PMID: 8595567Jan 1, 1996Paper

Management of intracardiac device recalls: a consensus conference

The Canadian Journal of Cardiology
Bernard GoldmanM Irwin

Abstract

The incidence of cardiac device recalls seems to be increasing, due in part to increasing complexity, but also to greater public awareness and regulatory overview. Manufacturers are responsible for postmarket surveillance of their implanted products; evidence for poor performance is usually evaluated by a physician advisory committee, and unacceptable failure rates or modes prompt the issuance of a recall. A consensus conference was held March 6, 1995 in Toronto, Ontario to discuss the management of cardiac device recalls after the provincial Ministry of Health issued unique guidelines regarding a recent lead problem. Various stakeholders expressed their views and concerns: the federal regulatory body, the provincial Ministry of Health and hospital association, manufacturers, hospital legal counsel, patient and media advocates and physicians from the United Kingdom, the United States and Canada. Specific recommendations included the establishment of a national (or regional) pacemaker (device/lead) registry interposed between the manufacturer and the federal authority; the creation of a recall task force to deal with specific problems distinct from the manufacturers' physician advisory committee; emphasis on patient responsibili...Continue Reading

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Citations

Jan 20, 2006·Journal of Interventional Cardiac Electrophysiology : an International Journal of Arrhythmias and Pacing·Sanjeev Saksena
Aug 15, 2001·Chest·B KleinmanC Andrus
May 11, 2006·The Canadian Journal of Cardiology·Christopher S Simpson, Anne M Gillis
Dec 17, 2003·Pacing and Clinical Electrophysiology : PACE·Osnat GurevitzMichael Glikson
Sep 25, 2008·Pacing and Clinical Electrophysiology : PACE·David S Cannom, John Fisher
Jun 6, 2007·Pacing and Clinical Electrophysiology : PACE·Suraj KapaDavid L Hayes
Jul 5, 2005·Heart Rhythm : the Official Journal of the Heart Rhythm Society·N A Mark Estes
Feb 25, 1998·Pacing and Clinical Electrophysiology : PACE·K NanthakumarD Newman
Jan 15, 2011·Stroke; a Journal of Cerebral Circulation·Suk Jae KimGyeong-Moon Kim
Apr 26, 2006·Europace : European Pacing, Arrhythmias, and Cardiac Electrophysiology : Journal of the Working Groups on Cardiac Pacing, Arrhythmias, and Cardiac Cellular Electrophysiology of the European Society of Cardiology·Angelo AuricchioUNKNOWN Writing Committee for the European Heart Rhythm Association Guidance Document on Cardiac Rhythm Management Product Performan

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