FDA Calls for Stricter Defibrillator Testing

The U.S. Food and Drug Administration (FDA) has recommended stricter safety measures for cardiovascular defibrillators after years of increasing problems with the emergency medical devices. The tighter regulation is intended to bring design and manufacturing flaws with the devices under control. Though not required to follow its advice, the FDA will ask an expert panel to evaluate the recommendations.

Defibrillators use electric shocks to jolt the heart back to normal after patients collapse from cardiac arrest. The new guidelines would not apply to implantable cardioverter defibrillators, which are surgically inserted into patients with heart problems.

Manufacturers of external defibrillators would have to submit more data and undergo manufacturing inspections before launching a new product. External defibrillators can be purchased for the home and often can be found throughout airports, shopping malls, sporting arenas, office buildings and other larger areas where numbers of people gather.

External defibrillators usually include two plastic pads that attach to the patient’s chest and detect whether the heart is suffering an abnormal heart rhythm. If the problem can be corrected, which is the case about one-fourth of the time, the pads deliver an electric shock that resets the heart’s pumping action. Nearly 300,000 people in the U.S. collapse each year from cardiac arrest, according to the FDA. Academics estimate nearly 500 lives are saved each year in the U.S. as a result of bystanders using the devices.

Medical device manufacturers have issued 68 recalls of defibrillators in the last five years, according to the FDA, and the agency has received more than 23,000 reports of device malfunctions, “including some where the device failure occurred during a rescue attempt and may have contributed to patient harm or death.”

Currently, makers of defibrillators are approved through the 510(k) system, which traditionally has allowed for a quicker time to market because approval is based on devices that are similar to products already on the market. Regulators only inspect the companies’ manufacturing facilities if they have cause to suspect a problem. Companies including Philips Healthcare, Cardiac Science Corp., Defibtech and others have petitioned the FDA to keep their devices approved at this standard. The FDA argues that stricter measures are needed because defibrillator makers have failed to fix problems that have led to the recall of hundreds of thousands of devices.

Under the FDA’s proposal, device manufacturers would be subject to regular inspections and could be required to submit additional clinical data before launching a new version of their defibrillator. This is the current standard for implantable defibrillators, heart valves and other devices that help keep patients alive.