A UK-based company Pace4Life plans to use the donated pacemakers of deceased individuals and send them to the developing world to give those with heart troubles a second chance at life.
However, the Food and Drug Administration (FDA) expressedly forbids the implantation of used pacemakers within the US and questions its safety with great concern, calling the idea “an objectionable practice”. While there are no Federal laws against harvesting of the pacemakers for implantation outside of the US. The process does not seem to be well known to patients and the general public in the US.
The British charity intends to send recycled pacemakers removed from the dead to the developing world for reuse. Pace4life is now collecting used devices from funeral directors across the United Kingdom. Approximately 40 000 people have pacemakers implanted annually in the UK but according to the report, many people in the developing world cannot afford these expensive devices. As a result, Pace4life says that many may die.
A visit to their website by Caribbean Medical News showed the downloadable donation forms for those living with pacemakers (patients) which include instructions for them to make their intentions clear, to have the pacemaker removed should they be cremated and also in the case of burial. The other forms include those of the next of kin to donate the pacemakers while funeral directors must have next of kin consent in order to remove and recycle the pacemakers.
As it relates to the safety of the devices, Pace4life assures the public that the pacemakers are safe. The website says “There is a growing body of scientific publications that support the claim that pacemaker devices can be reused after appropriate sterilisation and functionality checks. According to Pace4Life’s website, The University of Michigan is currently undertaking a large-scale clinical study with the FDA to obtain regulatory approval for the refitting of used pacemakers.http://www2.med.umich.edu/prmc/media/newsroom/details.cfm?ID=1592.
Pace4life has already established partnerships and is actively encouraging hospitals, mortuaries and funeral directors to donate the pacemakers within the legal and regulatory framework of the UK.
According to Pace4life, recycling of pacemakers is nothing new. The devices have been reused by Heart to Heart since the 1990s. Indeed, the University of Michigan’s Dr Timir Baman is associated with Project My Heart, Your Heart recycling pacemakers project.
On the University of Michigan’s Health System page, the My Heart, Your heart project says “our ultimate goal is to acquire FDA approval and begin a clinical trial to determine if pacemaker reutilization is a safe and effective means of delivering healthcare to those with great need in underserved countries. http://www.med.umich.edu/myheartyourheart/index.htm
However an FDA report says the harvesting of pacemakers has skyrocketed in recent times causing great concern to the regulatory body.
A policy statement from the European Society of Cardiology [11], 1998 says “The only available figures on the national extent of pacemaker reuse originate from Sweden. During 1996, 5% of pacemakers were reused devices, and there is no evidence that reuse has increased patient risk. It must be acknowledged, however, that none of the available reports had a prospective, randomized design.”
The patient looking for a heart transplant or pacemaker may view the words “objectionable” in a completely different light. Co-author of the University of Michigan study Dr Timir Baman says that there are approximately 15 studies in the literature saying that this type of initiative can be done effectively and safely,” Baman said.
