Human detection thresholds of DC, AC, and hybrid electric fields: a double-blind study.

BACKGROUND: In the course of the ongoing transition of electric energy systems, transmission corridors are often upgraded to higher voltages and other technologies leading to another quality of human exposure. The study aims to determine human detection thresholds for direct current (DC), alternating current (AC), and hybrid electric fields (various DC; constant AC). METHODS: A total of 203 participants were exposed to DC, AC, and hybrid electric fields (EFs) in a highly specialized whole-body exposure laboratory using a double-blind experimental setting. Additionally, the participants were exposed to ion currents in part of the DC and hybrid sessions. To investigate environmental influences, relative humidity was changed in two subgroups during EF perception. Methods derived from the signal detection theory and the adaptive staircase procedure based on the single interval adjustment matrix were used to assess individual sensitivity and detection thresholds, respectively. RESULTS: The results indicated that detection thresholds of hybrid EF were lower compared to single EF presentation of DC or AC. Ion current exposure enhanced EF perception. High relative humidity facilitated DC EF perception, whereas low relative humidity reinforced the perception of AC EFs. CONCLUSIONS: With this systematic investigation of human perception of DC, AC, and hybrid EFs, detection thresholds were provided, which can help improve the construction processes of energy transmission systems and the prevention of unwanted sensory perception by contributing to the determination of limit values.

Identification of Environmental and Experimental Factors Influencing Human Perception of DC and AC Electric Fields.

As part of the energy transition in Germany, high-voltage direct current (HVDC) lines producing DC electric fields (EF) are in planning. Since the human perception of DC EF was rarely investigated in the past, we aimed to identify environmental and experimental factors influencing the human perception of direct current (DC) EF, alternating current (AC) EF, and the co-exposure of DC EF and AC EF (hybrid EF) under whole-body exposure. Additionally, first estimates of DC EF and AC EF perception thresholds as well as differences in human perception of DC EF and AC EF concerning the type of sensation experienced and the affected body part were evaluated. A highly sophisticated exposure lab was built to expose participants to various EF strengths and ask for their assessment concerning the presence of an EF. To estimate the individual perception thresholds of 11 participants, the signal detection theory as well as the single-interval-adjustment matrix procedure were applied. Relative humidity could be identified as an environmental factor influencing the perception of AC EF and DC EF in different ways. An appropriate ramp slope and an exposure duration for future studies could be elaborated. Additionally, perception thresholds were lower under hybrid EF exposure than under DC EF or AC EF exposure alone. Cutaneous sensations evoked under DC EF and AC EF exposure were individually different and attributed to various parts of the body. Several environmental and experimental factors influencing the human perception of EF could be identified and provide an essential basis for a large-scale study. © 2021 Bioelectromagnetics Society.

Interference of cardiovascular implantable electronic devices by static electric and magnetic fields.

Introduction: Electromagnetic interference (EMI) of cardiovascular implantable electronic devices (CIED) can lead to malfunctions and pose a danger for implant carriers. The increased use of DC technologies, e.g. in electric mobility, creates more static fields representing an increasing hazard for implant carriers.Areas covered: A combination of approaches was used to determine thresholds for EMI by static fields. A literature search was conducted to identify relevant EMI mechanisms and to extract possible thresholds. The literature search revealed four interference mechanisms caused by static magnetic fields and none for static electric fields. Due to the scarce information on motion-induced EMI, numerical simulations were performed to obtain a threshold. The simulation results were evaluated using medical product standards and benchmark tests on commercially available CIEDs. The results show that motion-induced interference should not occur below the activation of the magnetic safety switch (reed switch or Hall-effect sensor, MSS).Expert opinion: The determined threshold for motion-induced EMI at 24.8 mT shows that the MSS activation is still the most relevant mechanism that can occur at 0.8 mT. Limit values for the general population do not protect implant carriers from EMI.

Computational models for contact current dosimetry at frequencies below 1 MHz.

