title: [MR implant labelling and its use in clinical MRI practice].
abstract: 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complex as the implants are often poorly documented and detailed information on the implant MR labelling is also often outdated or not easy to interpret.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.
authors: Institut für Radiologie, Krankenhaus Martha-Maria Halle-Dölau, Röntgenstr. 1, 06120, Halle (Saale), Deutschland, martin.muehlenweg@web.de.
authors: M
authors: M
authors: Mühlenweg
authors: G
authors: G
authors: Schaefers
mesh_terms: D000075202:Contraindications; D005858:Germany; D008279:Magnetic Resonance Imaging / Q000592:standards*; D061214:Patient Safety / Q000592:standards*; D017410:Practice Guidelines as Topic; D011356:Product Labeling / Q000331:legislation & jurisprudence / Q000592:standards*; D019736:Prostheses and Implants / Q000592:standards*