Registry-Based Prospective Active Medical Device Safety Surveillance

BACKGROUND: Assuring the safety of medical devices is challenged by reliance on voluntary reporting of adverse events. We evaluated a strategy of prospective, active surveillance of a national clinical registry to monitor the safety of a vascular closure device suspected as potentially associated wi...

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Veröffentlicht in:N Engl J Med
Hauptverfasser: Resnic, Frederic S., Majithia, Arjun, Marinac-Dabic, Danica, Robbins, Susan, Ssemaganda, Henry, Hewitt, Kathleen, Ponirakis, Angelo, Loyo-Berrios, Nilsa, Moussa, Issam, Drozda, Joseph, Normand, Sharon-Lise, Matheny, Michael E.
Format: Artigo
Sprache:Inglês
Veröffentlicht: 2017
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Article
Online Zugang:https://ncbi.nlm.nih.gov/pmc/articles/PMC6145132/
https://ncbi.nlm.nih.gov/pubmed/28121489
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1056/NEJMoa1516333
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