<?xml version="1.0" encoding="UTF-8"?>
<rss version="2.0"
	xmlns:content="http://purl.org/rss/1.0/modules/content/"
	xmlns:wfw="http://wellformedweb.org/CommentAPI/"
	xmlns:dc="http://purl.org/dc/elements/1.1/"
	xmlns:atom="http://www.w3.org/2005/Atom"
	xmlns:sy="http://purl.org/rss/1.0/modules/syndication/"
	xmlns:slash="http://purl.org/rss/1.0/modules/slash/"
		xmlns:itunes="http://www.itunes.com/dtds/podcast-1.0.dtd"
	xmlns:media="http://search.yahoo.com/mrss/"
>

<channel>
	<title>MRI Metal Detector Blog &#187; suit</title>
	<atom:link href="http://mrimetaldetector.com/blog/tag/suit/feed/" rel="self" type="application/rss+xml" />
	<link>http://mrimetaldetector.com/blog</link>
	<description>Info on ferromagnetic detection and MRI safety &#38; screening</description>
	<lastBuildDate>Tue, 27 Dec 2011 18:38:54 +0000</lastBuildDate>
	<language>en</language>
	<sy:updatePeriod>hourly</sy:updatePeriod>
	<sy:updateFrequency>1</sy:updateFrequency>
	<generator>http://wordpress.org/?v=3.3</generator>
	<copyright>2006-2007 </copyright>
	<managingEditor>tobias.gilk@mednovus.com (MRI Metal Detector Blog)</managingEditor>
	<webMaster>tobias.gilk@mednovus.com (MRI Metal Detector Blog)</webMaster>
	<image>
		<url>http://mrimetaldetector.com/blog/wp-content/plugins/podpress/images/powered_by_podpress.jpg</url>
		<title>MRI Metal Detector Blog</title>
		<link>http://mrimetaldetector.com/blog</link>
		<width>144</width>
		<height>144</height>
	</image>
	<itunes:subtitle></itunes:subtitle>
	<itunes:summary>Info on ferromagnetic detection and MRI safety &#38; screening</itunes:summary>
	<itunes:keywords></itunes:keywords>
	<itunes:category text="Society &#38; Culture" />
	<itunes:author>MRI Metal Detector Blog</itunes:author>
	<itunes:owner>
		<itunes:name>MRI Metal Detector Blog</itunes:name>
		<itunes:email>tobias.gilk@mednovus.com</itunes:email>
	</itunes:owner>
	<itunes:block>no</itunes:block>
	<itunes:explicit>no</itunes:explicit>
	<itunes:image href="http://mrimetaldetector.com/blog/wp-content/plugins/podpress/images/powered_by_podpress_large.jpg" />
		<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>
]]></content:encoded>
			<wfw:commentRss>http://mrimetaldetector.com/blog/2010/12/colombini-leaks-how-did-a-6-year-old-boy-die-in-mri-accident/feed/</wfw:commentRss>
		<slash:comments>1</slash:comments>
		</item>
		<item>
		<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>
		<category><![CDATA[magnetic]]></category>
		<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>
		<category><![CDATA[resonance]]></category>
		<category><![CDATA[safety]]></category>
		<category><![CDATA[screening]]></category>
		<category><![CDATA[suit]]></category>
		<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>
]]></content:encoded>
			<wfw:commentRss>http://mrimetaldetector.com/blog/2010/02/2-9-million-settlement-closes-colombini-mri-death-case/feed/</wfw:commentRss>
		<slash:comments>3</slash:comments>
		</item>
		<item>
		<title>Gurney Crashes MRI, Patient Injured, Hospital Fined $50K</title>
		<link>http://mrimetaldetector.com/blog/2010/01/gurney-crashes-mri-patient-injured-hospital-fined-50k/</link>
		<comments>http://mrimetaldetector.com/blog/2010/01/gurney-crashes-mri-patient-injured-hospital-fined-50k/#comments</comments>
		<pubDate>Sun, 24 Jan 2010 16:08:45 +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[death]]></category>
		<category><![CDATA[detection]]></category>
		<category><![CDATA[detector]]></category>
		<category><![CDATA[FDA]]></category>
		<category><![CDATA[ferromagnetic]]></category>
		<category><![CDATA[hazard]]></category>
		<category><![CDATA[imaging]]></category>
		<category><![CDATA[injury]]></category>
		<category><![CDATA[magnetic]]></category>
		<category><![CDATA[magnetic resonance]]></category>
		<category><![CDATA[MAUDE]]></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>
		<category><![CDATA[resonance]]></category>
		<category><![CDATA[risk]]></category>
		<category><![CDATA[safety]]></category>
		<category><![CDATA[screening]]></category>
		<category><![CDATA[suit]]></category>

		<guid isPermaLink="false">http://mrimetaldetector.com/blog/?p=739</guid>
		<description><![CDATA[A California hospital got slapped with a $50,000 fine after failing to prevent a patient from being injured by a ferromagnetic gurney (that the patient was riding on) brought into the MRI scanner room.]]></description>
			<content:encoded><![CDATA[<p>It is the stuff of fabled oral-histories, often dismissed as MRI urban-legend. The patient is wheeled into the MRI room on a gurney that goes flying toward the scanner. &#8220;<em>How on Earth could these accidents happen when we </em>know<em> about these risks</em>,&#8221; the skeptics question? Almost never does more than a single fragment of information surface about these sorts of accidents and, without verification, nearly all accounts can be erroneously written-off as fiction.  Or, that <strong><em>was</em></strong> until enough pieces fell into place to conclusively document a recent episode&#8230;  <span id="more-739"></span></p>
<p>Many people in the medical industry, even within radiology, are quick to dismiss stories of accidents in the MRI suite as &#8216;fish stories&#8217; which, though they may be based on a kernel of truth from the original telling, grow and grow as the story gets passed along the line. What may have begun as a pager getting drawn into the MRI scanner, winds up becoming a telephone repairman&#8230; or so goes the rationalization.  And some seem to think that most MRI accident stories aren&#8217;t even really exaggerations, but rather pure fiction, akin to what you would see on some nighttime television medical drama. To these people, any account of a patient bed hitting the MRI could only have come from an episode of ER (as opposed to a real accident having become the basis of the TV show&#8217;s fictionalized version)&#8230;</p>
