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

Author(s):  
Eugenio Mattei ◽  
Federica Censi ◽  
Giovanni Calcagnini ◽  
Rosaria Falsaperla

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.

Environments ◽  
2019 ◽  
Vol 6 (11) ◽  
pp. 119
Author(s):  
Eugenio Mattei ◽  
Giovanni Calcagnini ◽  
Federica Censi ◽  
Iole Pinto ◽  
Andrea Bogi ◽  
...  

The occupational health and safety framework identifies workers with an active implantable medical device (AIMD), such as a pacemaker (PM) or an implantable defibrillator (ICD), 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 describe the results of in vitro testing/measurements performed according to the EN50527-2-1:2016 standard, for the risk assessment of employees with a PM exposed to three EMF sources: (1) An electrosurgical unit (ESU); (2) a transcranial stimulator (TMS); and (3) an arc welder. The ESU did not affect the PM behavior in any of the configurations tested. For the TMS and the arc welder, interference phenomena were observed in limited experimental configurations, corresponding to the maximum magnetic field coupling between the EMF source and the implant. The in vitro measurements presented can be considered an example of how the specific risk assessment for a worker with a PM can be performed, according to one of the methodologies proposed in the EN50527-2-1:2016, and can be used as scientific evidence and literature data for future risk assessments on the same EMF sources.


2020 ◽  
Vol 29 (1) ◽  
pp. 37-43
Author(s):  
H Potockova ◽  
P Kusnierik ◽  
J Dohnal

Medical devices form a large heterogeneous group of products ranging from simple tools to medical testing and implants, the safety and efficacy of which are strictly regulated in all developed countries. Thanks to the health and cost benefits, medical devices have also found their way into veterinary medicine but, surprisingly, the regulation of these products is far less complex or, in some cases, missing altogether. Given the complexity and potential hazards of certain veterinary devices, the current state of affairs may lead to health and safety risks, both for animals and personnel involved. This review is the first to systematically map the current situation in the EU, revealing health and safety risks in practice for both animals and personnel involved and discussing them in a broader context. Only six out of the EU's 28 member states (Belgium, Croatia, Czech Republic, Germany, Hungary, and Slovakia) were found to have at least a degree of regulation of veterinary devices. As a result, a single product may be regulated as a veterinary medicinal product, a veterinary medical device or not be regulated at all, depending on the particular EU member state in question. As things stand, veterinary medicine makes use of all kinds of medical devices, including human products, regardless of their regulatory status and (pre-market) control. However, the use of such devices may influence the health and well-being of animals. Several measures are therefore suggested to attain the required levels of safety and efficacy surveillance for veterinary medical devices without creating excessive administration.


2017 ◽  
Vol 2017 (1) ◽  
pp. 2017254
Author(s):  
Amanda Hwa Ling Chee ◽  
Edelina Melisa ◽  
Xin Dong

Following key oil spill incidents in the Gulf of Mexico and Australia, the industry initiated a three-year Joint Industry Project to develop guidelines for oil spill preparedness and response management. These documents are commonly known as the Oil Spill Response JIP (OSR-JIP) Good Practice Guides. As the OSR-JIP originated from lessons learnt from offshore incidents, it is only natural that the industry would apply it with the same type of operation, hence the tendency to limit the practical application for inland or near-shore facilities. This paper presents two examples where the OSR-JIP guides are applied at downstream operations located inland and near-shore. The first study is on a refinery located near-shore with an operational jetty and a single buoy mooring. We started with a comprehensive review of their operations and updated their oil spill risk assessment profile in line with the framework described in the OSR-JIP Tiered Preparedness and Response. This process provided a reflection of their current capability and identified the gaps for further improvement. Following this, we proceeded to update the contingency plan using the OSR-JIP Contingency Planning to ensure that the risks identified are adequately mitigated with training of personnel and equipment selection. This exercise supported in improving the readiness of the facility to respond to oil spill incidents in future. The second study involves a terminal located inland that supplies refined products through a pipeline that leads towards a jetty on the coast. We developed several area specific tactical response plans that cover risks from their above-ground pipelines and at the jetty where loading and offloading of the products to tankers are conducted. To accurately define the suitable response technique, we started the planning process with an oil spill risk assessment following OSR-JIP Risk Assessment. The tactical response plans were then developed with reference to several other OSR-JIP guides such as OSR-JIP Inland Response and NEBA. The resulting plans describe health and safety concerns, identification of sensitive receptors, response techniques, location and quantity of resources, logistical requirements and timings and waste management. Based on these case studies, we demonstrated that the OSR-JIP guides can certainly be applied for inland and near-shore facilities and have a more far wider application for the whole oil and gas industry rather than be limited to offshore operations.


