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Home > Archive > Emergency services > September 2004 > fda approves over-the-counter defib sales
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fda approves over-the-counter defib sales
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| danny burstein 2004-09-21, 3:31 am |
| "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.
http://www.fda.gov/bbs/topics/ANSWE...4/ANS01314.html
_____________________________________________________
Knowledge may be power, but communications is the key
dannyb@panix.com
[to foil spammers, my address has been double rot-13 encoded]
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|
| danny burstein wrote:
>
> "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.
>
> http://www.fda.gov/bbs/topics/ANSWE...4/ANS01314.html
Just wait 'til some irresponsible parent lets their kid
get their hands on one!
Notan
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| Carey Gregory 2004-09-21, 3:31 am |
| Notan <notan@ddress.com> wrote:
>Just wait 'til some irresponsible parent lets their kid
>get their hands on one!
So what? It won't do anything.
| |
|
| Carey Gregory wrote:
>
> Notan <notan@ddress.com> wrote:
>
>
> So what? It won't do anything.
Call me old fashioned.
I know they're supposed to be able to interpret cardiac rhythms,
and shock, or not, accordingly, but I still have a problem with
that.
While it's FDA approved (The FDA... A whole 'nother can of worms!),
I can still see a unit interpreting artifact as fib, and...
Notan
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| Carey Gregory 2004-09-21, 3:31 am |
| [cross-posting tweaked]
Notan <notan@ddress.com> wrote:
>Call me old fashioned.
Okey dokey. ;-)
>I know they're supposed to be able to interpret cardiac rhythms,
>and shock, or not, accordingly, but I still have a problem with
>that.
Actually, they're a bit better than "supposed to be able to interpret."
They've been proven more accurate than experienced cardiologists. I've seen
medics and docs shock manually when they shouldn't, but I've never seen an
AED do that. Sometimes taking the human element out of the equation is a
good thing.
>While it's FDA approved (The FDA... A whole 'nother can of worms!),
>I can still see a unit interpreting artifact as fib, and...
When's the last time you heard about an AED interpreting artifact as fib?
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| Alan Erskine 2004-09-21, 3:31 am |
| "Carey Gregory" <tiredofspam123@comcast.net> wrote in message
news:qdekk0tdlfccfmtnifk6h0b3566ev46gc7@4ax.com...
> Notan <notan@ddress.com> wrote:
>
>
> So what? It won't do anything.
>
I don't think any equipment for life support should be in untrained hands -
even something as basic as a first aid kit can cause problems if it's not
used properly. Something like a defibrilator would be just as bad.
--
Alan Erskine
We can get people to the Moon in five years,
not the fifteen GWB proposes.
Give NASA a real challenge
Alanterskine1@bigpond.com
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|
| Carey Gregory wrote:
>
> [cross-posting tweaked]
>
> Notan <notan@ddress.com> wrote:
>
>
> Okey dokey. ;-)
>
>
> Actually, they're a bit better than "supposed to be able to interpret."
> They've been proven more accurate than experienced cardiologists. I've seen
> medics and docs shock manually when they shouldn't, but I've never seen an
> AED do that. Sometimes taking the human element out of the equation is a
> good thing.
I, too, have seen some scary personnel, with their fingers on the
buttons!
>
> When's the last time you heard about an AED interpreting artifact as fib?
I admit, it was quite some time ago. The hospital, I was working in,
was involved in testing some of the first prototypes.
Notan
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|
| Notan wrote:[vbcol=seagreen]
>
> Carey Gregory wrote:
Thanks for the tweak... It was getting a bit confusing!
Notan
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| Carey Gregory 2004-09-21, 3:31 am |
| [cross-posting tweaked]
"Alan Erskine" <alanerskine1@bigpond.com> wrote:
>I don't think any equipment for life support should be in untrained hands -
>even something as basic as a first aid kit can cause problems if it's not
>used properly. Something like a defibrilator would be just as bad.
You mean like fire extinguishers? What percentage of the public do you
think really knows how and when to use a fire extinguisher? Nevertheless,
they're hanging on walls all over the world.
