There is no dispute that portable defibrillators, simple-to-use device that supply jolts to shock a stilled heart to beat again, could save tens of thousands of lives a year in this country alone if they are accessible to willing bystanders.
But across America, there is anything but agreement among states about rules for the use of automated external defibrillators (or AEDs): Where they must be located; if they should be registered so authorities know where they are; whether a business that installs one is fully protected from liability; or even if a company is obliged to use one if someone on the premises suffers sudden cardiac arrest.
And some experts say the uneven patchwork of laws and regulations is a worrisome barrier to more widespread distribution and use of the battery-powered devices, which, if employed within minutes of cardiac arrest, can bring a person back to life.
For instance, many AEDs still carry labels saying they should only be used by "medical professionals" even though there are laws in every state giving "good Samaritan'' protection to anyone who tries to use one to save the life of someone in cardiac arrest.
"The concerns about risk and liability remain very high,'' said Richard Lazar, president of Readiness Systems LLC, a Portland, Ore., firm that consults with businesses and governments on AED training and placement.
Mandates for where AEDs should be placed are a national checkerboard. Nineteen states impose no mandates. But, in New York state, AEDs are required in health clubs, while in Florida, they're mandatory in public high schools. Yet recent court rulings in both states have held that, just because those facilities are required to have the devices, they are under no legal obligation to use them.
Many states require AED owners to register the devices with state or local emergency services, but only a few dozen communities use the information when they dispatch calls.
At least 14 states plus the District of Columbia require AEDS in health clubs, but most exempt spas in hotels. Nineteen states require the devices to be in at least some schools. Some states budget money for the devices, which can cost up to $2,000 each, but most leave it up to the schools to find the funds.
But only a few states, including New York and Oregon, have broad requirements to install the devices in "places of public assembly" or in buildings that have 25 or more people inside them each day.
That could change as several cases wind through the courts questioning whether stores, hotels and other businesses have a common-law duty to have and use an AED if a visitor goes into cardiac arrest. One such case, against Target Corp., is pending before the California Supreme Court, arising from the 2008 cardiac-arrest death of a customer in a Los Angeles store that did not have an AED. The family sued Target, arguing it had a duty under California common law to have an AED on hand.
For now, the lines are divided. "In many companies, the insurers and risk-management guys still seem to think they're better off not having AEDS than having them,'' said Linda Campbell, a retired American Airlines occupational-health nurse who helped found the company's AED program in the mid-1990s, and is now on the board of the Sudden Cardiac Arrest Association.
Much of the confusion arises from the very nature of AEDs. On the one hand, they are sophisticated, high-risk medical devices on par with pacemakers and replacement heart valves under U.S. Food and Drug Administration rules. Although they've been available for "public use" since the 1990s, only in the past 10 years has the FDA allowed any of the devices to be sold without a doctor's prescription. Most states still require physician supervision of AED deployment, and formal training of some or all "expected users" in a particular place.
At the same time, the machines have grown both more technically sophisticated and yet simpler to use, with more and more places installing them to be accessible to the general public as well as to more highly trained staff.
So while every state enacted laws addressing public access to AEDs between 1997 and 2001 that included language giving "good Samaritan'' protection to anyone who uses one to try to save a life, many of the laws also included provisions that could limit immunity if requirements for things like training, maintenance, doctor supervision or registration of AEDs are not followed.
"They screw things up by conditioning the immunity on silly operating rules or not covering everyone or all activities,'' Lazar said. "As a result, it's nearly impossible for companies and individuals to know whether they've got liability protection and that may make them hesitate to buy, retrieve or use an AED."
One industry group, the American Hotel and Lodging Association, singled out the patchwork of state laws as a major reason hotels in the U.S. "do not uniformly provide training and AEDs onsite,'' in a 2009 report.
Dr. Jonathan Reiner, a cardiologist at George Washington University in Washington, D.C., co-authored a paper in an American Heart Association journal Circulation several years ago titled "Shock and Law,'' which concluded that the lack of legal unity surrounding AEDs in different states creates "a virtual speed brake on the dissemination of this now-mature technology."
He notes that in Washington, D.C., for a business to put an AED on a wall, it must be registered, supervised by a doctor and have trained operators, while the same company installing one across the Potomac River in Virginia faces no registration requirement, but does have training and supervision mandates.
And in nearby Maryland, the law until recently conditioned immunity on training and imposed tight requirements on anyone installing an AED to ensure that any expected user had been trained; there's now an exception protecting untrained users.
Reiner and several other experts have worked since 2011 with U.S. Rep. Pete Olson, R-Texas, and a small bipartisan group of lawmakers to pass legislation setting a national minimum standard of protection from liability for people using an AED to try and save a life, but the proposal has gained little momentum so far.
Lazar thinks it might be more effective if each state just passed a straightforward immunity law with no strings attached. "But ultimately, what matters is not the laws, but all the people and organizations who go ahead and buy AEDs and work to save lives."