Health IT FDA Recall: Philips Xcelera Connect - Incomplete Information Arriving From Other Systems

Another health IT FDA recall notice, this time on middleware, an interface engine that routes data:<br /><br /><a href="http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-1942-2012&w=07112012&" target="_blank">Week of July 11 </a><br /><br /><b>Product description:  </b><br /><br />Philips Xcelera Connect, Software R2.1 L 1 SP2,<b> an interface engine for data exchange </b><i style="color: red;"><b>[a specialized computer and accompanying software package - ed.]</b></i><b>.</b> Philips Xcelera Connect R2.x is a generic interface and data mapping engine <b>between a Hospital Information System (HIS), Imaging Modalities, Xcelera PACS and Xcelera Cath Lab Manager (CLM)</b>. This interface engine simplifies the connection by serving as a central point for data exchange. The data consists <b>only of demographic patient information, schedules, textual information and text reports</b>.<br /><br />Classification:  <b>Class II </b> <br /><br /><table border="1" class="ProductInfo"><tbody><tr><th scope="row">Reason For Recall </th><td>Xcelera Connect R2.1 L 1 SP2 ,<b> incomplete information arriving </b>from unformatted reports interface </td></tr></tbody></table><br />The data consists<b> "only"</b> of demographic patient information, schedules, textual information and text reports?<br /><br />This is a dangerous fault mode, indeed. <br /><br />"Incomplete information" moving between a hospital information system, imaging systems, a PACS system used to manage the images, and a cardiac cath lab can lead to very bad outcomes (and million dollar lawsuits), such as at "<a href="http://www.chicagotribune.com/health/ct-met-technology-errors-20110627,0,5447654.story">Babies' deaths spotlight safety risks linked to computerized systems</a>", second example.<br /><br />Note that the interface engine is in release 2.1, level 1, service pack 2.<br /><br />In other words, a critical hardware/software product such as this undergoes constant tweaking (like Windows).<br /><br />As a Class II device, at least the <a href="http://en.wikipedia.org/wiki/Medical_device#Class_II:_General_controls_with_special_controls" target="_blank">software is vetted to some degree by FDA</a>: <br /><br /><blockquote class="tr_bq">Class II devices are those for which general controls alone are insufficient to assure safety and effectiveness, and existing methods are available to provide such assurances.<sup class="reference" id="cite_ref-classification_7-3"><a href="http://en.wikipedia.org/wiki/Medical_device#cite_note-classification-7">[8]</a></sup><sup class="reference" id="cite_ref-controls_9-3"><a href="http://en.wikipedia.org/wiki/Medical_device#cite_note-controls-9">[10]</a></sup> In addition to complying with general controls, Class II devices are also subject to special controls.<sup class="reference" id="cite_ref-controls_9-4"><a href="http://en.wikipedia.org/wiki/Medical_device#cite_note-controls-9">[10]</a></sup> A few Class II devices are exempt from the premarket notification.<sup class="reference" id="cite_ref-controls_9-5"><a href="http://en.wikipedia.org/wiki/Medical_device#cite_note-controls-9">[10]</a></sup> Special controls may include special labeling requirements, mandatory performance standards and <a href="http://en.wikipedia.org/wiki/Postmarketing_surveillance" title="Postmarketing surveillance">postmarket surveillance</a>.<sup class="reference" id="cite_ref-controls_9-6"><a href="http://en.wikipedia.org/wiki/Medical_device#cite_note-controls-9">[10]</a></sup> Devices in Class II are held to a higher level of assurance than Class I devices, and are designed to perform as indicated without causing injury or harm to patient or user. Examples of Class II devices include powered wheelchairs, infusion pumps, and surgical drapes.<sup class="reference" id="cite_ref-classification_7-4"><a href="http://en.wikipedia.org/wiki/Medical_device#cite_note-classification-7">[8]</a></sup><sup class="reference" id="cite_ref-controls_9-7"><a href="http://en.wikipedia.org/wiki/Medical_device#cite_note-controls-9">[10]</a></sup></blockquote><br />One wonders how testing of tweaks and updates to this product is done, if at all, other than on live and unsuspecting patients.<br /><br />When you go into the hospital you are not just putting your life in the hands of the doctors and nurses, you're putting your life into the hands of computer geeks and software development experiments.<br /><br />-- SS<br /><br />July 25, 2012 Addendum:<br /><br />The WSJ covered this here:  <a href="http://blogs.wsj.com/cio/2012/07/20/philips-recalls-flawed-patient-data-system/">http://blogs.wsj.com/cio/2012/07/20/philips-recalls-flawed-patient-data-system/</a>.  From their report:<br /><blockquote class="tr_bq"><br />... The problem that led to the recall: hitting the “enter” button, to start a new paragraph, in the summary field of <b>heart test reports</b>, sometimes caused the text entered below that point to be stripped from the report as it was transmitted into the patient’s electronic health record. And doctors later reviewing the patient’s electronic health record would not necessarily know they had received only part of the report, <b>which could lead them to make “incorrect treatment decisions,”</b> Philips said in a letter to hospitals.<br /><br />...  Mike Davis, managing director at The Advisory Board Company, a healthcare research firm, says in the case of the Xcelera Connect, Philips should have caught the problem in testing. “How the hell does this get out? It shows there wasn’t good quality assurance processes in place.”</blockquote><br />Indeed. <br /><br />-- SS

Health IT FDA Recall: Philips Xcelera Connect - Incomplete Information Arriving From Other Systems

