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Objective:To explore the research hotspots and effective promotion paths of post market surveillance and supervise of medical consumables with non-active medical devices.Methods:Data mining methods were used to collect related journal literatures and documents from the websites of China regulatory institutions and the China National Knowledge Infrastructure(CNKI),order sub item data of medical device adverse event reports,extract the MeSH element words of literatures and documents,perform bibliometric analysis and visual display.Results:The number of medical devices adverse event reports in China has been increasing year by year,reaching 694 866 in 2022,in the four statistical years from 2019 to 2022,the number of reports on non-active medical devices and IVD reagents also showed a parallel increasing trend,accounting for about 65.00% of the total number of adverse event reports on medical devices in the year.The bibliometric analysis of journal literature shows that research in this field has received varying degrees of participation from regulatory institutions,universities,medical institutions,and enterprises.Regulatory institutions have contributed 46 articles,accounting for 56.79% of the total number of articles,followed by 28 articles from universities.The co-occurrence analysis shows that hot topic is focused in 5 clusters:quality management,risk management,international experiences discussion and adverse event surveillance and re-evaluation and real-world research.China regulatory institutions attach great importance to post market surveillance and supervise,and have issued more than 20 relevant documents since 2006,focusing on specific topics and gradually deepening around safety and effectiveness.Conclusion:The post market surveillance and supervise of medical devices,especially medical consumables based on non-active medical devices,need to be promoted synchronously in three dimensions:regulatory institutions,medical institutions,and enterprises.Universities,research institutes,and industry organizations should work in coordinating to strengthen the collection,identification,and active surveillance of risk signals based on adverse event surveillance,safety evaluation based on risk management,and conducting real-world research,research and develop risk control and corrective and preventive measures.
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Objective:To analyze the characteristics of adverse events of active medical devices in Shandong province, as well as the impact of device use duration on the risk rate of adverse events, for reference in improving the monitoring system of active medical device adverse events in China and the level of hospital medical quality management.Methods:The data came from the adverse event reporting data of active medical devices collected by Shandong Adverse Drug Reaction Monitoring Center from January 2019 to October 2021. The R software was used to analyze the distribution, cause and severity of adverse events, and a linear regression model of adverse event risk rate(Y) and adverse event time point(X) was established.Results:A total of 35 254 adverse events of active devices were included, of which 3 059 were serious injuries. The province/municipality with the largest number of reported adverse events was Shanghai(8 006 cases), and the least was Hainan province(4 cases); The majority of adverse events were reported by hospitals, with 34 056(96.60%). The medical devices reporting a higher number of adverse events were ventilators(688 cases), monitors(4 623 cases), infusion pumps(1 079 cases), syringe infusion pumps(1 995 cases), medical electron accelerators(529 cases)and infant incubators(513 cases). In the linear regression model, the risk rate of adverse events increased with the useduration of the device when 0.00%≤ X<14.14%; the risk rate of adverse events decreased with the increase of service time when 14.14%≤ X<100.00%. Conclusions:The number of adverse events reported in each province is different, and hospitals are the main reporting units.The causes of adverse events of different medical devices indicate different correlation strengths with the product itself. The use duration of medical devices poses a great impact on the risk rate of adverse events.
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Objective To explore the bidding evaluation method of the active medical device to meet clinical requirements. Methods The present situation of bidding purchase and bidding evaluation methods were analyzed for the active medical device, and a new evaluation method was put forward with considerations on the device's characteristics as well as its advantages in technology and commerce. Results The method contributed to purchasing the device with the highest cost-performance ratio, which showed the technical advantages of medical engineering department. Conclusion The method ensures that the purchased medical device meets clinical requirements,and enhances the social and economic benefits of the hospital.