Phantom Model Testing of Active Implantable Cardiac Devices at 50/60 Hz Electric Field

Area of Science:

• Bioelectromagnetics
• Medical Device Engineering

Background:

• External extremely low-frequency (ELF) electric and magnetic fields induce internal electric fields.
• The impact of these fields on active implanted cardiac devices requires investigation.

Purpose of the Study:

• To assess the potential for perturbation of active implanted cardiac devices by 50/60 Hz electric fields.
• To determine the threshold levels at which such perturbations may occur.

Main Methods:

• Numerical modeling was employed to design the experimental setup.
• In vitro bench testing evaluated 11 implantable cardioverter-defibrillators and 43 cardiac pacemakers.
• Tests were conducted at electric field strengths up to 100 kV/m (50 Hz) and 83 kV/m (60 Hz).

Main Results:

• Over 99% of clinical cases showed no device failure at ICNIRP public exposure levels.
• Six pacemakers, tested in unipolar mode with maximum sensitivity and atrial sensing, experienced issues.
• Devices in bipolar mode with nominal sensitivity resisted electric fields exceeding EU action levels.

Conclusions:

• Active implanted cardiac devices demonstrate significant resistance to ELF electric fields under typical exposure conditions.
• Specific configurations, particularly pacemakers in unipolar mode with high sensitivity, may be susceptible.
• Bipolar mode configurations offer robust protection against relevant electric field levels.