Strengthening Medical Device Postmarket Safety Surveillance
نویسندگان
چکیده
منابع مشابه
The data extraction and longitudinal trend analysis network study of distributed automated postmarket cardiovascular device safety surveillance.
BACKGROUND Current approaches for postmarket medical device safety surveillance are limited in their ability to produce timely and accurate assessments of adverse event rates. METHODS AND RESULTS The Data Extraction and Longitudinal Trend Analysis (DELTA) network study was a multicenter prospective observational study designed to evaluate the safety of devices used during percutaneous coronar...
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BACKGROUND In September 2004, rofecoxib was voluntarily withdrawn from the worldwide market. Our objective was to determine whether and when analysis of published and unpublished placebo-controlled trials could have revealed cardiovascular risk associated with rofecoxib before its withdrawal as an example to inform future postmarket pharmaceutical safety surveillance efforts. METHODS We condu...
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BACKGROUND As implantable cardioverter-defibrillator technology evolves, clinicians and patients need reliable performance data on current transvenous implantable cardioverter-defibrillator systems. In addition, real-world reliability data could inform postmarket surveillance strategies directed by regulators and manufacturers. METHODS AND RESULTS We evaluated Medtronic Sprint Quattro, Boston...
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ژورنال
عنوان ژورنال: JAMA Internal Medicine
سال: 2015
ISSN: 2168-6106
DOI: 10.1001/jamainternmed.2015.2650