equipment were compared. Results The image performance of the three devices was stable, and all of them could meet the standard requirements. The state parameters of the core components basically maintained stable operation.The reliability parameters of imported equipment A and domestic equipment B were good, and the availability parameters of both equipment were greater than 95%. The fault time of domestic equipment C was relatively long, and its availability was in the range of 90% to 95%. The maintenance, supportability parameters of domestic equipment performed better. The average maintenance time was 67% faster than that of imported equipment, and the maintenance support delay time was more than 70% lower. Conclusion Based on the basic method of reliability verification, analyzing the reliability level of DR equipment in the clinical application process can provide an objective evaluation of the long-term stability of equipment for medical institutions. The results indicate that domestic high-end equipment with shorter operation time does not have an average reliability performance and shows a large difference from mature imported equipment.
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  Performance Quality Control Test and Analysis of 327 DR Equipment in Beijing

  ZHANG Wenlong, HOU Yiwei, LIU Yuan, WANG Yukun, LI Baoxin, DONG Shuo

  China Medical Devices. 2024, 39(12): 16-21. https://doi.org/10.3969/j.issn.1674-1633.2024.12.004

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  Objective To conduct quality control test on 327 DR equipment in Beijing, analyze the stability of the test data, and enhance the level of DR quality control management. Methods Using the multifunctional dosimeter Unfors Raysafe X2, low contrast test card, spatial resolution test card, and other detection models, the universal and specialized detection items of DR equipment were tested using the detection methods specified in the WS 76-2020 standard, and the stability of equipment performance was analyzed using Minitab 17.0 software. Results The qualification rate of 327 DR equipment quality control tests was 98.17%. The unqualified condition involved three performance indicators, namely the deviation between the light field and the four sides of the irradiation field, response uniformity, and useful beam deviation from perpendicularity. The quality control of most test items were at level Ⅰ, and the quality control of deviation (large focus) of tube voltage indication was at level Ⅲ. Conclusion Through the stability analysis of the performance quality control test data of DR equipment, it is found that the tested equipment still has room for improvement in such important indicators as the deviation between the light field and the four sides of the irradiation field, response uniformity, useful beam deviation from perpendicularity and deviation (large focus) of tube voltage indication. The important results of this study can provide scientific basis and reasonable suggestions for the quality management of DR equipment, provide a guarantee basis for the stable operation of the equipment, and ensure the image diagnosis quality and radiation safety of DR equipment.
RESEARCH WORK
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  Peripheral Blood Cells and Antibodies Detection Approach Based on Deep Convolutional Neural Network

  LI Aitong, LI Mingshi, LI Jingpeng, LI Chen

  China Medical Devices. 2024, 39(12): 22-27. https://doi.org/10.3969/j.issn.1674-1633.2024.12.005

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  Objective To solve the problems of time-consuming detection, few cell types and time-consuming manual microscopic examination methods. Methods In order to detect blood cells more quickly, reduce the workload of doctors and provide accurate reports, this study combined the regional convolutional neural network, YOLO, single shot multiBox detector (SSD) and other deep learning methods to detect blood cells. In this experiment, the peripheral blood cell data set was selected, and the SSD model and five network models in the YOLO series, YOLOv5, YOLOX, YOLOv6 and YOLOv7 were used for training. The advantages and disadvantages of the network were discussed by comparing the evaluation indicators. Results This study built a new model with higher accuracy and faster running speed. The accuracy reached 99.3%, the single-image detection time was 10.3 ms, and the memory occupied was only 71.2 MB, surpassing other network models. An ablation experiment was designed to verify the practicality of the newly added fully connected layer module and generalization module. Conclusion This model can detect blood cells excellently and accurately, with fast detection speed and high accuracy. The model is small and easy to use and maintain.
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  Development of Heart Normothermic Machine Perfusion Device

  LIU Qian, LIU Wenyan, ZHAO Changying, YAN Yang, WANG Feiyang, ZHENG Xinglong

  China Medical Devices. 2024, 39(12): 28-32. https://doi.org/10.3969/j.issn.1674-1633.2024.12.006

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  Objective To introduce a heart normothermic machine perfusion device to achieve in vitro preservation of transplanted hearts. Methods The peristaltic pumps and membrane oxygenators were utilized to simulate an artificial heart and lung. The solution of infusing normothermic blood perfusate to the transplanted heart was used to achieve rhythmic beating and long-term preservation of the transplanted heart in vitro. At the same time, The cardiac perfusion status was determined by the lactate level of the perfusate, and the cardiac perfusion flow and pressure were monitored in real-time. Results The device parameters met the necessary requirements, and it had been used for in vitro perfusion experiments in Chinese miniature porcine hearts (n=3). The results showed that the heart was well paced in vitro, which preliminary validated its feasibility. Conclusion Normothermic machine perfusion provides a novel strategy for heart preservation and is expected to extend the preservation time of the heart in vitro and expand the number of potential donor organs.
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  Design and Research on MCU Bluetooth Wireless Physiotherapy Device Controlled by Mobile Phone APP

