Electromagnetic Fields Exposure Assessment in Europe Utilizing Publicly Available Data.

The ever-increasing use of wireless communication systems during the last few decades has raised concerns about the potential health effects of electromagnetic fields (EMFs) on humans. Safety limits and exposure assessment methods were developed and are regularly updated to mitigate health risks. Continuous radiofrequency EMF monitoring networks and in situ measurement campaigns provide useful information about environmental EMF levels and their variations over time and in different microenvironments. In this study, published data from the five largest monitoring networks and from two extensive in situ measurement campaigns in different European countries were gathered and processed. Median electric field values for monitoring networks across different countries lay in the interval of 0.67-1.51 V/m. The median electric field value across different microenvironments, as evaluated from in situ measurements, varied from 0.10 V/m to 1.42 V/m. The differences between networks were identified and mainly attributed to variations in population density. No significant trends in the temporal evolution of EMF levels were observed. The influences of parameters such as population density, type of microenvironment, and height of measurement on EMF levels were investigated.

Radiofrequency-induced heating of broken and abandoned implant leads during magnetic resonance examinations.

PURPOSE: The risks of RF-induced heating of active implantable medical device (AIMD) leads during MR examinations must be well understood and realistically assessed. In this study, we evaluate the potential additional risks of broken and abandoned (cut) leads. METHODS: First, we defined a generic AIMD with a metallic implantable pulse generator (IPG) and a 100-cm long lead containing 1 or 2 wires. Next, we numerically estimated the deposited in vitro lead-tip power for an intact lead, as well as with wire breaks placed at 10 cm intervals. We studied the effect of the break size (wire gap width), as well as the presence of an intact wire parallel to the broken wire, and experimentally validated the numeric results for the configurations with maximum deposited in vitro lead-tip power. Finally, we performed a Tier 3 assessment of the deposited in vivo lead-tip power for the intact and broken lead in 4 high resolution virtual population anatomic models for over 54,000 MR examination scenarios. RESULTS: The enhancement of the deposited lead-tip power for the broken leads, compared to the intact lead, reached 30-fold in isoelectric exposure, and 16-fold in realistic clinical exposures. The presence of a nearby intact wire, or even a nearby broken wire, reduced this enhancement factor to <7-fold over the intact lead. CONCLUSION: Broken and abandoned leads can pose increased risk of RF-induced lead-tip heating to patients undergoing MR examinations. The potential enhancement of deposited in vivo lead-tip power depends on location and type of the wire break, lead design, and clinical routing of the lead, and should be carefully considered when performing risk assessment for MR examinations and MR conditional labeling.

Mitigation of magnetic particle hyperthermia side effects by magnetic field controls.

Objective: In magnetic particle hyperthermia, a promising least-invasive cancer treatment, malignant regions in proximity with magnetic nanoparticles undergo heat stress, while unavoidably surrounding healthy tissues may also suffer from heat either directly or indirectly by the induced eddy currents, due to the developed electric fields as well. Here, we propose a facile upgrade of a typical magnetic particle hyperthermia protocol, to selectively mitigate eddy currents' heating without compromising the beneficial role of heating in malignant regions.Method: The key idea is to apply the external magnetic field intermittently (in an ON/OFF pulse mode), instead of the continuous field mode typically applied. The parameters of the intermittent field mode, such as time intervals (ON time: 25-100 s, OFF time: 50-200 s, Duty Cycle:16-100%) and field amplitude (30-70 mT) are optimized based on evaluation on healthy tissue and cancer tissue phantoms. The goal is to sustain in cancer tissue phantom the maximum temperature increase (preferably within 4-8°C above body temperature of 37°C), while in the healthy tissue phantom temperature variation is suppressed far below the 4°C dictating the eddy current mitigation.Results: Optimum conditions of intermittent field (ON/OFF: 50/100 in s, Duty Cycle: 33%, magnetic field: 45mT) are then examined in ex-vivo samples verifying the successful suppression of eddy currents. Simultaneously, a well-elaborated theoretical approach provides a rapid calculation of temperature increase and, furthermore, the ability to quickly simulate a variety of duty cycle times and field controls may save experimental time.Conclusion: Eventually, the application of an intermittent field mode in a magnetic particle hyperthermia protocol, succeeds in eddy current mitigation in surrounding tissues and allows for the application of larger field amplitudes that may augment hyperthermia efficiency without objecting typical biomedical applicability field constraints such as Brezovich criterion.

