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心脏植入式电子医疗器械(CIED)工人接触电磁场:在欧洲法规框架内进行风险分析的方法和案例研究。

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

机构信息

Department of Cardiovascular, Endocrine-Metabolic Diseases and Aging, National Institute of Health, 00199 Rome, Italy.

Department of Occupational and Environmental Medicine, Epidemiology and Hygiene, Italian Workers' Compensation Authority, 00078 Roma, Italy.

出版信息

Int J Environ Res Public Health. 2021 Sep 15;18(18):9709. doi: 10.3390/ijerph18189709.

DOI:10.3390/ijerph18189709
PMID:34574648
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8470458/
Abstract

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.

摘要

患有心脏活性植入式医疗器械(AIMD)的工人,如起搏器(PM)或植入式除颤器(ICD),被职业健康和安全法规框架视为一个特别敏感的风险群体,必须防止电磁场(EMF)干扰造成的危险。在本文中,我们首先描述了根据欧盟法规,特别是 EN 50527-2-1:2016 和 50527-2-2:2018 标准,对暴露于电磁场的患有心脏 AIMD 的员工进行风险评估所应遵循的一般方法。然后,提出了三个与特定电磁场源相关的案例研究,以更好地描述如何在实践中进行风险评估的初步分析,并了解是否需要进一步进行特定的风险评估分析。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6b23/8470458/acec1b6224c0/ijerph-18-09709-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6b23/8470458/acec1b6224c0/ijerph-18-09709-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6b23/8470458/acec1b6224c0/ijerph-18-09709-g001.jpg

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本文引用的文献

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Seventeen-year trend (2001-2017) in pacemaker and implantable cardioverter-defibrillator utilization based on hospital discharge database data: An analysis by age groups.基于医院出院数据库数据的起搏器和植入式心脏复律除颤器使用的 17 年趋势(2001-2017 年):按年龄组分析。
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智能手机与当代植入式心脏复律除颤器之间发生电磁干扰的风险较低。
Europace. 2016 May;18(5):726-31. doi: 10.1093/europace/euv374. Epub 2016 Feb 8.
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Are patients with cardiac implants protected against electromagnetic interference in daily life and occupational environment?心脏植入物患者在日常生活和职业环境中是否免受电磁干扰的影响?
Eur Heart J. 2015 Jul 21;36(28):1798-804. doi: 10.1093/eurheartj/ehv135. Epub 2015 Apr 22.
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Electromagnetic immunity of implantable pacemakers exposed to wi-fi devices.植入式心脏起搏器暴露于Wi-Fi设备时的电磁抗扰性。
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Setups for in vitro assessment of RFID interference on pacemakers.用于体外评估起搏器上 RFID 干扰的设置。
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Adhoc electromagnetic compatibility testing of non-implantable medical devices and radio frequency identification.非植入式医疗器械和射频识别的临时电磁兼容性测试。
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