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10th January 2012, 01:41 AM
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MRI Marking - The level of information the FDA expects on the Patient ID Card
Hello, for an implant, what has been your experience on the level of information FDA expects on the patient ID card, specifically for devices which are MRI conditional?
ASTM F2503 requires the MR conditional symbol on the product labelling, but kind of gives the option of having only the symbol on the patient ID card, and refer to a specific labelling insert with the full conditions and precautions for MRI safety.
We are experiencing a request from FDA to basically duplicate all this information on the patient ID card, but it is quite impractical, due to the size of the card.
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Thanks to murena for your informative Post and/or Attachment!
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11th January 2012, 02:29 AM
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Re: MRI Marking - The level of information the FDA expects on the Patient ID Card
A Quick Bump!
Can someone help?
Thank you very much!
Stijloor.
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11th January 2012, 09:47 PM
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Re: MRI Marking - The level of information the FDA expects on the Patient ID Card
Another quick "Bump". My Thanks in advance to anyone who can help with this one.
People Helping People around the world!
Thank You!
Marc
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One Test is Worth 1000 Expert Opinions - The plural of anecdote is not data - Correlation does not imply Causation
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5th July 2012, 01:24 PM
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Re: MRI Marking - The level of information the FDA expects on the Patient ID Card
Our company has an implant that is MRI conditional. We don't put all of the information we have on MRI compatibility in the Patient Implant Card but have the most important information for the patient to take to a physician where they can assess the conditional properties. It's been hard to find a standard that addresses what the minimum info required is. Does anybody have one they can reference?
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11th July 2012, 11:54 PM
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Re: MRI Marking - The level of information the FDA expects on the Patient ID Card
Be sure to check FDA has not issued any specific MRI testing/labeling guidelines for the implant device you are working on.
Checkout one of the examples of patient infocard below:
"medtronic.com/mrisurescan/downloads/mri-patient-card.pdf"
Deep
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Thanks to Deep Krothapalli for your informative Post and/or Attachment!
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26th July 2012, 04:33 AM
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Re: MRI Marking - The level of information the FDA expects on the Patient ID Card
Who have ASTM F2503-2008? if you can offer this ,i will appreciate you! Thank you
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26th July 2012, 05:03 AM
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Re: MRI Marking - The level of information the FDA expects on the Patient ID Card
Quote:
In Reply to Parent Post by Tonyfang
Who have ASTM F2503-2008? if you can offer this ,i will appreciate you! Thank you
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This is a copyrighted document and can not be requested, nor shared.
This document can be purchased at www.astm.org
http://www.astm.org/Standards/F2503.htm
Stijloor.
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