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Newmatic Medical MRI Safety Standards


We’ve got you covered for safety!
Newmatic Medical is proud to be among the leaders of the MRI industry working to adhere to the American Society of Testing and Materials (ASTM) International Standards for MRI Device Marking. These new standards are aimed at eliminating the confusion of the Food and Drug Administration’s (FDA) previous terms “MR Safe” and “MR Compatible.” When you see an item marked with one of the icons shown below, it is your guarantee that an independent organization has been utilized to conduct the appropriate testing, and the results of those tests are available to you! We encourage our customers to request an email copy of the test results. There are now three terms applicable to MRI Device Marking for safety:


MR SAFE
MR SAFE as defined by the ASTM International document is applied to an item that poses no known hazards in all MR environments. MR SAFE items would include nonconducting, nonmagnetic items such as a plastic Petri dish. The document further states that an item may be determined to be MR SAFE by providing a scientifically based rationale rather than test data. Unlike the previous FDA’s definition of MR Safe, the new MR SAFE may only be applied if the item is 100% safe, without exception, regardless of MR system field strength or any environmental or extenuating circumstances. The universal icon to be used for all MR SAFE products is a green square with white capital letters “MR”, or, a white square with green border and green capital letters “MR”. Items marked with the green MR SAFE icon may be taken into, used, or placed anywhere within any MR environment without risk or potential harm.


MR CONDITIONAL
MR CONDITIONAL is defined by the ASTM International as an item that has been demonstrated to pose no known hazards in a specified MR environment with specifiedconditions of use. Conditions that may be used to define the specified MR environment include field strength, spatial gradient, RF fields, specific absorption rate (SAR) as well as the potential for additional conditions such as operational conditions for a device. The MR CONDITIONIAL label is used to alert the user that there are certain limitations to the usability of the item, or the testing that was performed. As an example, an item may have been tested for a 1.5-Tesla system, but not a 3-Tesla. Items bearing the MR CONDITIONAL icon should include additional information on the label, as to what the conditionality of use is, such as a gauss-line restriction or SAR level limitation. The icon designated for MR CONDITIONAL marking is a yellow equilateral triangle with a black border and black capital letters “MR” inside.


MR SAFE
MR UNSAFE as defined by the ASTM International is any item that is a known threat or poses ahazard in all MR environments. An example of an MR UNSAFE item would be a pair of ferromagnetic scissors, or any item constructed of ferrous metals. The MR UNSAFE icon consists of a white circle with red border and diagonal strike through and the capital black letters “MR” inside.



What if a product doesn’t have a safety icon? Does that mean it can’t be used for MRI?

No, it may still be designated as “MRI Compatible” according to the old standard. The lack of an icon simply means that the manufacturer has yet to re-test their products according to the new standard. We have strongly encouraged all our suppliers to adopt these new standards and look forward to bringing newly tested products to our customers in the future.


We at Newmatic Medical also take safety a step further for you
Every item that ships from our warehouse has been double checked and retested for magnetic parts that do find their way into nonmagnetic products. We start at the manufacturing process, when we are designing a product. Our manufacturers work with us in development to make sure the materials being used exhibit the least amount of magnetic properties available, or preferably, none at all. When the item gets to our warehouse, it is inspected and checked for magnetic reaction with a test magnet equivalent to the strength of a .7-Tesla MR system. Beware, as some vendors may purchase items from manufacturers that make two different versions of the same product, one magnetic, one not. And it has happened that the wrong (magnetic) item is pulled for shipment, and sent out to a company without the thorough quality measures we have, and out it goes to the customer. Once an order has been placed with us, the product is pulled and then re-inspected with the same test magnet in detail. If the wrong bolt or screw was used by accident, we find it. Safety is not a worry you will have when ordering from Newmatic Medical. We’ve been serving the MRI community for over 20 years; we are educated about the issues important to the community and take all the necessary precautions to make sure your job is a little easier, and a lot safer.




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