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Although not specifically mentioned in my original question, an additional concern of mine is of infection risk.
Occasionally we get instances of blood being splattered across our blood bas analysers and occasionally on the walls at POCT areas. Presumably this also occurs with pleural aspirates. Given this scenario, a risk assessment could be quite alarming?
Ian Barlow
-----Original Message-----
From: Ian McFarlane [mailto:[log in to unmask]]
Sent: 13 December 2005 21:09
To: [log in to unmask]
Subject: Re: Pleural fluid pH
<snip>
>3. MHRA would not be able to support labs modifying CE marked methods in
>house and I draw your attention to a Medical Device Alert issued in 2004
>regarding off label use and user modifications of CE marked products.
As the 'evidence base', such as it is, supports the use of blood gas
analysers over pH meters. And, although some manufacturers do have a fluid
setting for their analysers, they may not have CE-marked their machines. The
document referred to above states
* Where the healthcare organisation or healthcare professional judges that
there is no alternative but to use a medical device off-label or to modify
an existing medical or non-medical device, carry out and document a full
risk assessment, and consider the ethical and legal implications
* Where a healthcare professional judges there is no alternative to
off-label device use, the patient must be fully informed during the consent
procedure and a note made in the patient's records.
It appears that as long as you add a good dollop of extra NHS bureaucracy
the MHRA does support the use of devices 'off-label'. Correct?
Ian McFarlane
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