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Medical Device Adverse Event Monitoring System Development in China:Delphi Method

ZHANG Su-min~1 CAO Li-ya~1 ZENG Guang~2 1 National Center forADR Monitoring(Beijing 100061) 2 National Center for Disease Control(Beijing 100050)  
Objective and method:Delphi method was used.According to the collection and analysis of expert's opinion,providing reference to our country's medical device adverse event monitoring system development.Results:DELPHI method was conducted two rounds. Positivity Coefficient are respectively 87.5% and 92.9%,Authority Coefficient are both 0.78 of two rounds.Through two rounds investigation,76.9% experts suggested that serious injuries or death related to medical devices should be reported;reports submitting procedure should be reporter-provincial center-national center(61.5%);manufacturers,distributors and user faculties should man- datory to submit reports(53.8%);when death related to medical device happens,respectively 46.2% experts suggest that“reporting as soon as possible”or“reporting within 72 hours after preliminary review”;we should have two kinds of forms in our country for manufacturers and user faculties(69.2%);adverse event reports should be submit via mail,fax,internet and so on(78.6%).Conclusion: the use of DELPHI method could provide some references to our country's adverse event monitoring system construction.
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