The board of the Minnesota Funeral Directors Association has endorsed a program to recycle pacemakers from deceased people and reuse them in needy patients abroad. A team of doctors at the University of Michigan, the non-profit group World Medical Relief and Michigan's funeral directors developed the plan, and now the Minnesota association will encourage members to participate.
According to the St. Louis Post-Dispatch, pacemakers cost $10,000 to $50,000 to implant. About 100,000 Americans undergo the surgery each year. However, most of the devices are discarded in medical waste or buried with people when they die. But the Michigan team says they want to show that recycling the devices after thorough sterilization is feasible and ethical.
In the Oct. 19 issue of Circulation, experts at the U of M Cardiovascular Center examined the legality and logistics of collecting pacemakers, after they are removed for burial or cremation, for sterilization and reuse across the globe. They found that the practice could help those in need. "Establishing a validated pacemaker reutilization program could transform a currently wasted resource into an opportunity for a new life for many citizens in the world," says study senior author Kim Eagle, cardiologist and a director of the U of M Cardiovascular Center.
However, the National Funeral Directors Association advises against shipping the devices. It discussed the issue with the FDA and issued a legal advisory three years ago warning funeral directors that if they shipped pacemakers, they would be considered medical device distributors subject to federal and state legal requirements. "Funeral directors that ship devices to a charitable organization are violating device distribution laws and are at risk for sanctions," the advisory stated, as quoted by the Post-Dispatch.
The Michigan team is in the process of seeking FDA approval to ship and export the devices to remove any legal concerns. Once they have approval, they plan to conduct a clinical trial testing the safety of the collection process and long-term success of the implantation surgery.
Gary Anderson, executive director of the Minnesota Funeral Directors Association, said funeral directors can decide individually whether to participate. "Funeral directors are compassionate people who care about helping and assisting families and making sure there's not just tragedy at the end of life," he said, as quoted by the Star Tribune.
None of the recycled devices will be used in the U.S. as the FDA prohibits the activity. Medtronic, Boston Scientific and St. Jude Medical all oppose the practice.