FDA eyes help with defibrillators?
Paper says the agency is recruiting outsiders to better monitor the heart aid and other devices.
NEW YORK (CNNMoney.com) - The Food and Drug Administration is recruiting outside help to monitor the safety of defibrillators for the first time, according to a news report.
The FDA is using outside medical experts to review defibrillators, which provide electric shocks to stalled hearts, and other medical devices that have been released into the market, according to a Friday report from the New York Times.
The FDA decided to use the outside help ahead of a expected report from the Heart Rhythm Society, which might urge defibrillator makers to use outside panels to review product safety, the Times said.
Generally, the FDA uses advisory panels to weigh the safety and efficacy of drugs and medical devices, before and after they enter the market. The panelists take votes and make suggestions to the FDA, which usually follows the advice of the advisors.
The FDA is trying to strengthen its monitoring of medical devices after weaknesses in its oversight were revealed last year. Guidant (up $1.12 to $77.85, Research), one of the market leaders in defibrillators that was recently acquired by Boston Scientific (up $0.24 to $21.93, Research), recalled tens of thousands of pacemakers last year because of faulty sealants.
To read more about Guidant, click here.