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.

Personalized Antiarrhythmic Therapy Using a Self-Managed Daily-ECG Device.

A 50-year-old Caucasian man arrived at the emergency department presenting paucisymptomatic atrial fibrillation. Once discharged after the appropriate treatments, the patient continued to have paucisymptomatic episodes. For this reason, he was provided with the Cardionica device which made it possible to better investigate the type of arrhythmic episodes, in order to tailor his therapy and to finally restore a normal sinus rhythm in the patient.

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.

iPhone 12 MagSafe technology and cardiac implantable devices: Assessment of the actual risk.

BACKGROUND: Pacemaker (PM) and implantable cardioverter defibrillators (ICD) are equipped with a magnetic sensor activated by external application of magnets to easily manage some functions of these devices. If activated inadvertently or outside a controlled environment and without the supervision of clinical personnel, this magnetic mode introduces a potential risk. In reality, the possibility of a static magnetic field affecting a PM or ICD is remote. However, the presence of the magnet in the iPhone 12 made the possibility of inadvertently activating the magnetic switch of PM and ICD less remote. OBJECTIVE: This study investigates the effects of magnetic interference of the iPhone 12 on a large set of cardiac implantable devices representative of the current market and proposes adequate rules of conduct. METHODS: We investigated the risk of the magnetic interference of the iPhone 12 and its MagSafe accessories on a comprehensive set of PMs and ICDs, including the subcutaneous ICD. For the first time, the magnetic interference phenomena were correlated with the magnetic field levels measured all around iPhone 12. RESULTS: We discovered that the magnets inside iPhone 12 trigger the magnetic mode in the 12 tested devices up to a distance of 1 cm. CONCLUSIONS: Considering the implications related to the activation of the magnetic switch, to date, it is advisable to follow Apple's indications relating to the safety distance of 15 cm, which is widely compatible with the results obtained from this paper and in line with the indications provided by the implantable cardiac device manufacturers.

Estimate and reporting of longevity for cardiac implantable electronic devices: a proposal for standardized criteria.

BACKGROUND: Cardiac implantable electronic devices (CIEDs) are widely used according to consensus guidelines in various patient categories. The longevity of CIED is a major determinant of the frequency with which patients require device replacement. Given the mismatch between the useful life of the devices and patient survival, device replacement is often needed. There is a great variability in the criteria used by manufacturers to determine the longevity of pacemakers (PM), implantable defibrillators (ICDs), and devices for cardiac resynchronization therapy (CRT). Thus, a fair comparison and an effective device evaluation is often difficult. METHODS: The objective of this paper is to provide standardized criteria based on typical clinical settings for estimating the longevity of single and dual chamber ICDs, cardiac resynchronization defibrillators (CRT-D), single and dual chamber PMs, and cardiac resynchronization PMs (CRT- P) to be used in health technology assessment for an appropriate comparison among different devices. RESULTS: The proposed parameters, if applied to the current marketed devices, provide longevity values in the range 5-17.2 years. CONCLUSION: The values of longevity with the non-standardized criteria used by the manufacturers result in higher maximum values respect to the proposed standardized criteria for CRT-D, CRTD-MPP, CRT-P, and Dual-chamber PM.

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.

Electrical Stun Gun and Modern Implantable Cardiac Stimulators: Update for a New Stun Gun Model.

ABSTRACT: In 2017, the Italian National Institute of Health conducted a study to evaluate the potential risks of Conducted Electrical Weapons (CEW, AKA "stun guns") for users bearing a pacemaker (PM) or an implantable cardioverter defibrillator (ICD). The study addressed two specific models of stun guns: the TASER model X2 and AXON model X26P. In 2019, the same experimental protocol and testing procedure was adopted to evaluate the risk for another model of stun gun, the MAGEN model 5 (MAGEN, Israel). The MAGEN 5 differs from the previous stun guns tested in terms of peak voltage generated, duration of the shock, and trigger modality for repeated shocks. This note is an update of the previous study results, including the measurements on the MAGEN 5 stun gun. Despite the differences between the stun gun models, the effects on the PM/ICD behavior were the same as previously observed for the TASER stun guns.

