Social and Ethical Principles of Device Therapy: The Ethics of Cardiac Implantable Electronic Device Reuse and Deactivation

Disparities in Access to Cardiac Implantable Electronic Devices

As discussed in the Institute of Medicine Report, the developing world faces significant shortages of infrastructure and health care providers, as well as high cost of advanced cardiovascular technologies. Inability to afford costly medical devices such as CIEDs partially accounts for the great disparities in the provision of health care between the developed world and LMIC. The World Society of Arrhythmias reported on the unequal access to CIED therapy in a 2009 survey. The survey, conducted in 61 countries across Europe, Asia/Pacific, the Middle East/Africa, and the Americas, showed a wide spectrum of pacemaker implantation rates, ranging from 782 new implants per million of population in France to two implants per million of population in Indonesia and Myanmar. A more recent comprehensive report on electrophysiologic procedures in the 55 European Society of Cardiology (ESC) member countries corroborated those findings. There were large disparities in both pacemaker and ICD implantations. The highest rate was in Germany, where patients received 326 ICD implants per million of inhabitants. The lowest rate was in the Ukraine, with a rate of one ICD implant per million of population annually. Multiple factors are likely responsible for the observed variations in both surveys; among them are socioeconomic disparities, varied access to health care, and quality of care. The most direct causes of disparity may be variable availability of implanting physicians, health care infrastructure, and device access.

Though it is conceivable that some patients in high-implant countries may not substantially benefit from CIED therapy, it is much more likely that the severe lack of access to appropriate therapy in LMIC is resulting in preventable morbidity and mortality in the underserved countries. In low-income countries, the per capita gross domestic product may be less than the cost of a single pacemaker unit, or a new ICD. In countries without universal coverage, only the wealthy can afford a CIED or they seek treatment abroad. In other cases, universal insurance does not cover the high cost of electrophysiologic therapy. It has been estimated that perhaps as many as a million people die each year in the world due to lack of access to pacemaker therapy. There are no data on the number of patients dying from preventable sudden cardiac death due to lack of access to guideline-directed ICD therapy.

Donations to Improve Access to Cardiac Implantable Electronic Device Therapy

One source to alleviate the shortage of devices has been donations of CIEDs by the device manufacturers. Over the years, manufacturers have made charitable product donations of pacemakers and ICDs to indigent patients in LMIC through a variety of channels. The manufacturers provide CIED product donations to physicians traveling to the developing world on medical missions. A more systematic effort to provide donated CIEDs to LMIC has been spearheaded by the nonprofit Heartbeat International, which has received and distributed over 14,000 pacemakers since its inception in 1984. The organization has established relationships with the device industry, local Rotary International chapters, and other civic organizations in 24 countries. Despite this, new CIED product donations are a drop in the bucket. Because of this, it has been argued that the immense gap between the need and the supply of donated devices may be remedied by CIED reuse.

Potential Sources of Reused Devices

There are three scenarios in which CIEDs could be harvested for reuse. CIEDs may be donated after patient death, retrieved in the hospital during device upgrades, or from extractions due to CIED infection.

A large number of potentially reusable CIEDs would be available for reuse if a fraction of the deceased donated their devices post mortem. In 2009, 188,700 pacemaker implantations were performed in the United States. The median age at implant is 77 years, and nearly 40% of patients die within 4 years after implantation. The mean longevity of pacemakers in a recent registry was 11.2 ± 2.6 years.

The crematory industry is well suited to play a major role in CIED reutilization. All individuals undergoing cremation must have their CIEDs removed to prevent explosion of the device, and as many as 5% of individuals choose to have their device removed before a traditional burial. According to the Cremation Association of North America, 34% of deaths resulted in cremation in 2007, and it is projected that by 2025 over 55% of the deceased will undergo cremation in the United States.

The feasibility of large-scale CIED collection from the funeral home industry was recently shown by Project My Heart Your Heart, a collaborative of citizens, physicians, crematories, and funeral directors of the State of Michigan, The University of Michigan Cardiovascular Center, Implant Recycling, LLC. (Detroit, MI), and Detroit-based medical charity, World Medical Relief. Through the website www.myheartyourheart.org , Michigan funeral directors receive postage-paid packages containing instructions on harvesting CIED with a biohazard bag in compliance with U.S. Department of Transportation shipping laws. My Heart Your Heart has collected over 14,000 CIEDs, which are evaluated for basic integrity and battery longevity. The collaborative reported that 21% of the CIEDs were reusable, which was defined as having at least 75% of the original battery, or at least 4 years of remaining estimated longevity. The yield for pacemakers and ICDs was 18%, and cardiac resynchronization therapy (CRT) devices was 30%.

