Reporting standards for adverse events after medical device use in the peripheral vascular system
نویسندگان
چکیده
منابع مشابه
Reporting of Cardiovascular Medical Device Adverse Events to Pharmaceuticals and Medical Devices Agency, Japan☆
BACKGROUND Marketing authorization holders (MAHs) are obligated to report adverse events (AEs) within 15 days (some cases 30 days) to the Pharmaceuticals and Medical Devices Agency (PMDA) of Japan. METHODS To analyze the timeliness of AE reporting to the PMDA, 6610 reports for five categories of cardiovascular devices were retrieved. Two durations were calculated: (1) time from the date the A...
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متن کاملReporting of adverse events.
From the Harvard School of Public Health, Boston. HEN the Institute of Medicine (IOM) issued To Err Is Human,1 the recommendation to expand reporting of serious adverse events and medical errors, particularly mandatory reporting, received the most attention and sparked controversy.2 The American Medical Association and the American Hospital Association raised strong objections, claiming that ma...
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15 صفحه اولA Systematic Review of the Reporting of Adverse Events Associated With Medical Herb Use Among Children
PURPOSE Information about the safety of herbal medicine often comes from case reports published in the medical literature, thus necessitating good quality reporting of these adverse events. The purpose of this study was to perform a systematic review of the comprehensiveness of reporting of published case reports of adverse events associated with herb use in the pediatric population. METHODS ...
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ژورنال
عنوان ژورنال: Journal of Vascular Surgery
سال: 2013
ISSN: 0741-5214
DOI: 10.1016/j.jvs.2013.06.059