FDA plans stricter defibrillator approval process

FDA plans stricter defibrillator approval process

External defibrillators will be subject to stricter testing pending approval by the Food and Drug Administration under a proposal revealed online Friday by health officials.

The move comes amid several reports over the last few years that the medical devices which are designed to revert life-threatening heart rhythms have been failing at an unacceptable rate. The proposal only covers external defibrillators and not implantable ones.

Manufacturers of defibrillators will need to give regulatory officials more information about their devices and will submit them to rigorous inspections before the products can be launched into the market.

The FDA says medical device companies have issued 68 recalls of the life-saving devices in the past five years and officials also say about 23,000 malfunctions have been reported to them, "including some where the device failure occurred during a rescue attempt and may have contributed to patient harm or death."

The proposal will be submitted by the FDA next week to a panel of experts for review.

The present system being implemented by the FDA allows low-risk devices such as hospital beds to be approved quickly. Inspectors only visit manufacturing plants if a problem is suspected. Medical device companies Cardiac Science Corp., Philips Healthcare and Defibtech, among others, have requested regulators to have their products approved using the existing system.

However, health officials said they intend to improve the approval process because the companies have not addressed the issues that led to the recall of their products.

The new plan will require medical device companies to submit new data for new models of their external defibrillators just like what is done for implantable defibrillators and heart valves.

Posted by George Daniels on Saturday January 22 2011, 3:21 AM EDT. Ref: AP. All trademarks acknowledged. Filed under Featured News, Health. Comments and Trackbacks closed. Follow responses: RSS 2.0