The two other clinical scenarios where potentially reusable CIEDs could be collected are (1) CIED upgrades and (2) device extractions due to infection. Assuming the same basic battery requirements for reuse, the yield of potentially reusable CIEDs is higher than when the source is the funeral industry. After eliminating the CIEDs explanted for elective device replacement, Gakenheimer et al reported that 52% of pacemakers, 54% of ICDs, and 48% of CRT-defibrillators (CRT-Ds) met the basic criteria for reuse. According to the National Cardiovascular Data Registry (NCDR), 63,522 devices were explanted annually in the United States in years 2010 to 2012 (personal communication, Paul Heidenreich, M.D., M.S. member, NCDR Science & Quality Oversight Committee, NCDRR ICD Registry October 11, 2012), potentially yielding 10,000 to 13,000 reusable devices available for donation. One must emphasize, however, that it is recommended by the Heart Rhythm Society Task Force on Device Performance Policies and Guidelines that explanted CIEDs should be returned to the manufacturer for analysis for quality improvement, even if they are not subject to advisories. One solution could be to return CIEDs to the manufacturers or a third party for nondestructive tests and only randomly commit devices to destructive testing protocols. A successful large-scale device reuse program would necessitate the coordinated participation of many stakeholders, including the manufacturers, the regulators, and the professional societies.

Support for Cardiac Implantable Electronic Device Reuse on Humanitarian Grounds

The Heart Rhythm Society (HRS) policy document also recommends that after a patient dies, morticians immediately notify the physician monitoring the device and return the patient's device to the manufacturer. However, studies show that only 4% of CIEDs are removed and returned to the manufacturer. The study showed that 69% of funeral directors lacked the knowledge or found it difficult to return devices to the original manufacturer. Seventy-seven percent discarded them as waste. The survey, however, showed that 81% of funeral directors supported a central independent organization to regulate device distribution, and 89% were willing to donate devices to humanitarian organizations with the purpose of reuse in LMIC.

Survey data indicate that there is support for CIED donation and reuse among patients and their families. Eighty-seven percent of device patients and 71% of general medicine patients indicated that they would support the initiative of CIED reuse. Kirkpatrick et al showed that 91% of device patients were willing to sign an advance directive allowing their device to be donated for human use in an underserved country. For some, CIED donation is not only an act of altruism, but also an edifying experience of honoring their loved ones. It may enable the surviving family to build an empathetic interconnection with patients who, like their loved ones, suffer from cardiovascular disease (personal communication with donors).

This brings us to another important facet in the CIED reuse—the acceptance of the gift by the recipient. There may exist cultural or religious obstacles to accepting a donated device which has been removed from the deceased. My Heart Your Heart surveyed 593 patients and family members at Centro Nacional Cardiologia in Managua, Nicaragua, and Indus General Hospital in Karachi, Pakistan. Ninety-six percent were not able to afford the cost of a new pacemaker (150,000 Pakistani Rupees or 18,000 Nicaraguan Cordobas). The vast majority of patients and their family members would accept a reused pacemaker (77%), even knowing that they may carry a higher risk of infection or device failure (56% and 68%, respectively). These respondents were also overwhelmingly in favor of donating their own hypothetical pacemaker postmortem. Respondents with the ability to pay for their own pacemaker, those with excellent health status, and respondents without personal experience with heart disease were less willing to accept a used device. It is essential that comprehensive discussion takes place and the recipient fully understands his or her condition, the risks associated with the implantation procedure, and specifically additional risks involving reused CIEDs. This will be further discussed in the subsequent sections.

Acceptance by physicians in both the donor and recipient countries is essential to the success of a CIED reuse program. CIED reuse is not endorsed by any physician organization, and the practice of CIED reimplantation is expressly illegal in many countries. However, among professional society members there is widespread belief that, under certain conditions, reimplantation of resterilized CIEDs may be safe, reasonable, and ethical. In a survey of HRS members, 86% agreed or strongly agreed that reimplantation may be safe, and 88% thought it was ethical. In this survey, 81% would be comfortable approaching their patients about CIED donation in the event of death, and 83% would be willing to implant a reusable CIED in a patient who would not be able to receive a new device.

