While FDA Tightens Defibrillator Regulations, AED.com Offers Preemptive Maintenance Against Potential Liability Mishaps

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FDA regulations may cause AED manufactures to undergo more stringent premarket approval processes due to reported failures and recalls. AED.com suggests program to ensure AED readiness.

An AED is going to do what an AED is designed to do. Where AEDs fail are the people.

The FDA proposed that the seven manufacturers of AEDs or automated external defibrillators need more stringent pre-market approval processes for any AED they manufacture. This proposal does not entertain the idea of mass recalls of automated external defibrillators. Dr. William Maisel of the FDA did not question the safety or quality of the estimated 2.4 million publicly assessable AEDs.

Although the FDA’s faith in AEDs is unhindered as confirmed when Dr. Maisel said, "[The] FDA is not questioning the clinical utility of AEDs," it is possible for errors to occur. In the last 8 years, the FDA received 45,000 reports of AED device failures. Compared to overall AED usage 45,000 is a relatively small percentage, yet it has sparked action by the FDA. (Source)

Common AED failures include dead batteries, expired pads, and poor readings due to bad cables. According to Second Life Biomedical Engineer Megan Sass, “Proper AED maintenance can prevent these common failures from happening.” Under the Good Samaritan law, any bystander who uses an AED on a sudden cardiac arrest victim is protected from legal action. The same may not be true for businesses or those responsible for AED upkeep. (Source)

Until the FDA reaches a decision on its proposal to tighten regulation on AEDs or automated external defibrillators, proactive AED owners can take preemptive measures against possible AED maintenance negligence by implementing an AED Program. AED.com has partnered with En-Pro AED management to offer the peace of mind that comes with knowing an AED is save ready at all times. Blaire Czarniecki of AED.com noted that, “An AED is going to do what an AED is designed to do. Where AEDs fail are the people. People become busy with their everyday lives and forget to check the AED, change the pads and batteries, etc. With an effective management program in place you are guaranteed compliance. En-Pro Management takes all of the work and concern out of owning and maintaining an AED.”

AED.com serves customers in all 50 States and 35 countries worldwide. For more information about AED.com, please visit: http://www.aed.com/en-pro.

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Justin Darby
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