The pre-research of medical device standards is of great significance for the enactment and amendment of standards.This study discusses four aspects and explores how to promote more scientific and reasonable pre-research.Based on the pre-research practice of medical device standards project,this study puts forward relevant work ideas and suggestions.

The incidence of osteoporotic thoracolumbar vertebral fracture (OTLVF) in the elderly is gradually increasing. The kyphotic deformity caused by various factors has become an important characteristic of OTLVF and has received increasing attention. Its clinical manifestations include pain, delayed nerve damage, sagittal imbalance, etc. Currently, the definition and diagnosis of OTLVF with kyphotic deformity in the elderly are still unclear. Although there are many treatment options, they are controversial. Existing guidelines or consensuses pay little attention to this type of fracture with kyphotic deformity. To this end, the Lumbar Education Working Group of the Spine Branch of the Chinese Medicine Education Association and Editorial Committee of Chinese Journal of Trauma organized the experts in the relevant fields to jointly develop Clinical guidelines for the diagnosis and treatment of osteoporotic thoracolumbar vertebral fractures with kyphotic deformity in the elderly ( version 2024), based on evidence-based medical advancements and the principles of scientificity, practicality, and advanced nature, which provided 18 recommendations to standardize the clinical diagnosis and treatment.

Osteoporotic thoracolumbar fracture in the elderly will seriously reduce their quality of life and life expectancy. For osteoporotic thoracolumbar fracture in the elderly, spinal reconstruction is necessary, which should comprehensively consider factors such as the physical condition, fracture type, clinical characteristics and osteoporosis degree. While there lacks relevant clinical norms or guidelines on selection of spinal reconstruction strategies. In order to standardize the concept of spinal reconstruction for osteoporotic thoracolumbar fracture in the elderly, based on the principles of scientificity, practicality and progressiveness, the authors formulated the Clinical guideline for spinal reconstruction of osteoporotic thoracolumbar fracture in elderly patients ( version 2022), in which suggestions based on evidence of evidence-based medicine were put forward upon 10 important issues related to the fracture classification, non-operative treatment strategies and surgical treatment strategies in spinal reconstruction after osteoporosis thoracolumbar fracture in the elderly, hoping to provide a reference for clinical treatment.

Effects of heat treatment conditions (including temperature and time) on the shape memory recovery and corrosion resistance of NiTi self-expanding vascular stents were studied based on working mechanism and clinical use. The
Alloys ; Corrosion ; Hot Temperature ; Materials Testing ; Stents ; Surface Properties ; Temperature ; Titanium

Objective: To explore the lung damage caused by repeated inhalation of polyhexamethyleneguanidine (PHMG) disinfectant aerosol and the corresponding toxicological characteristics. Methods: Thirty four-week-old mice of C57BL/6N strain were randomly divided into three groups, the control group, low-dose group, and high-dose group. Each group had 5 male mice and 5 female mice. Lab II-level purified water was used in the control group. The PHMG disinfectant aerosol was generated by using the ultrasonic atomization of the aqueous solution containing PHMG. The PHMG concentrations in the low-and high-dose groups were 0.1 mg/ml (0.01%) and 1 mg/ml (0.1%), respectively. The concentration of PHMG in the post-chemical exposure room was 1.03 mg/m³ and 9.09 mg/m³ according to the air sampler analysis. The experimental mice were exposed to the PHMG in dynamic respiratory exposure mode for 4 hours every day in 21 days. After 21-day exposure, bronchia alveolus lung fluids (BALFs) were used to evaluate the inflammatory cells in the lungs, and pathological evaluation, special staining and immunohistochemical methods were further performed to evaluate the key indicators of pulmonary fibrosis. Results: Compared to the control group, the body weight of mice in the high-dose group was significantly decreased (P<0.05), while that of mice in the low-dose group did not significantly differ (P>0.05). The number of inflammatory cells in BALFs of low-dose exposed mice was slightly reduced, and the lung tissue pathology began to show lung damage with early fibrosis symptoms (P<0.05). The pathological examination of mice in the high-dose group showed changes in pulmonary fibrosis. Immunohistochemical staining showed that pulmonary fibrosis marker, α-SMA, was significantly increased in low-dose group and high-dose group (P<0.05). Conclusion The repeated inhalation of PHMG disinfectant could cause lung damage such as pulmonary fibrosis in mice. It could suggest that special warnings should be given to this common disinfectant and respiratory protection measures should be adopted during industrial production and daily use.