A new insight on postural tachycardia syndrome in 102 adults with hypermobile Ehlers-Danlos Syndrome/hypermobility spectrum disorder.

There is an association between joint hypermobility, hypermobile Ehlers-Danlos syndrome (hEDS) and different forms of orthostatic intolerance. Objective: to explore autonomic profile in a large cohort of adults with hEDS and hypermobility spectrum disorder (hEDS/HSD) with a multimodal approach. In this observational retrospective study, heart rate, blood pressure and baroreflex sensitivity were estimated in 102 hEDS/HSD subjects during deep breathing, Valsalva maneuver, standing up: 30-15 ratio, Head-Up Tilt and sustained handgrip. Abnormal results and head-up tilt test were common and included postural orthostatic tachycardia syndrome (POTS; 48%), orthostatic intolerance (25.5%) and hypotension (3.9%). Baroreflex sensitivity was significantly different in individuals with POTS compared to the others. This study confirms the high rate and heterogeneity of abnormal autonomic regulation in hEDS/HSD, and suggests the baroreflex sensitivity might distinguish comorbid POTS from other profiles in this subgroup of patients. Abnormal autonomic regulation is common in adults with hEDS/HSD and should be regularly assessed for tailoring the management approach.

The Italian External Quality Assessment Program for Cystic Fibrosis Sweat Chloride Test: Does Active Participation Improve the Quality?

(1) Background: Diagnostic testing for cystic fibrosis (CF) is based on a sweat chloride test (SCT) considering the appropriate signs and symptoms of the disease and results of a gene mutation analysis. In 2014, the Istituto Superiore di Sanità (ISS) established a pilot Italian external quality assessment program for CF SCT (Italian EQA-SCT), which is now a third party service carried out by the ISS. (2) Methods: The ongoing scheme is prospective, enrollment is voluntary, and the payment of a fee is required. Results are shared through a dedicated web-facility. Assessment covers the analysis, interpretation, and reporting of results. (3) Results: Thirteen, fifteen, sixteen, and fifteen different laboratories, respectively, participated from 2015 to 2016 and from 2018 to 2019 in the Italian EQA-SCT scheme. Eleven different laboratories participated each year in all four rounds of the Italian EQA-SCT. (4) Conclusions: The overall results obtained from the laboratories participating constantly clearly show that their qualitative and quantitative performance improved significantly. This is due to the opportunity-after receiving the EQA results-to constantly review their performance and address any inconsistencies. We firmly believe that participation in the EQA program will improve the quality of participating laboratories and that EQA participation should become mandatory as a fundamental requirement for laboratory accreditation.

Electrical Stun Gun and Modern Implantable Cardiac Stimulators.

The aim of the study is to investigate systematically the possible interactions between two types of stun guns and last-generation pacemakers and implantable defibrillators. Experimental measurements were performed on pacemakers and implantable defibrillators from five leading manufacturers, considering the effect of stun gun dart positioning, sensing modality, stun gun shock duration, and defibrillation energy level. More than 300 measurements were collected. No damage or permanent malfunction was observed in either pacemakers or implantable defibrillators. During the stun gun shock, most of the pacemakers entered into the noise reversion mode. However, complete inhibition of the pacing activity was also observed in some of the pacemakers and in all the implantable defibrillators. In implantable defibrillators, standard stun gun shock (duration 5 s) caused the detection of a shockable rhythm and the start of a charging cycle. Prolonged stun gun shocks (10-15 s) triggered the inappropriate delivery of defibrillation therapy in all the implantable defibrillators tested. Also in this case, no damage or permanent malfunction was observed. For pacemakers, in most cases, the stun guns caused them either to switch to the noise reversion mode or to exhibit partial or total pacing inhibition. For implantable defibrillators, in all cases, the stun guns triggered a ventricular fibrillation event detection. No risks resulted when the stun gun was used by a person wearing a pacemaker or an implantable defibrillator. This work provides novel and up-to-date evidence useful for the evaluation of risks to pacemaker/implantable defibrillator wearers due to stun guns.

