* For many, biggest barrier to pacemakers is cost
* No devices approved by the FDA for reuse
* Two manufacturers oppose reuse or reprocessing
By Andrew M. Seaman
NEW YORK, Sept 13 (Reuters Health) - Some pacemakers removed during hospital autopsies have enough battery life left in them to be reused in people with heart problems in developing countries, a new study says.
Researchers found that of 334 autopsies performed at the University of Pennsylvania between February 2009 and July 2011, 27 pacemakers and implantable cardioverter-defibrillators (ICDs) were recovered.
Of those, eight devices had at least four years of battery life remaining.
“That’s a substantial length of time to alleviate symptoms,” said Dr. Payman Zamani, the study’s lead author and a cardiology fellow at the Hospital of the University of Pennsylvania in Philadelphia.
The findings were reported this month in the American Journal of Cardiology.
An estimated 1 million to 2 million people die worldwide each year because they lack access to pacemakers, which send electrical impulses into the heart to help maintain a normal heartbeat.
The biggest barrier is cost. In the U.S. market, pacemakers can sell for about $5,000, more than some people in developing countries make in a year. That does not include the cost of surgery, a hospital stay and additional care.
One way to overcome that barrier, according to some researchers, is to donate used pacemakers and ICDs to developing countries.
Until now, researchers have focused on getting used devices when a person’s pacemaker or ICD was upgraded and from funeral directors before burial.
Zamani and his colleagues found that hospital morgues may be another place to get devices with enough battery life remaining.
“There are a lot of devices that we could potentially tap into if we just got the message across,” said Dr. Thomas Crawford, a cardiologist at the University of Michigan School of Medicine in Ann Arbor.
Crawford, who was not part of the new research, is involved with Project My Heart Your Heart, a program at the University of Michigan that is collecting used devices from patients and funeral directors to be someday donated to developing countries - with the patients’ or families’ consent.
So far, the project has collected over 9,000 devices - 15 percent of them with more than four years of remaining battery life.
Shipping devices overseas is easier said than done, however.
The U.S. Food and Drug Administration considers pacemakers and ICDs to be single-use devices.
Devices used once can be approved for reuse if the safety and effectiveness of the device can be shown after reprocessing, an FDA spokesperson wrote in an email to Reuters Health. The FDA would also need to issue an export certificate for the devices to be shipped to another country.
To date, no pacemakers or ICDs have been approved by the FDA for reuse.
Crawford said his group plans to file an application with the FDA this week for permission to test the used devices in a clinical trial for safety.
He added that the group has hired a company to confirm the used devices are sterilized, which if not done properly can lead to a serious infection.
Studies have looked into the safety of reusing pacemakers, including one from 2011 that found all but two of 40 patients who received used pacemakers reported improved health.
Regulations are not the only hurdle. Medtronic Inc and St. Jude Medical Inc - two manufacturers of pacemakers and ICDs based in Minnesota - said they do not support the reuse or reprocessing of their products, citing concerns over cleanliness and sterilization.
“We are concerned that the integrity and performance of devices intended for single use may be compromised by reprocessing and reuse,” St. Jude said in a statement.
Medtronic said the company encourages “the return of devices for evaluation and tracking, including those explanted in funeral homes.”
Both device makers said they donate new devices to charities around the world. But such donations do not cover everyone who needs pacemakers, said Crawford.
Project My Heart Your Heart cites research that found 90 percent of patients with a pacemaker would donate their used devices if given the chance.
“The overwhelming message is that we should be thinking about pacemaker reuse,” said Zamani. “It certainly beats keeping these devices in drawers.”