“Automated external defibrillators save lives,” said William Maisel, M.D., deputy director of science and chief scientist at the FDA’s Center for Devices and Radiological Health. While expressing his concern about recalls and manufacturing problems associated with some devices, he said, “we’re committed to working with manufacturers to address these issues.”
Mary M. Newman, president and co-founder of the Sudden Cardiac Arrest Foundation, said she is encouraged by the FDA’s statement that “the FDA will make sure that automated external defibrillators remain available so that they can continue to save lives . . . their life-saving benefits outweigh the risk of making them unavailable.”
She added that AEDs remain significantly underutilized. She hopes the FDA’s action does not discourage further deployment of these devices. Sudden cardiac arrest survival is less than 10 percent, and she cited a clinical study of 13,769 out-of-hospital cardiac arrests published in the Journal of the American College of Cardiology demonstrating that survival increases to 38 percent when victims receive AED treatment before EMS arrives. “If more victims had access to defibrillation and we could get the national average to 38 percent survival, this translates to 100,000 additional lives saved each year,” she emphasized.
Misperceptions about SCA
There are common misperceptions about sudden cardiac arrest, which kills about 380,000 Americans each year. One is that sudden cardiac arrest is the same as a heart attack, and another is that victims can often be saved by CPR. Both statements are false.
Sudden cardiac arrest is an arrhythmic disorder causing the heart to fibrillate, or beat inefficiently. A heart attack is caused by a blocked artery. Only a shock from an AED within a few minutes after sudden cardiac arrest can save a victim.
CPR alone cannot defibrillate a heart.
About 90 percent of victims defibrillated within the first two minutes live, but the survival odds tick by with each passing minute. By 10 minutes after arrest, 95 percent of the victims die.
It truly is a race against the clock and “speed to shock” is crucial. Having an AED on the premises significantly improves speed to shock because EMS often must travel some distance, making it difficult for paramedics to arrive in time to save a sudden cardiac arrest victim.
Fortunately for those saved by AEDs, and for those to be saved in the future, 2.4 million AEDs are currently deployed in the U.S., according to The New York Times. AED numbers continue to grow, spurred by the lifesaving results these devices have achieved. In turn, these results have created public expectations that AEDs be made available, influenced court decisions recognizing AED placement as a standard of care, and spawned legislation mandating or encouraging AED placement.
Saving lives in many places
Significant numbers of AED life saves have occurred on airlines and in airports, schools, casinos, fitness centers, workplaces and public places. Hundreds of saves connected with the airline industry have led to increased AED presence in train stations and other transportation hubs. The health club company LA Fitness alone has saved more than 50 sudden cardiac arrest victims with AEDs. In Seattle and Kings County (Wash.) exercise facilities having AEDs, survival was 50 percent, according to a presentation at the Heart Rhythm Society’s annual conference.
The Sudden Cardiac Arrest Foundation’s “You Can Save a Life At School” and “You Can Save a Life on Campus” campaigns keep track of life saves of children, teachers and others occurring on school campuses. Life saves such as these have led 17 states and counting to mandate or encourage AEDs in schools. In the New York state public schools alone, 68 lives have been saved since AEDs were mandated in 2002 by “Louis’ Law,” according to the Louis J. Acompora Memorial Foundation.
Protecting Good Samaritans
As the lifesaving value of AEDs became more evident, legislation protecting Good Samaritans coming to the aid of a sudden cardiac arrest victim became stronger. These laws protect bystanders who help victims with public-access AEDs and have dispelled the liability concerns some had in the past, even though no one trying to help a victim with an AED has ever been successfully sued.
But because sudden cardiac arrest is a common and foreseeable occurrence, courts have ruled that having an AED is a standard of care, and organizations have paid significant damages when AEDs were not available to save a victim. Because of these rulings, many legal experts believe NOT having an AED puts an organization in greater potential legal jeopardy than having one.
Still, finding an AED in an emergency can be a challenge. The Journal of the American College of Cardiology study found that only about 2 percent of the victims were treated with an AED before EMS arrived. When an AED shock was provided, survival jumped from 7 percent to 38 percent.
AED manufacturers are using advanced technology to make the devices easier to use and maintain, as well as more reliable and affordable. For example, one AED has an LCD video feature that shows rescuers how to perform each step of an SCA rescue in real time — in accordance with the latest American Heart Association guidelines. In addition to the videos, the AED has a status screen that shows the readiness of defibrillation pads and the AED’s battery, as well as the overall AED operational status. To ensure its readiness when needed, the AED virtually maintains itself through automated daily self-tests.
The health care industry is now striving for zero quality defects, and the AED industry is not exempt from this movement. If made official, the FDA move may ask AED makers to provide additional clinical data that demonstrates reliability and proves what AED proponents already know — that these powerful devices are important and highly reliable lifesavers.
When announcing the proposed regulations, the FDA stated it would make sure that AEDs remained available so that they can continue to save lives. Public health experts agree that the best way to reduce sudden cardiac death mortality is to have AEDs readily available, especially in public locations. Virtually all AED manufacturers foresee business as usual, expressing confidence in their ability to meet any new regulations with devices now in use.