审查俄罗斯关于磁共振成像室和部门的组织和运作的监管文件

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使用任何医疗设备进行的诊断研究都有许多监管文件提供的全面控制。 特别关注X射线成像方法,但在磁共振成像领域,人们可以注意到缺乏这种关注和多方向的努力来规范化。

这是可以理解的:这种诊断方法的基础没有使用电离辐射源,虽然磁场对人体健康有一定的影响,尤其是对一直在磁共振成像室工作的工作人员,但对于不是进行诊断的患者来说是安全的,而在身体没有金属异体(钢植入物)或电子产品(起搏器、神经刺激器)。

但是,无知和不遵守建议性和强制性的要求会显着增加对患者或工作人员造成伤害的风险,并降低成像和诊断的质量。磁共振成像监管领域的另一个特点是,在过去几十年中,重新发布或修订了十多个不同的标准、卫生规范、规则、信函和建议,其中很大一部分相互补充或重复,或与其他文件相矛盾。因此,很难确保MRI室符合监管要求。

本文回顾了俄罗斯现行的与核磁共振室的组织和运行有关的监管文件,从安全和高质量操作的角度强调了最重要的方面,并制定了必要的步骤在诊断质量和使用核磁共振的诊断研究的安全性方面对系统进行现代化改造。

作者简介

Aleksey V. Smirnov

Research and Practical Clinical Center for Diagnostics and Telemedicine Technologies of Moscow Health Care Department

Email: smirnov@npcmr.ru
SPIN 代码: 4801-5777
俄罗斯联邦, 28-1 Srednyaya Kalitnikovskaya str., 109029, Moscow

Dmitriy S. Semenov

Moscow Center for Diagnostics and Telemedicine

Email: d.semenov@npcmr.ru
ORCID iD: 0000-0002-4293-2514
SPIN 代码: 2278-7290
俄罗斯联邦, 28-1 Srednyaya Kalitnikovskaya str., 109029, Moscow

Ekaterina S. Ahkmad

Moscow Center for Diagnostics and Telemedicine

Email: e.ahkmad@npcmr.ru
ORCID iD: 0000-0002-8235-9361
SPIN 代码: 5891-4384
俄罗斯联邦, 28-1 Srednyaya Kalitnikovskaya str., 109029, Moscow

Anna N. Khoruzhaya

Research and Practical Clinical Center for Diagnostics and Telemedicine Technologies of Moscow Health Care Department

