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HRS Guidelines Could Improve External Defibrillator Surveillance

This article was originally published in The Gray Sheet

Executive Summary

Companies that make automated external defibrillators should develop systems to track where their devices are stored and who is using them in order to improve recall efforts, say two leading electrocardiologists

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Heart Rhythm Society Annual Meeting In Brief

ICD replacement woes?: Mayo Clinic physicians identified nine complications that resulted from 732 implantable cardioverter defibrillator replacement procedures performed at the clinic from 2000 through 2005 in research reported at the Heart Rhythm Society annual meeting May 18 in Boston. The group found that 162 of the replacements were due to recalls and advisories; 570 were elective procedures performed due to expected battery depletions. However, research recently published in the Journal of the American Medical Association and presented at the HRS meeting reported a notably higher complication rate. That study found 43 complications, including 31 requiring re-operation, resulting from 533 ICD replacement procedures performed in 17 Canadian centers between October 2004 and October 2005 (1"The Gray Sheet" May 1, 2006, p. 4). University of Western Ontario Professor Paul Gould, lead author of the latter study, said the observed complication rate "was much higher than we anticipated" and should make physicians think twice before replacing an ICD. Meanwhile, data from a 96-patient survey presented at the meeting by Mount Sinai Medical Center physicians revealed no significant difference in emotional status and overall quality of life between patients with recalled heart devices and devices that had not been recalled...

Recent And Upcoming FDA Advisory Committee Meetings

Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.

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