10 August 2024, Volume 39 Issue 8

    

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EXPERT CONSENSUS
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  Expert Consensus on the Value Evaluation of Intracranial Stent

  Chinese Medical Association Chinese Society of Medical Engineering

  China Medical Devices. 2024, 39(8): 1-10. https://doi.org/10.3969/j.issn.1674-1633.2024.08.001

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  As key tools of the treatment of aneurysm and intracranial atherosclerotic disease, intracranial stents have different morphological structures with different clinical indications, as well as different technical characteristics for various periods with generation gap on clinical values. Thus, for intracranial stents applying to intracranial aneurysm assist and intracranial arteriosclerosis dilatation, an expert consensus on the multi-criteria evaluation, which contains critical classification attributes, clinical value index system and feasibility validation, has been developed to provide guidance for medical institutions in selection and clinical application of intracranial stents.
RESEARCH WORK
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  Finite Element Analysis of the Dynamic Stability of the Osteotomy End After Minimally Invasive Treatment of Hallux Valgus Using “8” Shaped Bandage External Fixation During Gait Cycle

  CAO Xuhan¹, XIONG Binglang¹, SUN Chengyi², SUN Xudong¹, GUO Ziyan¹, WEN Jianmin¹, SUN Weidong¹

  China Medical Devices. 2024, 39(8): 11-19. https://doi.org/10.3969/j.issn.1674-1633.2024.08.002

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  Objective To establish a biomechanical model of plantar-pressure of hallux valgus with minimally invasive technique combined with traditional Chinese and western medicine, and to study the distribution characteristics and biomechanical rules of plantar-pressure mechanical data of “8” shaped bandage external fixation system in dynamic mechanical environment after hallux valgus. Methods Three different angles of the foot were obtained by combining the time phase corresponding to the ground reaction force with the synchronous three-dimensional motion test, and the stress situation of the foot and ankle during the gait cycle after surgery was simulated. Effective constraints and loading were carried out in the finite element model of external fixation of “8” shaped bandage after minimally invasive treatment of hallux valgus. The stress and displacement force of the osteotomy end in each working period during the walking cycle were calculated (heel following the ground period, support period, accelerated push off period), and then the constant changes of the stress of the fixed osteotomy and the displaced end during the surgical gait cycle were explored. Results During the period of mid-heel following the ground, the maximum total stress at the osteotomy end of the first metatarsal bone was 0.118 MPa, following the ground conditions of the midfoot. The first principal stress was located in the Z-axis direction, at -0.116620 MPa. The maximum total displacement of the osteotomy end was 0.447 mm, and the maximum displacement occured on the X-axis, which was -0.446 mm. The displacement direction was opposite to the X-axis, indicating lateral displacement. During the accelerated push off period, the maximum total stress at the osteotomy end was 1.485 MPa; the first principal stress was -1.467620 MPa; the maximum total displacement of the osteotomy end was 1.667 mm; and the maximum displacement occured on the X-axis, which was -1.658 mm. The working condition during the full support period was the same as the direction during the push off period, followed by the numerical value. Conclusion During the gait cycle, the stress on the osteotomy end of the first metatarsal bone is mainly compressive stress, and the displacement is mainly the lateral shift of the distal osteotomy. Postoperative “8” shaped bandage external fixation can ensure the dynamic stability of the osteotomy end after minimally invasive treatment of hallux valgus in the gait cycle, increase the compressive stress of the osteotomy end, and promote the healing of the osteotomy end.
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  Phantom Study on the Impact of Non-Standard Localizer Radiograph on Image Quality and Radiation Dose in CT Scanning

  BIAN Hongli^1a, HU Mei^1a, SUN Xiaolei^1b, CHEN Jiliang², ZHANG Jiulou^1a, XU Lulu^1a

  China Medical Devices. 2024, 39(8): 20-24. https://doi.org/10.3969/j.issn.1674-1633.2024.08.003

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  Objective To investigate the impact of non-standard localizer radiographs on the image quality and radiation dose of spiral CT scans through phantom experiments. Methods A standard localizer radiograph including the phantom was utilized for scanning the phantom and obtaining baseline group images, followed by a non-standard localizer radiograph containing the phantom and syringe to scan the phantom for non-baseline group images. The quality parameters of the two groups of images were compared including noise, linear CT value (3 materials: Teflon, LDPE, Air), density resolution and spatial resolution. Additionally, dose-related parameters between the two scanning protocols including effective milliampere seconds (eff.mAs) and CT dose index volume (CTDIvol) were compared. Results The comparison of noise in baseline group was lower than that in non-baseline group (P<0.05). Regarding CT value linearity, the baseline group showed a closer alignment to the standard CT value than the non-baseline group (P<0.05). In terms of density resolution, the baseline group significantly outperformed the non-baseline group in identifying the smallest diameter of the hole array (P<0.05). The difference was not statistically significant in spatial resolution between the two image groups (P>0.05). In the comparison of scanning protocols between the two groups, the eff.mAs and CTDIvol were higher in the non-baseline group than in the baseline group (all P<0.05). Conclusion Using standard localizer radiographs in spiral CT scans can achieve image quality requirements with lower radiation doses. The use of non-standard positioning images not only increases the radiation dose, but also damages the image quality
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  Research on Life Prediction of Medical Ultrasonic Equipment Based on Improved Particle Filter Algorithm

  WU Yiwei^a, ZHANG Ye^a, WANG Wenjie^a, JIN Wei^b

  China Medical Devices. 2024, 39(8): 25-31. https://doi.org/10.3969/j.issn.1674-1633.2024.08.004

