Examination of Witnesses (Questions 720-739)
MR BERNHARD
JANSEN AND
MR JOSÉ
RAMON BIOSCA
DE SAGASTUY
11 MAY 2006
Q720 Chairman: But nobody
had a major concern at that time?
Mr Biosca de Sagastuy:
No.
Q721 Bob Spink: I would
like to come back to press you on the fact that it seems to us
the actual limits in the Directive are based very much on the
ICNIRP original guidelines.
Mr Biosca de Sagastuy:
That is correct.
Q722 Bob Spink: They seem
to follow those.
Mr Biosca de Sagastuy:
That is correct.
Q723 Bob Spink: So all
this research that you did simply confirmed that the ICNIRP guidelines
were the ones that you should use?
Mr Biosca de Sagastuy:
Yes.
Q724 Bob Spink: The ICNIRP
guidelines were based on a massive safety factor built in.
Mr Biosca de Sagastuy:
I would not say a massive safety factor.
Q725 Bob Spink: What then?
Mr Biosca de Sagastuy:
It was based on a safety factor which varies depending on the
range of frequency. It varies from two to ten.[4]
Q726 Bob Spink: At any
time during this period before the Directive was passed in 2004,
was there any research done on the adverse health effects suffered
by workers from MRI usage?
Mr Biosca de Sagastuy:
No.
Q727 Bob Spink: Do you
know how many people in the medical industry, how many workers,
have been adversely impacted in terms of health by using or working
with MRI scanners?
Mr Biosca de Sagastuy:
In terms of health, no, but in terms of safety there have been
quite a few accidents.
Q728 Bob Spink: Are these
incidents the result of accidents or of routine operation or maintenance
of the scanners?
Mr Biosca de Sagastuy:
Sorry?
Q729 Bob Spink: Where
you say there have been a number of incidents that have been reported—we
will come on to what they are in a moment—are they the result
of accidents, you called them accidents, or was that a slip of
the tongue and were they the result of routine operation or routine
maintenance of the equipment?
Mr Biosca de Sagastuy:
No, it was because of medical personnel operating.
Q730 Bob Spink: It was
just routine operation?
Mr Biosca de Sagastuy:
Yes.
Q731 Bob Spink: Can you
tell us what the incidents were or where we can see a record of
those incidents so we can see the evidence to support this?
Mr Biosca de Sagastuy:
You can look at the web page of the Food and Drugs Administration
of the US and you will find several examples there. You will see
chairs and medical equipment which flew off into the machine and
in some cases killed the patient. In some cases there were scissors
that had injured medical personnel. You can look at the Food and
Drugs Administration web page, which is www.fda.org, and you will
see those pictures.
Q732 Chairman: Are these
not just accidents?
Mr Biosca de Sagastuy:
These are accidents but this is a health and safety Directive.
Q733 Chairman: But you
would never have a car on the road, would you?
Mr Biosca de Sagastuy:
As I told you before, how can we see health effects in medical
personnel if exposure levels of the medical personnel are lower
than the limit values which are set there in order to ensure that
there is no health effect so you cannot see them? That is why
we maintain our position that the Directive will not have an impact
on magnetic resonance imaging equipment that is already there,
but in the future we do not know.
Q734 Chairman: We take
that point.
Mr Biosca de Sagastuy:
This is a question that—
Q735 Chairman: You are
quite definite about that. We are very grateful to you for putting
that on the record. You have stated quite clearly that as far
as the Directive is concerned there should be no impact in terms
of the use of this equipment as it is currently being used within
our hospitals for routine MRI scans or, indeed, for interventional
procedures.
Mr Biosca de Sagastuy:
If medical personnel follow the protocols they already have in
place there should be no impact.
Q736 Bob Spink: Could
I press you on that. Would there be an impact on the maintenance
of that equipment which would equally prevent it being used?
Mr Biosca de Sagastuy:
It could have an impact on the maintenance procedures, yes.
Q737 Bob Spink: What would
that impact be? Potentially would that restrict the use of that
equipment?
Mr Biosca de Sagastuy:
You cannot test the equipment without the presence of the technician.
The technician should be in the control room after doing the adjustments.
He does the adjustment, he goes back to the control room and checks
the results, then switches off and goes in.
Q738 Bob Spink: So this
is going to establish better working procedures?
Mr Biosca de Sagastuy:
Safer working procedures.
Q739 Bob Spink: It is
not going to in any way restrict or threaten the continued use
of the equipment in hospitals?
Mr Biosca de Sagastuy:
In our view, no, and that is the view of the scientific experts
also.
4 Note by the witness: The rationale for their
choice is explained in the ICNIRP guidelines. The safety factors
are a matter of scientific judgement and compensate for uncertainties
about exposure-effect thresholds, including extrapolation of animal
data to effects on humans, differences in the psychological reserves
of different peoples and in the dose-response function. Back
| 
