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	<title>MRI Metal Detector Blog &#187; fatality</title>
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	<link>http://mrimetaldetector.com/blog</link>
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	<itunes:summary>Info on ferromagnetic detection and MRI safety &#38; screening</itunes:summary>
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		<title>Transparency &amp; Disappearance</title>
		<link>http://mrimetaldetector.com/blog/2011/06/transparency-disappearance/</link>
		<comments>http://mrimetaldetector.com/blog/2011/06/transparency-disappearance/#comments</comments>
		<pubDate>Sat, 25 Jun 2011 23:44:12 +0000</pubDate>
		<dc:creator>Tobias Gilk</dc:creator>
				<category><![CDATA[Other MRI Safety]]></category>
		<category><![CDATA[accident]]></category>
		<category><![CDATA[accreditation]]></category>
		<category><![CDATA[ACR]]></category>
		<category><![CDATA[ambulatory]]></category>
		<category><![CDATA[American College of Radiology]]></category>
		<category><![CDATA[fatality]]></category>
		<category><![CDATA[hospital]]></category>
		<category><![CDATA[JCAHO]]></category>
		<category><![CDATA[JCR]]></category>
		<category><![CDATA[Joint Commission]]></category>
		<category><![CDATA[MRI]]></category>
		<category><![CDATA[safety]]></category>
		<category><![CDATA[TJC]]></category>

		<guid isPermaLink="false">http://mrimetaldetector.com/blog/?p=992</guid>
		<description><![CDATA[Ironically, those two words &#8211; so similar on the surface &#8211; often turn out to be antonyms. Today I&#8217;m going to attempt to provide you with some transparency relative to a recent disappearance here on this site. First, a little background. I am neither beholden to, or have an axe to grind against, any of [...]]]></description>
			<content:encoded><![CDATA[<p>Ironically, those two words &#8211; so similar on the surface &#8211; often turn out to be antonyms. Today I&#8217;m going to attempt to provide you with some transparency relative to a recent disappearance here on this site.</p>
<p><span id="more-992"></span>First, a little background. I am neither beholden to, or have an axe to grind against, any of the prominent (potential) players in MRI safety. They&#8217;ve each provided me opportunities to advance the cause, and rebuffed me. In the interest of transparency, here are my relationships with both the American College of Radiology (ACR) and the Joint Commission (TJC).</p>
<p>Dr. Emanuel Kanal, MRI safety guru extraordinaire, has been the ACR&#8217;s MRI Safety Committee chairperson since the group was formed in 2001. He invited me to serve on that committee in 2006, and an ACR executive group, which holds veto power over committee appointments, approved me. I participated on that committee and am one of the authors of what became the 2007 ACR Guidance Document for Safe MR Practices. When Dr. Kanal successfully lobbied the ACR to support an update to the Guidance Document last year, the prior committee was disbanded and each individual was subject to re-appointment. I was renominated by Dr. Kanal, but my reappointment was blocked by the ACR executive group. I do not serve on the current incarnation of that committee (which is working on an update to the ACR Guidance Document due out later this year).</p>
<p>Through the ACR, I got one superb opportunity to influence MRI safety. I thought I would get more than one&#8230; but it was just one. I have no engrained personal interest in lifting up the ACR, so when I recommend the Guidance Document, it&#8217;s because I believe that this product is worth my support. Similarly, when I criticize the ACR with respect to MRI safety (as I did, pretty unabashedly, <a title="click for my earlier critique of ACR's actions on MRI safety" href="http://mrimetaldetector.com/blog/2011/05/mri-safety-per-acr-accreditation-standards/" target="_blank">here</a>), it is because I believe that they can do better, and not some petty personal resentment. I did, after all, get that superb opportunity through them.</p>
<p>Switching gears, my relationship with the Joint Commission is strikingly similar to my relationship with the ACR. Over the years, Joint Commission Resources (their educational arm) has asked me to write several pieces for them on MRI safety for various publications. They&#8217;ve also interviewed me for another publication (a piece that almost didn&#8217;t see print because of a disagreement between me and TJC&#8217;s Standards and Survey Methods division about what SEA #38 meant to an accredited provider&#8217;s internal risk assessment). I also had the opportunity to provide an introduction to MRI safety as surveyor training to TJC&#8217;s ambulatory accreditation surveyor corps after TJC was selected as an approved radiology accrediting body under the MIPPA law. That&#8217;s the good (or, at least &#8216;mostly good&#8217;).</p>
<p>TJC is a large organization, and while I&#8217;ve gotten along successfully with their education group, spoken at one of their conferences, and provided services to their ambulatory group, the &#8216;mother ship&#8217; of TJC is their hospital accreditation organization. I&#8217;ve butted heads, usually privately&#8230; though sometimes not, with the hospital side of the organization. Most recently I&#8217;ve been informed that TJC can not accept any of my services, paid or volunteered, because of a potential appearance of a conflict of interest. Effectively, I&#8217;ve been &#8216;blackballed&#8217; from the Joint Commission. While there is much more that I would like to accomplish with and through TJC, I&#8217;ve already managed to do a fair amount with them. As with the ACR, I think I&#8217;m on even terms with TJC&#8230; no debt&#8230; no malice.</p>
<p>I lay this groundwork to get around to the main gist of this post. A few weeks ago I posted, and then, within a week, took down the TJC companion piece to the ACR critique.</p>
<p style="padding-left: 30px;"><em>&#8220;Why would you give preferential treatment to the Joint Commission&#8230; or did you go off the deep-end and say something you regretted?&#8221;</em></p>
<p>I think that the TJC piece was equivalent to the ACR piece. They&#8217;re both accurate and critical of certain actions within each organization. I don&#8217;t think that anything in either piece is inflammatory, or hurtful. I didn&#8217;t write anything that I regret having put down in bits. I know that several regular readers of this blog did see the TJC piece, and I invite any who did read it to post with any thoughts they had that it was / wasn&#8217;t appropriate and fair.</p>
<p style="padding-left: 30px;"><em>&#8220;So, why&#8217;d you take it down then?&#8221;</em></p>
<p>Those of you who know me know that I&#8217;m something of an MRI safety evangelist. I have said and done (foolishly and unrepentantly) things that were not in my own personal best interest when I felt that they advanced MRI safety. I have zero interest in having an &#8220;I told you so&#8221; moment, either in elevating myself or in denigrating healthcare / radiology institutions. I want improvement. I want results. And that&#8217;s why I took down the Joint Commission critique.</p>
<p style="padding-left: 30px;"><em>&#8220;Ummm, OK&#8230; But how did taking it down advance those improvements or results?&#8221;</em></p>
<p>For a long time, years in fact, TJC has been toying with the idea of substantive MRI safety programs, but there are both internal and external hurdles to overcome to allow this to happen. Every historical effort towards implementing MRI safety on the hospital side of the organization has atrophied and died.</p>
<p>Very shortly after I posted the Joint Commission MRI safety critique, I learned that my friend and colleague, Dr. Kanal, was arranging a meeting with TJC to re-spark the conversation about advancing MRI safety within TJC&#8217;s hospital accreditation program. While I have no direct involvement with TJC and Dr. Kanal in these conversations, Dr. Kanal and I did collaborate for the non-hospital MRI safety introduction for the Joint Commission, and I didn&#8217;t want the critique I wrote, coupled with any legacy of prior collaboration, to poison Dr. Kanal&#8217;s current efforts. So I took the post down.</p>
<p>If I felt that there were any parallel efforts underway at the ACR, and that taking down that post would advance those efforts, I&#8217;d pull it down in a heartbeat, too. To my knowledge, however, there aren&#8217;t, so until I see an advantage to taking it down, it stays and I invite everyone interested in this topic to read it, <a title="Here it is, again" href="http://mrimetaldetector.com/blog/2011/05/mri-safety-per-acr-accreditation-standards/" target="_blank">here</a>.</p>
<p>And if the situation with the Joint Commission changes, and the current effort on MRI safety slips into the comfortable, well-worn precedent of failure, know that the post isn&#8217;t gone, it&#8217;s only disappeared, and will reappear if / when it&#8217;s absence isn&#8217;t more constructive.</p>
<p>Ultimately, it&#8217;s all about affecting change. We expect that we have thousands, perhaps tens-of-thousands, of MRI adverse events occurring every year in the US, and the vast, VAST majority of these are readily preventable, or would be if we had enforced standards. That&#8217;s what I&#8217;m after.</p>
