[Analysis on evaluation of medical device adverse events monitoring and some factors influencing MDAE's reporting by medical personnels].
OBJECTIVE
To investigate the knowledge level related to medical device adverse events (MDAEs) among medical personnels, some factors influencing the reporting behavior and supervision and administrative strategies.


METHODS
Stratified sampling, cluster sampling and random sampling were adopted together and a questionnaire survey was conducted among 1897 subjects from 33 hospitals.


RESULTS
Medical personnels knew a very little about MDAEs and medical devices' post-market monitoring, but their attitudes towards its benefits were positive. Their intentions to report MDAEs were relatively strong, but there were still some barriers about it.


CONCLUSIONS
A monitoring system and a professional training model about MDAEs reporting should be established and improved in hospitals.
Liu
Ai-Ping
AP
School of Public Health, Peking University, Beijing 100083. apingliu@163.com
Zhang
Li-Ming
LM
Yan
Wei
W
Zhang
Jing-Hang
JH
Zhu
Yan-Ping
YP
D004864:Equipment and Supplies / Q000009:adverse effects*; D007722:Health Knowledge, Attitudes, Practice; D006282:Health Personnel / Q000193:education*; D006801:Humans; D019300:Medical Errors / Q000706:statistics & numerical data*