Free MRSO ASTM F2503 Device Labeling Questions and Answers — Questions and Answers
Question 1: What does the ASTM F2503 'MR Unsafe' symbol, a red circle with a diagonal line over a magnet, signify?
- The device is safe only under very specific conditions
- The device is MR Safe and has no magnetic interaction
- The device poses a known hazard in all MR environments (Correct answer)
- The device has not yet been tested for MR safety
Correct answer: The device poses a known hazard in all MR environments
This symbol represents 'MR Unsafe.' It indicates that the item poses known and significant hazards in all MR environments due to factors like strong ferromagnetic attraction. Such items must never be brought into the MR scanner room (Zone IV).
Question 2: An infusion pump is labeled 'MR Conditional.' What is the most important action an MRSO must take before allowing it into the magnet room?
- Assume it is safe for all scanners up to and including 3.0T
- Verify the specific conditions of use from the manufacturer's labeling/IFU (Correct answer)
- Place the pump as far from the magnet bore as possible and hope for the best
- Ensure the patient is disconnected from the pump during image acquisition
Correct answer: Verify the specific conditions of use from the manufacturer's labeling/IFU
The 'MR Conditional' label signifies that the device is safe only when a specific set of conditions are met. These conditions, which can include field strength, spatial gradient, and physical placement, must be found in the manufacturer's Instructions For Use (IFU) and strictly followed.
Question 3: Which of the following items would most likely be labeled 'MR Safe'?
- A modern, weakly magnetic titanium aneurysm clip
- A non-ferromagnetic, non-conductive plastic basin (Correct answer)
- A battery-operated 'MR-compatible' pulse oximeter
- A high-grade stainless steel IV pole
Correct answer: A non-ferromagnetic, non-conductive plastic basin
An item is designated 'MR Safe' if it poses no known hazards in any MR environment. This applies to items that are entirely non-metallic, non-electrically conductive, and non-RF reactive. A plastic basin perfectly fits this description.
Question 4: The labeling for an 'MR Conditional' patient monitor specifies 'For use at 1.5T only, must be placed outside the 100 Gauss line.' What does this mean for a 3.0T facility?
- The monitor can be used at 3.0T if it is kept outside the 200 Gauss line
- The monitor must not be brought into the 3.0T magnet room (Correct answer)
- The monitor can be used at 3.0T, but only for a short duration
- The monitor's software needs to be updated by the manufacturer for 3.0T use
Correct answer: The monitor must not be brought into the 3.0T magnet room
The conditions of use are specific and not transferable between different MR systems or field strengths. If a device is explicitly rated for 1.5T only, it is considered MR Unsafe in a 3.0T environment and must not be brought into the 3.0T magnet room.
Question 5: An unmarked, metallic tool is found in a clinical area. How should it be treated with respect to MR safety?
- It can be brought into Zone III for testing with a powerful handheld magnet
- It is safe to bring into the magnet room if it appears to be made of aluminum
- It must be assumed to be MR Unsafe until proven otherwise (Correct answer)
- It is considered MR Conditional by default until labeled
Correct answer: It must be assumed to be MR Unsafe until proven otherwise
A fundamental principle of MR safety is that any unknown or unlabeled metallic item must be presumed to be ferromagnetic and therefore MR Unsafe. It should not be brought into the controlled access areas (Zones III or IV) until its safety status can be definitively confirmed by appropriate testing.
Question 6: A patient has an orthopedic implant with an 'MR Conditional' label. The MRSO's primary responsibility is to:
- Inform the patient that all conditional implants are generally safe at 1.5T
- Refuse to scan the patient to avoid any potential liability or risk
- Verify the exact make and model and consult its specific MR conditions for the planned scan (Correct answer)
- Proceed with the scan using only low SAR pulse sequences by default
Correct answer: Verify the exact make and model and consult its specific MR conditions for the planned scan
For any implanted device, the MRSO must identify the exact make and model to look up the manufacturer's specific conditions for safe scanning. These conditions dictate the required static field strength, maximum spatial gradient, and maximum specific absorption rate (SAR), which must be followed precisely.
What does the ASTM F2503 'MR Unsafe' symbol, a red circle with a diagonal line over a magnet, signify?