The New Directive 2013/35/EU on Occupational Exposure to Electric
Fields and Electrical Workers’ Use of Implantable Cardioverter
Defibrillators (ICDs)
Leena Korpinen
1
, Rauno Pääkkönen
2
, Martine Souques
3
and Vesa Virtanen
4
1
Environmental Health, Tampere University of Technology, Tampere, Finland
2
Finnish Institute of Occupational Health, Tampere, Finland
3
Medical Studies Department, EDF, Levallois-Perret, France
4
The Heart Center, Tampere University Hospital, Tampere, Finland
Keywords: Implantable Cardioverter Defibrillators, ICD, Worker, Directive.
Abstract: The indications for implantable cardioverter-defibrillators (ICDs) are expanding and workers’ use of ICDs
has increased. The aim of this paper was to investigate the new directive, 2013/35/EU, on occupational
exposure to ELF electric fields and the electrical workers’ use of Implantable Cardioverter Defibrillators
(ICDs). For example, the directive includes information about medical implants, e.g. ICDs and possible
interference problems. In this paper, we describe our earlier study of ICDs and analyze where it is possible
to find such high electric fields that the exposure can influence the ICDs. Based on experiments at Tampere
University of Technology, the electric field under a 400 kV power line may disturb an ICD, when the
electric field is below the low action level (10 kV/m). However, there were no no effects observed on ICDs
functioning up to 0.9 kV/m, and only anomalous behavior in some conditions was observed when levels
exceeded 5.1 kV/m. The risk of disturbances is not considered to be high.
1 INTRODUCTION
With the advance of medical technology, a variety of
new devices or aids facilitating – or even sustaining
– human vital functions have entered the market. For
example, these devices include cardiac pacemakers
(PMs), implantable cardioverter defibrillators
(ICDs), neurostimulators, and drug pumps.
Directive 2013/35/EU of the European
Parliament and of the Council on the minimum
health and safety requirements regarding the
exposure of workers to the risks arising from
physical agents (electromagnetic fields) includes
minimum requirements for the protection of workers
from risks to their health and safety arising, or likely
to arise, from exposure to electromagnetic fields
during their work. According to directive
2013/35/EU, some specific workers may experience
interference problems, so that EMFs can affect the
functioning of medical devices (for example,
metallic prostheses, PMs and ICDs, cochlear
implants, and other implants or medical devices
worn on the body). It is possible that interference
problems, especially with PMs, may occur at levels
below the ALs (action levels), which are (at 50 Hz):
(1) for electric fields (EFs): low ALs 10 kV/m (rms),
and high ALs 20 kV/m (rms); (2) for magnetic fields
(MFs): low ALs 1,000 μT (rms), high ALs 6,000 μT
(rms), ALs 18 mT (rms) for exposure of limbs to a
localized magnetic field (European Parliament and
Council, 2013).
The European Committee for Electrotechnical
Standardization (CENELEC) has also published
some standards from this area (CENELEC 2010,
2011). For example, the European Norm 50527-1,
according to which magnetic ux density of 100 µT,
is considered to be the ‘safety level’ for pacemakers.
EMF interference with PMs and ICDs has been
studied, in vivo and in vitro, for example in Finland
and France (Korpinen et al. 2012, 2013a, 2014;
Trigano et al. 2005; Katrib et al. 2013; Souques et
al., 2011). The PM tests (in Finland) found that the
electric field under a 400 kV power line (6.7–
7.5 kV/m) may disturb a PM in unipolar mode,
which can occur at tasks under 400 kV power lines
or at 110 kV (or higher) substations. However, the
45
Korpinen L., Pääkkönen R., Souques M. and Virtanen V..
The New Directive 2013/35/EU on Occupational Exposure to Electric Fields and Electrical Workers’ Use of Implantable Cardioverter Defibrillators
(ICDs).
