Doctors call for changes in the law to allow use of second hand cardioverter defibrillatorsBMJ 2012; 345 doi: http://dx.doi.org/10.1136/bmj.e7053 (Published 18 October 2012) Cite this as: BMJ 2012;345:e7053
Eighty one adults in Mumbai, India, have been given second hand implantable cardioverter defibrillators, removed from adults in the United States, doctors from the two countries have reported.
Collaborating doctors arranged their own transport for the devices, which were taken from the US to the Holy Family Hospital in Mumbai, where they were cleaned, sterilised, and given to informed patients who were too poor to afford a new cardioverter defibrillator.
Behzad Pavri, from the Thomas Jefferson University Hospital in Philadelphia, and his colleagues report few complications—one fractured lead, and one dislodged lead—and no infections, in a retrospective case series in Annals of Internal Medicine.1
The report tracks 75 of the 81 patients for more than two years. Devices were deployed appropriately in half of the patients, giving shocks or antitachycardia pacing when required. Nine patients died during follow-up, an average of 771 days after receiving a second hand device.
The US team procured many cardioverter defibrillators from funeral directors. Other devices were donated by patients having an upgrade or a replacement.
Because the US Food and Drug Administration prohibits the reuse of implantable cardioverter defibrillators and federal laws prohibit funeral directors from collecting them the authors concede that they are on uncertain ground legally and call for changes to liberalise the “charitable use” of second hand cardioverter defibrillators.
But two experts in global health warn that that might be premature. Giving potentially substandard drugs or devices to the world’s poor is highly controversial and has been rightly discredited in the past, they say in an editorial to accompany the report.2 Clear ethical guidance is urgently needed to shape well intentioned efforts to reduce health inequalities and get life saving treatments to those who need them most. First we must ensure that those efforts are safe, they say.
Pavri is confident that donating used cardioverter defibrillators to patients in India is ethical. “The most unethical stance would be to withhold appropriate therapy in a patient who would benefit from therapy simply because of financial considerations. A reused device is better than no device, given the risk of sudden death in such patients. The high utilization rate recorded in this cohort bears testimony to this risk of sudden death,” he told the BMJ.
The report is preliminary, however, and establishes feasibility not safety.
“This strategy needs to be proven safe in additional studies in a prospective manner with more rigorous data collection,” it says before listing a series of important limitations. Patients in the series were managed at one hospital by two surgeons. They gave no specific consent for research. Both patients and devices were poorly characterised. The team did not record precisely where each device had come from or why it had been removed. They were unable to compare old devices with new ones, or with alternative treatments such as recommended drug treatments.
Cite this as: BMJ 2012;345:e7053