We also have to be aware of the way that the MHRA and similar agencies
work. They are not staffed by experts so rely on weight of evidence. One
report of a problem is only worth one vote so that issue does not rise
to the top. The only way to get concerted action is for lots of reports
to be submitted. So, for example if there is a problem with a particular
assay that always gives results 30% higher than every other
manufacturer's assay, a report from every EQA provider and complaints
from a dozen or so laboratories would be more likely to initiate action
than if only one person bothered to write in.
************************************************************************
**************
Prof. Tim Reynolds
Consultant Chemical Pathologist / Clinical Director - Diagnostics / R&D
Lead,
Burton Hospitals NHS Foundation Trust
work tel: 01283 511511 ext 4035
work fax: 01283 593064
work email: [log in to unmask]
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-----Original Message-----
From: Clinical biochemistry discussion list
[mailto:[log in to unmask]] On Behalf Of Rita Horvath
Sent: 14 May 2013 12:24 AM
To: [log in to unmask]
Subject: Re: Decrypt: RE: Roche crosslaps assay
Indeed and whilst each EU country has a competent authority which
operates such postmarket surveillance and feedback system on IVD
failures, they are not very well known and utilized by ourselves. Maybe
some more training and education at EU conferences on how various
systems work would raise more awareness of their availability and
processes?
Whilst these bodies have a common European voice, we as a profession in
Europe would be better served by a central European repository where all
these observations and notifications could go to so that labs all over
Europe could see that it is "not just their lab" which had a problem
with a particular IVD - a comment so often heard from manufacturers when
labs file a complaint or an observation to them. The FDA IVD
notification system seems to work more efficiently and I often go to
their website to see if there are reports on failed or troublesome IVD
lots and devices. The UK site is very helpful too, but as said, it would
be best to have a common repository. Something we might have to discuss
in EFLM's IVD working group, Ian?
On this website http://www.meddev.info/_documents/ca_vig.htm all EU
authorities are seen and the map is quite blank in Central-Eastern
Europe or they have only internal rudimentary and thus hardly used
systems in place - so undoubtedly these counteries are potentially more
vulnerable when manufacturers sell some lots or products that may not be
up to the highest stds? This was seen in the past decades with POCT
devices that they could not sell in more advanced parts of Europe and
which were dumped on not even labs (!) but non-vigilant GP offices,
using government funds to support (the politically correct agenda, i.e.)
primary care.
This easy to read article sums up the EU situation and the typical
procedures, but this mostly places reporting into the hands of the
manufacturer and incident reports mostly tackle serious failures that
caused harm to patients and near miss scenarios all of which are
seemingly underreported:
http://www.emergogroup.com/resources/articles/reporting-incidents-europe
How much do labs all over Europe (and elsewhere) use their own
authority's reporting system?
Best regards, Rita
________________________________
From: Clinical biochemistry discussion list
[[log in to unmask]] On Behalf Of IAN WATSON
[[log in to unmask]]
Sent: Tuesday, 14 May 2013 3:25 AM
To: [log in to unmask]
Subject: Decrypt: RE: Roche crosslaps assay
We have long had a duty to do so!
Dr Ian D Watson
Clinical Director
Consultant Biochemist & Toxicologist
Clinical Laboratories
University Hospital Aintree
LIVERPOOL
L9 7AL
UK
Tel +44 151 529 3575
Fax +44 151 529 3310
From: Clinical biochemistry discussion list
[mailto:[log in to unmask]] On Behalf Of GIFFORD BATSTONE
Sent: 13 May 2013 11:23
To: [log in to unmask]
Subject: Re: Roche crosslaps assay
Perhaps we as a pathology community should be reporting our concerns re
assays to MHRA - I note recent report on Siemens HbA1c Gifford
Dr Gifford Batstone
MBBS, BSc, FRCPath, MSc
Tel 01962 860761
Mob 0791 285 9344
--- On Wed, 8/5/13, Reynolds Tim (RJF) BHFT
<[log in to unmask]<mailto:[log in to unmask]>>
wrote:
From: Reynolds Tim (RJF) BHFT
<[log in to unmask]<mailto:[log in to unmask]>>
Subject: Re: Roche crosslaps assay
To:
[log in to unmask]<mailto:[log in to unmask]
>
Date: Wednesday, 8 May, 2013, 17:08
It is probably the only assay where they have looked!
Most assays using a biotin-avidin linkage system will have a similar
interference - but the manufacturers have been careful not to look...
The same sort of issue affects statins: Rosuvastatin can only be used in
asians in half the caucasian dose because of a drug metabolism effect.
Have the other drug compoanies done similar tests? It's doubtful because
if they had they would have been using the data in marketing - they have
simply buried their heads in the sand and been careful not to look too
far beneath the surface...
************************************************************************
**************
Prof. Tim Reynolds
Consultant Chemical Pathologist / Clinical Director - Diagnostics / R&D
Lead, Burton Hospitals NHS Foundation Trust work tel: 01283 511511 ext
4035 work fax: 01283 593064 work email:
[log in to unmask]<http://uk.mc1861.mail.yahoo.com/mc/compose?
[log in to unmask]>
work URL: www.burtonhospitals.nhs.uk<http://www.burtonhospitals.nhs.uk>
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-----Original Message-----
From: Clinical biochemistry discussion list
[mailto:[log in to unmask]<http://uk.mc1861.mail.yahoo.com
[log in to unmask]>] On Behalf Of Gerald
Cox
Sent: 08 May 2013 4:44 PM
To:
[log in to unmask]<http://uk.mc1861.mail.yahoo.com/mc/comp
[log in to unmask]>
Subject: Roche crosslaps assay
A recent urgent field safety notice arrived stating a reducded stability
from 8 hrs to 6 hrs for serum and a reduced level biotin interference,
from 368 nmol/L to 123 nmol/L. My question is how do we know who is on
biotin and who measures biotin routinely?
Second question is why is it only beta crosslaps the only immunoassay
affected?
Thanks
Gerry
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