Contemplation and Suggestion on the Medical Device Adverse Event Reporting Program
10.3969/j.issn.1671-7104.2014.01.019
- VernacularTitle:对我国医疗器械不良事件监测系统的思考和建议
- Author:
Baodong YU
1
;
Yingjie GUAN
;
Xiaomei MO
Author Information
1. 山东省青岛市妇女儿童医院
- Keywords:
medical device;
adverse event;
evaluation;
deficiency;
suggestion
- From:
Chinese Journal of Medical Instrumentation
2014;(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 stil existed some deficiencies which resulting in confusion when fil ing the forms, especial y 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.
