DETROIT - The term "certified preowned" usually applies to cars, not pacemakers.
But now a lifesaving program that uses reconditioned pacemakers to help people around the globe has been officially launched from right here in southeast Michigan.
According to Dr. Kim Eagle, director of the cardiovascular center at the University of Michigan, "We believe there are as many as a million people in the world each year who die for lack of a pacemaker.”
The most common impediment to people in underserved countries getting a pacemaker is cost, although some African nations don’t even have the capability to implant pacemakers.
For years, humanitarian-minded doctors have been quietly bringing previously used pacemakers to patients in underserved countries. For the most part, these efforts were conducted completely under the radar.
Eagle and his colleagues, in a partnership with World Medical Relief, have brought the practice out of the shadows and formalized a legitimate program to get previously used pacemakers to patients in need.
World Medical Relief is the perfect partner to develop Project My Heart Your Heart. Since its founding in Detroit in 1953, the organization has charitably distributed medical supplies around the world. Project My Heart Your Heart is a logical extension of that mission.
The process of reconditioning pacemakers begins at funeral homes. Currently, about 45 percent of all pacemakers are removed from the dead. Thirty-five percent must be removed because they are an explosion risk when a person is cremated. The additional 10 percent are removed at the discretion of the funeral home and the family. In the past, these pacemakers were either discarded as medical waste, sent back to the device manufacturers or sent to have the metals reclaimed. Project My Heart Your Heart has contacted funeral homes across America and has been able to reclaim over 25,000 for possible reuse. Roughly 20 percent of these reclaimed pacemakers are suitable for reuse.
The first thing that is tested is the remaining battery life.
“The ones that have four years or more -- those are prime devices for us to recycle.” Eagle said.
After that, the pacemakers go for an initial round of cleaning and sterilization. Then they're tested for function, a technically complex process.
According to Eagle, “For a while, it took us over an hour just to analyze whether a device responded properly.”
After working with the engineering department at the University of Michigan, the Project My Heart Your Heart team developed a box that simulates the electrical rhythms of a human heart. This has allowed the testing team to assess the function of a pacemaker in minutes.
Eagle said the goal is “to meet an industry level of standard for a new device, and if you’re that patient receiving a used device you would love that, to know that my device is having that same standard met.”
After some additional processing and an additional round of sterilization and packaging, the pacemakers are ready for export.
World Medical Relief and Project My Heart Your Heart has worked closely with the FDA to meet and exceed all applicable standards. According to Dr. Eagle, “the FDA had a very positive influence on our project… they’ve given us that export approval assuming we have letters from governments receiving the devices which we have.”
So far, pacemakers have been sent to such countries as Ghana, Sierra Leone, Pakistan, Nicaragua, Kenya and the Philippines. The patients receiving pacemakers will all be followed in a study to verify the ongoing track record of the devices.
“We're thinking big here, thinking the whole world and a million lives. This is a long-term goal. This is not a short-term fix. We want to do this correctly so that anybody looking at it says, "If you do it this way, it’s safe its effective and it can last,'” Eagle said.
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