<p style="text-align: center;"></p>
<p>Not that there haven&#8217;t been cases of gurneys drawn to MRI scanners before, because the MRI professional communities are awash in stories of all manners of ferromagnetic materials inadvertently becoming MRI-homing magnet missiles. Everything from personal computers, iPods, pagers, cell phones, anesthesia machines, &#8216;sand&#8217; bags, medical gas (oxygen) cylinders, welding tanks, rolling carts, wheelchairs, hand-tools, canes &amp; walkers, furniture, filing cabinets, hand-trucks, and the list goes on, and on, and on (to see pictures of a number of items, please check out <a title="Click for Post With Lots Of MRI Accident Pictures" href="http://mrimetaldetector.com/blog/2009/05/fmd-dont-we-have-screening-protocols-for-that/" target="_blank">this prior post</a>). And yes, even hospital gurneys&#8230;</p>
<div id="attachment_198" class="wp-caption aligncenter" style="width: 310px"><a href="http://mrimetaldetector.com/blog/wp-content/uploads/2008/11/mri-scanner-eats-patient-bed.jpg"><img class="size-medium wp-image-198" title="mri-scanner-eats-patient-bed" src="http://mrimetaldetector.com/blog/wp-content/uploads/2008/11/mri-scanner-eats-patient-bed-300x225.jpg" alt="" width="300" height="225" /></a><p class="wp-caption-text">MRI Scanner Eats an ICU Patient Bed</p></div>
<p>Much to my chagrin, I&#8217;ve heard people dismiss the above as somebody&#8217;s Photoshop fantasy. Those sorts of statements, sadly, work to diminish all efforts toward MRI safety. But a recent account should, permanently, put to rest any question of whether this sort of thing can really happen.  Late last year I posted a <a title="Click Here For That Story" href="http://mrimetaldetector.com/blog/2009/12/can-we-still-call-them-never-events-when-accidents-happen-so-frequently-in-mri/" target="_blank">story</a> that included links to a number of FDA MRI accident reports. One of the reports to the FDA&#8217;s MAUDE database described an incident in which a patient had their foot-ankle-leg injured when they were transported into the MRI scanner room on a conventional gurney (click <a title="Click to Download FDA Report in PDF Format" href="http://mrimetaldetector.com/media/downloads/MAUDE-Gurney.pdf" target="_blank">here</a> to download the PDF file from the FDA&#8217;s data). The date in the FDA&#8217;s anonymized report coincides very nicely with this somewhat-less-than-anonymous newspaper article that just came out&#8230;</p>
<p style="padding-left: 30px;"><em>Hoag Hospital has been fined $50,000 by the state Department of Public Health after an MRI patient on a metal gurney was magnetically pulled into the imaging machine, the hospital said Friday.</em></p>
<p style="padding-left: 30px;"><em> [Dr. Richard] Afable, [chief executive officer of Hoag Memorial Hospital Presbyterian], said that last January a woman was taken into an MRI room on a metal gurney that was not compatible with the machine. The powerful magnet in the MRI pulled the gurney into the machine and the patient&#8217;s leg was trapped for about three minutes. She was taken to the emergency room and spent three days in the hospital for treatment of fractures in her lower leg and foot.</em></p>
<p>The above quote is taken from the January 22nd, 2009 article appearing on the Orange County Register&#8217;s website (click <a title="Click Here For That Story" href="http://www.ocregister.com/articles/mri-230615-hospital-hoag.html" target="_blank">here</a> to go straight to the article).  Based on the dates, the description of the accident, and the patient injuries, it sounds as if the FDA account <em><strong>is the same incident</strong></em> as what is described in this newspaper article.  The $50,000 fine may sound like steep punishment, but considering the cost to restore the magnet after the quench (described in the FDA account), the cost of downtime and lost revenue between the accident and the time the MRI was returned to service, the cost of care to treat the patient, the cost of internal safety / quality / regulatory investigations, the legal costs for the hospital, and any lawsuit settlement costs, the state&#8217;s penalty is likely to just be icing on the cake. The cost to the hospital for this transgression could very easily be into 7-figures!  All of this simply demonstrates two critical points about MRI safety.</p>
<ol>
<li>MRI accidents do happen, and at greater frequency and cost than many are led to believe.</li>
<li>The costs of the safety provisions to help prevent these accidents are peanuts when compared to the costs of accidents.</li>
</ol>
<p>My soap-box pontificating on this point will likely become moot over the next many months. In a &#8216;perfect storm&#8217; of regulatory and accreditation attention to MRI safety, we&#8217;re very likely to see <strong>requirements</strong> for MRI safety provisions, such as ferromagnetic detectors (which could have been instrumental in helping to avoid this gurney accident). I will share more about each of these efforts, as I&#8217;m able.  In the meantime, MRI providers should put a great deal more stock in the validity of MRI accidents accounts and ask themselves, &#8220;Do I have adequate physical protections in place, beyond what&#8217;s written in my policy manual, to help prevent this sort of accident?&#8221; The likely answer is &#8220;No.&#8221;</p>
<address><a href="../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="www.twitter/com/tobiasgilk"><img class="size-full wp-image-721 alignnone" title="twittericon_32-32" src="http://mrimetaldetector.com/blog/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>
