Safety Screening and Implant Review Process

Our Commitment to MRI Safety

CFMI dedicates itself to providing a safe research environment for all users and research participants. Our safety procedures are meticulously designed to protect participants, users, and staff at every stage of the imaging process, adhering to the safety guidelines of the American College of Radiology (ACR). Our team trains in the latest MRI safety practices, and we continuously update our protocols to meet or exceed clinical standards. We strive to deliver high quality imaging data for all of our users while first and foremost ensuring the care and safety of all of our participants.

Why MRI Safety Matters

Magnetic Resonance Imaging (MRI) involves powerful magnetic fields and requires strict adherence to safety protocols to prevent harm. Because of these unique hazards, it is essential to maintain and follow well-defined MRI safety standards and train everyone who works in CFMI in our safety standard operating procedure.

CFMI is a research-dedicated facility, not a clinical imaging center. This means that research participants do not receive direct medical benefit* from undergoing MRI. For that reason, we only conduct studies that pose no more than minimal risk for participants. Following a strict set of safety procedures is imperative to maintaining this classification as a minimal risk activity. 

Core Principles of MRI Safety

  1. Understanding and mitigating risks associated with the three magnetic fields (static, gradient and RF).
  2. Performing careful, consistent participant screening.
  3. Throughly reviewing implants to ensure their safety.
  4. Restricting access to the MRI scanner, and ensuring direct supervision in controlled zones.
  5. Moving with intention in each of the access-restricted zones to prevent accidents.
  6. Responding effectively to emergency situations.

Failure to follow MRI safety protocols can result in serious injury or death. As such, violation of safety procedures may lead to the revocation of scanner access privileges.

MRI Safety Process at CFMI

This diagram outlines the step-by-step MRI safety screening process for research participants at CFMI:

1. Telephone Screen (Pre-Screen)

Conduct a telephone screen (or pre-screening interview) with the participant at least 2 weeks before the potential scan date. During this screen, researchers should determine any MR contraindications and identify any known or potential implants that require approval prior to scanning.

  • Examples of MR contraindications: Pacemakers, cochlear implants, inability to lie comfortably in the MRI scanner for any reason. 
  • Examples of surgeries/implants that require prior approval: Hip replacement, thyroid removal (thyroidectomy), stents, craniotomy, craniectomy, or cranioplasty.

Telephone Screening Resources:

2. Implant Review and Approval

During pre-screening, note any known implants or surgeries that commonly utilize implants. An implant review involves gathering detailed information about any implanted medical device a participant may have (e.g., stents, surgical clips, etc.). Not all implants are MRI-safe, and some require very specific scanning conditions.

Our Implant Approval Guide for Users is a list of common surgeries and implants meant to aid CFMI researchers in making decisions regarding participant safety. Please refer to this document when deciding the necessity of an implant review.

Note: Our safety documentation is constantly evolving. Please check this guide often for updates.

If an implant review is necessary, please complete the following steps:

First, speak with your participant and try to get as much information as possible regarding the surgery/implant. If the participant does not have the information or cannot recall, please have them contact their physician or performing surgeon as soon as possible to get the information. 

The information we need includes:

  • The type of implant (e.g. IUD, pacemaker, surgical clip, etc.)
  • The location of the implant in participant’s body (as specific as possible)
  • The manufacturer
  • The model #
  • The material
  • The date implanted

This information is typically included in the participant’s medical record, operative report, or on the device’s medical implant card, which should be submitted as part of the implant review.

Once you have details from your participant, you, as the researcher, should conduct a preliminary review. 

