核磁共振成像与医疗设备的相互作用

F. Censi, E. Mattei, G. Calcagnini
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引用次数: 0

摘要

给定由磁共振成像(MRI)扫描仪创建的特定环境,根据设备的性质(主动或被动)以及材料,可以与其他医疗设备发生各种类型的相互作用。一般来说,医疗设备制造商必须分析并指出与合理可预见的环境条件(如磁场)和其他医疗方法(如MRI)相关的任何潜在风险。因此,医疗设备与MRI的兼容性信息应在设备用户手册上提供。根据最新的国际标准(ASTM 2503),医疗器械可分为磁共振(MR)安全、磁共振条件和磁共振不安全。MR Safe在所有MRI环境中均不构成已知危害;条件磁共振已被证明在特定的磁共振环境中,在特定的使用条件下不会造成已知的危害;已知磁共振不安全在所有MRI环境中都会造成危害。植入式医疗设备是那些在磁共振环境中引起主要关注的设备。必须清楚地识别每个植入的装置,在MRI检查之前对每个患者进行筛查是很重要的。使用各种种植体的患者越来越多。对于这些设备,重要的是不仅要参考用户手册,还要参考科学文献。事实上,可能发生的情况是,有必要进行MRI检查,但不完全尊重设备制造商指示的MRI条件。在这些情况下,科学文献中报告的临床或体外实验经验可能有助于提供支持医疗决定的因素。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
MRI interactions with medical devices
Given the particular environment created by a magnetic resonance imaging (MRI) scanner, various kinds of interaction can occur with other medical devices, depending on the nature of the device, active or passive, on the materials. Generally speaking, manufacturers of medical devices must analyse and indicate any potential risk related to reasonably foreseeable environmental conditions such as magnetic fields and to other medical treatments such as MRI. Thus, information about the compatibility of a medical device with MRI should be available on the device user manual. According to the latest international standard (ASTM 2503), a medical device can be magnetic resonance (MR) Safe, MR Conditional, and MR Unsafe. MR Safe poses no known hazards in all MRI environments; MR Conditional has been demonstrated to pose no known hazards in a specified MRI environment with specified conditions of use; MR Unsafe is known to pose hazards in all MRI environments. Implanted medical devices are those raising major concerns in MR environments. Each implanted device must be clearly identified, and it is important to screen each patient before MRI examination. The prevalence of patients with various kinds of implants is increasing. For these devices, it could be important to refer not only to the user manual, but also to the scientific literature. Indeed, it could happen that it is necessary to perform an MRI examination which does not completely respect the MRI conditions indicated by the device manufacturer. In these cases, the clinical or in vitro experiences reported in the scientific literature could help in yielding elements to support the medical decision.
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