The New Directive 2013/35/EU on Occupational Exposure to Electric

Fields and Electrical Workers’ Use of Implantable Cardioverter

Defibrillators (ICDs)

Leena Korpinen

, Rauno Pääkkönen

, Martine Souques

and Vesa Virtanen

Environmental Health, Tampere University of Technology, Tampere, Finland

Finnish Institute of Occupational Health, Tampere, Finland

Medical Studies Department, EDF, Levallois-Perret, France

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 ﬂux 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

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

 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

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)

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.

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CARDIOTECHNIX2014-InternationalCongressonCardiovascularTechnologies

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TheNewDirective2013/35/EUonOccupationalExposuretoElectricFieldsandElectricalWorkers'UseofImplantable

CardioverterDefibrillators(ICDs)