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  Objective To design a method for predicting the lifespan of medical ultrasound equipment based on an improved particle filter algorithm, to solve the problems of inaccurate analysis of equipment degradation process in traditional medical ultrasound equipment lifespan prediction, which lead to the inability to update prediction model parameters in real time and a decrease in prediction accuracy. Methods Firstly, the entire lifecycle of medical ultrasound equipment was divided into normal degradation state and imperfect maintenance degradation state. The equipment degradation process was analyzed, and a life prediction model was established based on the degradation process of medical ultrasound equipment. Then, the maximum likelihood theory was used to calculate the degradation parameters in the model, and the model parameters were randomly updated based on actual degradation data to obtain a life prediction model that was more in line with the actual degradation process of the equipment. Finally, the improved particle filter algorithm was used to solve the model and obtain the life prediction results of medical ultrasound equipment. Results The model established by the proposed method had a coefficient of determination above 0.80 and was closer to 1, with a high accuracy in predicting the lifespan of medical ultrasound equipment, with an average of 88.5%. Conclusion The improved particle filter algorithm has a high accuracy and reliability in predicting the lifespan of medical ultrasound equipment, which can effectively identify early signs of equipment failure, take maintenance or replacement measures in advance, and avoid possible equipment damage and downtime.
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  Study on Simulation Model for Nanoparticle Enhanced Laser Ablation Based on Monte Carlo Methods

  XU Lei¹, JIANG Xuejiao², LIANG Huishan²

  China Medical Devices. 2024, 39(8): 32-37. https://doi.org/10.3969/j.issn.1674-1633.2024.08.005

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  Objective To design a numerical simulation model of laser ablation and determine the laser ablation treatment for brain tumors, and to determine the effects of ablation time, laser power and aqueous solution of gold nanoparticles on laser ablation. Methods In this study, a simplified brain tumor geometric model was established, and the photon distribution in brain tissue was simulated by the Monte Carlo calculation method to determine laser energy deposition. Then, the Pennes biological heat transfer model was used to calculate the temperature increase process of spheroid tumors embedded in cylindrical human brain tissue. The Arrhenius integral was combined with the heat transfer model to calculate the thermal damage of the tissue and determine the laser ablation scheme. Gold nanoparticles were introduced in the model where the thermal damage range exceeded the tumor volume, and the feasibility of gold nanoparticles in reducing the damage of surrounding healthy tissues was explored. Results Increasing the laser power or ablation time increased the maximum temperature during the ablation process and the range of thermal damage. For the spheroid brain tumor with a diameter of 10 mm assumed in this study, when the ablation time was 300 s, the laser power was 3 W, the ablation time was 180 s, and the laser power was 5 W, the spheroid tumor was completely ablated. Gold nanoparticles were injected into the tumor, assuming that the gold nanoparticles were evenly distributed in the tumor, the selected ablation combination with a demelting time of 180 s laser power of 5 W and when did not add gold nanoparticles, the volume of thermal damage was 1.98 cm3, the damage rate to surrounding healthy tissues was 2.96%, the thermal damage volume after adding gold nanoparticles in the same combination was 0.95 cm3, and the damage rate to surrounding healthy tissues was 0.88%. Conclusion The numerical simulation model established in this study has a certain reference role in determining the laser ablation parameters. Increasing laser power and ablation time can increase the volume of thermal damage and increase the maximum ablation temperature, while the addition of gold nanoparticles can reduce the thermal damage to healthy tissues.
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  Study on Morphological Structure and Wear Resistance of Porous Coatings on the Surface of Joint Implants

  LI Fan^1，2,3, WANG Changbin^1，2,3, GAO Na^1，2,3, LIANG Jinkui^1，2,3, FANG Yuan^1，2,3, ZHANG Luwen^1，2,3, YANG Jing^1，2,3, ZHANG Bo^1，2,3

  China Medical Devices. 2024, 39(8): 38-43. https://doi.org/10.3969/j.issn.1674-1633.2024.08.006

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  Objective To analyze and explore the morphological structure, and wear resistance of porous coatings with different processes on the surface of joint implants. Methods Three types of plasma sprayed titanium coating samples, one type of titanium bead sintered coating sample, and one type of 3D printed porous structure sample were selected. The porous structure of the surface coating of the samples were analyzed according to YY/T 0988.14-2016, and the porosity and pore intercept of the porous structure were measured on the longitudinal section of coating under metallographic microscope. And the wear resistance of the samples were tested according to ASTM F1978-22. The surface morphology of the coating before and after wear were observed under a scanning electron microscope, and the wear behavior and wear mechanism of coatings with different processes and pore structures were analyzed. Results The porosity of several coatings ranged from 30% to 60%, with a pore intercept between 100 and 510 μm, in compliance with FDA regulations, the pore connectivity of titanium bead sintered coatings and 3D printed porous coatings were better than that of plasma sprayed coatings. The wear process of plasma sprayed coatings was characterized by particle detachment accompanied by abrasive wear, while the wear process of titanium bead sintered coatings and 3D printed porous samples was mainly characterized by abrasive wear. Conclusion The difference in wear resistance is significantly related to coating process, porosity, and structural form.
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  Effect of IMRT and VMAT on Intra-Fractional Errors in Breast Cancer Patients

  HUANG Wenzheng, LIN Haitao, Sun Hangbiao, He Xuwei, Li Feng, HU Qunchao

  China Medical Devices. 2024, 39(8): 44-48. https://doi.org/10.3969/j.issn.1674-1633.2024.08.007

