OBJECTIVE: To investigate the transfusion and infusion warmer manufacturers, combine the use failures to analyze adverse events, and provide support for enterprise risk management and clinical safe use. METHODS: The sentinels from 7 manufacturing enterprises and 11 medical institutions that participated in Shandong Province's key monitoring program during the "14th Five-Year Plan" period were targeted. This was done by understanding the equipment's principles, structures, and quality control. Additionally, real-world data from January 2019 to December 2023 were collected to count adverse events. RESULTS: During production, there are risks in switching power supply stability and solder joint firmness. Fifteen kinds of faults occurred during use, and common faults such as inability to heat, unable to turn on the machine, and bubbles in the infusion tube accounted for more than 80%. CONCLUSION There are many risk points and failures for transfusion and infusion warmers, so enterprises should improve processes and quality control to address risks, and medical institutions should formulate specifications and maintenance plans to provide targeted theoretical basis for supervision.
Blood Transfusion/instrumentation* ; Risk Factors ; Quality Control ; Humans ; Risk Management ; Equipment Failure

Background: One of the most common chronic respiratory diseases in the world, asthma placed a significant burden on adult populations in low- and middle-income nations like Tunisia. Although many patients continue to have less than ideal results, effective self-management is crucial to reaching optimal asthma control and avoiding exacerbations. Objective: This study aimed to assess the level of asthma control and explored the self-management practices of adult asthma patients in Southern Tunisia while identifying key socio-behavioral and environmental factors associated with poor disease outcomes. Methods: A descriptive cross-sectional study was conducted among adult asthma patients attending healthcare facilities in Southern Tunisia. Data was gathered using validated tools to measure asthma control, self-management behaviors, and exposure to potential risk factors such as passive smoking, sleep disturbances, and adverse environmental conditions. Descriptive and inferential statistical analyses were used to interpret the data. Results: The findings revealed a substantial proportion of participants who had uncontrolled asthma, which was significantly associated with insufficient self-management practices and high exposure to modifiable risk factors. Limited health literacy, lack of structured education, and inconsistent communication with healthcare providers emerged as key barriers. Conversely, patients who received tailored education and support demonstrated improved asthma control. Conclusion Enhancing asthma outcomes in Southern Tunisia required a patient-centered, multidisciplinary approach that integrates personalized education, structured self-management plans, and risk reduction strategies. Strengthening patient-provider communication and addressing socio-environmental determinants were critical to reducing the disease burden and improving the quality of life among adults with asthma.
Self-Management ; Patient Education ; Patient Education as Topic ; Tunisia ; Risk Factors

Through the analysis of laws and policies related to registration self-inspection, visiting and researching enterprises, holding symposiums, and issuing nationwide questionnaires, the risks in the registration self-inspection process were summarized, analyzed, and evaluated. From the aspects of regulatory departments and manufacturing enterprises, we suggest to improve China's medical device registration regulations system and reduce the risks of all parties in the registration self-inspection work.
Risk Management ; Commerce ; Medical Device Legislation

Introduction: Accidents are unpredictable and sometimes unavoidable. Businesses such as shopping complexes need to follow safety protocols to ensure that nobody is hurt. The shopping complex should have preventive measures and an accident management team to offer efficient and timely treatment for these accident victims. Objective: This paper aims to identify problems experienced by the accident management team in dealing with accidents in a shopping complex. The report will also propose and implement solutions to all issues identified. Methods: Two action research cycles were conducted for this paper, with the results of the first action research flowing into the second action research cycle. Reeves et al.’s interprofessional teamwork framework addressed concerns related to teamwork. The data used in this action research came from journal entries, informal and formal one-on-one discussions, and discussions with each department. Results: The workflow for the current post-accident management activities was evaluated. The problems identified were grouped into 5: roles and responsibilities, procedures, knowledge transfer, logistics, and skills. The issues concerning the roles and responsibilities of each team member were addressed by realigning these with their current skills, training, and job description. The remaining and new problems were addressed by developing an accident management policy. Inclusions in the policy are protocols on transporting patients, communication and transportation procedures, letter of authorization (LOA) approval procedures, post-accident evaluation procedures, pre-accident recommendations, policy revision procedures to address organizational changes, changes in the job description or government regulatory mandates, and the evaluation of current skills in case training is needed. Conclusion Accident management requires a coordinated effort amongst all the team members, with members from different social and health specialties. Using Reeves et al.’s interprofessional teamwork framework, the team identified the problems and implemented solutions by realigning the roles and responsibilities of each team member and implementing an accident management policy that can improve preventive measures and improve post-accident responses.
policy development ; accountability ; action research ; risk management

