Can pacemakers be used twice?
NEW YORK (Reuters Health) - People in developing countries with heart problems may not be able to afford new pacemakers, but a new study suggests devices removed during autopsies may have enough remaining battery life to be donated and used again.
Researchers found that of 334 autopsies preformed 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.
It's estimated that between one million and two million people die worldwide each year because they do not have access to pacemakers, which send electrical impulses into the heart to help maintain a normal heartbeat.
For many of those people, the biggest barrier is cost. A pacemaker in the U.S. has a price tag of about $5,000, which can be 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 for free.
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 used devices with a sufficient amount of 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's collecting used devices from patients and funeral directors to be someday donated to developing countries - with the patients' or patients families' consent.
So far, the project has collected over 9,000 devices - 15 percent of them with over four years of remaining battery life.
REGULATIONS, PUSHBACK AND SUPPORT
Shipping devices overseas is easier said than done, however.
The Food and Drug Administration (FDA), which oversees medical devices in the U.S., approves pacemakers and ICDs to be used only once.
Single-use devices, however, 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 also hired a company to confirm the used devices are sterilized, which if not done properly can lead to a serious infection.
There have already been some studies looking 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 (see Reuters Health story of October 26, 2011).
But regulations aren't the only hurdle. Crawford said the devices' manufacturers do not support reuse.
In statements emailed to Reuters Health, Medtronic 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 and cited 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," the St. Jude statement said.
A Medtronic spokesperson said the company encourages "the return of devices for evaluation and tracking, including those explanted in funeral homes."
Both device makers also added that they donate new, unused devices to charities around the world.
But donations of new devices do not cover everyone who needs pacemakers, said Crawford.
Project My Heart Your Heart reports that past research found 90 percent of patients with a pacemaker would donate their used devices if given the chance.
"I think the overwhelming message is that we should be thinking about pacemaker reuse," said Zamani.
He later added, "It certainly beats keeping these devices in drawers."
SOURCE: bit.ly/PWE9CH The American Journal of Cardiology, online September 3, 2012.
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