DOI: 10.5220/0005142500450049
In Proceedings of the 2nd International Congress on Cardiovascular Technologies (CARDIOTECHNIX-2014), pages 45-49
ISBN: 978-989-758-055-0
Copyright
c
2014 SCITEPRESS (Science and Technology Publications, Lda.)
risk of interference is not considered to be high,
because only one of the several PMs tested showed a
major disturbance (Korpinen et al., 2012). For the
50 Hz magnetic field, PM tests (in France) show no
interference under 50 µT in unipolar mode and
under 100 µT in bipolar mode (Trigano et al. 2005).
For ICDs, in vitro tests (in France) show no
interference until 3.000 µT, but only 4 devices were
tested (Katrib et al. 2013).
The aim of this paper was to investigate, the new
directive 2013/35/EU on occupational exposure to
ELF electric fields and the electrical workers’ use of
ICDs.
In addition, we describe our earlier study of
ICDs and analyze where it is possible to find such
high electricity that the exposure can influence the
ICDs (Korpinen et al., 2014)
2 METHODS
2.1 Measurement Places and Phantom
During the four measurement days, 37 ICD tests
were performed using a human-shaped phantom in
three different places (A, B and C) near 400 kV
power lines. The place A was 5.1 m from the
outermost conductor of the 400-kV power line
(laterally) on a hill and place B was at a distance of
2.5 m from place A in the direction of the power
lines. The place C was located 11.6 m away from
place A. Details of the places were published in the
earlier article. (Korpinen et al., 2014)
We used a human–shaped phantom (height
1.92 m) for testing ICDs under 400 kV power lines
or at 400 kV substations. The phantom was filled
with 0.9% saline solution. Figure 1 shows the
phantom under the power line. In Figure 2, there is
an example ICD inside the phantom.
We used a simulated heart signal in the ICD
tests. In the tests, we added a lead from the
phantom’s leg to the ICD so that we could apply a
simulated heart signal to the ICD according to EN
45502–2–1 2003 standards. (EN 45502–2–1, 2003)
The electric field (height 1.7 m) was measured
with an EFA-300 meter (Narda Safety Test
Solutions GmbH, Pfullingen, Germany; accuracy
± 3%, root mean square [RMS] value) and EFA-3
field meter (Wandel and Goltermann GmbH,
Eningen, Germany; accuracy ± 5%, RMS).
The magnetic field was measured with a Narda
ELT-400 meter (L-3 Communications, Narda Safety
Test Solutions, Hauppauge, NY, USA; accuracy
± 4% RMS).
Figure 1: The phantom under the power line (in place B).
Figure 2: An example of the ICD inside the phantom.
The temperature inside the head of the phantom
was measured with a Yellowspring Industries (YSI)
temperature meter, containing a thermistor probe
(Yellowspring Industries, Yellowsprings, OH,
USA).
We also measured conductivity of the liquid
using the conductivity meter DiSTWP 4 (Hanna
Instruments, Ann Arbor, MI, USA). Figure 3 shows
an example of the conductivity measurements.
CARDIOTECHNIX2014-InternationalCongressonCardiovascularTechnologies
46
Figure 3: An example of the conductivity measurements.
Figure 4 shows an example of an electric field
measurement, and figure 5 presents an example of a
magnetic field measurement.
Figure 4: An example of a EF measurement (in place A).
Figure 5: An example of a MF measurement (in place A).
Figure 6 shows a laptop, which we used to simulate
a heart signal.
Figure 6: A laptop, which simulated a heart signal.
3 RESULTS
Altogether, 37 ICD tests were performed, and we
used 10 different ICDs. Details of the ICDs were
published in the earlier (Korpinen et al., 2014).
3.1 First Experiment Period
In place A, the electric fields were from 6.8 kV/m to
7.5 kV/m (height 1.7 m), and the humidity of air was
70.5%. The magnetic field was 2.0 μT. In Place B,
the measured electric field was 5.1 kV/m (height 1.7
m) when the humidity was 67.0%, and the magnetic
field was 3.6 μT. In place C, where the measured
electric field was 0.9 kV/m (height 1.7 m) when the
humidity was 68%, the magnetic field was 1.4 μT.
In one ICD test with the heart signal (place A),
an ICD recorded 258 ventricular beats/min, and in
the test with the same ICD without a heart signal, it
recorded 194 ventricular beats/min. In Place C, the
ICD had no disturbances.
