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

Abstract

Overview

In recent years, there has been an exponential increase in the use of wearable medical devices (WMDs) by people of all ages, including workers. Workers utilizing WMDs must be considered at particular risk from exposure to electromagnetic fields (EMFs) and, under EU Directive 2013/35/EU, require an individual risk assessment.

Key Points

• There currently exists no international standard providing specific guidance for performing risk assessments for workers with WMDs exposed to EMFs.
• This paper centers on the effects of electromagnetic fields on wearable medical devices, explicitly not covering direct EMF effects on human tissues.
• It provides practical recommendations tailored to employers and/or health physicists concerning the risk assessment process for such workers.

Findings

• The study first reviews the requirements set out by EN 60601-1-2, the technical standard for electromagnetic compatibility (EMC) of medical electrical equipment in the EU.
• General guidelines are provided for performing the risk assessment.
• The assessment method suggests comparing electromagnetic field values measured in the workplace to the immunity test levels specified in technical EMC standards for medical equipment.
• If workplace field values are below immunity test levels and the worker’s distance from the EMF source exceeds that used in EMC testing (typically 30 cm), the risk is considered acceptable.
• If field measurements exceed immunity test levels or distance criteria are not met, further specific case-by-case evaluation is necessary.

Conclusion

• Workers using wearable medical devices are at a particular risk from electromagnetic exposure. Employers and safety professionals must perform careful, individualized risk assessments following current EU directives and, where needed, conduct further evaluation if environmental exposures are significant.