Evidence in Favor of Safety and Efficacy of Cardiac Implantable Electronic Device Reuse

The initial concept of pacemaker reuse was described over three decades ago, when magnesium-zinc battery powered pacemakers, which might have lasted 20 to 24 months, were replaced by the much longer-lasting nuclear and lithium units. Over the decades, pacemakers have been reutilized in many countries. There is published literature from Sweden, Norway, Finland, Holland, Hungary, Romania, Italy, Israel, India, Brazil, Australia, and Canada, which showed safety of pacemaker reuse. A meta-analysis of 18 studies including 2270 patients reported on outcomes of patients with reused pacemakers, mostly in 1980s and 1990s. Infection occurred in 1.97% of reused pacemakers and the incidence of pacemaker malfunction was 0.68%. There was no significant difference in infection rate between reused and new pacemakers ( P = 0.58). Compared with new pacemaker implantation, however, there was a six-fold increased risk for malfunction in the reuse group (0.11% vs. 0.68%). This difference was mainly due to abnormalities in set-screws, as well as nonspecific “technical errors,” some of them discovered during the implant procedure. There were no deaths in the meta-analysis of the five studies.

Newer generations of pacemakers have similar findings. Kantharia et al presented their experience with devices explanted from the deceased between 2004 and 2010. From the pool of 121 donated pacemakers, 53 were deemed to be acceptable for reuse and implanted in patients at a charity hospital in Mumbai, India. Cleaning involved the use of bleach solution, Asepti-zyme (Ecolab, St. Paul, MN), and 70% ethanol. Sterilization with ethylene oxide was performed at the recipient hospital. No infections or device failures occurred over a mean of 661 days of follow-up (19 to 1827 days). Ninety-five percent of patients reported improvement in symptoms. In many cases, having the pacemaker enabled patients to be employed again.

Another recent cohort was a case series by Pavri et al of indigent patients in India with indications for CRT-D. In this report 81 patients received 106 explanted devices (22 patients received a second device, and 3 received a third device). No infectious complications and no identifiable device-related complications occurred, apart from a lead dislodgement and a lead fracture. Appropriate therapy (shocks or antitachycardia pacing) was delivered to 54% of patients. Nine of 81 (11.1%) patients died; mean time from implantation to death was 771.3 days.

Finally, recent noninferiority study from Nava et al in Mexico reported on 603 consecutive patients who received pacemakers from 2000 to 2010. Patients who could not afford new pacemakers were offered refurbished devices ( n = 307). A combined end point of unexpected battery depletion, infection, and device malfunction was not different between new and refurbished pacemakers.

Although there is probably sufficient evidence to assert that reuse of CIEDs is reasonably safe, a comprehensive evaluation and sterilization protocol is lacking. Before this practice could be embraced on a large scale, a validated sterilization protocol and standards for optimal electrical testing protocol should be established for CIEDs. Further prospective clinical studies with robust follow-up are needed to further assess the safety and efficacy of reusing CIEDs. Cost effectiveness studies could inform the discussion on the economic impact of device reuse in LMIC.

Legal Obstacles, Regulatory Considerations, and Solutions

Reuse of pacemakers and implantable cardioverter-defibrillators raises a variety of safety and effectiveness issues. An obvious potential safety risk is the transmission of infectious disease from one patient to another from an improperly sterilized product and malfunction of the reprocessed CIED. The North American Society of Pacing and Electrophysiology Policy Conference examined the issue of pacemaker reuse in 1985. Based on the examination of the literature available at that time (nearly 2000 patients with refurbished pacemakers) the policy conference concluded that pulse generator reuse was not a risk factor for device infection. According to the Policy Conference “the implantation of a previously used pacemaker should not be considered substandard care.” The Conference supported the development of policies, which would govern reuse by addressing the ownership of the pacemaker and reregistration of the device with the manufacturer. The authors suggested a projected remaining useful lifetime requirement of 5 years. The authors of the document urged that legal and technical criteria be established to remove the impediments to the adoption of this practice as a means of improving cost-efficiency.