]]></content:encoded>
			<wfw:commentRss>http://mrimetaldetector.com/blog/2010/01/gurney-crashes-mri-patient-injured-hospital-fined-50k/feed/</wfw:commentRss>
		<slash:comments>4</slash:comments>
	<!-- Media File exists for this post, but its not enabled for this feed -->
	</item>
		<item>
		<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>
]]></content:encoded>
			<wfw:commentRss>http://mrimetaldetector.com/blog/2009/10/colombini-lawsuit-for-most-infamous-mri-death-settled/feed/</wfw:commentRss>
		<slash:comments>3</slash:comments>
		</item>
		<item>
		<title>Colombini Case &#8211; Lawsuit Machinations</title>
		<link>http://mrimetaldetector.com/blog/2009/08/colombini-case-lawsuit-machinations/</link>
		<comments>http://mrimetaldetector.com/blog/2009/08/colombini-case-lawsuit-machinations/#comments</comments>
		<pubDate>Sun, 23 Aug 2009 15:45:52 +0000</pubDate>
		<dc:creator>Tobias Gilk</dc:creator>
				<category><![CDATA[Ferromagnetic Detection for MRI Safety]]></category>
		<category><![CDATA[Other MRI Safety]]></category>
		<category><![CDATA[colombini]]></category>
		<category><![CDATA[court]]></category>
		<category><![CDATA[death]]></category>
		<category><![CDATA[fatality]]></category>
		<category><![CDATA[ferromagnetic]]></category>
		<category><![CDATA[injury]]></category>
		<category><![CDATA[lawsuit]]></category>
		<category><![CDATA[legal]]></category>
		<category><![CDATA[liability]]></category>
		<category><![CDATA[magnet]]></category>
		<category><![CDATA[magnetic resonance]]></category>
		<category><![CDATA[metal]]></category>
		<category><![CDATA[missile]]></category>
		<category><![CDATA[MRI]]></category>
		<category><![CDATA[New York]]></category>
		<category><![CDATA[patient]]></category>
		<category><![CDATA[projectile]]></category>
		<category><![CDATA[radiologist]]></category>
		<category><![CDATA[radiology]]></category>
		<category><![CDATA[risk]]></category>
		<category><![CDATA[safety]]></category>
		<category><![CDATA[suit]]></category>
		<category><![CDATA[Technologist]]></category>
		<category><![CDATA[trial]]></category>
		<category><![CDATA[Westchester]]></category>

		<guid isPermaLink="false">http://mrimetaldetector.com/blog/?p=558</guid>
		<description><![CDATA[The legal lawsuit for the Michael Colombini case is moving forward. This time, the judge in the case decides 3 pre-trial motions.]]></description>
			<content:encoded><![CDATA[<p>Last month, the judge in the Michael Colombini lawsuit (the case resulting from the infamous death by oxygen tank / cylinder brought into the MRI room while the boy was in the scanner) decided on three of the last outstanding pre-trial motions. The Judge&#8217;s decisions appear to have excused one defendant, entirely, and tempered the degree of potential liability for others.</p>
<p><span id="more-558"></span>The first of the three motions decided was from GE Healthcare, seeking to be excused, altogether, as a defendant in the case. The trial judge granted GE&#8217;s motion, citing (primarily) <em>Riegel v. Medtronic</em> which gives manufacturers of medical devices very broad protections in state courts because the devices have been vetted for safety at the federal level.</p>
<p>The second outstanding motion, which was one filed by the Colombini family&#8217;s attorney, sought the ability to reinstate punative damages claims against GE Healthcare for their involvement in the accident. This motion was rendered moot when the judge granted GE&#8217;s motion to be excused from the case, entirely.</p>
<p>The last of the decided motions was a smorgasbord of requests of the remaining (non-GE) defendants to dismiss claims against assorted defendants, to disallow punitive damages against some defendants, and to disallow claims of &#8216;emotional distress&#8217; by the father of the boy.</p>
<ul>
<li>The judge dismissed all causes of action against the senior MR technologist in the suite at the time of the accident because (1) it was not demonstrated that he bore any responsibility for a safe suite environment (in fact the judge&#8217;s decision defines the limits of his responsibility to the scanner room, itself), and (2) he was not the tech administering the scan for the boy and therefore had no direct responsibility for his care. The judge&#8217;s notes also diminish the technologists&#8217; role in safety by stating that they are not MD&#8217;s and had minimal safety training.</li>
<li>The judged refused to dismiss claims agains New York Medical College (affiliated with the hospital) based on the College&#8217;s contention that NYMC had no direct role in training of persons involved in the accident, allowing this issue to be tried in court.</li>
<li>The judge dismissed claims associated with the father&#8217;s contention that he suffered emotional distress based on the legal definition which requires that the person filing the claim feel &#8220;unreasonbly threatened by bodily harm&#8221; directly to them. That the father felt that his son was unreasonably threatened falls outside the legal definition for the basis of a claim of emotional distress.</li>
<li>The judge refused to dismiss claims for punitive damages against UIMA, the company that ran the MRI unit for the hospital, allowing that the failure to provide complete and effective safety training may ammount to &#8220;utter indifference or conscious disregard for the safety of others.&#8221;</li>
