Automated surveillance to detect post-procedure safety signals of approved medical devices

CONTEXT: Assuring the safety of medical devices challenges current surveillance approaches which rely heavily on voluntary reporting of adverse events. Automated surveillance of clinical registries may provide early warnings in the post-market evaluation of medical device safety. OBJECTIVE: To deter...

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Detalhes bibliográficos
Publicado no:JAMA
Main Authors: Resnic, Frederic S., Gross, Thomas P., Marinac-Dabic, Danica, Loyo-Berrios, Nilsa, Donnelly, Sharon, Normand, Sharon-Lise T., Matheny, Michael E.
Formato: Artigo
Idioma:Inglês
Publicado em: 2010
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Article
Acesso em linha:https://ncbi.nlm.nih.gov/pmc/articles/PMC5130290/
https://ncbi.nlm.nih.gov/pubmed/21063011
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1001/jama.2010.1633
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