In this study, the pre-market regulatory requirements for typical Class Ⅱ wound dressings, as well as the status of testing and post-market adverse events monitoring, were reviewed from the perspective of the whole lifecycle of medical devices. Additionally, the regulatory requirements for wound dressings in China, the United States, and the European Union were compared. Supplementary research was also conducted on Class Ⅰ and Ⅱ liquid and paste dressing products. Furthermore, this study analyzed the issues in the registration and application of typical Class Ⅱ wound dressings and provided regulatory recommendations, aiming to offer technical references for the review and approval, inspection and testing, and post-market supervision of wound dressing products.
Bandages/standards* ; United States ; China ; Humans ; European Union

Objective　To explore the mediating role of cognitive function in the association between literacy level and depressive symptoms in middle-aged and elderly people in China. Methods　 Using the fourth national follow-up data of the China Health and Elderly Care Tracking Survey 2018, 8 124 middle-aged and elderly people aged 45 years and above were included as the study subjects. The PROCESS 4.0 program was used to test the mediating effect of cognitive function between literacy level and depressive symptoms, and the Bootstrap method was used for the mediator variable validation. Results The detection rate of depressive symptoms among middle-aged and elderly people in China was 38.10%. After controlling for gender, place of residence, marital status, smoking, alcohol consumption, and exercise, literacy level was a negative predictor of depressive symptoms in middle-aged and elderly people (β =－0.480, t =－11.248, P<0.001). Cognitive function accounted for 58.75% of the amount of mediating effect between literacy level and depressive symptoms. Conclusion 　Literacy level and cognitive function are associated with depressive symptoms in middle-aged and elderly people. Literacy level can influence depressive symptoms directly or indirectly through the mediation of cognitive dysfunction.

Objective:To investigate the clinical efficacy of over-the-top reconstruction combined with the modified Lemaire technique in the treatment of anterior cruciate ligament (ACL) injuries with pivot-shift positive.Methods:From March 2020 to October 2021, a total of 46 patients with ACL injury and pivot-shift test grade II or above were admitted to Xinhua Hospital Affiliated to Dalian University. There were 28 males and 18 females, aged 28.0±10.5 years (range, 15-45 years). All cases were unilateral, including 17 cases of left knee and 29 cases of right knee. The pivot-shift test showed that 30 cases were grade II and 16 cases were grade III, and the cause of injury was sports injury. The semitendinosus muscle and gracilis muscle were harvested, and the ACL was reconstructed with the over-the-top combined modified Lemaire technique. The International Knee Documentation Committee (IKDC) score, Lysholm score and KT-2000 side-to-side difference before and after operation were compared.Results:All patients successfully completed the operation and were followed up for 26.6±2.3 months (range, 24-28 months). The Lysholm scores of the patients at 3 months and 24 months after operation were 73.6±4.3 and 91.6±2.8, which were higher than those before operation (58.5±4.6), and the difference was statistically significant ( F=18.351, P<0.001). The IKDC scores of patients at 3 months and 24 months after operation were 59.0±2.0 and 91.8±3.2, respectively, which were higher than those before operation 50.3±2.8, and the difference was statistically significant ( F=17.290, P<0.001). The side-to-side difference of KT-2000 was 1.7±0.8 mm and 1.5±0.4 mm at 3 and 24 months after operation, respectively, which was lower than that before operation (5.9±1.1 mm), and the difference was statistically significant ( F=14.192, P<0.001). At 24 months after operation, 3 patients had pivot shift test grade I and 4 patients had Lachman test grade I, but they complained of good knee stability and did not receive further treatment. At the last follow-up, there were no complications such as incision and intra-articular infection, deep vein thrombosis, knee stiffness, quadriceps musculus ossificans myositis, and reconstruction ligament rupture. All patients returned to sports with an average time of 15.7±2.6 months (range, 12-24 months). Conclusion:Over-the-top reconstruction combined with the modified Lemaire technique for the treatment of ACL injury with positive pivot shift test effectively improves knee function and promotes the patient's return to sports, with a low incidence of surgical complications.

