Analysis on evaluation of medical device adverse events monitoring and some factors influencing MDAE's reporting by medical personnels / 中国医疗器械杂志

ABSTRACT

<p><b>OBJECTIVE</b>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.</p><p><b>METHODS</b>Stratified sampling, cluster sampling and random sampling were adopted together and a questionnaire survey was conducted among 1897 subjects from 33 hospitals.</p><p><b>RESULTS</b>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.</p><p><b>CONCLUSION</b>A monitoring system and a professional training model about MDAEs reporting should be established and improved in hospitals.</p>