British charity calls for re-use of pacemakers abroad
- 19 November 2013
- From the section Health
A British charity wants to remove pacemakers from people who have died in the UK and send the devices to developing countries for re-use. Pace4Life says thousands of the life-saving devices, which cost thousands of pounds, are typically thrown away or buried with patients each year in the UK.
Ganpat Jadhav used to work as a labourer on a farm a few hours from Mumbai. He would spend all day in the paddy fields harvesting rice. He was paid £6 (US$10) a month. It was a difficult life, but he had his family and his health.
But in 2003 everything changed.
"I started having blackouts and would lose consciousness," he says.
"I couldn't do my work on the farm."
Ganpat, 68, had an abnormally slow heartbeat. At times he would have long gaps without any heartbeat and that is when he would pass out.
His body's natural pacemaker wasn't working. He needed a new battery-operated one and without it he could die.
But in India a pacemaker costs around £2,500 (US$4,000). There was no way Ganpat could afford one.
"We didn't even know the meaning of the word pacemaker," says Ganpat's daughter Meena.
"We just knew a machine existed that would be fitted in the heart and people would survive."
They travelled to Mumbai looking for help, and they found it. They heard about a hospital where doctors had reimplanted donated pacemakers from abroad for free.
Ganpat went to see a doctor there who agreed to reimplant a donated pacemaker from the US. It changed his life.
"I don't care who has used this pacemaker before me," he says. "I couldn't have afforded a new one so I am thankful for the old one that saved my life."
Ganpat is now on his second donated pacemaker after the battery on his first one ran low.
The concept of reusing pacemakers is not new. Philanthropic doctors who have worked in the developed world but have family links to countries like India have been doing this on an informal basis for years. More recently there have been academic studies looking at the wider feasibility of the idea.
Some 4,500 miles away hundreds of used pacemakers are stacked up in boxes at Anstey & District Funeral Services in Leicester.
It is one of around one hundred funeral parlours across the UK which has agreed to start distributing pacemaker donation forms to families who have lost loved ones, asking for their permission to reimplant the devices in poor patients abroad.
Thousands of pacemakers are removed by funeral directors and in hospitals each year in the UK. They have to be removed from bodies which are going to be cremated to avoid explosions. It is a straightforward procedure which can be carried out by a mortician.
"It's such a waste," says Balasundaram Lavan, from the British Charity Pace4Life
"At the moment the pacemakers end up with recycling companies as medical waste, when they could be saving a life abroad."
EU rules mean pacemakers are only allowed to be used once within Europe. Medtronic is a major pacemaker manufacturer and said it does not support the reuse of its devices.
In a statement, it said: "(This is) to maintain a consistently high level of quality and reliability that ensure safety and efficacy for patients.
"The sterility or performance of the device cannot be guaranteed with reused devices. "
But heart surgeon and president elect of the Royal College of Medicine Babulal Sethia says - with safeguards around the re-sterilisation and battery-checking process - the idea is a good one.
"Pacemakers with significant battery life are potentially life-saving devices for people elsewhere," he says.
"In that situation I think our humanitarian response is at least as important as any commercial issues, and if there are such issues we need to address them and modify them so other people can benefit in developing countries."
The Medicines and Healthcare Products Regulatory Agency says as long as the person or the family of the person gives informed consent for the pacemaker to be reused abroad, the devices can legally leave the country. The MHRA has no jurisdiction over devices once they are used outside the UK, however, a spokesperson said: "Our position is that pacemakers are regulated as single use devices and should not be reused".
Pace4Life says it is taking these issues very seriously.
"We are trying to establish a robust regimented, transparent process," says Balasundaram Lavan.
"We are taking pacemakers, we're re-sterilising them, testing them (for battery life) and looking to reimplant them abroad."
The charity is taking its lead from the University of Michigan in the US which has been researching the reuse of pacemakers for the past four years.
It is currently conducting small scale studies in Bolivia and the Philippines.
"This type of activity already goes on on a small scale," says Dr Thomas Crawford, cardiologist and assistant professor of medicine at the University of Michigan.
"Doctors will literally reprocess them themselves and then take them in a suitcase and go on medical missions for a week or two to reimplant devices.
"The difference in our programme is that we want to develop a standardised protocol that can be followed by any other charity that wants to do this."
Dr Crawford and his team are awaiting approval from US regulators the Food and Drug Administration for a much wider clinical trial involving 300-400 patients in countries including Ghana, Pakistan and Nicaragua.
Pace4Life says pacemakers donated by families in Britain will be used as part of this American study.
The World Health Organization says the reuse of pacemakers will be discussed at a conference on medical devices in Geneva later this week.
Back in his tiny house in a Mumbai slum, Ganpat coos over his four-month-old grand-daughter Arathi.
She is his sixth grandchild. His family say it is a miracle he is here to see her.
Ganpat lifts little Arathi into the air sending her into a fit of giggles.
His daughter Meena, looking on, says: "If I met the person who donated this pacemaker, I would fall at their feet and thank them and their family. I would tell them they have given a new life to my father."