Why the study?
Does exposure to a 1.5-T MRI system affect the safety and operation of implantable infusion pumps and neurostimulators?
Does exposure to a 1.5-T MRI system affect the safety and operation of implantable infusion pumps and neurostimulators?
Implantable infusion pumps and neurostimulators experience operational interference and cause significant image artifacts in a 1.5-T MRI environment, highlighting the need for rigorous compatibility assessment.
MRI effects on device function in animals support pre-scan compatibility checks; leaves open human safety translation pending clinical data.
We have developed a protocol to evaluate the magnetic resonance (MR) compatibility of implantable medical devices. The testing protocol consists of the evaluation of magnetic field-induced movement, electric current, heating, image distortion, and device operation. In addition, current induction is evaluated with a finite element analysis simulation technique that models the effect of radiofrequency fields on each device. The protocol has been applied to several implantable infusion pumps and neurostimulators with associated attachments. Experiments were performed using a 1.5-T whole-body MR system with parameters selected to approximate the intended clinical and worst case configuration. The devices exhibited moderate magnetic field-induced deflection and torque but had significant image artifacts. No heating was detected for any of the devices. Pump operation was halted in the magnetic field, but resumed after removed. Exposure to the magnetic field activated some of the neurostimulators.J. Magn. Reson. Imaging 1999;9:596–603.
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Schueler et al. (1999) studied this question.
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