  XU Jinjiu, WU Wengang, LIU Yujie, HUANG Weilong, LV Anjing, HUO Junting, LI Mai, LIAO Wenyan

  China Medical Devices. 2024, 39(12): 33-38. https://doi.org/10.3969/j.issn.1674-1633.2024.12.007

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  Objective To develop a wireless physiotherapy device controlled by mobile phone APP in order to achieve portability, high efficiency and aesthetics. Methods The system was designed based on STC12C5A60S2 single chip microcomputer chip. The Bluetooth module was used as the communication platform between the upper computer and the lower computer, and the capture/compare/PWM (CCP) module of the single chip microcomputer chip was used to output the treatment mode pulse width modulation (PWM) pulse electrical stimulation information to the human body, and the frequency domain characteristics and intensity of the human electromyography signal were used as the control parameter standard for the treatment of muscle fatigue. The hardware of the whole system was composed of main control module, Bluetooth connection module, electromyography amplification module, stimulation intensity control module, voltage coupling output module and power module. The upper computer program in the software was based on E4A (Easy Android) open source technology development platform, written in Chinese language; The lower computer program was based on Keil5 development platform and written in C language. Results The experiment showed that the system used the CCP pulse module in STC12C5A60S2 MCU chip, the output PWM pulse electrical stimulation had more powerful, the duty cycle of PWM pulse was easier to control. The wireless communication signal was within 3 m of the controllable distance of Bluetooth, and the physiotherapy module connected based on Bluetooth function could communicate smoothly with the mobile phone APP. Conclusion The research on the physiotherapy device +APP software using single-chip wireless Bluetooth technology has the characteristics of wide operating range, small size, convenient portability and strong output power and low cost, which not only supports mobile medical treatment but also can carry out local treatment for specific parts. This technology has important significance in the development of physiotherapy medicine field.
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  Application of EBT3 Film in Heavy Ion Quality Control

  WANG Ziheng, MA Xiaoyun, YE Yancheng, ZHANG Yanshan, KOU Hairui, WU Xiaosi

  China Medical Devices. 2024, 39(12): 39-45. https://doi.org/10.3969/j.issn.1674-1633.2024.12.008

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  Objective To analyze the response characteristics of EBT3 film to heavy ion beam and explore its application in heavy ion quality control. Methods The EBT3 film was irradiated by 6 MV photons and heavy ion beams of various energies. The net optical density analysis method was introduced to explore the dose-response of the EBT3 film to heavy ion beams. The EBT3 film was utilized to measure the heavy ion field, beam spot, heavy ion peak position and virtual source wheelbase, and the results were compared with PTW 1500XDR ionization chamber matrix and Markus ionization chamber. Results Dose calibration of EBT3 film was performed using net optical density analysis. The range of heavy ion linear energy transfers (LET) was 12.660-19.071 keV/μm, and the range of film net optical density was 0.05-0.40. The dose response of the film to carbon ion beam was 85.71%-95.62% of photons. In the range measurement, compared with PTW 34070-34080 ionization chamber, the dose response was 39.43%-85.88%. In the measurement of field flatness, compared with the PTW 1500XDR ionization chamber, the matrix deviation was -0.50%±1.13%, and the deviation of field size was 4.1 mm. Conclusion The study reveals that the EBT3 film dose-response of carbon ion beams is affected by the LET value and can only be used for absolute dose measurement under specific conditions. In most cases, the EBT3 film can only be used for the measurement of intensities and relative values. However, considering the intuitive nature and high spatial resolution of film results, some of the measurement results are more useful for reference, and it can be employed in the quality control of heavy ion facilities to enhance work efficiency and accuracy.
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  Study on Predictive Maintenance for Medical Oxygen Generator Based on Digital Twin Technology

  LIU Jixun, JIANG Yigang, ZUO Jianxiong, QIU Chao, ZHANG Xing

  China Medical Devices. 2024, 39(12): 46-52. https://doi.org/10.3969/j.issn.1674-1633.2024.12.009

