Management of intracardiac device recalls: a consensus conference.
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 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.
Goldman
B S
BS
Division of Cardiac Surgery, University of Toronto, Ontario.
Newman
D
D
Fraser
J
J
Irwin
M
M
D000465:Algorithms; D002170:Canada; D003663:Decision Trees; D004868:Equipment Failure; D006801:Humans; D007221:Industry; D010138:Pacemaker, Artificial / Q000191:economics / Q000592:standards* / Q000706:statistics & numerical data; D010358:Patient Participation; D010819:Physician's Role; D006113:United Kingdom; D014481:United States; D014486:United States Food and Drug Administration