FDA Panel to Vote on Risk of AEDs

FDA Panel to Vote on Risk of AEDs

April 14th, 2011 // 11:32 am @ admin

Jan. 25, 2011: WASHINGTON — Injuries and deaths from malfunctioning automated external defibrillators (AEDs) could have been avoided if the devices were approved through a more stringent review process, FDA staff reviewers said.

On Tuesday, an agency advisory committee will vote on whether AEDs, now in the high-risk Class III device category, should be moved into a less-risky class, or remain where they are and be subject to the stringent premarket approval application (PMA) process.

Currently AEDs are allowed to enter the market through the 510(k) process, which allows device-makers to bypass the traditional approval pathway and show only that their product is substantially similar to one already on the market.

In 2009, the Government Accountability Office (GAO) recommended that the 510(k) process not be available for Class III devices. Such devices, the GAO said, should either be reclassified into the less-risky Class II category or be required to follow the PMA process.

In an analysis released Monday, FDA staff reviewers concluded that the devices should remain in the Class III category, given that AED malfunctions have been responsible for thousands of injuries and as many as 721 deaths over the past five years.

The low-energy devices — which analyze heart rhythm, identify whether it’s shockable or not, and either deliver or advise the operator to deliver an electrical shock — are now found in many public places, where they are intended for use by the general public on victims of sudden cardiac arrest.

The FDA reviewers noted that 300,000 people go into sudden cardiac arrest each year and, bystander use of AEDs saves 474 lives per year, according to a study published in the Journal of the American College of Cardiology.

But the FDA has received more than 23,000 reports of AEDs malfunctioning, including some instances where the devices failed to work at all and reports from manufacturers indicate there were 721 deaths resulting from AED malfunction between 2005 and 2010.

And there have been 68 recalls of AEDs in the past five year, affecting hundreds of thousands of devices, FDA reviewers wrote.

The FDA found that more than half of the recalls occurred because of incompatible device components, such as a manufacturer ordering a component that the vendor had changed, unbeknownst to the manufacturer. Nearly 40% of the recalls occurred because of design issues.

“The majority of recalls that have occurred since 2005 can be mainly attributed to issues associated with the firm’s handling of purchasing controls or design controls” FDA reviewers said.

The FDA staff also recommended the agency do a premarket review of AED manufacturer procedures, perform pre-approval inspections, review any changes in manufacturing facilities, and require manufacturers to annually report any changes in their manufacturing process or design.

The reviewers noted that there was a “minority FDA perspective” that AED technology is constantly evolving, and new versions of AEDS are being developed, so “future regulation under the PMA regulations may be overly restrictive and may slow the pace of improved AED technology reaching the marketplace.”

That minority view recommended reclassifying the devices to Class II, which allows for 510(k) clearance instead of a PMA.