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FDA May Strengthen Rules on External Defibrillators

By Rheingold Giuffra Ruffo Plotkin & Hellman LLP

External defibrillators are medical devices for use on people who collapse because of sudden cardiac arrest. In an emergency, the external defibrillator should restore heart rhythm with a jolt of electricity.

While medical professionals such as doctors and nurses use external defibrillators, one advantage of the devices is that people with little training can use them as well. If a defibrillator is used properly within the first few minutes of a victim’s collapse, it could save his or her life.

Of course, the automated external defibrillator must function properly for the victim to have a chance of being revived by the device. Unfortunately, external defibrillators have experienced numerous, troubling recalls.

FDA’s Warning Letter: “Persistent Safety Problems”

The Food and Drug Administration (FDA) recently sent a letter the manufacturers of external defibrillators stating that it had “seen persistent safety problems with all types of external defibrillators, across all manufacturers of these devices.” It wrote that the problems with the devices were preventable, and they affected patient safety.

The FDA warned the industry that it may heighten regulations concerning external defibrillators. This could reduce future risks and, the FDA believes, lessen current risks as well.

The FDA’s response to the shocking number of recalls is logical. Between January 1, 2005, and July 10, 2010, 68 external defibrillators were recalled. They were recalled for issues like failure and turning on and off by themselves.

Dangerous Medical Devices

A medical device may be considered defective when it is unreasonably dangerous. If the manufacturer produced a device that is defective because of poor design or quality, the manufacturer could be liable for the injuries the device causes. A medical device manufacturer may also be liable for injuries if it fails to provide adequate warning of the risks associated with the device. Medical care providers could be responsible if they were negligent in the use of the device.

A person who is injured by a defective medical device may be able to pursue compensation for pain and suffering, medical expenses and other damages. A family member who has lost a loved one due to wrongful death may be able to seek compensation for the loss of financial support and companionship, in addition to funeral expenses and medical bills for the loved one.

In an emergency, an external defibrillator should be a reliable tool. Anything less could lead to tragic results.

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