3.2 Second Experiment Period
During the second experiment period, we performed
ICD tests in place A. The measured electric field
was from 7.2 kV/m to 7.5 kV/m (height 1.7 m) when
the humidity was 52.9% and 53.3%.
In the second experiment period, the ICD, which
had disturbances in the first experiment period, had
no disturbances in the second experiment period.
Details of all ICD tests were published in the
earlier article. (Korpinen et al., 2014)
TheNewDirective2013/35/EUonOccupationalExposuretoElectricFieldsandElectricalWorkers'UseofImplantable
CardioverterDefibrillators(ICDs)
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4 DISCUSSION
The earlier publication (Korpinen et al., 2009)
presented 15 simulated normal work tasks of
workers (n=151) at 400-kV substations. The
maximum electric fields were the following: (1)
main transformer inspection from maintenance
platform: 18.5 kV/m; (2) maintenance of contacts of
reach disconnect or from a man hoist: 8.5 kV/m; (3)
maintenance of operating device of disconnector
from service platform 8.5 kV/m; (4) maintenance of
operating device of circuit breaker at ground level
15.5 kV/ m, (5) inspection of primary terminals of
current transformer from a man hoist: 19.2 kV/m,
(6) inspection of secondary terminals of busbar
voltage transformer using ladder 43.5 kV/m; (7)
changing a bulb by climbing to a pylon: 35.0 kV/m,
(8) walking in the substation 15.2 kV/m; (9)
maintenance of operating device of circuit breaker
from ladder 44.3 kV/m, (10) maintenance of
operating device of circuit breaker from service
platform 36.3 kV/m, (11) breaker head maintenance
from man hoist 44.3 kV/m and (12) inspection of
secondary terminals of current transformer from
ladder: 47.0 kV/m.
In another earlier study (Korpinen et al., 2011),
the occupational exposure to electric and magnetic
fields were studied during various work tasks at
switching and transforming stations of 110 kV (in
some situations 20 kV). The electric (n = 765) and
magnetic (n = 203) fields were measured. The
average values of all measurements were 3.6 kV/m
and 28.6 µT. The maximum value of electric fields
was 15.5 kV/m.
When we compare the electric field exposure at
ICD tests to the electric fields at the 110 kV or
400 kV substations, it is possible to find such a high
electric field as was in the ICD tests.
Therefore, it is possible that an ICD disturbance
can occur at tasks under 400 kV power lines or at
110 kV (or higher) substations.
Based on our ICD tests, it is possible to find PM
disturbances, when the electric field is below low
ALs (10 kV/m). It is important to take it into
account, in the future, if an electrical worker will
start to use an ICD.
A methodology for evaluating the risk of PMs
and ICDs dysfunction with occupational exposure to
EMF has been developed at EDF to help the
occupational physician make a decision about fitness
for work (Souques et al., 2011).
5 CONCLUSIONS
It is important to analyze the possible interference
with medical electronic devices, including ICDs and
other implants, based on the new directive
2013/35/EU. In the ICD tests at TUT, the electric
field under a 400 kV power line, no effect on ICD
functioning was observed up to 0.9 kV/m, while
anomalous behavior in some conditions was
observed when levels exceeded 5.1 kV/m, which is
below low ALs (10 kV/m, at Directive). However,
the risk of interference problems is not considered to
be high, because only one of the several ICDs
showed an anomalous behavior.
ACKNOWLEDGEMENTS
The assistance of the staff of the, Environmental
Health research group, Tampere University of
Technology (Markus Annila, Tero Haapala, and
Markus Wirta) is gratefully acknowledged. We
thank Harri Kuisti and Jarmo Elovaara (Fingrid Oyj)
for their advice and Hiroo Tarao (Department of
Electrical and Computer Engineering, Kagawa
National College of Technology, Japan) for his
advice and help with the measurements. In addition,
we thank Seppo Malinen (WL-Medical Oy) for
making programming devices available.
REFERENCES
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CENELEC European Committee for Electrotechnical
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CARDIOTECHNIX2014-InternationalCongressonCardiovascularTechnologies
48
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CardioverterDefibrillators(ICDs)
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