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  Objective To explore a method based on digital twin, to improve the life cycle performance of medical oxygen generator and achieve its predictive maintenance. Methods The digital twin technology was used throughout the whole process of the technogy and system design and operation of the medical oxygen generator, and the “data+model+algorithm” was used to address the problems such as condition changes, risk loss and cost escalation that the medical oxygen concentrator would encounter in the process of intelligent operation and maintenance. The 6-step method was adopted to create a virtual digital twin of medical oxygen generator, and the multi-source information fusion, equipment online accurate adaptive diagnosis, prediction and evaluation of operation and maintenance risks were applied to improve the data acquisition and operation paradigm of medical oxygen generator. Meanwhile, through the data collected by the sensors installed on the medical oxygen generator and the machine learning model and algorithm deployed on the “Medox” server, the predictive maintenance based on the digital twin technology was realized. Results Digital twin based predictive maintenance was deployed for total 43 projects with a total of 105 sets medical oxygen generators. The total operating time was 2.148 million hours, and the unplanned downtime rate had decreased from 0.283% to 0.029% and the spare part cost per unit time from 0.55 yuan/h down to 0.31 yuan/h. The statistical analysis showed that there was a significant difference in unplanned downtime rate and spare part cost per unit time after implementing digital twin based predictive maintenance (P<0.05). Conclusion Digital twin based predictive maintenance reduces unplanned downtime and improves the reliability of medical oxygen generators in its lifespan. And it can extend the service life of the equipment and reduce its operating costs.
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  Performance Testing and Data Analysis of Defbrillators

  WU Chao, YU Qiang, WEN Tao, JIANG Xinfu, ZHONG Zhilong

  China Medical Devices. 2024, 39(12): 53-57. https://doi.org/10.3969/j.issn.1674-1633.2024.12.010

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  Objective To provide guidance for preventive maintenance and procurement decisions through performance testing and data analysis of defibrillators in use from different brands. Methods According to the national measurement standards, the performance of the defibrillator in use was tested and the data were collected, including the discharge energy, charging time, synchronization delay time and heart rate. The parameters of data were tested by SPSS software. Results The actual discharge energy analysis showed no significant differences in discharge energy of 30 J (P=0.118>0.05) and 100 J (P=0.084>0.05) among different brands of defibrillators. However, there were significant differences of discharge energy of 200 J in actual discharge energy (P<0.001), charging time (P=0.001<0.05), and synchronizing delay time (P=0.001<0.05). There was no significant correlation between duration of use and the deviation in maximum defibrillation energy (r=-0.009, P=0.956>0.05), while there was a significant positive correlation between duration of use and charging time (r=0.556, P<0.001). Conclusion Fully utilizing the data from the usage process of medical devices can assist in equipment management decisions and improve the clinical quality and level of precision in medical device utilization and management.
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  Prediction of Efcacy of Neoadjuvant Chemotherapy for Breast Cancer Based on Ultrasound

  MA Na, SUN Zuozheng, WANG Yupei, LIU Qinfeng

  China Medical Devices. 2024, 39(12): 58-63. https://doi.org/10.3969/j.issn.1674-1633.2024.12.011

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  Objective To develop a new method called context attention network (CA-Net) based on deep learning using ultrasound (US) images for early prediction of neoadjuvant chemotherapy (NAC) efficacy in patients with locally advanced breast cancer. Methods A total of 101 women were selected as research objects to receive US surveillance before NAC and 6 to 8 cycles after NAC. The embedded feature ensemble in CA-Net took a multi-scale null convolution and channel attention mechanism was combined and then spatial attention maps were generated using the spatial relations of the spatial attention feature maps. The sensory field was increased by this combined architecture and this combined architecture was also able to focus more accurately on important target regions, improving network performance. The optimal model structure of CA-Net was determined by ablation experiments and basic network comparison experiments. The diagnostic performance of CA-Net for predicting pathologic complete response (pCR) was compared with three recently studied methods, and the predictive performance of the models was assessed by the area under the curve (AUC) of the receiver operating characteristic. Results The AUC value of CA-Net training set was 0.950 (95%CI: 0.870-0.960), with an accuracy of 92.3%, a sensitivity of 89.5%, and a specificity of 94.7%. The AUC value of the test set was 0.920 (95%CI: 0.850-0.930), with an accuracy of 90.7%, a sensitivity of 88.2%, and a specificity of 94.4%, which indicated that the the model had high performance and potential clinical applications, and improved performance over other extant models. Conclusion The deep learning model for prediction of the efficacy of neoadjuvant chemotherapy for breast cancer based on ultrasound has a better prediction efficacy, and can be used as a method to determine whether NAC reaches pCR.
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  Construction Practice of Hospital Network Security Collaborative Linkage Defense System

  CAO Xiaojun, ZHAI Zhibin

  China Medical Devices. 2024, 39(12): 64-70. https://doi.org/10.3969/j.issn.1674-1633.2024.12.012

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  Objective With the rapid development of internet technology, the traditional network security defense system based on perimeter defense as the core is no longer able to meet the security requirements of hospitals. This study aims to explore the construction of the hospital security collaborative linkage defense system based on a situational awareness platform. Methods This study used the situational awareness platform to build three major capabilities of whole-network situational awareness, threat detection, and linkage response, which achieved the security defense system characterized by overall protection and collaborative linkage. Results Through actual application, the situational awareness platform achieved visualization of the whole-network service, threats, and attack and suspicious traffic. After the implementation of the situational awareness system, the number of security incidents was significantly improved compared with that before the implementation, and the difference was statistically significant (P=0.002), which significantly improved the overall security level of the hospital. Conclusion The hospital network security collaborative linkage defense system constructed in this study can effectively respond to the complex network security threats faced by modern hospitals, improve the hospital’s network security protection ability, and has important social significance.
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  Design and Application of Intelligence Medical Record Quality Control System Based on Natural Language Processing

