Workers with Active Implantable Medical Devices Exposed to EMF: In Vitro Test for the Risk Assessment

Author:

Mattei EugenioORCID,Calcagnini Giovanni,Censi Federica,Pinto Iole,Bogi Andrea,Falsaperla Rosaria

Abstract

The occupational health and safety framework identifies workers with an active implantable medical device (AIMD), such as a pacemaker (PM) or an implantable defibrillator (ICD), as a particularly sensitive risk group that must be protected against the dangers caused by the interference of electromagnetic field (EMF). In this paper, we describe the results of in vitro testing/measurements performed according to the EN50527-2-1:2016 standard, for the risk assessment of employees with a PM exposed to three EMF sources: (1) An electrosurgical unit (ESU); (2) a transcranial stimulator (TMS); and (3) an arc welder. The ESU did not affect the PM behavior in any of the configurations tested. For the TMS and the arc welder, interference phenomena were observed in limited experimental configurations, corresponding to the maximum magnetic field coupling between the EMF source and the implant. The in vitro measurements presented can be considered an example of how the specific risk assessment for a worker with a PM can be performed, according to one of the methodologies proposed in the EN50527-2-1:2016, and can be used as scientific evidence and literature data for future risk assessments on the same EMF sources.

Funder

Istituto Nazionale per l'Assicurazione Contro Gli Infortuni sul Lavoro

Publisher

MDPI AG

Subject

General Environmental Science,Renewable Energy, Sustainability and the Environment,Ecology, Evolution, Behavior and Systematics

Reference27 articles.

1. Directive 2013/35/EU of the European Parliament and of the Council of 26 June 2013 on the Minimum Health and Safety Requirements regarding the Exposure of Workers to the Risks Arising from Physical Agents (Electromagnetic Fields) (20th Individual Directive within the Meaning of Article 16

2. (1) of Directive 89/391/EEC) and repealing Directive 2004/40/EChttps://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex%3A32013L0035

3. Directorate-General for Employment, Social Affairs and Inclusion (European Commission), Non-binding Guide to Good Practice for Implementing Directive 2013/35/EU Electromagnetic Fields,2014

4. EN 50527-1:2016, Procedure for the Assessment of the Exposure to Electromagnetic Fields of Workers Bearing Active Implantable Medical Devices—Part 1: General,2016

5. EN 50527-2-1:2016, Procedure for the Assessment of the Exposure to Electromagnetic Fields of Workers Bearing Active Implantable Medical Devices—Part 2-1: Specific Assessment for Workers with Cardiac Pacemakers,2016

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