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	<title>MRI Metal Detector Blog &#187; death</title>
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	<link>http://mrimetaldetector.com/blog</link>
	<description>Info on ferromagnetic detection and MRI safety &#38; screening</description>
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	<managingEditor>tobias.gilk@mednovus.com (MRI Metal Detector Blog)</managingEditor>
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	<itunes:summary>Info on ferromagnetic detection and MRI safety &#38; screening</itunes:summary>
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	<itunes:author>MRI Metal Detector Blog</itunes:author>
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		<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>
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]]></content:encoded>
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		<item>
		<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>
		<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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		<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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		<item>
		<title>Radiology Safety</title>
		<link>http://mrimetaldetector.com/blog/2010/09/radiology-safety/</link>
		<comments>http://mrimetaldetector.com/blog/2010/09/radiology-safety/#comments</comments>
		<pubDate>Sat, 25 Sep 2010 02:34:15 +0000</pubDate>
		<dc:creator>Tobias Gilk</dc:creator>
				<category><![CDATA[Other MRI Safety]]></category>
		<category><![CDATA[accident]]></category>
		<category><![CDATA[cancer]]></category>
		<category><![CDATA[death]]></category>
		<category><![CDATA[imaging]]></category>
		<category><![CDATA[injury]]></category>
		<category><![CDATA[lifetime]]></category>
		<category><![CDATA[magnetic]]></category>
		<category><![CDATA[medicine]]></category>
		<category><![CDATA[MRI]]></category>
		<category><![CDATA[nuclear]]></category>
		<category><![CDATA[NY Times]]></category>
		<category><![CDATA[patient]]></category>
		<category><![CDATA[radiation]]></category>
		<category><![CDATA[radiography]]></category>
		<category><![CDATA[radiology]]></category>
		<category><![CDATA[resonance]]></category>
		<category><![CDATA[risk]]></category>
		<category><![CDATA[safe]]></category>
		<category><![CDATA[safety]]></category>
		<category><![CDATA[therapy]]></category>
		<category><![CDATA[Walt Bogdanich]]></category>

		<guid isPermaLink="false">http://mrimetaldetector.com/blog/?p=901</guid>
		<description><![CDATA[I am enthralled by MRI, and I am certainly doing myself no worldly favor by suggesting that the 'simple fix' of moving more patients to the safe solution, MRI, is neither simple nor necessarily safe (or safer, which is really the object). Hear me out...]]></description>
			<content:encoded><![CDATA[<p>Make no mistake, I believe that healthcare has a special obligation to protect the well being of our patients, our beneficiaries, our charges. When it comes to radiology, nuclear medicine and radiation therapy (where treating the patient involves sticking them in an astoundingly complex machine and exercising advanced concepts in physics to have a computer reconstruct fragments of data into an intelligible picture)&#8230; well its just so damned complicated that we have to assume the full responsibility for patient safety because, under those circumstances, it is wholly unreasonable to expect the patient to be active participants in their own safety.</p>
<p><span id="more-901"></span>Also, make no mistake that I find the highly publicized flock of radiation exposure accidents abhorrent oversights. Whether it was equipment calibration, record errors, or simple human foul-ups, each of these violates the simple truth of the special obligation to patient safety that imaging has. But I think we have to look at these accidents squarely, and assess what went wrong, what the adverse outcomes were, and the appropriate preventative and mitigating steps are before we promote knee-jerk responses.</p>
<p>I am enthralled by MRI. And while my life and livelihood are by no means tied exclusively to this one modality, I am certainly doing myself no worldly favor by suggesting that the &#8216;simple fix&#8217; of moving more patients to the <em>safe</em> solution, MRI, is neither simple nor necessarily safe (or safer, which is really the object). Hear me out&#8230;</p>