Objective To collect data on imported malaria cases in Jiangsu Province from 2019 to 2023 after malaria elimination and to analyze the current epidemic situation and prevention and control measures of imported malaria, discussing future prevention and control strategies. Methods Malaria case information for Jiangsu Province from 2019 to 2023 was extracted and downloaded from the China Information System for Disease Control and Prevention (CISDCP) as well as the Jiangsu Provincial malaria epidemic database. Statistical analysis was conducted using Stata 12.0 and SPSS 16.0 software. Results From 2019 to 2023, a total of 534 cases of malaria were directly reported online in Jiangsu Province, with annual cases numbering 244, 90, 32, 36, and 132 respectively, all being laboratory-confirmed imported malaria cases from abroad. During the COVID-19 pandemic from 2020 to 2022, the number of imported malaria cases significantly decreased, with several months reporting zero cases. Among the 534 malaria cases, the vast majority were individuals who had traveled to countries in sub-Saharan Africa and Southeast Asia for work, business, international studies, or tourism. Over the five years, the median, minimum, and maximum days for patients from onset of illness to health-seeking were 1(0,12), 1(0,8), 0(0,6), 0(0,10), and 1(0,18) days, with a statistically significant difference in health-seeking time among patients (Fisher's exact test, P=0.03). Over the past three years of the COVID-19 pandemic, compared to outside centralized isolation stations, malaria cases within centralized isolation stations were diagnosed in a shorter time (Fisher exact test, P=0.007). A total of 24 severe malaria cases were reported, with no deaths, including 23 cases of P. falciparum and 1 case of P. ovale. Conclusions After the elimination of malaria, imported malaria cases in Jiangsu Province have sharply decreased due to the impact of the COVID-19 pandemic. Malaria cases in centralized isolation stations (CIS) for COVID-19 control of Jiangsu Province are more likely to be promptly diagnosed, and the timeliness from onset to health-seeking among malaria patients returning from high-malaria areas improved. As COVID-19 prevention and control policies adjusted, there has been a sharp increase in imported malaria cases in 2023. It's still necessary to strengthen measures for malaria prevention and control and maintain the capacity to prevent malaria re-transmission in Jiangsu Province.

To revise GBZ 188 Technical Specification for Occupational Health Surveillance based on national laws, regulations, standards, specifications and legal documents of occupational disease, and combination with the actual situation in China. The main modifications are as follows: the occupational health surveillance for workers exposed to toluene (xylene may implement by reference), bromopropane, methyl iodide, ethylene oxide, chloroacetic acid, indium and its compounds, coal tar, coal tarasphalt, asphalt, β-naphthylamine, dust of metal and its compounds(tin, iron, antimony, barium and its compounds), hard metal dust, erionite dust, low temperature, laser, tick-borne encephalitis virus, Borrelia burgdorferi, and human immunodeficiency virus, for scraper or grind operators, and underground workers using squatting or kneeling position, crawling position, side-lying position, or shoulder position for a long period of time are included. The emergency health screening for workers exposed to arsenic, fluorine and its inorganic compounds, and acrylamide are included. The occupational medical examination (OME) for workers exposed to amino and nitro compounds of benzene, phosgene, monomethylamine, organic fluorine and dimethyl sulfate has been adjusted and made mandatory, with corresponding assessments required upon leaving the job. The special occupational health surveillance for workers exposed to mycobacterium tuberculosis and hepatitis virus is removed. The OME conclusion of reexamination is removed, and standardize recheck/additional inspection requirements. The optional items in OME performed before, during and after leaving post are removed, but the optional items in emergency medical examination are retained. Additional OME items are added. The Guideline for OME Summary Reports is added as informative appendix, and so on. The revised GBZ 188 Technical Specification for Occupational Health Surveillance is more scientific and practical.

Objective     To explore the safety and feasibility of preferential manual bronchoplasty in single-port video-assisted thoracoscopic surgery (VATS) upper lobectomy. Methods    The clinical data of 457 patients with non-small cell lung cancer who underwent single-port VATS lobectomy in the Department of Thoracic Surgery of Peking University First Hospital from March 2020 to March 2022 were retrospectively analyzed. The patients were divided into a preferential manual bronchoplasty group and a traditional single-port VATS lobectomy group with a 1 : 1 propensity score matching for further research. Results     A total of 204 patients were matched, and there were 102 patients in each group. There were 50 males and 52 females aged 62.2±10.1 years in the preferential bronchoplasty group, and 49 males and 53 females aged 61.2±10.7 years in the traditional single-port VATS group. The preferential bronchoplasty group had shorter surgical time (154.4±37.0 min vs. 221.2±68.9 min, P<0.01), less bleeding (66.5±116.9 mL vs. 288.6±754.5 mL, P=0.02), more lymph node dissection (19.8±7.5 vs. 15.2±4.7, P<0.01), and a lower conversion rate to multi-port or open surgery (2.3% vs. 13.8%, P=0.04) in left upper lobe resection. In the right upper lobe resection surgery, there was no statistical difference in postoperative results between two groups. There was no perioperative death or occurrence of bronchopleural fistula in both groups. Conclusion    Compared with traditional single-port VATS upper lobectomy, preferential bronchoplasty has similar safety and feasibility. In addition, priority bronchoplasty in left upper lobectomy has the advantages of shorter surgical time, less bleeding, more lymph node dissection, and lower conversion rate to multi-port or open surgery.