  HAO Anqi, SHEN Jie

  China Medical Devices. 2024, 39(12): 71-77. https://doi.org/10.3969/j.issn.1674-1633.2024.12.013

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  Objective In order to address the problems of insufficient coverage and low accuracy of the connotation quality control of traditional medical records, to construct an intelligent electronic medical record quality control system, so as to realize the improvement of the quality control of medical records. Methods A highly structured medical record database was constructed based on natural language processing, and the medical record quality control engine was used to carry out connotation quality control of medical record. And the quality control function of full coverage, automatic and whole process of electronic medical records was realized. The rate of grade A medical record, the average score of medical record quality control and the proportion of connotation defect items before and after the intelligent medical record quality control system were compared, and the impact of the system on the quality of medical record was analyzed. Results After the intelligent medical record quality control system was launched, the rate of grade A medical record (76.60%) was higher than that before the launch (68.70%); the average score of medical record quality control [(567.68±30.11) scores] was higher than that before the launch [(550.01±46.78) scores], and the differences were statistically significant (P<0.001). And the proportion of connotation defect items decreased significantly compared with that before the launch, with an average decrease of 3.52%. Conclusion Intelligent medical record quality control system can assist clinicians and quality controllers to efficiently and accurately complete the quality control of clinical medical records in hospital, which can improve the quality of medical records in hospitals and the level of hospital management.
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  Research on Information Management of In Vitro Diagnostic Reagents Based on Supply Chain Mode

  LIU Yang, LIU Yajun, LIU Ran, ZOU Ziyao, CHENG Yang

  China Medical Devices. 2024, 39(12): 78-84. https://doi.org/10.3969/j.issn.1674-1633.2024.12.014

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  Objective To explore the influence of information management scheme on the management effect of in vitro diagnostic reagents in hospitals based on the supply chain mode. Methods Through the establishment of the information management system, the whole process traceability management of the procurement, supply, transportation, storage and in-out storage of in vitro diagnostic reagents was realized. At the same time, it had multiple functional modules such as procurement, supply chain coordination, inventory control, in vitro diagnostic reagents whole supply chain temperature monitoring, with information means to realize the comprehensive management of reagents. The in vitro diagnostic reagents purchased from January 2022 to December 2023 were selected as the study object. The control group implemented the routine management mode (n=3521), the observation group implemented the information management mode based on the supply chain mode (n=4125). The effect of purchasing and inventory management of the two groups was compared, and the incidence of work errors and clinical satisfaction of each group were analyzed. Results The matching rate of reagent procurement and the matching rate of clinical use in observation group were higher than those of control group (92.02% vs. 85.15%, 97.02% vs. 93.01%). The time of average reagent inventory of observation group was shorter than that of the control group [(32.53±4.43) min vs. (56.42±5.29) min], and the average monthly reagent inventory accuracy was higher than that of the control group (97.19%±1.64% vs. 93.35%±2.87%). The total incidence of work errors in the observation group was lower than that of control group (0.27% vs. 1.11%). The satisfaction scores of the observation group were higher than the satisfaction scores control group. And all the differences were statistically significant (P<0.05). Conclusion The implementation of information management scheme based on the supply chain mode is helpful to improve the management effect of in vitro diagnostic reagents in hospitals, reduce the occurrence of various work errors during the management period, and obtain higher clinical use satisfaction, which is worth being widely promoted.
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  Application and Discussion of Total Cost of Ownership in Medical Equipment Procurement

  XIE Haoshi

  China Medical Devices. 2024, 39(12): 85-90. https://doi.org/10.3969/j.issn.1674-1633.2024.12.015

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  Objective To explore the application effect based on the method of total cost of ownership in high supply chain costs, backward purchasing management and inability to fully meet clinical needs caused by the current medical equipment procurement method that only focuses on price factors. Methods The composition of medical equipment cost was analyzed, the total cost of ownership computation module was established, and the method of lowest total cost of ownership in medical equipment procurement was adopted. The total cost of procurement before and after implementation of the method was compared in 20 medical equipment procurement projects, and then the application effect of total cost of ownership method were evaluated. Results The procurement price was not equivalent to the total cost of ownership. Calculating the procurement cost using two different procurement methods, the results showed that there was a significant statistically difference (P<0.05) in procurement cost for 20 medical equipment procurement projects. Conclusion Traditional procurement model is difficult to adapt the development of hospitals. Combined with the actual application of the total cost of ownership method in the medical equipment procurement, it can reduce the total costs of the supply chain, optimize procurement process of medical equipment to better meet the clinical requirement and has good application prospects.
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  Construction and Efect Analysis of Ofine and Online Dual Inspection System for Neonatal Medical Equipment in Children’s Specialized Hospital