Polyhexamethylene guanidine (PHMG) is a high molecular guanidine compound with a broad spectrum of antibacterial effects. Since the outbreak of the 'humidifier disinfectant-induced lung injury’ event in South Korea, the respiratory toxicity of PHMG had become a public concern. An epidemiological survey in Korea found that PHMG-containing disinfectants were an important risk factor for pulmonary fibrosis. Animal experiments also showed that the exposure to PHMG through the respiratory tract could cause irreversible fibrosis in the lungs. TGF-β signaling pathway, epithelial-mesenchymal transition and pulmonary inflammation might be the main pathways that could mediate PHMG-induced pulmonary fibrosis. This article provided an overview of the characteristics of population exposure to PHMG and research progress in the field of respiratory toxicology and recommendations for the rational and standard of using PHMG-related products in China.

Objective:To investigate the measurement of small airways by high-resolution CT and image post-processing software. Screen and analyze the reconstructed airway parameters in order to find the best imaging biomarker parameters of small airway changes and calculate the reference value range; meanwhile, explore its influencing factors.Methods:From a water plant and a medical school, 169 cases of the general population aged 20 to 60 were selected as research objects, and questionnaire surveys and CT tests were performed, and CT data were reconstructed with image post-processing software. The reference value range of the general population was evaluated, and a linear mixed effect model was used to adjust the age, gender, height, BMI, and smoking status, and analyze the influencing factors of airway parameters.Results:The ratio of sixth-grade tracheal wall area to total tracheal area in the Left B1+2 to carina was (53.01±13.35) %, Left B9 to carina was (50.44±12.98) %, Right B1 to carina was (52.73±12.22) %, and Right B9 to carina was (52.93±11.85) %. The ratio of nineth-grade tracheal wall area to total tracheal area in the Left B1+2 to carina was (44.08±14.66) %, Left B9 to carina was (42.44±15.89) %, Right B1 to carina was (46.51±14.03) %, and Right B9 to carina is (43.54±15.87) %. BMI affect the area of the tracheal wall, all p value<0.05.Conclusion:High-resolution CT small airway morphology can make a preliminary assessment of the susceptible population of small airway-related diseases based on a range of reference values, and prevent and control it in combination with influencing factors.

Objective:To investigate the measurement of small airways by high-resolution CT and image post-processing software. Screen and analyze the reconstructed airway parameters in order to find the best imaging biomarker parameters of small airway changes and calculate the reference value range; meanwhile, explore its influencing factors.Methods:From a water plant and a medical school, 169 cases of the general population aged 20 to 60 were selected as research objects, and questionnaire surveys and CT tests were performed, and CT data were reconstructed with image post-processing software. The reference value range of the general population was evaluated, and a linear mixed effect model was used to adjust the age, gender, height, BMI, and smoking status, and analyze the influencing factors of airway parameters.Results:The ratio of sixth-grade tracheal wall area to total tracheal area in the Left B1+2 to carina was (53.01±13.35) %, Left B9 to carina was (50.44±12.98) %, Right B1 to carina was (52.73±12.22) %, and Right B9 to carina was (52.93±11.85) %. The ratio of nineth-grade tracheal wall area to total tracheal area in the Left B1+2 to carina was (44.08±14.66) %, Left B9 to carina was (42.44±15.89) %, Right B1 to carina was (46.51±14.03) %, and Right B9 to carina is (43.54±15.87) %. BMI affect the area of the tracheal wall, all p value<0.05.Conclusion:High-resolution CT small airway morphology can make a preliminary assessment of the susceptible population of small airway-related diseases based on a range of reference values, and prevent and control it in combination with influencing factors.

OBJECTIVETo investigate the feasibility of using liquid chromatography (HPLC) to characterize the 3, 4-Dihydroxyphenylalanine (DOPA) redox state of mussel adhesive protein (MAP).

METHODSThe DOPA and protein contents of MAP were determined by HPLC, Arnow and Bradford methods respectively.

RESULTSWith extended oxidation time, the protein contents of MAP samples remained unchanged whereas the DOPA contents declined. The retention times of main peaks in HPLC for both the accelerated oxidation and retained samples shifted as the storage time extended, which could be related to the changes of sample redox state.

CONCLUSIONSThe redox state of MAP can be characterized by the change of HPLC peak retention time. HPLC can be used in the research on the MAP redox state, which is beneficial to the product development and quality control.

Objective The present study was designed to analysis some misunderstanding on "medical devices classification rules" of CFDA, in order to correct understand and use the regulation. Methods The contents of "medical devices classification rules" by CFDA have been analysis and generalized. Results Through analyzing, we can conclude as followed: the priority principle of classification catalogue; the comprehensive judgment principle based on the classification decision table and special classification principles; medical devices' management class could be changed by CFDA according to risk analysis results. Conclusion It is helpful to reach an agreement on the classification of a medical device among the regulatory authorities, production enterprises and other aspects, and establish a solid foundation for CFDA's regulatory science.