<p>And this is me, being as transparent about the whole situation as I can be.</p>
<address><a href="../2011/05/2011/02/2011/02/2011/01/2010/12/2010/12/2010/12/2010/12/2010/10/about-tobias-gilk-editor/" target="_blank"><strong>Tobias Gilk</strong></a>, </address>
<address> </address>
<address> </address>
<address>President &amp; MRI     Safety Director — Mednovus, Inc.</address>
<address>Tobias.Gilk@Mednovus.com</address>
<address><a title="Click for Mednovus.com" href="http://www.mednovus.com/products.html" target="_blank">www.MEDNOVUS.com</a></address>
<address> </address>
<address> </address>
<address> </address>
<address>Sr. Vice President — RAD-Planning.com</address>
<address>TGilk@RAD-Planning.com</address>
<address><a title="Click For RAD-Planning.com" href="http://www.rad-planning.com/" target="_blank">www.RAD-Planning.com</a><br />
</address>
<address> </address>
<p><a href="http://www.twitter.com/tobiasgilk"><img class="alignnone size-full wp-image-852" title="TwitterIcon_32-32" src="http://mrimetaldetector.com/blog/wp-content/uploads/2010/06/TwitterIcon_32-321.gif" alt="Click for Tobias Gilk's Twitter Page" width="32" height="32" /></a><a title="Tobias Gilk on Twitter" href="http://twitter.com/tobiasgilk" target="_blank"> Click here for Tobias’ Twitter Profile</a></p>
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		<item>
		<title>MRI Safety Resolution</title>
		<link>http://mrimetaldetector.com/blog/2011/01/mri-safety-resolution/</link>
		<comments>http://mrimetaldetector.com/blog/2011/01/mri-safety-resolution/#comments</comments>
		<pubDate>Sat, 01 Jan 2011 23:15:07 +0000</pubDate>
		<dc:creator>Tobias Gilk</dc:creator>
				<category><![CDATA[Ferromagnetic Detection for MRI Safety]]></category>
		<category><![CDATA[Other MRI Safety]]></category>
		<category><![CDATA[2011]]></category>
		<category><![CDATA[accident]]></category>
		<category><![CDATA[accreditation]]></category>
		<category><![CDATA[ACR]]></category>
		<category><![CDATA[American College of Radiology]]></category>
		<category><![CDATA[care]]></category>
		<category><![CDATA[Center for Medicare]]></category>
		<category><![CDATA[CMS]]></category>
		<category><![CDATA[death]]></category>
		<category><![CDATA[fatality]]></category>
		<category><![CDATA[FDA]]></category>
		<category><![CDATA[Food and Drug Administration]]></category>
		<category><![CDATA[injury]]></category>
		<category><![CDATA[Joint Commission]]></category>
		<category><![CDATA[magnetic resonance]]></category>
		<category><![CDATA[MRI]]></category>
		<category><![CDATA[New Year]]></category>
		<category><![CDATA[practice]]></category>
		<category><![CDATA[resolution]]></category>
		<category><![CDATA[risk]]></category>
		<category><![CDATA[safety]]></category>
		<category><![CDATA[standard]]></category>
		<category><![CDATA[TJC]]></category>

		<guid isPermaLink="false">http://mrimetaldetector.com/blog/?p=944</guid>
		<description><![CDATA[What do the ACR, TJC, CMS and FDA all have in common? They're all going to be on my MRI safety 'speed dial' in 2011... and they should be on yours, too!]]></description>
			<content:encoded><![CDATA[<p>I&#8217;m not big on New Years&#8217; resolutions. In fact, I&#8217;ve previously resolved to not resolve&#8230; but today I&#8217;m breaking that vow (or would that be a &#8216;disavow&#8217;?). This year there are just too many things precariously poised &#8212; that could fall our way or not &#8212; that I can&#8217;t help but to resolve to rededicate myself to making substantive changes to industry standards and practices for MR safety, and here&#8217;s how I&#8217;m going to do it&#8230;</p>
<p><span id="more-944"></span>The Joint Commission (TJC or, to those of us schooled in their acronym more than 3 years ago, JCAHO): TJC has just referenced the 2010 edition of the <em>Guidelines for Design and Construction of Health Care Facilities</em> as the new design and construction standard (effective today). The 2010 Guidelines codifies a number of the <a title="Click for TJC MR Safety Article" href="http://mrimetaldetector.com/blog/2010/12/2011_npsg/" target="_blank">MR safety recommendations that have passed from the Joint Commission&#8217;s own lips</a> and makes them standards for new construction. In 2011 I will apply whatever cajoling, leveraging, sweet-talking, or shaming that will help the Joint Commission to apply it&#8217;s own standards to the thousands of existing MRIs at TJC accredited providers. This began last year with training provided to TJC&#8217;s ambulatory care surveyors, forestalled and rebuffed offers of the same for their hospital surveyors.</p>
<p>Centers for Medicare / Medicaid (CMS): At least somewhat in response to the public attention that was focused on the issues of radiology / nuclear medicine safety through the ongoing series of articles by Walt Bogdanich of the New York Times, in 2010 CMS began development of a set of radiology / nuclear medicine patient safety standards that they intend to roll-out as a condition of reimbursement. It is anticipated that these will be unveiled in the spring for public comment before being enacted some time later. I know that, last year, MR safety proposals were presented to CMS, and at the anticipated public meeting I will seek to make sure that the single largest healthcare benefits provider in the US includes substantive MR safety standards.</p>
<p>Food and Drug Administration (FDA): Quick as they were to arrange public hearings on radiology safety (after the first couple Bogdanich articles saw print), the FDA has been &#8216;in the planning and coordination&#8217; stages of a similar meeting on MRI safety for well over six months. Originally proposed for last year September, the prospective date has been nudged enough times that, as of my last inquiry, they&#8217;ve stopped even suggesting months, or even seasons, and I was last left with the promise of &#8216;sometime in 2011&#8230; hopefully the first half&#8230;&#8217; I will endeavor to see that this meeting takes place (perhaps in concert with the CMS meeting), because I <em><strong>know</strong></em> that smart, capable people within the FDA have done analyses of MRI accidents and have developed an MR safety &#8216;short list&#8217; of preventions which the FDA has yet to release, to say nothing of promulgate or endorse. Sitting on effective safety solutions when the accident rate is quadrupling is&#8230; well&#8230; inconceivable.</p>
<p>American College of Radiology (ACR): At the ACR&#8217;s presentation at the 2009 annual meeting of the American Healthcare Radiology Administrators (AHRA), the ACR representatives announced that the organization was going to incorporate MR safety standards from it&#8217;s own <em>ACR Guidance Document for Safe MR Practices: 2007</em> in the ACR&#8217;s MR accreditation program. In 2010 I was privately told by a very well-placed person within the ACR that the new CMS oversight of the MIPPA accreditation process made it &#8216;logistically onerous&#8217; to change the existing MR accreditation program (this despite the fact that the ACR was pleased to submit to CMS &#8212; and receive prompt approval for &#8212; an entirely new breast MR accreditation program). In 2011 we expect to see a new edition of the <em>Guidance Document</em>, which will make the fourth publication appearing under the ACR&#8217;s name that speaks to effective solutions for the reduction of MR accidents&#8230; and the fourth one that the ACR will have <span style="text-decoration: underline;">not</span> included as an element of their own MR accreditation program. Whether it&#8217;s through meaningful standards passed down from CMS, or by reversing the apparent hypocrisy of the ACR, itself, I will spend 2011 working to see that substantive MR safety standards are incorporated as a part of the ACR&#8217;s MR accreditation program.</p>
<p>So what is the monster-list of standards that would be necessary to mitigate the vast majority of MRI accidents and injuries? Well, it turns out that it isn&#8217;t long at all, and all of these are already promulgated as best practice recommendations&#8230;</p>
<ol>
<li>Provide annual MR safety training for all MR personnel (and MR irregulars)</li>
<li>Restrict access to controlled areas of the MR suite for unscreened / unsupervised persons and untested equipment per the ACR 4-zone model</li>
<li>Provide uniform and documented screening for all persons entering controlled areas of the MR suite</li>
<li>Screen persons and objects with a ferromagnetic-only detector before allowing access to controlled areas of MR suite</li>
<li>Provide hearing protection (and ensure proper usage) for all persons remaining in the magnet room during the MR exam</li>
<li>Use positioning aids and insulating pads as recommended to separate the MR patient from RF elements and conductive materials (including their own tissues)</li>
</ol>
<p>These six items would likely cut the rates of MR accidents by more than 90%! These items have also been recommended (or very similar elements) by the Joint Commission, ACR, and others. If they were <em><strong>enforced</strong></em>, however, we could very nearly eliminate MR accidents in governed facilities!</p>
