A Philadelphia heart specialist and his colleagues have been smuggling used cardiac devices into India for the last eight years. These used cardiac devices are being used to save the lives of people who might die without them.
NBC News reports that Dr. Behzad B. Pavri, a cardiac electrophysiologist at Thomas Jefferson University Hospital, says recycled implantable cardioverter-defibrillators (ICD’s), devices that jolt a failing heart back into normal rhythm, can be recollected from U.S. patients and funeral homes, transported, sterilized, and re-implanted into new patients who would not normally be able to afford them.
“The patients who are getting these devices are the sickest of the sick, the poorest of the poor,” Pavri said.
Pavri and his colleagues were able to review 75 out of 81 patients who received recycled ICD’s between 2004 and 2011 and found no traces of infection or malfunction of the ICD’s. Nine patients died during follow-up, however, the deaths did not appear to be related to the recycled ICD’s.
Pavri’s study was conducted in cooperation with Holy Family Hospital in Mumba. The study’s patients included 66 men and 15 women. The patients ranged in age from 27 to 79 and they were all at great risk for life-threatening irregular heart rhythms that could be treated with ICDs.
The patients who received the recycled ICDs were people who would not have been able to afford ICD’s normally. In India, a new ICD might cost 3 lakhs, this is the equivalent of $6,000 U.S., normal Mumbai residents only earn about 1.41 lakhs a year.
The residents that can pay would pay for it themselves, but those who can’t afford the ICD’s are treated with other, often inferior methods, including drug therapies.
There are many ICD’s removed every day from patients in the U.S. that swap them out for newer devices or who die, said Pavri. The normal battery life for a newer ICD is about 6-10 years, and most of the ICD’s still have about 3 years or more remaining on their battery life when they are removed.
Approximately one-third to one-fifth of the ICD’s that are disposed of by funeral homes may have sufficient battery life to save someone else.
Even though, the recycling of ICDs is prohibited in the United States by the federal Food and Drug Administration, the FDA has no jurisdiction over the devices if they are treated and implanted elsewhere, so the Cardiological Society of India has authorized the practice.
In order to get the used ICD’s to India, Pavri and his team collected the used ICD’s one by one over several years from consenting patients and funeral homes. Since shipping them by traditional methods was difficult because of the explanation involved, they packed the ICD’s into checked luggage and transported them to India themselves.
Even though the practice of recycling ICD’s is not exactly legal, Pavri says that such actions and off-label research is grounds to bolster arguments to allow reuse of these devices on humanitarian grounds.
“It is worse practice, in my opinion, to not offer a patient anything,” Pavri said.
“A secondhand device is better than no device at all.”