The main take-home point of my letter can be summarized in one word: STOP!
Stop making up your own terminology. What does "nonmagnetic" mean when it's used to describe a wheelchair with steel bolts and wheel bearings? How about "almost completely, but not all the way nonferromagnetic" instead? You'll have to get bigger stickers, but at least then it would accurately describe the product.
Stop using outdated or superseded terms. ASTM International (formerly the American Society for Testing and Materials, now known solely by their acronym), and the U.S. Food and Drug Administration (FDA) have discontinued the use of "MR Compatible" and so should you. If you mean to say that the use of the object or appliance does not cause any image artifacts, then say that. If it means the object isn't attracted to the magnet, then you're not only using an outdated term, you're using the wrong outdated term!
Stop using the old definitions of terms that have been changed. ASTM and the FDA have made wholesale changes to the meaning of "MR Safe." A majority of products that were marketed under the old definition of "MR Safe" wouldn't qualify for the new designation. If you're marketing a product manufactured by someone else, make sure that you're not facilitating misinformation.
Stop using misleading look-alike or sound-alike terms. There is no standard definition for "MRI Safe" or "Safe for MRI," (as opposed to the standardized "MR Safe") but these terms are often used to insinuate a level of safety that has not been proved. If your products are identified with any look-alike terms, it's time to change.
Stop attempting to trademark or right protect derivations of "MR Safe." We need to "dejargon" this marketplace and not try and stake claims for legal rights to use deceptive alternates to the standard terminology.
This is not to say that vendors should provide only a photo and a price for their products and leave buyers to fend for themselves. There are a number of things that vendors of equipment for the MRI suite should do to benefit their clients, the marketplace, and themselves. What are these?
Start using the new ASTM/FDA naming and labeling conventions of "MR Safe," "MR Conditional," and "MR Unsafe" on all products.
Start disclosing the testing criteria used when identifying products for the MR environment. If you're selling an older version of a product that was tested under a previous standard -- and you can't get information on its designation under the current standards -- clearly state the criteria under which it was tested.
Start providing information and resources to your existing clients to help them classify the products you've already sold them under the current standards. You could probably also sell them a number of stick-on labels with the new designations and icons!
Start to clearly identify the safe limits for use of products. If an object is conditionally safe up to 1.5-tesla, put that information on the product if at all possible.
Vendors of devices and equipment are invaluable to the safe and effective delivery of care in the MRI environment. However, when hyperbole and marketing innuendo cloud the real safety properties of MRI products, vendors undermine the safety of patients and staff that their products are intended to support.
By Tobias Gilk
AuntMinnie.com contributing writer
April 12, 2007
Reprinted from www.mri-planning.com by permission of the authors. If you would like more information on any aspect of MR facility design or safety, please contact Robert Junk or Tobias Gilk at MRI-Planning.com.
MR suite level designations: Don't let complex procedures overwhelm your facility, March 27, 2007
How to calculate your MRI suite safety score, February 8, 2007
MRI risk isn't standing still -- are you? January 29, 2007
It's 300 gauss: Do you know where your vent is? December 29, 2006
Medical gases in the MRI suite, December 14, 2006
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