FDA to review heart devices

The US food and drug administration (FDA) plans to use outside experts to help review heart devices.

Defibrillators and other such products are being reviewed following a recall of devices by Guidant, which has been accused of being slow to tell the FDA that its machines had life-threatening faults.

This marks the first time that the FDA has turned to outside experts to advise on how best to respond to problems and how to interpret manufacturers’ data.

In an interview with the New York Times, Daniel Schultz, director of the agency’s centre for devices and radiological health, said: “We recognise that we need to do a better job and that we need to do a better job in leveraging outside expertise.”

Moves for better regulation come after a report last month by doctors that called for a board to monitor companies’ heart devices and independently report problems.

A jolt of electricity is used to restore normal heartbeat via defibrillators, however in the Guidant case they often short circuited.

Critics say that the company kept information hidden for some time due to a fear of denting sales of their devices in a market of around 150,000 patients.

Through the new review of heart devices, the FDA hopes that this “logical step” will respond better to the need for recalls and should be less reliant on manufacturers to inform it of any problems.

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