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  Objective To compare the intra-fractional errors of breast cancer patients after breast-conserving surgery when applying intensity modulated radiation therapy (IMRT) and volumetric modulated arc therapy (VMAT), and to investigate whether adding an abdominal thermoplastic during position fixation can reduce intra-fractional errors or not. Methods A total of 60 female patients who received radiation therapy after breast conserving surgery from October 2022 to March 2023 were selected as the study objects, and randomly divided into IMRT group (n=30) and VMAT group (n=30) according to different treatment techniques. A total of 15 patients in each of the 2 groups were randomly selected to add thermoplastic film to the abdomen when the body position was fixed, and were divided into the conventional group and the peritoneal group according to whether the attachment was fixed with thermoplastic film. With the planned target volume as the main registration area, the intra-fractional errors of IMRT group and VMAT group, conventional group and peritoneal group were compared by the cone-beam CT gray scale registration algorithm. Results According to independent sample t-test, the treatment duration of VMAT group was significantly smaller than that of IMRT group [(4.17±0.86) min vs. (9.69±1.13) min], and the difference was statistically significant (P<0.05). According to Wilcoxon rank sum test, the intra-fractional errors in the left and right (x), head and foot (y), anterior-posterior (z) directions in VMAT group were smaller than those in IMRT group, with statistical significance (P<0.05). According to independent sample t-test, there was no significant difference in the treatment duration between the conventional group and the peritoneal group (P>0.05). According to Wilcoxon rank sum test, the intra-fractional error in x and y directions in peritoneal group was smaller than that in conventional group, the difference was statistically significant (P<0.05), but there was no statistically significant difference in z direction (P>0.05). Conclusion The application of VMAT technique results in smaller intra-fractional errors compared to IMRT for breast cancer patients after breastconserving surgery. The addition of abdominal thermoplastic film in the body position fixation can reduce the intra-fractionated error in x and y directions.
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  Dosimetric Analysis of Gamma Knife, IMRT and VMAT in Treatment of Recurrent High-Grade Gliomas

  LIU Xiao¹, WANG Kai¹, CHEN Jiawei¹, HU Fanxiang², YANG Yang², LI Yanjing¹, LV Haipeng¹

  China Medical Devices. 2024, 39(8): 49-54. https://doi.org/10.3969/j.issn.1674-1633.2024.08.008

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  Objective By analyzing the dosimetric differences of gamma knife, fixed field intensity modulated radiation therapy (IMRT) and volumetric modulated arc therapy (VMAT) in patients with recurrent high-grade glioma, to discuss the advantages and disadvantages of the three radiotherapy methods. Methods A total of 19 patients with recurrent high-grade gliomas who received radiotherapy in No.971 Hospital of The People’s Liberation Army Navy from January 2020 to January 2022 were selected as the study objects. The gamma knife, fixed field IMRT and VMAT treatment plans were designed in treatment planning system. Fixed field IMRT and VMAT were designed target uniform dose plan and target simultaneous integrated boost (SIB) plan (SIB-IMRT, SIB-VMAT) respectively, requiring the prescription dose to contain 95% volume. The evaluation parameters included low-dose area V5, brain radiation necrosis index V12, target conformal index (CI), target homogeneity index (HI), target maximum dose (Dmax), average dose (Dmean) and gradient index. Results Among the five treatment plans, the V5 of SIB-IMRT was lower than that of fixed field IMRT and SIB-VMAT (both P<0.05); The V12 of gamma knife was the lowest (all P<0.05), and The V12 of SIB plan were lower than that of conventional plan (SIB-IMRT vs. fixed field IMRT, SIB-VMAT vs. VMAT) (all P<0.05). There was no statistically significant difference in CI between fixed field IMRT and VMAT, SIB-IMRT and SIB-VMAT (all P>0.05), and all better than gamma knife (all P<0.05). There was no statistically significant difference in HI and Dmean between gamma knife and SIB-IMRT, SIB-VMAT (both P>0.05). Conclusion The protective effect of gamma knife on normal brain tissue is better, but the conformal degree of complex target area is slightly worse. The conformal degree of fixed field IMRT and VMAT is higher, and SIB-IMRT and SIB-VMAT can reach the target dose distribution similar to gamma knife, and the dose of normal brain tissue is lower than that of conventional IMRT.
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  Application of Intelligent Fusion Technology Based on Multi-Source Features in Breast Cancer Recognition

  WANG Longqi¹, ZHOU Xuechao²

  China Medical Devices. 2024, 39(8): 55-61. https://doi.org/10.3969/j.issn.1674-1633.2024.08.009

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  Objective To propose a multi-source features fusion technology combined with limited-memory broyden-fletcher-goldfarbshanno- back propagation (L-BFGS-BP) neural network model to provide reference for screening and diagnosis of breast cancer. Methods A total of 388 breast cancer patients and 288 non breast cancer patients who were diagnosed in Jinling Hospital, Affiliated Hospital of Medical School, Nanjing University, from September 1, 2016 to August 31, 2022 were collected as research objects. Multi source feature sets were collected and sorted out from the aspects of biogenetics, clinical characteristics, serum markers, imaging, etc. The L-BFGS optimization algorithm and L-BFGS-BP model were established. Results Compared with random forest, BP neural network model, support vector machine, naive Bayes model, the accuracy of L-BFGS-BP model test increased by 8.07%, 13.55%, 3.55% and 8.39%, with statistically significant differences (P<0.05); the accuracy had been improved by 9.12%, 16.42%, 7.50%, and 7.19% respectively, with statistically significant differences (P<0.05). The L-BFGS-BP model also showed the same results in recall rate and F1 score. Conclusion L-BFGS-BP model has a better robustness, faster rate of convergence, better optimization ability, strong prediction ability, which has broad application prospects and research value.
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  Research and Application of Overlay Network for Telemedicine Model

