Recycled pacemakers donated from US funeral homes could end up helping poor people in the developing world who need these devices, a small study suggests.
It's been estimated that between 1 million and 2 million people worldwide die each year because they have no access to a pacemaker. In India, where the used pacemakers in this study ended up, the devices cost R18 000 to R46 000. That's more than many poor and middle-class Indians make in a year. And it doesn't even include doctor and hospital fees, or the cost of the wires connected to the pacemaker.
One potential, untapped source of pacemakers for the world's poor could be the significant number of Americans who die each year with a functioning pacemaker.
A survey of Michigan and Illinois morticians, for example, found that 19% of the deceased had a pacemaker or other heart device. But the large majority of those devices are buried with the body. And if they are removed, they are usually thrown away as medical waste.
Donated by funeral homes
A small percentage, however, have been donated to developing nations as part of small-scale efforts by some charitable groups.
In the new study, US researchers followed 53 heart patients in India who had received pacemakers donated from US funeral homes.
All the patients fared well immediately afterward. And there were no cases of infection or pacemaker malfunctions over an average follow-up of nearly two years.
Four patients died over the study period, but none of the deaths was related to the pacemaker itself, the researchers reported October 14th in the American Journal of Cardiology.
Recycled pacemakers safe
The new results support earlier data showing no increase in infections, malfunctioning or overall complications in hundreds of patients with reused pacemakers (see Reuters Health story from May 20, 2010).
Recycled pacemakers appear safe, provided you take precautions and follow the proper protocol, said lead researcher Dr Bharat K. Kantharia, of the University Of Texas Health Science Centre in Houston.
The pacemakers in this study were collected over six years from US funeral homes, with permission from the families of the deceased.
Of 122 pacemakers Dr Kantharia's team collected, half had enough battery life left (at least 3 years) to be used again. They were partially sterilised, then sent to Holy Family Hospital in Mumbai, India. There, the devices underwent final sterilisation and were implanted in 53 heart patients.
A quarter of the patients lived in remote areas, and could not be followed up after successfully having the pacemaker implanted – a limitation of implanting the devices in poor people in the developing world, according to Dr Kantharia.
"But the ones who were followed up were doing well," he said. Of those 40 patients, all but two reported marked improvement in their symptoms and quality of life, according to the researchers.
"All we are saying is, there are people who need a pacemaker and would not otherwise get one," Dr Kantharia said.
But there are still significant barriers to getting recycled pacemakers to the world's poor on any large scale.
One is that the safety needs further study. "This study is suggestive that it's safe," said Dr Thomas Crawford, an assistant professor of cardiovascular medicine at the University of Michigan in Ann Arbor.
"But definitive data are not available yet," said Dr Crawford, who was not involved in the study.
Dr Crawford and his colleagues in Michigan are working on getting pacemakers to the developing world on a wider scale. In a study dubbed Project My Heart - Your Heart, the researchers have collected more than 4,000 pacemakers from funeral homes in the past three years.
The goal is to have a supply of pacemakers that have been inspected and sterilised and can be sent to medical centres in the developing world that have the expertise to do the implantation. Those patients can then be followed to better pin down the safety and effectiveness of reused pacemakers.
But first there are legal questions. In the US, the Food and Drug Administration (FDA) has approved pacemakers only for one-time use, meaning they cannot be recycled for US patients. Pacemakers that are collected in the US but sterilised overseas may not, however, fall under the FDA's jurisdiction.
The Michigan researchers are currently trying to get the FDA's OK to study their recycled pacemakers overseas as investigational devices.
Both Dr Crawford and Dr Kantharia said there are logistical issues as well, including getting pacemakers from the US to those impoverished patients who need them.
And what happens when the battery dies is still an open question.
The Michigan researchers are working with a Detroit-based charity called World Medical Relief, which specialises in delivering used medical equipment to underdeveloped countries.
(Reuters Health, October 2011)