European Society of Cardiology Policy Conference in 1998 addressed the issue of device reuse in cardiology shortly after the European Union law produced harmonized legislation. The law, MDD/93/42/EEC and AIMD 90/385/EEC, which governed the regulations applicable to all medical devices placed on the European Community market, did not allow reprocessing of single-use devices. According to the conference report, “if an institution can arrange with the original manufacturer to refurbish the devices (and provide them with a new CE mark, or perhaps a CE mark of their own), there is no reason why reuse might not become medically and economically acceptable.” The authors expressed the hope that the document would encourage increased cooperation between the medical profession and industry in order to solve the complex issues that are related to safe reuse of devices. Nonetheless, the regulatory issues were never resolved and reuse of single use devices remains off limits in the European Union.

Pulse generators and ICDs are also approved in the United States as single-use devices (SUDs). Certification of reprocessed devices was not required until October 26, 2002 when Medical Device User Fee and Modernization Act (Public Law 107-250) passed Congress. Since then, the FDA has regulated hospitals, third-party reprocessors, and original equipment manufacturers (OEMs) identically, requiring hospitals and third party reprocessors to obtain marketing approval or clearance for reprocessed products. Regulatory authority over reprocessing entities is found in the FDA's definition of “device manufacturer,” which includes user facilities engaging in the reprocessing of SUDs. Although reuse of dialysis filters is allowed under these regulations, the FDA compliance manual considers pacemaker reuse “an objectionable practice.” As long as CIEDs are shipped to LMIC before reprocessing, the practice may not fall under the FDA jurisdiction. However, if CIED is reprocessed in the U.S., the FDA would regulate its transfer overseas as it regulates interstate commerce. Unfortunately, this does not eliminate all regulatory risk and puts the onus of testing and sterilization on the party that is least able to shoulder the burden.

Regulations, which would guide and encourage the medical device manufacturers to support international interchange of reprocessed single-use devices, are lacking. Original equipment manufacturer standards may not, however, be applicable in many LMIC. The reprocessor may still be subject to liability claims arising from the possible mishandling of the donated CIEDs. No standards, however, exist for collection and reprocessing of CIEDs.

Given the lack of consensus on the proper implementation of CIEDs reuse program, it has been proposed that a broad collaborative effort emerge to address these issue. This partnership involves patients and their families, the funeral industry, physicians, academic centers of excellence, Food and Drug Administration, nonprofit organizations, and implantation centers in LMIC ( Fig. 44-1 ). In this model, the academic center establishes communication with the funeral industry, carries out research in the technical evaluation of CIEDs, and develops a validated sterilization protocol. The academic center interacts with the Food and Drug Administration to obtain necessary permits for a clinical study and a registry in countries, whose governments expressly approve the initiative as a means of improving the health care of their citizens. The academic center establishes partnerships with nonprofit charitable organizations to provide the logistical support for CIED distribution, and oversees safe implantation of CIEDs under clinical protocol in LMIC, and manages the database of devices and patients. LMIC implantation center screens potential patients, who meet the clinical need and can demonstrate indigent status. Patients receive the donated devices only after full informed consent. If safety and efficacy can be established to the satisfaction of the professional societies and regulatory bodies, further partnerships and models for collaboration can be developed, and the initiative can be scaled up for maximum benefit of the underserved population.

Ultimately, improving access of LMIC patients to refurbished devices cannot succeed without some support of the manufacturers. A system of notification to the original manufacturer would be required, because the manufacturers are mandated to maintain patient information. A tracking system for donated product should include the new patient information, so that appropriate notification is made in case of an advisory. Would the manufacturers have any inclination to work toward the goal of charitable CIED reuse? Would anyone expect the manufacturers to provide educational and technical support? Would the manufacturers expose themselves to legal jeopardy by participating in such an initiative? Would the donating or recipient countries' governments bear any responsibility or indemnify the manufacturers and the reprocessors? There are indeed great many unanswered questions. If CIED reutilization is to be accepted as a mainstream approach to address the disparities in electrophysiologic care, there must be a higher level of public awareness and support, established quality standards of the type recommended by national regulatory authorities, and almost unprecedented spirit of cooperation among stakeholders across continents.

Ethical Considerations of Cardiac Implantable Electronic Device Reuse

The ethical considerations regarding CIED reuse are grounded in the principle of justice in health care. The principle of distributive justice is based on socially just allocation of goods in a society. Health care may be considered both a private and public good. The society has an interest in health of its members, in part so that they may participate fully as citizens. Health care is a special case of such goods, because of the unique role health plays in a person's functioning and opportunity. Lack of health care may cause pain and suffering and may affect equality of opportunity. Access to health care is in effect access to opportunities. Given the paramount role that good health plays in the well-being of individuals, access to health care is required for a just society. According to Daniels, “by keeping people close to normal functioning, health care preserves for people the ability to participate in the political, social, and economic life of their society. It sustains them as fully participating citizens—normal collaborators and competitors—in all spheres of social life.” Implantation of a donated pacemaker in a patient with complete heart block may extend the life of that person, and allow him or her to function as parents, children, or siblings, and contribute to their well-being and livelihood, which otherwise would be impossible.

