healthy4u: software glitch

FDA: Software Failures Responsible for 24% Of All Medical Device Recalls

At "<a href="https://threatpost.com/en_us/blogs/fda-software-failures-responsible-24-all-medical-device-recalls-062012" target="_blank">FDA: Software Failures Responsible for 24% Of All Medical Device Recalls</a>" via Kapersky Labs, a software security company, it is observed (emphases mine): <blockquote class="tr_bq">Software failures were behind 24 percent of all the medical device recalls in 2011, according to data from the U.S. Food and Drug Administration, which said it is gearing up its labs to spend more time analyzing the quality and security of software-based medical instruments and equipment. The FDA's Office of Science and Engineering Laboratories (OSEL) released the data in its 2011 Annual Report on June 15, amid reports of a compromise of a Web site used to distribute software updates for hospital respirators. The absence of solid architecture and "principled engineering practices" in software development affects a wide range of medical devices, with potentially life-threatening consequences, the Agency said. In response, FDA told Threatpost that it is developing tools to disassemble and test medical device software and locate security problems and weak design. ... "Manufacturers are responsible for identifying risks and hazards associated with medical device software (or) firmware, including risks related to security, and are responsible for putting appropriate mitigations in place to address patient safety," the agency said in an e-mail statement. </blockquote> <a href="http://hcrenewal.blogspot.com/2011/04/fda-decides-regulating-implantable.html" target="_blank">Health IT medical devices</a> are the exception, of course.  A health IT virtual medical device is always of <a href="http://sydney.edu.au/engineering/it/%7Ehitru/essays/Pt%207%20-%20The%20Integrated%20Assessment%20-%20The%20Washup.pdf" target="_blank">rock-solid architecture</a>, always uses "<a href="http://hcrenewal.blogspot.com/2011/10/nist-on-ehr-mission-hostile-user.html" target="_blank">principled engineering practices</a>" in software development, and never has <a href="http://hcrenewal.blogspot.com/2011/06/babys-death-spotlights-safety-risks.html" target="_blank">life-threatening consequences</a>, of course. Hence its special regulatory accommodations over non-virtual (tangible) medical devices. -- SS

FDA: Software Failures Responsible for 24% Of All Medical Device Recalls

At " FDA: Software Failures Responsible for 24% Of All Medical Device Recalls " via Kapersky Labs, a software security company, it...

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Twelve Hour Health IT "Glitch" at Allegheny General Hospital - But Patients Unaffected, Of Course...

At "<a href="http://hcrenewal.blogspot.com/2011/05/transplant-team-at-upmc-missed.html">Transplant Team at Univ. of Pittsburgh Medical Center Missed Hepatitis Result</a>" I wrote about a kidney transplant gone bad at UPMC that may have been due to a computer "glitch." Now <a href="http://www.wpahs.org/agh/">Allegheny General Hospital</a> in Pittsburgh has suffered a "glitch" that shut down their entire health IT system for approximately 12 hours: <blockquote> <a href="http://www.pittsburghlive.com/x/pittsburghtrib/news/pittsburgh/s_738944.html">Allegheny General Hospital's records system back online</a> By Pittsburgh Tribune-Review Wednesday, May 25, 2011 Last updated: 10:26 pm Allegheny General Hospital's electronic medical records system was online Wednesday afternoon after a morning shutdown caused by a glitch in a vendor's computer software, a spokesman [Dan Laurent] said. ... The hospital's system underwent a routine upgrade during the weekend, Laurent said. Staff shut down the system about 5 a.m. Wednesday after noticing it was running too slow. New Jersey-based software vendor Allscripts made repairs, and the system was online by 5 p.m., he said.</blockquote> One might think the vendors of mission critical hospital systems would check their upgrades better before roll out to hospitals teeming with real, live, sick patients. Of course, patient care was unaffected. It never is when a "glitch" occurs, despite the massive inconvenience to doctors who actually have patients to care for, and the need for backloading paper data - with inherent opportunity for error - after the computer system is resuscitated. At a Jan. 2011 post "<a href="http://hcrenewal.blogspot.com/2011/01/orderless-in-seattle-software-glitch.html">Orderless in Seattle: Software glitch shuts down Swedish Medical Center's medical-records system</a>" I observed: <blockquote> There's that word "glitch" again that I see so frequently in the health IT sector when a system suffers a major crash that could harm patients. Why do we not call it a "glitch" when a doctor amputates the wrong body part, or kills someone? ... the shutdown likely affected about 600 providers, 2,500 staffers and perhaps up to 2,000 patients, but no safety problems were reported. As I've <a href="http://hcrenewal.blogspot.com/2010/08/huffington-post-investigative-fund-fda.html">noted at this blog before</a>, it is peculiar how such "glitches" never seem to produce safety problems, or even acknowledgments of increased risk.</blockquote> Same in this Allegheny General Hospital case: <blockquote>... [spokesman] Dan Laurent said staffers took drug and lab orders on paper forms, and that patient care was not affected by the shutdown.</blockquote> If patient care is never affected by shutdowns even as long as an entire working day, one wonders why the tens or hundreds of millions of dollars spent on these systems is needed in the first place... I have a solution. <a href="http://www.computerworld.com/s/article/9216098/Amazon_outage_sparks_frustration_doubts_about_cloud">Cloud computing!</a> -- SS

Twelve Hour Health IT "Glitch" at Allegheny General Hospital - But Patients Unaffected, Of Course...

At " Transplant Team at Univ. of Pittsburgh Medical Center Missed Hepatitis Result " I wrote about a kidney transplant gone bad at...

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