Medical Device Link.

Originally Published MX May/June 2005

BUSINESS NEWS

Healthcare consumers are widely considered to be more savvy and attuned to the use of medical technologies today than ever before. But apparently that fact isn't enough to convince businesses that they should equip their workplaces with automatic external defibrillators (AEDs)—devices that can dramatically increase the survival rate among victims of sudden cardiac arrest (SCA). Instead, many companies have so far sidestepped recommendations to install AEDs, frequently citing the liability claims that could arise from use of the devices.

The Lifepak CR Plus by Medtronic. (click to enlarge)

But that trend could soon be changing. To eliminate the liability barrier to greater adoption of AEDs in the workplace, Medtronic Emergency Response Systems (Redmond, WA), a business unit of Medtronic Inc. (Minneapolis), has introduced a liability protection program for corporate AED buyers.

The indemnity program is offered as part of Medtronic’s Heart Safe Solutions service and support package. The package includes facility and AED unit needs assessment, personnel training, AED maintenance and updating, postevent counseling, and access to an on-line portal for tracking battery and electrode replacement schedules as well as the latest advisory information about the program.

Medtronic launched the indemnity program in April at the annual meeting of the Risk and Insurance Management Society Inc. (RIMS; New York City), the nation's largest gathering of insurance executives and risk managers.

Brian Webster

"The biggest barrier to full-scale adoption of cost-effective, lifesaving AEDs has been a misguided fear that companies expose themselves to liability claims if they adopt the technology," says Brian Webster, vice president and general manager of Medtronic's Emergency Response Systems business unit. "The indemnification program provides a level of comfort while protecting qualified participants from claims arising directly from personal injuries to patients which occur during the use of the devices."

In Webster's view, "Deployment of Lifepak AEDs also delivers a powerful, positive message to employees, who understand that the placement of these devices shows that our customers’ companies are committed to their well-being."

Medtronic has sold more than 500,000 of its Lifepak devices to customers around the world, and is the leading provider of AEDs to Fortune 500 corporations.

AEDs have been shown to dramatically improve the survival rate for victims of sudden cardiac arrest, which is caused by a rapid and erratic arrhythmia known as ventricular fibrillation. The only effective emergency treatment is defibrillation, which shocks the heart back to its normal rhythm via an electric pulse.

While out-of-hospital survival rates for SCA are only about 5%, health experts believe they could improve to as much as 70% if victims were treated with an AED within three minutes of an attack. If defibrillation is done within two minutes of SCA, the survival rate is 90%. It drops to 45% if defibrillation takes place within six minutes, and falls off to 5% if 10 or more minutes pass without treatment. According to the American Heart Association (Dallas), SCA accounts for 250,000 deaths annually in the United States.

AEDs are increasingly finding their way into all sorts of places where large numbers of people gather, including sports facilities, shopping malls, restaurants, and schools. In 1998, the U.S. Congress passed legislation requiring commercial airliners to carry on-board AEDs. The Cardiac Arrest Survival Act of 2000 (CASA) encouraged the deployment of AEDs in federal buildings. CASA also recommended establishment of uniform 'good-Samaritan' immunity for the emergency use of AEDs.

Many states and localities have so-called good-Samaritan laws regarding AED use, but there is a great deal of variation from jurisdiction to jurisdiction.

All AEDs required a prescription until September 2004, when FDA approved the HeartStart AED by Philips Medical Systems (Andover, MA) for over-the-counter (OTC) purchase. Medtronic's Heart Safe Solutions program includes a prescription for its Lifepak device. Other AED manufacturers have already applied to FDA for approval of OTC sales, or are expected to do so.

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