Compliance Assessment of the Epithelial or Absorbed Power Density Below 10 GHz Using SAR Measurement Systems.

The introduction of new dosimetric quantities, in particular, epithelial or absorbed power density for frequencies above 6 GHz, in exposure guidelines and safety standards requires the development of new experimental assessment procedures for compliance testing. In this study, we propose to approximate the peak spatial-average absorbed power density (psSab ) using the same measured data and algorithms that are used for determining the peak spatial-average specific absorption rate psSAR, which is currently limited to frequencies up to 10 GHz. The uncertainty component for the transformation of psSAR to psSab was evaluated as less than 0.55 dB (13.5%) for any source as close as 0.02 λ from the tissue simulating media. The approach is easy to implement and allows determining compliance with the basic restrictions of the latest safety guidelines. In the next project, we will expand dosimetric probes, phantoms, and procedures for frequencies above 10 GHz. © 2021 Bioelectromagnetics Society.

Reflection Properties of the Human Skin From 40 to 110 GHz: A Confirmation Study.

Several recent theoretical dosimetric studies above 6 GHz apply generic layered skin models. For this frequency range, new experimental phantoms for over-the-air performance of wireless devices were proposed that simulate the impedance matching effects of the stratum corneum layer (SCL) with a low-loss coating layer. The aim of this study was to verify the skin models by comparing their reflection coefficients S11 with measurements of 37 human volunteers (21 males, 16 females, 5-80 years) at 21 body locations (10 at palm, 11 at arm/face) with different SCL thicknesses, using waveguides covering frequencies from 40 to 110 GHz. Such measurements were also carried out with the phantom material. The statistical analysis showed strong evidence that S11 depends on the SCL thickness and no evidence that S11 depends on sex. The measured S11 values for thin and thick skin can be represented by SCL layers of 15 and 140 µm, respectively. These values correspond well to the assumptions of previous studies. (The cohort did not include volunteers doing heavy manual work.) The phantom material mimics the matching effect of the SCL with deviations from the waveguide measurements of less than 0.85 dB (22%), which confirms the suitability of layered phantoms to represent the electromagnetic reflection/absorption of human skin. © 2021 Bioelectromagnetics Society.

Final opinion on the safety of breast implants in relation to anaplastic large cell lymphoma: Report of the scientific committee on health, emerging and environmental risks (SCHEER).

The Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) was requested by the European Commission (EC) to provide a scientific opinion on the safety of breast implants in relation to anaplastic large cell lymphoma (ALCL). There are several types of textured breast implants; surface textures of breast implants are not all manufactured in the same way, and breast implants with diverse surface textures may also present different benefits. The magnitude of the risk per type of textured implant is difficult to establish due to the low incidence of the breast implants associated anaplastic large cell lymphoma (BIA-ALCL). Therefore, risk assessments per implant type are needed. Overall SCHEER considers that there is a moderate weight of evidence for a causal relationship between textured breast implants and BIA-ALCL, particularly in relation to implants with an intermediate to high surface roughness.The pathogenic mechanisms are not fully elucidated; current hypotheses include genetic drivers, chronic inflammation resulting either from bacterial contamination, shell shedding of particulates, or shell surface characteristics leading to friction, or by implant associated reactive compounds. Reporting of new BIA-ALCL cases by the national clinical registries is critically important to obtain a better estimate of the risk of BIA-ALCL for patients with a breast implant.

Discussion on Spatial and Time Averaging Restrictions Within the Electromagnetic Exposure Safety Framework in the Frequency Range Above 6 GHz for Pulsed and Localized Exposures.

