# FDA removes AED prescription requirement!



## SafetyPro2 (Sep 17, 2004)

Right now, its only a specific make and model of AED from Philips, but in my opinion, its a good start and means that all the rest of the manufacturers will be petitioning to have the prescription requirement dropped from their units as well.

Here's the press release from the FDA.

FDA Clears Over-the-Counter Sale of Automatic External Defibrillator 

_The Food and Drug Administration (FDA) today granted marketing clearance for the first time for the over-the-counter sale of an automatic external defibrillator designed specifically for lay users. The device shocks the heart to restore rhythm in people who are experiencing cardiac arrest. 

The device, the HeartStart Home Defibrillator manufactured by Philips Medical Systems of Andover, Mass., is already available with a prescription for use at home. Today's clearance means it can now be purchased for home use without a prescription. 

Automatic external defibrillators (AEDs) are used to treat someone with cardiac arrest whose heart is beating irregularly (fibrillating). If the heart does not return to a regular rhythm within five minutes, this fibrillation could be more difficult to treat or be fatal. 

The AED administers an external electric shock through the chest wall to the heart with the use of conductive adhesive pads. Built-in computers analyze the person's heart rhythm and interpret the rhythms that require defibrillation shocks. Voice and visual prompts guide the user through the process. 

FDA based its decision to grant over-the-counter marketing clearance on a review of data submitted by Philips Medical that showed the AED could be used without medical supervision. FDA's decision was also based on the recommendation of an outside advisory panel that met in July to evaluate the product for non-prescription use. 

In order for FDA to grant over-the-counter clearance, Philips had to demonstrate that its device could be safely and effectively used by lay people based on written instructions and the device itself. 

Philips conducted usability testing that focused on the ability of untrained users to set up the device, place pads promptly, follow voice and visual prompts, and deliver shocks safely. Philips also developed instructions and training materials designed to help lay users know when and how to use the device. 

The HeartStart home defibrillator is cleared for use on adults or on children who are at least eight years old or older or who weigh at least 55 pounds. Special small pads are available by prescription for use on infants and young children. 

The device is intended for use when a person is believed to be in sudden cardiac arrest, does not respond when shaken and is not breathing properly. It should not be used if the person is responsive when shaken or breathing normally. 

The AED comes with a training video and also instructs users that they should obtain training in cardiopulmonary resuscitation (CPR) in case that is needed instead of a shock. The instructions remind users that in the event of a possible cardiac arrest, they should also call 911 immediately. 

Philips plans to conduct a post-market study to further determine the device's performance when used in the general population without physician oversight. 

By FDA regulation, all automatic external defibrillators are “tracked” devices. Tracking requires that the manufacturer have a process in place to promptly identify users in the event of a recall. The Philips AED comes with an enrollment form that should be completed and returned to the company so that users can be notified in the event of a recall. _


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## ffemt8978 (Sep 18, 2004)

I, for one, think that this is long overdue and am glad to see that the FDA approved it.


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## kyleybug (Sep 18, 2004)

I think it is a great idea too. It is long over due. Think of all of the people that would be here today if the AED would have been available to them yesterday!


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## rescuecpt (Sep 19, 2004)

I think it's great too...  I just wonder what sort of discrimination law suits will follow because it costs too much and people feel entitled to owning an AED even though they can't afford the rent, food, etc.  (I know, I'm not a nice person today)


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## Chimpie (Sep 19, 2004)

I don't think John Q Public will be buying these up as much as you think, but I believe more businesses will be buying them now.  The words 'prescription needed' is misleading and scares a lot of people (read: businesses) away.  

I can't wait for this requirement to be lifted.

Chimp


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## MMiz (Sep 25, 2004)

This is absolutely great news.  For years I've wanted to implement a Public Access Defibrillation program in my community, but felt as though I was taking on the impossible.

I'm all for widespread use of AEDs.  Now all Teachers in Michigan are required to be certified in AHA or Red Cross First Aid, CPR, and AED.

Great news, thanks for sharing!


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## rescuecpt (Sep 27, 2004)

A big part of the PAD movement in NY (and some say across the country) started in my hometown when a 14 year old lacrosse player was killed when he was hit in the chest with a lacrosse ball and died.  It was shown that an AED would have saved his life.  I believe this happened in 2000.



