Interference thresholds for active implantable cardiovascular devices in occupational low-frequency electric and magnetic fields: a numerical and in vitro study

Abstract

Interference thresholds for active implantable cardiovascular devices in occupational low-frequency electric and magnetic fields: a numerical and in vitro study Zhou M, Kourtiche D, Claudel J, Deschamps F, Magne I, Roth P, Schmitt P, Souques M, Nadi M. Interference thresholds for active implantable cardiovascular devices in occupational low-frequency electric and magnetic fields: a numerical and in vitro study. Med Eng Phys. 2022 Jun;104:103799. doi: 10.1016/j.medengphy.2022.103799. Abstract In light of concerns regarding the occupational safety and health of workers wearing active implantable medical devices (AIMDs), this study aims to investigate the potential risks of electromagnetic interference (EMI) between AIMDs and low-frequency 50/60 Hz electromagnetic fields (EMFs) in the workplace. A total of 58 AIMDs, consisting of pacemakers (PMs) and implantable cardiac defibrillators (ICDs) of different brands, models, and configurations were tested to determine the immunity thresholds for high-voltage electric fields (EFs) and magnetic fields (MFs) at 50/60 Hz. The EFs and MFs at the levels in workplaces are reproduced by setups using Helmholtz coils and aluminum plates, respectively, to ensure that the EM/MF exposures are controllable and reproducible. The EMI thresholds were recorded by observing the occurrences of PM or ICD dysfunctions. In addition, numerical studies on anatomical models were carried out using CST® software. The results indicate that the recorded thresholds all exceed the EF and MF public exposure limits given in the ICNIRP 2010 guidelines. No dysfunction was observed among four ICDs tested under MF exposure up to 2750 µT at 50 Hz and 2480 µT at 60 Hz. However, among the 43 PMs and 11 ICDs tested under EF exposures, potential hazards may occur below the occupational exposure level proposed in the ICNIRP guidelines. pubmed.ncbi.nlm.nih.gov

AI evidence extraction

Main findings

Fifty-eight AIMDs (pacemakers and ICDs) were tested for immunity thresholds to 50/60 Hz electric and magnetic fields using in vitro setups and numerical anatomical modeling. Recorded thresholds exceeded ICNIRP 2010 public exposure limits; no dysfunction was observed in four ICDs under magnetic-field exposure up to 2750 µT at 50 Hz and 2480 µT at 60 Hz. Under electric-field exposures, potential hazards were observed that may occur below the occupational exposure level proposed in ICNIRP guidelines.

Outcomes measured

• Electromagnetic interference (EMI) thresholds
• Pacemaker (PM) dysfunctions
• Implantable cardiac defibrillator (ICD) dysfunctions

Limitations

• Exposure duration not reported in abstract
• Specific electric-field threshold values not provided in abstract
• Only four ICDs were tested under magnetic-field exposure conditions described
• In vitro and numerical modeling may not fully represent real-world workplace exposure scenarios

Suggested hubs

• occupational-exposure (0.9)
  Study explicitly evaluates workplace (occupational) 50/60 Hz electric and magnetic fields and interference risks for workers with AIMDs.
• who-icnirp (0.75)
  Findings are discussed relative to ICNIRP 2010 public limits and occupational exposure levels.

{
    "study_type": "other",
    "exposure": {
        "band": "ELF",
        "source": "occupational",
        "frequency_mhz": null,
        "sar_wkg": null,
        "duration": null
    },
    "population": "Workers wearing active implantable medical devices (pacemakers and implantable cardiac defibrillators)",
    "sample_size": 58,
    "outcomes": [
        "Electromagnetic interference (EMI) thresholds",
        "Pacemaker (PM) dysfunctions",
        "Implantable cardiac defibrillator (ICD) dysfunctions"
    ],
    "main_findings": "Fifty-eight AIMDs (pacemakers and ICDs) were tested for immunity thresholds to 50/60 Hz electric and magnetic fields using in vitro setups and numerical anatomical modeling. Recorded thresholds exceeded ICNIRP 2010 public exposure limits; no dysfunction was observed in four ICDs under magnetic-field exposure up to 2750 µT at 50 Hz and 2480 µT at 60 Hz. Under electric-field exposures, potential hazards were observed that may occur below the occupational exposure level proposed in ICNIRP guidelines.",
    "effect_direction": "mixed",
    "limitations": [
        "Exposure duration not reported in abstract",
        "Specific electric-field threshold values not provided in abstract",
        "Only four ICDs were tested under magnetic-field exposure conditions described",
        "In vitro and numerical modeling may not fully represent real-world workplace exposure scenarios"
    ],
    "evidence_strength": "low",
    "confidence": 0.7399999999999999911182158029987476766109466552734375,
    "peer_reviewed_likely": "yes",
    "keywords": [
        "active implantable medical devices",
        "AIMD",
        "pacemaker",
        "implantable cardiac defibrillator",
        "ICD",
        "electromagnetic interference",
        "EMI",
        "occupational exposure",
        "low-frequency",
        "50 Hz",
        "60 Hz",
        "electric field",
        "magnetic field",
        "ICNIRP 2010",
        "Helmholtz coils",
        "CST software"
    ],
    "suggested_hubs": [
        {
            "slug": "occupational-exposure",
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        },
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            "reason": "Findings are discussed relative to ICNIRP 2010 public limits and occupational exposure levels."
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}

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