The Analysis of 1295 Adverse Events of Vein Detained Needles and Suggestions for Improvement in Regulatory Work
Objective Based on real-world data,to explore the relevant factors that affect the safety of using vein detained needles,and propose improvement suggestions for adverse event monitoring of the product.Methods With the collection of adverse event reports of vein detained needles produced by enterprises in Henan Province received by the Henan Provincial Drug Adverse Reaction Monitoring Center from April 2020 to March 2021,deletion of false reports,duplicate reports,and invalid reports,a total of 1295 adverse event reports were included.With the analysis of adverse event reporting,patient condition,type and presentation,the suggestions for improvement were proposed for monitoring adverse events of vein detained needles.Results Among the 1295 cases of adverse events,there were 919 cases(70.97%)of vein detained needle failure,among which leakage and blockage were the most common,and the causes mainly included product quality problems,operation technology and out-of-range use;There were 548 patients with injury adverse events,accounting for 42.32%,among which redness and swelling at the puncture site were the most common,and the main causes included hose burrs,unskilled operation,poor vascular conditions of patients,etc.Conclusion Through the analysis of 1295 adverse events,it is recommended to improve the monitoring of adverse events related to vein detained needles through the following aspects:(1)It is recommended that medical institutions strengthen training and publicity,cultivate awareness of active monitoring and reporting,and continuously improve the quality of adverse event reporting;(2)It is recommended that product production/operation enterprises undertake the responsibility of monitoring adverse events,strengthen analysis and evaluation and take effective control measures;(3)It is recommended that the regulatory authorities standardize the terminology of adverse events,actively carry out key monitoring,and continue to improve equipment safety.
万方数据
维普