Electric contact currents (CC) can cause muscle contractions, burns, or ventricular fibrillation which may result in life-threatening situations. In vivo studies with CC are rare due to potentially hazardous effects for participants. Cadaver studies are limited to the range of tissue's electrical properties and the utilized probes' size, relative position, and sensitivity. Thus, the general safety standards for protection against CC depend on a limited scientific basis. The aim of this study was therefore to develop an extendable and adaptable validated numerical body model for computational CC dosimetry for frequencies between DC and 1 MHz. Applying the developed model for calculations of the IEC heart current factors (HCF) revealed that in the case of transversal CCs, HCFs are frequency dependent, while for longitudinal CCs, the HCFs seem to be unaffected by frequency. HCFs for current paths from chest or back to hand appear to be underestimated by the International Electrotechnical Commission (IEC 60479-1). Unlike the HCFs provided in IEC 60479-1 for longitudinal current paths, our work predicts the HCFs equal 1.0, possibly due to a previously unappreciated current flow through the blood vessels. However, our results must be investigated by further research in order to make a definitive statement. Contact currents of frequencies from DC up to 100 kHz were conducted through the numerical body model Duke by seven contact electrodes on longitudinal and transversal paths. The resulting induced electric field and current enable the evaluation of the body impedance and the heart current factors for each frequency and current path.

Biological and health-related effects of weak static magnetic fields (≤ 1 mT) in humans and vertebrates: A systematic review.

BACKGROUND: There is a rapid development in technologies that generate weak static magnetic fields (SMF) including high-voltage direct current (HVDC) lines, systems operating with batteries, such as electric cars, and devices using permanent magnets. However, few reviews on the effects of such fields on biological systems have been prepared and none of these evaluations have had a particular focus on weak SMF (≤ 1 mT). The aim of this review was to systematically analyze and evaluate possible effects of weak SMF (≤ 1 mT) on biological functioning and to provide an update on the current state of research. METHODS: This review was prepared in accordance with the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) statement. Methodological limitations in individual studies were assessed using the Office of Health Assessment and Translation (OHAT) Risk-of-Bias Rating Tool. RESULTS: Eleven studies fulfilled the eligibility criteria and were included in this review. All included studies were experimental animal studies as no human studies were among the eligible articles. Eight of the eleven studies reported responses of rat, rabbits and quails to weak SMF exposure that were expressed as altered melatonin biosynthesis, reduced locomotor activity, altered vasomotion and blood pressure, transient changes in blood pressure-related biochemical parameters, or in the level of neurotransmitters and increases in enzyme activities. It remained largely unclear from the interpretation of the results whether the reported effects in the evaluated studies were beneficial or detrimental for health. CONCLUSION: The available evidence from the literature reviewed is not sufficient to draw a conclusion for biological and health-related effects of exposure to weak SMF. There was a lack of homogeneity regarding the exposed biological systems and the examined endpoints as well as a lack of scientific rigor in most reviewed studies which lowered credibility in the reported results. We therefore encourage further and more systematic research in this area. Any new studies should particularly address effects of exposure to SMF on biological functioning in humans to evaluate whether SMF pose a risk to human health.

Direct current electrical injuries: A systematic review of case reports and case series.

BACKGROUND: Direct current (DC) powered equipment and devices, including photovoltaic systems, high-voltage direct current power lines and novel concepts in electromobility have become increasingly popular in recent years. However, under adverse circumstances by malfunction or mishandling of these applications electrical injuries may occur when electric current passes through the human body. This review aimed at systematically summarizing the medical consequences of DC electrical injuries described in case reports and case series. METHODS: The Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) guided the methodological conduct and reporting. RESULTS: Sixteen case reports and 3 case series were eligible for this review and included 70 patients. The reviewed articles were very heterogeneous regarding sources of DC electrical injuries and the reported medical consequences, including burns and skin lesions (n=67), neurological consequences (n=11), unconsciousness (n=10), cardiac consequences (n=8) and bone fractures (n=6). Seventeen individuals did not survive the electrical injuries. CONCLUSION: From the few available data and partly incomplete documentations of cases we could gather hints of DC medical consequences, however, it was not possible to identify well-defined medical consequences for various circumstances of DC electrical injuries in occupational and non-occupational settings. To achieve this goal, additional studies are required, each providing a comprehensive description of the medical consequences and the circumstances of the electrical injuries.

Systematic review on the biological effects of electric, magnetic and electromagnetic fields in the intermediate frequency range (300 Hz to 1 MHz).

