Medical Device Daily Associate

Now corporations can “do the right thing” by bringing automated external defibrillators (AEDs) into their offices around the world without the added fear of litigation, thanks to the pioneering efforts of a major player in the sector.

The Emergency Response Systems (ERS) business of Medtronic Physio-Control (Redmond, Washington), one of the world’s largest and oldest makers of AEDs, has introduced what it says is the first program to protect companies that deploy the devices to help treat the up to 450,000 victims of sudden cardiac arrest (SCA) each year.

Medtronic (Minneapolis) – which through its ERS unit has distributed more than 500,000 Lifepak defibrillators worldwide – unveiled its new indemnification program in Philadelphia at the Risk and Insurance Management Society’s (RIMS; New York) annual meeting, the nation’s largest gathering of insurance executives and risk managers.

The indemnification program, available to Heart Safe Solution customers, protects qualified participants from claims arising directly from personal injuries to patients that occur during the use of the devices.

“The biggest barrier to full-scale adoption of cost-effective, life-saving AEDs has been a misguided fear that companies expose themselves to liability claims if they adopt the technology,” said Brian Webster, vice president of Medtronic EMR’s commercial business.

Speaking from the floor of the RIMS meeting, he told Medical Device Daily that his company’s indemnification program “protects companies from liability risks resulting from AED use, allowing corporate risk managers and human resource executives to focus on the real issue we face in America: fighting one of the nation’s leading causes of death and increasing workplace safety.”

Webster said that the company was not spurred to offer this protection to its commercial customers based on any historically high volume of lawsuits arising from use of AEDs in the workplace but rather from “feedback from our customers saying that they were concerned about the potential of liability.”

He said that about 63 of the Fortune 100 companies are currently Medtronic customers, and they have consistently told Medtronic that they would love to have these devices available for their employees and customers, but they were a little bit concerned that they would be bringing liability into their organizations.

The Heart Safe Solution, available to commercial customers, is a package of training and support services developed so the company’s customers can rely on the Lifepak AED. Medtronic said this solution also assists companies in meeting federal, state and local AED requirements.

Webster said that the Heart Safe Solution is a “wrap-around set of services that we sell with the device. This unique package of services and protection eliminates the barrier to adopting AEDs by reducing our customers’ liability for fundamentally doing the right thing,” he said.

Medtronic designs individual AED programs to suit the unique needs of each corporate customer. “It’s really in that situation where we participated in the design of their AED program to make sure that it is set up and implemented correctly,” said Webster. “It’s in that situation that we protect them.”

Companies sign up for Medtronic to manage their AED programs via contracts that range on average from one to five years, and the price for the service to a corporate customer varies, based on such factors as the length of the agreement and the number of AED units covered.

Webster said that competitors within the AED sector would have to respond in kind to his company’s indemnification program in order to retain their customers.

“We really pioneered this industry,” he said, adding that as the market leader, “our competitors are most likely to respond to this at some point because [customers] like this offering.”

Although not everyone can be saved from sudden cardiac arrest, some studies have shown that early defibrillation can dramatically improve survival rates. Today, out-of-hospital survival rates from sudden cardiac arrest are about 5%, yet recent studies show that more than 70% of victims may survive when AEDs are accessible and used within three minutes of collapse.

The company noted that average response time for emergency medical response teams to arrive at the scene of a sudden cardiac arrest is six to 12 minutes. This fact, it said, underscores the importance for AEDs in businesses, schools and public places. Lifepak AEDs are prescription devices. To receive a prescription, a physician must be consulted. AED users should be trained in CPR and the use of the AED.

Webster said that Medtronic felt comfortable adding the indemnity for its AED program customers. “We’re basically just simply standing behind the product and the program. When we design [a program], we help the customer implement it [and] we manage it then we’re going to take the responsibility for that customer.”