Both the current and newly proposed safety guidelines for local human exposure to millimeter-wave frequencies aim at restricting the maximum local temperature increase in the skin to prevent tissue damage. In this study, we show that the application of the current and proposed limits for pulsed fields can lead to a temperature increase of 10°C for short pulses and frequencies between 6 and 30 GHz. We also show that the proposed averaging area of 4 cm2 , that is greatly reduced compared with the current limits, does not prevent high-temperature increases in the case of narrow beams. A realistic Gaussian beam profile with a 1 mm radius can result in a temperature increase about 10 times higher than the 0.4°C increase the same averaged power density would produce for a plane wave. In the case of pulsed narrow beams, the values for the time and spatial-averaged power density allowed by the proposed new guidelines could result in extreme temperature increases. Bioelectromagnetics. 2020;41:164-168. © 2019 Bioelectromagnetics Society.

Limitations of Incident Power Density as a Proxy for Induced Electromagnetic Fields.

The most recent safety guidelines define basic restrictions for electromagnetic field exposure at frequencies more than 6 GHz in terms of spatial- and time-averaged transmitted power density inside the body. To enable easy-to-perform evaluations in situ, the reference levels for the incident power density were derived. In this study, we examined whether compliance with the reference levels always ensures compliance with basic restrictions. This was evaluated at several distances from different antennas (dipole, loop, slot, patch, and helix). Three power density definitions based on integration of the perpendicular real part of the Poynting vector, the real part of its three vector components, and its modulus were compared for averaging areas of λ2 /16, 4 cm2 (below 30 GHz) and 1 cm2 (30 GHz). In the reactive near-field (d < λ/(2π)), the transmitted power density can be underestimated if an antenna operates at the free space exposure limit. This underestimation may exceed 6 dB (4.0 times) and depends on the field source due to different coupling mechanisms. It is frequency-dependent for fixed-size averaging areas (4 and 1 cm2 ). At larger distances, transmission can be larger than the theoretical plane-wave transmission coefficient due to backscattering between the body and field source. Using the modulus of the incident Poynting vector yields the smallest underestimation. © 2020 Bioelectromagnetics Society.

Benchmark of different assessment methods for non-sinusoidal magnetic field exposure in the context of European Directive 2013/35/EU.

For the assessment of non-sinusoidal magnetic fields the European EMF Directive 2013/35/EU specified the Weighted Peak Method in Time Domain (WPM-TD) as the reference method. However, also other scientifically validated methods are allowed, provided that they lead to approximately equivalent and comparable results. In the non-binding guide for practical implementation of 2013/35/EU three methods alternative to the WPM-TD are described, i.e. the Weighted Peak Method in Frequency Domain (WPM-FD), the Multiple Frequency Rule (MFR), and an alternative Time Domain Assessment Method (TDAM). In this paper the results of a benchmark comparison of these assessment methods, based on 12 different time domain signals of magnetic induction, measured close to real devices and nine additional generic waveforms, are presented. The results demonstrated that assessments obtained with WPM-TD and WPM-FD can be considered approximately equivalent (maximum deviation 3.4 dB). The MFR systematically overestimates exposure, due to its inherently conservative definitions. In contrast, the TDAM significantly and systematically underestimates exposure up to a factor of 22 (26.8 dB) for the considered waveforms. The main reasons for this exposure underestimation by the TDAM are the introduction of an inappropriate time averaging, and the fact that the characteristic time parameter τ p,min, describing the minimum duration of all field changes dB/dt of the waveform is derived independently from the extent of the field change in the definitions of the TDAM. Consequently, we recommend not to use the TDAM as presently published in the non-binding guide to 2013/35/EU, as its application would be in contradiction with the underlying aim of 2013/35/EU, i.e. a harmonised level of occupational safety with respect to exposure to electromagnetic fields.

Dosimetric issues with simplified homogeneous body models in low frequency magnetic field exposure assessment.

