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Some animals had loose stools during the trial and one animal vomited. The original approval of ivermectin injection was as an over-the-counter drug. JIM OLSEN, B.S.M.E., Sr. Manager, MRI Technology, Medtronic Neuromodulation SUNDER RAJAN, Ph.D., Moderator, Office of Science and Engineering Labs Good morning and welcome to the second day of the MRI Safety Public Meeting. We look forward to another day of lively scientific discussion on the topics. There are both passive and electrically active devices in both of those places. An MR safe item is one that poses no known hazards in all MR environments.

MR safe things are things that are nonconducting, nonmagnetic, and nonmetallic. Do we have cards to collect questions for the roundtable discussion? Okay.

This is the typical example. This is a DBS lead. You can see the artifact. The challenges here is we develop our constraints for our MR thermometry. Looping of the extracranial DBS lead produced harmful heating in all the cases. Should it not be a condition of reimbursement that the paperwork gets done? DR. McINTYRE: I'm Charlie McIntyre from the Chickasaw Nation in Ada, Oklahoma. I'll try to present that and continue to reinforce the new terminology. Sometimes, they accept that. Sometimes, they storm off upset and mad. The next item is monitoring. We've gotten quite a bit of feedback on this. So I think, in the near future, like I said, this will take care of itself. So the proposed solutions, there's actually two proposals that I'm making.

Those who don't want to deal with these issues, we believe in further training. Mr. Gilk said that some of the manufacturers do not have reliable information. DR. SHEIN: Manny, could you bring this to a close? We're running out.

The background, we heard it. We have continuously increased usage of MR scans. We need to assess how many models are needed, how many MR coils are needed. So we need more industry research, in the interest, foremost, of the patient. DR. SHELLOCK: Morning. Frank Shellock, University of Southern California. Another good example, poorly worded, difficult to understand labeling. That's the key, not the SAR values, but the applied B 1 field and micro-tesla. So without further ado, I thought I'd share this or we thought we'd share this. As we all know, the number of patients with implants is steadily increasing. I don't think that's always done, and that would be a useful thing to know. What you see here, it's pretty complicated still. There is one caveat here.

DR. SHEIN: Thank you very much to all of our public commenters this morning. DR. SHELLOCK: Why do you give me these high tech things on the Panel? Thank you very much. I am the Chief Medical Officer for GE Healthcare MRI.

MS. SMITH: Karen Smith. I agree with Dr. Kanal, what Dr. Kanal just said. Because, again, at the end of the day, it comes down to what Karen just said.

Ultimately, the decision to scan is, of course, not determined by the label. It's dependent on the clinician's decision in context of the labeling. There, the maximum spatial gradient is plotted for the patient accessible area. MR. STANLEY: I'm going to provide a nontechnical answer to this. Did that hurt? It's sad that it's na ve. I would relate this a little bit to drugs.

It could even be on the manufacturer's scanner or on your scheduling system. DR. KANAL: I just want to go back to the comment that was made by Dr. Crues. Nobody cares if Manny agrees. He's selling you a de facto observation.

If you need things reviewed, send them our way. We'll be glad to help you. So we don't need to just do that for electronically activated devices. MR. OLSEN: This is Jim Olsen from Medtronic. I'll take a shot at that question. DR. RUGGIERI: I'm going to bridge that. I think SAR is very straightforward. DR. SHELLOCK: Frank Shellock. I think you're getting to a very important point. Then, at some point, there was the decision to go and include information.

Why do we need to put paragraph after paragraph of information? Calorimetry. It's just we're doing it in an incredibly inefficient and dangerous way. Is there another modality that can be used for imaging in that patient? So I think that should be something to be carefully considered by the FDA. On the second one, somebody said about temperature time curves on the website.