[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.

The Italian National External Quality Assessment Program in Cytogenetics: 4 years of activity (2013-2016) following the introduction of poor performance criteria.

BACKGROUND: Italian External Quality Assessment (IEQA) Program in Cytogenetics, established in 2001 by the Istituto Superiore di Sanità (ISS), covers both Constitutional and Oncohaematological diagnosis. In 2013, performance criteria were defined and adopted. In this paper, we present the data from the first 4 years of activity (2013-2016) following the introduction of performance criteria. METHODS: The enrollment is voluntary, fee-based and open to both public and private Italian laboratories. The scheme is annual and retrospective; a national panel of experts assess technical, analytical and interpretative performance. RESULTS: Overall, 95 distinct Italian laboratories participated in different Cytogenetics IEQA schemes over the 2013-2016 years and most of the laboratories took part in Constitutional diagnosis. General hospitals and local health centers represented 40% of the total participants and the percentage of laboratories from Northern Regions was more than 45% of total participants throughout the 4-year period. As regards the performance evaluation, on average, 11, 9 and 23% of participants were marked as poor performers in Prenatal, Postnatal and Oncohaematological schemes, respectively. With regard to critical errors, ISCN nomenclature in Prenatal and Postnatal schemes, and interpretation in Oncohaematological diagnosis, were identified as main issues. On the other hand, karyotype errors and inadequate analysis decreased strongly, over the 4 years, in Constitutional and Oncohaematological diagnosis, respectively. CONCLUSIONS: Our data show that the introduction of poor performance encourages laboratories to address critical issues, and the IEQA participation helps to improve quality in cytogenetic testing.

Brain-Heart Pathways to Blood Pressure-Related Hypoalgesia.

OBJECTIVE: High blood pressure (BP) is associated with reduced pain sensitivity, known as BP-related hypoalgesia. The underlying neural mechanisms remain uncertain, yet arterial baroreceptor signaling, occurring at cardiac systole, is implicated. We examined normotensives using functional neuroimaging and pain stimulation during distinct phases of the cardiac cycle to test the hypothesized neural mediation of baroreceptor-induced attenuation of pain. METHODS: Eighteen participants (10 women; 32.7 (6.5) years) underwent BP monitoring for 1 week at home, and individual pain thresholds were determined in the laboratory. Subsequently, participants were administered unpredictable painful and nonpainful electrocutaneous shocks (stimulus type), timed to occur either at systole or at diastole (cardiac phase) in an event-related design. After each trial, participants evaluated their subjective experience. RESULTS: Subjective pain was lower for painful stimuli administered at systole compared with diastole, F(1, 2283) = 4.82, p = 0.03. Individuals with higher baseline BP demonstrated overall lower pain perception, F(1, 2164) = 10.47, p < .0001. Within the brain, painful stimulation activated somatosensory areas, prefrontal cortex, cingulate cortex, posterior insula, amygdala, and the thalamus. Stimuli delivered during systole (concurrent with baroreceptor discharge) activated areas associated with heightened parasympathetic drive. No stimulus type by cardiac phase interaction emerged except for a small cluster located in the right parietal cortex. CONCLUSIONS: We confirm the negative associations between BP and pain, highlighting the antinociceptive impact of baroreceptor discharge. Neural substrates associated with baroreceptor/BP-related hypoalgesia include superior parietal lobule, precentral, and lingual gyrus, regions typically involved in the cognitive aspects of pain experience.

System Biology Approach: Gene Network Analysis for Muscular Dystrophy.