  WANG Ruiqing^1a,2, WANG Can^1b, SUN Hao^1b, MA Jun³, ZHU Di^1a, CUI Xuelei^1b, CAO Desen^1b, HE Kunlun^1a

  China Medical Devices. 2024, 39(8): 62-66. https://doi.org/10.3969/j.issn.1674-1633.2024.08.010

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  Objective To study an overlay network for telemedicine (ONTM) model in order to improve the problem that the traditional internet can not fully meet the diversified service quality of telemedicine services. Methods The ONTM model was established based on the architecture of overlay network, which was divided into control plane and data plane, and was responsible for the overall policy regulation and network transmission. A multilink aggregation strategy was used on the access side of ONTM model, and the transport layer was further subdivided into a source/channel transport sublayer. Network monitoring software was used to test the network performance parameters of models between terminals. Results The novel telemedicine system based on ONTM model has completed more than 10000 telemedicine services, covering 15 clinical departments. Under the control of ONTM model, the average delay from Beijing to Sanya during the operation of 5G remote brain pacemaker surgery was 76 ms, the packet loss rate was mostly 0, and the transmission traffic was stable at 10 Mbps, which was superior to the general 5G network. Conclusion The ONTM model can ensure the stable transmission of telemedicine data and provide a new idea for telemedicine in special environment.
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  Design and Application of the Whole-Process One-Stop Medical Technology Appointment Platform

  YAN Guotao, LIAO Zhixuan, LI Xing

  China Medical Devices. 2024, 39(8): 67-73. https://doi.org/10.3969/j.issn.1674-1633.2024.08.011

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  Objective To design a whole-process one-stop medical technology appointment platform based on the actual situation within the hospital, in order to improve the work efficiency of medical technology departments, develop in tandem with inpatients and outpatients, and improve patient satisfaction. Methods Based on JAVA development platform, the multi-port, whole-process and one-stop medical technology appointment platform was built by using new generation of middle platform architecture. The WebService technology was used to connect with related systems and map to middle platform, and dynamic programming algorithm was used to recommend the optimal examination reservation scheme for patients. Results The multi-port platform design enabled patients to make whole-process medical technology appointments under different circumstances, and implemented overall control of medical technology examination resources in the whole hospital. The waiting time of patients for various examinations and the transport time of patients were significantly shortened (P<0.05). The efficiency of medical technology departments was greatly improved, and the number of examination cases increased significantly. The patient satisfaction increased from 21.44% to 92.86%, and the differences were statistically significant (P<0.05). Conclusion The whole-process one-stop medical technology appointment platform greatly improves the utilization rate of inspection equipment, significantly improves the quality of medical services through reasonable arrangement of inspection time, indirectly improves the outpatient reception capacity and inpatient bed turnover rate, which promotes the informatization process of smart hospitals.
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  Development and Application of Radiation Therapy Information and Imaging Management Software KylinRay-OIMS

  CHENG Mengyun^1,2,3, SHANG Leiming^1,2,3, ZHENG Huaqing^1,2,3, LONG Pengcheng^1,2,3, JIA Jing^1,2,3, HE Tao^1,2,3, HU Liqin^1,2,3

  China Medical Devices. 2024, 39(8): 74-82. https://doi.org/10.3969/j.issn.1674-1633.2024.08.012

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  Objective Aiming at the problems of difficult and low efficiency of radiotherapy management due to complex business processes and long treatment cycles, and thus affecting the quality of radiotherapy, to design a radiotherapy information system to realize the information management of the whole-process of radiotherapy business and effectively improve the efficiency of radiotherapy work. Methods Combining patient needs, medical technology operation process and department quality management, the accuracy method of web-based rapid visualization of DICOM-RT data and dose and volume histogram calculation based on organ outlining and dose data was developed. The oncology information management system (KylinRay-OIMS) based on B/S architecture was developed, which included the core functions of patient management, workflow, image and DICOM-RT display and management, appointment management, queue call, charge management, statistical analysis, quality control management, patient follow-up, wechat mini program, multi-hospital management and so on. Results KylinRay-OIMS realized the paperless office of radiotherapy, improved the clinical effect and efficiency of plan evaluation, broke through the information barriers with treatment planning system, medical accelerator and other systems in the hospital, and made the seamless connection between diagnosis data and treatment process, which has been widely used in hospitals. Conclusion KylinRay-OIMS can meet the clinical needs, realize the information management of radiotherapy, ensure the standardization of radiotherapy process, and improve clinical work efficiency.
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  Design and Application of Intelligent Audit System Based on Whole-Process of Medical Insurance

  LIU Jie, HU Shengli

  China Medical Devices. 2024, 39(8): 83-87. https://doi.org/10.3969/j.issn.1674-1633.2024.08.013

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  Objective To maximize the avoidance of medical insurance violations, ensure the smooth implementation of medical insurance settlement for patients, and to solve the problem of traditional audit systems not being able to meet the supervision of all patient diagnosis and treatment processes in hospitals. Methods The system adopted object-oriented method, Java programming language and Oracle database to realize the whole-process audit, regular audit and discharge audit of the medical activities of patients after admission (such as the first page of medical records, inpatient records, inspection reports, temperature sheets, long-term and temporary medical orders, expenses, etc.). And the application effectiveness of the system was discussed. Results After launch of the system, unreasonable diagnosis and treatment behaviors could be timely fed back to medical personnel to realize the audit of all diagnosis and treatment activities in the outpatient and inpatient departments. The number of suspected violations decreased from (91.0±2.3) thousand before the system launched to (33.0±0.8) thousand, and the amount of non-payment decreased from (9820.0±31.6) thousand yuan to (3510.0±16.9) thousand yuan. The average review time of each medical record was shortened from (10.30±0.12) min to (3.20±0.11) min, and patient satisfaction was increased from 96.20%±0.12% to 98.60%±0.10%, with statistical significance (P<0.001). Conclusion The whole-process medical insurance audit system is of great significance for standardizing the diagnosis and treatment behavior, optimizing the audit process, and promoting the fine management of medical insurance work, and it is worth promoting and applying.
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  Clinical Evaluation of Hemostatic Medical Consumables in Grade Ⅲ-A Hospital in Shanghai

