The ethics of pacemaker reuse: might the best be the enemy of the good?

Symptomatic bradycardia contributes significantly to mortality and decreased functional status in many low and middle income countries (LMIC). In contrast to the developed world, where bradycardia often results from sinus node dysfunction, patients requiring pacemakers in LMIC more commonly present with complete heart block. Yet many patients in LMIC have little to no access to electrophysiological therapies, as the cost of one device often exceeds the annual income of the average citizen. Several countriesdincluding Sweden, India and Canadadhave previously explanted and resterilised pacemakers from deceased donors for reutilisation. With increasing global disparities in medical care, post mortem explantation and reuse of pacemakers presents a potential means for mitigating the rising burden of cardiovascular disease in LMIC. Recent survey data indicate that almost 45% of deceased pacemaker patients in the USA have their devices extracted for reasons including family request and risk of device explosion during cremation. Notably, over 80% of these extracted devices are discarded or stored as waste. The vast majority of funeral directors, device patients and the general population support donation of explanted pacemakers to LMIC. ‘Project My HearteYour Heart’ is a proof of concept pacemaker donation initiative that allows funeral directors to send explanted devices to an academic centre for evaluation and resterilisation before donation to underserved patients in LMIC. A recent case study of 12 resterilised pacemakers donated through this programme to indigent patients in the Philippines demonstrated successful implantation with no complications. Given such pacemaker availability, public support and potential efficacy, a pacemaker donation effort appears quite viable. With growing evidence to suggest the plausibility of pacemaker recovery and reuse, it is imperative to reflect on whether, ethically, it ought to be done. Surely pacemaker donation promotes the well being of recipients with no access to therapy. And based on the available data, resterilised pacemakers do no harm provided there is adherence to protocols regarding standardised sterilisation, proper device handling and implantation, oversight to prevent diversion or re-sale, and patient education and follow-up. Furthermore, informed consent by both donors and recipients ensures respect for autonomy. The primary ethical justification for pacemaker reuse involves the principle of distributive justice, or the fair allocation of resources within society. In a seminal 1972 essay entitled ‘Famine, affluence and morality,’ philosopher Peter Singer bases an argument for global distribution and liberalism on two simple premises: (1) “[S]uffering and death from lack of food, shelter, and medical care are bad,” and (2) “[I]f it is in our power to prevent something bad from happening, without thereby sacrificing anything of comparable moral importance, we ought, morally, to do it”. Certainly, one can debate what constitutes a ‘morally important’ purpose or need. While it could be argued that pacemaker reuse might aid domestic populations with less access to healthcare, uninsured patients in the USA still have better access to devices than most patients in LMIC through governmental services and charity programs. Moreover, given a safety regulation by the US Food and Drug Administration that prohibits domestic reuse of pacemakers, explanted devices remaining in the USA could only serve the purpose of promoting future quality improvement if returned to manufacturers. If, rather, they are discarded, then, by Singer ’s definition, there exists a moral duty to donate them abroad to those most in need. Several device companies oppose pacemaker donation, preferring instead the return of explanted devices for assessment and quality improvement. While returning pacemakers to manufacturers for quality improvement is endorsed by the Heart Rhythm Society, only a tiny fraction of funeral directors currently do so. 9 The increased public awareness created by a charitable pacemaker donation initiative would likely influence funeral directors to allocate more devices for potential donation. As only the devices with battery life $70% are selected for donation, the rest could be returned to manufacturers. With a significant increase in devices returned for quality improvement, the marginal benefit of returning those with $70% battery life would be diminished. Donation of these pacemakers to needy recipients in LMIC might then be possible without sacrificing anything of ‘comparable moral importance.’ Still, there is concern that expanded pacemaker reuse overseas may lead to domestic reuse in developed nations, and that such a practice is below the standard of care in these countries. A recent meta-analysis of studies investigating pacemaker reuse (several of which were performed in Sweden prior to its integration into the European Common Market) demonstrated low absolute rates of infection and device malfunction but also raised the following concerns: (1) there was a significantly higher rate of device malfunction with resterilised Division of Cardiovascular Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA Division of Cardiovascular Medicine, University of Michigan, Ann Arbor, Michigan, USA Washtenaw Country Circuit Court, Ann Arbor, Michigan, USA