<li>The judge stated that she thought that the technologist administering the scan exaggerated her job duties when she had previously stated that technologists were the MRI suite &#8220;gatekeepers&#8221; with responsibility to keep a &#8220;watchful eye&#8221; to prevent ferromagnetic material from being brought in. Since, per the judge, overall suite safety was NOT deemed a reasonable responsibility of a technologist, the judge disallowed the possibility of punitive damages against the tech that administered the scan.</li>
<li>Finally, the judge dismissed any action for punitive damages against the radiologist who served both as the hospital&#8217;s Director of Radiology and president of UIMA, the contractor providing MRI services to the hospital, because he &#8220;had no experience supervising MRI facilities . . . and did not view himself as having taken on any supervisory responsibilities with respect to the MRI facility. . .&#8221;</li>
</ul>
<p>If we accept that some level of MRI safety should be a basic right of everyone inside the MRI suite (including staff), then we need to identify who has a role in making sure that MRI safety is actually implemented.</p>
<p>My view is that all parties involved in providing and administering MRI exams have an obligation to the safety of the patient. This includes the organizations who own and operate the scanners for establishing standards and providing applicable training and verifying competencies, directors / administrators / safety officers who have broad duties on behalf of the organization for the protection of patient safety, any person &#8212; whether MD, RN or technologist &#8212; who works in the MR environment, sites where accidents occur to report incidents in which there was a reasonable potential for harm, and MR equipment manufacturers to actively collect, report, and distribute details of accidents that might help others to better protect against these risks. These responsibilities are both institutional and individual.</p>
<p>If the judge&#8217;s decisions on these motions are not challenged (as has happened previously in this case), we should be inching closer towards a real trial date. As of the date of this post, the case is still scheduled to be fully resolved by early January of 2010. It remains to be seen whether that deadline will hold, or be pushed back.</p>
<p>If you would like to read this most recent decision by the judge on the three pre-trial motions she decided, it is available for download. Just click <a href="http://www.newyorkinjurycasesblog.com/uploads/file/Wrongful%20Death%20Colombini%202009%20decision.doc" target="_blank">here</a> to download the judge&#8217;s decision in Word format (.doc) from the blog site New York Injury Cases. To see the blog site, just click <a href="http://www.newyorkinjurycasesblog.com/uploads/file/Wrongful%20Death%20Colombini%202009%20decision.doc" target="_blank">here</a>.</p>
<p>Of course, if you come back here to the &#8216;MRI Metal Detector&#8217; blog, or subscribe to the RSS updates (click <a href="http://mrimetaldetector.com/blog/2008/08/subscribing-to-the-mri-metal-detector-blog/" target="_blank">here</a> for more information on the free RSS subscription), I&#8217;ll provide you with any and all updates as I get them.</p>
<address><a href="../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>
<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>
]]></content:encoded>
			<wfw:commentRss>http://mrimetaldetector.com/blog/2009/08/colombini-case-lawsuit-machinations/feed/</wfw:commentRss>
		<slash:comments>10</slash:comments>
		</item>
		<item>
		<title>MRI Safety Week &#8211; Free Training Downloads</title>
		<link>http://mrimetaldetector.com/blog/2009/07/mri-safety-week-free-training-downloads/</link>
		<comments>http://mrimetaldetector.com/blog/2009/07/mri-safety-week-free-training-downloads/#comments</comments>
		<pubDate>Mon, 06 Jul 2009 17:08:53 +0000</pubDate>
		<dc:creator>Tobias Gilk</dc:creator>
				<category><![CDATA[Other MRI Safety]]></category>
		<category><![CDATA[accident]]></category>
		<category><![CDATA[death]]></category>
		<category><![CDATA[imaging]]></category>
		<category><![CDATA[injury]]></category>
		<category><![CDATA[magnet]]></category>
		<category><![CDATA[magnetic resonance]]></category>
		<category><![CDATA[Mednovus]]></category>
		<category><![CDATA[MR]]></category>
		<category><![CDATA[MRI]]></category>
		<category><![CDATA[radiology]]></category>
		<category><![CDATA[SAFESCAN]]></category>
		<category><![CDATA[safety]]></category>
		<category><![CDATA[screening]]></category>
		<category><![CDATA[suit]]></category>
		<category><![CDATA[Technologist]]></category>

		<guid isPermaLink="false">http://mrimetaldetector.com/blog/?p=531</guid>
		<description><![CDATA[MRI Safety Week comes only once per year. This year, thanks to Mednovus, makers of the SAFESCAN® MRI screening products, we have a number informative and entertaining resources for you.]]></description>
			<content:encoded><![CDATA[<p>Once again, we&#8217;re approaching the anniversary date of the most infamous MRI fatality and the corresponding MRI Safety Week. This year, through the in-kind support of my employer, Mednovus, I&#8217;m able to make available a MRI safety quiz (actually, it&#8217;s two quizzes, one for radiology / MR staff and one for the MRI layperson).</p>
<p><span id="more-531"></span>Eight years ago this month (July 27th, 2001, to be exact), young Michael Colombini was fatally injured in an MRI accident involving a portable oxygen cylinder. The week surrounding the date of that accident is set aside each year as MRI Safety Week. This year, 2009, it falls July 27th through August 2nd.</p>
