Evaluation of the safety of users of active implantable medical devices (AIMD) in the working environment in terms of exposure to electromagnetic fields - Practical approach to the requirements of European Directive 2013/35/EU.

Abstract

OBJECTIVES: Electromagnetic fields (EMF) may cause malfunctions in electronic devices, in particular in active implantable medical devices (AIMD), along with discomfort or health hazards to users. The use of AIMD by workers is increasing (especially cardiac pacemakers, implantable cardioverter defibrillators and wearable insulin infusion pumps). Electromagnetic fields may be much stronger in the working environment than applied in basic immunity tests of AIMD (based on EN 60601- 1-2:2015 and EN 50527-1:2016). European Directive 2013/35/EU regarding the safety of workers exposed to EMF considered the AIMD users to be "workers at particular risk" who need an individual evaluation of EMF hazards. The study aimed at evaluating the safety of users of AIMD in medical and industrial working environments exposed to EMF. MATERIAL AND METHODS: Near the common sources of strong EMF applied in medical and industrial use, the "standard safety distances" (SSD) for AIMD users were evaluated (i.e., distances from the EMF source, where exposure drops below limits from Recommendation 1999/519/EC and AIMD safety may be expected). The analysis is based on the results of measurements of magnetic and electric field strengths near 127 typical devices, in their normal use. RESULTS: The longest electric field related SSD was identified near dielectric sealers (up to 180 cm), and the longest magnetic field related SSD - near induction heaters (up to 450 cm). CONCLUSIONS: Electromagnetic fields related AIMD malfunctions need to be considered up to several meters from EMF sources. The "individual safety distance," that is sufficient to ensure the safety of a particular AIMD user may be significantly different (usually shorter) from the presented SSD, but needs to be considered in the context of detailed safety data from the AIMD manufacturer (if available). The labelling indicating the location of the area of a strong EMF increases safety of AIMD users in the work environment. Int J Occup Med Environ Health 2018;31(6):795-808.

AI evidence extraction

Main findings

Based on measurements near 127 typical medical and industrial devices, the longest electric-field-related standard safety distance (SSD) was found near dielectric sealers (up to 180 cm), and the longest magnetic-field-related SSD near induction heaters (up to 450 cm). The authors conclude that EMF-related AIMD malfunctions may need to be considered up to several meters from EMF sources and that individual safety distances may differ depending on device-specific manufacturer data.

Outcomes measured

• Standard safety distances (SSD) from EMF sources where exposure drops below limits from Recommendation 1999/519/EC and AIMD safety may be expected
• Measured electric field strengths near typical devices
• Measured magnetic field strengths near typical devices
• Implications for potential AIMD malfunctions in workplace EMF

Limitations

• Frequencies and detailed exposure characteristics are not specified in the abstract
• SSD is derived from measured field strengths and comparison to limits (Recommendation 1999/519/EC) rather than direct testing of AIMD malfunction outcomes
• Individual AIMD susceptibility and manufacturer-specific immunity data may vary and may not be available

Suggested hubs

• occupational-exposure (0.9)
  Evaluates EMF safety distances for AIMD users in medical and industrial working environments under worker protection requirements.

{
    "study_type": "exposure_assessment",
    "exposure": {
        "band": null,
        "source": "occupational (medical and industrial EMF sources)",
        "frequency_mhz": null,
        "sar_wkg": null,
        "duration": null
    },
    "population": "Workers who are users of active implantable medical devices (AIMD), including cardiac pacemakers, implantable cardioverter defibrillators, and wearable insulin infusion pumps",
    "sample_size": 127,
    "outcomes": [
        "Standard safety distances (SSD) from EMF sources where exposure drops below limits from Recommendation 1999/519/EC and AIMD safety may be expected",
        "Measured electric field strengths near typical devices",
        "Measured magnetic field strengths near typical devices",
        "Implications for potential AIMD malfunctions in workplace EMF"
    ],
    "main_findings": "Based on measurements near 127 typical medical and industrial devices, the longest electric-field-related standard safety distance (SSD) was found near dielectric sealers (up to 180 cm), and the longest magnetic-field-related SSD near induction heaters (up to 450 cm). The authors conclude that EMF-related AIMD malfunctions may need to be considered up to several meters from EMF sources and that individual safety distances may differ depending on device-specific manufacturer data.",
    "effect_direction": "mixed",
    "limitations": [
        "Frequencies and detailed exposure characteristics are not specified in the abstract",
        "SSD is derived from measured field strengths and comparison to limits (Recommendation 1999/519/EC) rather than direct testing of AIMD malfunction outcomes",
        "Individual AIMD susceptibility and manufacturer-specific immunity data may vary and may not be available"
    ],
    "evidence_strength": "low",
    "confidence": 0.7399999999999999911182158029987476766109466552734375,
    "peer_reviewed_likely": "yes",
    "keywords": [
        "electromagnetic fields",
        "active implantable medical devices",
        "AIMD",
        "occupational exposure",
        "workplace safety",
        "European Directive 2013/35/EU",
        "Recommendation 1999/519/EC",
        "standard safety distance",
        "dielectric sealers",
        "induction heaters",
        "pacemaker",
        "implantable cardioverter defibrillator",
        "insulin infusion pump"
    ],
    "suggested_hubs": [
        {
            "slug": "occupational-exposure",
            "weight": 0.90000000000000002220446049250313080847263336181640625,
            "reason": "Evaluates EMF safety distances for AIMD users in medical and industrial working environments under worker protection requirements."
        }
    ]
}

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