Monday 26 November 2012

Secondhand ICDs to be Legalised?

Over the years, the development of biology and medicine has often been hindered by the towering obstacle that is "ethics". The latest debate surrounding this topic has been over the use of second hand implantable cardioverter defibrillators (ICDs), which is a small battery-powered electrical impulse generator that is implanted in patients who are at risk of sudden cardiac arrest due to ventricular fibrillation. The device is designed to pick up any signs of cardiac arrhythmia and correct it by initiating a jolt of electricity. It has been reported in Mumbai, India that 81 adults have been given second hand ICDs, removed from adults in the United States. 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 not in a position where they could afford a new one.

Implantable Cardioverter Defibrillators can cost up to $87,000
Behzad Pavri, from the Thomas Jefferson University Hospital in Philadelphia, and his colleagues reported few complications (only one fractured lead, and one dislodged lead) and no infections, in a case series in Annals of Internal Medicine. The report tracked 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 the follow-up, an average of 771 days after receiving the second hand device. The American team procured many cardioverter defibrillators from funeral directors. Other devices were donated by patients having a replacement.

In actual fact, the reuse of ICDs in America has been prohibited by the US Food and Drug Administration and federal laws prohibit funeral directors from collecting up. Therefore, the doctors taking part in this exercise are on uncertain ground legally but are calling for changes to liberalise the "charitable use" of second hand ICDs. However, 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 rightly been discredited in the past. 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. It is paramount that in the first instance they ensure their efforts are completely and utterly 100% safe.

Pavri is confident that donating used ICDs 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." I, for one, completely agree with him.

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