Examination of Witnesses (Questions 680-699)
MR BERNHARD
JANSEN AND
MR JOSÉ
RAMON BIOSCA
DE SAGASTUY
11 MAY 2006
Q680 Chairman: Is there
any evidence to demonstrate that in terms of personnel working
with MRI scanners at up to three teslas or, indeed, over three
teslas with known equipment, there have been any permanent health
risks to any worker in any European country in any piece of research?
Mr Biosca de Sagastuy:
No. Up to now there are no permanent health risks, but do not
forget that the Directive covers health and safety. If you enter
any metallic material in any magnetic field it gets attracted,
does it not?
Q681 Chairman: Yes.
Mr Biosca de Sagastuy:
So you could have flying objects. You could have induced currents
in the body, induced charges in the body, and when you touch a
grounded object you get a very painful shock. If you are handling
something else, like a patient, the immediate reaction is to let
that go so the patient could fall. There could be accidents due
to that.
Q682 Chairman: This Directive
is basically saying that health workers will not be able to work
for more than a certain period of time using this equipment.
Mr Biosca de Sagastuy:
No. First of all, the Directive does not refer to health workers
but to workers in general, in all sectors of activity who are
exposed to—
Q683 Chairman: Specifically
we are looking at workers with MRI scanners.
Mr Biosca de Sagastuy:
Basically, what the directive says is, "Employers, if you
have workers working in an electromagnetic field, whose strength
is above the action levels specified in the directive, which are
directly measurable parameters in terms of electrick field strength,
magnetic field strength, magnetic flux density and power density,
you have to undertake a risk assessment to see whether the limit
values are exceeded. In that case, you will have to take measures,
either technical or organisational measures, like limiting the
time the person will be there, in order to eliminate or reduce
exposure to a minimum". In the case of magnetic resonance
equipment, of course you have not got any permanent health effects
so far with the current machines because the electromagnetic field
strengths are not exceeding the action values. If there is no
exposure above the specified action values, there is no adverse
health effect. There are two types of effect. There are the biological
effects when exposure to EMF causes some detectable psychological
damage in a biological system, but that does not necessarily mean
an adverse effect. An adverse effect occurs when the body cannot
respond to that biological change, which is outside the normal
range for the body compensation, and this leads to some detrimental
health condition. That is exactly what happens with magnetic resonance
equipment: there are biological effects but no adverse health
effects because exposures are lower than the limit values specified
in the directive. Nevertheless, in a recent meeting between Commissioner
Mr Spidla and the European Radiological Society it was agreed
to constitute a working group of the European Radiological Society,
the Commission's services and an independent body like the National
Radiological Protection Board, a scientific body, because we want
to clarify the situation once and for all. We want to go and measure
in hospitals, follow the procedures that the medical personnel
are following and measure the real exposures. Then we will see
who is right because scientific experts on one side tell us there
is no problem but medical doctors say there is a problem. In my
view, manufacturers have not said anything at all, they are very
happy with the Directive so far.
Q684 Bob Spink: Very happy?
Mr Biosca de Sagastuy:
So far, nobody from Siemens nor Philips have expressed any concern.
We do not have any complaints to the Commission so far from manufacturers
of magnetic resonance equipment.
Q685 Chairman: Just before
I pass you on to my colleagues. You are saying you have now set
up a piece of research which is looking at—
Mr Biosca de Sagastuy:
We are going to.
Q686 Chairman: You are
going to. When is that coming in?
Mr Biosca de Sagastuy:
We are going to have our first meeting with the European Radiological
Society in order to constitute that working group in June.
Q687 Chairman: So the
MR community will be involved in that piece of research?
Mr Biosca de Sagastuy:
Of course.
Q688 Chairman: If, in
fact, it demonstrates our thesis that there are no significant
risks, is there a likelihood that before the 2008 implementation
of the Directive there could either be changes or a derogation
for MRI equipment? Would you support that?
Mr Biosca de Sagastuy:
The Directive contains provisions to allow for technical amendments
in line with technical progress and new scientific findings concerning
EMF. Even contains a specific invitation of the legislator to
the Commission to review the health effects especially as regards
static magnetic fields.
Q689 Chairman: You have
removed static fields from this.
Mr Biosca de Sagastuy:
For the moment. If something proves that there is no health or
safety risk—both—then we will proceed to remove it,
but if there are health or safety risks then the Directive will
stay.
Chairman: Thank you very
much indeed.
