|
Elsmar Cove Forum Sidebar
|
|
|
|
Monitor the Elsmar Forum
|
| Monitor New Forum Posts
|
|
Follow Marc & Elsmar
|
    
|
|
Elsmar Cove Groups
|
|
|
|
Sponsor Links
|
|
|
|
|
|
Donate and $ Contributor Forum Access
|
 |
|
Sponsored Links
|
|
|
|
Courtesy Quick Links
|
Links that Elsmar Cove visitors will find useful in your quest for knowledge:
Howard's
International Quality Services
Atul's
Symphony Technologies
Marcelo Antunes'
SQR Consulting
Bob Doering's
Correct SPC - Precision Machining
NIST's Engineering Statistics Handbook
IRCA - International Register of Certified Auditors
SAE - Society of Automotive Engineers
Quality Digest Portal
IEST - Institute of Environmental Sciences and Technology
ASQ - American Society for Quality
|
|
 |
10th January 2012, 01:41 AM
|
 |
Involved in Discussions
Registration Date: Nov 2003
Location: Australia
|
|
Posts: 14
Thanks Given to Others: 5
Thanked 4 Times in 3 Posts
Karma Power: 40 Karma: 30
|
|
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.
Thanks
|
|
Thanks to murena for your informative Post and/or Attachment!
|
|
11th January 2012, 02:29 AM
|
 |
Cross Forum Moderator
Registration Date: May 2003
Location: Charlotte, North Carolina.
|
|
Posts: 13,432
Thanks Given to Others: 2,950
Thanked 4,271 Times in 3,027 Posts
Karma Power: 1431
|
|
|
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.
|
11th January 2012, 09:47 PM
|
 |
Your Elsmar Cove Host
Registration Date: Jan 1996
Location: West Chester - Southern Ohio - USA
Age: 62
|
|
Posts: 22,809
Thanks Given to Others: 7,452
Thanked 4,541 Times in 2,893 Posts
Karma Power: 400
|
|
|
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
__________________
A Search is a terrible thing to waste!
One Test is Worth 1000 Expert Opinions - The plural of anecdote is not data - Correlation does not imply Causation
We can't solve problems by using the same kind of thinking we used when we created them. - Unknown
|
5th July 2012, 01:24 PM
|
 |
Shy Poster (1 to 5 Posts)
Registration Date: Nov 2009
|
|
Posts: 3
Thanks Given to Others: 2
Thanked 4 Times in 2 Posts
Karma Power: 15 Karma: 30
|
|
|
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?
|
11th July 2012, 11:54 PM
|
|
Involved in Discussions
Registration Date: Feb 2005
Location: USA
|
|
Posts: 19
Thanks Given to Others: 0
Thanked 7 Times in 5 Posts
Karma Power: 35 Karma: 45
|
|
|
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
|
|
Thanks to Deep Krothapalli for your informative Post and/or Attachment!
|
|
26th July 2012, 04:33 AM
|
|
Getting Involved (6 to 9 Posts)
Registration Date: May 2012
|
|
Posts: 9
Thanks Given to Others: 0
Thanked 1 Time in 1 Post
Karma Power: 5 Karma: 15
|
|
|
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
|
26th July 2012, 05:03 AM
|
|
Cross Forum Moderator
Registration Date: May 2003
Location: Charlotte, North Carolina.
|
|
Posts: 13,432
Thanks Given to Others: 2,950
Thanked 4,271 Times in 3,027 Posts
Karma Power: 1431
|
|
|
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
|
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.
|
Lower Navigation Bar
|
|
|
Do you find this discussion thread helpful and informational?
|
Visitors Currently Viewing this Thread: 1 (0 Registered Visitors (Members) and 1 Unregistered Guest Visitors)
|
|
|
| Thread Tools |
Search this Thread |
|
|
|
| Display Modes |
Rate Thread Content |
 Linear Mode
|
|
Forum Posting Settings
|
You may not post new threads
You may not post replies
You may not post attachments
You may not edit your posts
HTML code is Off
|
|
|
|
|
