Sachin Logani1, Maia Gottlieb, Ralph J Verdino, Timir S Baman, Kim A Eagle, James N Kirkpatrick.
Abstract
BACKGROUND: Following high-profile device failures, the Heart Rhythm Society emphasized the need for postmarketing surveillance by recommending that physicians return all explanted devices to the manufacturer for analysis.
METHODS: We conducted a national survey of electrophysiologists (EPs) regarding recovery for analysis of explanted pacemakers and implantable cardioverter defibrillators (devices), and attitudes toward device-specific advance directives to facilitate return of devices. Online survey invitations were sent in four waves from December 2008 to June 2009 to 300 e-mail addresses from the Heart Rhythm Society member database.
RESULTS: From 250 invitations, there were 95 responses (38%). Demographics included average age 50 years (range, 31-87); 95% male; 81% Caucasian. Only 23% reported returning all explanted devices to the manufacturers. Of all the respondents, 32% discarded >10 devices/year as medical waste, 42% stored devices in a box in the electrophysiology lab, and 10% donated at least 1 device/year to charity for reuse overseas. Sixty-seven percent felt that it would not be helpful to have an advance directive specifying what the patient would want done with their device postmortem.
CONCLUSIONS: Few EPs return all explanted devices or send interrogation reports to the manufacturers, though nearly all said it was easy to do so. A majority either dispose of explanted devices as medical waste or store them in laboratories or offices, and a small percentage donate for reuse in underserved nations or to veterinary hospitals. This study suggests a need for initiatives such as educational campaigns to increase the retrieval and return of devices, either for analysis or reuse. ©2011, The Authors. Journal compilation ©2011 Wiley Periodicals, Inc.
BACKGROUND: Following high-profile device failures, the Heart Rhythm Society emphasized the need for postmarketing surveillance by recommending that physicians return all explanted devices to the manufacturer for analysis.
METHODS: We conducted a national survey of electrophysiologists (EPs) regarding recovery for analysis of explanted pacemakers and implantable cardioverter defibrillators (devices), and attitudes toward device-specific advance directives to facilitate return of devices. Online survey invitations were sent in four waves from December 2008 to June 2009 to 300 e-mail addresses from the Heart Rhythm Society member database.
RESULTS: From 250 invitations, there were 95 responses (38%). Demographics included average age 50 years (range, 31-87); 95% male; 81% Caucasian. Only 23% reported returning all explanted devices to the manufacturers. Of all the respondents, 32% discarded >10 devices/year as medical waste, 42% stored devices in a box in the electrophysiology lab, and 10% donated at least 1 device/year to charity for reuse overseas. Sixty-seven percent felt that it would not be helpful to have an advance directive specifying what the patient would want done with their device postmortem.
CONCLUSIONS: Few EPs return all explanted devices or send interrogation reports to the manufacturers, though nearly all said it was easy to do so. A majority either dispose of explanted devices as medical waste or store them in laboratories or offices, and a small percentage donate for reuse in underserved nations or to veterinary hospitals. This study suggests a need for initiatives such as educational campaigns to increase the retrieval and return of devices, either for analysis or reuse. ©2011, The Authors. Journal compilation ©2011 Wiley Periodicals, Inc.
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Year: 2011
PMID: 21314698 DOI: 10.1111/j.1540-8159.2011.03032.x
Source DB: PubMed Journal: Pacing Clin Electrophysiol ISSN: 0147-8389 Impact factor: 1.976