[Assessment of the risk due to exposure to EMF with particular reference to the protection of sensitive subjects]. / La valutazione del rischio da esposizione a CEM con particolare riguardo alla tutela dei soggetti sensibili.

SUMMARY: Purpose. The work illustrates useful elements for the risk assessment for workers exposed to electromagnetic fields, also in reference to sensitive subjects such as those with active implantable medical devices (AIMD). Methods. The approach introduced by Legislative Decree 81/08 for risk assessment does not explicitly include operational criteria and specific measures for the protection of sensitive subjects. In the case of workers with DMIA, the employer may refer to relevant harmonized technical standards. Results. They are shown the results of in vitro tests performed on pacemakers following the indications of the technical reference standard and employing sources of electromagnetic fields that, due to the type of signal emitted, do not allow to exclude an a priori influence on the operation of the device. Conclusions. Workers at particular risk are generally protected if the requirements established for the population are respected. This measure may, under certain conditions, not be sufficient,making it necessary to carry out more in-depth and individual assessments. However, the cases illustrated here for AIMD showed interference phenomena only in limited experimental configurations despite the levels of the electric and magnetic fields generated by the sources exceeding the limits for the general population.

Occupational exposure to physical agents: the new Italian database for risk assessment and control.

This article presents the new Italian database of physical agents, which is available at http://www.portaleagentifisici.it. It supports in risk assessment employers who have to comply with Italy's Legislative Decree 81/2008 (transposing into law European Union Directives 2003/10/EC, 2002/44/EC, 2004/40/EC and 2006/25/EC). The database currently contains measurements and declared European Community (EC) values from over 2540 machines; in particular, the database hosts data on mechanical vibration from over 1430 hand-held power tools (e.g., pneumatic and electric hammers, chainsaws, grinders, drills, sanders and saws) and from over 1020 whole-body machines (e.g., buses, fork lifts and wheel tractors). The database is continuously updated as soon as new experimental and declared data are acquired.

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.

Systematic numerical assessment of occupational exposure to electromagnetic fields of transcranial magnetic stimulation.

PURPOSE: This study aims to perform a classification and rigorous numerical evaluation of the risks of occupational exposure in the health environment related to the administration of transcranial magnetic stimulation (TMS) treatment. The study investigates the numerically estimated induced electric field that occurs in the human tissues of an operator caused by exposure to the variable magnetic field produced by TMS during treatments. This could be a useful starting point for future risk assessment studies and safety indications in this context. METHODS: We performed a review of the actual positions assumed by clinicians during TMS treatments. Three different TMS coils (two circular and one figure-of-eight) were modeled and characterized numerically. Different orientations and positions of each coil with respect to the body of the operator were investigated to evaluate the induced electric (-E) field in the body tissues. The collected data were processed to allow comparison with the safety standards for occupational exposure, as suggested by the International Commission on Non-Ionizing Radiation Protection (ICNIRP) 2010 guidelines. RESULTS: Under the investigated conditions, exposure to TMS shows some criticalities for the operator performing the treatment. Depending on the model of the TMS coil and its relative position with respect to the operator's body, the numerically estimated E-field could exceed the limits suggested by the ICNIRP 2010 guidelines. We established that the worst-case scenario for the three coils occurs when they are placed in correspondence of the abdomen, with the handle oriented parallel to the body (II orientation). Working at a maximum TMS stimulator output (MSO), the induced E-field is up to 7.32 V/m (circular coil) and up to 1.34 V/m (figure-of-eight coil). The induced E-field can be modulated by the TMS percentage of MSO (%MSO) and by the distance between the source and the operator. At %MSO equal to or below 80%, the figure-of-eight coil was compliant with the ICNIRP limit (1.13 V/m). Conversely, the circular coil causes an induced E-field above the limits, even when powered at a %MSO of 30%. Thus, in the investigated worst-case conditions, an operator working with a circular coil should keep a distance from its edge to be compliant with the guidelines limit, which depends on the selected %MSO: 38 cm at 100%, 32 cm at 80%, 26.8 cm at 50%, and 19.8 cm at 30%. Furthermore, attention should be paid to the induced E-field reached in the operator's hand as the operator typically holds the coil by hand. In fact in the hand, we estimated an induced E-field up to 10 times higher than the limits. CONCLUSIONS: Our numerical results indicate that coil positions, orientations, and distances with respect to the operator's body can determine the levels of induced E-field that exceed the ICNIRP limits. The induced E-field is also modulated by the choice of %MSO, which is related to the TMS application. Even under the best exposure conditions, attention should be paid to the exposure of the hand. These findings highlight the need for future risk assessment studies to provide more safety information for the correct and safe use of TMS devices.

