Abstract 4363796: Results of a pacing program with re-sterilized pacemakers: 18,615 lives saved across 29 countries over 50 years.

Abstract

Introduction: Significant disparities remain between high-income countries and low- and middle-income countries (LMICs) in access to pacemaker therapy. In LMICs, the high cost of devices and limited healthcare infrastructure lead to preventable deaths. Addressing this inequity requires innovative and ethical solutions. Pacemaker reuse by retrieving, testing, re-sterilizing, and re-implanting devices, offers a cost-effective, sustainable, and ethical alternative. Despite robust evidence demonstrating its safety, reuse remains limited due to regulatory and legal concerns. Fears of infection, device failure, and liability have hindered broader adoption, even though properly reprocessed pacemakers have been shown to be safe. Objective: To describe a 50-year humanitarian program led by a French NGO, which has distributed re-sterilized pacemakers to LMICs and trained local providers in cardiac pacing. Methods: STIM Développement is a French NGO promoting access to cardiac rhythm management in LMICs through medical training and the distribution of reprocessed pacemakers to patients in need. Devices were collected post-mortem and sent to the NGO by various hospitals. Each underwent strict quality control, including 1) visual inspection, 2) programmer interrogation to assess battery life and detect malfunctions, and 3) review of implant date and voltage to estimate remaining longevity. Sterilization followed an FDA-approved protocol: cleaning with pipe cleaners, isopropyl alcohol bath, overnight soak in enzyme solution (1:128 concentration), 70% ethanol wipe, air drying, gas-permeable packaging, and 8-hour ethylene oxide gas sterilization. Devices were shipped based on demand, often with training support for local medical teams. Results: From 1974 to 2024, 18,615 pacemakers were distributed to 29 countries. Distribution peaked in the early 2000s (600 units/year) but declined to around 150/year due to legal and regulatory challenges. Early recipients included India, Romania, and several African nations. Infection rates remained negligible, with no adverse events reported in recent FDA-monitored trials. Conclusion: Pacemaker reuse is a safe, effective, and scalable strategy to address unmet needs in LMICs. Wider adoption requires international regulatory harmonization, legal safeguards, and public awareness. The recent FDA approval of re-sterilization protocols may help renew global efforts and expand access to this life-saving therapy.