Interventional cardiology live case presentations regulatory considerations

Live case presentations are increasingly common at interventional cardiology conferences. Taking advantage of significant advances in communication technology, broadcasts of procedures can be viewed as an extension of traditional medical education targeted to large groups of practitioners. However,...

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Bibliographic Details
Published inHeart rhythm Vol. 7; no. 10; p. e1
Main Authors Farb, Andrew, Brown, Sheila A, Wolf, Deborah A, Zuckerman, Bram
Format Journal Article
LanguageEnglish
Published United States 01.10.2010
Subjects
Cardiology - legislation & jurisprudence
Cardiology - standards
Clinical Trials as Topic - legislation & jurisprudence
Device Approval - legislation & jurisprudence
Government Regulation
Humans
Informed Consent
Therapies, Investigational
United States
United States Food and Drug Administration
United States
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Summary:Live case presentations are increasingly common at interventional cardiology conferences. Taking advantage of significant advances in communication technology, broadcasts of procedures can be viewed as an extension of traditional medical education targeted to large groups of practitioners. However, there are important ethical, commercial, and patient safety issues associated with live cases that deserve attention. Use of investigational devices in live case demonstrations is subject to review and approval by FDA's Center for Devices and Radiological Health (CDRH), and the outcomes of patients participating in live cases are considered in the overall clinical study results. This article discusses CDRH's regulatory view of live case presentations with a focus on patient safety, clinical trial integrity, and concerns regarding improper medical device promotion.
ISSN:1556-3871
DOI:10.1016/j.hrthm.2010.08.024