New FDA Restrictions May Call Defibrillator Makers to Task

Here’s a question for you: What medical condition kills more Americans than car accidents, diabetes, and Alzheimer’s combined? The answer is cardiac arrest, and with more than 400,000 Americans dying of the condition each year, chances are that you know someone who has passed away from a heart attack. Fortunately, as technology advances, there are more and more ways to prevent or stop cardiac arrest. One of the most common ways is the use of Automatic External Defibrillators, or AEDs. According to the American Red Cross, AEDs analyze a person’s heart rate, and if necessary, deliver an electric shock to regulate it. They are designed for anyone to use and can greatly increase a person’s chance of survival as they wait for first responders to arrive. On average, it takes 911 teams 8-12 minutes to arrive at the scene of an emergency. When a person is in cardiac arrest, each minute that goes by before defibrillation is administered can reduce a person’s chance of survival by 10%.

Defibrillators are so important that many people at risk of cardiac arrest have their own private AEDs. Many public locations, such as gyms, airports, malls, and stores have AEDs on hand, and some locations are even required by law to have them on site. However, as important as the devices are, it is far too common for them to malfunction. According to the Food and Drug Administration, there have been dozens of recalls in recent years, with hundreds of thousands of defibrillators being affected. Some of these recalls came after failed rescue attempts in which the machines malfunctioned and caused patients to experience further injury or death.

A recent article in the New York Times reports that the FDA is seeking stricter regulations for defibrillators. Under new requirements, manufacturers will be required to submit AED designs to the administration. They will also be required to report on the controls they are using in the machines, many of which are purchased overseas. In addition, FDA officials will now be permitted to inspect AED manufacturing plants. Manufacturers will be given time to meet the new requirements, and experts anticipate that the reforms will be completely in effect by the end of 2014. Proponents of the regulations hope that they will help cut down on malfunctions, recalls, and cardiac deaths. Dr. William Maisel, the chief scientist at the FDA’s Center for Devices and Radiological Health said, “We think tens of thousands of adverse events is too many and 88 recalls is too many.”

Personal injury attorneys could not agree more with Maisel’s statement. Unfortunately, the stricter regulations are coming too late for many. If your loved one has died because of a malfunctioning automatic external defibrillator, contact a lawyer to find out about seeking financial compensation. Cases that are brought to court will also help promote these stricter regulations and see that they are put in force.

About the Author:

Mark J. Leeds is a personal injury lawyer in Portland, OR whose 30-year career in personal injury law has distinguished him as a highly esteemed and accomplished professional in his field, as evidenced by his Martindale-Hubbell AV rating—the highest ranking from among his peers for ability in the courtroom and professional ethics. A member of the American Board of Trial Advocates, he is also an experienced trial lawyer. Mr. Leeds also practices in Florida where he is a Bar Board Certified Civil Trial Lawyer.