Implant Approval Guidelines


Steps to getting an Implant approved

Only Dr. Roger Woods can approve the safety of an implant for subjects being scanned at the BMC.
‐ A subjects personal physician cannot approve the safety of an implant.
‐ A PI of a study cannot approve the safety of an implant.
‐ Just because a subject tells you that they have been scanned with this implant previously does not mean you can skip the approval process.
Note: implant approvals are only valid for 6 months. For longitudinal studies, you must resubmit your implant request to Dr. Woods if your initial approval has expired.
‐ The approval process takes time and is not instantaneous. You should expect a reply in 24-48 hours. Therefore, you should have your subjects fill out the metal screening form as far in advance as possible to eliminate delays on the day of the scan or the possibility of having to cancel a scan due to an unapproved implant.

 

The researcher then goes over the form to check if the subject has indicated there is an implant.

 

 

 

If they do not have the information, have them contact their physician to get the details.

 

Information required:
‐ Type of implant (ie IUD, pacemaker, surgical clip, etc)
‐ Manufacturer
‐ Model #
‐ Material
‐ Date implanted

 

 

Once you have all the details of the implant, you must then research if the implant is safe for scanning on our 3T MRI scanner. You can do this two ways:

 

Go to MRISafety.com
‐ Search for the implant in their database.
‐ If MRISafety.com states it is "Safe" or "Conditional", you can proceed with the approval process. If they state the implant is "Not Safe" for scanning on a 3T system, the subject is not allowed to be scanned at the BMC and there is no need to contact Dr. Woods.

 

Contact the manufacturer of the implant
‐ Simply Google the manufacturers name and/or, place a call to get documentation stating the implant is safe for scanning on a 3T MRI scanner. It is always best to get a hard copy for your records.
‐ If the manufacturer states it is "Safe" or "Conditional," you can proceed with the approval process. If they state the implant is "NOT SAFE" or has "NOT BEEN TESTED" for scanning on a 3T system, the subject is not allowed to be scanned at the BMC and there is no need to contact Dr. Woods.

 

 

You may come across an Implant that is designated as "Conditional" in MRISafety.com or from the manufacturers documentation.

 

For Conditional 5 Implants, you MUST find documented research that includes the necessary safety conditions of the implant before contacting Dr. Woods.
 
Here is an example of what you should look for:
‐ Static magnetic field of 3 Tesla or less
‐ Maximum spatial gradient magnetic field of "#"-Gauss/cm or less
‐ Maximum MR system reported whole-body-averaged specific absorption rate (SAR) of "#"-W/kg for 15 minutes of scanning (per pulse sequence)

 

These types of implants can be safe to scan at 3 Tesla BUT they routinely require that a BMC technologist (or staff member) is present during the entire scan to monitor the SAR level and ensure implant safety.

 

Dr. Woods will alert you when a BMC technologist is required to be in attendance and will assign you an ISMA #. You should then look for a time-slot during regular daytime tech hours and then contact the BMC techs at BMCtechs@mednet.ucla.edu. Let them know the date, time, ISMA #, details of the conditional scan and ask if they can attend the scan to monitor the conditional implant. If a BMC tech cannot staff that scan then you must reschedule until a later date/time when they can be present.

 

 

After you've researched that the implant is safe for scanning on a 3T MRI scanner, email Dr. Woods at: rwoods@mednet.ucla.edu for approval. You must include the Implant safety documentation in this email.

 

Note: implant approvals are only valid for 6 months. For longitudinal studies, you must resubmit your implant request to Dr. Woods if your initial approval has expired.