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

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 - Korea Adverse Event Reporting System (KIDS-KAERS) database, a nationwide database of adverse events reports, between January 2008 and December 2017 to investigate the reporting count of all drug eruptions and calculated the ratio of DRESS/SJS/TEN reports for each AED.RESULTS: Among a total of 2,942 reports, most were of rash/urticaria (2,702, 91.8%), followed by those of DRESS (109, 3.7%), SJS (106, 3.6%), and TEN (25, 0.85%). The common causative AEDs were lamotrigine (699, 23.8%), valproic acid (677, 23%), carbamazepine (512, 17.4%), oxcarbazepine (320, 10.9%), levetiracetam (181, 6.2%), and phenytoin (158, 5.4%). In limited to severe drug eruptions (DRESS, SJS, and TEN; total 241 reports), the causative AEDs were carbamazepine (117, 48.8%), lamotrigine (57, 23.8%), valproic acid (20, 8.3%), phenytoin (15, 6.3%), and oxcarbazepine (10, 4.2%). When comparing aromatic AED with non-aromatic AED, aromatic AEDs were more likely to be associated with severe drug eruption (aromatic AEDs: 204/1,793 versus non-aromatic AEDs: 37/1,149; OR, 3.86; 95% CI, 2.7–5.5). Death was reported in 7 cases; DRESS was the most commonly reported adverse event (n = 5), and lamotrigine was the most common causative AED (n = 5).CONCLUSION: Although most cutaneous drug eruptions in this study were rash or urticaria, approximately 8% of reports were of severe or life-threatening adverse drug reactions, such as SJS, TEN, or DRESS. When hypersensitivity skin reactions occurred, aromatic AEDs were associated with 4 fold the risk of SJS/TEN/DRESS compared with non-aromatic AEDs. Our findings further emphasize that high risk AEDs should be prescribed under careful monitoring, and early detection and prompt interventions are needed to prevent severe complications.]]>
Anticonvulsants ; Carbamazepine ; Drug Eruptions ; Drug Hypersensitivity Syndrome ; Drug-Related Side Effects and Adverse Reactions ; Exanthema ; Hypersensitivity ; Korea ; Pharmacovigilance ; Phenytoin ; Risk Management ; Skin ; Stevens-Johnson Syndrome ; Urticaria ; Valproic Acid

No abstract available.
Financial Management ; Platinum

The projects which supported by National Natural Science Foundation of China(NSFC) including General Program, Young Scientist Fund, and Fund for Less Developed Regions, in field of pharmacology of traditional Chinese medicine in 2019 were reviewed. Based on these research items, the main contents and characteristics, as well as the main problems from academic and non-academic point of view, were summarized for reference.
China ; Financial Management ; Foundations/economics* ; Medicine, Chinese Traditional/economics* ; Natural Science Disciplines