In vitro tests reveal sample radiofrequency identification readers inducing clinically significant electromagnetic interference to implantable pacemakers and implantable cardioverter-defibrillators.

Abstract

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. CONCLUSION: 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.

AI evidence extraction

Main findings

In vitro, reactions consistent with EMI were observed during exposure to low-frequency (134 kHz) RFID in 67% of pacemaker tests (maximum distance 60 cm) and 47% of ICD tests (maximum distance 40 cm). During high-frequency (13.56 MHz) RFID exposure, reactions were observed in 6% of pacemaker tests (maximum distance 22.5 cm) and 1% of ICD tests (maximum distance 7.5 cm). No reactions were observed during exposure to ultra-high-frequency (915 MHz) RFID or continuous-wave RFID; devices were most susceptible to modulated LF RFID readers.

Outcomes measured

• Electromagnetic interference (EMI) reactions in pacemakers
• Electromagnetic interference (EMI) reactions in ICDs
• Maximum distance at which reactions observed

Limitations

• In vitro testing (not in vivo/clinical setting)
• Exposure details beyond frequency bands (e.g., field strength) not provided in abstract
• Outcome described as 'reaction' without further definition in abstract
• Authors note lack of FDA incident reports and do not consider it an urgent public health risk

Suggested hubs

• medical-implants-emi (0.95)
  Study tests EMI from RFID readers on implantable pacemakers and ICDs.
• rfid (0.85)
  Exposure source is passive RFID readers across LF/HF/UHF bands.

{
    "study_type": "in_vitro",
    "exposure": {
        "band": "RF",
        "source": "RFID reader",
        "frequency_mhz": null,
        "sar_wkg": null,
        "duration": null
    },
    "population": "Implantable pacemakers and implantable cardioverter-defibrillators (ICDs) tested in vitro",
    "sample_size": 30,
    "outcomes": [
        "Electromagnetic interference (EMI) reactions in pacemakers",
        "Electromagnetic interference (EMI) reactions in ICDs",
        "Maximum distance at which reactions observed"
    ],
    "main_findings": "In vitro, reactions consistent with EMI were observed during exposure to low-frequency (134 kHz) RFID in 67% of pacemaker tests (maximum distance 60 cm) and 47% of ICD tests (maximum distance 40 cm). During high-frequency (13.56 MHz) RFID exposure, reactions were observed in 6% of pacemaker tests (maximum distance 22.5 cm) and 1% of ICD tests (maximum distance 7.5 cm). No reactions were observed during exposure to ultra-high-frequency (915 MHz) RFID or continuous-wave RFID; devices were most susceptible to modulated LF RFID readers.",
    "effect_direction": "harm",
    "limitations": [
        "In vitro testing (not in vivo/clinical setting)",
        "Exposure details beyond frequency bands (e.g., field strength) not provided in abstract",
        "Outcome described as 'reaction' without further definition in abstract",
        "Authors note lack of FDA incident reports and do not consider it an urgent public health risk"
    ],
    "evidence_strength": "low",
    "confidence": 0.7800000000000000266453525910037569701671600341796875,
    "peer_reviewed_likely": "yes",
    "keywords": [
        "RFID",
        "electromagnetic interference",
        "EMI",
        "electromagnetic compatibility",
        "EMC",
        "pacemaker",
        "implantable cardioverter-defibrillator",
        "ICD",
        "low frequency",
        "high frequency",
        "ultra high frequency"
    ],
    "suggested_hubs": [
        {
            "slug": "medical-implants-emi",
            "weight": 0.9499999999999999555910790149937383830547332763671875,
            "reason": "Study tests EMI from RFID readers on implantable pacemakers and ICDs."
        },
        {
            "slug": "rfid",
            "weight": 0.84999999999999997779553950749686919152736663818359375,
            "reason": "Exposure source is passive RFID readers across LF/HF/UHF bands."
        }
    ]
}

Comments

Log in to comment.

No comments yet.