In vitro tests reveal sample radiofrequency identification readers inducing clinically significant electromagnetic interference to implantable pacemakers and implantable cardioverter-defibrillators.
BACKGROUND
The use of radiofrequency identification (RFID) systems is expanding and highlights the need to address electromagnetic interference (EMI) to implantable pacemakers and implantable cardioverter-defibrillators (ICDs).


OBJECTIVE
This study sought to examine the electromagnetic compatibility (EMC) between RFID readers and implantable pacemakers or ICDs.


METHODS
During in vitro testing, 15 implantable pacemakers and 15 ICDs were exposed to 13 passive RFID readers in 3 frequency bands: 134 kHz (low frequency [LF]), 13.56 MHz (high frequency [HF]), and 915 MHz (ultra high frequency [UHF]).


RESULTS
While being exposed to LF RFID, a reaction was observed for 67% of all pacemaker tests (maximum distance 60 cm) and 47% of all ICD tests (maximum distance 40 cm). During HF RFID exposure, a reaction was observed for 6% of all pacemaker tests (maximum distance 22.5 cm) and 1% of all ICD tests (maximum distance 7.5 cm). For both pacemakers and ICDs, no reactions were observed during exposure to UHF RFID or continuous-wave RFID. Pacemakers and ICDs were most susceptible to modulated LF RFID readers.


CONCLUSIONS
Although there is in vitro testing evidence for concern for implantable pacemaker and ICD EMI at LF and HF, the FDA has not received any incident reports of pacemaker or ICD EMI caused by any RFID system. We do not believe the current situation reveals an urgent public health risk.
U.S. Food and Drug Administration, Silver Spring, MD, USA. seidman@fda.hhs.gov
Seth J
SJ
Seidman
Randall
R
Brockman
Brian Marc
BM
Lewis
Joshua
J
Guag
Mitchell J
MJ
Shein
Wesley J
WJ
Clement
James
J
Kippola
Dennis
D
Digby
Catherine
C
Barber
Dan
D
Huntwork
D017147:Defibrillators, Implantable / Q000009:adverse effects / Q000592:standards*; D004574:Electromagnetic Fields / Q000009:adverse effects*; D004868:Equipment Failure; D004869:Equipment Safety; D006801:Humans; D010138:Pacemaker, Artificial / Q000009:adverse effects / Q000592:standards*; D019047:Phantoms, Imaging; D010865:Pilot Projects; D057233:Radio Frequency Identification Device / Q000592:standards*; D018570:Risk Assessment; D012307:Risk Factors