Workers with Cardiac AIMD Exposed to EMF: Methods and Case Studies for Risk Analysis in the Framework of the European Regulations.

Workers with cardiac active implantable medical devices (AIMD), such as a pacemaker (PM) or an implantable defibrillator (ICD), are considered by the occupational health and safety regulation framework 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 first describe the general methodology that shall be followed for the risk assessment of employees with a cardiac AIMD exposed to EMF, according to the EU regulation, and in particular to the EN 50527-2-1:2016 and 50527-2-2:2018 standards. Then, three case studies related to specific EMF sources are presented, to better describe how the initial analysis of the risk assessment can be performed in practice, and to understand if a further specific risk assessment analysis is required or not.

Issues in the Implementation of Directive 2013/35/EU Regarding the Protection of Workers against Electromagnetic Fields.

In 2016 the Directive 2013/35/EU regarding the protection of health and safety of workers exposed to electromagnetic fields was transposed in Italy. Since then, the authors of this paper have been faced with several issues related to the implementation of the provisions of the Directive, which pose some interpretative and operative concerns. A primary critical feature of the Directive is that, in some circumstances, conditions of "overexposure", i.e., of exceeding the exposure limits, are allowed. In the case of transient effects, the "flexibility" concerning the compliance with exposure limits is based on the approach introduced by ICNIRP in its guidelines on static magnetic fields and on time-varying electric and magnetic fields. On the contrary, the possibility of exceeding the exposure limits for health effects, formally recognized in the article of the Directive dealing with derogations, is not included in the ICNIRP guidelines. This paper analyzes the main concerns in interpreting and managing some provisions of the Directive with particular reference to the issue of how the employer can manage the situations of overexposure.

Exposure of workers to electromagnetic fields. A review of open questions on exposure assessment techniques.

European Directive 2004/40/EC on occupational exposure to electromagnetic fields (EMF), based on the guidelines of the International Commission on Non-Ionizing Radiation Protection, was to be implemented in the Member States of the European Union by 2008. Because of some unexpected problems the deadline was postponed until 2012. This paper reviews some of the problems identified and presents some suggestions for possible solutions based on the authors' experience in assessing occupational exposure to EMF. Among the topics discussed are movement in static magnetic fields, ways to time average extreme low frequency signals, the difference between emission and exposure standards, and ways of dealing with those issues.

Occupational exposure in MR facilities due to movements in the static magnetic field.

PURPOSE: The exposure of operators moving in the static field of magnetic resonance (MR) facilities was assessed through measurements of the magnetic flux density, which is experienced as variable in time because of the movement. Collected data were processed to allow the comparison with most recent and authoritative safety standards. METHODS: Measurements of the experienced magnetic flux density B were performed using a probe worn by volunteers moving in MR environments. A total of 55 datasets were acquired nearby a 1.5 T, 3 T, and 7 T whole body scanners. Three different metrics were applied: the maximum intensity of B, to be compared with 2013/35/EU Directive exposure limit values for static fields; the maximum variation of the vector B on every 3s-interval, for comparison with the ICNIRP-2014 basic restriction aimed at preventing vertigo effects; two weighted-peak indices (for "sensory" and "health" effects: SENS-WP, HLTH-WP), assessing compliance with ICNIRP-2014 and EU Directive recommendations intended to prevent stimulation effects. RESULTS: Peak values of |B| were greater than 2 T in nine of the 55 datasets. All the datasets at 1.5 T and 3 T were compliant with the limit for vertigo effects, whereas six datasets at 7 T turned out to be noncompliant. At 7 T, all 36 datasets were noncompliant for the SENS-WP index and 26 datasets even for the HLTH-WP one. CONCLUSIONS: Results demonstrate that compliance with EU Directive limits for static fields does not guarantee compliance with ICNIRP-2014 reference levels and clearly show that movements in the static field could be the key component of the occupational exposure to EMF in MR facilities.

Electromagnetic fields: principles of exposure mitigation.

Basic principles of reducing exposure to electromagnetic fields are reviewed in this article. Measures to reduce exposure can be divided into organisational/administrative and technical/engineering actions. Both strategies are briefly analysed and the basic principles of the theory of shielding are presented. A definition of shielding effectiveness (SE) is given, and the results from the general Transmission Lines Theory are presented. Practical situations of shielding static and time-varying electric and magnetic fields are discussed on the basis of the physical properties of the fields and of the shield.

Global and Mediterranean climate change: a short summary.

