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用于分析的起搏器和除颤器回收及设备预先指示:电生理学家的观点

Recovery of pacemakers and defibrillators for analysis and device advance directives: electrophysiologists' perspectives.

作者信息

Logani Sachin, Gottlieb Maia, Verdino Ralph J, Baman Timir S, Eagle Kim A, Kirkpatrick James N

机构信息

Drexel University College of Medicine, Philadelphia, Pennsylvania, USA.

出版信息

Pacing Clin Electrophysiol. 2011 Jun;34(6):659-65. doi: 10.1111/j.1540-8159.2011.03032.x. Epub 2011 Feb 11.

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.

摘要

背景

在发生引人注目的设备故障后,心律协会强调了上市后监测的必要性,建议医生将所有取出的设备返还给制造商进行分析。

方法

我们针对电生理学家开展了一项全国性调查,内容涉及取出的起搏器和植入式心脏复律除颤器(设备)的回收分析情况,以及他们对有助于设备返还的特定设备预先指示的态度。2008年12月至2009年6月期间,分四批向心律协会会员数据库中的300个电子邮件地址发送了在线调查邀请。

结果

在250份邀请中,有95份回复(38%)。受访者的人口统计学特征包括:平均年龄50岁(范围为31 - 87岁);95%为男性;81%为白种人。只有23%的受访者报告将所有取出的设备返还给了制造商。在所有受访者中,32%每年将超过10台设备作为医疗废物丢弃,42%将设备存放在电生理实验室的盒子里,10%每年至少捐赠1台设备给慈善机构以供在海外重复使用。67%的人认为预先指示明确患者死后其设备的处理方式并无帮助。

结论

很少有电生理学家将所有取出的设备返还给制造商或向其发送问询报告,但几乎所有人都表示这样做很容易。大多数人要么将取出的设备作为医疗废物处理,要么将其存放在实验室或办公室,只有一小部分捐赠给服务欠缺国家重复使用或捐赠给兽医医院。这项研究表明需要开展诸如教育活动等举措,以增加设备的回收和返还,用于分析或重复使用。

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