编辑信件的主要联系方式.
Email: a.khoruzhaya@npcmr.ru
ORCID iD: 0000-0003-4857-5404

MD

俄罗斯联邦, 28-1 Srednyaya Kalitnikovskaya str., 109029, Moscow

参考

  1. Zelikman MI, Kruchinin SA, Snopova KA. Methods and means of monitoring the operational parameters of magnetic resonance tomographs. Medicinskaya Tehnika. 2010;(5):27–31. (In Russ).
  2. Semenov DS, Smirnov AV, Ahmad ES, et al. Recommendations for the design of a magnetic resonance imaging room: guidelines. Seriya “Luchshie praktiki luchevoy i instrumental’noy diagnostiki”. Issue 74. Moscow; 2021. 46 р. (In Russ).
  3. Sergunova KA, Ahmad ES, Petryaykin AV, et al. Safety Fundamentals for Magnetic Resonance Imaging. Seriya «“Luchshie praktiki luchevoy i instrumental’noy diagnostiki”. Issue 47. Moscow; 2019. 68 р. (In Russ).
  4. Sergunova KA, Petryaykin AV, Gombolevskiy VA, et al. Methodical recommendations for the development of labor protection instructions for the personnel of the office (department) of magnetic resonance imaging. Seriya “Luchshie praktiki luchevoy i instrumental’noy diagnostiki”. Issue 7. Moscow; 2017. 32 р. (In Russ).
  5. Medical electrical equipment. Magnetic resonance equipment with superconduction magnets. Technical requirements for governmental purchases (GOST R 56310-2014). (In Russ). Available from: https://docs.cntd.ru/document/1200117515. Accessed: 15.11.2021.
  6. National standard of the Russian Federation. Medical electrical equipment. Magnetic resonance tomographs with permanent magnets. Technical requirements for public procurement (GOST R 56320-2014). (In Russ). Available from: https://docs.cntd.ru/document/1200117523. Accessed: 15.11.2021.
  7. National standard of the Russian Federation. Medical electrical equipment. Magnetic resonance tomographs for examining the extremities. Technical requirements for public procurement (GOST R 56610-2015). (In Russ). Available from: https://docs.cntd.ru/document/1200124990. Accessed: 15.11.2021.
  8. Information and methodological letter of the Office of Rospotrebnadzor in Moscow dated 01.08.2007 N 9-05/122-486 “Sanitary and hygienic requirements for magnetic resonance imaging and organization of work”. (In Russ). Available from: https://docs.cntd.ru/document/537992889. Accessed: 15.11.2021.
  9. The system of regulatory documents in construction. Moscow city building codes. Treatment-and-prophylactic institutions. TSN 31-313-98 Moscow. (In Russ). Available from: https://docs.cntd.ru/document/1200000502. Accessed: 15.11.2021.
  10. Sanitary rules SP 2.1.3678-20 “Sanitary and epidemiological requirements for the operation of premises, buildings, structures, equipment and transport, as well as the conditions of activity of economic entities selling goods, performing work or”. (In Russ). Available from: https://docs.cntd.ru/document/573275590. Accessed: 15.11.2021.
  11. SP 118.13330.2012 “Set of rules. Public buildings and structures. Updated edition of SNiP 31-06-2009”. (In Russ). Available from: https://docs.cntd.ru/document/1200092705. Accessed: 15.11.2021.
  12. SP 158.13330.2014 “Code of rules. Buildings and premises of medical organizations. Design rules”. (In Russ). Available from: https://docs.cntd.ru/document/1200110514. Accessed: 15.11.2021.
  13. Order of December 18, 2020 N 928n “On approval of the Rules for labor protection in medical organizations”. (In Russ). Available from: https://docs.cntd.ru/document/573264177. Accessed: 15.11.2021.
  14. Order of Yune 9, 2020 N 560n “On approval of the Rules for conducting X-ray examinations (as amended on February 18, 2021)”. (In Russ). Available from: https://docs.cntd.ru/document/565342962. Accessed: 15.11.2021.
  15. Sanitary rules and standards “Hygienic requirements for the design and operation of X-ray machines and the conduct of X-ray examinations. SanPiN 2.6.1.1192-03”. (In Russ). Available from: https://docs.cntd.ru/document/901854044. Accessed: 15.11.2021.
  16. Resolution of Yanuary 28, 2021 N 2 “On the approval of sanitary rules and norms SanPiN 1.2.3685-21” Hygienic standards and requirements for ensuring the safety and (or) harmlessness to humans of environmental factors”. (In Russ). Available from: https://docs.cntd.ru/document/573500115. Accessed: 15.11.2021.
  17. Medical electrical equipment. Part 2-33. Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis. (In Russ). Available from: https://docs.cntd.ru/document/1200107233. Accessed: 15.11.2021.
  18. Part 7-710. Requirements for special electrical installations. Medical locations (GOST R 50571.28-2006). (In Russ). Available from: https://docs.cntd.ru/document/1200050064. Accessed: 15.11.2021.
  19. Occupational safety standards system. Fire safety. General requirements (GOST 12.1.004-91). (In Russ). Available from: https://docs.cntd.ru/document/9051953. Accessed: 15.11.2021.
  20. Letter of October 27, 2003 N 293-22/233 “On the introduction of the Methodological Recommendations” Maintenance of medical equipment”. (In Russ). Available from: https://docs.cntd.ru/document/901899842. Accessed: 15.11.2021.
  21. Control technical condition and functioning of medical devices. The main provisions (GOST R 56606-2015). (In Russ). Available from: https://docs.cntd.ru/document/1200124986. Accessed: 15.11.2021.
  22. Magnetic resonance equipment for medical imaging. Quality control of images. Test methods (GOST R 56602-2020). (In Russ). Available from: https://docs.cntd.ru/document/566277458. Accessed: 15.11.2021.
  23. Order of August 17, 2018 N 564 “On approval of the regulations for the operation, maintenance and repair of medical equipment in medical organizations of the state health care system of the city of Moscow.” (In Russ). Available from: https://docs.cntd.ru/document/551248489. Accessed: 15.11.2021.

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