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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Détails bibliographiques
Publié dans:JAMA
Auteurs principaux: Resnic, Frederic S., Gross, Thomas P., Marinac-Dabic, Danica, Loyo-Berrios, Nilsa, Donnelly, Sharon, Normand, Sharon-Lise T., Matheny, Michael E.
Format: Artigo
Langue:Inglês
Publié: 2010
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Article
Accès en ligne: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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