Topic: Guidance on deciding whether to scan MR conditional devices outside FDA-approved labeling

Speaker: Dr. Travis White

Objective: 

-    Understand the role of the radiologist in making a clinical risk vs. benefit decision for MRI scans involving non-labeled or conditionally approved implants.
-    Explain the main categories of MRI-related safety hazards for implanted medical devices:
o    Displacement forces
o    RF-induced heating
o    Device malfunction or unintended stimulation
-    Interpret and apply MRI Hazard Considerations when device information is incomplete or unknown.
-    Differentiate between MRI operating parameters and their impact on implanted device safety, including:
o    Static magnetic field strength (B₀)
o    Spatial gradient
o    Specific Absorption Rate (SAR)
o    dB/dt (rate of RF gradient switching)
o    Gradient slew rate (T/m/s)
o    B1+rms
o    Coil type and operating mode
-    Assess patient-specific risk factors (e.g., inability to communicate, tissue perfusion, thermoregulation) that may increase safety concerns.
-    Evaluate special situations - retained bullet fragments, distinguishing between ferromagnetic and non-ferromagnetic materials.
-    Understand artifact risks (e.g., susceptibility artifacts) and how they can affect diagnostic quality in MRI.
-    Complete documentation required for off-label or uncertain device scanning situations."