A simplified procedure, using circular disk models with homogeneous electric conductivity as representations for different body parts, has been proposed recently by product standard IEC 62822-3 for the assessment of magnetic field exposure in proximity to current-carrying conductors of welding equipment. Based on such simplified models, worst case coupling coefficients CCEi(I), i.e. maximum induced electric field strength, normalised for current and frequency, for body parts at different distances d to straight single and double wire arrangements, as well as rectangular loop-shaped current paths are tabulated in the standard. In this work we compared CCEi(I) values obtained by numerical computations with detailed anatomical models of the hand/forearm with the corresponding values given in IEC 62822-3 for current-carrying single wire conductors along the forearm at distances d = 30, 50 and 100 mm, respectively. Our results clearly indicated that the CCEi(I) given in the standard may substantially underestimate the actual exposure. Using average values for tissue conductivities the observed extent of underestimation was up to 8.9 dB (factor 2.79) and may be even higher for worst case combinations of tissue conductivities. The reasons for this substantial underestimation are the oversimplified geometry, i.e. the circular disk does not reflect anatomical constrictions of the induction area present in realistic hand/forearm geometries, as well as the missing conductivity contrast between different tissues in the homogeneous disk models. Results of exposure assessment and corresponding minimum distances to components of welding equipment obtained by the simplified disk model approach suggested by IEC 62822-3 should therefore be considered with caution.

Pregnant women models analyzed for RF exposure and temperature increase in 3T RF shimmed birdcages.

PURPOSE: MRI is increasingly used to scan pregnant patients. We investigated the effect of 3 Tesla (T) two-port radiofrequency (RF) shimming in anatomical pregnant women models. THEORY AND METHODS: RF shimming improves B1+ uniformity, but may at the same time significantly alter the induced current distribution and result in large changes in both the level and location of the absorbed RF energy. In this study, we evaluated the electrothermal exposure of pregnant women in the third, seventh, and ninth month of gestation at various imaging landmarks in RF body coils, including modes with RF shimming. RESULTS: Although RF shimmed configurations may lower the local RF exposure for the mother, they can increase the thermal load on the fetus. In worst-case configurations, whole-body exposure and local peak temperatures-up to 40.8°C-are equal in fetus and mother. CONCLUSIONS: Two-port RF shimming can significantly increase the fetal exposure in pregnant women, requiring further research to derive a very robust safety management. For the time being, restriction to the CP mode, which reduces fetal SAR exposure compared with linear-horizontal polarization modes, may be advisable. Results from this study do not support scanning pregnant patients above the normal operating mode. Magn Reson Med 77:2048-2056, 2017. © 2016 International Society for Magnetic Resonance in Medicine.

A novel strategy combining magnetic particle hyperthermia pulses with enhanced performance binary ferrite carriers for effective in vitro manipulation of primary human osteogenic sarcoma cells.

The present study examines the heating efficiency of a combination of manganese or cobalt ferrites in a binary (Co- or Mn-) ferrite nanoparticle form with magnetite, covered with citric acid to improve biocompatibility. The nanoparticle synthesis is based on the aqueous co-precipitation of proper salts, a facile, low-cost, environmentally friendly and high yield synthetic approach. By detailed structural and magnetic characterisation, the direct influence of structural and magnetic features on magnetic hyperthermia concludes to optimum heating efficiency. At a second stage, best performing magnetic nanoparticles undergo in vitro testing in three cell lines: one cancer cell line and two reference healthy cell lines. Both binary ferrite (MnFe2O4/Fe3O4 and CoFe2O4/Fe3O4) appear to be internalised and well tolerated by the cells while a versatile hyperthermia protocol is attempted in an effort to further improve their in vitro performance. Within this protocol, hyperthermia sequences are split in two runs with an intermediate 48 h time interval cell incubation stage while in each run a variable field mode (single or multiple pulses) is applied. Single-pulse field mode represents a typical hyperthermia application scheme where cells undergo the thermal shock continuously. On the other hand multiple-pulses mode refers to multiple, much shorter in duration AC field changes (field ON/OFFs), at each hyperthermia run, resulting eventually in high heating rate and much more harmful cell treatment. Consequently, we propose a novel series of improved performance heat mediators based on ferrite structures which show maximum efficiency at cancer cells when combined with a versatile multiple-pulse hyperthermia module.