<p>Getting us to enforcement, <span style="text-decoration: underline;">that</span> is my 2011 New Year&#8217;s Resolution, but I won&#8217;t make it there alone. Can I count on you to work on this with me?</p>
<address><a href="../2010/12/2010/12/2010/12/2010/12/2010/10/about-tobias-gilk-editor/" target="_blank"><strong>Tobias Gilk</strong></a>, </address>
<address> </address>
<address> </address>
<address>President &amp; MRI     Safety Director — Mednovus, Inc.</address>
<address>Tobias.Gilk@Mednovus.com</address>
<address><a title="Click for Mednovus.com" href="http://www.mednovus.com/products.html" target="_blank">www.MEDNOVUS.com</a></address>
<address> </address>
<address> </address>
<address> </address>
<address>Sr. Vice President — RAD-Planning.com</address>
<address>TGilk@RAD-Planning.com</address>
<address><a title="Click For RAD-Planning.com" href="http://www.rad-planning.com/" target="_blank">www.RAD-Planning.com</a><br />
</address>
<address> </address>
<p><a href="http://www.twitter.com/tobiasgilk"><img class="alignnone size-full wp-image-852" title="TwitterIcon_32-32" src="http://mrimetaldetector.com/blog/wp-content/uploads/2010/06/TwitterIcon_32-321.gif" alt="Click for Tobias Gilk's Twitter Page" width="32" height="32" /></a><a title="Tobias Gilk on Twitter" href="http://twitter.com/tobiasgilk" target="_blank"> Click here for Tobias’ Twitter Profile</a></p>
]]></content:encoded>
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		<title>As 2010 Ends, Can&#8217;t We Please Let Go Of NSF?</title>
		<link>http://mrimetaldetector.com/blog/2010/12/as-2010-ends-cant-we-please-let-go-of-nsf/</link>
		<comments>http://mrimetaldetector.com/blog/2010/12/as-2010-ends-cant-we-please-let-go-of-nsf/#comments</comments>
		<pubDate>Fri, 31 Dec 2010 23:56:24 +0000</pubDate>
		<dc:creator>Tobias Gilk</dc:creator>
				<category><![CDATA[Ferromagnetic Detection for MRI Safety]]></category>
		<category><![CDATA[Other MRI Safety]]></category>
		<category><![CDATA[accident]]></category>
		<category><![CDATA[burn]]></category>
		<category><![CDATA[contrast]]></category>
		<category><![CDATA[damage]]></category>
		<category><![CDATA[death]]></category>
		<category><![CDATA[dye]]></category>
		<category><![CDATA[fatality]]></category>
		<category><![CDATA[Gadolinium]]></category>
		<category><![CDATA[hearing]]></category>
		<category><![CDATA[injury]]></category>
		<category><![CDATA[kidney]]></category>
		<category><![CDATA[magnetic resonance]]></category>
		<category><![CDATA[missile]]></category>
		<category><![CDATA[MRI]]></category>
		<category><![CDATA[nephrogenic fibrosing dermopathy]]></category>
		<category><![CDATA[nephrogenic systemic fibrosis]]></category>
		<category><![CDATA[NSF]]></category>
		<category><![CDATA[projectile]]></category>
		<category><![CDATA[radiologist]]></category>
		<category><![CDATA[radiology]]></category>
		<category><![CDATA[tinitus]]></category>

		<guid isPermaLink="false">http://mrimetaldetector.com/blog/?p=936</guid>
		<description><![CDATA["Lest old NSF be forgot..." Is the end of 2010 the time to end the MR safety focus on NSF and turn our attention to long-standing (and unresolved) MR safety issues? I think so...]]></description>
			<content:encoded><![CDATA[<p>Make no mistake, Nephrogenic Systemic Fibrosis (NSF), a horrible (and thankfully very rare) disease which can afflict persons with significantly impaired kidney function who receive certain gadolinium based MRI contrast agents. Over the past few years, tremendous resources have been poured into the identification of patients, research on the specific mechanisms of disease, and effective means of prevention. NSF has run into a problem, however, which has dramatically curtailed further research&#8230; we&#8217;ve darn-near eliminated this disease!</p>
<p><span id="more-936"></span>In about 4 years, NSF was identified (originally called Nephrogenic Fibrosing Dermopathy), the culprit identified, the population-specific susceptibility deduced, and effective screening protocols developed and deployed. Yes, it is still possible to develop NSF today, but we also have the tools requisite to interdict the agents that trigger the disease, and an industry-wide awareness of the preventative steps which are effective in doing so.</p>
<p>This is a testament to an international confederation of radiologists, nephrologists, pharmacologists and pathologists who collaborated on the challenge of this disease. It is worthy of a self-congratulatory pat on the back for radiology that we were able to sleuth-out the cause, and disciplined enough to execute effective prevention, in such a short time. But lest we spend too much time singing our own accolades, we should remember that more than 92% of MR accidents studied (selected based on the availability of information on causation), were made up burns, projectiles and hearing damage. These aren&#8217;t clinical problems, per se, rather they&#8217;re operational in nature.</p>
<p>Perhaps that accounts for the disparity in response. MR is a clinical instrument, and NSF was in the clinical wheelhouse. Yes, it extended well beyond radiology, but it was (and still is) essentially a clinical issue.</p>
<p>More often than not you will never find a radiologist actually <strong><em>in</em></strong> an MRI suite, so they are unfamiliar with &#8211; and often uncomfortable with &#8211; operational concerns. There are, of course, exceptions to this but those are&#8230; well&#8230; exceptional.</p>
<p>If NSF can be identified, studied, researched, and ultimately almost universally prevented in the course of a handful of years, how is it that we continue to see alarming year-over-year growth in combined burns, projectiles and hearing damage? If we can study a brand new disease and prevent it with nearly 100% effectiveness, why can&#8217;t we make sure insulating pads are used, or that ferromagnetic detectors are part of every MRI center, or that we make sure that hearing protection is used (and used properly)?</p>
<p>For these injuries there is no direct-causation mystery. We don&#8217;t need expensive animal trials, or chemical analysis of different contrast agents. We don&#8217;t need an international interdisciplinary clinical team. We need pads, ferromagnetic detectors, and earmuffs.</p>
<p>So my appeal, made plain in the headline, is for us to let NSF go. Let us not dwell in an anachronistic state of fear, nor linger any longer in self-congratulation. We have other tasks to help make MRI as safe as we know it can be, and we need to redirect our attention to that job ahead of us.</p>
<address><a href="../2010/12/2010/12/2010/12/2010/10/about-tobias-gilk-editor/" target="_blank"><strong>Tobias Gilk</strong></a>, </address>
<address> </address>
<address> </address>
<address>President &amp; MRI     Safety Director — Mednovus, Inc.</address>
<address>Tobias.Gilk@Mednovus.com</address>
<address><a title="Click for Mednovus.com" href="http://www.mednovus.com/products.html" target="_blank">www.MEDNOVUS.com</a></address>
<address> </address>
<address> </address>
<address> </address>
<address>Sr. Vice President — RAD-Planning.com</address>
<address>TGilk@RAD-Planning.com</address>
<address><a title="Click For RAD-Planning.com" href="http://www.rad-planning.com/" target="_blank">www.RAD-Planning.com</a><br />
</address>
<address> </address>
<p><a href="http://www.twitter.com/tobiasgilk"><img title="TwitterIcon_32-32" src="../wp-content/uploads/2010/06/TwitterIcon_32-32.gif" alt="Click for Tobias Gilk's Twitter Page" width="32" height="32" /></a><a title="Tobias Gilk on Twitter" href="http://twitter.com/tobiasgilk" target="_blank"> Click here for Tobias’ Twitter Profile</a></p>
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		<item>
		<title>Colombini-Leaks &#124; How Did a 6-Year-Old Boy Die in MRI Accident?</title>
		<link>http://mrimetaldetector.com/blog/2010/12/colombini-leaks-how-did-a-6-year-old-boy-die-in-mri-accident/</link>
		<comments>http://mrimetaldetector.com/blog/2010/12/colombini-leaks-how-did-a-6-year-old-boy-die-in-mri-accident/#comments</comments>
		<pubDate>Sun, 19 Dec 2010 18:09:13 +0000</pubDate>
		<dc:creator>Tobias Gilk</dc:creator>
				<category><![CDATA[Other MRI Safety]]></category>
		<category><![CDATA[civil]]></category>
		<category><![CDATA[colombini]]></category>
		<category><![CDATA[cylinder]]></category>
		<category><![CDATA[death]]></category>
		<category><![CDATA[department of health]]></category>
		<category><![CDATA[deposition]]></category>
		<category><![CDATA[fatality]]></category>
		<category><![CDATA[imaging]]></category>
		<category><![CDATA[incident]]></category>
		<category><![CDATA[injury]]></category>
		<category><![CDATA[investigation]]></category>
		<category><![CDATA[lawsuit]]></category>
		<category><![CDATA[layer]]></category>
		<category><![CDATA[legal]]></category>
		<category><![CDATA[magnetic resonance]]></category>
		<category><![CDATA[MRI]]></category>
		<category><![CDATA[New York]]></category>
		<category><![CDATA[oxygen]]></category>
		<category><![CDATA[projectile]]></category>
		<category><![CDATA[radiology]]></category>
