Chinese Journal of Pharmacovigilance ›› 2010, Vol. 7 ›› Issue (11): 676-680.

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Study on Quality Analysis of Adverse Events of Medical Device Reports

MIAO Hui-qing1, HUANG Sheng-quan2 ,MA Ning3, GUO Xue4* ,ZHANG Su-qiong4, CAO Bo4   

  1. 1.Certer for Adverse Drug Reactions Monitoring of Hainan Province, Hainan Haikou 570216, China;
    2.Jianou Food and Drug Administrator, Fujian Jianou 353100, China;
    3.Beijing Center for ADR Monitoring, Beijing 100024, China;
    4.Center for Drug Reevaluation, SFDA, Beijing 100045, China
  • Received:2010-07-12 Revised:2016-03-09 Online:2010-11-08 Published:2016-03-09

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Abstract: Objective To explore quality analysis of adverse events of medical device(MDAEs) Reports with characteristic of MDAEs Reports and quality standard of adverse drug reactions Reports. Methods Quality scoring table is prepared with the Weighted Coefficient of each item in Reports by using literature research, questionnaire and small group discussion. MDAEs Reports of a random 5% of MDAEs Reports database from Jan. to Apr. 2010 in center for drug deevaluation of SFDA were analysed with the scoring table, that is to validate feasibility and merit of Quality scoring table. Results Quality scoring method of MDAEs Reports is established. Conclusion The quality scoring method is scientific, effective and easy to be operated. The Results are accurate. It is propitious to improve quality of MDAEs Reports and to furnish true information for risk management of supervisory board.

Key words: adverse events of medical device reports, quality scoring table

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