Objective:To construct a failure mode and effects analysis(FMEA)evaluation model for medical devices to manage devices,so as to enhance management efficiency for medical devices.Methods:The FMEA was adopted to construct FMEA evaluation model for medical devices,so as to conduct comprehensive lifecycle management for medical devices.The process of management for equipment was optimized,and the operational risk of medical devices was reduced through failure mode(FM)analysis and the construction of management system for equipment.A total of 47 medical devices in clinical use of The First People's Hospital of Neijiang from January to December 2023 were included.In them,23 devices received conventional management mode during January and June 2023,and 24 devices received FMEA evaluation model(model management mode)during July and December 2023.For each group,2,000 patients'medical records were selected.The control effectiveness of infectious indicators,effect of cleaning and disinfection,and quality scores of infectious control for medical devices were compared between different management modes.A self-designed questionnaire was adopted to investigate the recognition scores of engineers who used and managed devices,operators,physicians,and department administrators for two kinds of management modes.Results:In 2,000 patients'medical records,who adopted model management mode,the infection rate of patients,and infection rate of aseptic surgical incision were respectively 0.15%and 0.05%,both were significantly lower than those in the conventional management mode(x2=5.420,8.358,P<0.05).The cleaning rate,and disinfection qualification rate of 24 medical devices,which adopted model management mode,were respectively 83.33%and 87.50%,all of which were significantly higher than these of conventional management mode(x2=8.080,6.741,P<0.05).The scores of standardized operation,rational use,disinfection and cleaning,and emergency intervention for medical devices in adopting model management mode were significantly higher than those in adopting conventional management mode(t=14.435,16.014,13.049,12.537,P<0.05).The recognition scores of engineers who used and managed devices,operators,physicians,and department administrators for adopting model management mode were significantly higher than those for adopting conventional management mode,and the differences were significant(t=12.219,12.147,17.437,13.420,P<0.05).Conclusion:The FMEA evaluation model for medical devices can real-time monitor the entire management process for medical devices,and reduce clinical infections,and ensure normal operation of devices,and improve clinically operational quality of them,and increase satisfaction of staffs in clinical departments.

Objective:To evaluate the advantages and short-term clinical effects of totally robotic Nissen 360° fundoplication compared with laparoscopic surgery.Methods:A retrospective analysis was conducted on data of 110 patients undergoing Nissen 360° fundoplication at the Second Department of General Surgery, Yan'an Hospital Affiliated to Kunming Medical University from Aug 2023 to Aug 2024. Among them, 50 cases underwent totally robotic fundoplication, and 60 cases underwent laparoscopic fundoplication. By comparing and analyzing the fatigue level of the primary surgeon during the operations, postoperative incisional pain in patients, swallowing function recovery and the time to resume a normal solid-food diet within 3 months post-surgery, the advantages of totally robotic surgery were evaluated. Additionally, by examining the postoperative recovery of reflux symptoms, postoperative patient comfort, and satisfaction levels in both groups, the short-term clinical outcomes of totally robotic surgery were assessed.Results:Both groups of patients successfully completed the surgeries without any intraoperative or postoperative complications occurring. The fatigue score of the primary surgeon in the totally robotic group was significantly better than that in the laparoscopic group[ (2.34±1.38) vs. (2.89±1.51), t=1.385, P<0.01]. The time taken to resume a normal solid-food diet postoperatively in the totally robotic group was significantly shorter than that in the laparoscopic group[ (27.90±6.77) d vs. (40.78±13.60) d, t =5.765, P<0.01]. Moreover, the postoperative pain comfort level was better in the robotic group than in the laparoscopic group [(1.65±0.72) points vs. (2.23±0.59) points, t=3.742, P<0.01]. Within 12 months postoperatively, the GERD-Q scores in the totally robotic group decreased significantly, and reflux symptoms disappeared, comparable to that in the laparoscopic group. Conclusions:The totally robotic Nissen 360° fundoplication leads to lower fatigue levels for the surgeon. Patients experience significant advantages in terms of postoperative pain perception and dietary recovery. Additionally, it demonstrates excellent postoperative anti-reflux efficacy, high patient comfort, and the surgery is safe and reliable.