As AEDs become commonplace, it will become commonplace for people to know
how to use them. Sure, some idiot will find a way to do something stupid
with one, but for every case like that there will probably be 100s of
successful defibs. I don't see a problem with that.
| |
| Alan Erskine 2004-09-21, 3:31 am |
| "Carey Gregory" <tiredofspam123@comcast.net> wrote in message
news:iu0mk0h3mtlco3gqj1i5k39s3rm0m6hpqa@4ax.com...
> [cross-posting tweaked]
>
> "Alan Erskine" <alanerskine1@bigpond.com> wrote:
>
hands -[vbcol=seagreen]
>
> You mean like fire extinguishers? What percentage of the public do you
> think really knows how and when to use a fire extinguisher? Nevertheless,
> they're hanging on walls all over the world.
Exactly like fire extinguishers! They lead to a sense of complacency - "I'm
safe now, I have a fire extinguisher". The same thing will happen with
defibs.
alt.emergency-services.moderated still isn't on Bigplod... grrrr....
--
Alan Erskine
We can get people to the Moon in five years,
not the fifteen GWB proposes.
Give NASA a real challenge
Alanterskine1@bigpond.com
| |
| Carey Gregory 2004-09-21, 3:31 am |
| Jerome Senturia <senturiaNOSPAM@pivot.net> wrote:
>First, let me state that I think this is a great step forward.
I agree.
>Second, How is this going to affect state AED laws?
>Vermont, where I live has a rather complex law which requires that PAD
>AED's have a prescription and an MD willing to sign off for training and
>maintenance. I realize that this ruling by FDA is for "Home Use", but
>how will this affect the PAD market?
My guess would be this will lead to a lot of states simplifying their laws
and regs, many of which were written back in the 1980s and are pretty
cumbersome and obsolete today.
>If an AED is a "Fire Extinquisher" that you can pick up at Walmart, Sams
>Club, Cosco, or your neighboorhood drugstore (assuming you can afford
>the 1 - 1.5K cost) what keeps it from being a small business / small
>workplace AED??
Probably nothing at all.
>Jerry (crossposts removed -- I have unsubscribed to the other groups due
>to inability to get any grain from the chaff)
Don't blame you, but no need to trim the cross-posting. Only messages
approved here will appear in any group regardless of how they're
cross-posted.
--
Carey Gregory
Not the moderator, just me
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| Carey Gregory 2004-09-21, 3:31 am |
| "Alan Erskine" <alanerskine1@bigpond.com> wrote:
>Exactly like fire extinguishers! They lead to a sense of complacency - "I'm
>safe now, I have a fire extinguisher". The same thing will happen with
>defibs.
Maybe, but I would foresee a lot more successes than problems caused by
complacency. Anyone even thinking about the need for a home defib probably
isn't the sort who pays no attention to their health.
>alt.emergency-services.moderated still isn't on Bigplod... grrrr....
You can cross-post to aesm and see it here. Just be aware that anything
cross-posted to aesm won't appear in *any* group until it's approved there.
| |
| Jerome Senturia 2004-09-21, 3:31 am |
|
Carey Gregory wrote:
> Jerome Senturia <senturiaNOSPAM@pivot.net> wrote:
>
>
>
>
> I agree.
>
>
>
>
> My guess would be this will lead to a lot of states simplifying their laws
> and regs, many of which were written back in the 1980s and are pretty
> cumbersome and obsolete today.
Carey, Vermont's AED law was written in THIS century (Sigh!)
>
>
>
>
> Probably nothing at all.
>
>
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| |
| Alan Erskine 2004-09-21, 3:31 am |
| "Carey Gregory" <tiredofspam123@comcast.net> wrote in message
news:g2emk05kap6tebu2au6gmu9a538h0upncv@4ax.com...
> "Alan Erskine" <alanerskine1@bigpond.com> wrote:
> You can cross-post to aesm and see it here. Just be aware that anything
> cross-posted to aesm won't appear in *any* group until it's approved
there.