  LI Yang, ZHANG Xiaobo, SHAO Peng, LI Chensheng, TAO Qilin

  China Medical Devices. 2024, 39(12): 91-96. https://doi.org/10.3969/j.issn.1674-1633.2024.12.016

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  Objective To explore the implementation value of offline and online dual inspection system of neonatal medical equipment in children’s specialized hospital. Methods The Center of Equipment Management and the Department of Neonatology jointly set up the equipment inspection team to clarify the offline and online inspection contents and achieved the equipment inspection objectives, then gradually established and improved the offline and online dual inspection system of the medical equipment in the Department of Neonatology, so as to realize the effective operation of the medical equipment in the Department of Neonatology and ensure the treatment of clinically critical newborns. The application effect of the dual inspection system was verified by comparing the average single maintenance time, the average trouble-free continuous use time of a single device, the annual maintenance cost ratio and the satisfaction of equipment management staffs and doctors before and after the implementation of the offline and online dual inspection system. Results After the implementation of the offline and online dual inspection system, the average single maintenance time was significantly shortened, the average trouble-free continuous use time of a single device was significantly increased, the average annual maintenance cost ratio was significantly reduced, and the satisfaction of equipment management staffs and doctors was significantly increased, all differences were statistically significant (P<0.05). Conclusion Regular offline inspection can show the basic operation status and feedback of the equipment. Online inspection can realize the supervision of the use status and efficiency of online equipment. The implementation of offline and online dual inspection system can improve the utilization rate of equipment, reduce hospital costs, and provide basis for equipment management and decision support.
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  Construction and Application of Lean Management Scheme for Low-Value Pricing Consumables Based on Informatization

  LI Yan, DU Juan, ZENG Xingling, WANG Rong, JIANG Hong, ZENG Jing

  China Medical Devices. 2024, 39(12): 97-102. https://doi.org/10.3969/j.issn.1674-1633.2024.12.017

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  Objective To construct a set of lean management scheme for low-value pricing consumables based on informatization, taking the management of pediatric intravenous indwelling needle as the pilot, so as to improve the efficiency of consumables management. Methods Based on the method of lean management problem-solution, the main reasons affecting the low efficiency of indwelling needle management was clarified through Plato. A lean management scheme based on informatization on the basis of clinical investigation was constructed, and the management process was improved from three aspects: establishment of secondary library, research and development of quantity management tools and optimization of bookkeeping functions. Taking the implementation of lean management as the time node, the daily management time, accounting accuracy rate and nursing staff satisfaction were compared before and after the implementation to verify the implementation effect of lean management scheme. Results After the implementation of the lean management scheme based on informatization, the daily management time of indwelling needles decreased from (44.40±4.73) min to (6.43±2.97) min, the accounting accuracy rate increased from 84.53% to 99.05%, and the satisfaction of nursing staff also increased, with all statistical significance (P<0.05). Conclusion The lean management scheme based on informatization constructed in this study can effectively improve the management efficiency of indwelling needles. This approach can be promoted and continuously optimized in the management of various consumables in the future.
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  Research on Scientifc and Technological Innovation Trends of Aerospace Medicine Based on the Analysis of Articles and Patents

  ZHANG Ting, XU Dongzi, CHEN Juan, OUYANG Zhaolian

  China Medical Devices. 2024, 39(12): 103-111. https://doi.org/10.3969/j.issn.1674-1633.2024.12.018

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  Objective To reveal the trends of scientific and technological innovation through analysis of research articles and invention patents in the field of aerospace medicine. Methods The research articles included in the Web of Science database and invention patents included in the Patsnap patent database were selected as the research objects, and the trends of scientific and technological innovation in the field of aerospace medicine in the global and China were revealed from perspectives of time trend, research and development hotspot, major countries/regions and research and development subjects. Results In the field of global aerospace medicine, there were 716 articles published, and 161 invention patent families (199 patent applications), with a steadily rising development trend. China started late in this field, but has achieved remarkable results in recent years. Global scientific research focused on the aspects of space biopharmaceuticals, pathogenic mechanisms, disease risks and health monitoring, and technological innovation focused on space pharmacy, organ chips, physiological monitoring systems, radiation protection technology and equipment, etc. The United States had a leading edge in scientific research in the field of aerospace medicine. Obviously, China had certain advantages in technological innovation. The dominant technological innovation entities at home and abroad had different characteristics. In foreign countries, enterprises led technological innovation, while in China, universities/research institutes dominated, and the military system led technological innovation in the field of aerospace medicine in China. Conclusion The global scientific and technological innovation in the field of aerospace medicine is on the rise. The United States leads technological innovation, and there are certain differences among domestic and foreign innovators. This study analyzes research articles and invention patents in the field of aerospace medicine, comprehensively reveals the trends of scientific and technological innovation, and provides information support for the development of aerospace medicine from the perspective of information science.
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  Analysis of the Situation and Development Trends of Smart Healthcare Patent Applications