<p>During MRI Safety Week, MRI providers are encouraged to provide additional emphasis on safety provisions, training, inspection and equipment. This could serve as the anniversary date for annual inspections (cryogen safety systems, infection control, etc&#8230;). It is sometimes the additional motivator for special projects like labeling all portable equipment with the contemporary MR Safe, MR Conditional, MR Unsafe labels and designations. And sometimes it can be an opportunity to reinforce safety training for our MR staff and share a little bit of our daily safety mission with those outside MRI.</p>
<p>To make this easier, I&#8217;m posting two free Jeopardy-styled MRI safety quizzes (in Power Point format) for you to use for your staff, or for those who may not be quite so familiar with MRI safety. These resources are available at my new <a title="MRI Safety Week" href="http://mrimetaldetector.com/media/proving_grounds/MRI_safety_week.html" target="_blank">MRI Safety Week webpage</a>.</p>
<p>But beyond sharing these resources with you, I am also offering for this to serve as a clearinghouse of MRI safety resources that you want to share with your colleagues. Drop me an email (my contact information is always at the foot of each post, or in the &#8216;about Tobias Gilk, editor&#8217; in the box above and to the right) and we&#8217;ll see if we can share your posters, table-tents, questionnaires, articles, quizzes, or other downloadable resource with the broader MRI community.</p>
<p>This year, MRI Safety Week is more important than ever. The number of MRI exams continues to slowly climb, year-over-year, but rates of reported accidents are skyrocketing! We&#8217;ve seen nearly a 3-fold increase in the number of MRI accident reports to the FDA in just the last 4 years. Collectively, we have the opportunity to make a substantial impact in MRI safety.</p>
<p>Thanks to Mednovus for allowing me the time and resources to prepare these materials for you. But mostly, thank you for joining with me in again celebrating and promoting excellence in MRI safety through this special week.</p>
<address><a href="../../?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>
]]></content:encoded>
			<wfw:commentRss>http://mrimetaldetector.com/blog/2009/07/mri-safety-week-free-training-downloads/feed/</wfw:commentRss>
		<slash:comments>2</slash:comments>
		</item>
		<item>
		<title>MRI Technologist Sues For MRI Safety</title>
		<link>http://mrimetaldetector.com/blog/2009/04/mri-technologist-sues-for-safety/</link>
		<comments>http://mrimetaldetector.com/blog/2009/04/mri-technologist-sues-for-safety/#comments</comments>
		<pubDate>Sat, 18 Apr 2009 14:21:11 +0000</pubDate>
		<dc:creator>Tobias Gilk</dc:creator>
				<category><![CDATA[Other MRI Safety]]></category>
		<category><![CDATA[coil]]></category>
		<category><![CDATA[colombini]]></category>
		<category><![CDATA[daignostic]]></category>
		<category><![CDATA[death]]></category>
		<category><![CDATA[diagnosis]]></category>
		<category><![CDATA[fatality]]></category>
		<category><![CDATA[FL]]></category>
		<category><![CDATA[Florida]]></category>
		<category><![CDATA[Horizon]]></category>
		<category><![CDATA[image quality]]></category>
		<category><![CDATA[injury]]></category>
		<category><![CDATA[lawsuit]]></category>
		<category><![CDATA[magnetic]]></category>
		<category><![CDATA[maintenance]]></category>
		<category><![CDATA[MRI]]></category>
		<category><![CDATA[news]]></category>
		<category><![CDATA[practice]]></category>
		<category><![CDATA[protocol]]></category>
		<category><![CDATA[resonance]]></category>
		<category><![CDATA[safety]]></category>
		<category><![CDATA[standard of care]]></category>
		<category><![CDATA[suit]]></category>
		<category><![CDATA[Technologist]]></category>
		<category><![CDATA[television]]></category>
		<category><![CDATA[TV]]></category>
		<category><![CDATA[Westchester]]></category>

		<guid isPermaLink="false">http://mrimetaldetector.com/blog/?p=430</guid>
		<description><![CDATA[A Florida MR Technologist is fired for insisting on MRI safety and image quality now sues for wrongful termination, calling into question years of MRI exams...]]></description>
			<content:encoded><![CDATA[<p>Nearly all MRI accidents that wind up the subject of civil lawsuits conclude the same way&#8230; in confidential settlement protected by a non-disclosure agreement (NDA). This makes it extremely difficult to get to the facts associated with any particular accident. Currently the highest profile MRI accident (the death of a young boy from a flying oxygen cylinder) is in pre-trial litigation and is our best window into the legal responsibility of Technologists and providers. Today, however, I learned of another suit in which a Tech is suing her former employer for willfully putting off needed system repairs that compromised image quality and diagnostic value.</p>
<p><span id="more-430"></span>The Technologist, Laura Price, claims that her former employer, Horizon Diagnostic Center in Orange Park, FL, ignored repeated requests from Ms. Price and other Technologists to repair the coils on the MRI, and that the image quality was so poor as to compromise the clinical value of the scans. She was purportedly fired for insisting that the coils be repaired. She is suing for wrongful termination and has taken her efforts public in an <a title="Click to read / watch the interview" href="http://www.news4jax.com/news/19200827/detail.html#story" target="_blank">interview with a local television news station</a>.</p>
<p>What is particularly interesting (to me at least) is that there is not currently any claim of injury or misdiagnosis based on the claimed failure to keep the MRI equipment in operational condition. Therefore, this is strictly a claim against the practices of the provider and their adherence to standards of care and best practices.</p>
