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Re: [IP] NYT article about FDA oversight of infusion pump manufacturers

At 04:47 PM 4/24/2010, Clinton Randolph wrote:
>I have spoken with Animas on several occasions regarding the new 
>Ping and the last I heard was maybe the fall.  They are indeed 
>trying to jump through the FDA hoops to get approval.  Being in 
>healthcare I have a number of contacts and I heard from a reliable 
>CDE source ( non Animas, please understand this) that the main issue 
>has nothing to do with the pump, but with some sort of inane 
>regulations regarding PACKAGING.  So we wait.  I was going to wait 
>to get my Dexcom-Plus until the new pump came out but was advised to 
>go ahead, so I did.  I know that the main FDA issue  addressed 
>in  the article is with "hospital" pumps because we have had to deal 
>with several issues with the one's we carry on our ambulances.  We 
>have received an informational letter from both the FDA and the 
>manufacturer and have had software upgrades in the last few 
>months.  I know that several monitor/defibrillator manufacturers 
>have had issues with the FDA, as well as the pumps. Hope this does 
>not effect us too much.

I was also told by an Animas rep that if I got the Dexcom-Plus now it 
would just be a low price ($300 I think) to upgrade to the integrated 
pump when it becomes available.

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