  HUANG Ahong^1a,2, ZHENG Yunxin^1b,2, SUI Haiyu^1c,2, WANG Fangjie^1b,2, LUO Li^1d,2, YU Junren^1c,2

  China Medical Devices. 2024, 39(8): 88-92. https://doi.org/10.3969/j.issn.1674-1633.2024.08.014

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  Objective To evaluate and analyze the use of hemostatic consumables in the surgical treatment of malignant tumors in the general surgery department of a certain hospital, and provide policy suggestions for the rational use and supervision of hospital consumables. Methods A total of 391 patients who underwent surgical treatment for malignant tumors in the general surgery department of the hospital from January to September 2023 were selected as the research objects. Stratified sampling was used to determine the research samples. Stata 16.0 was used to conduct statistical analysis on the effectiveness and cost-effectiveness of four types of hemostatic consumables based on case data. The effectiveness indexes included intraoperative blood loss and postoperative drainage tube placement days, while the cost-effectiveness indexes included postoperative hospital stay and hemostatic treatmentrelated costs. Results Different types of hemostatic consumables showed statistically significant differences in intraoperative blood loss and postoperative drainage tube placement days (P<0.05); there were no significant differences among the four types of hemostatic consumables in terms of postoperative hospital stay and postoperative hemostatic treatment-related costs (P>0.05). Conclusion The results of this study showed that the effectiveness of different types of hemostatic consumables was highlighted, with consumables that demonstrate better effectiveness having relatively higher unit prices, but it was difficult to reflect the economic value. This study provides a reference for the rational standardized use as well as effective supervision of hemostatic consumables.
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  Quantitative Measurement of International Collaboration Participation for Chinese Cities in the Field of Biomedical Engineering

  PAN Lizi¹, CHEN Juan¹, OUYANG Zhaolian¹, WU Xusheng²

  China Medical Devices. 2024, 39(8): 93-99. https://doi.org/10.3969/j.issn.1674-1633.2024.08.015

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  Objective To identify Chinese cities and institutions with high participation in international cooperation in the field of biomedical engineering, and to discover the characteristics of China’s international cooperation in this field. Methods Papers on the topic of biomedical engineering was searched from the Web of Science database. Excel and Pajek software were used to make a descriptive statistical analysis of the international cooperation papers issued by Chinese cities and institutions, and the change trend of cooperation networks was analyzed. The technique for order preference by similarity to an ideal solution (TOPSIS) was used to evaluate the importance of cities and institutions in the cooperative network. Results A total of 45944 papers related to biomedical engineering were retrieved. Descriptive statistics showed that Beijing, Shanghai, Guangzhou and Shenzhen rowed in the forefront of China in the number of international cooperation publications. Hong Kong, Xi’an and Wenzhou had a higher proportion of international cooperation papers. By quantifying the level of international cooperation, it was found that the enthusiasm of the above cities in international cooperation, the importance of cooperation network and TOPSIS scores were at a high level. At the institutional level, some universities in Beijing, Shanghai and Guangdong were more active in international cooperation. Conclusion By quantifying the international cooperation network of research papers in the field of biomedical engineering, this study identified the most active and important cities and institutions in domestic and international cooperat ion, understood the current popular research directions in the field of international cooperation, and put forward suggestions for promoting the degree of international cooperation in the field o f biomedical engineering in China.
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  Visualization Analysis of Hospital SPD Mode Research in China Based on CiteSpace

  YIN Pengyu^a, LIU Chuang^b, ZHANG Hongjia^b

  China Medical Devices. 2024, 39(8): 100-105. https://doi.org/10.3969/j.issn.1674-1633.2024.08.016

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  Objective To analyze the current research status, hot spots and frontier problems in the field of hospital SPD model in China, and provide reference for future research on the construction of hospital SPD model. Methods With “hospital”and “SPD model” as the main title or keywords, the Chinese journal papers on the SPD model of Chinese hospitals published from 2013 to 2022 were searched from CNKI and Wanfang database. In addition, CiteSpace software was used to make a visual analysis of the literatures included in the study, so as to understand the hot spots in the study of hospital SPD model and the keyword cluster emergence. Results A total of 394 literatures were initially searched, and 224 literatures were eventually included. The number of papers published in the study of hospital SPD model showed an overall upward trend. The visual keyword analysis of hospital SPD mode showed that the keywords such as “medical consumables” “hospital” “logistics management” “high-value consumables” “consumables management” “supply chain” and “drugs” appeared more frequently. After visualization, 9 clusters were presented, which were medical consumables, hospital, logistics management, management, operating room, supply chain, consumables management, risk, testing reagents. The analysis of emergent words showed that logistics, mode, Internet of Things, medicine, drug procurement, consumables management were the hot spots of SPD model research in hospitals in recent years. Conclusion Through visual analysis of the research literature on hospital SPD model, this study revealed the trend of publication, core authors and institutions, research hotspots and development trend of hospital SPD model in China in the past 10 years, which can provide reference for further related research and construction in the future.
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  Construction of Comprehensive Evaluation System for Hospital Valuable Equipment Using the Boston Matrix——Taking Large-Scale Ultrasound as an Example