Another health IT FDA recall notice, this time on middleware, an interface engine that routes data:Week of July 11 Product description:  Philips Xcelera Connect, Software R2.1 L 1 SP2, an interface en…

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Philips Medical: A Followup

In a Nov. 2008 post entitled "<a href="http://hcrenewal.blogspot.com/2008/11/who-leads-in-intellectually-challenged.html">Who Leads in Intellectually Challenged Responses to Medical Informatics Backgrounds, The U.S. or Europe?</a>", I chastised Philips Medical for their ossified and uninspired approach to biomedical informatics talent management (by nonmedical "experts", in fact), and that ossification's deleterious effect on innovation.<br /><br />I forwarded the post to Philips management. Needless to say, I never received a response.<br /><br />This appeared on Aug. 5, 2009 at layofftracker.blogspot.com:<br /><br /><h2 class="date-header"><span style="font-size:100%;"></span></h2><blockquote><h2 class="date-header"><span style="font-size:100%;">Wednesday, August 5, 2009</span></h2> <a name="3426548320135672823"></a> <h3 class="post-title entry-title"> <a href="http://layofftracker.blogspot.com/2009/08/philips-healthcare-announces-layoffs.html">Philips Healthcare announces layoffs</a> </h3> <div>Got via a <a href="http://visakhcr.googlepages.com/layofftracker-tipme">Tip</a>. </div><div><br /></div><div><b>Philips Healthcare announces layoffs. Memo below.</b></div><div><br /></div><div>Message from Steve Rusckowski</div><div><br /></div><div>Dear Colleague,</div><div><br /></div><div>In our Q2 and Semi-Annual 2009 Report released on July 13, Philips reported a year-on-year decline in Healthcare sales. While we are substantially lower in our profitability as compared to Q2 2008, material improvements were made in our profitability from Q1 2009 to now, due to our sustained efforts on cost-containment. However, we still fell short of our targets and there is risk for further deterioration in several of our markets.</div><div><br /></div><div>To build a stronger organization for our future, we need to be a simpler, leaner, more flexible organization, while continuing to bring costs and capacity in line with current demand levels. Our long-term success will be measured by our ability to pro-actively and purposefully navigate through the lingering economic slowdown.</div><div><br /></div><div>The Healthcare Executive Team, in collaboration with our extended management across the sector, will adapt our organization to the needs of the markets. Where we see opportunities we will seize them, where markets change we will take the necessary steps to enable profitable growth.</div><div><br /></div><div>To safeguard and strengthen our business, our sector will expand, and where possible, accelerate our efforts to cut further operating costs, <span style="font-weight: bold;">including an additional reduction in our workforce. After careful analysis and consideration, this action will impact nearly all of our businesses and functions within North America beginning this month.</span></div><div><br /></div><div>The necessity of this workforce reduction is driven by <span style="font-weight: bold;">increasing double-digit declines in equipment orders across all of our businesses in North America.</span> The combination of tightening credit markets, persistent delays in capital equipment purchases, reimbursement pressures and the uncertainty of health care reform, are contributing to a weak overall U.S. health care market. <span style="font-weight: bold; font-style: italic; color: rgb(255, 0, 0);">[He forgot to mention innovation failure - ed.]</span> Responding to these dynamics is crucial to secure our immediate business performance and preparation for our future.</div><div><br /></div><div>In North America, the vast majority of employees affected by the workforce reduction will be notified next week. Some employees will be notified as early as this week, with others notified later, as business needs dictate. Impacted employees will be notified by management and/or representatives from Human Resources.</div><div><br /></div><div>As always, Philips is fully committed to supporting all employees through this process and will treat everyone fairly, professionally and with respect. In accordance with local legislation and procedures, affected employees will be offered severance packages and other appropriate assistance and support.<span style="font-weight: bold; font-style: italic; color: rgb(255, 0, 0);"> [Being treated with "respect" at a time of massive unemployment, of course, means being handed a few months' salary -- unless you are an executive -- and then being booted out the door - ed.].</span></div><div><br /></div><div>I recognize the impact of these decisions is difficult and distracting on a personal and business level.<span style="font-weight: bold; font-style: italic; color: rgb(255, 0, 0);"> [Getting laid off is indeed somewhat "personally distracting" - ed.]</span> On behalf of the Executive Team, I want to thank you for pulling together and giving your best effort to stay focused during these challenging times.</div><div><br /></div><div>It is important to recognize, we are battling a global recession, with impact extending across all sectors and geographies. While we are taking these measures within the North American region, we will continue to assess economic conditions and business challenges across our sector and will implement further cost measures whenever needed.</div><div><br /></div><div>I will continue to keep our lines of communication open <span style="font-weight: bold; font-style: italic; color: rgb(255, 0, 0);">[to survivors - ed.]</span>, as we proceed ahead. As we do, let’s continue to focus on our customers, as we commit to supporting one another.</div><div><br /></div><div>I remain confident in our business strategy and our collective passion to make a positive difference in health care.</div><div><br /></div><div>Best regards,</div><div><br /></div><div>Steve Rusckowski</div><div>CEO</div><div>Philips Healthcare</div></blockquote><div></div><br />I suggest that to "build a stronger organization for our future" ("our" referring to those who actually retain their positions for now), Philips management start reforms at the top. One reform would be to re-evaluate just how "expert" their experts are.<br /><br />Philips shareholders, take note.<br /><br />-- SS

Philips Medical: A Followup

In a Nov. 2008 post entitled "Who Leads in Intellectually Challenged Responses to Medical Informatics Backgrounds, The U.S. or Europe?", I chastised Philips Medical for their ossified and uninspired a…

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