Eagle Kim A, Crawford Thomas C, Baman Timir
Ann Arbor, MI.
Trans Am Clin Climatol Assoc. 2015;126:158-66.
It is estimated that nearly 1 million patients in low-income countries die every year from bradyarrhythmias coupled with no access to a pacemaker. At the same time, it is estimated that tens of thousands of used devices could be harvested from hospitals, funeral homes, and crematories in wealthy nations if such a practice was legal and proven to be safe and efficacious. Project My Heart Your Heart is a collaborative, multinational effort with a goal of making pacemaker recycling a reality. Since its inception 4 years ago, the project has studied beliefs and attitudes of this idea among patients, pacemaker recipients, funeral home directors, and arrhythmia specialists. The project has explored the safety and efficacy of this practice in several small pilot studies. Nearly 15,000 used devices have been received and evaluated. Efforts to fully define optimal methods for sterilization and device processing have progressed positively. Safe, effective pacemaker recycling is possible and is generally supported by the public, patients, and cardiovascular specialists. An ongoing dialogue with the FDA will hopefully lead to a large pivotal study in five countries which will definitively establish this practice including optimal strategies for device removal, interrogation, sterilization, handling, implantation, and follow-up at charitable pacemaker facilities servicing low income patients throughout the world.
据估计,低收入国家每年有近100万患者死于缓慢性心律失常,且无法获得起搏器。与此同时,据估计,如果这种做法合法且被证明安全有效,那么在富裕国家的医院、殡仪馆和火葬场中,可能会回收数以万计的废旧设备。“我的心脏你的心脏”项目是一项跨国合作努力,目标是使起搏器回收成为现实。自4年前启动以来,该项目研究了患者、起搏器接受者、殡仪馆馆长和心律失常专家对这一想法的看法和态度。该项目在几项小型试点研究中探索了这种做法的安全性和有效性。已经收到并评估了近15000台废旧设备。全面确定最佳消毒和设备处理方法的工作取得了积极进展。安全、有效的起搏器回收是可行的,并且普遍得到公众、患者和心血管专家的支持。与美国食品药品监督管理局(FDA)正在进行的对话有望促成在五个国家开展一项大型关键研究,该研究将最终确立这种做法,包括在为全球低收入患者服务的慈善起搏器设施中进行设备取出、问询、消毒、处理、植入和随访的最佳策略。