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The importance of identifying interactions in surgical implants

The identification of implant interactions when exposed to magnetic fields, such as imaging artifacts, magnetically induced torque and displacement force, and radiofrequency induced heating, are crucial aspects to ensure the safety and effectiveness of surgical implants, whether active or non-active, as established in ABNT ISO/TR 14283 and ABNT NBR ISO 14630.

To assist implant manufacturers, the technical standards ASTM F2119, ASTM F2182, ASTM F2052, and ASTM F2213 have been developed to provide information and requirements for testing to prove the safety and effectiveness of implants throughout the design development process.

What aspects involve the clinical success of implants?

The clinical success of the use of an implant involves aspects related to the project, to the handling of the components from the factory storage to their availability in the surgical centers, to the implantation procedures, to the expertise of the professional responsible for the surgical act, and to the patient’s health status, commitment, and care.

Besides these, it is also important to consider aspects related to the design and quality of auxiliary components, as well as other associated components, including instruments and auxiliary components.

Ensaios de MRI | SCiTec

Learn more about safety associated with implants

Static fields in MRI environments induce displacement forces and torques on magnetic and paramagnetic materials, and radio-frequency heating of bodies is a consequence of currents induced by the excitation pulses applied during MRI scanning. These effects have already led to accidents caused by magnetically projected or rotated implants, or even burns during MRI scans

In addition, the presence of an implant can produce an image artifact that can appear as an empty region or as a geometric distortion of the true image. If the imaging artifact is near an area of interest, the artifact may render the MRI scan uninformative or lead to an inaccurate clinical diagnosis, potentially resulting in inappropriate medical actions.

Although a commercial 1.5 T MRI system currently produces the conditions typically encountered by an implant, 3 T MRI systems are commercially cleared and have become more common in clinical situations.

IMPORTANT: an implant characterized as safe in a 1.5 T device may not be in a system with a higher or lower static magnetic field strength (e.g., 3 T or 1 T).

In addition, there may be large differences in the characteristics of open and cylindrical MRI systems, for example, the spatial gradients of static field may be significantly larger in open systems.

Standards:

ASTM F2052 – Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment
ASTM F2119 – Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants
ASTM F2182 – Standard Test Method for Measurement of Radio Frequency Induced Heating On or Near Passive Implants During Magnetic Resonance Imaging
ASTM F2213 – Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment
ISO TS 10974 – Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device

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Ensaios de MRI | SCiTec