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Deploying portable heart defibrillators in workplaces, large buildings and public facilities may save the lives of cardiac arrest victims, but the trend also may raise new liability exposures.
As portable defibrillators become more affordable and easier to use, ultimately they might become as commonplace in workplaces and public buildings as first-aid kits.
In the process, though, manufacturers and purchasers of defibrillators must ensure that the devices are used and maintained properly if they want to reduce their exposure to liability suits.
"When you put life-saving medical equipment in the hands of laypeople and you have untoward outcomes, you're going to have claims against the manufacturer," said Kevin M. Quinley, senior vp at MEDMARC Insurance Group in Fairfax, Va.
Heart defibrillators send an electrical shock to restore a normal heart rhythm after fibrillation -- rapid and irregular contractions of the heart muscle. When used properly, the devices can greatly reduce the risk of death from sudden cardiac arrest. If used improperly, though, they can exacerbate fibrillation or fail to restore a normal heart rhythm.
One factor behind the wider deployment of the devices is that current models are far easier to use. In the past, defibrillator users, typically emergency medical personnel, had to be able to recognize irregular heart rhythms and determine whether to administer an electric shock to the heart. New computerized models, called automatic external defibrillators, or AEDs, use microcomputers to determine whether shocking the victim's heart is appropriate, as well as the appropriate level of electrical shock.
Employers or property owners deploying defibrillators must ensure that anyone who might use the equipment is adequately trained to use the devices and to recognize when they should be used, Mr. Quinley said.
At the same time, if deploying portable defibrillators does become commonplace -- a situation that already may be developing among airlines -- employers or property owners that don't make the life-saving equipment available might find themselves subject to claims for failing to meet a new standard of care.
While AEDs may be easier to use and more foolproof, and even though manufacturers such as HP Heartstream are offering to indemnify users, liability concerns still have hindered some recent moves toward defibrillator deployment.
In June, for example, a measure brought before a Chicago City Council committee to require that the devices be available in large private and city-owned buildings was tabled as a local realtors group and others raised the question of liability exposures.
Using her own company as an example, Deborah DiSanzo, operations manager of defibrillator manufacturer HP Heartstream in Seattle, noted that before Hewlett-Packard Co. bought Heartstream last year, HP already had approached the company about purchasing defibrillators for the computer company's Vancouver, Wash., work site.
That initiative stemmed "from the sheer reason that they wanted to help prevent peoples' deaths from sudden cardiac arrest if they could," Ms. DiSanzo said. After using the Vancouver facility as a test site, HP subsequently deployed the devices at its Andover, Mass., work site.
"From a Hewlett-Packard Co. perspective, if we can help our employees by getting them the best medical care in emergency circumstances, then HP wanted to do that," said Ms. DiSanzo.
HP Heartstream has seen employer interest in deploying defibrillators grow in the past two years, and Ms. DiSanzo said she thinks it stems from various sources. In the last quarter of 1997, HP Heartstream reported $3.3 million in sales, compared with $957,000 for the same quarter in 1996.
One source, she said, is that many companies are following the lead of commercial airlines and installing the devices on corporate aircraft.
"Then you have CEOs saying, 'Well, if they're going on my airplane, why aren't they just as good in my plant?' " Ms. DiSanzo said.
Another factor is that some companies see the growing availability and affordability of high-tech life-saving equipment in the same light as other opportunities afforded by new technology. "Forward-thinking companies who are on the edge of other technologies are starting to consider AEDs," she said.
Dr. David Brill, medical director of Michelin North America in Greenville, S.C., said, "When you think about it, industry has a tremendous opportunity, because we can get to people much more rapidly than an ambulance."
Michelin has had AEDs at its work sites since 1986.
"We've had them in the hands of company (emergency medical technicians), which we have decided was the floor of emergency response we want to have in our company," said Dr. Brill, who noted that some companies have decided they wanted the devices available to whoever is first to respond to an employee suffering cardiac arrest.
"People are as likely to have these events at work as anywhere else," he said, adding that an aging workforce gives employers even more reason to consider deploying defibrillators at the sites.