Observed changes at the global scale. An increase of the annual mean global temperature and changes of other climate parameters have been observed in the last century. The global temperature and the atmospheric concentration of greenhouse gases are changing at a very fast pace compared to those found in palaeoclimate records. Changes in the Mediterranean. Variations of some climate change indicators can be much larger at the local than at the global scale, and the Mediterranean has been indicated among the regions most sensitive to climate change, also due to the increasing anthropogenic pressure. Model projections for the Mediterranean foresee further warming, droughts, and long-lasting modifications. IMPACTS: Regional climate changes impact health and ecosystems, creating new risks, determined not only by weather events, but also by changing exposures and vulnerabilities. These issues, and in particular those regarding occupational safety, have not been sufficiently addressed to date.

Wrong detection of ventricular fibrillation in an implantable cardioverter defibrillator caused by the movement near the MRI scanner bore.

The static magnetic field generated by MRI systems is highly non-homogenous and rapidly decreases when moving away from the bore of the scanner. Consequently, the movement around the MRI scanner is equivalent to an exposure to a time-varying magnetic field at very low frequency (few Hz). For patients with an implanted cardiac stimulators, such as an implantable cardioverter/defibrillator (ICD), the movements inside the MRI environment may thus induce voltages on the loop formed by the leads of the device, with the potential to affect the behavior of the stimulator. In particular, the ICD's detection algorithms may be affected by the induced voltage and may cause inappropriate sensing, arrhythmia detections, and eventually inappropriate ICD therapy.We performed in-vitro measurements on a saline-filled humanshaped phantom (male, 170 cm height), equipped with an MRconditional ICD able to transmit in real-time the detected cardiac activity (electrograms). A biventricular implant was reproduced and the ICD was programmed in standard operating conditions, but with the shock delivery disabled. The electrograms recorded in the atrial, left and right ventricle channels were monitored during rotational movements along the vertical axis, in close proximity of the bore. The phantom was also equipped with an accelerometer and a magnetic field probe to measure the angular velocity and the magnetic field variation during the experiment. Pacing inhibition, inappropriate detection of tachyarrhythmias and of ventricular fibrillation were observed. Pacing inhibition began at an angular velocity of about 7 rad/s, (dB/dt of about 2 T/s). Inappropriate detection of ventricular fibrillation occurred at about 8 rad/s (dB/dt of about 3 T/s). These findings highlight the need for a specific risk assessment of workers with MR-conditional ICDs, which takes into account also effects that are generally not considered relevant for patients, such as the movement around the scanner bore.

Currents induced by fast movements inside the MRI room may cause inhibition in an implanted pacemaker.

The static magnetic field generated by MRI systems is highly non-homogenous and rapidly decreases when moving away from the bore of the scanner. Consequently, the movement around the MRI scanner is equivalent to an exposure to a time-varying magnetic field at very low frequency (few Hz). If people with an implanted pacemaker (PM) enter the MRI room, fast movements may thus induce voltages on the loop formed by the PM lead, with the potential to modify the correct behavior of the stimulator. In this study, we performed in-vitro measurements on a human-shaped phantom, equipped with an implantable PM and with a current sensor, able to monitor the activity of the PM while moving the phantom in the MRI room. Fast rotational movements in close proximity of the bore of the scanner caused the inappropriate inhibition of the PM, programmed in VVI modality, maximum sensitivity, unipolar sensing and pacing. The inhibition occurred for a variation of the magnetic field of about 3 T/s. These findings demonstrate that great care must be paid when extending PM MRI compatibility from patients to healthcare personnel, since the safety procedures and the MRI-conditional PM programming (e.g. asynchronous stimulation or bipolar sensing) used for patients cannot be applied.

Mobile phones exposure induces changes of contingent negative variation in humans.

Event-related potentials have been largely employed to test effects of GSM emissions on human brain. The aim of the present study was the evaluation of initial contingent negative variation (iCNV) changes, induced by 900 MHz GSM exposure, in a double blind design in healthy volunteers, subjected to a threefold experimental condition, EXPOSED (A), a real GSM phone emitting electromagnetic power, SHAM (B), a real phone where the electromagnetic power was dissipated on an internal load and OFF (C), a phone completely switched-off. Ten healthy right-handed volunteers were evaluated. The CNV was recorded during a 10 min time interval in each of the three experimental conditions A, B, and C, in order to assess the iCNV amplitude and habituation. The iCNV amplitude decreased and habituation increased during both A and B conditions, compared with condition C. This effect was diffuse over the scalp, and there was no significant prevalence of iCNV amplitude reduction on the left side, were the phones were located. Mobile Phones exposures A and B seemed to act on brain electrical activity, reducing the arousal and expectation of warning stimulus. This evidence, limited by the low number of subjects investigated, could be explained in terms of an effect induced by both the GSM signal and the extremely low frequency magnetic field produced by battery and internal circuits.