10 Questions You Should to Know about mri machine manufacturing company

There are several safety concerns for patients with metallic implants who require MRI, including magnetic forces, torques, radiofrequency-induced heating, gradient induced heating and vibrations, unintended stimulation, and device malfunction.  We help medical device manufacturers evaluate their devices for safety in the MRI environment and perform physical testing according to ASTM F, F, F and F [1-4].  After the physical testing is complete, we provide the necessary information for MRI safety labeling and supporting scientific rationale that is reported in the instructions for use (IFU) of the device according to ASTM F and FDA guidance documents [5-8].

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We have successfully evaluated numerous medical devices for MRI safety and have supported global regulatory submissions with testing and computational simulation data.  During the accumulation of this experience, our team has identified the top ten challenges that are commonly faced when evaluating medical devices for MRI safety.  To address many of the challenges, it is advantageous for medical device manufacturers to out-source MRI safety evaluations and have a dedicated external resource to stay current with changes in MRI technology, testing standards, and regulatory expectations.  Moreover, consulting companies like MED are able to be more efficient and cost effective by amortizing the cost of expensive testing equipment, cost of validating the test method, and on-going expenses to maintain test method accreditation across numerous projects over many years.

One of the primary challenges in evaluating radiofrequency-induced heating is determining the worst-case device.  We have successfully used validated simulation tools to identify the worst-case device size, configuration, material, orientation and MRI scanner for a wide range of medical devices.  You can learn more about this process by reading our recent whitepaper or by watching a webinar we participated in by using this link. These resources discuss the challenges that medical device manufacturers face when evaluating medical devices for MRI safety.  A case study is shared about using COMSOL Multiphysics® simulation software to predict the worst-case device size for RF-induced heating during MRI.  Through this example, a brief introduction to the coupled electromagnetics and transient heat transfer and the associated experimental methods used for calibration of the model are provided.  This webinar will be of interest to regulatory scientists, development engineers, and clinicians concerned with MRI safety for patients with medical devices.

To learn more about our services and how we can partner with you, please visit medinstitute.com, call us at 855.463., or send us an .

References

[1]  ASTM F, Standard test method for measurement of magnetically induced displacement force on medical devices in the magnetic resonance environment. ASTM International, .

[2]  ASTM F, Standard test method for measurement of magnetically induced torque on medical devices in the magnetic resonance environment. ASTM International, .

[3]  ASTM F, Standard test method for evaluation of MR image artifacts from passive implants. ASTM International, .

[4]  ASTM F, Standard test method for measurement of radio frequency induced heating on or near passive implants during magnetic resonance imaging. ASTM International, .

[5]  ASTM F, Standard practice for marking medical devices and other items for safety in the magnetic resonance environment. ASTM International, .

[6]  Guidance for Industry and FDA Staff: Establishing safety and compatibility of passive implants in the magnetic resonance (MR) environment, .

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[7]  Guidance for Industry and FDA Staff: Assessment of radiofrequency-induced heating in the magnetic resonance (MR) environment for multi-configuration passive medical devices, .

[8]  Guidance for Industry and FDA Staff: Testing and Labeling Medical Devices for Safety in the Magnetic Resonance Environment, .

The MRI examination is performed in a special room that houses the MR system or "scanner." You will be escorted into the room by a staff member of the MRI facility and asked to lie down on a comfortably padded table that gently glides you into and out of the scanner. The typical scanner is open on each end, or at least two sides.

In general, in preparation for the MRI examination, you will be required to wear earplugs or headphones to protect your hearing because many scanning procedures produce loud noises. These loud noises are normal and should not worry you.

For some MRI exams, a contrast agent called gadolinium may be injected into a vein to help obtain a clearer picture of the area being examined. Typically, at the beginning of the imaging procedure, a nurse or MRI technologist will place an intravenous line in your arm or hand vein using a small needle. This will allow injection of the gadolinium contrast agent during the MRI. The line will be connected to a saline solution that will drip through the intravenous line to prevent clotting until the actual contrast agent is injected at some point during the exam. Sometimes, the contrast agent is injected with an automatic device and sometimes it is necessary for the technologist or nurse to come into the room to inject the contrast agent. They may even have to slide the table out of the scanner to do this.

The most important thing for the patient to do is to lie still and relax. Most MRI exams take between 15 to 45 minutes to complete depending on the body part imaged and how many images are needed, although some exams may take up to 60 minutes or longer. You will be told ahead of time how long your scan is expected to take.

You will be asked to remain perfectly still during the time the imaging takes place, but between sequences some minor movement may be allowed. The MRI technologist will advise you, accordingly.

When the MRI exam begins, you may breathe normally. However, for certain examinations it may be necessary for you to hold your breath for a short period of time.

During your MRI examination, the MRI technologist will be able to speak to you, hear you, and observe you at all times. Consult the MRI technologist if you have questions or feel anything unusual.

When the MRI exam is over, you may be asked to wait until the images are examined to determine if more images are needed. After the exam, you have no restrictions and can go about your normal activities.

Once the entire MRI examination is completed, the images will be reviewed by a radiologist, a physician who has been specially trained to interpret images used for diagnostic purposes. The radiologist will communicate the findings of the MRI exam to your physician.

For more information, please visit mri machine manufacturing company.