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.
Highlights
IntroductionWorkers who wear active implanted medical devices (AIMD), such as a cardiac pacemaker (PM)
The electrical signals recorded during the test not shown any evidence of the activation of the electrosurgical unit
Workers who wear active implanted medical devices (AIMD) are considered at particular risk if exposed to electromagnetic fields (EMF) and, according to the EU Directive 2013/35/EU [2], need an in-depth and individual risk assessment
Summary
Workers who wear active implanted medical devices (AIMD), such as a cardiac pacemaker (PM). An implantable cardioverter/defibrillator (ICD), have always been considered at particular risk if exposed to electromagnetic fields (EMF). The EU Directive 2013/35/EU on the minimum health and safety requirements regarding the exposure of workers to the risks arising from physical agents (electromagnetic fields) [1], stresses that “a system ensuring a high level of protection as regards the adverse health effects and safety risks that may result from exposure to EMF should take due account of specific groups of workers at particular risk and avoid interference problems with, or effects on the functioning of, medical devices such as PM and ICD”. The new European Medical Device Regulation (MDR) [6]
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