THE LIST - INFORMATION
AND TERMINOLOGY

The List contains information for over 2,300 implants, devices, materials, and other products. The objects in The List are divided into general categories to facilitate access and review of pertinent information.

To properly utilize The List, particular attention must be given to the information indicated for the highest static magnetic Field Strength used for testing and the Status information indicated for a given Object (Note: These specific terms correspond to the column headings for information compiled in The List). In addition, for certain objects (for example, those designated as “Conditional”), it will be necessary to refer to specific recommendations or guidelines found on this website or to contact the manufacturer of the implant or device (see Safety Info topic list for over 150 websites).

The relevant terminology for The List is, as follows:
Object: This is the implant, device, material, or product that underwent evaluation relative to an MR procedure or the MR environment. Information is also provided for the material(s) used to make the object and the manufacturer of the object, if known. The term “SS” refers to stainless steel.

Status: This information pertains to the results of the tests conducted for the object. Testing typically included an assessment of magnetic field interactions (i.e., deflection and/or torque) and MRI-related heating, as needed. In some cases, medical products were assessed for induced electrical currents and the impact of an MR procedure or the MR environment on the functional or operational aspects of the object.

Information for each object has been specifically categorized using a Status designation, which indicates the object to be Safe, Conditional, or Unsafe,as follows (IMPORTANT NOTE: See section below entitled *Terminology Applied to Implants and Devices):

Safe – The object is considered to be safe for the patient undergoing an MR procedure or an individual in the MR environment, with special reference to the highest static magnetic field strength that was used for the MR safety test. The object has undergone testing to demonstrate that it is safe or it is made from material(s) considered to be safe with regard to the MR environment (e.g., plastic, silicone, glass, etc.) or an MR procedure. Refer to additional information for the particular object indicated on this website.

Terminology from the American Society for Testing and Materials (ASTM) International refers to MR safe as an item that poses no known hazards in all MRI environments. Using the current terminology, MR safe items include non-conducting, non-metallic, non-magnetic items such as a plastic Petri dish. An item may be determined to be MR Safe by providing a scientifically based rationale rather than test data.

Conditional – The object may or may not be safe for the patient undergoing an MR procedure or an individual in the MR environment, depending on the specific conditions that are present.

Current terminology from the American Society for Testing and Materials (ASTM) International refers to MR conditional as an item that has been demonstrated to pose no known hazards in a specified MRI environment with specified conditions of use. Field conditions that define the MRI environment include static magnetic field strength, spatial gradient, dB/dt (time varying magnetic fields), radio frequency (RF) fields, and specific absorption rate (SAR). Additional conditions, including specific configurations of the item (e.g., the routing of leads used for a neurostimulation system), may be required.

This information has been sub-categorized to indicate specific recommendations for the particular object, as follows:

Conditional 1 – The object is acceptable for the patient or individual in the MR environment, despite the fact that it showed positive findings for magnetic field interactions during testing. Notably, the object is considered to be “weakly” ferromagnetic, only.

In general, the object is safe because the magnetic field interactions were characterized as “mild” or “weak” relative to the in vivo forces or counter-forces present for the object. For example, certain prosthetic heart valve prostheses and annuloplasty rings showed measurable magnetic field interactions during exposure to the MR systems used for testing, but the magnetic field interactions were less than the forces exerted on the implants by the beating heart.

Additionally, there may be substantial “retentive” or counter-forces provided by the presence of sutures or other means of fixation, tissue ingrowth, scarring, or granulation that serve to prevent the object from presenting a risk or hazard to the patient undergoing an MR procedure or an individual in the MR environment.

For a device or product that is used for an MR-guided procedure (e.g., laryngoscope, endoscope, etc.), there may be minor magnetic field interactions in association with the MR system. Eddy currents may also be present. However, the device or product is considered to be acceptable if it is used in its “intended” manner, as specified by the manufacturer. Special attention should be given to the strength of the static magnetic field used for testing the device or product.

Functional or operational aspects may need to be considered. Additionally, specific recommendations for the use of the device or product in the MR environment or during an MR procedure (i.e., typically presented in the Product Insert) should be followed carefully. See also Conditional 7 information below.

Conditional 2 – These particular “weakly” ferromagnetic coils, filters, stents, clips, cardiac occluders, or other implants typically become firmly incorporated into the tissue six weeks following placement. Therefore, it is unlikely that these objects will be moved or dislodged by interactions with the magnetic fields of MR systems operating at the static magnetic field strength used for testing. Furthermore, to date, there has been no report of an injury to a patient or individual in association with an MR procedure for these coils, stents, filters, cardiac occluders or other similar implants designated as “Conditional 2”.