		<category><![CDATA[report]]></category>
		<category><![CDATA[safety]]></category>
		<category><![CDATA[settlement]]></category>
		<category><![CDATA[suit]]></category>
		<category><![CDATA[tank]]></category>
		<category><![CDATA[testimony]]></category>
		<category><![CDATA[trial]]></category>
		<category><![CDATA[Westchester Medical Center]]></category>

		<guid isPermaLink="false">http://mrimetaldetector.com/blog/?p=930</guid>
		<description><![CDATA[Perhaps the only thing Julian Assange and I have in common is our melanin-free complexion... that and a desire to share unvarnished truth. My truth happens to be MRI safety.]]></description>
			<content:encoded><![CDATA[<p>First, let me say that this isn&#8217;t a &#8216;leak&#8217; in the sense that none of the information I&#8217;m about to share is (any longer) confidential. This information is all public record as a result of court filings for the now-settled civil suit surrounding the 2001 MRI fatality of Michael Colombini. There are documents associated with that civil lawsuit which did not wind up as filings with the court and therefore are not a part of the public record. I have no difficulty not releasing those because (among other reasons) I don&#8217;t have any of them.</p>
<p>&#8220;Why &#8212; now &#8212; ten years later would you post these documents?&#8221;</p>
<p>Excellent question! Here&#8217;s why I didn&#8217;t publish these long ago&#8230;</p>
<p><span id="more-930"></span>I didn&#8217;t have them.</p>
<p>Yes, the civil suit had been underway for years. Yes, individual documents had been filed and made public during the course of the civil litigation, but the civil suit was only resolved a year ago and it took several months for the last of the documents to be made public through the <a title="Westchester County Clerk's Website" href="http://www.westchesterclerk.com/" target="_blank">Westchester County Clerk&#8217;s Office</a> (who, by the way, were profoundly helpful in accessing these public records).</p>
<p>Here&#8217;s why I am publishing them now&#8230; Despite the fact that this is the watershed event in MR safety, the degree to which the industry has really dissected this event and identified the causative factors has been wanting. Desperately wanting.</p>
<p>I&#8217;m currently working with a colleague on a root-cause-analysis of this event, drilling down through the simple (don&#8217;t have ferrous oxygen tanks in the MR suite) to get at more meaningful elements of this accident that we can work to prevent similar accidents. It promises to be unlike anything you&#8217;ve learned about why this accident happened.</p>
<p>Given the trajectory of MR accidents and adverse events, this sort of analysis appears to be desperately needed.</p>
<p><a href="http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/search.CFM"><img class="aligncenter size-medium wp-image-931" title="2009_FDA_MAUDE_MRI_accident_chart.001" src="http://mrimetaldetector.com/blog/wp-content/uploads/2010/12/2009_FDA_MAUDE_MRI_accident_chart.001-300x225.jpg" alt="Multi-Year FDA Data on MRI Accidents" width="300" height="225" /></a></p>
<p>So, what are the documents? They are transcripts of the depositions of many of the key people involved in the accident and couple of &#8216;official&#8217; reviews. These are the source materials. The news accounts you&#8217;ve previously read are all synthesized from these (or from others&#8217;  interpretations of these). If you&#8217;re so inclined, you can download and read these for yourself.</p>
<p>The essential elements of the sequence of events for the accident are these:</p>
<ul>
<li>Michael Colombini, a young boy, was injured from a playground accident</li>
<li>The ER had a head CT run, which revealed an unknown / asymptomatic brain tumor</li>
<li>The boy had surgery very shortly thereafter to remove the tumor</li>
<li>Prior to discharge, the boy was sent for a baseline MRI as a reference for future monitoring</li>
<li>The boy was sedated prior to the exam and placed in the MR with a cannula to deliver oxygen</li>
<li>Before the exam began, the anesthesiologist observed a decline in O2 saturation, and realized that the oxygen from the wall outlet was not flowing, despite his attempts to turn it up</li>
<li>The anesthesiologist called the technologist who was to administer the exam to the door of the MR room, instructing her to find and fix the source of the problem with the oxygen flow</li>
<li>This technologist was not familiar with the oxygen supply system, which &#8212; in apparent violation of codes &#8212; was fed to only the MR exam room from a bulk cylinder without any pressure or flow alarms</li>
<li>The technologist sought her colleague who she believed knew the oxygen system and together they entered the MR equipment room to try and fix the supply problem</li>
<li>The anesthesiologist cried out for help, though the technologists in the MR equipment room could not hear this</li>
<li>A nurse (who had accompanied an earlier patient to the MR suite was returning to retrieve an item she had left) heard the anesthesiologist&#8217;s cries for help and handed him a portable cylinder near the door to the MR exam room</li>
<li>The anesthesiologist turned to approach the boy with the oxygen tank when the magnetic attractive force of the MRI pulled the cylinder from the doctor&#8217;s grasp</li>
<li>The tank flew into the MRI where it struck the boy in the face and head, inflicting fatal wounds</li>
</ul>
<p>The following PDF documents vary in size from 1 MB to 25 MB, and will take a few minutes to download, depending on your connection speed.</p>
<p style="padding-left: 30px;"><a title="Patricia Lauria Depo ~25 MB" href="http://www.mripatientsafety.com/Colombini/Depo_Patricia_Lauria.pdf" target="_blank">Deposition of Patricia Lauria</a>, technologist who was to have administered the Colombini scan<a title="Paul Daniels Depo ~25 MB" href="http://www.mripatientsafety.com/Colombini/Depo_Paul_Daniels.pdf" target="_blank"><br />
Deposition of Paul Daniels</a>, other technologist on duty who assisted in the repair of the oxygen supply<a title="Jian Hou Depo ~14 MB" href="http://www.mripatientsafety.com/Colombini/Depo_Jian_Hou.pdf" target="_blank"><br />
Deposition of Jian Hou, MD</a>, anesthesiologist who sedated / monitored Colombini for the MR exam<a title="Terrence Matalon Depo ~27 MB" href="http://www.mripatientsafety.com/Colombini/Depo_Terrence_Matalon.pdf" target="_blank"><br />
Deposition of Terrence Matalon, MD</a>, Radiologist who was simultaneously the hospital&#8217;s Director of Radiology <strong><em>and</em></strong> president of the private company subcontracted by the hospital to provide operations for the MRI service<br />
New York State <a title="NY DoH Report ~2 MB" href="http://www.mripatientsafety.com/Colombini/NYS_DoH_Report.pdf" target="_blank">Department of Health incident report</a><a title="WMC Review ~1 MB" href="http://www.mripatientsafety.com/Colombini/Westchester_Incident_Review.pdf" target="_blank"><br />
Westchester Medical Center incident review</a></p>
<p>As you might suspect, these documents are but the tip of the iceberg of the body of the court filings in this civil suit. However, for those interested in what happened and why (as opposed to the legal maneuvering), these documents are the most illuminating.</p>
<p>In the months ahead, the 10th anniversary of the 2001 Colombini fatality will include a deeper look into this accident and the changes that have taken place (and those that are still needed if we wish to avoid repeating this accident). This has begun, slowly, with the new building code requirements that are being adopted by various US states and the Joint Commission, but may pick up steam with federal government intervention.</p>
<p>Please check back periodically for the latest information on MRI safety&#8230; both as it relates to specific preventions, such as ferromagnetic detection systems, and broader awareness such as knowledge of the factors in the Colombini fatality.</p>
<address><a href="../2010/12/2010/12/2010/10/about-tobias-gilk-editor/" target="_blank"><strong>Tobias Gilk</strong></a>, </address>
<address> </address>
<address> </address>
<address>President &amp; MRI     Safety Director — Mednovus, Inc.</address>
<address>Tobias.Gilk@Mednovus.com</address>
<address><a title="Click for Mednovus.com" href="http://www.mednovus.com/products.html" target="_blank">www.MEDNOVUS.com</a></address>
<address> </address>
<address> </address>
<address> </address>
<address>Sr. Vice President — RAD-Planning.com</address>
<address>TGilk@RAD-Planning.com</address>
<address><a title="Click For RAD-Planning.com" href="http://www.rad-planning.com/" target="_blank">www.RAD-Planning.com</a><br />
</address>
<address> </address>
<p><a href="http://www.twitter.com/tobiasgilk"><img class="size-full wp-image-852 alignleft" title="TwitterIcon_32-32" src="http://mrimetaldetector.com/blog/wp-content/uploads/2010/06/TwitterIcon_32-321.gif" alt="Click for Tobias Gilk's Twitter Page" width="32" height="32" /></a><a title="Tobias Gilk on Twitter" href="http://twitter.com/tobiasgilk" target="_blank"> Click here for Tobias’ Twitter Profile</a></p>
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		<item>
