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FDA Issues Safety Protocols on Using Philips Healthcare Defibrillators

Update Date: Dec 04, 2013 09:32 AM EST

Automated external defibrillators (AED) are mechanical devices that could save the lives of people who have suffered from a cardiac emergency event. Defibrillators work by sending an electrical shock to the heart, which helps restore the body's normal rhythm. In many out-of-hospital situations, having a working defibrillator on hand could mean life or death. Due to the importance of a defibrillator, the U.S. Food and Drug Administration (FDA) has issued safety protocols about the use of faulty Philips Healthcare's HeartStart AED devices.

"The FDA advises keeping all recalled HeartStart AEDs in service until you obtain a replacement from Philips Healthcare or another AED manufacturer, even if the device indicates it has detected an error during a self-test," said Steve Silverman, director of the Office of Compliance in the FDA's Center for Devices and Radiological Health according to the News Release. "Despite current manufacturing and performance problems, the FDA considers the benefits of attempting to use an AED in a cardiac arrest emergency greater than the risk of not attempting to use the defibrillator."

The recalled HeartStart AEDs were produced and distributed from 2005 to 2012. The products were named HeartStart FRx, HeartStart HS1 Home, and HeartStart HS1 OnSite. The FDA stresses the importance for consumers, who include first responders and firefighters, who have bought these models to contact the company and ask for an immediate AED unit replacement. However, since replacements could take some time, the FDA has stated that using the faulty defibrillators in an emergency situation would be necessary.

The recall dates back to September 2012 and affected around 700,000 devices. Philips Healthcare announced that these specific devices could fail during an emergency situation due to an issue with the internal electrical component. Since AEDs are vital for survival, the FDA stated that it plans to closely track all AED companies' practices to ensure that the devices are made correctly.

The FDA is awaiting the finalization of a proposal it issued in March 2013. The proposal would mandate all AED manufacturers and accessories to submit approval applications. These applications would allow the agency to double check that all critical requirements in making AEDs are safe and effective.

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