Postmortem Analysis and Retrieval of Implantable Pacemakers and Defibrillators
http://www.100md.com
《新英格兰医药杂志》
To the Editor: Recent recalls of implantable pacemakers and defibrillators have cast a spotlight on the need for improved product reliability.1 Although it is estimated that the failure rate of these devices is low, the true rate of device malfunction is not known. The Food and Drug Administration recently stated that it supports a policy requiring that defibrillators be returned to the manufacturer to be studied for possible defects after the death of a patient.2 The few published guidelines available for morticians concerning the handling of devices make no mention of routine interrogation or retrieval.3,4 Therefore, we surveyed embalmers or directors at 100 funeral homes in the Chicago area to determine their current practices and opinions.
The rate of response to the survey was 71 percent. Each funeral home reported providing services for an annual mean (±SD) of 343±437 deceased persons, and the mean percentage of deceased persons with an implantable device was 11±9 percent (range, 1 to 33). Only four respondents recalled an interrogation of an implantable device. The mean number of devices removed per year was 7±10 (range, 1 to 50). Many embalmers mentioned that the most common reason for removal was preparation for cremation, because devices explode in extreme heat. The national cremation rate is 27 percent, and this rate is expected to rise to 36 percent by 2010.5 Table 1 summarizes the responses with regard to the disposition of devices. Several respondents reported that they used more than one method of disposition.
Table 1. Postmortem Disposition of Implantable Devices, as Reported by Embalmers and Funeral Directors.
When queried about the possibility of routine device analysis, 80 percent of respondents thought it would be feasible to interrogate devices in the funeral home, and 87 percent said it would be possible to return all devices to the manufacturer. Although most respondents said that without the consent of the family, it would not be appropriate to interrogate devices (72 percent) or remove the devices for analysis (93 percent), 65 percent estimated that the majority of families would consent to interrogation, and 68 percent thought the majority of families would approve of the return of a device to the manufacturer.
The results of our survey of morticians demonstrate that implantable pacemakers and defibrillators are rarely interrogated or returned to the manufacturer after a patient dies. Almost half of retrieved devices are treated as medical waste. However, funeral directors and embalmers believe routine postmortem interrogation and retrieval of devices would be feasible, assuming that proper consent could be obtained from the family. These results suggest that there is considerable potential for improved postmortem analysis of implantable devices.
James N. Kirkpatrick, M.D.
Martin C. Burke, D.O.
Bradley P. Knight, M.D.
University of Chicago
Chicago, IL 60637
bknight@medicine.bsd.uchicago.edu
Drs. Knight and Burke report having received research grants from Guidant, Medtronic, and St. Jude Medical; Dr. Knight, consulting fees from Guidant and Medtronic and fellowship funding from Guidant; and Dr. Burke, consulting fees from Guidant, Spectranetics, and AJ Medical Devices.
References
Steinbrook R. The controversy over Guidant's implantable defibrillators. N Engl J Med 2005;353:221-224.
Sherman D. FDA supports returning ICD to maker for study. New York: Reuters, November 8, 2005.
Cardiac Society of Australia and New Zealand, Australian Funeral Directors Association, CPI (JR Management), Medtronic, Intermedics (Sulzer), Telectronics Pacing Systems. Guidelines for the prevention of accidental exposure to high voltage electric shocks during the preparation for burial of deceased persons with implantable cardioverter defibrillators (ICDS). 1999. (Accessed March 23, 2006, at http://www.csanz.edu.au/guidelines/practice/defibrgl.pdf.)
Medical Devices Agency. Removal of Implantable Cardioverter Defibrillators (ICDs). Safety notice SN(NI) 2002(40). December 2002. (Accessed March 23, 2006, at http://www.dhsspsni.gov.uk/niaic_sn(ni)2002_40.pdf.)
Cremation Association of North America. Confirmed 2001 statistics: projections based on past 5 years' average percent change. October 31, 2003. (Accessed March 23, 2006, at http://www.cremationassociation.org/html/statistics.html.)
The rate of response to the survey was 71 percent. Each funeral home reported providing services for an annual mean (±SD) of 343±437 deceased persons, and the mean percentage of deceased persons with an implantable device was 11±9 percent (range, 1 to 33). Only four respondents recalled an interrogation of an implantable device. The mean number of devices removed per year was 7±10 (range, 1 to 50). Many embalmers mentioned that the most common reason for removal was preparation for cremation, because devices explode in extreme heat. The national cremation rate is 27 percent, and this rate is expected to rise to 36 percent by 2010.5 Table 1 summarizes the responses with regard to the disposition of devices. Several respondents reported that they used more than one method of disposition.
Table 1. Postmortem Disposition of Implantable Devices, as Reported by Embalmers and Funeral Directors.
When queried about the possibility of routine device analysis, 80 percent of respondents thought it would be feasible to interrogate devices in the funeral home, and 87 percent said it would be possible to return all devices to the manufacturer. Although most respondents said that without the consent of the family, it would not be appropriate to interrogate devices (72 percent) or remove the devices for analysis (93 percent), 65 percent estimated that the majority of families would consent to interrogation, and 68 percent thought the majority of families would approve of the return of a device to the manufacturer.
The results of our survey of morticians demonstrate that implantable pacemakers and defibrillators are rarely interrogated or returned to the manufacturer after a patient dies. Almost half of retrieved devices are treated as medical waste. However, funeral directors and embalmers believe routine postmortem interrogation and retrieval of devices would be feasible, assuming that proper consent could be obtained from the family. These results suggest that there is considerable potential for improved postmortem analysis of implantable devices.
James N. Kirkpatrick, M.D.
Martin C. Burke, D.O.
Bradley P. Knight, M.D.
University of Chicago
Chicago, IL 60637
bknight@medicine.bsd.uchicago.edu
Drs. Knight and Burke report having received research grants from Guidant, Medtronic, and St. Jude Medical; Dr. Knight, consulting fees from Guidant and Medtronic and fellowship funding from Guidant; and Dr. Burke, consulting fees from Guidant, Spectranetics, and AJ Medical Devices.
References
Steinbrook R. The controversy over Guidant's implantable defibrillators. N Engl J Med 2005;353:221-224.
Sherman D. FDA supports returning ICD to maker for study. New York: Reuters, November 8, 2005.
Cardiac Society of Australia and New Zealand, Australian Funeral Directors Association, CPI (JR Management), Medtronic, Intermedics (Sulzer), Telectronics Pacing Systems. Guidelines for the prevention of accidental exposure to high voltage electric shocks during the preparation for burial of deceased persons with implantable cardioverter defibrillators (ICDS). 1999. (Accessed March 23, 2006, at http://www.csanz.edu.au/guidelines/practice/defibrgl.pdf.)
Medical Devices Agency. Removal of Implantable Cardioverter Defibrillators (ICDs). Safety notice SN(NI) 2002(40). December 2002. (Accessed March 23, 2006, at http://www.dhsspsni.gov.uk/niaic_sn(ni)2002_40.pdf.)
Cremation Association of North America. Confirmed 2001 statistics: projections based on past 5 years' average percent change. October 31, 2003. (Accessed March 23, 2006, at http://www.cremationassociation.org/html/statistics.html.)