Of note is that if the implant is made from a nonmagnetic material (e.g., Phynox, Elgiloy, titanium, titanium alloy, MP35N, Nitinol, etc.), it is not necessary to wait a minimum of six weeks before performing and MR procedure using an MR system operating at 1.5-Tesla or less (in some cases, this may also apply to 3-Tesla MR systems).

Special Note: If there is any concern regarding the integrity of the implant or the integrity of the tissue with regard to its ability to retain the object in place during an MR procedure or during exposure to the MR environment, the patient or individual should not be allowed into the MR environment.

Conditional 3 – Certain transdermal patches with metallic foil (e.g., Deponit, nitroglycerin transdermal delivery system) or other metallic components, although not attracted to an MR system, have been reported to heat excessively during MR procedures. This excessive heating may produce discomfort or burn a patient or individual wearing a transdermal patch with a metallic component. Therefore, it is recommended that the patch be removed prior to the MR procedure. A new patch should be applied immediately after the examination. This procedure should only be done in consultation with the patient’s or individual’s personal physician responsible for prescribing the transdermal medication patch.

Conditional 4 - This halo vest or cervical fixation device is known to have ferromagnetic component parts, however, the magnetic field interactions have not been determined. Nevertheless, there has been no report of patient injury in association with the presence of this device in the MR environment at the static magnetic field strength used for MR safety testing. Issues may still be present with regard to MRI-related heating. As such, guidelines provided in the Product Insert for a given halo vest or cervical fixation device should be carefully followed. It should be noted that halo vests and cervical fixation devices made from conducting metals may heat excessively during an MR procedure, resulting in serious patient injury. Contact the manufacturer for further information. Also, refer to recent information for cervical fixation devices, as several have now been evaluated at 3-Tesla.

Conditional 5 - This object is acceptable for a patient undergoing an MR procedure or an individual in the MR environment only if highly specific guidelines or recommendations are followed (see specific information for a given object on this website and contact the manufacturer for further information). Please refer to the specific criteria for performing the MR procedure by reviewing the information for the object in the text of this book. Consult the manufacturer of the particular device for the latest safety information. A list of biomedical company websites is shown on this website. See the Safety Info section.

Conditional 6 - The implant/device was determined to be MR-conditional according to the terminology specified in the American Society for Testing and Materials (ASTM) International, Designation: F2503-05. Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment.

Non-clinical testing demonstrated that the implant/device is MR Conditional. A patient with this implant can be scanned safely immediately after placement under the following conditions:

- Static magnetic field of 3-Tesla or less

- Maximum spatial gradient magnetic field of 720-Gauss/cm or less

- Maximum MR system reported whole-body-averaged specific absorption rate (SAR) of 3-W/kg for 15 minutes of scanning.

In non-clinical testing, the implant/device produced a temperature rise of less than or equal to 1.5 degrees C at a maximum MR system-reported whole body averaged specific absorption rate (SAR) of 3-W/kg for 15-minutes of MR scanning in a 3-Tesla MR system using a transmit/receive body coil (Excite, Software G3.0-052B, General Electric Healthcare, Milwaukee, WI).

MR image quality may be compromised if the area of interest is in the exact same area or relatively close to the position of the implant/device. Therefore, optimization of MR imaging parameters to compensate for the presence of this implant/device may be necessary.

Attention: Contact the manufacturer of this implant/device for further information.

Conditional 7 - Important Note: This device is not intended for use during the operation of an MR system for an MR procedure. That is, this device should not be inside of the bore of the MR system, exposing this device to the time-varying and RF fields activated during an MR procedure.

Attention: Contact the manufacturer of this implant/device for further information.

Conditional 8 – Note: This information pertains to an implant/device that has MRI labeling at both 1.5-Tesla and 3-Tesla. In some cases, it may pertain to a single and two-overlapped version of a stent, as well. Contact the manufacturer for additional MRI information.

The implant/device was determined to be MR-conditional according to the terminology specified in the American Society for Testing and Materials (ASTM) International, Designation: F2503-05. Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment.

