ORIGINAL PAPER
Evaluation of the safety of users of active implantable medical devices (AIMD)
in the working environment in terms of exposure to electromagnetic fields –
Practical approach to the requirements of European Directive 2013/35/EU
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Central Institute for Labour Protection – National Research Institute, Warszawa, Poland
(Laboratory of Electromagnetic Hazards)
Online publication date: 2018-11-05
Corresponding author
Jolanta Karpowicz
Central Institute for Labour Protection – National Research Institute (CIOP-PIB), Laboratory of Electromagnetic Hazards, Czerniakowska 16, 00-701 Warszawa, Poland
Int J Occup Med Environ Health. 2018;31(6):795-808
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ABSTRACT
Objectives: Electromagnetic fields (EMF) may cause malfunctions in electronic devices, in particular in active implantable
medical devices (AIMD), along with discomfort or health hazards to users. The use of AIMD by workers is increasing (especially
cardiac pacemakers, implantable cardioverter defibrillators and wearable insulin infusion pumps). Electromagnetic
fields may be much stronger in the working environment than applied in basic immunity tests of AIMD (based on EN 60601-
1-2:2015 and EN 50527-1:2016). European Directive 2013/35/EU regarding the safety of workers exposed to EMF considered
the AIMD users to be “workers at particular risk” who need an individual evaluation of EMF hazards. The study
aimed at evaluating the safety of users of AIMD in medical and industrial working environments exposed to EMF Material and Methods: Near the common sources of strong EMF applied in medical and industrial use, the “standard safety distances”
(SSD) for AIMD users were evaluated (i.e., distances from the EMF source, where exposure drops below limits from
Recommendation 1999/519/EC and AIMD safety may be expected). The analysis is based on the results of measurements
of magnetic and electric field strengths near 127 typical devices, in their normal use. Results: The longest electric field related
SSD was identified near dielectric sealers (up to 180 cm), and the longest magnetic field related SSD – near induction
heaters (up to 450 cm). Conclusions: Electromagnetic fields related AIMD malfunctions need to be considered up to several
meters from EMF sources. The “individual safety distance,” that is sufficient to ensure the safety of a particular AIMD user
may be significantly different (usually shorter) from the presented SSD, but needs to be considered in the context of detailed
safety data from the AIMD manufacturer (if available). The labelling indicating the location of the area of a strong EMF
increases safety of AIMD users in the work environment. Int J Occup Med Environ Health 2018;31(6):795–808