1. Only an Authorized User (AU) can approve the safety of an implant for participants being scanned at CFMI
- A participant's personal physician cannot approve the safety of an implant.
- A PI of a study cannot approve the safety of an implant.
- Just because a participant tells you that they have been scanned with this implant previously does not mean you can skip the approval process.
- The approval process takes time and is not instantaneous. You should expect a reply in 5-7 days. Therefore, you should screen your participants 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.
- Please be sure to have as much information as possible including anyof the following:
- Note of approval from the performing surgeon or other qualified physician
- Manufacturer's labeling or documentation
- Report of MR safety testing
- Description of the material, size and location of the implant
- The subject has a history of MRI scans with this implant
- This is the screening form we use.