Q690 Dr Turner: Can I
get some absolute clarity here. You are saying that there will
not be any impact on the use of MRI equipment, at least such as
is currently in routine use in hospitals and laboratories, as
a result of the Directive. Are you saying that the imaging departments
in hospitals can go on as before, as at present, without any interference?
Mr Biosca de Sagastuy:
I would say so. If you follow the procedures in magnetic resonance
departments of hospitals you will see that they have already in
place very stringent procedures to go in and position the patients
and everything.[1]
The time that medical personnel are allowed to be there is very,
very limited, not only because of magnetic resonance but also
because of noise. Levels of noise are around 120 dBs and occupational
exposure limit for noise is 87 dBs.
Q691 Dr Turner: The concern
is not so much with the straightforward scanning of a patient
but the use of MRI equipment in invasive procedures, neurosurgical
procedures which are carried out using MRI equipment, so naturally
people will have to be exposed to radiation for much longer than
simply taking the scan of a patient. Do you envisage that those
procedures would be affected?
Mr Biosca de Sagastuy:
No. I will tell you why. In the operating theatre the machines
that are used for brain surgery or heart surgery are very low
powered machines, a maximum of 0.4 teslas. You can easily verify
this with the manufacturers and hospitals. Secondly, there are
machines that when they are permanently installed in operating
theatres they are hidden below the table and when the doctor needs
to see an image after doing a certain operation it comes out from
under the table and it is switched on. There is very limited exposure.
Do not ever think that the doctors in operating theatres use the
machines continuously throughout the whole operation because that
is not true. They use it for a very limited amount of time.
Q692 Dr Turner: Do you
envisage any impact on medical applications involving the use
of newer machines of higher power?
Mr Biosca de Sagastuy:
With the newer machines of higher power we will have to investigate
more. The ICNIRP, the Institute of Electrical Engineers and FDA
in the US and other specialised organisations, are looking into
the health effects of exposure to such high fields because of
the potential risks for patients as well.
Q693 Dr Turner: You would
say that the concerns which have been expressed to us about the
impact of the Directive on the medical community have been greatly
exaggerated?
Mr Biosca de Sagastuy:
In our view, yes. The only way to clear this up is to set up this
working group and perform measures in hospitals by a recognised
body.
Q694 Chairman: Is there
a deadline for when it will finish its work?
Mr Biosca de Sagastuy:
We do not know because we will have to place a contract with the
National Radiological Protection Board in the UK in order for
them to perform the measures.[2]
Q695 Chairman: Before
2008?
Mr Biosca de Sagastuy:
We have to have the first meeting to constitute the group and
then we are going to set up a timescale.
Q696 Dr Turner: We are
curious that before the Directive was enacted in 2004 there was
not a fresh impact assessment undertaken because the old one was
ten years old and likely to be quite out of date. Why did the
Commission refuse to undertake a fresh assessment?
Mr Biosca de Sagastuy:
The Commission was asked by the UK Representation in Council to
update the risk assessment and we said that the existing risk
assessment could be extrapolated later to the costs and that could
be done easily. In any case, the debate on the proposal had already
started in Council and the rest of delegations considered that
a new impact assessment, at this point in time, would be of little
added value since Member States had done their own impact assessments
and knew very well the socio-economic impact at national level.
For instance, the Health and Safety Executive had done that.
Chairman: They have and
they have found no problems.
Q697 Dr Turner: They found
no risk.
Mr Biosca de Sagastuy:
No, because that was not the position of the UK during the negotiations.
They found risks. If they did not find risks why did they produce
a 200 page long document?
Dr Turner: I can quote
from what they said which was that they were "unable to identify
any health and safety benefit from the Directive".
Q698 Chairman: That is
a direct quote from them.
Mr Biosca de Sagastuy:
That is an opinion of the Health and Safety Executive. Anyhow,
they did not take this line in Council as far as I know, and I
was President. Sorry, what was the original question?
Q699 Dr Turner: The original
question was why did you not undertake a new risk assessment?
Mr Biosca de Sagastuy:
Because to undertake an impact assessment takes one year and at
that time the discussions had already started in Council and there
was no time. We had an impact assessment after. It would not enlighten
discussions in Council.
1 Note by the witness: We do not expect that
the implementation of the directive will impose more stringent
procedures or medical protocols than the ones already in place. Back
2
Note by the witness: The group of experts have to be constituted,
its mandate has to be jointly defined with the European Radiology
Association, a contract will need to be placed with a specialised
body for performing the measures and then a time schedule would
be defined. Back
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