<p>Medical radiation accidents, in most of the reported cases, involve over-exposure of the individual. While there are extreme examples of this that result in clear, severe and sometimes fatal outcomes, most these over-exposures are similar in incremental lifetime risk to that of having spent your teenage years sun-worshiping, instead of worshiping bottles SPF 30. The best estimations for many of these accidents are that they involve modest increases to lifetime risks of developing cancer&#8230; outcomes that will manifest themselves often 20 years or more after the exposure.</p>
<p>It should not be forgotten that MRI is not without its risks. While they aren&#8217;t insidious, clandestine biological risks like lifetime cancer probabilities, they are equally serious. Recent examples include burns (up to a severity requiring amputation) magnetically-induced projectiles breaking bones or crushing body parts, and earlier this year a woman who was struck, killed, and her corpse magnetically-pinned to the MRI scanner!</p>
<p>Because the negative effects of medical ionizing radiation exposure (from X-ray based modalities, radiopharmecuticals or beam therapies) often won&#8217;t be realized for decades, particular consideration should be paid to treating the young, those under 30. Whenever feasible and clinically appropriate, these patients should be considered for non-ionizing exams and therapies, such as MRI or ultrasound, in lieu of CT. But we shouldn&#8217;t simply redirect everyone who can name all three Jonas Brothers to MRI, certainly not with how well we&#8217;ve been managing <em>those</em> risks.</p>
<p>While it hasn&#8217;t made Walt Bogdanich&#8217;s New York Times series on radiology accidents, the last several years of MRI accident data show accidents and adverse events quadrupling over four years! MRI is currently still an extraordinarily safe imaging option, but the meteoric growth in accidents, and the continued acceleration of that growth, are each frightening.</p>
<p>I have a ten-year-old daughter, and we have (reluctantly) acceded to her having a fluoroscopic exam, and I would choose an MRI, hands-down, for anything for which it was equally diagnostic. But each year that I watch the accident-trend data, the calculus gets a little bit more difficult. The MRI grows less appealing, and this is egregious because it should be the irrefutably safe option.</p>
<p>You see, we <em>know</em> what causes MRI accidents, and we <em>know</em> how to prevent them. The fact of quadrupled MRI accidents isn&#8217;t because of sunspots, or statistical clusters, or global warming, or MRI voodoo dolls, or anything else similarly beyond our understanding or control. The fact of quadrupled MRI accidents is because we, individually and collectively, fail to act. We fail to follow industry best practices. We fail to even <em>expect</em> best practices of our providers!</p>
<p>We should directly confront the issues of radiology safety, and not just those that land on the pages of the NY Times. In imaging we have a particular obligation to protect our patients, including those going for MRI.</p>
<address><a href="http://mrimetaldetector.com/blog/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/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>
<p>PS: They&#8217;re Nick, Joe and Kevin (the Jonas Brothers). You could either think I&#8217;m under 30 (&#8216;Ha&#8217;), or realize that I have a pre-teen daughter&#8230; Take your pick.</p>
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		<title>Wired UK Feature On MRI Projectile Accidents</title>
		<link>http://mrimetaldetector.com/blog/2010/09/wired-uk-feature-on-mri-projectile-accidents/</link>
		<comments>http://mrimetaldetector.com/blog/2010/09/wired-uk-feature-on-mri-projectile-accidents/#comments</comments>
		<pubDate>Mon, 06 Sep 2010 16:10:15 +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[ferromagnetic]]></category>
		<category><![CDATA[flat screen]]></category>
		<category><![CDATA[floor]]></category>
		<category><![CDATA[gun]]></category>
		<category><![CDATA[gurney]]></category>
		<category><![CDATA[handgun]]></category>
		<category><![CDATA[image]]></category>
		<category><![CDATA[imaging]]></category>
		<category><![CDATA[injury]]></category>
		<category><![CDATA[link]]></category>
		<category><![CDATA[magnetic]]></category>
		<category><![CDATA[missile]]></category>
		<category><![CDATA[monitor]]></category>
		<category><![CDATA[MRI]]></category>