> *Since Dec. 1, 2001, New York State's public schools have been required to maintain defibrillators and train coaches, teachers, nurses, and custodians to use them. John and Karen Acampora of Northport fought for the state mandate after their 14-year-old son collapsed a year ago while playing lacrosse and could not be revived.
> 
> http://www.easthamptonstar.com/20030320/news1.htm*



http://town.huntington.ny.us/newsdetails.cfm?ID=50


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## SafetyPro2 (Sep 27, 2004)

I get questions about AEDs a lot from the school districts I work with. I wouldn't say they're becoming common in schools, but I am beginning to see districts implement programs.

However, at my last job I travelled a lot (and still do some for personal reasons), and it's becoming rare to go through a major airport and not see a dozen or more AEDs mounted in wall cabinets just like fire extinguishers. The Chicago-area airports (O'Hare, Midway and Meigs) actually documented 11 uses and, I believe, 7 saves during the first year they had their PAD program in place.


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## GFD940 (Sep 28, 2004)

I can't wait for the day that all schools, supermarkets, churches, etc. has an AED.  Two weeks ago I was on a call where a 80 yo F arrested in the parking lot of her doctor's office.  They defibbed once prior to our arrival and she had spontaneous return of pulse and respirs.  In my rural area where response times of 10+ mins. are common it is nice to not have a DOA on arrival


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## SafetyPro2 (Oct 27, 2004)

Well, its hit the mainstream. My wife opened up Amazon.com a few minutes ago, and what did she find on her front page but a Philips HeartStart AED. 

So now you can order a couple CDs, Shrek 2 and an AED all at once. God I love e-commerce.


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## rescuecpt (Oct 28, 2004)

I had a scary thought... kids playing with the AED and either by accident or on purpose shocking someone who doesn't need it.  How do you make it accessible in an emergency but keep it safe from small (or irresponsible) hands?


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## MMiz (Oct 29, 2004)

> _Originally posted by rescuecpt_@Oct 28 2004, 09:25 AM
> * I had a scary thought... kids playing with the AED and either by accident or on purpose shocking someone who doesn't need it.  How do you make it accessible in an emergency but keep it safe from small (or irresponsible) hands? *


 I had the same thought, but then took a different approach.  Children have access to knives, scissors, rocks, and a whole bunch of other everyday items that can harm someone.  

I don't see an AED being the most dangerous of items, and feel it will probably do more good than harm.  It will only shock if it finds a shockable rhythm, and that is rare in itelf.  

I would think for the FDA to approve the item, it would have to be pretty safe.  And then I think of Fen Phen.  Maybe not.


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## ffemt8978 (Oct 29, 2004)

Even scarier...

Imagine the following on EBay: One slightly used AED.  Used only one time, but documentation missing.


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## rescuecpt (Oct 29, 2004)

> _Originally posted by ffemt8978_@Oct 29 2004, 12:52 AM
> * Even scarier...
> 
> Imagine the following on EBay: One slightly used AED.  Used only one time, but documentation missing. *


 Hahaha


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## SafetyPro2 (Oct 29, 2004)

> _Originally posted by rescuecpt_@Oct 28 2004, 07:25 AM
> * I had a scary thought... kids playing with the AED and either by accident or on purpose shocking someone who doesn't need it.  How do you make it accessible in an emergency but keep it safe from small (or irresponsible) hands? *


 With the type of AED that's sold to non-EMS personnel, you can't accidentally shock someone. If the microprocessor doesn't detect a shockable rhythm (v-fib, v-tach or SVT usually), it will not deliver a shock, no matter how many times you press the shock button. 

Now, the AED we carry on our rigs DOES have an override that allows a medic to basically use the device as a manual defibrillator, but I've never seen that feature on any non-professional AED.


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## rescuecpt (Oct 29, 2004)

> _Originally posted by SafetyPro_@Oct 29 2004, 03:25 PM
> * Now, the AED we carry on our rigs DOES have an override that allows a medic to basically use the device as a manual defibrillator, but I've never seen that feature on any non-professional AED. *


 I'm sure a smart little deviant could figure out a way to bypass the system, but then again, he could make the same thing out of a car battery and some wires.


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