Support for heart implants to be returned to manufacturers after death

Nov 9 2005

The U.S. Food and Drug Administration (FDA) is throwing it's weight behind a policy that would mean implantable heart defibrillators would be returned to their manufacturers to be studied for possible defects after the patient dies.

The move comes amid growing debate over when doctors and patients should be told about malfunctioning implantable heart devices.

Scott Gottlieb the FDA Deputy Commissioner for Policy, says the agency has been discussing the value of post-mortem studies with the Heart Rhythm Society, the professional group which represents cardiologists specializing in electrophysiology, in an effort to to encourage more 'explants', the practice of removing devices after it they have been implanted.

At a Health Summit in New York, Gottlieb suggested that a patient could sign a consent form when they received the implant.

Following the sudden death earlier this year of a 21-year-old college student, who died of cardiac arrest when his implantable cardioverter defibrillator (ICD) short-circuited, concerns have risen about the devices' failure rates.

Manufacturers of the defective device, Guidant Corp., recalled its ICDs over the summer and have been criticised for knowing about the problems but not disclosing them for years.

Manufacturers and regulators have been criticized for not providing more transparency, and critics of the current policy say that without post-mortem studies, it is likely an even higher failure rate goes undetected.

Robert Hauser, a cardiologist with the Minneapolis Heart Institute, says without question post-mortem studies would reveal a higher failure rate.

It seems that when an ICD patient dies, the stop-watch size device implanted in the chest is buried with the body, along with important information about the device's functionality.

Eric Topol, head of cardiovascular medicine at the Cleveland Clinic, has said despite such important medical technology, there is no system to retrieve the devices if a patient dies.

However Mark Carlson, a cardiologist heading a task force to make policy recommendations for Heart Rhythm Society, says although he is not opposed to conducting post-mortem studies, it is not that simple and doubts it would uncover any significant new information.

He is not convinced that there are large numbers of undetected failures out there.

His task force is working closely with regulators and he hopes to present guidelines for doctors and policy recommendations by May 2006.

Stan Myrum, vice president of quality and operations for the cardiac rhythm management business at Medtronic Inc., the world's biggest maker of ICDs, said that such studies would be challenging as the emotional issue of getting consent from the families of the deceased is required.

He also does not believe a post-mortem study would significantly change failure rates on ICDs.