		<category><![CDATA[picture]]></category>
		<category><![CDATA[pistol]]></category>
		<category><![CDATA[polisher]]></category>
		<category><![CDATA[projectile]]></category>
		<category><![CDATA[resonance]]></category>
		<category><![CDATA[safety]]></category>
		<category><![CDATA[scissors]]></category>
		<category><![CDATA[Vaughan Bell]]></category>
		<category><![CDATA[wheelchair]]></category>
		<category><![CDATA[Wired]]></category>

		<guid isPermaLink="false">http://mrimetaldetector.com/blog/?p=867</guid>
		<description><![CDATA[Wired UK features the MRI Metal Detector blog! See what they said and get a mess of additional links.]]></description>
			<content:encoded><![CDATA[<p>Color me flattered! (which I think is the color of that shirt in the illustration)</p>
<div id="attachment_871" class="wp-caption aligncenter" style="width: 345px"><a href="http://www.wired.co.uk/wired-magazine/archive/2010/09/start/mri-fatal-attraction"><img class="size-full wp-image-871 " title="Wired UK Illustration by Lee Hasler of MRI Projectiles (click image for Wired UK source)" src="http://mrimetaldetector.com/blog/wp-content/uploads/2010/09/MRI2.jpg" alt="" width="335" height="281" /></a><p class="wp-caption-text">Wired UK Illustration by Lee Hasler. Click for Wired UK source.</p></div>
<p>The UK edition of Wired magazine just ran one of their &#8216;featurettes&#8217; on this blog and picked their <em>favorite</em> (though, that&#8217;s a slightly squint word-choice for potentially deadly accidents) types of projectile accidents. Quote&#8217;s from &#8212; and a direct link to &#8212; the article follow.</p>
<p><span id="more-867"></span>Often when I renew my subscription to Wired (the US edition) I get the complimentary tote, or whatever other trinket they&#8217;re giving away. This time, however, apparently my renewed subscription coincided with a small feature in the UK edition for this blog! [Perhaps I should start subscriptions to Forbes or Yachting to see if there's content-related good fortune that rubs off from either of those!!]</p>
<p>Below are quotes from the article (the original version of which is just a click away on the article title, below) and some of my added links to related content that aren&#8217;t in the online edition of the article. Please do visit the Wired UK site (click on the quoted headline, below) because they have embedded links to other, very interesting related Wired articles.</p>
<h2 style="padding-left: 30px;"><a href="http://www.wired.co.uk/wired-magazine/archive/2010/09/start/mri-fatal-attraction" target="_blank"><em>MRI&#8217;s fatal attraction</em></a></h2>
<p style="padding-left: 30px;"><em>By <a title="Link To Vaughan Bell's Brilliant Twitter Feed" href="http://twitter.com/vaughanbell" target="_blank">Vaughan Bell</a></em><em title="          CD                /CD:2010-08-06T16:49:58/DD:/ED:2010-09-01T10:47:43">|</em><em>06 August 2010</em></p>
<p style="padding-left: 30px;"><em>Look out! It’s the dark side of the magnetic force</em></p>
<p style="padding-left: 30px;"><em>“It’s like Russian roulette, except that many don’t know that they’re  even playing,” says Tobias Gilk, a California-based MRI safety  consultant. MRI scanners have electromagnets so powerful that they can dislodge pacemakers, <a title="Hospital Bed Drawn To MRI" href="http://www.ocregister.com/articles/mri-230615-hospital-hoag.html" target="_blank">suck  in beds from across the room</a> and turn small metal objects into  dangerous “ferromagnetic projectiles”. Gilk now collects data and  reports of incidents at <a href="http://mrimetaldetector.com/blog/" target="_blank">mrimetaldetector.com/blog</a>.</em></p>
<p>[Well, maybe not <em>dislodge</em> pacemakers, but certainly disrupt them... sometimes with fatal results.]</p>
<p style="padding-left: 30px;"><em>Here are six of  Wired’s favourite MRI metal menaces.</em></p>
<p style="padding-left: 30px;"><em><strong>Floor polisher<br />
</strong>This is so common that the  internet has whole galleries of trapped cleaning machines. Floor  polishers end up stuck in scanners when cleaners stroll into MRI  facilities out of hours and only realise they’re in trouble when their  equipment starts to gravitate towards the magnet.</em></p>
