A literature review scanning nearly 35 years of research has concluded recycling pacemakers might help save some of the millions of people who die every year because they're too poor to afford the implanted medical devices.

In the meta-analysis of four studies conducted between 1975 and 2009, the researchers found no significant difference in complications, device failure or infection between implanting reused devices and new ones. The findings were shared Thursday at the American Heart Association Scientific Forum on Quality of Care and Outcomes Research in Cardiovascular Disease and Stroke held in Washington, D.C.

"Currently, when a patient expires, the technology is thrown away," Dr. Kim Eagle, professor of internal medicine at the University of Michigan Health System in Ann Arbor, Mich., and a co-author of the study, told DOTmed News. "We're trying to develop a program to reuse this in a safe and effective way."

One to 3 million people die every year because they can't afford a pacemaker, according to Heartbeat International, a charity that donates (new) pacemakers supplied by the medical device industry. But the U.S. Food and Drug Administration considers the devices, which stimulate slow-beating hearts with mild electrical jolts, too risky to be reused after a patient's death.

But some recycling has occurred, largely in other countries. "There was a history of not U.S. reuse, but Canada, Sweden, some of the Scandinavian countries had programs in the '70s, '80s, then for reasons, probably legal or ethical or both, it was stopped," Eagle said.

Switzerland, India, Israel and France have also allowed pacemakers to be reused.

"Ironically, there was enough experience with it that one could study and verify that generally the devices were safe and effective," Eagle added.

The evidence from the current study corresponds with results from earlier research. Just last year, many of the same scientists who worked on the meta-analysis published a pilot study in the Journal of the American College of Cardiology. Coordinating with the charity World Medical Relief, they evaluated 12 sterilized, reused devices in patients in the Philippines. No functional problems were detected after several months of close supervision.

"They've done well," Eagle said.

Eagle and his colleagues now hope to run a large-scale clinical trial to monitor hundreds of patients after implantation with a recycled device. He said they are in talks with the FDA, and are waiting for its approval of the trials before starting.

Already, they have set up a charitable project called "My Heart Your Heart," and have established relationships with hospitals in developing countries, such as Ghana and Vietnam, he said.

In such a program, recycled pacemakers would be sterilized and given new leads. The device would be handed off to local physicians who would donate their time surgically implanting them and following up with the patients to make sure they're healthy.

Critically, Eagle said they would only use devices with 70 percent of their expected battery life remaining, which would be four to seven years. (The typical life span of a pacemaker's battery is between five and 10 years, Eagle said, and rarely more than 15.)

CHEAPER OPTION

In the United States, new pacemakers and implantable defibrillators cost between $10,000 and $50,000, according to the researchers.

Even on the low end, the cost of the device could be the equivalent of four years of family income for someone in a developing country, Eagle said.

"People who are destitute, they can't get close to paying for a device," he said.

"A refurbished device would cost about $15 (if done by a hospital with their other sterilized equipment) to resterilize plus the cost of shipping to the third world," Dr. Timir S. Baman, a professor of cardiovascular medicine at the University of Michigan, and another co-author of the study, told DOTmed by email.

And it seems many Americans are willing to donate their pacemakers after they die. According to the University of Michigan, 90 percent of surveyed device patients in the United States would be donors if given a chance.

STATE OF DONATIONS

Already, in a modest way, American opportunities for charitable giving of the devices do exist. Since 1994, Heart Too Heart, a nonprofit set up by Bill Daem of Billings, Mont., has worked to get used devices to nearly 5,000 patients, mainly in South America and Eastern Europe, according to the publication Heartwire.

In Heart Too Heart, posthumously removed pacemakers are sterilized and hand-carried by U.S. medical doctors to physicians abroad, who surgically implant them at no cost to the patients.

But the process of getting those pacemakers to charities, now, is tricky.

"It's a very complicated issue," David Penepent, manager of Herson Funeral Home in Ithaca, N.Y., and president of Finger Lakes Funeral Association, told DOTmed News by phone.

Penepent said Herson donated the devices from 2003 until 2006, when management decided to put the kibosh on the donations for fear of running afoul of FDA rules or federal law.

"Do funeral directors do this? Yeah, but it's pretty hush-hush," he said.

Not being able to give pacemakers away can put the funeral homes in something of a bind, Penepent pointed out, especially if the deceased chooses cremation. Bodies can't be cremated with pacemakers inside because the medical devices can explode under the intense heat.

"It acts like a hand grenade," Penepent said.

Yet if funeral directors remove the pacemaker, they can't put it in the landfill because it's a biohazard and they can't dispose of it in an incinerator at a biowaste disposal site because of the explosion risk, Penepent said. But they're also not really supposed to hold onto or transport the devices, he added.

"We don't know what to do," Penepent said. "Funeral directors would love to send them to a charity. It's a catch-22. No matter what you do with this thing, it's wrong."