Dr. Brill said he didn't have statistics on how often Michelin's defibrillators were used, but he said they have saved lives over the years. He cited the example of a retiree visiting the employee wellness center in January "who walked behind the counter and just fell over. He was unconscious. There was no pulse."
A Michelin EMT called to the scene defibrillated the cardiac arrest victim before sending him by ambulance to the hospital, "and by the time he arrived at the hospital he was awake and talking," Dr. Brill said.
Ms. DiSanzo said her company also is seeing interest from recreational facilities, such as golf courses and ski areas -- "any place where large groups of people congregate and could have a risk of sudden cardiac arrest."
As the devices' use increases, it also might become increasingly necessary for employers and property owners to consider whether to include them in their own facilities or risk exposure to claims that they are not meeting a new standard of care.
"As these things become increasingly prevalent in airplanes, at ball games, I think the bar is raised with respect to standard of care," said Mr. Quinley of MEDMARC.
"If you own or operate premises, commercial premises particularly, you've got to look at whether there is a responsibility to stock some resuscitating equipment," Mr. Quinley said.
"For workplaces, I would see where, from a safety and management standpoint, companies might want to have that on hand just like a first-aid kit," he said. "And if companies forgo the technology just because they don't want to take on the training responsibilities, that could create some new liabilities."
"There are concerns coming up where, if the standard of care is providing first-aid and emergency medical care and defibrillators and you're not providing defibrillators, could you be held liable?" Ms. DiSanzo said.
"I think you could make a case that, in the airlines right now, it's becoming a standard of care," she said. "Most of the major airlines in the world now are putting AEDs in their planes."
Another exposure likely to increase along with the deployment of portable defibrillators in workplaces and public facilities is the risk of product liability claims against defibrillator manufacturers.
MEDMARC insures some of the "leading players" in the portable defibrillator market, Mr. Quinley said, adding: "We haven't seen these claims yet from anybody but ambulance types. The claims have involved professionals."
But, he said, it's probably a matter of time until claims emerge involving situations where the equipment was used by laypeople.
Those suits will focus on the design and manufacturer of the equipment, its labeling and training for potential users, Mr. Quinley said.
Defibrillator use requirements as established by the federal Food and Drug Administration "are sort of the bare minimum" that the equipment's manufacturers must consider, Mr. Quinley said.
"But," he continued, "well beyond that, (manufacturers) have to take a look at who's going to be using the equipment, what kind of training they're going to undergo, how accessible will that equipment be, and if and how well will it be maintained."
HP Heartstream went so far as to indemnify those purchasing, renting or leasing their defibrillators against claims emerging from their use, providing the devices were properly used and maintained. Such a move isn't unique in the medical device industry, but it's not standard operating procedure, Mr. Quinley said.
HP Heartstream indemnified its defibrillators' users to eliminate potential purchasers' "barriers" to acquiring AEDs, Ms. DiSanzo said, namely, the concern that if an AED didn't work, the purchaser would be liable.
But Michelin's Dr. Brill suggested that the new generation of portable defibrillators is so superior to its forebears that it greatly reduces the risks associated with defibrillator use, while making training remarkably easy.
In the past, defibrillator users had to be able to recognize irregular heart rhythms and determine which people would benefit from defibrillation, but the new computerized models can determine whether shocking the victim's heart is appropriate.
Dr. Brill described the defibrillators his company acquired earlier this year to replace aging equipment as "about the size of a college geography textbook."
"In a sense, what it is is a computer that delivers a shock," he said. "Almost any person can be trained to use it within 10 minutes."
His company's decision to keep the defibrillators in the hands of EMTs was based on their high level of training and experience in emergency situations, Dr. Brill explained. "We value the coolness and professional expertise that comes with that."
That approach also allows Michelin to better synchronize emergency medical activities with local emergency medical systems, he said.
The company isn't trying to replace the local ambulance service, according to Dr. Brill."Our goal is to intervene in the 10 to 15 minutes before the ambulance arrives.'