Background/Aims: The aim of this study was to analyze the chronological changes in postoperative complications in surgical ulcerative colitis patients over the past decade in China and to investigate the potential parameters that contributed to the changes. Methods: Ulcerative colitis patients who underwent surgery during 2008–2017 were retrospectively enrolled from 13 hospitals in China. Postoperative complications were compared among different operation years. Risk factors for complications were identified by logistic regression analysis. Results: A total of 446 surgical ulcerative colitis patients were analyzed. Fewer short-term complications (24.8% vs. 41.0%, P=0.001) and more laparoscopic surgeries (66.4% vs. 25.0%, P<0.001) were found among patients who received surgery during 2014–2017 than 2008–2013. Logistic regression suggested that independent protective factors against short-term complications were a higher preoperative body mass index (odds ratio [OR], 0.870; 95% confidence interval [CI], 0.785–0.964; P=0.008), laparoscopic surgery (OR, 0.391; 95% CI, 0.217–0.705; P=0.002) and elective surgery (OR, 0.213; 95% CI, 0.067–0.675; P=0.009). The chronological decrease in short-term complications was associated with an increase in laparoscopic surgery. Conclusions Our data revealed a downward trend of short-term postoperative complications among surgical ulcerative colitis patients in China during the past decade, which may be due to the promotion of minimally invasive techniques among Chinese surgeons.

BACKGROUND: It is common for patients with lung cancer to have concomitant coronary artery disease, some of them have underwent coronary stenting and accepted antiplatelet therapy. Whether antiplatelet agents should be continued in the perioperative period remains controversial, especially in patients requiring lung cancer resection with coronary artery stents. We reviewed the data of our institute to clarify the perioperative outcomes of this specific population. METHODS: We retrospectively analyzed the data on patients who underwent pulmonary resection for lung cancer following coronary stent placement between January 2013 and September 2019 in the Department of Thoracic Surgery in Peking University First Hospital. All of them discontinued oral antiplatelet agents before operation at least 5 days. The primary outcomes were the cardiovascular morbidity and mortality in hospital. RESULTS: 111 patients were identified and included in the analysis. The time intervals between stenting and lung surgery were 1-3 months, 3-12 months, and more than 12 months in 6.3%, 13.5% and 80.2% of the patients, respectively. Sublobectomy, lobectomy, biolobectomy, pneumonectomy and sleeve lobectomy were performed in 10.8%, 71.2%, 9.0%, 2.7% and 6.3% of the patients. The overall incidences of cardiovascular complications were 11.6%, including unstable angina (n=1, 0.9%), hypotention (n=1, 0.9%), congestive heart failure (n=2, 1.8%) and new-onset atrial fibrillation (n=10, 9.0%). There was no perioperative death. No major adverse cardiac events (MACE) occurred. CONCLUSIONS It was safety to discontinued oral antiplatelet agents before operation, with no MACE and death in perioperative period.

In October 2017, the General Office of the CPC Central Committee and the General Office of the State Council issued "The opinion on deepening the reform of the review and approval system and encouraging the innovation in pharmaceutical and medical devices" which clearly requires the unification of the evaluation stand for the second class medical device and realizes national review gradually. According to this requirement, this paper firstly reviews situation of foreign medical device evaluation system, and then introduces general situation of medical device review in our country, including the establishment of institutions and existed problem of medical device registrations, and corresponding reasons are also be analyzed. Finally we focus on giving proposal on how to realize the unification of class Ⅱ medical device technology review in China combined with real situation based on referring foreign experience.
China ; Device Approval ; Technology