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Super Hero
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The Sigma Spectrum?

I had been wondering what Sir Clive had been up to recently!


If you don't inspect ... don't expect.
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Can't see any evidence of a CE mark on the piccys, only UL and the Canadian standards.

Hmmmmmmm.


Brian


**** Still grumbling in the Pennines ****
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Doesn’t look like they have been launched in Europe. It will be interesting to see how the how the local authorities and users react to the FDA action. With the FDA targeting Infusion Device Manufacturers there could be a lot of companies watching there backs
FDA Planning more regulation on Infusion Companies


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Hero
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Quote:
It is hard to see how a pump can be recalled and replaced in the US and left in place with the rest of the poor unfortunates everywhere else.

The FDA has real power, the MHRA is hampered by Uk and EU law which restricts its activities.
I spoke to someone in the MHRA quite a while ago who said they were envious of the power of the FDA. The MHRA often gets a bad press for inactivity but in reality they have their hands tied.
Robert


My spelling is not bad. I am typing this on a Medigenic keyboard and I blame that for all my typos.
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I agree that the MHRA does not have the power of the FDA, but if the general public is made aware of it, I believe it will only be a matter of time.

Such a damning action from the FDA has to have repercussions over here. After all, we now live in a US style blame culture too.

Any UK hospital using the Baxter Colleague now had better fear the Ambulance Chasers!!

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I also believe there will be a fair bit of publicity regarding this development............

from all of their competitors!!!!!

PS. Is there anyone out there working in a hospital that uses these pumps? If so, have you phoned Baxter UK to see what they have to say?

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Geoff,

I believe that Danby was bought by Baxter. The Danby pumps 'shuttle' pump mechanism was used by Baxter in the Colleague.

We had Danby DCR(?) pumps for a while in HDU - not very well liked, I must admit.

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Originally Posted By: RoJo
Quote:
It is hard to see how a pump can be recalled and replaced in the US and left in place with the rest of the poor unfortunates everywhere else.

The FDA has real power, the MHRA is hampered by Uk and EU law which restricts its activities.
I spoke to someone in the MHRA quite a while ago who said they were envious of the power of the FDA. The MHRA often gets a bad press for inactivity but in reality they have their hands tied.
Robert


Not true as the EU MDD gives the competent authority something called the safe guard clause. Ask any manufacturer about how the French competent authority uses this to restrict devices it considers unsafe. MHRA is just making excuses for its lack of braveness in removing suspect devices from the UK market.

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The safeguard clause referred to in Article 7 of the Directive is the EU procedure whereby any measure taken by a Member State, on the grounds of non-compliance with the Essential Health and Safety Requirements and where it is deemed that equipment is liable to endanger persons, animals or property for the purpose of withdrawing from the market, prohibiting the placing on the market or restricting the free movement of equipment accompanied by one of the means of attestation provided for in the Directive and therefore bearing the CE marking, must be immediately notified to the Commission by the Member State which has taken it.

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Philosopher
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Quote:
French competent authority


Sorry but isn't that a contradiction in terms much like Oldham Athletic or Military Intelligence? shades

Seriously though, we have had some initial feedback down this part of the world from our local Baxter chaps. Their line currently runs something like...there is currently zero effect in Australia and that it's business as usual. Baxter have met with TGA (Oz equivalent of the FDA) and will continue to do so on the pump issues. If TGA are ok with Baxter's progress on implementing the new version 1.7 software, then Baxter will continue to push ahead with this solution. They did mention that Baxter HQ could dictate changes to this strategy at any time.

We shall see.


Thoughts and information provided on this forum are mine and mine alone and do not necessarily reflect the policy of NSW Health. They may also be complete bollocks!!
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