		<title>Radiation Therapy Accidents vs. MRI Accidents</title>
		<link>http://mrimetaldetector.com/blog/2010/12/radiation-therapy-accidents-vs-mri-accidents/</link>
		<comments>http://mrimetaldetector.com/blog/2010/12/radiation-therapy-accidents-vs-mri-accidents/#comments</comments>
		<pubDate>Fri, 17 Dec 2010 00:38:07 +0000</pubDate>
		<dc:creator>Tobias Gilk</dc:creator>
				<category><![CDATA[Other MRI Safety]]></category>
		<category><![CDATA[accident]]></category>
		<category><![CDATA[adverse event]]></category>
		<category><![CDATA[death]]></category>
		<category><![CDATA[fatality]]></category>
		<category><![CDATA[FDA]]></category>
		<category><![CDATA[imaging]]></category>
		<category><![CDATA[injury]]></category>
		<category><![CDATA[magnetic resonance]]></category>
		<category><![CDATA[MAUDE]]></category>
		<category><![CDATA[medicine]]></category>
		<category><![CDATA[MRI]]></category>
		<category><![CDATA[nuclear]]></category>
		<category><![CDATA[oncology]]></category>
		<category><![CDATA[radiation]]></category>
		<category><![CDATA[radiology]]></category>
		<category><![CDATA[safety]]></category>
		<category><![CDATA[therapy]]></category>

		<guid isPermaLink="false">http://mrimetaldetector.com/blog/?p=926</guid>
		<description><![CDATA[Lots of attention has been paid to medical radiation therapy accidents. They must dramatically outnumber accidents for 'safe' procedures, like MRI, right? Guess again...]]></description>
			<content:encoded><![CDATA[<p>I stumbled across a paper abstract from the International Journal of Medical Physics Research and Practice. The <a href="http://online.medphys.org/resource/1/mphya6/v38/i1/p78_s1?isAuthorized=no" target="_blank">abstract</a> described a meeting on radiation oncology safety which, &#8220;attracted 400 attendees, including medical physicists, radiation  oncologists, medical dosimetrists, radiation therapists, hospital  administrators, regulators, and representatives of equipment  manufacturers. The meeting was cohosted by 14 organizations in the  United States and Canada.&#8221;</p>
<p>Damn! I&#8217;m impressed, particularly since the abstract also states that this meeting was hastily called in response to articles appearing, starting in January of this year, in the New York Times on radiology and radiation therapy accidents. Such a coordinated response by the professional societies. Such representation from the professional community at a time when conference and professional development budgets are being slashed. How does this compare with MRI?</p>
<p><span id="more-926"></span>Well, MRI accidents haven&#8217;t been the focus of a string of national news articles, and I certainly wouldn&#8217;t begrudge safety-minded professionals within radiation oncology from seizing upon the public attention to address longstanding safety issues&#8230; but how do the raw numbers compare? Fortunately, we have an excellent resource for raw numbers and we don&#8217;t have to idly wonder.</p>
<p>The FDA&#8217;s medical device adverse event database, MAUDE, is much maligned (much of the maligning is by me), but its one redeeming value is that it gives us a snapshot, over time, of medical-device related adverse events.</p>
<p>I searched MAUDE, and from  1999 &#8211; 2009, three &#8216;radiation therapy&#8217; product codes (JAI, LHN, IWB)  accounted for 165 total adverse event reports. Some of those included things like pinched fingers while the couch was moving, but some were also the more serious adverse events, such as incorrect dose administration.</p>
<p>During the same 10 year  period, the MAUDE database revealed that MRI (product code LNH) has 838 adverse event reports! That&#8217;s 5 times as many as radiation therapy! Similar to the radiation therapy reports, there were also adverse event accounts that were spurious, at best, but mixed in were accounts of broken bones, penetrating wounds, and even death, related to MRI hazards.</p>
<p>At the risk of being repetitive, I do not begrudge or belittle the current efforts at making radiation therapy safer for all who administer and receive it. Everywhere there is error in healthcare delivery, we have a duty to work to squeeze it out of existence, and nowhere is that mission more important than in the highly technical arenas of radiology, nuclear medicine and radiation therapy. My frustration, however, lies in the fact that larger safety issues, and safety issues that clearly have a dangerous trajectory, are being ignored.</p>
<p>I would love to see a collaborative forum of 14 organizations, MR manufacturers, and regulatory agencies from multiple countries gather to speak to the alarming growth of MR accidents. I&#8217;d love to see 400 professionals convene for a conference dedicated to practical, actionable and direct solutions to our contemporary MR safety needs. Unfortunately, many organizations that have similar duties to the MR community are &#8216;just too busy&#8217; to look at MR safety right now.</p>
<p>I&#8217;ve said it before (and will say it again despite the fact that I hope I am completely and utterly wrong), it may take another high-profile MRI fatality to shake-off the professional indifference to MR safety issues.</p>
<address><a href="../2010/12/2010/10/about-tobias-gilk-editor/" target="_blank"><strong>Tobias Gilk</strong></a>, </address>
<address> </address>
<address> </address>
<address>President &amp; MRI     Safety Director — Mednovus, Inc.</address>
<address>Tobias.Gilk@Mednovus.com</address>
<address><a title="Click for Mednovus.com" href="http://www.mednovus.com/products.html" target="_blank">www.MEDNOVUS.com</a></address>
<address> </address>
<address> </address>
<address> </address>
<address>Sr. Vice President — RAD-Planning.com</address>
<address>TGilk@RAD-Planning.com</address>
<address><a title="Click For RAD-Planning.com" href="http://www.rad-planning.com/" target="_blank">www.RAD-Planning.com</a><br />
</address>
<address> </address>
<p><a href="http://www.twitter.com/tobiasgilk"><img title="TwitterIcon_32-32" src="../wp-content/uploads/2010/06/TwitterIcon_32-321.gif" alt="Click for Tobias Gilk's Twitter Page" width="32" height="32" /></a><a title="Tobias Gilk on Twitter" href="http://twitter.com/tobiasgilk" target="_blank"> Click here for Tobias’ Twitter Profile</a></p>
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		<title>NOT Magnet Safe Scissors!</title>
		<link>http://mrimetaldetector.com/blog/2010/07/not-magnet-safe-scissors/</link>
		<comments>http://mrimetaldetector.com/blog/2010/07/not-magnet-safe-scissors/#comments</comments>
		<pubDate>Tue, 06 Jul 2010 19:22:12 +0000</pubDate>
		<dc:creator>Tobias Gilk</dc:creator>
				<category><![CDATA[Ferromagnetic Detection for MRI Safety]]></category>
		<category><![CDATA[accident]]></category>
		<category><![CDATA[death]]></category>
		<category><![CDATA[fatality]]></category>
		<category><![CDATA[FDA]]></category>
		<category><![CDATA[force]]></category>
		<category><![CDATA[imaging]]></category>
		<category><![CDATA[injury]]></category>
		<category><![CDATA[magnetic]]></category>
		<category><![CDATA[MAUDE]]></category>
		<category><![CDATA[missile]]></category>
		<category><![CDATA[MRI]]></category>
		<category><![CDATA[patient]]></category>
		<category><![CDATA[projectile]]></category>
		<category><![CDATA[radiographer]]></category>
		<category><![CDATA[resonance]]></category>
		<category><![CDATA[safety]]></category>
		<category><![CDATA[scissors]]></category>
		<category><![CDATA[Technologist]]></category>
		<category><![CDATA[translational]]></category>

		<guid isPermaLink="false">http://mrimetaldetector.com/blog/?p=860</guid>
		<description><![CDATA[In case still pictures weren't enough, what about a video simulation of a scissors flying into an MRI scanner with such force that they embedded themselves in... well... what is that?]]></description>
			<content:encoded><![CDATA[<p>Last year I highlighted an FDA MRI accident report in which a technologist had to have a pair of scissors surgically removed from his forehead after they&#8217;d caught him between the magnet-homing missile that they became, and the isocenter of the MRI. You may remember that I fauxtoshopped a hypothesis as to what that accident would have looked like on plain film: perhaps something like this&#8230;<span id="more-860"></span></p>
<p><img class="aligncenter size-medium wp-image-801" title="scissors-in-skull-xray" src="http://mrimetaldetector.com/blog/wp-content/uploads/2010/02/scissors-in-skull-xray-300x235.jpg" alt="" width="300" height="235" /></p>
<p>Well, in case your imaginations have only wrapped around the aftermath, and not the incident, I&#8217;ve just recently come across another visual aid that might just help you with the complete picture. Imagine a pair of scissors, an MRI, and a pumpkin&#8230;</p>
<div id="attachment_861" class="wp-caption aligncenter" style="width: 310px"><img class="size-medium wp-image-861" title="scissors_pumpkin" src="http://mrimetaldetector.com/blog/wp-content/uploads/2010/07/scissors_pumpkin-300x222.jpg" alt="screen capture of MRI-impelled scissors in pumpkin" width="300" height="222" /><p class="wp-caption-text">MRI + scissors + pumkin = Do Not Try This!</p></div>
