22 May 2010
New York, USA
Ticker Harvesting .The FDA currently prohibits reuse of pacemakers from dead people, in part because of the risk of infection. But a study shows there is no increase in infections when reusing pacemakers Thousands of lives could be saved every year if the US were to donate used pacemakers to developing countries instead of throwing them in the trash, doctors say.
The US Food and Drug Administration currently prohibits reuse of pacemakers from dead people, in part because of the risk of infection. According to experts, this policy is supported by manufacturers and many physicians.
But at a meeting on Thursday, doctors from the University of Michigan in Ann Arbor presented pooled data from hundreds of patients showing there was no increase in infections, malfunctioning or overall complications when reusing pacemakers. “This is a potentially lifesaving technology that we are just throwing away right now,” said Dr Kim Eagle, a cardiologist who worked on the study.
Heart disease is traditionally considered a product of a Western lifestyle, but is on the rise in other parts of the world as well, Eagle said. He added that certain parasitic diseases also cause heart trouble.
“It’s estimated that there are a million deaths a year from people in low–and middle–income countries due to slow heart rhythms,” he said.
The FDA does not regulate export of pacemakers from cadavers, and so far the Michigan doctors have tested reused devices in about a dozen patients in the Philippines with good results.
A pacemaker costs from $3,500 up to $30,000 in the US, depending on the type. Eagle said this price was prohibitive in developing nations, even though they often have the medical expertise to treat patients. Instead of throwing away the devices, as is common practice at funeral homes according to Eagle, his team has offered to help sterilize and test them for reuse.
This offer clashes with guidelines from the Heart Rhythm Society, which recommends that pacemakers be returned to manufacturers for testing. But manufacturers do not recycle their products. “When given a choice I would rather put in a new device in a patient, but I have had the luxury of practicing in US,” he said, adding that reuse “is clearly preferred over failure to treat, especially now that we have data to suggest it is safe,” said Richard Page, immediate past president of the society.
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