BACKGROUND: Many novel technologies, including induction cookers or wireless power transfer, produce electric fields (EF), magnetic fields (MF) or electromagnetic fields (EMF) in the intermediate frequency (IF) range. The effects of such fields on biological systems, however, have been poorly investigated. The aim of this systematic review was to provide an update of the state of research and to evaluate the potential for adverse effects of EF, MF and EMF in the IF range (300 Hz to 1 MHz) on biological systems. METHODS: The review was prepared in accordance with PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines. Methodical limitations in individual studies were assessed using the Office of Health Assessment and Translation (OHAT) Risk of Bias Rating Tool for Human and Animal Studies. RESULTS: Fifty-six studies exposing humans, animals or in vitro systems were eligible for this review. In these studies, many different endpoints were examined and most of the findings were obtained in studies with exposure to MF. For most endpoints, however, the reviewed studies yielded inconsistent results, with some studies indicating no effect and some linking IF exposure with adverse effects. In the majority of the included studies, the applied field strengths were above the International Commission on Non-Ionizing Radiation Protection (ICNIRP) reference levels for the general public and the applied frequencies were mainly below 100 kHz. Furthermore, many of the reviewed studies suffered from methodical limitations which lowered the credibility of the reported results. CONCLUSION: Due to the large heterogeneity in study designs, endpoints and exposed systems, as well as the inconsistent results and methodical limitations in many studies, the quality of evidence for adverse effects remains inadequate for drawing a conclusion on investigated biological effects of IF fields for most endpoints. We recommend that in future studies, effects of EF, MF and EMF in the IF range should be investigated more systematically, i.e., studies should consider various frequencies to identify potential frequency-dependent effects and apply different field strengths, especially if threshold-dependent effects are expected. Priority should be given to the investigation of acute effects, like induction of phosphenes, perception, excitation of nerves or muscles and thermal effects. This would be an important step towards the validation of the reference levels recommended by ICNIRP. Furthermore, we recommend that any new studies aim at implementing high quality dosimetry and minimizing sources of risk of bias.

Electromagnetic interference in cardiac electronic implants caused by novel electrical appliances emitting electromagnetic fields in the intermediate frequency range: a systematic review.

Electromagnetic fields (EMF) in the intermediate frequency (IF) range are generated by many novel electrical appliances, including electric vehicles, radiofrequency identification systems, induction hobs, or energy supply systems, such as wireless charging systems. The aim of this systematic review is to evaluate whether cardiovascular implantable electronic devices (CIEDs) are susceptible to electromagnetic interference (EMI) in the IF range (1 kHz-1 MHz). Additionally, we discuss the advantages and disadvantages of the different types of studies used to investigate EMI. Using the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) statement, we collected and evaluated studies examining EMI in in vivo studies, in vitro studies (phantom studies, benchmark tests), and simulation studies. Our analysis revealed that cardiac implants are susceptible to malfunction induced by EMF in the IF range. Electromagnetic interference may in particular be provoked by security systems and induction hobs. The results of the studies evaluated in this systematic review further indicate that the likelihood for EMI is dependent on exposure-related parameters (field strength, frequency, and modulation) and on implant- as well as on lead-related parameters (model, type of implant, implant sensitivity setting, lead configuration, and implantation site). The review shows that the factors influencing EMI are not sufficiently characterized and EMF limit values for CIED patients cannot be derived yet. Future studies should therefore, consider exposure-related parameters as well as implant- and lead-related parameters systematically. Additionally, worst-case scenarios should be considered in all study types where possible.

Biological effects of exposure to static electric fields in humans and vertebrates: a systematic review.

BACKGROUND: High-voltage direct current (HVDC) lines are the technology of choice for the transport of large amounts of energy over long distances. The operation of these lines produces static electric fields (EF), but the data reviewed in previous assessments were not sufficient to assess the need for any environmental limit. The aim of this systematic review was to update the current state of research and to evaluate biological effects of static EF. METHODS: Using the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-analyses) recommendations, we collected and evaluated experimental and epidemiological studies examining biological effects of exposure to static EF in humans (n = 8) and vertebrates (n = 40). RESULTS: There is good evidence that humans and animals are able to perceive the presence of static EF at sufficiently high levels. Hair movements caused by electrostatic forces may play a major role in this perception. A large number of studies reported responses of animals (e.g., altered metabolic, immunologic or developmental parameters) to a broad range of static EF strengths as well, but these responses are likely secondary physiological responses to sensory stimulation. Furthermore, the quality of many of the studies reporting physiological responses is poor, which raises concerns about confounding. CONCLUSION: The weight of the evidence from the literature reviewed did not indicate that static EF have adverse biological effects in humans or animals. The evidence strongly supported the role of superficial sensory stimulation of hair and skin as the basis for perception of the field, as well as reported indirect behavioral and physiological responses. Physical considerations also preclude any direct effect of static EF on internal physiology, and reports that some physiological processes are affected in minor ways may be explained by other factors. While this literature does not support a level of concern about biological effects of exposure to static EF, the conditions that affect thresholds for human detection and possible annoyance at suprathreshold levels should be investigated.

