There are innovative approaches to global health care. Here is one, that involves reusing pacemakers recovered from deceased donors and refurbished for use in countries where pacemakers are too expensive for wide use. Unlike some of what we encounter in kidney transplants across borders, the legal bans that have to be overcome may not come from the war against the poor. A careful clinical trial is underway. There is also an unregulated black market...
Here's the encouraging story from Helio.com:
After death, a new life for refurbished pacemakers in low-, middle-income countries, February 23, 2024
"Lack of access to pacemakers is a major challenge to the provision of CV health care in low- and middle-income countries; however, postmortem pacemaker utilization could offer an opportunity to deliver this needed care, according to Thomas Crawford, MD, an electrophysiologist and associate professor of internal medicine at University of Michigan Health and the medical director of My Heart Your Heart, a cardiac pacemaker reuse initiative at the University of Michigan Cardiovascular Center
...
"Crawford: The need is great. Each year, somewhere between 1 million and 2 million people worldwide die due to a lack of access to pacemakers and defibrillators. There is literature reflecting this. When you query pacemaker implantation data for the United States, it is roughly 800 pacemakers per 1 million population. When you query countries like, for example, Nigeria, it says four pacemakers per million. Quite a difference.
"Per capita gross domestic product is such that, in many countries, a pacemaker costs more than a person’s annual income.
...
"Healio: What are the regulations around using a refurbished pacemaker?
"Crawford: Pacemaker reuse is illegal in all jurisdictions. The FDA states that pacemaker reuse is an “objectionable practice.” We know we can do it, but we need to develop partnerships with other entities to give us credibility. One of those methods to do this is by engaging the government. FDA issues export permits for this type of activity. We created a protocol where we reprocess the device, working with Northeast Scientific, which provides the pacemaker cleaning and sterilization. We have received permission from the FDA to export them. We have to put a sticker on them saying “not for use in the United States.” We are doing this in countries in which governments will allow it. One of the limitations is needing a government letter from each of the recipient countries. We have about 12 countries now, and the collection of countries we are working with is purely accidental. It is not a normal methodological process. A lot of it is through contact with individuals and opportunities that arise.
...
"Healio: You are leading a randomized controlled trial called Project My Heart Your Heart: Pacemaker Reuse. What is the study design, and what do you and your colleagues hope to learn?
"Crawford: The objective of the clinical trial is to determine if pacemaker reutilization can be shown to be a safe means of delivering pacemakers to patients in low- and middle-income countries without resources. The target enrollment is 270 patients, all from outside the United States, who each have a class I indication for pacing and who attest that they do not have the ability to purchase a device on their own. They must consent to be randomly assigned to receive either a brand-new pacemaker, which we purchase, or a reprocessed pacemaker, for which we provide the leads and accessories. Donated devices are inspected according to specific protocols that evaluate physical and electrical suitability, including battery longevity, for future use. Devices deemed to be acceptable are shipped to a third-party vendor, Northeast Scientific, for disassembly, cleaning and re-sterilization. There will be about 130 participants in each arm. We will follow those patients and report any adverse events. The countries that have contributed patients include Kenya, Nigeria, Paraguay, Sierra Leone and Venezuela. We hope to soon begin enrolling patients in Mexico and Mozambique.
"I have had clinicians outside the U.S. who tell me they removed a pacemaker device, cleaned it, reprocessed it and then implanted it in someone else — but the government does not know about it. This practice does happen and it is not regulated in any way; patients and physicians know about it and keep it quiet. The difference with what we are doing and these other efforts is we bring it to a much higher level, because that is what the FDA requires. "
Posts