From the point of the technical evaluation of the registration of medical devices, the technical evaluation focus of the disposable endoscopic injection needle registration are briefly described in the chapters of the application overview documents, risk management data, product technical requirements, research data, toxic substance residues, biocompatibility evaluation, clinical evaluation data, et al. The common terms of technical requirements are specified, risk management and research materials list the project requirements for product characteristics. So as to accurately judge the product quality, improve the review efficiency, promote the development of the industry.
Needles ; Endoscopy ; Injections ; Risk Management ; Industry

Outbreaks caused by highly industrialized food companies are characterized by cross-border, trans-regional, rapid and unpredictable, related to serious disease and economic burden. A cluster of cases with monophasic salmonella enterica serovar Typhimurium ST34 infection suspected to be associated with consumption of contaminated chocolate products have been reported in several Europe countries since December 2021. After retrospective investigations, the buttermilk circuit in the Belgian factory was suspected to be the point of origin of the contamination. This outbreak could provide a reference for the risk management of foodborne pathogens contamination in China. The objective of this paper was to summarize the process and characteristics of the outbreak of monophasic S. Typhimurium caused by contaminated chocolate products, analyze the characteristics of ST34 monophasic S. Typhimurium and the microbial management measures in the process of chocolate products, and systematically discuss the suggestions for the risk management of foodborne pathogens contamination and countermeasures for the rapid development of industrialization of food enterprises in China, in order to provide scientific and technological support for the prevention and control, prediction and early warning of sudden cases in China.
Humans ; Salmonella typhimurium ; Serogroup ; Salmonella Infections/prevention & control* ; Chocolate ; Retrospective Studies ; Salmonella enterica ; Disease Outbreaks/prevention & control* ; Risk Management

Objective: To analyzes the various occupational health investment and occupational health output of a steel enterprise, and propose a reasonable occupational health investment plan for this enterprise. Methods: In march 2016, various occupational health input and output data of various branches of an iron and steel company in 2015 were collected, and the efficiency of occupational health inputs and outputs of each branch was evaluated using data envelopment analysis (DEA) , and the branches with non-optimal efficiency were adjusted to propose a reasonable occupational health investment plan. Results: Among the branch plants investigated by this steel company, the occupational health input-output efficiency values of ironmaking north plant, power plant, hot rolling plant and stainless steel plant were 1, while the occupational health input-output efficiency of gas making plant, cold rolling plant, metallurgical furnace charge plant, coking plant, ironmaking south plant and long product plant were not the best, and the cold rolling plant has the lowest efficiency value of 0.759. For the cold rolling plant, only the parameters of acid rolling plant satisfy α=1 and s(-)=0, s(+)=0, while the remaining four workshops do not meet. After adjusting the inputs of each part according to the parameters, the occupational health output of the remaining four workshops can reach 1.7044, 2.0238, 1.3152 and 1.2136 times of the current workshop, respectively. Adjustment plans for other branch factories with unreasonable investment structures are also presented in the corresponding tables. Conclusion: The occupational health investment structure of the ironmaking south plant and other branches in this steel enterprise is unreasonable, and the adjustment using data envelopment analysis can maximize the benefits of its occupational health output.
Financial Management ; Iron ; Metallurgy ; Occupational Health ; Steel