Effect of lead position and orientation on electromagnetic interference in patients with bipolar cardiovascular implantable electronic devices.

Aims: Electromagnetic interferences (EMIs) with cardiovascular implantable electronic devices (CIEDs) are associated with potential risk for patients. Studies imply that CIED sensitivity setting and lead's tip-to-ring spacing determine the susceptibility of CIEDs with bipolar leads to electric and magnetic fields (EMFs); however, little is known about additional decisive parameters affecting EMI of CIEDs. We therefore investigated the influence of different patient-, device-, and lead-depending variables on EMIs in 160 patients. Methods and Results: We ran numerical simulations with human models to determine lead-depending variables on the risk of EMI by calculating the voltage induced in bipolar leads from 50/60 Hz EMF. We then used the simulation results and analysed 26 different patient-, device-, and lead-depending variables with respect to the EMI threshold of 160 CIED patients. Our analyses revealed that a horizontal orientation and a medial position of the bipolar lead's distal end (lead-tip) are most beneficial for CIED patients to reduce the risk of EMI. In addition, the effect of CIED sensitivity setting and lead's tip-to-ring spacing was confirmed. Conclusion: Our data suggest that in addition to the established influencing factors, a medial position of the lead-tip for the right ventricular lead as achievable at the interventricular septum and a horizontal orientation of the lead-tip can reduce the risk of EMI. In the right atrium, a horizontal orientation of the lead-tip should generally be striven independent of the chosen position. Still important to consider remains a good intrinsic sensing amplitude during implant procedure.

Contraindications for video capsule endoscopy.

Video capsule endoscopy (VCE) has been applied in the last 15 years in an increasing field of applications. Although many contraindications have been put into perspective, some precautions still have to be considered. Known stenosis of the gastrointestinal tract is a clear contraindication for VCE unless surgery is already scheduled or at least has been considered as an optional treatment modality. In patients with a higher incidence of stenosis, as in an established diagnosis of Crohn's disease, clinical signs of obstruction, prior radiation or surgical small bowel resection, a preceding test with the self-dissolving patency capsule can override this contraindication. Endoscopic placement of the capsule should be considered in patients with swallowing disorders to avoid aspiration. Esophageal or gastric motility disorders may require endoscopic capsule transport or application of prokinetics if the real-time viewer proofs delayed transit. In pregnant women, VCE should be restricted to urgent cases where diagnosis cannot be postponed after delivery, as data on safety are missing. There is theoretical and clinical evidence that patients with implanted cardiac devices such as a pacemaker, cardioverters or left heart assist devices, can safely undergo VCE in spite of still existing contraindication by manufacturers. Children from the age of 2 years have safely undergone VCE. Although video capsules are not proven safe with magnetic resonance imaging (MRI), first single cases of patients incidentally undergoing MRI with an incorporated capsule have been reported, showing susceptibility artifacts but no signs of clinical harm.

Assessment of Electromagnetic Interference with Active Cardiovascular Implantable Electronic Devices (CIEDs) Caused by the Qi A13 Design Wireless Charging Board.

Electromagnetic interference is a concern for people wearing cardiovascular implantable electronic devices (CIEDs). The aim of this study was to assess the electromagnetic compatibility between CIEDs and the magnetic field of a common wireless charging technology. To do so the voltage induced in CIEDs by Qi A13 design magnetic fields were measured and compared with the performance limits set by ISO 14117. In order to carry this out a measuring circuit was developed which can be connected with unipolar or bipolar pacemaker leads. The measuring system was positioned at the four most common implantation sites in a torso phantom filled with physiological saline solution. The phantom was exposed by using Helmholtz coils from 5 µT to 27 µT with 111 kHz sine­bursts or by using a Qi A13 design wireless charging board (Qi­A13­Board) in two operating modes "power transfer" and "pinging". With the Helmholtz coils the lowest magnetic flux density at which the performance limit was exceeded is 11 µT. With the Qi­A13­Board in power transfer mode 10.8% and in pinging mode 45.7% (2.2% at 10 cm distance) of the performance limit were reached at maximum. In neither of the scrutinized cases, did the voltage induced by the Qi­A13­Board exceed the performance limits.

Are patients with cardiac implants protected against electromagnetic interference in daily life and occupational environment?