<p>Though the MRI fatality case has yet to go to trial (having been postponed <em>ad nasuem</em> for years, now), the Technologists are named defendants in that suit, suggesting at least that Techs have a legal obligation for safety and the standard of care.</p>
<p>This Florida suit is intriguing because it puts operations squarely in the legal crosshairs. When legal liability is tied only to injury, it fosters an &#8216;ends justify the means&#8217; culture of safety. Something akin to, &#8220;if we haven&#8217;t hurt anybody, it proves that we&#8217;re doing things right.&#8221;</p>
<p>Many patient safety experts decry this sort of &#8216;negative proof&#8217; of safety. Getting all the way across the freeway unscathed, on foot, blindfolded, is not proof that walking blindfolded across the freeway is a safe practice, yet this is the logic that prevades MR safety at many locations.</p>
<p>Whatever you may think of this one case, or the Technologist who is bringing it, I am very interested simply because it does put safety practices in the spotlight. I&#8217;m also very interested in what you may think of this, so please share your comments, below.</p>
<address><a href="../../?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>
]]></content:encoded>
			<wfw:commentRss>http://mrimetaldetector.com/blog/2009/04/mri-technologist-sues-for-safety/feed/</wfw:commentRss>
		<slash:comments>2</slash:comments>
		</item>
		<item>
		<title>The Supreme Court, MRI Accidents, And You&#8230;</title>
		<link>http://mrimetaldetector.com/blog/2009/03/the-supreme-court-mri-accidents-and-you/</link>
		<comments>http://mrimetaldetector.com/blog/2009/03/the-supreme-court-mri-accidents-and-you/#comments</comments>
		<pubDate>Tue, 17 Mar 2009 01:59:02 +0000</pubDate>
		<dc:creator>Tobias Gilk</dc:creator>
				<category><![CDATA[Ferromagnetic Detection for MRI Safety]]></category>
		<category><![CDATA[Other MRI Safety]]></category>
		<category><![CDATA[accreditation]]></category>
		<category><![CDATA[ACR]]></category>
		<category><![CDATA[approval]]></category>
		<category><![CDATA[civil]]></category>
		<category><![CDATA[court]]></category>
		<category><![CDATA[decision]]></category>
		<category><![CDATA[detection]]></category>
		<category><![CDATA[detector]]></category>
		<category><![CDATA[device]]></category>
		<category><![CDATA[FDA]]></category>
		<category><![CDATA[ferromagnetic]]></category>
		<category><![CDATA[legal]]></category>
		<category><![CDATA[Levine]]></category>
		<category><![CDATA[liability]]></category>
		<category><![CDATA[magnetic]]></category>
		<category><![CDATA[medical]]></category>
		<category><![CDATA[Medtronic]]></category>
		<category><![CDATA[MRI]]></category>
		<category><![CDATA[NSF]]></category>
		<category><![CDATA[pharmaceutical]]></category>
		<category><![CDATA[regulatory]]></category>
		<category><![CDATA[resonance]]></category>
		<category><![CDATA[Riegel]]></category>
		<category><![CDATA[safety]]></category>
		<category><![CDATA[state]]></category>
		<category><![CDATA[suit]]></category>
		<category><![CDATA[supreme]]></category>
		<category><![CDATA[Wyeth]]></category>

		<guid isPermaLink="false">http://mrimetaldetector.com/blog/?p=369</guid>
		<description><![CDATA[The recent US Supreme Court decision throws a little salt in the wound for MRI providers regarding their legal liability for MRI accidents.]]></description>
			<content:encoded><![CDATA[<p>Last year, the United States Supreme Court decided that medical device manufacturers that had gone through the trial-by-fire of a FDA pre-market review are <a href="http://www.supremecourtus.gov/opinions/07pdf/06-179.pdf" target="_blank">immune from civil action in the state courts</a> for product liability (<em>Riegel v. Medtronic</em>). Just a few weeks ago, the Court threw what many considered to be a major curve-ball when they decided that comparable protections do <a href="http://www.supremecourtus.gov/opinions/08pdf/06-1249.pdf" target="_blank">NOT apply to pharmaceutical manufacturers</a> (<em>Levine v. Wyeth</em>). What does this suggest to MRI providers (Technologists, Radiologists and Administrators)?</p>
<p><span id="more-369"></span>It suggests that, legally, you&#8217;re out on your own.</p>
<p>Let&#8217;s contrast this with two situations, starting with an adverse Gadolinium contrast reaction.</p>
<p>If a site were to inject a patient with impaired renal function with Gadolinium contrast and that patient developed NSF (God forbid), and the damages were determined to be $10 million, that patient could conceivably sue the pharmaceutical manufacturer for failing to make the NSF warning sufficiently bold on the packaging (by the way, watch for news reports of lawsuits mimicking this hypothetical model following this decision). Yes, the provider would likely have a piece of the $10 million pie, but the liability would move up and down the &#8216;food chain&#8217;.</p>
<p>If, on the other hand, a catastrophic SAR accident in MRI facility were to critically injure a patient, and the damages for that accident were similarly determined to be $10 million, the Supreme Court decision suggests that the device manufacturer can not be held liable in a state suit. This reasoning concludes that the sum-total of any liability, malfunction, or negligence is laid at the feet of the MRI provider.</p>
<p>Personally, I think that these two decisions bracket the area where the law should be on this issue, but they are both so far from the rational middle-ground that it will require at least one more case before we can begin to make sense of this.</p>
<p>In the meantime, what this suggests to me is that MRI providers are out in the legal forest with no &#8216;Hansel and Gretel&#8217; breadcrumb trail back to others who share their responsibility to patient safety.</p>
