Objective:Through the adverse event information of disposable biopsy needles obtained from the"Zhejiang Device Alert"system,the risk types,causes and countermeasures of adverse events of disposable biopsy needles were investigated.Methods:By searching the"Zhejiang Equipment Alert"system,the State Drug Administration(NMPA)and other disposable biopsy needle products adverse event information sources,study the risk categories,analyze the risk factors and propose countermeasures.Results:Adverse events of disposable biopsy needles are mainly related to four aspects,namely,inherent product risk,registrant's product production quality control risk,clinical operation and use risk and patient risk.The reasons for the risk mainly include the registrant's choice of product materials and structural design,the degree of production quality control,the actual operation of clinical methods,individual differences in patients,patients and their families to cooperate with the degree.Countermeasures include product improvement by the registrant,strengthening of quality management system construction,standardization of clinical operation,strict grasp of the scope of application,and adequate communication and education.Conclusion:Disposable biopsy needle products have known and unintended risks that may lead to human injury,and risk monitoring and risk management should be strengthened in the production,use and regulation of such products to reduce and minimize the recurrence of similar adverse events.
维普
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