January 25, 2011
Stricter Oversight Urged for Defibrillators
By DUFF WILSON

A federal advisory panel on Tuesday called for stricter oversight of the defibrillators available in many schools, gyms, lobbies and other places that are used by the public to try to save victims of major heart attacks.

Food and Drug Administration staff also recommended tighter controls over the automated external defibrillators, citing concerns about product recalls and reliability. Over the last five years, according to a new agency report, there have been 68 recalls and more than 22,000 reports of malfunctioning devices. The F.D.A. staff said manufacturers followed up on only one-third of the reported problems.

More than a million automated defibrillator devices are available in the United States and Canada. They have been credited with saving nearly 500 lives a year.

The devices have been classified as high risk but under a grandfathering clause have been regulated as if they were lower risk, which allowed them to be brought onto the market faster. Devices in the high-risk category must meet requirements for approval before they can be sold, and may require more study, reporting or other controls to assure safety and effectiveness.

Manufacturers of the devices in the United States had sought a lower level of government oversight that would essentially continue the review system now in place. They argued that red tape would strangle innovation and raise prices. The manufacturers also said the vast majority of malfunctions arose from a self-reporting mechanism on the device and rarely affected people needing help.

But at the end of a daylong hearing on Tuesday, Dr. John W. Hirshfeld Jr., chairman of the advisory panel and a professor of cardiovascular medicine at the University of Pennsylvania, said, “There are a number of signals that raise questions about quality and reliability.”

The F.D.A. usually follows advisory committee recommendations.

Dr. Bram D. Zuckerman, director of the division of cardiovascular devices in the F.D.A. Office of Device Evaluation, said the companies would have 12 to 18 months after publication of a new rule to develop any additional studies or reports required to prove safety and effectiveness.

“There’s no question these are life-sustaining, life-saving devices,” he said.

The automated defibrillators, which cost about $2,500 apiece, can quickly and simply detect whether a collapsed person has the type of life-threatening abnormal heart rhythm that can be jolted back into normal rhythm, and if so, deliver the jolt. They have revived people without pulses.

An estimated 300,000 Americans suffer sudden cardiac arrest each year.

All of the doctors and professors on the F.D.A.’s Circulatory System Devices Panel acknowledged the value of the public defibrillator, but most agreed the devices should be put into a high-risk category to assure stronger product reviews.

The devices are manufactured by Cardiac Science Corporation, CU Medical Systems, Dfibtech, Heartsine Technologies, Philips Medical Systems, Physio-Control and Zoll Medical. They are already subject to manufacturing standards, engineering testing, animal testing when a new electrical waveform is proposed and certain clinical testing.

But the F.D.A. staff and advisers were critical of the lack of follow-up to malfunction reports, with some saying they were concerned the lifesaving devices might be accessible but inoperable.

There was no official vote, but only two or three of about a dozen panel members spoke in favor of the medium-risk category.

One of them was Dr. Myron L. Weisfeldt, a defibrillator pioneer and chairman of the department of medicine at Johns Hopkins University. He said the recalls were “concerning,” but mostly based on industry self-regulation, not patient problems. People who receive the treatment for ventricular fibrillation have a 42 percent survival rate, he said.

“The technology’s been around 26 years and its effectiveness when you have a safe and reliable device is beyond question,” Dr. Weisfeldt said.