Non-clinical testing demonstrated that the implant/device is MR Conditional. A patient with this implant/device can be scanned safely immediately after placement under the following conditions:

For magnetic field interactions,
-Static magnetic field of 3-Tesla or less
-Maximum spatial gradient magnetic field of 720-Gauss/cm or less

MRI-Related Heating
In non-clinical testing, the implant/device produced the following temperature rises during MRI performed for 15-min in 1.5-Tesla (1.5-Tesla/64-MHz, Magnetom, Siemens Medical Solutions, Malvern, PA. Software Numaris/4, Version Syngo MR 2002B DHHS) and 3-Tesla (3-Tesla/128-MHz, Excite, Software G3.0-052B, General Electric Healthcare, Milwaukee, WI) MR systems, as follows:

Highest temperature change and corresponding MRI Condition
Less than or equal to 2.5 degrees C 1.5-T/64-MHz
Less than or equal to 2.5 degrees C 3-T/128-MHz

Artifact Information
MR image quality may be compromised if the area of interest is in the exact same area or relatively close to the position of the implant/device. Therefore, optimization of MR imaging parameters to compensate for the presence of this implant/device may be necessary.

Attention: Contact the manufacturer of this implant/device for further information.

Terminology from the American Society for Testing and Materials (ASTM) International refers to MR Unsafe as an item that is known to pose hazards in all MRI environments. MR Unsafe items include magnetic items such as a pair of ferromagnetic scissors.

Unsafe 1 – The object is considered to pose a potential or realistic risk or hazard to a patient or individual in the MR environment primarily as the result of movement or dislodgement of the object. Other hazards may also exist. Therefore, in general, the presence of this object is considered to be a contraindication for an MR procedure and/or for an individual to enter the MR environment. Note that the “default” static magnetic field strength for an unsafe implant or device is 1.5-Tesla.

Unsafe 2 – This object displays only minor magnetic field interactions which, in consideration of the in vivo application of this object, is unlikely to pose a hazard or risk in association with movement or dislodgment. Nevertheless, the presence of this object is considered to be a contraindication for an MR procedure or for an individual in the MR environment. Potential risks of performing an MR procedure in a patient or individual with this object are related to possible induced currents, excessive heating, or other potentially hazardous conditions. Therefore, it is inadvisable to perform an MR procedure in a patient or individual with this object.

For example, although certain cardiovascular catheters and accessories typically do not exhibit magnetic field interactions, there are other mechanisms whereby these devices may pose a hazard to the patient or individual or in the MR environment (e.g., excessive MRI-related heating).

The Swan-Ganz thermodilution catheter (and other similar catheters) displays no attraction to the MR system. However, there has been a report of a Swan-Ganz catheter that “melted” in a patient during an MR procedure. Therefore, the presence of this cardiovascular catheter and any other similar device is considered to be a contraindication for a patient undergoing an MR procedure.

Field Strength – This is the highest strength of the static magnetic field of the MR system that was used for safety testing of the object. In most cases, a 1.5-Tesla MR system was used for testing. However, there are some objects that were tested at field strengths lower (e.g., 0.15-Tesla) or higher (e.g., 3-Tesla) than 1.5-Tesla. Note that the “default” field strength for an unsafe implant or device is 1.5-Tesla.
There are MR systems with static magnetic field strengths that exceed 3.0-Tesla (i.e., as high as 9.4-Tesla). Some objects have been assessed to determine the relative amount of magnetic field interactions in association with these very high-field-strength MR systems.

Important Note: An object that exhibits only “mild” or “weak” magnetic field interactions in association with exposure to a 1.5-Tesla MR system may be attracted with sufficient force by a higher field strength scanner ( e.g., 3-Tesla), potentially posing a risk to a patient or individual. Therefore, careful consideration must be given to each object relative to the static magnetic field strength of the MR system used for testing as well as the conditions that are present for the patient or individual under consideration prior to exposure to the MR environment. Furthermore, for implants and devices that have an elongated shape or form a closed loop of a certain diameter, MRI-related heating may be of concern. Please refer to 3-Tesla MR Safety Information for Implants and Devices on this website for additional guidance and recommendations.

Reference – This is the peer-reviewed publication or other documentation used for the MRI safety information indicated for a particular object.

*Terminology Applied to Implants and Devices
Previous Terminology
The terminology applied to implants and devices relative to the MRI environment has evolved over the years. In 1997, the U.S. Food and Drug Administration, Center for Devices and Radiological Health, proposed definitions for the terms “MR Safe” and “MR Compatible” (1). These terms were defined as follows:

MR Safe - the device, when used in the MRI environment, has been demonstrated to present no additional risk to the patient or other individual, but may affect the quality of the diagnostic information. The MRI conditions in which the device was tested should be specified in conjunction with the term MR safe since a device which is safe under one set of conditions may not be found to be so under more extreme MRI conditions.

