Study on Adverse Event Risk of Medical Devices with Central Venous Catheters
Objective To study the risk types,occurrence causes and countermeasures of adverse events of central venous catheter-based medical devices.Methods By searching on the official website of the US Food and Drug Administration,CNKI,the official websites of the National Medical Products Administration and the Zhejiang Medical Products Administration,the types of risks was investigated,the risk factors was analysed and the countermeasures for the adverse events of central venous catheter products was put forward.Results Adverse events of central venous catheter products mainly involved four aspects:product design risk,registrant product quality control risk,clinical operation and use risk and patient risk.The reasons for the occurrence of risks mainly included the choice of material and structural design of the registrant's products,the degree of production quality control,the actual clinical operation methods,individual differences in patients,and the degree of co-operation of patients and their families.Countermeasures included product improvement by the registrant,strengthening of quality management system construction,standardisation of clinical operations,strict control of the scope of application,and adequate communication and education.Conclusion Central venous catheter products have known and unintended risks that may lead to human injuries,and risk monitoring and risk management should be strengthened in the production,use and regulation of such products to prevent the recurrence of similar adverse events.
万方数据
维普