  • Refer to the Implant Approval Guide to find out if the surgery/implant falls into the “Pre-Approved” category.
    Pre-Approved surgeries/implants do not need to go through the review process. If the surgery/implant is not listed on this document, it should be considered MR conditional and a formal implant review should be submitted.
  • Go to MRIsafety.com and search the implant in the database.
    • If the database states the device has been tested at 3T and is “Safe”, “Conditional6”, or “Conditional8”, proceed with the approval process.
    • If the database states the device has been tested at 3T and is “Conditional5”, please locate the Instructions or Directions for Use document (see below).
    • If the database states the device has been tested at 3T and is “Not Safe”, the participant cannot be scanned at CFMI. 
  • For known implants, look up the manufacturer’s ‘Instructions for Use’ or ‘Directions for Use’ document.
    This document is typically available on the manufacturer’s website and will yield the most information about the device in question. There is usually a section on MRI safety or MRI testing that outlines the MR safety status of the implant.
    • An internet search with the implant name, keywords “IFU” or “DFU”, and the implant model is generally the quickest way to locate the document.
    • For MR Conditional devices, this section will specify the exact scanning conditions under which the implant can be safely imaged, such as magnetic field strength, SAR limits, scan duration, and device orientation. This information is essential for determining whether a participant can be safely scanned and should be included when submitting an implant review for approval.

In summary, the goal of your preliminary review is to determine whether the implant is safe, conditional, or unsafe, considering it’s materials, location in the body, and any safety information provided by a physician or manufacturer.

For a walkthrough of this process, please see our Implant Review Instructions & Examples.

Upload any relevant documentation regarding the implant to a separate Box folder and share it with cfmi@georgetown.edu. 

Typical documentation includes:

  • Medical records, operative reports, surgical notes, or medical device implant card
  • Manufacturer’s Directions for Use or Instructions for Use documents
  • Physician’s note (see our documentation on requesting Implant Approval from A Physician)
  • Previous imaging results

Do not include the Box link in the body of an email, and never send documents containing personal health information (PHI) as email attachments. Email is not a secure method for transmitting PHI and should not be used for sharing sensitive participant information.

Complete the MRI Safety Review Form at least 2 weeks before your scan date. This form will prompt you for the information about the implant that you should have found during your preliminary review. 

After submission, the Authorized Users will review the form and either make a decision on the safety of the implant or request more information.

If the implant has been approved for scanning, you will receive an email with a MRI Safety Review #, which provides justification for the approval and any special scanning instructions. Please print the MRI Safety Review email and write the MRI Safety Review # on the participant’s screening form next to the surgery/implant to which it applies.

3. Safety Screen

Participants must complete the MRI Procedure Screening Form within 24 hours of their appointment. They may complete a printable version or a digital version of the form. Blank, printed forms are also available in the CFMI waiting room.

All participants must undergo a two-step safety screening prior to their MRI scan:

  1. A first screen is conducted by a safety-trained researcher from the sponsoring research group.
  2. A second screen is then performed by a CFMI staff member.

When you sign off on a participant’s screening form, you are confirming that you have carefully reviewed each item on the form with the participant and have no concerns about their MRI safety. This signature indicates that, to the best of your knowledge, the participant meets all safety criteria for scanning.

In some cases, individuals other than the participant (such as a parent, caregiver, or support person) may be permitted to enter the MRI room. This is typically allowed when assistance is needed with transferring the participant to or from the MRI bed, or to provide emotional or physical support.
Anyone entering the MRI room must complete the MRI Environment Screening Form within 24 hours of the appointment. They must also undergo a two-step screening and follow the same de-metal procedures as participants.
If possible, please inform CFMI in advance if a support person will need access to the scan room, so we can ensure proper screening and accommodation.

4. De-Metal

Before entering the MRI room, you must guide your participant through the de-metal process to ensure their safety. This involves having them remove all metallic items, including jewelry (earrings, necklaces, bracelets, rings), watches, hairpins, bobby pins, hearing aids, orthotics, belts, wallets, phones, keys, and any other loose objects or accessories that may contain metal.

Participants should also empty their pockets and remove their shoes.

It’s essential to be thorough during de-metaling since even small metallic objects can pose serious safety risks or interfere with image quality. If you’re unsure about an item, consult CFMI staff before proceeding.

Final Reminders

MRI safety is a shared responsibility. Thoroughly following each step of the safety process ensures a safe and efficient scan experience for everyone at CFMI.

If you have any questions about the MRI screening process, implant reviews, or safety procedures, please contact us at cfmi-scanning-team@georgetown.edu. When in doubt, always ask — your caution helps protect everyone involved.

For other helpful information for ensuring a smooth scan day, visit our Scan Day Tips & Tricks page.