MR Compatible - a device shall be considered “MR compatible” if it is MR safe and the device, when used in the MRI environment, has been demonstrated to neither significantly affect the quality of the diagnostic information nor have its operations affected by the MR system. The MRI conditions in which the device was tested should be specified in conjunction with the term MR safe since a device which is safe under one set of conditions may not be found to be so under more extreme MR conditions.
Using this terminology, MRI testing of an implant or object to determine if it was MR safe involved assessments of magnetic field interactions, heating, and, in some cases, induced electrical currents while MR compatibility testing required all of these as well as characterization of artifacts. In addition, it may have been necessary to determine the impact of various MRI conditions on the functional or operational aspects of an implant or device (2).

Current Terminology
Over the years, manufacturers generally used the terms “MR safe” and “MR compatible” to label medical devices. However, in time it became apparent that these terms were confusing and often used interchangeably or incorrectly (3). Therefore, in an effort to clarify the terminology and, more importantly, because the misuse of these terms could result in serious accidents for patients, the MR task group of the American Society for Testing and Materials (ASTM) International developed a new set of terms with associated icons (4).

Thus, the current terms, MR Safe, MR Conditional, and MR Unsafe are defined by the ASTM document, as follows:

MR Safe - an item that poses no known hazards in all MRI environments. Using the current terminology, “MR safe” items include non-conducting, non-metallic, non-magnetic items such as a plastic Petri dish. An item may be determined to be MR Safe by providing a scientifically based rationale rather than test data.

MR Conditional - an item that has been demonstrated to pose no known hazards in a specified MRI environment with specified conditions of use. Field conditions that define the MRI environment include static magnetic field strength, spatial gradient, dB/dt (time varying magnetic fields), radio frequency (RF) fields, and specific absorption rate (SAR).

Additional conditions, including specific configurations of the item (e.g., the routing of leads used for a neurostimulation system), may be required.

For MR Conditional items, the item labeling includes results of testing sufficient to characterize the behavior of the item in the MRI environment. In particular, testing for items that may be placed in the MRI environment should address magnetically induced displacement force and torque, and RF heating. Other possible safety issues include but are not limited to, thermal injury, induced currents/voltages, electromagnetic compatibility, neurostimulation, acoustic noise, interaction among devices, and the safe functioning of the item and the safe operation of the MR system. Any parameter that affects the safety of the item should be listed and any condition known to produce an unsafe condition must be described.

MR Unsafe - an item that is known to pose hazards in all MRI environments. MR Unsafe items include magnetic items such as a pair of ferromagnetic scissors.

In addition to these terms, the ASTM document introduced corresponding icons, consistent with international standards for colors and shapes of safety signs. The icons are intended for use on items that may be brought into or near the MRI environment as well as in product labeling. The icons may be reproduced in color or in black and white, however the use of color is encouraged because of the added visibility.

Incons The “MR Safe” icon consists of the letters ‘MR’ in green in a white square with a green border, or the letters ‘MR’ in white within a green square. The “MR Conditional” icon consists of the letters ‘MR’ in black inside a yellow triangle with a black border. The “MR Unsafe” icon consists of the letters ‘MR’ in black on a white field inside a red circle with a diagonal red band.

For MR Conditional items, the item labeling must include results of testing sufficient to characterize the behavior of the item in the MRI environment.

Use of Terminology
The current labeling terminology is intended to help elucidate matters related to biomedical implants and devices in order to ensure the safe use of MRI technology. Notably, the current terminology has not been applied retrospectively to implants and devices that previously received U.S. Food and Drug Administration (FDA) approved labeling using the terms “MR safe” or “MR compatible” (i.e., this applies to those objects tested prior to December, 2005). Accordingly, this should be understood to avoid undue confusion regarding the matter of MRI-related labeling for “older” vs. “newer” implants.

REFERENCES
American Society for Testing and Materials (ASTM) International, Designation: F2503-05. Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment. ASTM International, West Conshohocken, PA, 2005.

Woods TO. Standards for medical devices in MRI: present and future. J Magn Reson Imaging. 2007;26:1186-9.

Woods TO. Guidance for Industry and FDA Staff - Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment. Document issued on: August 21, 2008; http://www.fda.gov/cdrh/osel/guidance/1685.html