  LIU Chunjie, LIANG Yan

  China Medical Devices. 2024, 39(12): 112-118. https://doi.org/10.3969/j.issn.1674-1633.2024.12.019

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  Objective To analyze and organize technological development trends and patent layout strategies in the global smart healthcare field through statistical analysis of patent data. Methods Global patent application documents in the field of smart healthcare were retrieved from the incoPat database, macro analysis was conducted from the perspectives of application trends, regional distribution, main innovative entities, and branch technology fields. In addition, the patent applications of Philips, IBM and Ping An Technology (Shenzhen) Co., Ltd. (hereinafter referred to as “Ping An Technology”) were analyzed to systematically reveal their technology development trends and patent layout strategies in the field of smart healthcare. Results Global patent applications in the field of smart healthcare were growing rapidly, and China had an advantage in the number of patents in this field. The research and development capabilities of European and American innovation entities were strong, while Chinese entities were working together, and scientific research institutions and innovative enterprises were widely involved in technology research and development. The branch technology field was showing a multi-point explosive trend. In terms of key innovation entities, Philips adopted a “broad layout” application strategy, IBM adopted a “prominent focus” application strategy, while Ping An Technology adopted a “last come, first served” application strategy. Conclusion China faces both opportunities and challenges in the field of smart healthcare, and should integrate scientific research resources, create core patents, attach importance to risk control, and promote the orderly development of smart healthcare technology.
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  Development Trend and Research Hotspot of Domestic SPD Model in Medical Field: A Visual Analysis Based on CiteSpace

  DAI Junhao, LI Guiming, LI Xiaoting, LONG Tianxiao, GUO Zhanxiong

  China Medical Devices. 2024, 39(12): 119-125. https://doi.org/10.3969/j.issn.1674-1633.2024.12.020

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  Objective To explore the development trend and research hotspot of the new supply chain SPD model in domestic hospitals and to put forward some suggestions for the development of this model according to the actual situation. Methods Thematic search was carried out in three databases: CNKI, Wanfang and VIP, and CiteSpace 6.1R6 was used for bibliometric and visual analysis. The annual publication volume analysis, author publication volume analysis, research institution analysis, keyword co-occurrence, keyword clustering, breakthrough word analysis were conducted to explore the development hotspot and research trend of this model. Results Since 2005, the domestic SPD model has experienced stages of introduction, transformation, organic integration, and diversified development. The number of papers published in this field was on the rise, and the scope of papers covered the direction of multiple medical fields. The research on the formation of the core author team found that the field has not formed a clear core team. At the same time, the distribution of scientific research institutions in China was scattered and the overall tendency of cooperation was low. Keywords “supply chain” “medical consumables” “hospital management” and “public hospital” had high centrality. The top 7 clusters with the largest copolymerization were #0 supply chain, #1 high-value consumables, #2 medical consumables, #3 public hospitals, #4 drugs, #5 logistics management, and #6 hospital management. From the analysis of emergent words, it could be found that the SPD model fitted well with the actual development of domestic hospitals in each development stage. Conclusion The research of SPD model in the medical field is on the rise in China, and this model can be further strengthened in the future.
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  Study on the Method of Detecting the Circle of Willis in the Neonatal Mouse Brain by 3D Vascular Doppler Ultrasound with Experimental Small Animal Ultrasound Instrument

  HUANG Song, LIU Lina, XU Qing

  China Medical Devices. 2024, 39(12): 126-130. https://doi.org/10.3969/j.issn.1674-1633.2024.12.021

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  Objective To explore the method of detecting the circle of Willis in the neonatal mouse brain by three-dimensional (3D) vascular ultrasound technology of small animals. Methods The neonatal mice with post-natal ages of 1 d (n=6) and 7 d (n=6) underwent ultrasound scan imaging using the ultra-high resolution ultrasonic imaging system at a center frequency of 30 MHz, and the detection path and direction of the circle of Willis were determined. Doppler imaging and 3D vascular ultrasound of the entire mouse brain with non-invasively through the intact skull and skin were performed to display the circle of Willis in brain. At the same time, the blood flow signals of the middle cerebral artery (MCA) of newborn mice were detected, and the end diastolic velocity (EDV), peak systolic velocity (PSV), resistive index (RI) and coefficient of variation (CV) were measured. The morphology and structure of the circle of Willis in neonatal mice were observed by perfusion technique. Results With the anterior fontanelle as the detection path, the probe was continuously scanned downward at a 45° angle, and color Doppler vascular imaging combined with 3D reconstruction technology was used to display the circle of Willis of newborn mice in stereo, which was consistent with the morphology and structure of the circle of Willis shown by perfusion technique. Pulse Doppler could be used to collect stable MCA blood flow signals, CV was 1.9%~7.9%, and there were no statistical significances in EDV, PSV and RI of MCA blood flow signals on the left and right sides (P>0.05). Conclusion It is feasible to non-invasively display the structure of the circle of Willis in neonatal mouse by 3D vascular ultrasound using small animal ultrasound system, and to detect stable blood flow parameters of MCA. This study can provide an experimental basis for understanding the structure and function of the circle of Willis in living mice during postnatal development.
REVIEW
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  Ethical Consideration and Application of Invasive Nerve Electrical Stimulation in Treating Epilepsy

