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Pushing For More Reliable Rescue Devices

Pushing For More Reliable Rescue DevicesTufts School of Medicine professor Mark Estes says it is time to revamp procedures for measuring the performance of automated external defibrillators.

Boston [08.22.06] From sports arenas to airports, automated external defibrillators (AEDs) —small, portable devices with life-saving potential—have become common fixtures in public places. While AEDs have the ability to restart the heart of person with a sudden cardiac arrest, a new study has raised questions about their safety and efficacy. The latest AED research, Tufts School of Medicine professor Mark Estes wrote in an editorial in one of the nation’s top medical journals, underscores the need for better methods of measuring their performance.

“As lifesaving devices, AEDs require the highest possible standards of reliability,” Estes, who directs the New England Cardiac Arrhythmia Center at Tufts-New England Medical Center, wrote in the Journal of the American Medical Association (also known as JAMA) recently.

Estes’ editorial accompanied a new study published in JAMA that found that more than 20 percent of AEDs sold in the United States from 1996-2005 were recalled, often unbeknownst to users. The research, by a team at Beth Israel Deaconess Medical Center in Boston, also showed that users did not promptly alert manufacturers to problems with the devices.

In an interview with United Press International, Estes stressed the need for better communication between AED users and manufacturers.

“Pre-market trials are too small to pick up reliability issues, and the current post-marketing surveillance system has many limitations,” Estes told UPI. "The flow of information from people who use the devices back to manufacturers is very limited. There's really no requirement that manufacturers track device performance, and no requirement that people who oversee use of AEDs report back to manufacturers."

He suggested the creation of a system for tracking purchasers with incentives for them to report problems to manufacturers. "The more rigorous that system is, the earlier you can detect design or manufacturing problems and the earlier you can fix them," he told UPI.

Estes pointed out in his JAMA editorial that there is a similar communication problem between manufacturers and the U.S. Food and Drug Administration, which regulates the devices. In what Estes calls a “passive adverse event reporting system,” AED manufacturers are only required to report malfunctions to the FDA that are brought to their attention; they don’t have to actively seek them out.

It’s time to revamp these procedures, Estes urged.

“The rational response to the [latest research] is to enhance efforts to improve AED reliability by reforming the process of monitoring and reporting on AEDs in postmarketing surveillance,” he wrote in the editorial.

In order for changes to take place, he told UPI, there needs to be “collaborative and cooperative effort among manufacturers, physicians, regulators and patient groups."

The end goal, he explained in the editorial, is saving lives.

“During cardiac arrest, when each minute really matters for survival, all stakeholders share the duty of ensuring the highest possible standards of AED reliability,” he wrote.

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