<p>[We could establish a very long gallery of floor polisher accident photos. In fact, in the <a href="http://www.simplyphysics.com/flying_objects.html" target="_blank">'Flying Objects' image collection</a> of my friend Moriel Ness Aiver on his website, SimplyPhysics.com, there are quite a number of them to see! And while they don't show you the actual accident, here's a <a href="http://www.seattlepi.com/local/207390_mri11.html" target="_blank">link to a Seattle news story on a floor-polisher meets MRI accident</a> that occurred there.]</p>
<p style="padding-left: 30px;"><em><strong>Metal gurney<br />
</strong>A patient and a metal gurney were  both lifted off the ground and pulled towards the magnet as they were  accidentally wheeled into the MRI room. The scanner had to be shut down  in order to free the bed, and the unlucky patient suffered from foot,  ankle and leg fractures.</em></p>
<p>[Here's a link to the<a title="Open the PDF Report" href="http://mrimetaldetector.com/media/downloads/MAUDE-Gurney.pdf" target="_blank"> FDA accident report</a> for this specific accident (the news account having been linked above). And here's a link to a popular image showing an <a href="../2008/12/mri-truth-is-sometimes-stranger-than-mri-fiction/" target="_blank">ICU bed magnetically adhered to the face of an MRI scanner</a>.]</p>
<p style="padding-left: 30px;"><em><strong>Pistol<br />
</strong>An MRI machine disarmed an off-duty US police officer. She forgot she was carrying her Glock pistol as she  accompanied her mother, who was being scanned. The gun was pulled by the  magnetic force, jamming her hand between the pistol and the machine and  trapping the officer.</em></p>
<p>[Here's a link to my <a href="http://mrimetaldetector.com/blog/2009/10/you-can-have-my-gun-when-you-pry-it/" target="_blank">summary of the news story from that specific incident</a>. There is also a <a href="http://www.ajronline.org/cgi/content/full/178/5/1092" target="_blank">peer-reviewed journal piece on a different, but similar, incident in which the handgun actually fired</a>, despite the presence of two engaged safeties.]</p>
<p style="padding-left: 30px;"><em><strong>Flat-screen<br />
</strong>A member of the public who was  inside the scanner solely for research purposes got badly injured when  hospital staff walked a flat-screen monitor through the room. The  magnetic field tried to put the screen and the participant in the same  place; the next stop was casualty.</em></p>
<p>[Here's the link to the <a href="http://mrimetaldetector.com/media/downloads/MAUDE-Flat-Panel_Monitor.pdf" target="_blank">FDA accident report PDF</a> for this one, too.]</p>
<p style="padding-left: 30px;"><em><strong>Scissors<br />
</strong>An MRI technician ended up with a pair of scissors embedded in his forehead as he prepared a patient. Someone entered the  scanner room with the scissors in their pocket &#8212; they were pulled out  by the magnet and collided arrowstyle with the technician’s head.</em></p>
<p>[There have been multiple accidents involving flying scissors in the MRI room. <a href="http://mrimetaldetector.com/blog/2010/07/not-magnet-safe-scissors/" target="_blank">This one is among the most severe</a>.]</p>
<p style="padding-left: 30px;"><em><strong>Wheelchair<br />
</strong>A wheelchair brought into the danger area shot across the room and pinned a  radiographer to the scanner. The staff member was unharmed but a patient  waiting for her scan was so frightened she fell off the bed and broke  her leg.</em></p>
<p>[As with floor polishers, there have been many, many incidents of not-safe-for-MRI wheelchairs being brought to the MRI room. You can see <a href="http://mrimetaldetector.com/blog/2009/05/fmd-dont-we-have-screening-protocols-for-that/" target="_blank">a couple of these, as well as a sampling of other projectile objects here</a>.]</p>
<div id="attachment_878" class="wp-caption aligncenter" style="width: 229px"><img class="size-medium wp-image-878" title="Wired_UK_09-10" src="http://mrimetaldetector.com/blog/wp-content/uploads/2010/09/Wired_UK_09-10-219x300.jpg" alt="" width="219" height="300" /><p class="wp-caption-text">Wired UK, September 2010</p></div>
<p>I am very flattered that the editorial staff at Wired UK included information on our humble little blog in their <a href="http://www.wired.co.uk/wired-magazine/archive/2010/09" target="_blank">September, 2010 issue</a>. I hope that this sort of attention raising opportunity is not lost on the audiences in the US and elsewhere.</p>
