#49072 - 17/09/10 12:07 PM
Re: Hypothetical situation
[Re: DaveC in Oz]
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Master
Registered: 10/02/03
Posts: 301
Loc: North West
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I think I would be firing off report to the MHRA, (or your equivalent regulatory safety body) as syringes are CE marked to the medical devices directive. Using an "equivalent" which has not been assessed and approved by the syringe driver manufacture may well compromise the safe and effective use of the drug infusion equipment.
For example, the equivalent may look like one of the well known syringe brands, but may have a slightly different bore stroke delivery per mm of travel, causing an under or over infusion.
In a similar vein I would not use third party cal gas mixtures unless they are specifically approved for use by the manufacturer of the CE marked Capnograph. Yes, you can source Cal gas mixtures cheaper, and your budget holder of finance manager will thank you, but in the event of an adverse incident, you would be hung out to dry by the proverbials because you havent followed manufacture's recommendations. Belt and brace's approach, I'm afraid...
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The opinions expressed in this article are those of the author, and they do not reflect in any way those of the institutions to which he is affiliated.
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#49074 - 17/09/10 12:40 PM
Re: Hypothetical situation
[Re: DaveC in Oz]
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Master
Registered: 10/02/03
Posts: 301
Loc: North West
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Wise, otherwise this thread will be highjacked.....
There are times when a concession can be obtained, so long as you have documented an appropriate risk management process and got it "signed off".
Try that approach to cover yourself Dave !
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The opinions expressed in this article are those of the author, and they do not reflect in any way those of the institutions to which he is affiliated.
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#49075 - 17/09/10 12:48 PM
Re: Hypothetical situation
[Re: Sean Fearon]
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Philosopher
Registered: 26/06/09
Posts: 606
Loc: Brisbane, Australia
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Thanks Sean, wise I'm sure (get the picture Geoff?  ) However, this IS just a hypothetical situation.....  ...... honest
Edited by DaveC in Oz (17/09/10 12:55 PM)
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#49076 - 17/09/10 01:15 PM
Re: Hypothetical situation
[Re: DaveC in Oz]
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Savant
Registered: 18/12/09
Posts: 114
Loc: Brisbane, Australia
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Dave, have a chat to the guys at "the slopes" I think they are doing some testing on those syringes.
But if it were down to me, for the sake of saving money they could be spending less on doctors lunches than syringes.
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