  TANG Jie, SHEN Yanwan, ZHANG Ziyu

  China Medical Devices. 2024, 39(8): 106-111. https://doi.org/10.3969/j.issn.1674-1633.2024.08.017

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  Objective To construct a complete comprehensive evaluation system of valuable medical equipment, so that the management of valuable medical equipment in hospitals can be based on evidence. Methods Literature analysis and expert questionnaire survey were used to build a comprehensive evaluation index system for valuable medical equipment. A total of 12 in-use color ultrasound equipment with a purchase amount of more than 1 million yuan in the ultrasound department of our hospital were selected, the use data of 2023 were collected form the hospital data system, and the use data were evaluated based on the comprehensive evaluation index system. The Boston matrix was used to analyze their comprehensive operating situation in 2023. Results Among the 12 valuable color ultrasound equipment, the star equipment was 2 LOGIQ E9 and ACUSON SEQUOIA; taurus equipment was ALOKA ARIETTA 850, LOGIQ E20, RS80A; dog slimming equipment was EPIQ CVX, EPIQ 5, VIVID E95, APLIO I900, APLIO 400 and MYLAB TWICE. There was no problem equipment, this result was consistent with the reality. Conclusion The comprehensive evaluation system of valuable medical equipment based on Boston matrix can clearly reflect the comprehensive benefits of valuable medical equipment in the hospital, and increase data support for the hospital upper management to decide whether to add new equipment, select the appropriate machine model, and whether to scrap, so as to avoid repeated acquisition and idle waste of resources.
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  Construction of the Whole Life Cycle Performance Evaluation System of Large Medical Equipment Based on Fine Management

  DU Zhongjun^a, JIANG Wenbin^b, CHEN Hao^c, YU Shui^d, YANG Fei^e, PAN Yueshuai^c, WEI Lili^f, LIU Fei^g

  China Medical Devices. 2024, 39(8): 112-119. https://doi.org/10.3969/j.issn.1674-1633.2024.08.018

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  Objective To construct a performance evaluation system for the whole life cycle of large medical equipment, and to provide reference for the fine management of large medical equipment. Methods Literature review and expert interviews were used to establish the initial indicator pool, then the research team sorted out and discussed the initial indicators and compiled the expert letter questionnaire. The Delphi method was used to consult 40 selected experts in the field of medical equipment management. The whole life cycle performance evaluation system of large medical equipment was established. The index weights were determined by analytic hierarchy process. The empirical analysis was carried out, taking the CT machine of a health examination center in a branch of a grade Ⅲ-A hospital in Qingdao as an example. Results The whole life cycle performance evaluation system of large medical equipment was established, including 4 first-level indicators, 12 second-level indicators and 117 third-level indicators. Using this evaluation system, the CT machine of a health examination center in a branch of a grade Ⅲ-A hospital in Qingdao was evaluated. The score of the CT machine in the procurement configuration stage was 47.1, and the score in the operation management stage was 37.9. The comprehensive evaluation result of the CT machine was excellent according to the evaluation criteria. Conclusion The active degree, authority degree and coordination degree of experts in this study are all in line with the standards, and the whole life cycle performance evaluation system constructed for large medical equipment is highly scientific and reliable, which can provide reference for the fine management of large medical equipment.
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  Exploration of the Standard for Simulation Transport Tests of Medical Electrical Equipment

  YU Xiaohui^1a,2, CHEN Fang^1b,2, LI Wenli^1a,2, SHAO Guojun^1c,2

  China Medical Devices. 2024, 39(8): 120-125. https://doi.org/10.3969/j.issn.1674-1633.2024.08.019

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  Objective To provide a better evaluation method and approach for verifying the transport stability of medical electrical equipment in China. Methods The circulation characteristics of medical electrical equipment and the problems existing in the standard GB/T 14710-2009 regarding transport tests was reviewed, and the contents of the main reference standards for simulated transportation tests at home and abroad were analyzed, and the technical differences between road transport as stipulated in GB/T 14710-2009 and other transport standards were compared. Results The simulated transport tests of medical electrical equipment were not limited to the third-class road transport specified in GB/T 14710-2009, but also included other aspects such as drops during handling, compression during stacking, vibrations from various road conditions and different modes of transportation. Conclusion It is essential to comprehensively assess the product itself and various potential environmental hazards that may be encountered during the circulation cycle, and determine the specific content of the transport test based on practical considerations.
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  Comparative Study on the Clinical Economy of Domestic and Imported Stapler Based on Real World Data

  GU Wei^1a, ZHOU Yang^1a, LIU Yang², PAN Changqing^1b

  China Medical Devices. 2024, 39(8): 126-131. https://doi.org/10.3969/j.issn.1674-1633.2024.08.020

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  Objective To analyze and evaluate the relevant cost indicators of domestic and imported staplers in clinical surgery from an economic perspective, and to provide references for statistical analysis and evaluation method selection of clinical evaluation of similar products. Methods Based on the guiding principles of the real world data formulated by the state and combined with the clinical application of staplers, the path and method of the study of the real world data related to staplers was put forward. A total of 2000 surgical procedures using staplers were selected from the Department of Thoracic Surgery and the Department of Surgical Oncology of Shanghai Chest Hospital from 2019 to 2021, of which 1000 cases used domestic staplers and the other 1000 cases used imported staplers. Descriptive statistical analysis and bias score correction were used to analyze the differences in patients, efficiency and economy of the two groups of data. Results The average cost of stapler per operation and hemostatic consumables per operation in the operation group using domestic stapler were significantly lower than those in the operation group using imported stapler (P<0.001). There was no significant difference in operation duration between the two groups (P=0.900). Correlation analysis showed that stapler cost was strongly correlated with operation time (r=0.987, P=0.002). There was no significant difference in the proportion of stapler cost and hemostatic consumables cost between imported stapler and domestic stapler (P>0.05). Conclusion Domestic staplers have a certain positive effect on affecting the cost of surgical direct consumables and related consumables. It is suggested to establish a consensus of domestic stapler experts to provide a certain reference basis for the fine management of domestic medical devices and the development of future innovative technologies.
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  Application Research on Cost Management of Medical Materials in Grade Ⅲ Hospitals Under SPD Mode

