AHA: Resterilized Defibrillators Can Be Reimplanted
The devices, which "jump start" erratic hearts, can be re-used, the AHA says.
Nov. 20, 2010— -- CHICAGO -- Defibrillators that still have significant battery life can be successfully removed from patients who no longer need them and reimplanted in other patients, researchers found.
A total of 21 implantable cardioverter defibrillators (ICDs) and 19 cardiac resynchronization therapy defibrillators (CRT-Ds) were removed from U.S. patients and reimplanted in Indian patients, resulting in a 35 percent successful shock rate and no instances of infectious complication, Dr. Behzad Pavri of Thomas Jefferson University in Philadelphia and colleagues reported here.
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The devices had been removed due to infections or a need to upgrade. "My objective was to primarily not waste these devices and, if possible, offer them to patients who would not be able to get them otherwise," Pavri said at the American Heart Association meeting.
To be accepted for reuse, the defibrillators had to have a charge of more than three volts or a projected remaining life of more than three years, could not be a recalled or "under advisory" device, and required verbal consent of the patient from whom the device was removed before it could be reused.
Once permission was acquired, the devices were sterilized, repackaged, and shipped to India for reimplantation. Patient and lead data were erased from the defibrillators.
Indian patients met inclusion criteria if they had a class I indication for ICD implantation, were impeded from receiving a new device due to socioeconomic status, and consented after the risks were explained to them.
No infectious complications were reported during follow-up. A lead dislodgment occurred in one patient and required reoperation.
In general, the defibrillators appeared to be undamaged by the sterilization process and the devices continued to work properly without increased risk of complication or malfunction, Pavri said.
Pavri affirmed that much of the legal grounding for the study was previously unexplored.
"This is a completely unknown territory; we are charting a new course here in uncharted waters," Pavri told MedPage Today. "I'm sure there will be plenty of potential legal ramifications to ensue."
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