  YANG Yi, WANG Fan, LIU Zhuo

  China Medical Devices. 2024, 39(12): 131-135. https://doi.org/10.3969/j.issn.1674-1633.2024.12.022

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  Nerve electrical stimulation techniques, including vagus nerve stimulation, responsive neurostimulation, and deep brain stimulation, are effective treatment methods for patients with drug-resistant epilepsy and those unsuitable for traditional epilepsy surgery. With the continuous progress and improvement of nerve electrical stimulation techniques in recent years, their application in treating drug-resistant epilepsy has gradually expanded. In clinical practice, in addition to considering the individual indications for patients, potential ethical issues during the application process need to be considered, such as patient autonomy, risk-benefit ratio, patient unrealistic expectations and privacy security, to fully protect patients’ rights and promote the standardization and safety of the clinical application of new medical technologies. This article reviewed the medical ethical issues that might arise or potentially arise during the clinical application of nerve electrical stimulation therapy technology, in order to further standardize its research and application in clinical practice.
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  Research Progress on Application of Musculoskeletal Ultrasound Technology in Sports Medicine

  ZHANG Li, NING Qingyun, WEI Yuyan, QIAN Jiajia, YING Yu, Zhang Yang, CAI Ren

  China Medical Devices. 2024, 39(12): 136-140. https://doi.org/10.3969/j.issn.1674-1633.2024.12.023

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  Musculoskeletal ultrasound (MSKUS), as a non-invasive and non-radiative imaging technique, is increasingly being applied in sports medicine. MSKUS detects internal structures through high-frequency sound waves and displays the real-time status of muscles, bones, joints, and surrounding tissues, providing important support for the diagnosis and treatment of sports injuries. This paper reviewed the progress of MSKUS technology in the diagnosis and rehabilitation of sports injuries, in order to provide reference value for its clinical application.
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  Application of Mobile Health Technology in Home Rehabilitation of Stroke Patients in China

  ZHANG Jiayu, REN Xin, CHEN Xi, GUO Xiaolan, ZHANG Meixia

  China Medical Devices. 2024, 39(12): 141-145. https://doi.org/10.3969/j.issn.1674-1633.2024.12.024

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  Effective rehabilitation treatment for post-stroke patients can improve limb function and enhance quality of life. Mobile health technology is highly accessible and has a wide coverage, breaking geographical limitations and saving medical resources. It is an important means of achieving home rehabilitation and continuity of care for stroke-disabled patients. This paper summarized the implementation methods, current status, and existing problems of mobile health technology in home rehabilitation for stroke-disabled patients, and discussed the future research directions and challenges.
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  Research Progress in Brain Networks and Paradigms of Rumination

  LONG Sina, ZHOU Yiqian, RUAN Jianghai

  China Medical Devices. 2024, 39(12): 146-152. https://doi.org/10.3969/j.issn.1674-1633.2024.12.025

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  Rumination thinking is a common psychological phenomenon that has received increasing attention in recent years. Rumination thinking specifically refers to an individual’s involuntary and repetitive thinking about the causes, processes, and outcomes of a negative life event, exhibiting negative self-referential processing, negative emotions, and persistence. This review systematically summarized the changes in the brain functional network of rumination thinking, common research paradigms, clinical applications, and intervention measures, aiming to improve the cognition of rumination thinking, explore its related mechanisms, and provide scientific basis for the intervention of rumination thinking. This paper advocated adopting a more objective research paradigm to study rumination thinking, improving the effectiveness of rumination thinking intervention can also be achieved through a combination of modern technology.
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  Progress in Endovascular Intervention Therapy for Ischemic Cerebrovascular Disease

  ZHAO Jiale, WU Qinqin

  China Medical Devices. 2024, 39(12): 153-158. https://doi.org/10.3969/j.issn.1674-1633.2024.12.026