This leads us to pose a question of what equitable allocation of resources means in a global society? The old boundaries between the advanced economies and the “third world” are to a large degree disappearing, with many in LMIC entering the “middle class.” High-income countries have experienced dramatic decreases in cardiovascular disease deaths, whereas the same benefits have not been translated to the poor countries. Still, 80% of cardiovascular disease (CVD) deaths occur in LMIC. One might argue that fair resource allocation requires the most needy get the “best” pacemakers. And if is not practical or possible to create strict equality across countries, should we feel morally and ethically obliged to at least attempt to seek solutions to the disparities in electrophysiologic care?

Additional questions could be raised about how best to allocate pacemakers with differing remaining battery longevity among the patients who receive them in LMIC. Should the focus be on equal access or maximum benefit? One appears to have support for the maximum benefit proposition in another setting of scarce resources—kidney transplantation. A maximum benefit approach to donor kidney allocation promotes stratifying donor organs based on viability and matching them to the predicted survival of intended recipients. It is argued that fewer cumulative life years would be lost by using more viable organs on patients with greater expected survival, and less viable organs in patients with shorter anticipated survival. The purpose of donated CIED is to extend and improve life, to which all men and women are entitled based on the principle of justice. The failure to initiate measures that would recycle “medical waste” and turn it into life-saving therapy appears to violate the principle of distributive justice.

The conception of justice as political and moral theory has been shaped by the influence of John Rawls, one of the most influential philosophers of the 20th century in the Western World. His seminal work, “A Theory of Justice,” became a primary text in political philosophy. In it Rawls described the core elements of justice: “First, each person is to have an equal right to the most extensive basic liberty compatible with a similar liberty for others. Second, Social and economic inequalities are to be arranged so that they are both (a) to the greatest benefit of the least advantaged, and (b) attached to offices and positions open to all under conditions of fair equality of opportunity.” Rawlsian conception of unequal arrangement for the purpose of maximum benefit for the least advantaged is known as the Difference Principle. The principle holds that in order to provide genuine equality of functioning and opportunity, society must give more attention to those with fewer native assets and to those born into the less favorable social positions. Rawls's theory of justice as fairness was not designed to address issues of health care, although it became a basis for a reinterpretation and application of the principle to heath by Norman Daniels. According to Daniels: “The central moral importance, for purposes of justice, of preventing and treating disease and disability with effective healthcare services … derives from the way in which protecting normal functioning contributes to protecting opportunity … By maintaining normal functioning, healthcare protects an individual's fair share of the normal range of opportunities (or plans of life) reasonable people would choose in a given society.” Fair equality of opportunity would support providing patients with insufficient resources CIEDs in order to prevent disability and death. If one believes that implanting reused CIEDs benefits people who are most disadvantaged, then the Rawlsian Difference Principle would tolerate the inequality of affording new versus reused CIEDs on the basis of economic conditions rather than need. Likewise, if one could prevent impoverishment of a person by obviating the need to purchase a new CIED, and refurbished CIEDs improve functioning and well-being, then the principle would also apply as it benefits the most disadvantaged.

Another fundamental ethical principle applicable to CIED reuse is that of beneficence. It imposes on us the obligation to prevent sickness or death whenever we reasonably can. Reutilization of CIEDs is justified if it reduces suffering from disability or death. Believing that CIED reuse is safe and effective, under the principle of beneficence, requires that we act to reduce the harm to the underserved patients. Additionally, as argued by Ochasi et al pacemaker reuse may be a cost-effective way to extend whatever resources LMIC have and be able to redirect the freed resources to other diseases like malaria, tuberculosis, and HIV/AIDS.