Objective To investigate the impact of enterovirus 71(EV71)on skeletal muscle injury and explore its mechanism in relation to the caspase-1/interleukin(IL)-1 β signaling pathway in EV71-induced skeletal muscle damage.Methods One-day-old BALB/c suckling mice were divided randomly into three groups:normal control(NC)(n=60),EV71 infection model(n=60),and caspase-1 inhibitor(EV71+VX765)(n=15)groups.The NC and EV71 model groups were further subdivided into four subgroups(5,7,10,and 14 days)(n=5 mice per group).An EV71-infected model was established by intraperitoneal injection of 25 × 103 μL/kg EV71 viral solution for 3 consecutive days.Mice in the caspase-1 inhibitor group received VX765(20 mg/kg)intraperitoneally 6 hours post-viral inoculation,continued daily for 10 days until sample collection.Mice in the NC group received an equivalent volume of saline containing 5％dimethylsulfoxide and 10％PEG300,followed by 2％cell maintenance solution after 6 hours.Post-modeling body weight and clinical disease scores were recorded.Pathological skeletal muscle damage was observed by hematoxylin-eosin(HE)staining,and expression levels of EV71 VP-1(viral capsid protein),pro-caspase-1,cleaved-caspase-1,IL-1 β,α-smooth muscle actin(SMA),and Collagen Ⅰ were detected by Western blot and immunofluorescence.Results Compared with the NC group at the same time points,mice in the EV71 model group exhibited reduced body weight,elevated disease scores,and skeletal muscle pathology characterized by inflammatory cell infiltration,myofiber dissolution,and decreased cross-sectional area(HE staining).Western blot showed significantly increased levels of EV71 VP-1,IL-1β,α-SMA,and Collagen Ⅰ in skeletal muscle homogenate from EV71 mice at 5,7,and 10 days post-infection(P＜0.001).In contrast,mice in the VX765 group showed improved body weight,reduced clinical scores(P＜0.01),and significant downregulation of EV71 VP-1(P＜0.01),pro-caspase-1,cleaved-caspase-1,IL-1β,and Collagen Ⅰ compared with the EV71 model group(P＜0.01).These findings were confirmed by immunofluorescence,indicating that inhibition of caspase-1 alleviated EV71-induced skeletal muscle injury.Conclusions EV71 may induce skeletal muscle injury by activating the caspase-1/IL-1β signaling pathway.

Objective:To analyze the spatiotemporal correlation between the surveillance data of influenza in students reported by medical institutions and school absenteeism due to illness, and evaluate the application of Bayesian Structural Time Series model (BSTS) in the prediction of school influenza epidemic.Methods:A total of 13 schools in Dapeng new district of Shenzhen were selected. The incidence data of influenza in schools in Shenzhen from January 1, 2015 to December 31, 2019 were collected from China Disease Control and Prevention Information System and the illness related school absentence data during this period were collected from Shenzhen Student Health Surveillance System, and the spatiotemporal correlation between the data from two systems was analyzed and compared. BSTS was used to make long-term predictions of the monthly incidence of influenza in students in 2019 and short-term predictions of the weekly incidence of influenza in week 1-8 and week 45-52 of 2019 by using the data from two systems.Results:There was a temporal correlation between the data from China Disease Control and Prevention Information System and the data from Shenzhen Student Health Surveillance System ( r=0.93, P<0.001), and the lag of the former one was 1 day ( r=0.73, P<0.001). Influenza outbreaks were randomly distributed in different schools in Shenzhen, and there was no spatial correlation. The root mean square error ( RMSE) and mean absolute error ( MAE) were 0.35 and 0.28, respectively, in the long-term prediction, and the RMSE was 0.33 and 0.34, and the MAE was 0.26 and 0.28, respectively, in the short-term predictions of week 1-8 and week 45-52 of 2019, respectively, showing good prediction accuracy and fitting effect. Conclusion:By analyzing the data from China Disease Control and Prevention Information System and Shenzhen Student Health Surveillance System with BSTS, the dynamics of the school influenza epidemic can be accurately predicted, and effective technical support can be provided for the early warning and prevention and control of influenza epidemic.

