This document will communicate MRI safety information regarding Acumed implants in the MR environment. While we cannot make specific MR claims for all of our implants at this time, Acumed will present the results of our testing in this document as additional information becomes available. When allowed by regulatory authorities, Acumed will use one of the internationally recognized ASTM symbols in our implant labeling. Magnetic Resonance Imaging (MRI) is one of many imaging modalities used by radiologists to diagnose and treat various conditions within the body. MRI is often favored for its detail and clarity when imaging soft tissues, and doing so without delivering the ionizing radiation inherent with X-ray and CT. Because of the strong, static magnetic field, and varying magnetic and electric fields during scanning, the safety of patients in the MR environment is of great importance to the healthcare professionals who perform these procedures. Safety concerns arise when a patient has orthopaedic implants manufactured from metal or carbon fiber, or when external fixation devices are in place, because of the potential for movement or heating of the devices in the MR environment. In some cases, safety concerns may be greater due to the type, location, or configuration of the implant or the presence of multiple implants in close proximity to one another. Consequently, the use of MRI technology may not always be possible.
|Document Title||Document Type||Language||Published||Updated|
|Acumed Implants in the MR Environment (GEN70-56-K)||Other||English EN||July 19, 2023||July 19, 2023|