Mühlenweg M, Schaefers G
Institut für Radiologie, Krankenhaus Martha-Maria Halle-Dölau, Röntgenstr. 1, 06120, Halle (Saale), Deutschland,
Radiologe. 2015 Aug;55(8):682-90. doi: 10.1007/s00117-015-2814-z.
Before a magnetic resonance imaging (MRI) examination, implants in patients must be cleared for MR safety in order to exclude the risk of possible severe injuries and implant malfunction in an MR environment. The general contraindication for measurements of patients with implants still applies; however, in the recent past a way has been found to legally circumvent this contraindication. For this purpose special conditions are required: explicit implant identification and the original manufacturer's labelling are necessary, the required conditions for conditionally MR safe implants must be assured and a risk-benefit analysis with appropriate explanation to the patient has to be performed. This process can be very complex as the implants are often poorly documented and detailed information on the implant MR labelling is also often outdated or not easy to interpret. This article provides information about legal and normative principles of MR measurement of patients with implants. The possible physical interactions with implants will be briefly dealt with as well as possible strategies for better identification and investigation of implants and MR labelling. General approaches for minimizing the risk will be discussed using some examples. The second part deals with the content of MR implant labelling and the current test standards. Furthermore, the additional information from the operating instructions of the MR scanner that are necessary for the interpretation of the MR implant labelling, will be explained. The article concludes with an explanation of the current pattern for MR labelling of implants from the U.S. Food and Drug Administration (FDA) and an exemplary application.
在进行磁共振成像(MRI)检查之前,必须对患者体内的植入物进行MR安全性评估,以排除在MR环境中可能发生严重损伤和植入物故障的风险。对于有植入物的患者进行测量的一般禁忌症仍然适用;然而,最近已经找到了一种合法规避这种禁忌症的方法。为此需要特殊条件:必须明确植入物标识并提供原始制造商标签,必须确保有条件MR安全植入物的所需条件,并对患者进行风险效益分析并给出适当解释。这个过程可能非常复杂,因为植入物的记录往往很差,而且关于植入物MR标签的详细信息也常常过时或难以解读。本文提供了有关有植入物患者MR测量的法律和规范原则的信息。将简要介绍与植入物可能的物理相互作用,以及更好地识别和研究植入物及MR标签的可能策略。将通过一些例子讨论将风险降至最低的一般方法。第二部分讨论MR植入物标签的内容和当前的测试标准。此外,还将解释MR扫描仪操作说明中对于解读MR植入物标签所必需的其他信息。文章最后解释了美国食品药品监督管理局(FDA)当前的植入物MR标签模式并给出了一个示例应用。