The pharmacokinetics of traditional Chinese medicine is a subject that studies the dynamic changes of the absorption, distribution, metabolism and excretion of complex components of traditional Chinese medicine, which is an important method for elucidating the pharmacodynamic material basis, action characteristics, and compatibility mechanisms of traditional Chinese medicine. However, given on the fact that traditional Chinese medicine is a multi-dimensional and complex system with multiple components, multiple pathways, multiple targets, and an unclear pharmacodynamic material basis, the research on the pharmacokinetics of traditio-nal Chinese medicine has become a scientific and technological problem. Although the pharmacokinetics of traditional Chinese medicine has achieved remarkable development with the emergence of new theories, methods and technologies, there are still some problems in the application of the research direction of the pharmacokinetics of traditional Chinese medicine judging from the current application of the National Natural Science Foundation of China. Therefore, this article discussed the current research status on pharmacokinetics of traditional Chinese medicines by analyzing the projects funded by the National Natural Science Foundation of China in the past 5 years from 2016 to 2020, mainly including the application and funding analysis, main research contents of the projects in pharmacokinetics of traditional Chinese medicines. And the research hotspots, difficulties and deficiencies were focused in order to provide certain reference for researchers engaged in pharmacokinetics of traditional Chinese medicine.
China ; Financial Management ; Foundations ; Medicine, Chinese Traditional ; Natural Science Disciplines

Risk management of medical devices covers the whole life cycle of medical devices, which is of great significance to the life safety and health condition of patients. The existing risk management of medical devices, especially the risk analysis in the research and development stage, often becomes a mere formality. The special risks faced by the research and development products in the clinical application scenarios are not well addressed. This study proves the necessity and importance of the combination of risk analysis and clinical application in the research and development stage of medical devices by the analysis of several special hazard sources in the process of clinical application of portable emergency ventilator.
Home Care Services ; Humans ; Risk Management ; Ventilators, Mechanical

To explore the general characteristics of adverse drug reactions/adverse events(ADR/AE) in patients after using Shujin Jianyao Pills, and explore risk warning signals, this study analyzed 166 cases of ADR/AE reports of Shujin Jianyao Pills collected from 2005 to 2017 based on the National Center for ADR Monitoring spontaneous reporting system(SRS). And the descriptive statistical method was used to analyze general characteristics. The results showed that among the 166 ADR/AE cases, 106 cases were female patients, accounting for 63.86%. Middle-aged and elderly people aged 45 to 64 accounted for the largest proportion(82 cases, 49.40%), which were followed by elderly aged 65 and over(48 cases, 28.91%). ADR/AE involved a wide range of systems and organs, of which skin and its accessories were the most damaged(30 cases, 12.93%), which were followed by systemic damage(27 cases, 11.64%). The top 10 ADR/AE manifestations were rash(15 cases, 6.33%), nausea(14 cases, 5.91%), dizziness(14 cases, 5.91%), abdominal pain(12 cases, 5.06%), pruritus(11 cases, 4.64%), low back pain(11 cases, 4.64%), vomiting(10 cases, 4.22%), hepatocyte damage(9 cases, 3.80%), headache(9 cases, 3.80%), and diarrhea(7 cases, 2.95%). Bayesian confidence propagation neural network(BCPNN) was used to mine the ADR/AE risk early warning signal of Shujin Jianyao Pills, and the propensity score method was used to control the balance of confounding factors. The results suggested warning signs for nausea, diarrhea, rash, and dizziness, vomiting, abdominal pain, headache, liver cell damage. This study provides a basis for the post-marke-ting safety evaluation of Shujin Jianyao Pills, and can provide guidance for its rational clinical use and risk management.
Adverse Drug Reaction Reporting Systems ; Aged ; Bayes Theorem ; Drug-Related Side Effects and Adverse Reactions ; Drugs, Chinese Herbal ; Female ; Humans ; Middle Aged ; Pharmacovigilance ; Risk Management