Would you use a recycled pacemaker?
Human organs can be transplanted from one person to another. So why not pacemakers?
The money-saving and life-saving practice of recycling used pacemakers is happening in countries like India and the Philippines, but it’s prohibited in the United States. However, some pacemakers that had been implanted in Americans are winding up in the bodies of foreigners.
In most cases, when a U.S. patient with a pacemaker dies, the device is lost as well. A study of Michigan and Illinois funeral directors conducted in 2010 found that 19 percent of the deceased had pacemakers; most of the devices were buried with the bodies or simply thrown away.
|Dr. Timir Baman (left) and Dr. Kim Eagle are co-founders of the University of Michigan’s Project My Heart Your Heart. The project collects pacemakers that are to be recycled and used in developing countries.|
FDA: Pacemaker recycling is ‘objectionable’
U.S. Food and Drug Administration (FDA) regulations ban the reuse of pacemakers in the United States. Why? The FDA says it’s not possible to properly sterilize a used pacemaker. Without that sterilization, an infection could be transmitted via bodily fluids.
The FDA says reuse of pacemakers is “an objectionable practice.” It’s even illegal to export used pacemakers overseas. Some research groups have gotten around this hurdle by allowing the importing countries to regulate the sterilization process themselves. Therefore, the devices no longer fall under the FDA’s jurisdiction.
“When the FDA approves devices for medical use, they approve certain protocols and specifications to which device is held up,” says Dr. Thomas Crawford, a leader of the University of Michigan research group Project My Heart Your Heart. “There are no quality controls for recycled pacemakers. In essence, you’re creating a new product.”
U.S. pacemakers usually covered by insurance
In the United States, surgery to insert a pacemaker, physicians’ costs and the cost of the device itself can add up to nearly $20,000, according to Healthcare Blue Book. Fortunately, if use of a pacemaker is deemed necessary, the procedure and device are fully covered by Medicare, Medicaid and most private insurance plans.
Because most people in the United States who need pacemakers are able to get them through government or private insurance, there’s no domestic demand for recycled pacemakers, some experts say. It’s worth noting, though, that roughly 50 million Americans lack health insurance.
“All patients in need in the U.S. do get new pacemakers,” says Dr. Mark Estes III of Tufts University’s medical school, a spokesman for the American Heart Association. “To my knowledge, the AHA has never formally considered the issue (of recycling pacemakers) and does not have a position, as it is not a clinically relevant issue in the U.S.”
Nearly 250,000 Americans a year get pacemakers to correct slow or irregular heartbeats. Crawford estimates that as many as 2 million Americans have such devices at any given time.
Pacemaker reuse in other countries
Outside the United States, some countries have no qualms about recycling pacemakers. One nonprofit organization, Heartbeat International, provides donated recycled pacemakers from the United States to patients in 14 countries, including Argentina, Egypt, India, Mexico, Pakistan and the Philippines. In Sweden, pacemakers have been recycled within the country for decades, with studies showing no negative effects.
Pacemakers typically last six to 10 years. Recycled pacemakers often have considerable battery power remaining, depending on how long the previous owner lived after the device was installed. In the United States, it’s not necessary for a pacemaker owner to grant permission to donate the device; after his death, his family members may make that decision.
Success in India
Dr. Gaurav Kulkarni, a first-year surgical resident at Loyola University Chicago’s Stritch School of Medicine, analyzed the outcomes of 53 patients in Mumbai, India, who received recycled pacemakers from the family members of deceased Americans between January 2004 and January 2010. Patients were followed for an average of two years each.
According to the study, the pacemakers significantly improved the patients’ quality of life in most cases. All but two patients showed substantial improvement. The four patients who had manual-labor jobs were feeling well enough to return to work, and 27 women said they once were again able to take care of household chores.
“Without pacemakers, these patients would pretty much be forced to remain on confined rest, due to cardiac fatigue,” Kulkarni says in a statement.
The patients would not have had access to pacemakers without the donation program. In India, the devices can cost more than $6,000 in U.S. money, which is more than most families there would make in a year. The donated devices may well have saved the patients’ lives.
Thousands of pacemakers await new owners
Crawford points out that heart disease is the world’s No. 1 killer. “There are 20 million people dying of cardiovascular disease,” he says, “and at least 1 million could be helped by pacemaker therapy.”
To help some of those 1 million or so people, Crawford’s Project My Heart Your Heart has collected more than 6,000 recycled pacemakers since 2008 and has evaluated their battery life. Devices with more than 70 percent battery life may be sent to patients overseas. The group is awaiting FDA approval to export the devices.
“The purpose of this endeavor is to show that it is safe and effective to recycle pacemakers,” Crawford says.
Crawford hopes that once his group’s study is complete, the FDA will reverse its ban on the export of sterilized pacemakers.
“If we could harness a major proportion of those patients that use devices, that could contribute to doing away with disparities in pacemaker access around the world,” he says.