No, I can't cross-post to aesm - 'cause it's not on my server, OE won't
accept it and refuses to post.
--
Alan Erskine
We can get people to the Moon in five years,
not the fifteen GWB proposes.
Give NASA a real challenge
Alanterskine1@bigpond.com
| |
| Little Lott , Tn Joe 2004-09-21, 3:31 am |
| this alan guy is jackass i hope all of you
email him and tell him he is a jackass.
From: "Alan Erskine" <alanerskine1@bigpond.com>
>Hurricane Ivan Is A Good Boy It Did Reach Land This Is
>Good News PLS. Email Me With Your Good News.
--
Alan Erskine
We can get people to the Moon in five years,
not the fifteen GWB proposes.
Give NASA a real challenge
Alanterskine1@bigpond.com
From: "Alan Erskine" <alanerskine1@bigpond.com>
Newsgroups: alt.firefighters
Subject: Hurricane Ivan Is A
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| |
| Alan P 2004-09-21, 3:31 am |
| littlelotttnjoe@hotmail.com (Little Lott , Tn Joe) wrote in
news:a4794fc4.0409171958.1b7aebc2@posting.google.com:
> <snip>
Well, Alan, it looks like you spoke too soon, the other day.
It's back.
Alan (The good looking one! <g> )
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|
| I don't think any equipment for life support should be in untrained hands
| |
| Carey Gregory 2004-09-21, 3:31 am |
| "Alan Erskine" <alanerskine1@bigpond.com> wrote:
>"Carey Gregory" <tiredofspam123@comcast.net> wrote in message
>news:g2emk05kap6tebu2au6gmu9a538h0upncv@4ax.com...
>
>there.
>
>No, I can't cross-post to aesm - 'cause it's not on my server, OE won't
>accept it and refuses to post.
Well, sorry, but you might want to tell your ISP they're being unreasonable
jackasses. They're one of the few providers left who aren't carrying it.
| |
| Kurt Ullman 2004-09-21, 3:31 am |
| In article <20ink05a79u1eb0bhvfdhqudp09bu6b5qt@4ax.com>, Carey
Gregory <tiredofspam123@comcast.net> wrote:
>"Alan Erskine" <alanerskine1@bigpond.com> wrote:
>
>
>Well, sorry, but you might want to tell your ISP they're being unreasonable
>jackasses. They're one of the few providers left who aren't carrying it.
>
Them an Earthlink....
--
"Even I realized that money was to politicians what the
ecalyptus tree is to koala bears: food, water, shelter and something to crap on."
---PJ O'Rourke
| |
| Carey Gregory 2004-09-21, 3:31 am |
| kurtullman@yahoo.com (Kurt Ullman) wrote:
> Them an Earthlink....
So Comcast hasn't bought them yet and fixed that?
| |
| googleing aussie 2004-09-21, 3:31 am |
| Carey Gregory <tiredofspam123@comcast.net> wrote in message news:<qdekk0tdlfccfmtnifk6h0b3566ev46gc7@4ax.com>...
> Notan <notan@ddress.com> wrote:
>
>
> So what? It won't do anything.
googleing aussie
this is ture
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| googleing aussie 2004-09-21, 3:31 am |
| Notan <notan@ddress.com> wrote in message news:<414A09A4.7ED2FE95@ddress.com>...
> danny burstein wrote:
>
> Just wait 'til some irresponsible parent lets their kid
> get their hands on one!
googleing aussie
this is ture
| |
| Kurt Ullman 2004-09-21, 3:31 am |
| In article <37ipk0puiat3f40qq81ope187amrmhl8om@4ax.com>, Carey
Gregory <tiredofspam123@comcast.net> wrote:
>kurtullman@yahoo.com (Kurt Ullman) wrote:
>
>
>So Comcast hasn't bought them yet and fixed that?
>
Not yet. But there is always hope (g).
--
"Even I realized that money was to politicians what the
ecalyptus tree is to koala bears: food, water, shelter and something to crap on."
---PJ O'Rourke
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