The MRI Equipment Vendor Diet

By Tobias Gilk

You may not have noticed it, but our website has lost a little weight. Earlier this year we sent a notice to the vendors of after-market MRI equipment and supplies which had been listed on MRI-Planning.com under the ‘Vendor Links’ page. In that notice we asked each vendor to tell us that they currently complied (or were working to comply by the end of the year) with the new ASTM / FDA testing and labeling criteria. Of the several multi-product vendors that were listed on the site at the beginning of 2007, only two have responded so far and remain listed today.

What we did:

In February we sent out an email to each multi-product vendor who had a link from our website to theirs. In that email we pointed them to an article we ran in our January Newsletter, “An Open Letter To MRI Equipment Vendors,” which identified confusing marketing practices and terminology that are sometimes used in the promotion of products for the MRI suite. We asked each vendor to respond and specifically tell us how they’re working to standardize the representation of their products’ safety features using the new MR Safe, MR Conditional, and MR Unsafe language of the new ASTM / FDA criteria.

Why we did it:

Obfuscated confabulation (unclear communication)

We felt compelled to contact the vendors of incidental MRI equipment because there is a vocabulary impasse that threatens the safety of patients and staff. What’s the difference between ‘MR Safe’ and ‘MRI Safe ®’? One is product classification structure developed by the ASTM and adopted by the FDA (which precludes the use of any metal) and the other is a registered trademark for a family of  products for use in the magnet room (that are all constructed largely from metal). What is the difference between ‘non-magnetic’ and ‘non-ferromagnetic’? One is commonly used to indicate that a product doesn’t have enough magnetic material for it to be grossly attracted to a magnet (though, the rate of attraction could vary depending upon which magnet was being used) and the other is being used to describe products that have no ferromagnetic components whatsoever and would not be attracted to a magnet of any strength.

At the moment, it takes an etymologist to parse the meanings of these different terms which are bandied about so recklessly that they are misused as often as they’re used correctly. What this means to consumers of these products is that – aside from the marketing suggestion that the product is supposed to be used in the MRI suite – buyers get very little information about the significant safety properties of the products they’re buying!

Safe? Safe under what conditions? At what maximum field strength? What maximum spatial gradient? Tested by whom? Using what testing protocols?

Non-magnetic? Does this mean not at all magnetic or not grossly attracted? How much attraction is ‘gross’ attraction, anyway? Again, at what maximum field strength and gradient? Are all components, down to the nuts, bolts, bearings and other parts equally as non-magnetic, or is it only the whole assembly, considered in total?

These are some of the basic pieces of information about the safety of MRI appurtenances that every buyer should have access to when considering the purchase of products for the MRI suite.

Who replied:

While we had hoped for a unanimous response from those organizations to who’s websites we had linked, so far we have received only two. We are very pleased to share with you information on these two vendors (listed in the order they responded).

Newmatic Medical (formerly Newmatic Sound) provided us with a copy of testing reports from a highly reputable third-party organization for a large number of their products. Though the test data hadn’t been available at the time of their last catalogue printing, safety data for these products is available for the asking and tested products will soon be identified with the correct ASTM / FDA nomenclature including tested limits of safe use, as appropriate.

Magmedix is currently working with their wholesale suppliers to get each of them to test and label their products sold for use in the MRI suite. As the principle threat from a portable piece of incidental equipment is that it is attracted to the magnet, Magmedix informed us that they have implemented a rigorous quality control program where every single product, not representative samples, is tested for ferromagnetic components prior to being shipped. It is Magnedix’s intention to have as many of their catalogue products identified under the new standard as possible by the end of this year.

What you’ll find on ‘Vendor Links’ today:

When you visit the ‘Vendor Links’ page on MRI-Planning.com today, you will see more than just these two companies listed. We currently list a number of single-product vendors (ferromagnetic detectors, fire extinguishers and safety signage) as well as Magmedix and Newmatic Sound.

As a reader of the MRI Newsletter and visitor to MRI-Planning.com, you should know that we provide links to vendors of products and services that we feel make the MRI environment safer and more productive. The only thing we have asked in return of those companies who wish to have you (our reader) as their customer, is to help unclutter the marketing vocabulary used to promote products for the MRI suite.

There will continue to be several sources from which you can purchase safety equipment for the MRI suite. We hope that you, as an educated consumer of these products, patronize those vendors who are actively working with us to further safety in the MRI suite.

You're reading the MRI Newsletter, which means you're plugged-in to the industry's leading source for information on MRI suite safety and design. Contact Robert Junk, AIA or Tobias Gilk for information on how we can help you develop your next MRI project.