Pacemaker recycling: A notion whose time has come

Abstract

The purpose of this paper is to summarize the need, feasibility, safety, legality, and ethical perspectives of pacemaker reutilization in low- and middle-income countries (LMICs). It will also describe, in-depth, Project My Heart Your Heart (PMHYH) as a model for pacemaker reuse in LMICs. The primary source of the discussion points in this paper is a collection of 14 publications produced by the research team at the University of Michigan and its collaborative partners. The need for pacemaker reutilization in LMICs is evident. Numerous studies show that the concept of pacemaker reutilization in LMICs is feasible. Infection and device malfunction are the main concerns in regard to pacemaker reutilization, yet many studies have shown that pacemaker reuse is not associated with increased infection risk or higher mortality compared with new device implantation. Under the right circumstances, the ethical and legal bases for pacemaker reutilization are supported. PMHYH is a proof of concept pacemaker donation initiative that has allowed funeral home and crematory directors to send explanted devices to an academic center for evaluation and re-sterilization before donation to underserved patients in LMICs. The time is now to pursue large-scale studies and trials of pacemaker reuse for the betterment of society. PMHYH is leading the way in the effort and is poised to conduct a prospective randomized, non-inferiority, multicenter study to confirm the clinical efficacy and safety of pacemaker reuse, for clinical and legal support.

Worldwide pacemaker and defibrillator reuse: Systematic review and meta‐analysis of contemporary trials

“…Due to the medico‐legal constraints on devices currently labeled as “single use only,” and the ethical requirement to inform patients of the possible hazards of device reuse, it is likely not feasible to undertake a double‐blind multicenter randomized control trial of this nature in high‐income nations where device cost is not a barrier to receiving therapy. Accordingly, a concerted effort is underway to secure operational funding, donation of new leads, and the standardized clinical care necessary to pursue an adequately powered prospective multicenter randomized control trial in a handful of underserved nations . If such a study confirms the noninferiority of reused devices, securing large‐scale lead availability beyond that provided by charitable partners remains a limitation.…”

Remaining longevity and evidence of failure of cardiac implantable electrophysiology devices recovered from funeral homes

“…The laws and regulations in the United States present a multitude of legal obstacles for device reuse. First and foremost, the Food and Drug Administration (FDA) has deemed CIEDs to be so called “single‐use devices,” and views the reuse of CIEDS as “an objectionable practice.” The device manufacturers themselves also adhere to the FDA's mantra and do not condone reuse, nor do they extend warranties to refurbished devices . One obstacle is the fact that there is no legal clarity as to the ownership of a device after patient's death.…”

“…One obstacle is the fact that there is no legal clarity as to the ownership of a device after patient's death. Device companies have devised contractual agreements that mandate return of explanted devices to the companies for quality improvement; however, there is no federal legislation in the United States that delineates the property rights of an explanted device . Many have argued that patients themselves own the CIEDs as they purchased them indirectly via insurance premiums or taxes, and the fact that the devices are implanted in their bodies would seem to logically establish them as personal property .…”

“…7 The device manufacturers themselves also adhere to the FDA's mantra and do not condone reuse, nor do they extend warranties to refurbished devices. 8 One obstacle is the fact that there is no legal clarity as to the ownership of a device after patient's death. Device companies have devised contractual agreements that mandate return of explanted devices to the companies for quality improvement 8 ; however, there is no federal legislation in the United States that delineates the property rights of an explanted device.…”

“…9 Many have argued that patients themselves own the CIEDs as they purchased them indirectly via insurance premiums or taxes, and the fact that the devices are implanted in their bodies would seem to logically establish them as personal property. 8,9 Kirkpatrick et al have proposed the concept of a "pacemaker will" that would serve as an advanced directive allowing a patient to designate whether the device could be explanted and donated for reuse; however, no such legal framework for this exists yet. 9 The safety of device reuse has now been established in a metaanalysis of 17 clinical trials that found no significant difference in infection rates when comparing new implantation to device reuse, and an overall malfunction rate in reused devices of 0.68%.…”