From the July 2011 issue of HealthCare Business News magazine


eMed America, a company that sells AEDs from a number of manufacturers, also has an online AED program management option. “It’s a Web-based software program that monitors and maintains every defibrillator that we put out into service,” says Ben J. Wellons, the company’s president and CEO. “It also monitors the trained personnel at each location so we can make sure they get retrained and refreshed every year.”

Currently, more than 2,000 of eMed’s customers are using the management program. “Owning or buying a defibrillator is only the first part of the equation to be prepared to save someone’s life,” Wellons says.

Defibtech’s Slusser says the company’s Lifeline View unit is a “benchmark in AED maintenance.”

“The pads and the batteries are programmed with the serial number and expiration dates,” Slusser says. “When they’re replaced, it automatically interacts with the unit to load that information directly to the status screen.”

In addition to the subscription-based maintenance programs, most AEDs are also designed to run a number of self-tests. For instance, if the batteries are low or the pads need to be replaced, the unit is programmed to emit an audible warning.

Philips’ units have an extensive suite of self-tests, according to Froman. “There’s more computing power devoted to the self-testing than anything else,” he says.

Challenges -- FDA and…bystanders?
Although most AED makers say business has been steady or up in the past year or so, the sector is not without challenges. A new Food and Drug Administration initiative and a recent study assessing the public’s relationship with AEDs present some obstacles to manufacturers.

Last year, the FDA launched a new AED initiative as a response to the thousands of reports it received regarding external defibrillator malfunctions.

The goals of the agency’s External Defibrillator Improvement Initiative include promoting innovation to enhance AED safety and improving the industry’s ability to pinpoint and resolve safety risks in a faster and more effective manner.

The FDA also vowed to establish a premarket regulatory pathway for AEDs that incorporate best practices for design and product testing.

Although manufacturers commend the FDA for the initiative, it’s worth noting that it will affect, and potentially slow down, the approval process for new AEDs. “It may require more time and more data as part of the effort to improve reliability,” says Zoll’s Hamilton.

Nevertheless, industry experts believe by working with the FDA on the improvement initiative, defibrillator products already on the market will not be significantly impacted.

July 2011 Magazine

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