[Acb-diabetics] Insulin Loading Devices

[Mike Freeman]

Chris, Veronica and Pat:

In fact, the FDA essentially did just that although for what seemed by its lights good and sufficient reasons. There are various "classes" of medical devices, each of which has a certain specified testing regimen in order to be approved for marketing by FDA. Originally, the Count-a-dose was not classified as a precision medical device and was therefore subject to less rigorous testing than were insulin syringes and pens. Last year or the year before, FDA reclassified the Count-a-dose in such a way that it required more extensive testing to continue to be marketed. On its face, this would seem a good thing in that all of us would wish that our insulin-measuring devices be as accurate as possible. However, MediCool, the company making the Count-a-dose, said it couldn't afford the additional testing so decided to no longer make the Count-a-dose.

The news is not all grim, however. DDI, maker of the Prodigy Voice Talking Blood Glucose Meter, has bought the Count-a-dose molds from MediCool and will produce the Count-a-dose which, of course, will be known as the "Prodigy Count-a-dose". The DDI version is in FDA testing and approval proceedings as I write this. So while we all know that FDA proceeds with all deliberate speed (with the accent on the "deliberate"), DDI anticipates again producing the Count-a-dose late this year or some time early next year.

I own two Count-a-doses though I don't remember where I stored them (undoubtedly in a safe place); I bought them in case I ever had to use syringes. I use and prefer insulin pens. But Veronica's and Pat's reasoning for wanting a syringe-based device is sound though, truthfuly, I suspect unused pen cartridges have the same refrigerated life as do bottles. But there's another reason why some want to use syringes: they're cheaper so those without health insurance find them more affordable. But for this, I see no reasons not to use pens: they're so convenient!

Mike Freeman

----- Original Message -----
From: Christopher Gray <chris at bayareadigital.us>
To: "Discussion list for diabetics and/or ACB issues." <acb-diabetics at acb.org>
Date: Wednesday, Oct 21, 2009 16:27:49
Subject: Re: [Acb-diabetics] Insulin Loading Devices

>
>
> It's hard to believe that the FDA would force the discontinuance of any of 
> these devices.  Let's hope somebody can clarify this a bit.
> 
> Chris
> 
> On Wed, 21 Oct 2009, 
> Veronica Elsea wrote:
> 
> > Actually, I'm glad you brought this up, Chris. I can't for the life of me 
> > understand why the count-a-dose went away. As someone who uses an insulin 
> > pump, it really would be a good idea to have a back-up insulin delivery 
> > system. The insulin pen is really impractical because it would get used so 
> > infrequently that when I did need it, the cartridges would most likely be 
> > expired. I use the same insulin vials when I'm filling my pump cartridge, so 
> > as a back-up, something that would just allow me to use a syringe with the 
> > insulin vial I already have would sure be nice.
> > So if someone can answer this question for you, it would help me as well.
> > Thanks.
> > Veronica
> > Check out my new CD, "We Woof You A Merry Christmas," at
> > http://www.laurelcreekmusic.com
> > Veronica Elsea, Owner
> > Laurel Creek Music Designs
> > Santa Cruz, California
> > 877-607-6407
> >
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> > acb-diabetics at acb.org
> > http://www.acb.org/mailman/listinfo/acb-diabetics
> >
> 
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