Researchers may have developed a novel strategy to improve access to pacemakers in low- and middle-income countries, according to a press release from Michigan Medicine. Recycled pacemakers may offer new opportunities for patients with life-threatening arrhythmias who face challenges affording the necessary procedures to implant the devices. In 2010, the University of Michigan’s My Heart Your Heart program began reconditioning pacemakers that were previously seen as single-use devices. Although the initiative originally utilized pacemakers only from Michigan, devices from across the United States are now being donated to the effort. Through the program, patients with pacemakers in place are given the opportunity to donate their devices if they are undergoing procedures to swap their old pacemakers for new ones, or after their death. Once donated, the recycled pacemakers undergo a rigorous process of testing and sterilization prior to shipment for compassionate use in patients residing in low- and middle-income countries across South America, Africa, Asia, and Europe. The devices are first inspected to ensure that there are at least 4 years of battery life remaining, and are then sent to a remanufacturing facility to be cleaned, decontaminated, and readjusted. Researchers next conduct electrical testing to ensure that safety parameters are met. The pacemakers are subsequently dipped in a silicone solution and ethylene oxide to prepare them for reimplantation.

Currently, researchers are also examining the impact of the recycled pacemakers in these countries through a new international clinical trial in which over 200 patients from Venezuela, Kenya, and Nigeria will be randomly assigned to receive either a new or recycled pacemaker. The researchers will monitor the patients for implant-related infections or software and hardware malfunctions. Already, more than 135 patients in Venezuela have received recycled pacemakers—none of which have been reported as faulty. The researchers hope the results of their new clinical trial can boost access to pacemakers and quality of life in underserved patient populations. “Beyond this trial, we could one day test the safety and efficacy of other implantable devices, specifically biventricular pacemakers, defibrillators, and implantable cardioverter-defibrillators. We will continue to push forward in a way that improves live across the globe,” concluded Kim Eagle, MD, Director of the Frankel Cardiovascular Center and founder of the My Heart Your Heart program at the University of Michigan.