Exactly!! I agree, if you follow the rules and
guidelines the laboratory with all its experience,
professionalism and evidence bases can do this. Many
doctors,paediatricians, in particular, have been using
medications and drugs "off label", where the
pharmaceutical companies have not-authorised their
use, in neonates for years.
"Off-label use of medications by physicians is legal
as long as a medication is approved for general use by
the FDA. Such practice is relatively commonplace for
many other types of medications".
David Brown
--- Ian McFarlane <[log in to unmask]> wrote:
> <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
>
> ------ACB discussion List Information--------
> This is an open discussion list for the academic and
> clinical
> community working in clinical biochemistry.
> Please note, archived messages are public and can be
> viewed
> via the internet. Views expressed are those of the
> individual and
> they are responsible for all message content.
>
> ACB Web Site
> http://www.acb.org.uk
> List Archives
>
http://www.jiscmail.ac.uk/lists/ACB-CLIN-CHEM-GEN.html
> List Instructions (How to leave etc.)
> http://www.jiscmail.ac.uk/
>
David G Brown
Valencia
España
Tel 00 34 96 328 7207
mov. 00 34 676064278
e-mail [log in to unmask]
http://www.proz.com/pro/56276
___________________________________________________________
Yahoo! Messenger - NEW crystal clear PC to PC calling worldwide with voicemail http://uk.messenger.yahoo.com
------ACB discussion List Information--------
This is an open discussion list for the academic and clinical
community working in clinical biochemistry.
Please note, archived messages are public and can be viewed
via the internet. Views expressed are those of the individual and
they are responsible for all message content.
ACB Web Site
http://www.acb.org.uk
List Archives
http://www.jiscmail.ac.uk/lists/ACB-CLIN-CHEM-GEN.html
List Instructions (How to leave etc.)
http://www.jiscmail.ac.uk/
|