Phenotypic changes at different organization levels from cell to entire organism are associated to changes in the pattern of gene expression. These changes involve the entire genome expression pattern and heavily rely upon correlation patterns among genes. The classical approach used to analyze gene expression data builds upon the application of supervised statistical techniques to detect genes differentially expressed among two or more phenotypes (e.g., normal vs. disease). The use of an a posteriori, unsupervised approach based on principal component analysis (PCA) and the subsequent construction of gene correlation networks can shed a light on unexpected behaviour of gene regulation system while maintaining a more naturalistic view on the studied system.In this chapter we applied an unsupervised method to discriminate DMD patient and controls. The genes having the highest absolute scores in the discrimination between the groups were then analyzed in terms of gene expression networks, on the basis of their mutual correlation in the two groups. The correlation network structures suggest two different modes of gene regulation in the two groups, reminiscent of important aspects of DMD pathogenesis.

ANMCO/AIIC/SIT Consensus Information Document: definition, precision, and suitability of electrocardiographic signals of electrocardiographs, ergometry, Holter electrocardiogram, telemetry, and bedside monitoring systems.

The electrocardiogram (ECG) signal can be derived from different sources. These include systems for surface ECG, Holter monitoring, ergometric stress tests, and telemetry systems and bedside monitoring of vital parameters, which are useful for rhythm and ST-segment analysis and ECG screening of electrical sudden cardiac death predictors. A precise ECG diagnosis is based upon correct recording, elaboration, and presentation of the signal. Several sources of artefacts and potential external causes may influence the quality of the original ECG waveforms. Other factors that may affect the quality of the information presented depend upon the technical solutions employed to improve the signal. The choice of the instrumentations and solutions used to offer a high-quality ECG signal are, therefore, of paramount importance. Some requirements are reported in detail in scientific statements and recommendations. The aim of this consensus document is to give scientific reference for the choice of systems able to offer high quality ECG signal acquisition, processing, and presentation suitable for clinical use.

Orthostatic Intolerance and Postural Orthostatic Tachycardia Syndrome in Joint Hypermobility Syndrome/Ehlers-Danlos Syndrome, Hypermobility Type: Neurovegetative Dysregulation or Autonomic Failure?

Background. Joint hypermobility syndrome/Ehlers-Danlos syndrome, hypermobility type (JHS/EDS-HT), is a hereditary connective tissue disorder mainly characterized by generalized joint hypermobility, skin texture abnormalities, and visceral and vascular dysfunctions, also comprising symptoms of autonomic dysfunction. This study aims to further evaluate cardiovascular autonomic involvement in JHS/EDS-HT by a battery of functional tests. Methods. The response to cardiovascular reflex tests comprising deep breathing, Valsalva maneuver, 30/15 ratio, handgrip test, and head-up tilt test was studied in 35 JHS/EDS-HT adults. Heart rate and blood pressure variability was also investigated by spectral analysis in comparison to age and sex healthy matched group. Results. Valsalva ratio was normal in all patients, but 37.2% of them were not able to finish the test. At tilt, 48.6% patients showed postural orthostatic tachycardia, 31.4% orthostatic intolerance, 20% normal results. Only one patient had orthostatic hypotension. Spectral analysis showed significant higher baroreflex sensitivity values at rest compared to controls. Conclusions. This study confirms the abnormal cardiovascular autonomic profile in adults with JHS/EDS-HT and found the higher baroreflex sensitivity as a potential disease marker and clue for future research.

Seasonal trends in atrial fibrillation episodes and physical activity collected daily with a remote monitoring system for cardiac implantable electronic devices.