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  Neurointervention in the diagnosis and treatment of cerebrovascular diseases has the characteristics of accuracy, safety, efficiency, wide indications, and few complications. It is a new technology used for the diagnosis and treatment of cerebrovascular diseases, fundamentally improving the accuracy of diagnosis and non-invasive treatment of cerebrovascular diseases. It has important research significance in the prevention and treatment of ischemic cerebrovascular diseases. This paper summarized and categorized the application of neural intervention in ischemic cerebrovascular disease, elaborated on the basic theory of neural intervention treatment devices, as well as the main research achievements currently achieved. At the same time, it analyzed the future development trend of neural intervention devices, in order to provide reference for the development of neural intervention diagnosis and treatment devices.
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  Clinical Application Progress of Dynamic Contrast-Enhanced MRI in Breast Background Parenchymal Enhancement

  LI Siye, HUANG Zikang, SHEN Jun, XU Bin, YU Yueyang, ZHU Yuchun

  China Medical Devices. 2024, 39(12): 159-164. https://doi.org/10.3969/j.issn.1674-1633.2024.12.027

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  Breast cancer has a high incidence rate among female malignant tumors, and the this rate is showing an increasing trend year by year. Background parenchymal enhancement (BPE) in breast dynamic contrast-enhanced MRI can be used as an image biomarker for promoting the targeted, precise diagnosis and treatment of breast lesions for sustainable development. BPE refers to the enhancement of normal fibroglandular breast tissue, influenced by various factors including breast blood supply, endogenous and exogenous hormones. This paper reviewed the classification and quantitative measurement of BPE, factors influencing BPE, the correlation between BPE and the risk of breast cancer, as well as the relationship between BPE, neoadjuvant chemotherapy for breast cancer, and prognosis.
RESEARCH WORK
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  Analysis and Elimination of Typical Faults of Beam in Elekta Versa HDMedical Linear Accelerator

  LIANG Wenjie, LUO Tingjun

  China Medical Devices. 2024, 39(12): 165-170. https://doi.org/10.3969/j.issn.1674-1633.2024.12.028

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  The beam system is the core module of the medical linear accelerator, which is mainly used for electron acceleration to form beam and beam shaping into radiation field. The beam system structure is complex, involves many circuit feedback signals, and is prone to all kinds of faults. This paper summarized two cases of beam system faults, including the beam transport system and beam shaping system. Through the analysis of fault phenomenon combined with the working principle, the beam fault caused by the aging of thyratron was solved by signal analysis and high voltage component replacement, as well as the primary scatterers reported faults one after another due to the damage of acquisition devices at different locations, the fault point was confirmed after the signal source detection and analogy. This pater clarifies the solution of such fault, which has reference significance for peers.
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  Analysis and Quality Control of Maintenance Cases of Weili High-Frequency Electric Knife

  NIE Tao, ZHENG Jun, FENG Jingyi

  China Medical Devices. 2024, 39(12): 171-177. https://doi.org/10.3969/j.issn.1674-1633.2024.12.029

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  Objective To analyze the routine maintenance cases of high-frequency electric knives, to establish a model to predict the recurrence of similar faults, and to carry out preventive maintenance to reduce the incidence of faults. Methods The study adopted methods such as literature review, case analysis, system modeling and simulation analysis to construct a simulation model for fault prediction based on real-world fault cases. The model was used to predict the occurrence rate of faults and compared with actual situations to verify the effectiveness of the model. Then targeted preventive maintenance was carried out based on the predicted results of the model to reduce the occurrence rate of faults. Results The research results showed that the predicting fault rate of 60 high-frequency electric knives was 22.4%, and the actual proportion that did not meet the quality control standards was 25%. The prediction accuracy was 89.6%, and the model validation was effective, and there was no statistical significance between the model and the measured results (P=0.12). Conclusion The prediction model constructed in this study has a high accuracy in predicting the occurrence of faults, and the prediction results can guide the preventive maintenance.
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  Analysis of Fault Cases of Color Doppler Ultrasound Diagnostic Instrument

  PAN Guobin

  China Medical Devices. 2024, 39(12): 178-182. https://doi.org/10.3969/j.issn.1674-1633.2024.12.030

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  Ultrasonic diagnostic instrument has become an indispensable tool in clinical diagnosis because of its high-precision imaging ability and wide application. Three different types of GE medical ultrasound diagnosis systems (LOGIQ E9, VIVID E9 and Voluson E8) were analyzed for their failure of starting without signal input, no response and indicator light off, and starting without response but key light on. Through the use of multimeter, oscilloscope logic analyzer and other tools for fault diagnosis and troubleshooting, the fault points were determined to be memory socket, main power failure, video interrupt cable, and finally the fault was eliminated by repair. Through in-depth analysis of the maintenance process, this paper used systematic maintenance process and logical reasoning to improve the accuracy and maintenance efficiency of fault diagnosis, which is helpful to improve the stability of equipment and prolong the service life, and can provide reference for peers.