Discussion on Quality and Improvement of Medical Device Adverse Event Monitoring Reports

Abstract

Abstract: Objective To explore the impact of all aspects of medical device adverse event(MDAE) monitoring and evaluation on the quality of MDAE reports, so as to provide references for upgrading the reporting quality and further improving the MDAE monitoring and evaluation. Methods Based on real working practices in MDAE data normalization, the quality of MDAE reports was analyzed by studying the data from national MDAE monitoring information system. Compared with related researches home and abroad, the factors influencing the reporting quality were summarized. Results and Conclusion The reporting quality is the foundation of the MDAE monitoring and evaluation, It can be improved at source by innovating reporting method and monitoring mode. Meanwhile, strengthening the construction and improvement of related regulations and technical standards, implementing the review and evaluation effectively by monitoring technology institutions, establishing data sharing and risk communication mechanism within relevant institutions might be powerful approaches to upgrade the reporting quality.

Key words: medical device, adverse event, reporting quality

CLC Number:

ZHANG Xue-ning, WANG Ling, WANG Gang, LIN Xu-dong, DU Hong-yang. Discussion on Quality and Improvement of Medical Device Adverse Event Monitoring Reports[J]. Chinese Journal of Pharmacovigilance, 2015, 12(8): 479-482.

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