  ZHOU Junyu

  China Medical Devices. 2024, 39(8): 132-138. https://doi.org/10.3969/j.issn.1674-1633.2024.08.021

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  Objective To analyze and research on the effect of SPD management mode on the cost management of medical materials in grade Ⅲ hospital. Methods The qualitative and quantitative analysis of the effect of medical materials cost management in grade Ⅲ hospital under the SPD mode was carried out by using the methods of expert investigation, AHP and fuzzy comprehensive analysis. And the changes of medical materials cost management before and after the application of SPD mode in a grade Ⅲ hospital were compared. Results An evaluation index system of medical materials cost management effect under SPD model based on management cost, procurement cost, information cost and financial cost was constructed, including 1 objective, 4 criterion-level indicators and 13 scheme-level indicators. By comparing the effect of medical materials cost management before and after the application of SPD mode in a grade Ⅲ hospital, the average monthly management time of operating room under the application of SPD mode was reduced by 64.33%, the consumption rate of medical consumables was reduced by 73.11%, the accuracy rate of medical consumables cost accounting was increased by 12.26%, and the average monthly inventory amount of medical consumables was decreased by 85.83%. The average monthly management consumables decreased by 98.77%, and the cost control level of medical materials management under SPD mode was above good. Conclusion SPD model significantly improves the cost management effect of hospital medical materials. The evaluation index system of cost management effect of medical materials under SPD model established in this study has certain popularization value.
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  Effects of CacyBP/SIP on Invasion, Migration and Angiogenesis of Stromal Cells in Endometriosis

  YANG Tao¹, DU Xiufang¹, YANG Hongjie¹, FU Changna¹, KANG Xiaobei¹, LIN Kaiqing²

  China Medical Devices. 2024, 39(8): 139-145. https://doi.org/10.3969/j.issn.1674-1633.2024.08.022

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  Objective To explore the mechanism of Calcyclin-binding protein/Siah-1-interacting protein (CacyBP/SIP) on the invasion, migration, and angiogenesis of endometriosis (EMs) stromal cells. Methods A total of 60 patients with EMs who visited the Obstetrics Department of Shijiazhuang Maternal and Child Health Hospital from January 2021 to December 2022 were selected as the research subjects. Through laparoscopic surgery, endometrial tissue was taken and endometrial stromal cells were isolated. The recombinant CacyBP/SIP lentivirus and inhibitor transfection was used to detect the virus and inhibit the transfection results. The experiment was divided into 5 groups including CacyBP/SIP lentivirus group, lentivirus negative control group, CacyBP/SIP inhibitor group, inhibitor negative control group, and untreated group. Quantitative PCR was used to identify CacyBP/SIP levels in each group of cells, Transwell method was used to detect cell invasion and migration in each group, MTT colorimetric method was used to detect the proliferation of cells in each group, flow cytometry was used to detect cell apoptosis in each group, immunoblotting was used to detect the expression of vascular endothelial growth factor (VEGF) and cyclooxygenase-2 (COX-2) in cells of each group. Results Compared with the inhibitor negative control group, the CacyBP/SIP lentivirus group showed an increase in cell proliferation at 24, 48 and 72 h (P<0.05); however, compared with the CacyBP/SIP lentivirus group, the CacyBP/SIP inhibitor group showed a decrease in cell proliferation (P<0.05). Compared with the inhibitor negative control group, the CacyBP/SIP lentivirus group showed an increase in CacyBP/SIP levels, number of cell invasion, migration, and expression of VEGF and COX-2 proteins (P<0.05); however, compared with the CacyBP/SIP lentivirus group, the CacyBP/SIP inhibitor group showed a decrease in above indicators (P<0.05). The cell apoptosis rates in the untreated group, lentivirus negative control group, inhibitor negative control group, CacyBP/ SIP lentivirus group, and CacyBP/SIP inhibitor group were 8.54%±0.26%, 8.42%±0.38%, 8.46%±0.19%, 3.38%±0.15%, and 18.42%±1.23%, respectively. Compared with the inhibitor negative control group, the cell apoptosis rate in the CacyBP/SIP lentivirus group decreased (P<0.05); compared with the CacyBP/SIP lentivirus group, the apoptosis rate of cells in the CacyBP/SIP inhibitor group increased (P<0.05). Conclusion The low expression of CacyBP/SIP can reduce the proliferation, invasion and migration ability of EMs mesenchymal cells, which is speculated to inhibit angiogenesis by inhibiting VEGF and COX-2 genes.
REVIEW
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  Advances in the Application of Postural Fixtures in Radiotherapy for Head and Neck Tumors

  CHEN Yang^1,2, FU Binhai^1,2 , WU Mingkang¹, SUN Xueqin^1,2, ZHANG Jianfang^1,2, CUI Yeqian^1,2, WANG Shaobo¹

  China Medical Devices. 2024, 39(8): 146-151. https://doi.org/10.3969/j.issn.1674-1633.2024.08.023

