A pacemaker is a small, battery-powered device implanted under the skin, typically near the collarbone, that sends electrical pulses to regulate a slow or irregular heartbeat. The issue of donation usually arises when a device is explanted after death (often required before cremation) or when a patient receives a replacement. Although these devices may still have years of functional life remaining, reusing them is complex. The path for an explanted device to find a second life is restricted by significant regulatory hurdles in the United States, yet specific programs exist to facilitate humanitarian reuse internationally.
Regulatory Barriers to Device Reuse
The immediate reuse of explanted pacemakers within the domestic healthcare system is prohibited due to stringent regulations from the U.S. Food and Drug Administration (FDA). The agency classifies pacemakers as Class III devices, which are high-risk, life-sustaining items, and considers them “single-use devices” (SUDs). The FDA compliance manual specifically labels the practice of pacemaker reuse as “objectionable,” primarily because of the challenge in guaranteeing complete and proper re-sterilization.
Experts have raised concerns that body fluids or foreign protein matter could enter the device’s terminal lead connections, making it difficult to eliminate all potential contaminants through sterilization. Furthermore, the regulatory framework requires medical devices to be tracked from the manufacturer to the patient through the Unique Device Identification (UDI) system. Reusing a device in a second patient breaks this established chain of custody and complicates the mandatory tracking and reporting of device performance or failure.
Significant liability concerns also discourage domestic reuse. Hospitals and third-party reprocessors that handle explanted devices could be viewed as “manufacturers” under federal law, subjecting them to the same product liability exposure as the original company. Device manufacturers explicitly warn against reuse, and any failure of a reconditioned device could result in legal action against the hospital or physician involved. This combination of liability risk and strict tracking requirements ensures that explanted pacemakers are typically discarded as medical waste or returned to the manufacturer for analysis, rather than being domestically re-implanted.
Global Humanitarian Repurposing Programs
Despite the domestic restrictions, established pathways exist for donating explanted pacemakers for use in low- and middle-income countries (LMICs) where new devices are often unaffordable. The FDA permits the export of re-sterilized devices for humanitarian purposes, which is the foundation for these global programs. These repurposing initiatives bridge a significant healthcare disparity, as cardiovascular disease is a leading cause of death worldwide, and many in developing nations cannot access a new pacemaker.
One prominent example is Project My Heart Your Heart (PMHYH), a program based at the University of Michigan that collaborates with non-profit organizations. This initiative systematically collects explanted pacemakers and implantable cardioverter-defibrillators (ICDs) from funeral homes and hospitals across the country. The mission focuses on providing a second chance for devices that would otherwise be destroyed, enabling them to save the lives of patients who have no other viable option.
For a potential donor, the process begins by contacting one of these humanitarian organizations directly to coordinate the donation. If the device is being explanted post-mortem, the family must provide signed consent authorizing the removal and donation of the device. Funeral directors and crematoriums, who are mandated to remove the devices before cremation, play a crucial role in the collection process by coordinating with the programs. By working with these specialized non-profits, donors ensure the device enters a formal, safety-focused reconditioning pipeline and reaches a patient in need overseas.
Safety and Logistical Requirements for Reuse
Once an explanted pacemaker is received by a humanitarian program, it undergoes a series of rigorous technical and logistical steps before it can be deemed safe for reimplantation. The first step involves a comprehensive interrogation of the device to assess its functional integrity and remaining battery life. Devices with insufficient battery longevity are rejected to ensure the recipient receives several years of reliable therapy; for example, many programs only accept devices with a minimum of 70% of their projected battery life remaining.
The device’s internal memory is then cleared to erase all patient-specific data, protecting the privacy of the original recipient and ensuring a clean slate for the new patient. Specialized technicians also inspect the device for any structural defects or damage, paying close attention to the set-screw areas, which can be prone to damage during the explantation process. Devices that pass the functional and structural checks proceed to a validated sterilization protocol.
The sterilization process is meticulous and is designed to eliminate any biological material and ensure the device meets industry standards for sterility. The protocol is highly controlled and often involves chemical processes to sterilize the complex device geometry. Only after a device has successfully cleared all stages—data clearing, functional testing, and validated sterilization—is it packaged and shipped to international partner centers for implantation by trained medical teams.