Desktop exposure system and dosimetry for small scale in vivo radiofrequency exposure experiments.

This paper describes a new approach to the risk assessment of exposure from wireless network devices, including an exposure setup and dosimetric assessment for in vivo studies. A novel desktop reverberation chamber has been developed for well-controlled exposure of mice for up to 24 h per day to address the biological impact of human exposure scenarios by wireless networks. The carrier frequency of 2.45 GHz corresponds to one of the major bands used in data communication networks and is modulated by various modulation schemes, including Global System for Mobile Communications (GSM), Universal Mobile Telecommunications System (UMTS), Radio Frequency Identification (RFID), and wireless local area network, etc. The system has been designed to enable exposures of whole-body averaged specific absorption rate (SAR) of up to 15 W/kg for six mice of an average weight of 25 g or of up to 320 V/m incident time-averaged fields under loaded conditions without distortion of the signal. The dosimetry for whole-body SAR and organ-averaged SAR of the exposed mice, with analysis of uncertainty and variation analysis, is assessed. The experimental dosimetry based on temperature measurement agrees well with the numerical dosimetry, with a very good SAR uniformity of 0.4 dB in the chamber. Furthermore, a thermal analysis and measurements were performed to provide better understanding of the temperature load and distribution in the mice during exposure.

Thermal tissue damage model analyzed for different whole-body SAR and scan durations for standard MR body coils.

PURPOSE: This article investigates the safety of radiofrequency induced local thermal hotspots within a 1.5T body coil by assessing the transient local peak temperatures as a function of exposure level and local thermoregulation in four anatomical human models in different Z-positions. METHODS: To quantize the effective thermal stress of the tissues, the thermal dose model cumulative equivalent minutes at 43°C was employed, allowing the prediction of thermal tissue damage risk and the identification of potentially hazardous MR scan-scenarios. The numerical results were validated by B1 (+) - and skin temperature measurements. RESULTS: At continuous 4 W/kg whole-body exposure, peak tissue temperatures of up to 42.8°C were computed for the thermoregulated model (60°C in nonregulated case). When applying cumulative equivalent minutes at 43°C damage thresholds of 15 min (muscle, skin, fat, and bone) and 2 min (other), possible tissue damage cannot be excluded after 25 min for the thermoregulated model (4 min in nonregulated). CONCLUSION: The results are found to be consistent with the history of safe use in MR scanning, but not with current safety guidelines. For future safety concepts, we suggest to use thermal dose models instead of temperatures or SAR. Special safety concerns for patients with impaired thermoregulation (e.g., the elderly, diabetics) should be addressed.

Simulation of radiofrequency ablation in real human anatomy.

PURPOSE: The objective of the current work was to simulate radiofrequency ablation treatment in computational models with realistic human anatomy, in order to investigate the effect of realistic geometry in the treatment outcome. MATERIALS AND METHODS: The body sites considered in the study were liver, lung and kidney. One numerical model for each body site was obtained from Duke, member of the IT'IS Virtual Family. A spherical tumour was embedded in each model and a single electrode was inserted into the tumour. The same excitation voltage was used in all cases to underline the differences in the resulting temperature rise, due to different anatomy at each body site investigated. The same numerical calculations were performed for a two-compartment model of the tissue geometry, as well as with the use of an analytical approximation for a single tissue compartment. RESULTS: Radiofrequency ablation (RFA) therapy appears efficient for tumours in liver and lung, but less efficient in kidney. Moreover, the time evolution of temperature for a realistic geometry differs from that for a two-compartment model, but even more for an infinite homogenous tissue model. However, it appears that the most critical parameters of computational models for RFA treatment planning are tissue properties rather than tissue geometry. CONCLUSIONS: Computational simulations of realistic anatomy models show that the conventional technique of a single electrode inside the tumour volume requires a careful choice of both the excitation voltage and treatment time in order to achieve effective treatment, since the ablation zone differs considerably for various body sites.