BACKGROUND: Remote monitoring (RM) of cardiac implantable electronic devices is an ideal experimental model to evaluate long-term trends of physiological and clinical data automatically collected from large patient cohorts. OBJECTIVES: We studied data of atrial fibrillation (AF) and physical activity (PA) transmitted daily during 3.5years from a subgroup of patients enrolled in the HomeGuide trial, a previously conducted study on patients routinely followed with a RM system transmitting clinical and diagnostic data daily. METHODS: We selected 988 patients (80% male, mean age 68±11) implanted with a pacemaker (16%) or an implantable defibrillator and provided with atrial sensing and movement sensors. Remotely transmitted data were processed in order to obtain AF incidence and time of PA in the form of collective time series daily sampled. RESULTS: We found that both PA and AF incidence clearly showed seasonal trends with an annual period and inverse correlation. In a first-order autoregressive model the regression coefficient of daily activity to AF incidence was -0.64 (standard error, 0.18, p<0.0001), while the cross-correlation coefficient reached its maximum values at ±180day lags. AF incidence was 14.4% higher and PA was 14.7% lower in winters than in summers (p<0.0001 for both comparisons). Power spectral analysis revealed weekly periodicity in the PA series (corresponding to festivity rest) but not in the AF incidence. CONCLUSIONS: RM data collected daily from a relatively large patient cohort revealed marked seasonal trends in AF incidence and PA with opposite behavior in winters and summers.

Italian external quality assessment program for cystic fibrosis sweat chloride test: a 2015 and 2016 results comparison.

BACKGROUND: Diagnostic testing in cystic fibrosis (CF) is based on the sweat chloride test (SCT) in the context of appropriate signs and symptoms of disease and results of the gene mutation analysis. In 2014 the Istituto Superiore di Sanità (ISS) established a pilot Italian external quality assessment program for CF sweat chloride test (Italian EQA-SCT). In 2015 this activity was recognized as a third party service carried out by the ISS. The aim of the paper is to compare 2015 and 2016 results and experiences. METHODS: The scheme is prospective; enrollment is voluntary and the payment of a fee is required. Participants are registered and identified by a specific Identification Number (ID) through a dedicated web-facility. Assessment covers analysis, interpretation and reporting of results. RESULTS: Thirteen and fifteen laboratories, participated in the 2015 and 2016 round respectively. Seven laboratories participated constantly from 2014, eleven participated both in 2015 and 2016 and four participated in 2016 for the first time. Variability in scores of chloride titration and heterogeneity in interpretation/reporting results were detected in both rounds. A total of 18 critical errors in chloride titration were made by eight different participants. Four laboratories made errors in chloride titration in 2015 but drastically improved their performance in 2016. In 2016 poor performance criteria were established and adopted. CONCLUSIONS: Even though results show variability in performance of laboratories, constant and mandatory participation may contribute to the improvement of performance and quality reached by laboratory.

Cardiovascular dysfunction in untreated Parkinson's disease: A multi-modality assessment.

BACKGROUND: The clinical presentation of Parkinson's disease (PD) includes a wide spectrum of non-motor features, including cardiovascular autonomic failure. OBJECTIVE: To evaluate cardiovascular autonomic status and cardiac functional capacity in drug-naïve PD patients. METHODS: 18 newly-diagnosed PD patients underwent laboratory cardiovascular autonomic function tests using power spectral analysis of the R-R interval, blood pressure (BP) short-term variability and non-invasive baroreflex sensitivity (BRS). A two-dimensional (2D) transthoracic echocardiogram, spirometry and cardiopulmonary exercise test (CPET) were also performed. Thirteen patients underwent myocardial scintigraphy with [123I] metaiodobenzylguanidine (MIBG). RESULTS: At rest, total power spectral analysis of heart rate variability was lower in PD patients than in controls. BRS decreased during sympathetic activation in both patients and controls. While echocardiography and spirometry were normal, a mild degree of exercise intolerance was observed at the CPET in PD patients (mean V'O2max: 83% of predicted; mean Wmax: 80% of predicted). The heart-to-mediastinum (H/M) ratio of MIBG uptake was pathologically impaired in 9 patients, one of whom displayed a definite cardiovascular dysautonomic pattern. CONCLUSIONS: Our results confirm that subclinical to overt cardiovascular autonomic failure may occur from the early stages of PD. The less efficient adaptive response to physical stimuli during the CPET and postural changes observed in untreated PD patients possibly reflect cardiac sympathetic denervation, although the involvement of PD-related motor impairment in physical deconditioning cannot be excluded.