Electronic security systems and active implantable medical devices.
How do active implantable medical devices react in the presence of strong magnetic fields in the frequency range between extremely low frequency (ELF) to radiofrequency (RF) as they are emitted by electronic security systems (ESS)? There are three different sorts of ESSs: electronic article surveillance (EAS) devices, metal detector (MDS) devices, and radiofrequency identification (RFID) systems. Common to all is the production of magnetic fields. There is an abundance of literature concerning interference by ESS gates with respect to if there is an influence possible and if such an influence can bear a risk for the AIMD wearers. However, there has been no attempt to study the physical mechanism nor to develop a model of how and under which conditions magnetic fields can influence pacemakers and defibrillators and how they could be disarmed by technological means. It is too often assumed that interference of AIMD with ESS is inevitable. Exogenous signals of similar intensity and rhythm to heart signals can be misinterpreted and, thus, confuse the implant. Important for the interference coupling mechanism is the differentiation between a "unipolar" and a "bipolar" system. With respect to magnetic fields, the left side implanted pacemaker is the most unfavorable case as the lead forms approximately a semicircular area of maximum 225 cm2 into which a voltage can be induced. This assumption yields an interference coupling model that can be expressed by simple mathematics. The worst-case conditions for induced interference voltages are a coupling area of 225 cm2 that is representative for a large human, a homogeneous magnetic field perpendicular to the area formed by the lead, and a unipolar ventricular pacemaker system that is implanted on the left side of the thorax and has the highest interference sensitivity. In bipolar systems the fields must be 17 times larger when compared to a unipolar system to have the same effect. The magnetic field for interfering with ICDs must be 1.7 stronger than that of the most sensitive unipolar pacemaker. The lowest interference thresholds measured over the last 10 years in the low frequency range (16 2/3 Hz-24 kHz) together with thresholds > 24 kHz that were supplied by the CETECOM study are listed. Both sets of data together with the coupling model, allow for judging which fields of ESSs could influence AIMDs. From measurements at gate antennas, it is possible to derive a "maximum allowed field" curve over the whole frequency range, below which no interference will occur. Comparison of data from literature with these maximum allowed fields confirm the correctness of the calculations. Thus, it is possible to predict interference situations in gates if the magnetic field is known. If all future pacemakers were to have the immunity against interference of the better 50% of today's pacemakers, the magnetic field ceiling values could be at least four times higher. The same is true if the ventricular sensitivity is routinely set at 7 mV. Pacemaker manufacturers should consider filter improvement with modern technology, but gate manufacturers should not claim the privilege of being out of bounds.
D017147:Defibrillators, Implantable; D004574:Electromagnetic Fields; D006801:Humans; D010138:Pacemaker, Artificial; D019736:Prostheses and Implants; D012449:Safety; D012637:Security Measures / Q000592:standards*