Contemplation and suggestion on the medical device adverse event reporting program.
- Author:
Baodong YU
;
Yingjie GUAN
;
Xiaomei MO
- Publication Type:Journal Article
- MeSH:
China;
Consumer Product Safety;
Equipment and Supplies;
Safety Management
- From:
Chinese Journal of Medical Instrumentation
2014;38(1):65-67
- CountryChina
- Language:Chinese
-
Abstract:
The number of medical device adverse events reported to national monitoring center increased greatly year by year, but the reporting system still existed some deficiencies which resulting in confusion when filling the forms, especially those selections about relationship evaluation. This paper proposed amendments about event-evaluation process according to the characteristics of medical device adverse events reported in China, in order to perform timely and effectively regulation on different types of adverse events for different purposes.
