BHR MRI Safety Information
BIRMINGHAM HIP◊ Resurfacing System: Important MRI Safety Information
Magnetic Resonance Imaging (MRI) scans are a commonly used diagnostic tool for a variety health related issue. Overseen by a radiologist, these scans use magnetic fields and pulses of radio wave energy to create images of organs and structures inside the body.
Because of the technology used in MRI scanning, some artificial implants, like the BIRMINGHAM HIP Resurfacing System, can affect the imaging quality or negatively impact the scanning due to their use of metallic components.
Below is the information your radiologist will need to ensure the appropriate scanning protocol is used based on non-clinical testing conducted by Smith & Nephew.
MRI SAFETY INFORMATION
Smith & Nephew, Inc. BIRMINGHAM HIP Resurfacing (BHR) System implants are manufactured from a non-ferromagnetic material, cobalt-chromium-molybdenum alloy. Smith & Nephew has performed non-clinical Magnetic Resonance Imaging (MRI) studies on BHR implants which are determined to be MR Conditional in accordance to ASTM F2503-08, Standard Practice for Marking Devices and Other Items for Safety in the Magnetic Resonance Environment. MR Conditional refers to an item that has been demonstrated to pose no known hazards in a specified MR environment with specified conditions of use.
Non-clinical testing has demonstrated that the BHR System is MR Conditional. A patient with this device can be safely scanned in an MR system meeting the following conditions:
- Static magnetic field of 1.5 and 3.0 Tesla only
- Maximum spatial gradient magnetic field of 3,000 gauss/cm (30 T/m) or less
- Maximum MR system reported, whole body averaged specific absorption rate (SAR) of 2 W/kg (Normal Operating Mode)
- Cylindrical Quadrature transmit coils only
Under the scan conditions defined above, the BHR System is expected to produce a maximum temperature rise of 7.1° C after 15 minutes of continuous scanning.
In non-clinical testing, the image artifact caused by the device extended up to 10.2 cm from the BHR system when imaged with a gradient pulse sequence, and up to 7.6 cm from the device when imaged with a spin echo pulse sequence and a 3 Tesla MRI system.
Be sure to share this information with your radiologist.
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