<p>What does this mean, in terms of how these facts should influence our behavior?</p>
<p>For a multitude of reasons (including the specter of legal liability), MRI providers should proactively look at their MRI safety protocols and provisions. All sites should follow the ACR and JCAHO recommendations and use ferromagnetic-only screening instruments. If you are Joint Commission accredited, take a look at the new EC Standards and Sentinel Event Alert #38. All MRI providers should also scrutinize the ACR Guidance Document as the basis for their own safety manuals.</p>
<p>A combination of these new 21st century MRI safety technologies, updated accreditation standards, and the industry-standard practices documents, should guide providers to help deploy the greatest protection for patients and staff (and liability protection for themselves).</p>
<p>Until this legal-liability disparity is resolved between pharmaceutical and device manufacturers, it seems to me that the most prudent course of action is to take the additional steps needed to provide the recommended safety solutions as indicated by the ACR and JCAHO. These would include careful adherence to established screening protocols and the use of recommended ferromagnetic detection systems.</p>
<address><a href="../../?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>
<address> </address>
<p>PS: you might be interested in a similar article I wrote for <a href="http://www.thehealthcareblog.com/the_health_care_blog/2009/03/pharma-vs-devices-fda-supreme-court-and-liability-whiplash.html" target="_blank">The Health Care Blog</a></p>
]]></content:encoded>
			<wfw:commentRss>http://mrimetaldetector.com/blog/2009/03/the-supreme-court-mri-accidents-and-you/feed/</wfw:commentRss>
		<slash:comments>0</slash:comments>
		</item>
		<item>
		<title>Countdown To Colombini &#8211; Under 100 Days.</title>
		<link>http://mrimetaldetector.com/blog/2008/12/countdown-to-colombini-under-100-days/</link>
		<comments>http://mrimetaldetector.com/blog/2008/12/countdown-to-colombini-under-100-days/#comments</comments>
		<pubDate>Tue, 16 Dec 2008 16:51:05 +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[fatal]]></category>
		<category><![CDATA[fatality]]></category>
		<category><![CDATA[injury]]></category>
		<category><![CDATA[law]]></category>
		<category><![CDATA[missile]]></category>
		<category><![CDATA[MRI]]></category>
		<category><![CDATA[projectile]]></category>
		<category><![CDATA[suit]]></category>
		<category><![CDATA[trial]]></category>

		<guid isPermaLink="false">http://mrimetaldetector.com/blog/?p=239</guid>
		<description><![CDATA[With roughly 100 days, the MRI world counts down to the biggest civil suit in MRI history...]]></description>
			<content:encoded><![CDATA[<p>Indeed. Nearly 8 years later, the civil lawsuit trial surrounding the infamous death of a 6-year old boy is scheduled to begin in March of 2009.</p>
<p>The multi-million dollar lawsuit has been grinding through the legal system as a myriad of claims and counter-claims have been ricocheting around among the parties. Those who&#8217;ve been watching the pre-trial activities may attest to it sometimes resembling a soap-opera with shifting alliances, but it appears that the parties&#8217; day in court will come in less than 100 days.</p>
<p><span id="more-239"></span>While skillful lawyering often has as much to do with the outcome of civil actions as do the merits of the case, the merits fall clearly in favor of the family, and are squarely against the combined defense which includes the Medical Director, hospital, Technologists, and the MRI manufacturer.</p>
<p>The young boy was not the first patient to die in an MR and, <a title="Click for summary of MRI accident rates" href="http://mrimetaldetector.com/blog/?p=209" target="_blank">given the current MRI accident trajectory</a>, won&#8217;t be the last (and already isn&#8217;t according to some anecdotal accounts). What makes this incident such a touchstone, however, are the incidental facts surrounding the boy&#8217;s death.</p>
<p>First, could there be a more sympathetic victim than a young boy who had just survived the removal of an otherwise fatal brain tumor? Second, this fatality was splashed across CNN and newspapers and was not immediately gagged with non-disclosure agreements and out-of-court settlements which is common of many MRI injuries. Lastly, as the spark that ignited the MRI safety movement, many industry watchers will follow this case if only to observe the epilogue. But odds are that the civil trial will be as central to MRI safety as the original accident was.</p>
<p>Nearly 8 years after-the-fact and there is not a single MRI safety requirement that has been imposed that would short-circuit the sequence of events that caused the accident in the first place. There is an impressive list of recommendations and best-practice calls from a heretofore unrelated collection of professional and accrediting bodies, but no requirements.</p>
<p>Would a multi-million dollar judgment change that? I think that it would. I think that the fear of a high-profile lawsuit and a huge judgment would spur action in ways that the accident which precipitated it hasn&#8217;t.</p>
<p>We may all learn, in about 100 days, whether I&#8217;m right or not&#8230; whether the echo of this incident is as loud as the event itself.</p>
<address><strong>Tobias Gilk</strong>, 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>
<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>
]]></content:encoded>
			<wfw:commentRss>http://mrimetaldetector.com/blog/2008/12/countdown-to-colombini-under-100-days/feed/</wfw:commentRss>
