A pacemaker is a small medical device implanted in the chest to regulate a slow or irregular heartbeat. It uses low-energy electrical pulses to prompt the heart to beat at a normal rate, preventing symptoms like fainting or fatigue. When a patient dies, the device often has significant battery life remaining, leading to questions about donation and reuse. However, the prevailing practice in many wealthy nations is to treat these devices as medical waste.
Reusing Pacemakers in Developed Nations
The standard procedure in countries such as the United States and those in Western Europe is generally not to reuse a pacemaker in a domestic patient. This practice is primarily driven by a strict regulatory framework that classifies these devices as single-use medical devices. The U.S. Food and Drug Administration (FDA) currently considers the reprocessing of explanted pacemakers for domestic reuse to be an objectionable practice.
This policy is rooted in concerns over safety, liability, and the challenge of assuring a device’s sterility and long-term function. Pacemakers are classified as Class III devices, requiring the highest standard of safety. Reprocessing a device for domestic reuse would require expensive and rigorous testing to meet this standard. Furthermore, manufacturers do not sanction reuse, and their warranties do not cover re-implanted devices. For these reasons, pacemakers are typically explanted after a patient’s death and disposed of as medical waste or returned to the manufacturer for analysis.
Programs for Reprocessing and International Donation
A powerful alternative to disposal exists through specific humanitarian programs that bridge this gap between regulatory policy and global need. Organizations like Project My Heart Your Heart, a non-profit initiative, collect explanted pacemakers from funeral homes, crematories, and hospitals. These devices are then cleaned, tested, and shipped for reuse in low- and middle-income countries (LMICs) where new devices are unaffordable and access to them is severely limited.
An estimated one to two million people worldwide die each year because they cannot access or afford a pacemaker. Reuse programs address this global health disparity by transforming a discarded resource into a life-saving therapy. Devices are refurbished in specialized facilities, such as the Sheldon & Marion Davis Pacemaker Recycling Center, the world’s first facility dedicated to reconditioning pacemakers. The FDA permits the export of re-sterilized devices, allowing these programs to conduct clinical trials proving the safety and effectiveness of the practice. Many programs also train local physicians in LMICs to perform the implantation procedures, ensuring sustainability.
Safety and Technical Considerations for Reuse
The feasibility of reusing an explanted pacemaker depends on successfully overcoming two major technical hurdles: sterilization and battery life assessment. The primary safety concern is the risk of infection, necessitating a rigorous sterilization process to remove all organic material and potential pathogens. This involves specialized cleaning and disinfection, followed by sterilization using a validated protocol, such as two cycles of ethylene oxide sterilization.
The second technical requirement is confirming the device’s long-term viability, which is done through battery life and function testing. Only devices with substantial remaining battery life, often a minimum of 70% or at least four years of longevity, are selected for reuse. Electrical function is also tested to ensure that all parameters are within acceptable limits. Studies have shown that when proper technical control and a standardized sterilization routine are followed, reused pacemakers do not result in a higher rate of infection or mortality compared to new devices.
How Individuals Can Participate in Donation
For an individual or family wishing to donate an explanted pacemaker, a few steps are necessary to ensure the device can be accepted by a reuse program. The decision to donate must be communicated promptly to the hospital staff or the funeral home handling the deceased’s arrangements. This is important because pacemakers must be removed before cremation, as they contain lithium batteries that can explode when exposed to high heat.
The family or next of kin must provide informed consent for the explantation and donation of the device. It is helpful to contact an established donation program, such as Project My Heart Your Heart, directly to obtain the necessary consent forms and instructions for proper handling. The funeral director or hospital then follows the program’s protocol to ensure the device is correctly prepared and shipped to the reprocessing center, completing the first step in giving the device a second life.