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Re: [IP] FDA stops sale of insulin pumps

> 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.


> FDA Stops Sale of Insulin Pumps!
>  Senior Disetronic representatives reported that the FDA has issued
>  an embargo
> on importation of new Disetronic insulin pumps into the United
> States. On Monday an official letter was issued, however private
> conversations with a high level Roche representative indicated that
> they knew about this previously.
>  In fact Diabetes in Control has learned that Roche has already sent
>  members of
> their manufacturing teams to Switzerland to take over operations.
> The embargo is seen as a result of continuing problems with
> documentation of the manufacturing processes, and back end
> procedures of the company.
>  The FDA has in no way indicated that there is a safety issue with
>  any of the
> pumps that Disetronic makes. Although the embargo means that new
> patients cannot be started on Disetronic insulin pumps. The FDA
> action does not affect the ability of Disetronic to provide support
> to existing pump users.
>  I met in private with Disetronic representatives at the ADA meeting
>  last week
> to find out what they will be doing and was informed that they will
> continue servicing current customers and will help patients waiting
> for Disetronic pumps select an alternative pump from another
> company. ----------------------------------------------------------
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