<address><a href="../2010/07/2010/07/2010/06/2010/06/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 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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		<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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		<title>CMS Asked To Review MRI For Pacemaker Patient Exclusion</title>
		<link>http://mrimetaldetector.com/blog/2010/07/cms-asked-to-review-mri-for-pacemaker-patient-exclusion/</link>
		<comments>http://mrimetaldetector.com/blog/2010/07/cms-asked-to-review-mri-for-pacemaker-patient-exclusion/#comments</comments>
		<pubDate>Fri, 02 Jul 2010 16:50:47 +0000</pubDate>
		<dc:creator>Tobias Gilk</dc:creator>
				<category><![CDATA[Other MRI Safety]]></category>
		<category><![CDATA[cardiac]]></category>
		<category><![CDATA[CMS]]></category>
		<category><![CDATA[comment]]></category>
		<category><![CDATA[death]]></category>
		<category><![CDATA[defibrillator]]></category>
		<category><![CDATA[device]]></category>
		<category><![CDATA[FDA]]></category>
		<category><![CDATA[hazard]]></category>
		<category><![CDATA[ICD]]></category>
		<category><![CDATA[imaging]]></category>
		<category><![CDATA[implant]]></category>
		<category><![CDATA[injury]]></category>
		<category><![CDATA[magnetic]]></category>
		<category><![CDATA[Medicaid]]></category>
		<category><![CDATA[Medicare]]></category>
		<category><![CDATA[MRI]]></category>
		<category><![CDATA[National Coverage Determination]]></category>
		<category><![CDATA[NCD]]></category>
		<category><![CDATA[pacemaker]]></category>
		<category><![CDATA[public]]></category>
		<category><![CDATA[radiology]]></category>
		<category><![CDATA[resonance]]></category>
		<category><![CDATA[risk]]></category>
		<category><![CDATA[Russo]]></category>
		<category><![CDATA[safety]]></category>
		<category><![CDATA[Scripps]]></category>

		<guid isPermaLink="false">http://mrimetaldetector.com/blog/?p=854</guid>
		<description><![CDATA[The US Centers for Medicare &#038; Medicaid Services (CMS) have opened a public comment period on a proposal to allow certain MRI scans of pacemaker patients.]]></description>
			<content:encoded><![CDATA[<p>The Centers for Medicare &amp; Medicaid Services (CMS) has opened a brief public comment period on a request to lift reimbursement restrictions on imaging pacemaker patients with pacemakers.</p>
<div id="attachment_807" class="wp-caption aligncenter" style="width: 260px"><img class="size-full wp-image-807" title="pacemaker" src="http://mrimetaldetector.com/blog/wp-content/uploads/2010/02/pacemaker.jpg" alt="" width="250" height="236" /><p class="wp-caption-text">Example of a Pacemaker Pulse-Generator Which Could Present Dangerous Contraindications For MRI Exams</p></div>
<p><span id="more-854"></span>The review has been requested by Robert Russo, MD, with Scripps Research Institute. A copy of Dr. Russo&#8217;s request can be viewed <a title="Click for Dr. Russo's Request Letter (PDF)" href="http://www.cms.gov/DeterminationProcess/downloads/id246.pdf" target="_blank">here</a>.</p>
<p>The public comment period is open through July 28, 2010, and I strongly encourage anyone with questions or concerns about the safety of MR imaging for patients with implanted cardiac devices (Dr. Russo correctly points out that CMS&#8217; restriction fails to speak directly to implanted cardio-defibrillators, or ICD&#8217;s) to offer their comments to CMS.</p>
<p>The full explanation of the current restrictions on MR imaging of pacemaker patients (also aneurysm clip patients, and pregnant patients), as well as the instructions for reviewing other public comments or submitting your own, can be found <a title="Click for CMS's Page on NCD Revision for Pacemakers" href="http://www.cms.gov/mcd/viewtrackingsheet.asp?from2=viewtrackingsheet.asp&amp;id=246&amp;" target="_blank">here</a>.</p>
<address><a href="../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 href="../wp-content/uploads/2010/06/TwitterIcon_32-321.gif"><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>MRI Accident Rates: It&#8217;s Not As Bad As Previously Reported&#8230;</title>
		<link>http://mrimetaldetector.com/blog/2010/06/mri-accident-rates-its-not-as-bad-as-previously-reported/</link>
		<comments>http://mrimetaldetector.com/blog/2010/06/mri-accident-rates-its-not-as-bad-as-previously-reported/#comments</comments>
		<pubDate>Mon, 28 Jun 2010 17:57:13 +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[accreditation]]></category>
		<category><![CDATA[adverse]]></category>
		<category><![CDATA[data]]></category>
		<category><![CDATA[death]]></category>