On the Evaluation of the Hyperthermic Efficiency of Magnetic Scaffolds.

Goal: Deep-seated tumors (DST) can be treated using thermoseeds exposed to a radiofrequency magnetic field for performing local interstitial hyperthermia treatment (HT). Several research efforts were oriented to the manufacturing of novel biocompatible magnetic nanostructured thermo-seeds, called magnetic scaffolds (MagS). Several iron-doped bioceramics or magnetic polymers in various formulations are available. However, the crucial evaluation of their heating potential has been carried out with significantly different, lab specific, variable experimental conditions and protocols often ignoring the several error sources and inaccuracies estimation. Methods: This work comments and provides a perspective analysis of an experimental protocol for the estimation methodology of the specific absorption rate (SAR) of MagS for DST HT. Numerical multiphysics simultions have been performed to outline the theoretical framework. After the in silico analysis, an experimental case is considered and tested. Results: From the simulations, we found that large overestimation in the SAR values can be found, due to the axial misplacement in the radiofrequency coil, while the radial misplacement has a lower impact on the estimated SAR value. Conclusions: The averaging of multiple temperature records is needed to reliably and effectively estimate the SAR of MagS for DST HT.

A Validated Methodological Approach to Prove the Safety of Clinical Electromagnetic Induction Systems in Magnetic Hyperthermia.

The present study focuses on the development of a methodology for evaluating the safety of MNH systems, through the numerical prediction of the induced temperature rise in superficial skin layers due to eddy currents heating under an alternating magnetic field (AMF). The methodology is supported and validated through experimental measurements of the AMF's distribution, as well as temperature data from the torsos of six patients who participated in a clinical trial study. The simulations involved a computational model of the actual coil, a computational model of the cooling system used for the cooling of the patients during treatment, and a detailed human anatomical model from the Virtual Population family. The numerical predictions exhibit strong agreement with the experimental measurements, and the deviations are below the estimated combined uncertainties, confirming the accuracy of computational modeling. This study highlights the crucial role of simulations for translational medicine and paves the way for personalized treatment planning.

CEM43°C thermal dose thresholds: a potential guide for magnetic resonance radiofrequency exposure levels?

OBJECTIVE: To define thresholds of safe local temperature increases for MR equipment that exposes patients to radiofrequency fields of high intensities for long duration. These MR systems induce heterogeneous energy absorption patterns inside the body and can create localised hotspots with a risk of overheating. METHODS: The MRI + EUREKA research consortium organised a "Thermal Workshop on RF Hotspots". The available literature on thresholds for thermal damage and the validity of the thermal dose (TD) model were discussed. RESULTS/CONCLUSIONS: The following global TD threshold guidelines for safe use of MR are proposed: 1. All persons: maximum local temperature of any tissue limited to 39 °C 2. Persons with compromised thermoregulation AND (a) Uncontrolled conditions: maximum local temperature limited to 39 °C (b) Controlled conditions: TD < 2 CEM43°C 3. Persons with uncompromised thermoregulation AND (a) Uncontrolled conditions: TD < 2 CEM43°C (b) Controlled conditions: TD < 9 CEM43°C The following definitions are applied: Controlled conditions A medical doctor or a dedicated trained person can respond instantly to heat-induced physiological stress Compromised thermoregulation All persons with impaired systemic or reduced local thermoregulation KEY POINTS: • Standard MRI can cause local heating by radiofrequency absorption. • Monitoring thermal dose (in units of CEM43°C) can control risk during MRI. • 9 CEM43°C seems an acceptable thermal dose threshold for most patients. • For skin, muscle, fat and bone,16 CEM43°C is likely acceptable.