FDA concerned over AED safety…should we be worried too?


Within the last week, there has been a lot of scuttlebutt regarding AED safety.  Could they hurt the victim?  Could they hurt the user?  Could they fail during an emergency?  Could they explode and release adorable puppies?   (Okay, the last one is silly.)

While I am not an AED manufacturer, and I do not work for, or distribute AEDs for any manufacturer, in the interest of full disclosure:  My company does contract work for some AED companies, though I do not receive any kickbacks/bonuses/pats on the head/Holiday cards …well, you get the idea.

Here are some answers to the myths:

1)  Could they hurt the victim?Answer:  No, as long as you follow proper protocol (ie:  only attach pads to a person who is unresponsive, not breathing—needs CPR!).  An AED is not a toy!  An AED is a medical device that should only be used during an emergency, when the victim, is Dead.  It doesn’t get any worse than Dead!  You, as the rescuer cannot hurt the victim.  The AED cannot hurt the victim.

(Yes, Dead is harsh.  But, what do you call unresponsive, not breathing, no heart beat?   Give up?  Yup, that’s Dead).

2)  Could they hurt the user?  Answer:  As long as you follow proper protocol, NO.  The user will not be harmed.  In plain English, do not, I repeat DO NOT touch the victim while the AED is analyzing or shocking.  Trust me, all AEDs will talk to you and the voice in the box will tell you to stop touching (stay clear, clear…you understand).  Do what the AED says and you will be safe. 

3)  Could they fail during an emergency? Answer:  Apparently, yes.  Being completely unsnarky here yes, an AED could fail.  So could your cars’ brakes (Toyota springs to mind).  So could the world’s most renowned surgeon.  (I doubt any surgeon has a 100% success rate).  But, do they work more often than they fail?  YES.  Ask anyone whose life has been saved by an AED and I am sure they will agree that using the AED was the right decision.  AEDs are made and designed by the hands of man, thus they will be flawed.  Man does not create Perfection.

The FDA has recently sent out a letter asking the AED manufacturers to appear before the Center for Devices and Radiological Health in order to set out improvements for testing, oversight etc.  I think this is a step in the right direction.  I am all for making improvements on technology.  I am even more pro-safety.

For those of you who may ever face the choice to use, or not use an AED, please, use it.

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About sescpr

This is the Official Blog of Safety Education Specialists. An Authorized American Heart Association Training Site located in Virginia, USA. www.ses911.com for all our course listings and information.
This entry was posted in AED, CPR Class, CPR in the Real World. Bookmark the permalink.

1 Response to FDA concerned over AED safety…should we be worried too?

  1. Andrew says:

    Great Article. My company, In Case Of Emergency, has put together a new HeartSafe AED Product package that comes with a HeartSine AED, alarmed wall storage cabinet, 3D AED wall sign, first aid kid, first aid/cpr/aed training for up to 12 people, and a 2 year AED management program all for the price of $1,895.00. Also check out the local Delaware County PA school AED video contest we have put together that kicks off January 1st, 2011. Check out our website http://www.iceems.com for the package info or give us a call!

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