Analysis on monitoring of medical device adverse events in grass roots of Heyuan city
Objective To analyze the monitoring situation of medical device adverse events in grass roots of Heyuan city,and to understand the overall monitoring situation of medical device adverse events in Heyuan city,so as to provide directions and suggestions for further strengthening the monitoring work.Methods A total of 1022 reports of medical device adverse events in Heyuan City from January 2016 to December 2020 were randomly selected and statistically analyzed by retrospective analysis.Results All the reports came from the using units,mainly including the reports of Class Ⅱ and Class Ⅲ medical devices,accounting for 50.59％and 37.18％respectively.There were 18 types of medical devices involved,among which infusion,nursing and protective devices accounted for the highest proportion,reaching 43.74％.The proportion of passive instruments was high,accounting for 59.59％.The proportion of reports of serious injuries was not high,accounting for 15.36％.In the preliminary cause analysis of adverse events,the simple product cause accounted for 75.54％.It was common that items were missing from the report,and missing of unique device identifier(UDI)accounted for the highest proportion,reaching 93.54％.Conclusion The report of medical device adverse events in Heyuan City comes from the using units,with a wide monitoring range,and the quality of the report form needs to be improved.It is beneficial to improve the ability of risk early warning and disposal by innovating working mode and strengthening business guidance.
万方数据
维普