		<slash:comments>0</slash:comments>
		</item>
		<item>
		<title>The Most Infamous MRI Accident: Colombini At Westchester</title>
		<link>http://mrimetaldetector.com/blog/2008/07/the-most-infamous-mri-accident-colombini-at-westchester/</link>
		<comments>http://mrimetaldetector.com/blog/2008/07/the-most-infamous-mri-accident-colombini-at-westchester/#comments</comments>
		<pubDate>Fri, 11 Jul 2008 11:23:31 +0000</pubDate>
		<dc:creator>Tobias Gilk</dc:creator>
				<category><![CDATA[Ferromagnetic Detection for MRI Safety]]></category>
		<category><![CDATA[accident]]></category>
		<category><![CDATA[colombini]]></category>
		<category><![CDATA[death]]></category>
		<category><![CDATA[fatality]]></category>
		<category><![CDATA[headline]]></category>
		<category><![CDATA[law]]></category>
		<category><![CDATA[MRI]]></category>
		<category><![CDATA[newspaper]]></category>
		<category><![CDATA[safety]]></category>
		<category><![CDATA[suit]]></category>
		<category><![CDATA[video]]></category>
		<category><![CDATA[Westchester]]></category>

		<guid isPermaLink="false">http://mrimetaldetector.com/blog/?p=6</guid>
		<description><![CDATA[In 2001, the death of a young MRI patient galvanized the MRI safety movement. Today new technologies are available which can help prevent the likely occurrence of similar events.]]></description>
			<content:encoded><![CDATA[<p>The single accident that really galvanized the very existence of the MRI safety movement was an accident that occurred in 2001 at Westchester Medical Center in New York State. In that tragedy, a steel oxygen cylinder was brought into the MRI room while Michael Colombini, a six-year old boy, was receiving a post-operative MRI to confirm they doctors had successfully removed his brain tumor.<br />
<span id="more-6"></span></p>
<h3 style="text-align: center;"></h3>
<p><a href="http://mrimetaldetector.com/blog/wp-content/uploads/2008/07/german_mri_cylinder_recreation.mp4"> </a></p>
<p>In order for that accident to occur, a few standard procedures had to go awry, and not in ways that you might think. The anesthesiologist&#8217;s primary goal was to get his patient oxygen. The Technologists&#8217; primary goal was to figure out why the oxygen (which the anesthesiologist was yelling for) wasn&#8217;t working. The nurse passing the MRI unit&#8217;s primary goal was to help out when she heard someone calling for help. This accident, like so many others, was the product of well-intended efforts in an environment where the rules are all imperceptibly changed.</p>
<p style="text-align: center;"><a href="http://mrimetaldetector.com/blog/wp-content/uploads/2008/07/newspaper-2.jpeg"><img class="alignnone size-medium wp-image-7" title="Colombini Accident Newspaper Clippings 2" src="http://mrimetaldetector.com/blog/wp-content/uploads/2008/07/newspaper-2.jpeg" alt="" width="502" height="376" /></a></p>
<p>There were a number of interventions that could have potentially broken the chain of events that resulted in this fatality. Better access controls, more effective training for the Technologists and anesthesiologist, storage to keep hazardous ferromagnetic materials out of sight, suitable portable cylinders, better QA/QC on the medical gas system&#8230; each of these might have been enough to avert this accident.</p>
<p>Add to this list the effective use of ferromagnetic detection, which might have provided the automatic feedback needed to sequester the fatal oxygen cylinder before the MRI exam even began, or remind the anesthesiologist of which materials were dangerous near the magnet, or provide warning feedback to the nurse who let herself into the suite.</p>
<p>As the Colombini accident illustrates, projectile accidents in the MRI suite are most often the result of multiple factors. Effectively interdicting these sorts of accidents requires vigilance on many fronts. While there are no &#8216;silver bullet&#8217; solutions to MRI risks, no one product or training session that can eliminate the risks, there are products and solutions that help to minimize the risks. Most of the solutions have been around nearly as long as MRI, but only recently has ferromagnetic detection been added to the MR safety armamentarium.</p>
<p>This new ferromagnetic-only detection technology substantially increases the opportunity for Technologists and MR-staff to find and quarantine ferromagnetic threats worn by, or carried by, persons approaching the MRI magnet. In a forthcoming post I&#8217;ll describe the flurry of recent &#8216;best practice&#8217; standards that all now call for the use of ferromagnetic detection to improve MRI safety.</p>
<address><strong>Tobias Gilk</strong>, 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>
]]></content:encoded>
			<wfw:commentRss>http://mrimetaldetector.com/blog/2008/07/the-most-infamous-mri-accident-colombini-at-westchester/feed/</wfw:commentRss>
		<slash:comments>1</slash:comments>
			<enclosure url="http://mrimetaldetector.com/blog/wp-content/uploads/German_MRI_cylinder_recreation.mp4" length="1714293" type="audio/mpeg" />
		<itunes:duration>0:00:01</itunes:duration>
		<itunes:subtitle>In 2001, the death of a young MRI patient galvanized the MRI safety movement. Today new technologies are available which can help prevent the likely occurrence of similar events.</itunes:subtitle>
		<itunes:summary>In 2001, the death of a young MRI patient galvanized the MRI safety movement. Today new technologies are available which can help prevent the likely occurrence of similar events.</itunes:summary>
		<itunes:author>tobias.gilk@mednovus.com</itunes:author>
		<itunes:explicit>no</itunes:explicit>
		<itunes:block>no</itunes:block>
	</item>
	</channel>
</rss>