Objective:To analyze the spatiotemporal correlation between the surveillance data of influenza in students reported by medical institutions and school absenteeism due to illness, and evaluate the application of Bayesian Structural Time Series model (BSTS) in the prediction of school influenza epidemic.Methods:A total of 13 schools in Dapeng new district of Shenzhen were selected. The incidence data of influenza in schools in Shenzhen from January 1, 2015 to December 31, 2019 were collected from China Disease Control and Prevention Information System and the illness related school absentence data during this period were collected from Shenzhen Student Health Surveillance System, and the spatiotemporal correlation between the data from two systems was analyzed and compared. BSTS was used to make long-term predictions of the monthly incidence of influenza in students in 2019 and short-term predictions of the weekly incidence of influenza in week 1-8 and week 45-52 of 2019 by using the data from two systems.Results:There was a temporal correlation between the data from China Disease Control and Prevention Information System and the data from Shenzhen Student Health Surveillance System ( r=0.93, P<0.001), and the lag of the former one was 1 day ( r=0.73, P<0.001). Influenza outbreaks were randomly distributed in different schools in Shenzhen, and there was no spatial correlation. The root mean square error ( RMSE) and mean absolute error ( MAE) were 0.35 and 0.28, respectively, in the long-term prediction, and the RMSE was 0.33 and 0.34, and the MAE was 0.26 and 0.28, respectively, in the short-term predictions of week 1-8 and week 45-52 of 2019, respectively, showing good prediction accuracy and fitting effect. Conclusion:By analyzing the data from China Disease Control and Prevention Information System and Shenzhen Student Health Surveillance System with BSTS, the dynamics of the school influenza epidemic can be accurately predicted, and effective technical support can be provided for the early warning and prevention and control of influenza epidemic.

Objective To investigate the impact of enterovirus 71(EV71)on skeletal muscle injury and explore its mechanism in relation to the caspase-1/interleukin(IL)-1 β signaling pathway in EV71-induced skeletal muscle damage.Methods One-day-old BALB/c suckling mice were divided randomly into three groups:normal control(NC)(n=60),EV71 infection model(n=60),and caspase-1 inhibitor(EV71+VX765)(n=15)groups.The NC and EV71 model groups were further subdivided into four subgroups(5,7,10,and 14 days)(n=5 mice per group).An EV71-infected model was established by intraperitoneal injection of 25 × 103 μL/kg EV71 viral solution for 3 consecutive days.Mice in the caspase-1 inhibitor group received VX765(20 mg/kg)intraperitoneally 6 hours post-viral inoculation,continued daily for 10 days until sample collection.Mice in the NC group received an equivalent volume of saline containing 5％dimethylsulfoxide and 10％PEG300,followed by 2％cell maintenance solution after 6 hours.Post-modeling body weight and clinical disease scores were recorded.Pathological skeletal muscle damage was observed by hematoxylin-eosin(HE)staining,and expression levels of EV71 VP-1(viral capsid protein),pro-caspase-1,cleaved-caspase-1,IL-1 β,α-smooth muscle actin(SMA),and Collagen Ⅰ were detected by Western blot and immunofluorescence.Results Compared with the NC group at the same time points,mice in the EV71 model group exhibited reduced body weight,elevated disease scores,and skeletal muscle pathology characterized by inflammatory cell infiltration,myofiber dissolution,and decreased cross-sectional area(HE staining).Western blot showed significantly increased levels of EV71 VP-1,IL-1β,α-SMA,and Collagen Ⅰ in skeletal muscle homogenate from EV71 mice at 5,7,and 10 days post-infection(P＜0.001).In contrast,mice in the VX765 group showed improved body weight,reduced clinical scores(P＜0.01),and significant downregulation of EV71 VP-1(P＜0.01),pro-caspase-1,cleaved-caspase-1,IL-1β,and Collagen Ⅰ compared with the EV71 model group(P＜0.01).These findings were confirmed by immunofluorescence,indicating that inhibition of caspase-1 alleviated EV71-induced skeletal muscle injury.Conclusions EV71 may induce skeletal muscle injury by activating the caspase-1/IL-1β signaling pathway.

