Risk Assessment for Workers with Wearable Medical Devices Exposed to Electromagnetic Fields

Abstract

Risk Assessment for Workers with Wearable Medical Devices Exposed to Electromagnetic Fields Vivarelli C, Censi F, Calcagnini G, Falsaperla R, Mattei E. Risk Assessment for Workers with Wearable Medical Devices Exposed to Electromagnetic Fields. Health Physics 127(2):p 269-275, August 2024. doi: 10.1097/HP.0000000000001798. Abstract The exponential diffusion of wearable medical devices (WMD) in recent years has involved people of all ages, including workers. Workers who use WMDs should be considered at a particular risk from electromagnetic fields, and in accordance with EU Directive 2013/35/EU, they require an individual risk assessment. Currently, there is no international standard that provides specific guidance on how to perform such a risk assessment. This paper focuses on the effects of electromagnetic fields on WMDs and does not consider the direct effects on human body tissues. It aims to offer practical recommendations to employers and/or health physicists for the risk assessment of workers with WMDs. Focusing on EU countries, we first describe the requirements outlined by the technical standard for the electromagnetic compatibility (EMC) of medical electrical equipment EN 60601-1-2. Then, some general guidelines on how to perform the risk assessment are provided. The assessment can be conducted by comparing the field values measured in the workplace with the immunity test levels specified in the technical standards of medical electrical equipment. If the measured values are lower than the immunity test levels indicated in the standard and the distance from the electromagnetic source is greater than the distance used by the manufacturer during the EMC (electromagnetic compatibility) tests (typically 30 cm), the risk for the worker may be considered acceptable. However, if the measured values exceed the immunity test levels or the distance criteria, a specific evaluation based on a case-by- case analysis is required. journals.lww.com physics/abstract/2024/08000/risk_assessment_for_workers_with_wearable_medical.1.aspx

AI evidence extraction

Main findings

The paper provides practical recommendations for individual risk assessment of workers with wearable medical devices exposed to workplace electromagnetic fields, focusing on effects on the devices (not direct tissue effects). It proposes comparing measured workplace field values to immunity test levels in relevant technical standards (e.g., EN 60601-1-2) and considering distance criteria (typically 30 cm used in EMC tests); if criteria are not met, case-by-case evaluation is recommended.

Outcomes measured

• Electromagnetic interference/compatibility risk for wearable medical devices in workplace EMF environments
• Risk assessment guidance for employers/health physicists under EU Directive 2013/35/EU

Limitations

• Does not consider direct effects of electromagnetic fields on human body tissues
• No specific exposure frequencies, levels, or workplace scenarios are detailed in the abstract
• No empirical study design, sample size, or measured results are reported in the abstract

Suggested hubs

• occupational-exposure (0.9)
  Focuses on workplace EMF exposure and risk assessment for workers using wearable medical devices.

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    },
    "population": "Workers with wearable medical devices (WMDs)",
    "sample_size": null,
    "outcomes": [
        "Electromagnetic interference/compatibility risk for wearable medical devices in workplace EMF environments",
        "Risk assessment guidance for employers/health physicists under EU Directive 2013/35/EU"
    ],
    "main_findings": "The paper provides practical recommendations for individual risk assessment of workers with wearable medical devices exposed to workplace electromagnetic fields, focusing on effects on the devices (not direct tissue effects). It proposes comparing measured workplace field values to immunity test levels in relevant technical standards (e.g., EN 60601-1-2) and considering distance criteria (typically 30 cm used in EMC tests); if criteria are not met, case-by-case evaluation is recommended.",
    "effect_direction": "unclear",
    "limitations": [
        "Does not consider direct effects of electromagnetic fields on human body tissues",
        "No specific exposure frequencies, levels, or workplace scenarios are detailed in the abstract",
        "No empirical study design, sample size, or measured results are reported in the abstract"
    ],
    "evidence_strength": "insufficient",
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    "peer_reviewed_likely": "yes",
    "keywords": [
        "wearable medical devices",
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        "electromagnetic fields",
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        "electromagnetic compatibility",
        "EN 60601-1-2",
        "EU Directive 2013/35/EU",
        "immunity test levels"
    ],
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