<p>Now, the screen shot, above, taken from the video doesn&#8217;t do the moving picture justice. I encourage you to take a look at it for yourself. But before you do it is vital to remember that this isn&#8217;t just a hypothetical. This accident and many, many other MRI projectile accidents &#8211; with, thankfully, less catastrophic outcomes -  occur all the time.</p>
<p>This isn&#8217;t simply a gee whiz scientific demonstration. This represents the real nature of projectile threats. It is at our (and our patients&#8217;) own peril that we relegate these to intellectual curiosities instead of cautionary tales.</p>
<p>So, with that prelude, you can find the video <a title="Click for Scissors Video" href="http://www.mrisafetyvideo.com/kch_mri_scissors_closeup.htm" target="_blank">here</a>.</p>
<p>I hope that every single MRI is adequately protected against similar sorts of accidents. This protection should include, in nearly every instance, ferromagnetic detection screening of patients, visitors, and equipment.</p>
<address><a href="../2010/07/2010/06/2010/06/about-tobias-gilk-editor/" target="_blank"><strong>Tobias Gilk</strong></a>, President &amp; MRI     Safety Director</address>
<address>Mednovus, Inc.</address>
<address>Tobias.Gilk@Mednovus.com</address>
<address> <a title="Click for Mednovus.com" href="http://www.mednovus.com/products.html" target="_blank">www.MEDNOVUS.com</a></address>
<p><a title="Click for Tobias' Twitter Page" href="http://www.twitter.com/tobiasgilk" target="_blank"><img class="alignnone size-full wp-image-852" title="TwitterIcon_32-32" src="http://mrimetaldetector.com/blog/wp-content/uploads/2010/06/TwitterIcon_32-32.gif" alt="Click for Tobias Gilk's Twitter Page" width="32" height="32" /></a><a title="Tobias Gilk on Twitter" href="http://twitter.com/tobiasgilk" target="_blank"> Click here for Tobias’ Twitter Profile</a></p>
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		<item>
		<title>No Vacation For MRI Safety (Recent Death)</title>
		<link>http://mrimetaldetector.com/blog/2010/06/no-vacation-for-mri-safety-recent-death/</link>
		<comments>http://mrimetaldetector.com/blog/2010/06/no-vacation-for-mri-safety-recent-death/#comments</comments>
		<pubDate>Tue, 15 Jun 2010 17:16:19 +0000</pubDate>
		<dc:creator>Tobias Gilk</dc:creator>
				<category><![CDATA[Ferromagnetic Detection for MRI Safety]]></category>
		<category><![CDATA[Other MRI Safety]]></category>
		<category><![CDATA[accident]]></category>
		<category><![CDATA[blower]]></category>
		<category><![CDATA[cylinder]]></category>
		<category><![CDATA[death]]></category>
		<category><![CDATA[design]]></category>
		<category><![CDATA[engineer]]></category>
		<category><![CDATA[fan]]></category>
		<category><![CDATA[fatality]]></category>
		<category><![CDATA[FDA]]></category>
		<category><![CDATA[gas]]></category>
		<category><![CDATA[imaging]]></category>
		<category><![CDATA[injury]]></category>
		<category><![CDATA[magnetic]]></category>
		<category><![CDATA[medical]]></category>
		<category><![CDATA[missile]]></category>
		<category><![CDATA[MRI]]></category>
		<category><![CDATA[oxygen]]></category>
		<category><![CDATA[projectile]]></category>
		<category><![CDATA[radiology]]></category>
		<category><![CDATA[report]]></category>
		<category><![CDATA[resonance]]></category>
		<category><![CDATA[safety]]></category>
		<category><![CDATA[service]]></category>
		<category><![CDATA[tank]]></category>
		<category><![CDATA[vendor]]></category>

		<guid isPermaLink="false">http://mrimetaldetector.com/blog/?p=841</guid>
		<description><![CDATA[When we let our guard down, and are confident that experience and standards will trump the physics of MRI accidents, that's when something ugly is ready to happen...]]></description>
			<content:encoded><![CDATA[<p>Yes, I&#8217;ve not kept up with my blog postings as I usually do. I&#8217;d like to tell you that it was because I&#8217;ve been spending the last month or so sipping umbrella-drinks on a sunny beach somewhere, but that&#8217;s about the furthest thing from the truth. The fact is that there have been torrents of activity, but they&#8217;re all happening below the glassy surface. For example, the radiology press has been strangely silent about the most recent MRI fatality&#8230;</p>
<p><span id="more-841"></span>Just a few months ago a service engineer was replacing a fan-blower assembly in an MRI unit (a part that is notoriously ferromagnetic). Working alone in the suite in the evening, after the regular staff had left, the engineer had finished early&#8230; or that&#8217;s what the security guard thought when he called to her and got no reply.</p>
<p>Turns out that she had been <a title="Click to View The  FDA Report" href="http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1648230" target="_blank">struck and pinned to the MR scanner</a> by the blower assembly, and was unconscious, if not already dead, when the guard checked to see if she was still there.</p>
<p>This tragic story is something of a departure from my typical mantra of patient and staff safety. Yes, this was a trained individual who knew about the risks of the MR environment and materials she was working with. And yes, this was a vendor, and not a hospital worker or patient. But this is a repeatable condition, and an accident which, because there have been MRI accidents involving such a tremendous variety of ferromagnetic materials, deserves a little analysis for a &#8216;lessons-learned&#8217; output.</p>
<p>One of the (theorized) main contributing factors to this accident is the design of the magnet room. Since the advent of active shielding, we&#8217;ve seen MRI rooms go from the size of racquetball courts to office cubicles. In this case, the clearances around the magnet were uncomfortably tight, and what space there was between the magnet and the walls of the suite was purportedly infringed by shelves, storage and clutter.</p>
<p>By failing to provide an appropriately-sized room to accommodate not only the MRI unit itself, but also the service and storage needs, the layout may have substantially increased the likelihood of an accident.</p>
<p>And while conventional screening methodologies wouldn&#8217;t have helped in this particular scenario (the object already in the MRI room), it&#8217;s not like this is the only strange thing that has been brought into a MRI room to be &#8216;sucked&#8217; into the scanner. Yes, we all know about oxygen tanks (well, apparently we don&#8217;t, as there was another one reported recently, <a title="FDA Report On Oxygen Tank #1" href="http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1659702" target="_blank">here</a>), but they aren&#8217;t all!</p>
<p><a href="http://mrimetaldetector.com/blog/wp-content/uploads/2010/06/tank_flies_into_MRI.gif"><img class="aligncenter size-full wp-image-842" title="tank_flies_into_MRI" src="http://mrimetaldetector.com/blog/wp-content/uploads/2010/06/tank_flies_into_MRI.gif" alt="" width="268" height="187" /></a></p>
<p>Personal computers, iPods, filing cabinets, desk chairs, anesthesia machines, cribs, gurneys, wheelchairs, dollies, staplers, power tools, axes, roller skates, &#8216;sand&#8217; bags, hampers, mop-buckets, and the list goes on, and on, and on&#8230; All of these, and many, many more objects have found their way into MRI scanner rooms. Sometimes the people involved, like in the circumstances surrounding the recent fatality, know that they&#8217;re taking a risk. But at least as often the accident occurs because the person is unaware of what they&#8217;re doing.</p>
<p>The magnets don&#8217;t take vacations. They&#8217;re not on just when &#8216;taking the picture&#8217;. They&#8217;re not turned off for the night when the last patient is done for the day. The risks are omnipresent, which demands that we are equally vigilant about providing the appropriate protections for everyone and everything that approaches the MRI room.</p>
<p>In the weeks ahead, I hope to have information for you about some of the efforts in the works that may help codify some of these expectations at the point of care. Suffice it to say that right now, for the first time in the U.S., substantive consideration is being given to explicit MRI safety <em>requirements</em> at the point of care. This is still all in the formative stages, and lots of work remains to be done. But perhaps when it is, there&#8217;s an umbrella drink and sandy beach with my name on them.</p>
<address><a href="../about-tobias-gilk-editor/" target="_blank"><strong>Tobias Gilk</strong></a>, President &amp; MRI  Safety Director</address>
<address>Mednovus, Inc.</address>
<address>Tobias.Gilk@Mednovus.com</address>
<address> <a title="Click for Mednovus.com" href="http://www.mednovus.com/products.html" target="_blank">www.MEDNOVUS.com</a></address>
<p><a href="http://www.twitter.com/tobiasgilk"><img title="twittericon_32-32" src="../wp-content/uploads/2009/12/twittericon_32-32.gif" alt="Click for Tobias Gilk's Twitter Profile" width="32" height="32" /></a><a title="Tobias Gilk on Twitter" href="http://twitter.com/tobiasgilk" target="_blank"> Click here for Tobias’ Twitter Profile</a></p>
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		<title>$2.9 Million Settlement Closes Colombini MRI Death Case</title>
