In 2016, the nationwide monitoring of medical device adverse events continued to develop steadily, and the number of reports of suspicious medical device adverse events in the year exceeded 350,000. While the number of reports continues to grow, the quality of reports continues to increase, providing a basis for the analysis and evaluation of risks after the listing of medical devices. I. Overall situation of national medical device adverse event report (1) Overall situation of national suspected adverse events in 2016 1. Number of suspected adverse events reported nationwide from 2002 to 2016 In 2016, the National Center for Adverse Drug Reaction Monitoring received a total of 353,240 “Reports of Suspicious Medical Device Adverse Eventsâ€, an increase of 10.0% over 2015 (Figure 1-1). From January 1, 2002 to December 31, 2016, the National Center for Adverse Drug Reaction Monitoring received 1,675,299 “Reports of Suspicious Medical Device Adverse Eventsâ€. Figure 1-1 Number of National Suspicious Medical Device Adverse Events Reports 2011-2015 2. Number of suspected adverse events reported for death and serious injury In 2016, the National Center for Adverse Drug Reaction Monitoring received 52,331 reports of suspected adverse events with serious injuries and 181 reports of suspected adverse events, a total of 52,512, an increase of 11.1% over 2015 (Figure 1- 2). The number of reports of suspected adverse events for death and serious injuries in 2016 accounted for 14.9% of the total number of reports, an increase of 0.2% over 2015. Figure 1-2 Comparison of Reported Suspected Adverse Events of Death and Serious Injury in 2011-2016 3. Average number of reports per million population In 2016, the number of reported suspicious medical device adverse events per million people in China was 264, an increase of 24 compared with 2015 (Figure 1-3). Figure 1-3 Comparison of the average number of reports per million people in the country from 2011 to 2016 Disposable Gloves,nitrile gloves, vinyl gloves,latex gloves,PVC gloves Disposable Gloves,Nitrile Disposable Gloves,Black Disposable Gloves,Latex Disposable Gloves Zhejiang Lanhine Medical Products Ltd. , https://www.lanheyiliao.com