The principle of egalitarianism is based on the premise that all human beings are equal in fundamental worth or moral status. Should refurbished CIEDs be donated to LMIC when they are below the standard of care in the donor country? World Health Organization (WHO) Medical Device Regulations stress that: “There should be no double standard in quality. If an item is unacceptable in the donor country it is also unacceptable as a donation.” Application of the egalitarian principles may lead two opposing conclusions, depending on whether the emphasis is on the equal quality of CIEDs or equal access to CIED therapy. WHO is applying strict egalitarianism by emphasizing equal quality, whereas the donation of reprocessed CIEDs would serve as a means of improving access to the therapies, thus emphasizing equality of health outcomes between the high- and low-income countries. Are we compelled to either accept or reject all donations falling below the standard of care in the donor country? It is understandable that one would be unwilling to accept product donations, which are nonfunctional or hazardous, as this would simply represent “dumping” of waste. Rigorously evaluated, tested, and sterilized CIEDs would not fit this description. Anderson's democratic egalitarianism would also permit the use of refurbished CIEDs, because it emphasizes the equality of opportunity, rather than equal health services.

Utilitarianism is a theory that is intuitively helpful to justify the concept of CIED reuse. Utilitarian principles governing the just distribution of resources are based on the premise of maximum benefit—the greatest good for the greatest number. The overarching goal is increased utility, that is, the greatest well-being. At hand we have devices that are currently discarded as waste by the majority of the funeral homes and crematories or buried within the corpses in an environmentally unfriendly fashion. We have access to a resource that, with a relatively modest investment of effort and money, could afford a human being an opportunity for improved quality of life or even extend longevity. When applied to the circumstance of a patient with no means of buying a new CIED, the utilitarian principles would support the concept of the reutilized device.

Respect for personal autonomy is a widely accepted precept in the world of medical ethics, and it should guide the process of donation and receipt of the refurbished CIED. According to this principle, all human beings are given autonomy over their bodies, which intrinsically belong to them. There is also a requirement to protect autonomy of people whose autonomy is diminished. Respect for persons reflects the right for self-determination and dignity. Informed consent is necessary to allow authorization of a medical intervention or participation in research. Informed consent should be sought both on the part of the donor or his or her next of kin and the recipient. Respect for personal autonomy requires either a premortem consent of the donor, or consent of his or her family to donate the device after death. Respect for patient autonomy also demands that all potential recipients are informed that the donated device has been removed from a donor postmortem, that the device is not approved in the donor country for reuse, and that there may be known and unknown risks associated with receiving the donated device. Such a conceived process of informed consent maintains respect for the autonomy of both the donor and the recipient.

Even if we accept the notion that a reused CIED has the same risk of infection as a new device, and the risk of malfunction in the reused CIED is nonprohibitive, at the very least, by definition, we must concede that the projected longevity of the refurbished device would be significantly less than a new one. Shorter battery longevity results in more frequent generator replacements. Generator replacements are associated with an incremental risk of infection (1%-2% in the Replace registry). Offering “lesser” care has been suggested to be an ethical approach in circumstances where there is inadequate supply of what the sick desperately need. Expanded criteria donor (ECD) organs for solid organ transplants provide an illustrative analogy. “Expanded criteria donor” or “marginal donor” transplant is one that carries additional risk for transplant recipient due to donor risk profile or comorbidities. Patients suffering from symptomatic bradycardia, especially complete heart block (most common indication for pacemaker in LMIC), who cannot access new pacemakers due to their prohibitive cost, are effectively denied this therapy. Reused devices offer them hope of reduced mortality and morbidity and an improvement in the quality of life.

Responsibilities of the Reprocessor

Stewardship of resources incorporates the responsibility to show concern and care for the scarce medical resources. Because the goal of the charitable CIED donation is to improve the health and functioning of the least well off, one must ensure that CIED reuse does not divert resources from other public health needs, like malnutrition or vaccination programs. In order for the CIED reuse initiative to be morally just, it must be done judiciously and provide additive value to what is already available in LMIC. The party involved in reprocessing CIEDs must ensure that donated CIEDs meet certain minimum criteria in terms of electrical performance and sterility. Procedures and guidelines establishing safe practices are essential. The reprocessor must also ensure that CIEDs are donated in a transparent system, free from corruption or black market. The reprocessor also assumes the responsibility of monitoring for advisories and having an actionable plan in case of the need to replace the device. The reprocessor is not likely to have the resources to support the infrastructure for CIED implantation. The required infrastructure is complex and involves the staff, the equipment, the space, and the systems that help the staff and the equipment work together in medical facilities. The reprocessor may, however, partner with professional societies, local health authorities, and nongovernmental organizations to foster the training of physicians and other personnel, and expansion of necessary facilities.