THE COHEN GROUP
  Environmental Health & Safety Consulting Services

The Cohen Group Newsletter - Volume 6  Issue 2, Article 2.  April, 2004

Tim Bormann, CIH

Sudden cardiac arrest (SCA) or massive heart attack as it sometimes known - kill 460,000 people in the U.S. each year according to the Centers for Disease Control and can strike anyone, without warning. In fact, most of us probably know someone who died of a sudden heart attack. The American Heart Association estimates that as many as 50% of SCA victims have no prior indication of heart disease. Approximately 15% of all workplace fatalities in recent years are attributable to sudden cardiac arrest.

The only definitive treatment for SCA is defibrillation shock - an electrical pulse through the heart - which restores normal heart rhythm. The American Heart Association recommends delivery of the first defibrillation shock within three to 5 minutes of cardiac arrest. However, the chance of survival decreases by about 10 percent for every minute that passes without treatment.

Most paramedics carry defibrillators, but since time is so crucial, more and more businesses and public facilities are installing automated external defibrillators (AEDs). Almost every state (including California) and the federal government have Good Samaritan laws that provide immunity from liability to those who provide or use AEDs. On January 22, 2004, Governor Schwarzenegger signed into law legislation to place AEDs in all state facilities.

AEDs are safe, easy-to-use, computerized devices that deliver doses of energy to restart hearts in cardiac arrest. AEDs are designed to recognize correctable heart rhythms and shock only those rhythms. The Federal Food and Drug Administration is the federal regulatory agency responsible for ensuring that medical devices like AEDs are safe and effective. The FDA imposes labeling requirements on AED manufacturers. Labels must describe the indications and conditions for AED use. Currently AEDs are viewed by the FDA as restricted, prescription devices.

Any company desiring to purchase AEDs for their facility must do so under the direction or "prescription" of a physician. In addition, there must be personnel ("authorized individuals") at the facility who have completed AED training. AED training consists of CPR training with specific training on the use of the AED. According to state law (Title 22, Social Security, §100031) the AED training component shall comply with the American Heart Association or American Red Cross Standard and be not less than 4 hours of training. The prescribing physician must issue to the authorized individual a written validation of the individual's ability to use an AED. While the facility must have trained users (here's where it gets a bit confusing), any person (though not specifically trained) may use the AED under the Good Samaritan law without liability.

AEDs have proven to be safe and reliable devices. If you choose to place AEDs at your facility it is essential you do so with the involvement and oversight of a physician from your clinic or medical provider.