I. Overall situation of national medical device adverse event report
In 2015, 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 320,000. 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 suspicious adverse events in 2015
In 2015, the National Center for Adverse Drug Reaction Monitoring received a total of 321,254 “Reports of Suspicious Medical Device Adverse Eventsâ€, an increase of 21.1% over 2014. From January 1, 2002 to December 31, 2015, the National Center for Adverse Drug Reaction Monitoring received 1,322,059 “Report Forms of Suspicious Medical Device Adverse Events†(Figure 1-1).
Figure 1-1 Number of Reports of Suspicious Medical Device Adverse Events in China from 2002 to 2015
1. Number of suspected adverse events reported for death and serious injury
In 2015, the National Center for Adverse Drug Reaction Monitoring received 184 reports of suspected adverse events and 47,065 reports of serious injuries and suspected adverse events, totaling 47,249, an increase of 15.2% over 2014 (Figure 1-2). The number of reports of suspected adverse events for death and serious injuries in 2015 accounted for 14.7% of the total number of reports, a decrease of 0.8% from 2014.
Figure 1-2 Comparison of Reported Suspected Adverse Events of Death and Serious Injury in 2011-2015
2. Average number of reports per million population
In 2015, the number of reported suspicious medical device adverse events per million people in China was 240, an increase of 42 compared with 2014 (Figure 1-3).
Figure 1-3 Comparison of the average number of reports per million people in the country from 2011 to 2015
3. Number of registered base users
As of December 31, 2015, there were 198,536 registered grassroots users (including medical device manufacturers, operating companies and users) in the National Medical Device Adverse Event Monitoring System. Among them, there were 10,344 medical device manufacturers, accounting for 5.2% of the total number of registered grassroots users; 91,322 operating companies, accounting for 46.0% of registered grassroots users; and 96,870 users, accounting for 48.8% of registered grassroots users (Figure 1-4).
Figure 1-4 Status of registered grassroots users of the National Medical Device Adverse Event Monitoring System in 2015
In 2015, the total number of registered grassroots users (including medical device manufacturers, operating companies and users) increased by 13.9% compared with 2014. Among them, the registered grassroots users of medical device manufacturers, operating companies and users increased by 11.8%, 21.8% and 7.5% respectively compared with 2014 (Figure 1-5).
Figure 1-5 Comparison of national registered grassroots user classifications in 2014 and 2015
Oxygen Generator & O2 Cylinder Filling
Oxygen Generator & O2 Cylinder Filling,Portable Oxygen Generator,O2 Cylinder Filling,Medical Oxygen Generator
Hangzhou Zhongju air separation equipment manufacturing Co., Ltd , https://www.hzzjkfzz.com