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Re: [IPk] Near-continuous monitoring of something that isn't blood glucose



Hi June

You wrote re DexCom, "However, they are not available in this country
yet due to British approval not having been given yet." Just to
clarify, it's not just the UK that can't get DexCom right now, it's
every country in the European Union. The issue is the CE Mark, which
is required for the product to be sold in any European Union country.
DexCom are in the process of getting the CE Mark, which usually takes
several months of paperwork and hundreds of thousands (if not
millions) of dollars to obtain. The MHRA usually takes CE Mark
approval of a medical device as a predicate and metaphorically
rubber-stamps the product for UK distribution. DexCom as a company
will determine which countries in the European Union are good places
to try to sell the product, though - there is no requirement that a
product that has a CE Mark be available across Europe.

In case anyone is wondering, CE Mark approval is a completely separate
process from whether a product gets paid for by the NHS. Many, many CE
marked items (your television, your microwave, your torch, your
calculator, your lamp) are not paid for by the NHS :>

Melissa
Type 1 15+ years; MiniMed pumper 7.5 years; Animas pumper 4.5 years;


On Tue, Jul 8, 2008 at 11:06 PM, June Searle <email @ redacted> wrote:
> Hi Pat
>
> I was interested to read that your clinic has recommended that you get a
> continuous glucose monitoring machine.  I have been looking into this over
> the past year and have decided that I want one too.  I have compared them on
> the internet and I have come down firmly in favour of the DexCom after
> reading what others and the companies have said.  In America they are
> considerably cheaper than the other 2 and so are the running costs.  I have
> seen one and the user and other reports I have read say that they give more
> accurate readings.  However, they are not available in this country yet due
> to British approval not having been given yet.
>
> I have been in touch with America and they say that it shouldn't be too long
> - next year is hoped for.  Eventually this one will join up with the Animas
> as well.  I have considered going on holiday to California and buying one
> but there is still the problem of the supplies which have to be sent to
> someone in America at present and forwarded to this country by this person
> and I don't know anyone out there.  Unfortunately also, my husband does not
> think my health is good enough to go on the sort of holiday we would like to
> have so that idea is out.  Any information you get hold of in making your
> decision I should very much like to hear.
>
> June
>
>  ----- Original Message ----- From: "Pat Reynolds"
>
>> Hi all,
>>
>> Has NICE pronounced on what are commonly called 'continuous blood glucose
>> sensors'?
>>
>> I have now been recommended to use one at both my last clinic visits ...
>> but (quote the last visit) 'Surrey PCT doesn't  pay for pumps, even, they
>> are donated by the manufacturer'.  Not strictly true since they paid for my
>> pump, but anyway ....
>>
>> Assuming that I am going to pay for this, do any of the manufacturers
>> offer a short-term hire scheme (or a your-money-back-if-you-can't-use-it)?
>>
>> Thanks,
>>
>> Pat
>
> .
.
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