[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. CONCLUSION: A monitoring system and a professional training model about MDAEs reporting should be established and improved in hospitals.