2011 ◽  
Vol 2 (4) ◽  
pp. 523-539 ◽  
Author(s):  
Anna Szajkowska

According to the principle of risk analysis established by Regulation 178/2002, food safety measures in the EU and Member States must be based on scientific risk assessment. Apart from science, however, decision makers should take into account other legitimate factors, such as societal, ethical or traditional concerns. The extent to which risk managers can deviate from scientific evaluations in considering these factors depends on how much discretion is conferred on public authorities. This article compares the discretion at both national and Union levels of food safety regulation in the context of the internal market mechanism by analysing the standard review applied to food safety measures by the European judiciary.


2013 ◽  
Vol 2013 ◽  
pp. 1-8 ◽  
Author(s):  
Jolanta Karpowicz ◽  
Krzysztof Gryz

Leakage of electromagnetic fields (EMF) from short-wave radiofrequency physiotherapeutic diathermies (SWDs) may cause health and safety hazards affecting unintentionally exposed workers (W) or general public (GP) members (assisting patient exposed during treatment or presenting there for other reasons). Increasing use of electronic active implantable medical devices (AIMDs), by patients, attendants, and workers, needs attention because dysfunctions of these devices may be caused by electromagnetic interactions. EMF emitted by 12 SWDs (with capacitive or inductive applicators) were assessed following international guidelines on protection against EMF exposure (International Commission on Nonionizing Radiation Protection for GP and W, new European directive 2013/35/EU for W, European Recommendation for GP, and European Standard EN 50527-1 for AIMD users). Direct EMF hazards for humans near inductive applicators were identified at a distance not exceeding 45 cm for W or 62 cm for GP, but for AIMD users up to 90 cm (twice longer than that for W and 50% longer than that for GP because EMF is pulsed modulated). Near capacitive applicators emitting continuous wave, the corresponding distances were: 120 cm for W or 150 cm for both—GP or AIMD users. This assessment does not cover patients who undergo SWD treatment (but it is usually recommended for AIMD users to be careful with EMF treatment).


2021 ◽  
Vol 27 (4) ◽  
Author(s):  
Yeong-Lin Chen

This article proposes a risk-based revalidation approach with a simple and pragmatic risk assessment method for mechanical-type medical device manufacturing. Use the risk assessment output in conjunction with initial validation approach as well as product, equipment and process characteristics, a risk-based revalidation approach can be determined. To facilitate the understanding of the determination process, four risk-based revalidation approach case studies are demonstrated.


2004 ◽  
Vol 5 (10) ◽  
pp. 1259-1274 ◽  
Author(s):  
Karolina Szawlowska

The outbreak of bovine spongiform encephalopathy (hereinafter BSE) in Europe has brought about serious tensions and fears – not only among consumers, but also among the national and European authorities responsible for risk management. Faced with the incapacity of the existing system to control the situation, on the one hand, and the need to restore consumers’ confidence on the other, the EU and national regulators felt obliged to repair the weaknesses as soon as possible. However, remedial actions undertaken at the time of the BSE crisis were not always the product of thorough consultations and they were often not well coordinated. Thus, they became a source of disagreement among the various actors in play. The case Commission v. France, which I will examine more closely in this paper, illustrates such a conflict among the national and European scientific authorities. The judgment was delivered in 2001, but the problem of the successful integration of science into the regulatory decision-making process of the EU still remains unsettled. In this paper I will present suggestions as to how the situation could be influenced by the outcomes of recent reforms of European food safety law and the establishment of the European Food Safety Authority.


2013 ◽  
Vol 154 (43) ◽  
pp. 1709-1712 ◽  
Author(s):  
Csaba Móczár

Introduction: Cardiovascular risk assessment may help in the identification of symptom-free subjects with high cardiovascular risk. Aim: The author studied the correlation between SCORE and Reynolds risk assessment systems based on data from the cardiovascular risk screening program carried out in subjects without cardiovascular disease. Method: Data obtained from 4462 subjects (1977 men and 2485 women; mean age, 47,4 years) were analysed. The comparison was based on risk categories of the SCORE system. Results: There was a strong correlation between the two scoring systems in the low risk population (under <2% SCORE risk the Spearman rho = 1, p < 0.001). A weak correlation was found in the medium risk group (between 3–4% the Spearman rho = 0.59–0.49, p < 0.001 and between 10–14% the Spearman rho = 0.42, ns.) and a stronger correlation in the high risk group (>15% the Spearmen rho = 0.8, p = 0.017). When correlations were analysed in gender and age categories, the weakest correlation was detected in medium risk women over 40 years of age. In cases when the differences between the two scoring systems were significant, the hsCRP levels were significantly higher (4.1 vs. 5.67 mg/L, p < 0.001). Conclusions: Introduction of hsCRP into cardiovascular risk assessments can refine the risk status of symptom-free subjects, especially among intermediate risk middle-age women (two-step risk assessment). Orv. Hetil., 154 (43), 1709–1712.


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