Title: Electromagnetic compatibility of pacemakers and implantable cardiac defibrillators exposed to RFID readers

Authors: Seth J. Seidman, Paul S. Ruggera, Randall G. Brockman, Brian Lewis, Mitchell J. Shein

Addresses: Food and Drug Administration, Center for Devices and Radiological Health, Silver Spring, MD 20993, USA. ' Food and Drug Administration, Center for Devices and Radiological Health, Rockville, MD 20850, USA. ' Food and Drug Administration, Center for Devices and Radiological Health, Rockville, MD 20850, USA. ' Food and Drug Administration, Center for Devices and Radiological Health, Rockville, MD 20850, USA. ' Food and Drug Administration, Center for Devices and Radiological Health, Rockville, MD 20850, USA

Abstract: A test method was adapted to test the Electromagnetic Compatibility (EMC) between active implantable cardiac devices and Radio Frequency Identification (RFID) readers. A total of 18 pacemakers and 19 Implantable Cardiac Defibrillators (ICDs) from five of the leading pacemaker and ICD manufacturers were tested for immunity to Radio Frequency (RF) emissions generated by seven RFID readers. The seven RFID readers came from five manufacturers and operated at one of the following frequencies: 134 kHz, 13.56 MHz or 915 MHz. The pacemaker (or ICD) was placed in a saline bath filled with 0.18% saline solution. The output signal of the implantable device was observed on an oscilloscope during exposure to electromagnetic fields from the RFID readers. Any change in output signal was noted as a reaction from the pacemaker (or ICD). Reactions ranged from non-clinically significant events to the potentially harmful inappropriate tachyarrhythmia detection and delivery of therapy or complete inhibition of cardiac pacing.

Keywords: electromagnetic compatibility; EMC; electromagnetic interference; EMI; radio frequency identification; RFID; cardiac pacemakers; cardiac defibrillators; radio frequency emissions.

DOI: 10.1504/IJRFITA.2007.015848

International Journal of Radio Frequency Identification Technology and Applications, 2007 Vol.1 No.3, pp.237 - 246

Published online: 25 Nov 2007 *

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