Objective:To construct a failure mode and effects analysis(FMEA)evaluation model for medical devices to manage devices,so as to enhance management efficiency for medical devices.Methods:The FMEA was adopted to construct FMEA evaluation model for medical devices,so as to conduct comprehensive lifecycle management for medical devices.The process of management for equipment was optimized,and the operational risk of medical devices was reduced through failure mode(FM)analysis and the construction of management system for equipment.A total of 47 medical devices in clinical use of The First People's Hospital of Neijiang from January to December 2023 were included.In them,23 devices received conventional management mode during January and June 2023,and 24 devices received FMEA evaluation model(model management mode)during July and December 2023.For each group,2,000 patients'medical records were selected.The control effectiveness of infectious indicators,effect of cleaning and disinfection,and quality scores of infectious control for medical devices were compared between different management modes.A self-designed questionnaire was adopted to investigate the recognition scores of engineers who used and managed devices,operators,physicians,and department administrators for two kinds of management modes.Results:In 2,000 patients'medical records,who adopted model management mode,the infection rate of patients,and infection rate of aseptic surgical incision were respectively 0.15%and 0.05%,both were significantly lower than those in the conventional management mode(x2=5.420,8.358,P<0.05).The cleaning rate,and disinfection qualification rate of 24 medical devices,which adopted model management mode,were respectively 83.33%and 87.50%,all of which were significantly higher than these of conventional management mode(x2=8.080,6.741,P<0.05).The scores of standardized operation,rational use,disinfection and cleaning,and emergency intervention for medical devices in adopting model management mode were significantly higher than those in adopting conventional management mode(t=14.435,16.014,13.049,12.537,P<0.05).The recognition scores of engineers who used and managed devices,operators,physicians,and department administrators for adopting model management mode were significantly higher than those for adopting conventional management mode,and the differences were significant(t=12.219,12.147,17.437,13.420,P<0.05).Conclusion:The FMEA evaluation model for medical devices can real-time monitor the entire management process for medical devices,and reduce clinical infections,and ensure normal operation of devices,and improve clinically operational quality of them,and increase satisfaction of staffs in clinical departments.

Objective:To evaluate the advantages and short-term clinical effects of totally robotic Nissen 360° fundoplication compared with laparoscopic surgery.Methods:A retrospective analysis was conducted on data of 110 patients undergoing Nissen 360° fundoplication at the Second Department of General Surgery, Yan'an Hospital Affiliated to Kunming Medical University from Aug 2023 to Aug 2024. Among them, 50 cases underwent totally robotic fundoplication, and 60 cases underwent laparoscopic fundoplication. By comparing and analyzing the fatigue level of the primary surgeon during the operations, postoperative incisional pain in patients, swallowing function recovery and the time to resume a normal solid-food diet within 3 months post-surgery, the advantages of totally robotic surgery were evaluated. Additionally, by examining the postoperative recovery of reflux symptoms, postoperative patient comfort, and satisfaction levels in both groups, the short-term clinical outcomes of totally robotic surgery were assessed.Results:Both groups of patients successfully completed the surgeries without any intraoperative or postoperative complications occurring. The fatigue score of the primary surgeon in the totally robotic group was significantly better than that in the laparoscopic group[ (2.34±1.38) vs. (2.89±1.51), t=1.385, P<0.01]. The time taken to resume a normal solid-food diet postoperatively in the totally robotic group was significantly shorter than that in the laparoscopic group[ (27.90±6.77) d vs. (40.78±13.60) d, t =5.765, P<0.01]. Moreover, the postoperative pain comfort level was better in the robotic group than in the laparoscopic group [(1.65±0.72) points vs. (2.23±0.59) points, t=3.742, P<0.01]. Within 12 months postoperatively, the GERD-Q scores in the totally robotic group decreased significantly, and reflux symptoms disappeared, comparable to that in the laparoscopic group. Conclusions:The totally robotic Nissen 360° fundoplication leads to lower fatigue levels for the surgeon. Patients experience significant advantages in terms of postoperative pain perception and dietary recovery. Additionally, it demonstrates excellent postoperative anti-reflux efficacy, high patient comfort, and the surgery is safe and reliable.

