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

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.

Pacemakers, Implantable Defibrillators, and 5G Technology: What We Need to Know.

ABSTRACT: Pacemakers (PM) and implantable cardioverter defibrillators (ICD) are active implantable medical devices (AIMD) needed in case of cardiac arrhythmias. Given their potentially life-sustaining nature, the interaction between any source of electromagnetic field and these AIMDs is an ongoing concern of patients, industry, and regulators. According to the current regulatory framework, the required immunity of PM and ICD provides a reasonable unperturbed behavior in the presence of cell phones and base stations that use pre-5G technologies. PM/ICD international standards do not consider some peculiar characteristics of 5G technology and some of the 5G technology frequency bands (those above 3 GHz), since these frequencies are considered not to add risks to the AIMD functioning. Here we analyze the theoretical issues about the interference between 5G technology and PM/ICD and propose an experimental approach to perform a measurement campaign.

5G Service and Pacemakers/Implantable Defibrillators: What Is the Actual Risk?

Rapidly growing worldwide, 5G service is expected to deeply change the way we communicate, connect and share data. It encompasses the whole spectrum of new technology, infrastructure and mobile connectivity, and will touch not only every sector in the industry, but also many aspects of our everyday life. Although the compliance with international regulations provides reasonable protection to public health and safety, there might be specific issues not fully covered by the current technical standards. Among the aspects that shall be carefully considered, there is the potential interference that can be induced on medical devices, and in particular on implantable medical devices that are critical for the patient's life, such as pacemakers and implantable defibrillators. This study aims to assess the actual risk that 5G communication systems pose to pacemakers and implantable defibrillators. The setup proposed by the ISO 14117 standard was adapted to include 5G characteristic frequencies of 700 MHz and 3.6 GHz. A total number of 384 tests were conducted. Among them, 43 EMI events were observed. Collected results reveal that RF hand-held transmitters operating in these two frequency bands do not pose additional risk compared to pre-5G bands and that the safety distance of 15 cm typically indicted by the PM/ICD manufacturer is still able to guarantee the patient's safety.