NAPSE policy statement. Management of intracardiac device recalls: a consensus conference [corrected] [published erratum appears in PACING CLIN ELECTROPHYSIOL 1996 Apr;19(4 part 1):viii].

The incidence of cardiac device recalls seems to be increasing, in part due to increasing complexity, but also due 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 (PAC) 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 (RTF) to deal with specific problems distinct from the manufacturers' PAC; emphasis on patient responsibility for obtaining regular follow-up and maintaining contact by a pacemaker passport system as exists in Europe; and the fair assignment of costs involved in a recall with specific emphasis on appropriate compensation for physicians and clinic personnel. [ABSTRACT FROM AUTHOR]