Objective:To evaluate the safety and effectiveness for the treatment of totally robotic fundoplication.Methods:A retrospective analysis was conducted on the clinical data of 21 patients with gastroesophageal reflux disease (GERD) who underwent unassisted totally robotic fundoplication at the Second Department of General Surgery, Yan'an Hospital Affiliated to Kunming Medical University from Aug 2023 to Jan 2024. The postoperative outcomes were evaluated using SF-36, GERD-Q, and NRS scoring indicators.Results:All 21 patients successfully underwent the surgery. The robotic surgery time was (99±41) minutes, with precise intraoperative anatomy and insignificant blood loss of (1.7±1.4) ml. There were no intraoperative or postoperative complications, and no conversions to open surgery . Postoperative recovery of bowel function was rapid (11.71±3.33) hours, with minimal postoperative pain (NRS score of 1.67±0.48).The postoperative hospital stay was short (3.86±2.90) days, and patient satisfaction was high, SF-36 score of (80.90±1.14);The symptoms of reflux after surgery was significantly reduced.Postoperative GERD-Q score of (4.38±1.69) significantly lower than the preoperative score of (13.90±2.07).Conclusion:Totally robotic fundoplication provides clear view of intraoperative anatomical structures, rapid postoperative recovery, minimal pain, and effective anti-reflux outcomes.

Objective To investigate the effect and mechanism of Di'ao Xinxuekang(hereinafter referred to as Xinxuekang)combined with Simvastatin on atherosclerosis(AS)mice.Methods Eight C57BL/6J mice were used as control group,and 32 ApoE-/-mice were randomly divided into model group,Xinxuekang group(160 mg·kg-1),Simvastatin group(1.3 mg·kg-1)and combined treatment group(Xinxuekang 160 mg·kg-1+Simvastatin 1.3 mg·kg-1),with eight mice in each group.The control group was fed with conventional diet,and the other four groups were fed with high-fat diet.At the same time,each administration group was given intragastric administration according to the above dose,and the volume of intragastric administration was 10 mL·kg-1,once a day for 18 weeks.After administration,the levels of serum total cholesterol(TC),triglyceride(TG),low density lipoprotein cholesterol(LDL-C)and high density lipoprotein cholesterol(HDL-C)were detected.Oil red O staining was used to observe the formation of aortic plaque and liver lipid accumulation in mice.Serum PCSK9 level was detected by ELISA.The mRNA and protein expression levels of LDLR,HNF1α and SREBP2 in liver tissues were detected by qRT-PCR and Western Blot.Results(1)Compared with the control group,the levels of serum TC,TG and LDL-C in the model group were significantly increased(P＜0.01),and the level of HDL-C was significantly decreased(P＜0.01).The percentage of aortic root plaque area,the percentage of total aortic plaque area and the percentage of liver lipid droplet area were significantly increased(P＜0.01).The mRNA and protein expression levels of LDLR in liver tissue were significantly decreased(P＜0.01),and the serum PCSK9 level was significantly increased(P＜0.01).The mRNA and protein expression levels of HNF1α and SREBP2 in liver tissues were significantly increased(P＜0.05,P＜0.01).(2)Compared with the model group,the levels of serum TC,TG and LDL-C in the Xinxuekang group and the combined treatment group were significantly decreased(P＜0.05,P＜0.01),and the level of HDL-C was significantly increased(P＜0.05).The level of serum LDL-C in Simvastatin group was significantly decreased(P＜0.01).The percentage of aortic root plaque area and the percentage of total aortic plaque area in the Xinxuekang group and the combined treatment group were significantly decreased(P＜0.05,P＜0.01),and the percentage of liver lipid droplet area in each administration group was significantly decreased(P＜0.01).The protein expression level of LDLR in liver tissue of mice in Xinxuekang group and combined treatment group was significantly increased(P＜0.05),the serum PCSK9 level was significantly decreased(P＜0.05,P＜0.01),and the mRNA and protein expression levels of HNF1 α and SREBP2 in liver tissue were significantly decreased(P＜0.05,P＜0.01).(3)Compared with the Simvastatin group,the serum HDL-C level in the combined treatment group was significantly increased(P＜0.05).The percentage of aortic root plaque area and the percentage of liver lipid droplet area were significantly decreased(P＜0.05,P＜0.01).The protein expression level of LDLR in liver tissue was significantly increased(P＜0.01),and the serum PCSK9 level was significantly decreased(P＜0.01).The expression levels of HNF1α protein and SREBP2 mRNA in liver tissues were significantly decreased(P＜0.05,P＜0.01).Conclusion Xinxuekang may play a synergistic effect on lipid-lowering and anti-AS effects of Simvastatin by inhibiting the expressions of SREBP2 and HNF1α and regulating the PCSK9/LDLR signaling pathway.