		<link>http://mrimetaldetector.com/blog/2010/02/2-9-million-settlement-closes-colombini-mri-death-case/</link>
		<comments>http://mrimetaldetector.com/blog/2010/02/2-9-million-settlement-closes-colombini-mri-death-case/#comments</comments>
		<pubDate>Thu, 04 Feb 2010 10:25:07 +0000</pubDate>
		<dc:creator>Tobias Gilk</dc:creator>
				<category><![CDATA[Ferromagnetic Detection for MRI Safety]]></category>
		<category><![CDATA[Other MRI Safety]]></category>
		<category><![CDATA[accident]]></category>
		<category><![CDATA[civil]]></category>
		<category><![CDATA[colombini]]></category>
		<category><![CDATA[death]]></category>
		<category><![CDATA[fatality]]></category>
		<category><![CDATA[ferromagnetic]]></category>
		<category><![CDATA[hazard]]></category>
		<category><![CDATA[imaging]]></category>
		<category><![CDATA[injury]]></category>
		<category><![CDATA[lawsuit]]></category>
		<category><![CDATA[liability]]></category>
		<category><![CDATA[magnet]]></category>
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		<category><![CDATA[magnetic resonance]]></category>
		<category><![CDATA[medical]]></category>
		<category><![CDATA[metal]]></category>
		<category><![CDATA[missile]]></category>
		<category><![CDATA[MR]]></category>
		<category><![CDATA[MRI]]></category>
		<category><![CDATA[patient]]></category>
		<category><![CDATA[projectile]]></category>
		<category><![CDATA[radiology]]></category>
		<category><![CDATA[regulation]]></category>
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		<category><![CDATA[screening]]></category>
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		<category><![CDATA[trial]]></category>

		<guid isPermaLink="false">http://mrimetaldetector.com/blog/?p=760</guid>
		<description><![CDATA[This week the documents detailing the Michael Colombini MRI-death civil suit ]]></description>
			<content:encoded><![CDATA[<p>This week the settlement documents were released &#8212; closing the chapter on the lawsuit that arose from the seminal event in MRI safety, the 2001 oxygen tank fatality of then-six-year-old Michael Colombini.</p>
<p><span id="more-760"></span>Nearly nine years after the accident, the lawsuit was settled for $2.9 million, a settlement that was likely both diminished by, and made possible by, a pre-trial motion which excused GE Healthcare as a defendant to the suit.</p>
<p>The county-owned hospital, which almost immediately asserted its responsibility for the accident, ultimately settled the case on behalf of all of the remaining defendants, which included the head of radiology and the technologist who administered the boy&#8217;s scan.</p>
<p>Perhaps now, with the lawsuit resolved, we can actually <em><strong>learn</strong></em> something about the events that precipitated this tragedy, beyond the fragmentary slivers of information gleaned from court documents and news accounts.</p>
<p>That&#8217;s right, despite the fact that this one event has become the touchstone for MRI safety, there has not been a single root-cause analysis to inform MRI suite design, departmental operations, regulatory and accreditation frameworks&#8230; at least not one that has been shared with the public.</p>
<p>Hopefully, with the lawsuit resolved and jeopardy attached for all defendants, we can have an open conversation about what contributed to the accident and what can be done, at the thousands of MRI suites across the country, to help see that this sort of accident never recurs. Based on <a title="Click for WSJ Article On Recent Accident" href="http://blogs.wsj.com/health/2010/01/28/yes-metal-things-do-fly-into-mris-and-hurt-people/" target="_blank">recent news accounts</a> and last year&#8217;s <a title="Click for Article On 2009 Projectile Accidents" href="http://mrimetaldetector.com/blog/2009/12/can-we-still-call-them-never-events-when-accidents-happen-so-frequently-in-mri/" target="_blank">shocking collection of ferromagnetic projectile accidents</a>, the lessons from the Colombini tragedy are still profoundly needed.</p>
<p>If we are willing to explore this darkest chapter in the brief history of MRI, we may learn lessons that will help protect the 30 million Americans who will receive MRI&#8217;s this year, and next year, and the year after that.</p>
<p>If we fail, next year we&#8217;ll be able to look back at this moment, wistfully, and imagine young Michael getting his drivers&#8217; license, or attending his junior prom, on the verge of adulthood. But he is forever trapped in 2001&#8230; a victim of circumstances he had no control over.</p>
<p><img class="aligncenter size-full wp-image-761" title="Michael_Colombini" src="http://mrimetaldetector.com/blog/wp-content/uploads/2010/02/Michael_Colombini.jpg" alt="Michael Colombini" width="119" height="130" /></p>
<p>Let&#8217;s see what we can do, together, to help make sure that this never happens again.</p>
<p>My heartfelt thoughts and prayers are extended to the Colombini family.</p>
<address><a href="../2010/01/2010/01/2010/01/2009/12/2009/12/2009/12/2009/12/2009/12/2009/11/2009/11/2009/11/2009/11/2009/11/2009/10/2009/10/2009/10/2009/10/2009/09/2009/09/2009/09/2009/09/2009/09/2009/08/2009/?page_id=314" target="_blank"><strong>Tobias Gilk</strong></a>, President &amp; MRI Safety Director</address>
<address>Mednovus, Inc.</address>
<address>Tobias.Gilk@Mednovus.com</address>
<address> <a title="Click for Mednovus.com" href="http://www.mednovus.com/products.html" target="_blank">www.MEDNOVUS.com</a></address>
<p><a href="../2010/01/gurney-crashes-mri-patient-injured-hospital-fined-50k/www.twitter/com/tobiasgilk"><img title="twittericon_32-32" src="../wp-content/uploads/2009/12/twittericon_32-32.gif" alt="Click for Tobias Gilk's Twitter Profile" width="32" height="32" /></a><a title="Tobias Gilk on Twitter" href="http://twitter.com/tobiasgilk" target="_blank"> Click here for Tobias’ Twitter Profile</a></p>
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		<title>Colombini Lawsuit For Most Infamous MRI Death &#8211; Settled</title>
		<link>http://mrimetaldetector.com/blog/2009/10/colombini-lawsuit-for-most-infamous-mri-death-settled/</link>
		<comments>http://mrimetaldetector.com/blog/2009/10/colombini-lawsuit-for-most-infamous-mri-death-settled/#comments</comments>
		<pubDate>Wed, 28 Oct 2009 03:00:09 +0000</pubDate>
		<dc:creator>Tobias Gilk</dc:creator>
				<category><![CDATA[Other MRI Safety]]></category>
		<category><![CDATA[accident]]></category>
		<category><![CDATA[colombini]]></category>
		<category><![CDATA[court]]></category>
		<category><![CDATA[death]]></category>
		<category><![CDATA[fatality]]></category>
		<category><![CDATA[ferromagnetic]]></category>
		<category><![CDATA[hazard]]></category>
		<category><![CDATA[imaging]]></category>
		<category><![CDATA[injury]]></category>
		<category><![CDATA[lawsuit]]></category>
		<category><![CDATA[legal]]></category>
		<category><![CDATA[magnetic]]></category>
		<category><![CDATA[MRI]]></category>
		<category><![CDATA[projectile]]></category>
		<category><![CDATA[radiology]]></category>
		<category><![CDATA[regulation]]></category>
		<category><![CDATA[resonance]]></category>
		<category><![CDATA[risk]]></category>
		<category><![CDATA[safety]]></category>
		<category><![CDATA[settlement]]></category>
		<category><![CDATA[suit]]></category>
		<category><![CDATA[Westchester Medical Center]]></category>

		<guid isPermaLink="false">http://mrimetaldetector.com/blog/?p=630</guid>
		<description><![CDATA[After 8 years of litigation, the (remaining) parties to the civil lawsuit from the infamous 2001 MRI fatality have reached a settlement.]]></description>
			<content:encoded><![CDATA[<p>That&#8217;s right. Yesterday, October 26th, the Colombini family formally accepted a settlement offer for the MRI vs. oxygen tank accident which killed their 6-year-old son in 2001. The settlement puts to rest 8 years of litigation resulting from the single largest MRI safety incident in the industry&#8217;s consciousness. And though precedent-setting verdicts won&#8217;t result, the dollar-value of the settlement will likely cause many MRI providers to sit up and take notice.</p>
<p>Just how much is the settlement? <span id="more-630"></span>Well that&#8217;s (temporarily) subject to a little &#8216;good news &#8211; bad news&#8217; dichotomy.</p>
<p>The good news is that the settlement is not confidential and will be part of the public record. The bad news is that we will have to wait a month or so until all of the formal paperwork is filed with the court to <em>become</em> part of the public record. The parties to the suit (and now the settlement) have agreed to keep everything on the down-low and not seek any publicity associated with the resolution. In short, they&#8217;re not talking.</p>
<p>My understanding is that Westchester Medical Center&#8217;s parent organization settled on behalf of itself, and the director of radiology / owner of the MRI management company, and the technologists who had been named. This settlement may, ironically, have been both enabled and motivated by the fact that <a title="Read About Pre-Trial Actions On The Various Defendants" href="http://mrimetaldetector.com/blog/2009/08/colombini-case-lawsuit-machinations/" target="_blank">GE had been dismissed as a defendant to the suit</a> in a pre-trial motion.</p>