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  The effect of radiotherapy in the treatment of head and neck tumors is very significant, but the current difficulty of radiotherapy lies in the complicated anatomy of head and neck and the large positioning, which must achieve accurate positioning. With the continuous improvement and innovation of the fixtures, it provides a good fixing effect for patients and improves the accuracy of radiotherapy positioning. This paper reviewed the application status, advantages and disadvantages and future development direction of various head and neck fixtures, aiming to provide reference for the selection of head and neck radiotherapy fixtures, so as to solve the difficult problems in the treatment process and improve the radiotherapy quality.
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  Development Status of Boron Neutron Capture Therapy Technique

  GU Xiaofang, HE Liping, YANG Pengfei, WANG Ying

  China Medical Devices. 2024, 39(8): 152-158. https://doi.org/10.3969/j.issn.1674-1633.2024.08.024

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  Boron neutron capture therapy (BNCT) is a new method to treat tumors, and it has outstanding advantages in the treatment of recurrent head and neck tumor, glioma and malignant melanoma at present. This paper described the development status of BNCT technology from the aspects of its principle, development history, boron-containing drugs, side effects of treatment, neutron generation mode and neutron sources, approval for marketing domestically and internationally, and provided future prospects for this treatment technology, and provided a review of the current development status of BNCT technology, in order to enhance the understanding of medical personnel, research and development personnel, regulatory personnel, and other relevant industries on BNCT. It aims to provide reference for the development of BNCT technology, the establishment of relevant technical guidelines, or specifications in China, so as to promote the early service of Chinese BNCT for the vast number of tumor patients.
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  Current Status and Research Progress of Medical Laser Treatment for Infantile Hemangiomas

  YU Wenyuan^1,2, XU Xiao², CHEN Zhenggang²

  China Medical Devices. 2024, 39(8): 159-164. https://doi.org/10.3969/j.issn.1674-1633.2024.08.025

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  With active exploration of the etiological mechanism behind infantile hemangiomas (IH) and the progressive replacement of treatment methods, propranolol has replaced traditional surgical therapy as a first-line medication. Since IH are mostly located in the face and neck, with patients being young and having high aesthetic requirements, it is necessary to actively seek various alternative therapies to meet the growing clinical needs of patients. Laser serves as a crucial supplementary means to treat IH, characterized by minimal trauma and short treatment periods. Pulsed dye laser and Nd:YAG laser, in particular, hold significant clinical value. This paper provided an overview and future perspectives on the industrial situation, therapeutic mechanism, classification, applications, and research outcomes related to medical lasers for IH, aiming to enhance attention on laser treatment for IH while offering multiple techniques and new ideas for medical lasers applications.
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  Research Progress of Multimodal Imaging in the Evaluation of Coronary Microcirculation Disorders

  YANG Jiamin¹, LIU Xiaolin^1,2

  China Medical Devices. 2024, 39(8): 165-170. https://doi.org/10.3969/j.issn.1674-1633.2024.08.026

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  Coronary microcirculation dysfunction (CMD) is a clinical syndrome of myocardial ischemia caused by abnormal structure or function of coronary arterioles under the joint action of a variety of pathogenic factors. Patients with CMD have significantly increased risk of adverse cardiovascular events. Myocardial perfusion imaging is an important noninvasive method to evaluate myocardial microcirculation and to determine the prognosis and adverse events of cardiovascular diseases. At present, the commonly used imaging techniques include computed tomography, cardiac magnetic resonance, single photon emission computed tomography, positron emission computed tomography, transthoracic Doppler ultrasound and other methods, which have high accuracy in the evaluation of myocardial ischemia. With the continuous development of imaging technology, imaging omics has played an increasingly important role in clinical diagnosis, which provides the possibility for early prediction and prognosis of diseases. This article reviewed the application of different imaging techniques in the diagnosis of CMD, discussed their different roles in clinical diagnosis, and looked forward to the potential value of radiomics in the evaluation of CMD. Through comparative analysis, it aimed to provide a more comprehensive diagnostic strategy for CMD in clinical practice and provide reference for future research directions.
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  Problems and Countermeasures of Medical Equipment Management in the Context of Ongoing Health Reform

  WU Yunheng, LI Weijia, ZHANG Lei

  China Medical Devices. 2024, 39(8): 171-176. https://doi.org/10.3969/j.issn.1674-1633.2024.08.027

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  As Chinese medical technology continues to advance, the introduction of medical equipment in various medical structures has increased year by year, and the management problems of medical equipment have also become prominent. Under the background that the new medical reform puts forward higher requirements for the standardized management of medical institutions, how to improve the scientific management of medical equipment has become one of the urgent problems to be solved. This paper undertook an analysis of the current state of medical equipment management in medical institutions, identified potential issues, and proposed feasible solutions by drawing on both domestic and international experiences. The objective was to bolster the management proficiency of medical equipment to meet the requirements of ongoing medical and health care reform.
DEVICE MAINTENANCE
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  Analysis and Discussion of Siemens Force Dual Source CT Fault Maintenance Case

  SUN Xiaolei, XIAO Wujin, WANG Ying, ZHANG Hui

  China Medical Devices. 2024, 39(8): 177-180. https://doi.org/10.3969/j.issn.1674-1633.2024.08.028

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  Siemens Force dual source CT is a high-end CT, with high overall configuration, good performance, wide application range, and good stability, playing a huge role in the operation of hospital. Due to the high usage of equipment, failures have occurred from time to time, and the high level of equipment integration makes overall maintenance difficult. This paper analyzed in detail the troubleshooting process of three cases of water cooling system, patient inspection bed and detector power supply faults occurred during use, and solved the faults by replacing the three-way valve, maintaining the lifting motor bearing and welding X10 joint, which can save maintenance costs and provide reference for peers to repair such faults.