		<category><![CDATA[event]]></category>
		<category><![CDATA[FDA]]></category>
		<category><![CDATA[imaging]]></category>
		<category><![CDATA[increase]]></category>
		<category><![CDATA[injury]]></category>
		<category><![CDATA[license]]></category>
		<category><![CDATA[magnetic]]></category>
		<category><![CDATA[MAUDE]]></category>
		<category><![CDATA[MRI]]></category>
		<category><![CDATA[patient]]></category>
		<category><![CDATA[radiology]]></category>
		<category><![CDATA[rate]]></category>
		<category><![CDATA[report]]></category>
		<category><![CDATA[resonance]]></category>
		<category><![CDATA[safety]]></category>
		<category><![CDATA[Technologist]]></category>

		<guid isPermaLink="false">http://mrimetaldetector.com/blog/?p=849</guid>
		<description><![CDATA[Maybe the FDA changed bookkeeping methods, but - whatever the reason - they found another 11% of MRI accidents that weren't previously tallied in 2008. What's worse than a 270% increase in accidents? A 310% increase in accidents, that's what!]]></description>
			<content:encoded><![CDATA[<p>IT&#8217;S WORSE!</p>
<p>That&#8217;s right, the FDA has updated it&#8217;s MRI accident figures available online through the MAUDE database. We were alarmed and astonished when we thought that the rate of increases in MRI accidents was <em>only</em> 270% (from 2004 to 2008). Turns out that the FDA must have found additional accident reports that were in a stack of junk-mail, or got lost between the sofa cushions, which means that the rate if adverse events went up, significantly, in 2008 from the prior calculation.</p>
<p><span id="more-849"></span>Somehow, when I did the analysis last year (in 2009) of the 2008 numbers, it was apparently 11% shy of the final total. When we add the (previously uncounted) adverse events, the actual rate of accident growth is 310%!!!</p>
<div id="attachment_850" class="wp-caption aligncenter" style="width: 310px"><a href="http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/search.CFM"><img class="size-medium wp-image-850" title="09_FDA_Accident_Rate_Table.003" src="http://mrimetaldetector.com/blog/wp-content/uploads/2010/06/09_FDA_Accident_Rate_Table.003-300x225.jpg" alt="Rates Of Reported MRI Accidents (UPDATED)" width="300" height="225" /></a><p class="wp-caption-text">Between 2004 and 2008, MRI Accident Rates Increased 310%</p></div>
<p>That&#8217;s right, in 2008 we were more than 4 times as likely to injure someone during an MR exam than we were just four years earlier!</p>
<p>What would happen in your town if:</p>
<ul>
<li>Traffic accidents quadrupled in 4 years?</li>
<li>Rates of violence in schools quadrupled?</li>
<li>Divorce rates increased 4x in 4 years?</li>
</ul>
<p>Alarm bells, that&#8217;s what! People for certain would not be complacent.</p>
<p>There would be efforts to figure out why, and fix whatever was going wrong. Reduced speed limits or more traffic enforcement? You bet! Counselors in the schools and demands for greater teacher and parent involvement? Darn right! Lay and religious leaders reassessing the very nature of the marital institution in our society? Abso-friggin-lutely!</p>
<p>So, with an exploding rate of MRI injuries and adverse events, what is being done to identify and curb the source of these incidents? [cue cricket sounds]</p>
<p>NOTHING!</p>
<p>Apart from the continuous efforts of a small cadre of MR safety advocates, whose cries have (apparently) fallen on deaf ears, there are no substantive accreditation, licensure, or regulatory actions that have reversed the trend of the last several years.</p>
<p>The silver-lining may be that the increase from 2008 to 2009 was very modest. Perhaps we&#8217;re leveling-off, or perhaps, like 2004, this is just a momentary pause before we skyrocket upwards again. And given the FDA&#8217;s marked upward adjustment of the 2008 numbers, it may wind up being another year before we can feel confident about the 2009 accident report numbers.</p>
<address><a href="../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 href="http://mrimetaldetector.com/blog/wp-content/uploads/2010/06/TwitterIcon_32-321.gif"><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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		<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>
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		<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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