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Re: [IP] FDA stops sale of insulin pumps

Michael wrote:

> > NewsFlash:
> My interpretation of this based on conversations with the people
> involved is that the FDA has its tail in a knot over differencex in
> the EU vs US standards and reporting and that Roche / Disetronic is
> an innocent victim. Frankly I think it is an example of heavy
> handedness on the part of the FDA over paperwork issues.
> Roche/Disetronic is in full compliance with ISO standards that all
> pump makers adhere to. While I don't champion any particular
> manufacturer, I think it's a shame that a fine company has to suffer
> from the incompetency of our own government agencies.

I called Roche/Disetronics yesterday to complain about their embargo, and
did not get what I thought were very good answers.  They must have
thought the same upon review as I was called today by a patient (a pumper
herself) advocate who made it clear that the embargo only affected new
sales, there was nothing in the FDA stuff about stopping supplies or even
2nd pumps to people that had already bought them.  I must agree with
Michael that it certainly appears as though the FDA is just throwing it's
weight around to show that it can, rather than having a legitimate gripe
here.  IE, if there is a problem, why does the FDA allow them to continue
to supply the pumps and warrenty work upon the pumps they have previously
sold?  And we wonder why the rest of the world resents us :(

Jon Wagner

Proud to be wearing a Dtron+
type something or other :)
or bad type'er :)
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