The typical MRI safety and compatibility assessment study will look something like this:

Risk analysis -> Tests / Rationale -> Labeling

Risk analysis: The first step of any MRI testing activity should be a detailed risk analysis. This involves both determining the possible risks to the patient, but also identifying any possible malfunction that can be induced. This step also involves drafting the strategy for project. Certain risks can be accessed via different methods or may be treated via scientific arguments with written rationale. So at this stage, determining the most adapted strategy to assess the device is key.

Testing / Rationale Writing: The second step is to either perform device testing or draft scientific arguments via a written rationale to address all the possible risks and malfunctions identified in step 1. At this stage, just prior to testing, for multiconfigurational devices, worst-cases are identified. Any simulations that are necessary to identify worst-case are performed, often in parallel to other device testing. At this step all test reports or rationales are objective and independent.

Labeling: In this third and final step, all test results and rationales are analysed, and based on the totality of the results an MRI label is determined. In almost all cases, the label will be an MRI Conditional label. During this phase, the conditions for which the device can be introduced in the MRI environment are determined.

The entire MRI safety and compatibility assessment workflow can take as little as 3-4 weeks to complete, and as long as 3-4 months depending on the complexity of the project. Typically, wholly implanted passive medical devices are on the order of 3-4 weeks while active implantable medical devices (AIMD) are on the order of 3-4 months. Often, the timeline is influenced by the ability of the device manufacturer to supply CAD for numerical simulations or test objects for testing.

The number for devices required for a test campaign will depend on the type of device, but typically 2-3 devices may be required as each main risk (force/ torque/artifacts, and RF heating) may require a unique worst-case. In instances where a configuration is the same worst-case for multiple tests, one sample for the tests is almost always sufficient as the testing is non-destructive and samples can thus be re-used for multiple tests.

Your tests will be performed on clinical MRIs, by qualified engineers, PhDs or test technicians.

Our instruments are selected or designed by our team of experts to meet all the constraints of the MRI environment and the normative requirements. All instruments are qualified, calibrated and regularly monitored.

We additionally have available a probe for measuring signals during an MRI exam; this allows, for example, to monitor the activity of an active implant in the MRI environment during an MRI exam.

HEALTIS has performed safety and MRI compatibility tests on a large number of implantable and non-implantable devices. Which, for the most part, have been introduced to the US, European, or Asian markets. More than 500 trials have already been conducted in our laboratory for clients from all backgrounds and a variety of devices. Here are some examples of devices we have tested:

Passive Implantable Devices

• Orthopedic Implants (Trauma, Cranial maxio facial, plates, screws, etc.)
• Joint prostheses (hip, knee, shoulder, finger, etc.)
• Spinal implants (Fixation, cages, etc.)
• Stents
• Catheters
• Valves
• Implantable chambers
• Dental Implants
• Etc.

Active Implantable Devices

• Heart valves
• Neurostimulators
• Cochlear / Bone conduction implants
• Pacemakers, implantable defibrillators
• Ocular
• Etc.

Semi-Implantable Devices

• Intracranial pressure sensors
• Suture anchors
• External Fixation
• Etc.

Non-Implantable Devices

• Monitoring devices
• RFID Tags
• Gas bottle and regulators
• Patient supports
• Etc.