Utilization of cardiac implants such as pacemakers and implantable cardioverter defibrillators is now commonplace among heart disease patients. The ever-increasing technological complexity of these devices is matched by the near omnipresent exposure to electric, magnetic, and electromagnetic fields (EMFs), both in everyday life and the occupational environment. Given that electromagnetic interferences (EMIs) are associated with potential risk in device patients, physicians are increasingly confronted with managing device patients with intermittent EMI and chronic occupational exposure. The current review aims to provide a contemporary overview of cardiovascular implantable electronic devices, their function and susceptibility of non-medical EMFs and provide recommendations for physicians caring for cardiac device patients presenting with EMI.

Capsule endoscopy in patients with cardiac pacemakers, implantable cardioverter defibrillators and left heart assist devices.

According to the recommendations of the US Food and Drug Administration and manufacturers, capsule endoscopy should not be used in patients carrying implanted cardiac devices. For this review we considered studies indexed (until 30.06.2013) in Medline [keywords: capsule endoscopy, small bowel endoscopy, cardiac pacemaker, implantable cardioverter defibrillator, interference, left heart assist device], technical information from Given Imaging and one own publication (not listed in Medline). Several in vitro and in vivo studies included patients with implanted cardiac devices who underwent capsule endoscopy. No clinically relevant interference was noticed. Initial reports on interference with a simulating device were not reproduced. Furthermore technical data of PillCam (Given Imaging) demonstrate that the maximum transmission power is below the permitted limits for cardiac devices. Hence, impairment of cardiac pacemaker, defibrillator or left ventricular heart assist device function by capsule endoscopy is not expected. However, wireless telemetry can cause dysfunction of capsule endoscopy recording. Application of capsule endoscopy is feasible and safe in patients with implanted cardiac devices such as pacemakers, cardioverter defibrillators, and left heart assist devices. Development of new technologies warrants future re-evaluation.

Electromagnetic interference with implantable cardioverter-defibrillators at power frequency: an in vivo study.

BACKGROUND: The number of implantable cardioverter-defibrillators (ICDs) for the prevention of sudden cardiac death is continuing to increase. Given the technological complexity of ICDs, it is of critical importance to identify and control possible harmful electromagnetic interferences between various sources of electromagnetic fields and ICDs in daily life and occupational environments. METHODS AND RESULTS: Interference thresholds of 110 ICD patients (1-, 2-, and 3-chamber ICDs) were evaluated in a specifically developed test site. Patients were exposed to single and combined electric and magnetic 50-Hz fields with strengths of up to 30 kV·m⁻¹ and 2.55 mT. Tests were conducted considering worst-case conditions, including maximum sensitivity of the device or full inspiration. With devices being programmed to nominal sensitivity, ICDs remained unaffected in 91 patients (83%). Five of 110 devices (5%) showed transient loss of accurate right ventricular sensing, whereas 14 of 31 (45%) of the 2- and 3-chamber devices displayed impaired right atrial sensing. No interference was detected in 71 patients (65%) within the tested limits with programming to maximum sensitivity, whereas 20 of 110 subjects (18%) exhibited right ventricular disturbances and 19 of 31 (61%) subjects exhibited right atrial disturbances. CONCLUSIONS: Extremely low-frequency daily-life electromagnetic fields do not disturb sensing capabilities of ICDs. However, strong 50-Hz electromagnetic fields, present in certain occupational environments, may cause inappropriate sensing, potentially leading to false detection of atrial/ventricular arrhythmic events. When the right atrial/right ventricular interferences are compared, the atrial lead is more susceptible to electromagnetic fields. CLINICAL TRIAL REGISTRATION URL: http://clinicaltrials.gov/ct2/show/NCT01626261. Unique identifier: NCT01626261.

Stochastic simulations of the exponential-beta function as an assessment of the validity of the choice of the Wagner-Nelson method for the analysis of ¹³C-octanoic acid breath tests.

A compartmental model that generates the exponential-beta function µkß(1 - e(-kt))(ß - 1) e(-kt) in order to run stochastic simulations has been constructed. The mathematical considerations that lead to the development of the model and the comparison of its performance with real data sets obtained from the studies of gastric emptying in healthy volunteers using ¹³C-octanoic acid breath tests are demonstrated. Stochastic simulations have been used to introduce randomness. These confirmed the choice of an exponential-beta function to model the physiological system, as agreement was obtained between experimental and theoretical data. The comparisons were made by visual inspection only, as the intention was to demonstrate that the stochastic exponential-ß model would generate the full range of observed curve shapes.