<p>I can&#8217;t begin to fathom the difficulty for the family, reliving their greatest loss through nearly a decade of incessant litigation. In that context, I can fully appreciate the desire to resolve the suit and avoid a trial. I have made no secret, however, of the fact that I wanted a public trial, replete with special reports from <a title="View Transcript Of CNN Coverage Of Original Accident" href="http://transcripts.cnn.com/TRANSCRIPTS/0107/31/lad.13.html" target="_blank">Sanjay Gupta televised on CNN</a>.</p>
<p>Why would I want to shine such a glaringly bright light on our industry? Not out of any lack of sympathy for the family. Not to feed an irrational panic about what is one of the safest medical services available. But to focus attention on how we can eliminate at least 90% of all the MRI accidents through changes to operations and protocols. I even had a &#8216;dream team&#8217; list of non-monetary concessions I wanted to see from the various parties.</p>
<p>From Westchester Medical Center: I wanted the hospital to <a title="Read A Retrospective Of The Accident From A Couple Years Ago" href="http://www.psqh.com/novdec07/imaging.html" target="_blank">honor the original promise of transparency</a> made by then-hospital President and CEO, Edward Stolzenberger. I wanted articles, presentations, papers, that explained what went wrong, and what interventions they&#8217;ve developed (or that others have developed that they support). I&#8217;d like to see a <em>real</em> failure mode effects analysis (FMEA) for this accident.</p>
<p>From GE Healthcare: I wanted to see a new corporate policy that every MRI projectile accident for magnets under GE&#8217;s care of which they&#8217;re notified (as in &#8220;please come and pull out this wheelchair,&#8221; or, &#8220;we got the wheelchair out, but we need to have this busted coil replaced,&#8221; or, &#8220;did we ever tell you about what happened here last week?&#8221;) to be recorded. Three things should happen. The event should be recorded in the magnet&#8217;s service history. A letter should be sent to the client site, notifying them that the record of this accident (and the grave safety risk that it presented) has been entered in the service history. And an incident report should be filed with the FDA for their Medwatch database.</p>
<p>The Colombini family: I do know that one of the principal motivations for the family was to try and make sure that similar accidents don&#8217;t happen to other families. I would like to see them lend their name to the development of a fund dedicated to the promotion of MRI safety. In fact, it could be something like an endowed faculty position, but with an ad hoc expert paid to provide presentations or develop materials free from institutional bias. I can even think of someone I&#8217;d nominate for the &#8216;Colombini MR Safety Chair&#8217;&#8230; the name (absurdly) rhymes with &#8220;banal.&#8221;</p>
<p>Do I think that these things can still happen without their having been a trial and jury verdict? Yes, they can. My fear, however, is that each of the parties involved would like nothing more than for this entire event to &#8216;slip quietly into the night&#8217; and fade from everyone&#8217;s memory. And while I understand that motivation, I&#8217;m afraid that this will rob us of the ability to leverage meaningful change from the MRI industry that would make the next fatality less likely.</p>
<address><a href="../2009/10/2009/10/2009/10/2009/09/2009/09/2009/09/2009/09/2009/09/2009/08/2009/?page_id=314" target="_blank"><strong>Tobias Gilk</strong></a>, President &amp; MRI Safety Director</address>
<address>Mednovus, Inc.</address>
<address>Tobias.Gilk@Mednovus.com</address>
<address> <a title="Link to MEDNOVUS.com" href="http://www.mednovus.com/" target="_blank">www.MEDNOVUS.com</a></address>
<address> </address>
<p><strong>UPDATE:</strong> Details of the lawsuit settlement are available <a href="http://mrimetaldetector.com/blog/2010/02/2-9-million-settlement-closes-colombini-mri-death-case/" target="_blank">here</a>.</p>
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		<title>The Boy Who Cried &#8220;Trial&#8221;!</title>
		<link>http://mrimetaldetector.com/blog/2009/09/the-boy-who-cried-trial/</link>
		<comments>http://mrimetaldetector.com/blog/2009/09/the-boy-who-cried-trial/#comments</comments>
		<pubDate>Wed, 30 Sep 2009 22:17:05 +0000</pubDate>
		<dc:creator>Tobias Gilk</dc:creator>
				<category><![CDATA[Other MRI Safety]]></category>
		<category><![CDATA[accident]]></category>
		<category><![CDATA[civil]]></category>
		<category><![CDATA[colombini]]></category>
		<category><![CDATA[cylinder]]></category>
		<category><![CDATA[death]]></category>
		<category><![CDATA[fatality]]></category>
		<category><![CDATA[ferromagnetic]]></category>
		<category><![CDATA[hazard]]></category>
		<category><![CDATA[hospital]]></category>
		<category><![CDATA[injury]]></category>
		<category><![CDATA[judge]]></category>
		<category><![CDATA[lawsuit]]></category>
		<category><![CDATA[lawyer]]></category>
		<category><![CDATA[magnet]]></category>
		<category><![CDATA[missile]]></category>
		<category><![CDATA[motion]]></category>
		<category><![CDATA[MRI]]></category>
		<category><![CDATA[oxygen]]></category>
		<category><![CDATA[patient]]></category>
		<category><![CDATA[projectile]]></category>
		<category><![CDATA[radiology]]></category>
		<category><![CDATA[safety]]></category>
		<category><![CDATA[sue]]></category>
		<category><![CDATA[tank]]></category>
		<category><![CDATA[Technologist]]></category>
		<category><![CDATA[translational]]></category>
		<category><![CDATA[trial]]></category>
		<category><![CDATA[Westchester]]></category>

		<guid isPermaLink="false">http://mrimetaldetector.com/blog/?p=597</guid>
		<description><![CDATA[Is his third prediction about the start of the civil trial stemming from the Colombini fatal MRI accident more accurate than the previous two?]]></description>
			<content:encoded><![CDATA[<p>Yes, I think I&#8217;ve written at least twice before about the imminent start of the trial for the civil lawsuit stemming from the Michael Colombini fatal MRI accident in 2001. And, yes, I was wrong both times before. So, I would expect nothing less than readers of this entry to take my 3rd prognostication of the start of the trial with something more than a grain of salt&#8230; perhaps an entire <a title="What the heck is a salt lick? Ask Wikipedia." href="http://en.wikipedia.org/wiki/Salt_lick" target="_blank">salt lick</a>! But today a little birdie told me that there&#8217;s a hole in the otherwise-booked New York Supreme Court trial schedule for late October / early November and the Colombini trial may just fit right in there.</p>
<p><span id="more-597"></span>Now, this time line actually fits nicely within the trial judge&#8217;s own disposition deadline of January 4th, 2010. At the moment, however, there still is one unresolved pre-trial motion, and there&#8217;s nothing to say that the parties to the trial won&#8217;t want to go and file more motions (which may wind up pushing the entire time line back, yet again).</p>
<p>Just over a month ago, I wrote about the <a title="My Thoughts On Some Of The Judge's Decisions" href="http://mrimetaldetector.com/blog/2009/08/colombini-case-lawsuit-machinations/" target="_blank">resolution of three of the pre-trial motions </a>in this case. I was startled by what appears to me to be a disconnect between the judge&#8217;s decisions on some of the questions put to the court in the pre-trial motions, and the real world practice of MRI.</p>
<p>It remains to be seen if, as has been done with an earlier pre-trial decision rendered by this same judge, the attorneys for the Colombini family seek to challenge the judge&#8217;s rulings on responsibility and authority of the defendants. If that happens, I imagine that it could easily result in another postponement of the actual start of the trial.</p>
<p>If you are interested in following developments on the trial (and other issues of MRI safety) more closely, you are invited to <a title="Tobias Gilk on Twitter" href="http://twitter.com/tobiasgilk" target="_blank">follow me on Twitter</a> for periodic updates, as they become available.</p>
<p>This case (and the event that precipitated it) are likely to be the most important influences on MR safety (hopefully) for a long time. I invite and encourage you to follow these events as they unfold.</p>
<address><a href="../2009/09/2009/09/2009/09/2009/09/2009/08/2009/?page_id=314" target="_blank"><strong>Tobias Gilk</strong></a>, President &amp; MRI Safety Director</address>
<address>Mednovus, Inc.</address>
<address>Tobias.Gilk@Mednovus.com</address>
<address> <a title="Link to MEDNOVUS.com" href="http://www.mednovus.com/" target="_blank">www.MEDNOVUS.com</a></address>
<address>
</address>
<p><strong>UPDATE:</strong> Details of the finalized lawsuit settlement are available <a href="../2010/02/2-9-million-settlement-closes-colombini-mri-death-case/" target="_blank">here</a>.</p>
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