Research on the Efficacy of Fulfillment of Medical Device Adverse Event Monitoring Entities and Safeguard Mechanism.
10.3969/j.issn.1671-7104.2018.01.016
- Author:
Wenxia REN
1
;
Yangdui MAO
1
;
Wenhua LUO
1
;
Jing DING
1
;
Wen WANG
2
;
Qing ZHU
1
Author Information
1. Zhejiang Pharmaceutical College, Ningbo, 315100.
2. Zhejiang Medical Devices Evaluation Center, Hangzhou, 311100.
- Publication Type:Journal Article
- Keywords:
adverse events monitoring;
entity responsibility;
medical devices
- MeSH:
Equipment Safety;
Equipment and Supplies;
adverse effects;
Product Surveillance, Postmarketing;
Surveys and Questionnaires
- From:
Chinese Journal of Medical Instrumentation
2018;42(1):58-61
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVES:To solve the problem that medical device adverse event monitoring entities perform their duties inadequately, to provide reference for perfecting the post-market surveillance system.
METHODS:Through theoretical and empirical research, the paper explored the ways to improve the performance of monitoring the adverse events of medical devices.
RESULTS:The survey found that the number of adverse event monitoring reports was few and the quality of report was poor. The root causes included lack of motivation of monitoring entities, the imperfect monitoring system, and the monitoring capability failure, etc.
CONCLUSIONS:The methods such as strengthening the main body responsibility consciousness, establishing evaluation system and accountability system, building social work network, are beneficial to the adverse events monitoring.
