healthy4u: E-cigarettes

In ECRI Institute's new 2014 "Top 10 Patient Safety Concerns for Healthcare Organizations", Healthcare IT is #1. (FDA: E-cigarettes are REALLY dangerous.)

The ECRI Institute in Pennsylvania (<a href="https://www.ecri.org/About/Pages/default.aspx">https://www.ecri.org/About/Pages/default.aspx</a>) has had health IT as among the "Top Ten Healthcare Technology Risks" for several years running.  Search this blog on "ECRI" for mention of those reports. Just off the press, though, is ECRI's "Top Ten patient safety concerns for 2014".  The PDF report is available at <a href="https://www.ecri.org/EmailResources/PSRQ/Top10/Top10PSRQ.pdf">https://www.ecri.org/EmailResources/PSRQ/Top10/Top10PSRQ.pdf</a>. Health IT is number one, perhaps as a result of the ECRI Deep Dive study of Health IT risk with its hair-raising numbers of 171 "IT incidents", 8 resultant injuries, and 3 possible deaths in 36 hospitals in just 9 weeks (<a href="http://hcrenewal.blogspot.com/2013/02/peering-underneath-icebergs-water-level.html">http://hcrenewal.blogspot.com/2013/02/peering-underneath-icebergs-water-level.html</a>). From the new report: CONCERN #1: Data integrity failures with health information technology systems <div>At page 7:</div><div> <div style="font-family: serif; margin-left: 40px;">With the federal government offering financial incentives for hospitals and physician practices to adopt EHR systems, use of these systems more than tripled from 2009 through 2012. “Health IT systems are very complex,” says James P. Keller, M.S., vice president, technology evaluation and safety, ECRI Institute. “They are managing a lot of information, and it’s easy to get something wrong” if the systems are not designed and implemented well. While appropriately designed and implemented systems can provide complete, current, and accurate patient care information so that the clinician can make appropriate treatment decisions, the presence of incorrect data can lead to incorrect treatment, potentially leading to patient harm.</div> <div style="font-family: serif; margin-left: 40px;">For example, the integrity of data in health IT systems can be compromised from any of the following: data entry errors, missing data or delayed data delivery, inappropriate use of default values, copying and pasting older information into a new report, use of both paper and electronic systems for patient care, and patient/data association errors (i.e., patient data from a medical device is mistakenly associated with another patient’s record). Key steps in safeguarding the integrity of electronic patient data include the following:</div><div dir="ltr" style="font-family: serif; font-size: 16.6667px;"> <div style="font-family: serif; margin-left: 40px;"> </div><div style="font-family: serif; margin-left: 40px;">x  Assessing the clinical workflow to understand how the data is, or will be, used by frontline staff  x  Testing the system and the associated interfaces, preferably in a simulated setting, to verify that the system is functioning as intended x  Providing sufficient user training and support x  Establishing a mechanism for users to report problems as they are discovered </div></div></div>In the Bizarro world in which we find ourselves in 2014, however: <ul><li>FDA has decided that healthcare information technology systems "for health information and data management" (I quote) are of "sufficiently low risk", even if they "meet the statutory requirements as medical devices" and thus fall under the Food, Drug & Cosmetic Act, to not require FDA oversight, and even though FDA admits they really do not and cannot know the true level of risks (<a href="http://hcrenewal.blogspot.com/2014/04/fda-on-health-it-risk-reckless-or.html">http://hcrenewal.blogspot.com/2014/04/fda-on-health-it-risk-reckless-or.html</a>).  </li></ul>(Got that?) While: <ul><li>Regulation of E-cigarettes is a National Priority of the Highest Importance due to Their Possible Deadly Dangers (<a href="http://hcrenewal.blogspot.com/2014/04/hypocrisy-at-fda-lets-regulate.html">http://hcrenewal.blogspot.com/2014/04/hypocrisy-at-fda-lets-regulate.html</a>).</li></ul>The E-cigarette focus is For The Children, no doubt. <ul><li>Except for children such as these, one might conclude:  <a href="http://hcrenewal.blogspot.com/2011/06/babys-death-spotlights-safety-risks.html">http://hcrenewal.blogspot.com/2011/06/babys-death-spotlights-safety-risks.html</a>.</li></ul> <ul> </ul> <table align="center" cellpadding="0" cellspacing="0" class="tr-caption-container" style="margin-left: auto; margin-right: auto; text-align: center;"><tbody><tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEh0BV8P-O5io5HPCOYJHdjddYwVGrOt4Fj_vfeeLDGHu1cvrn3-1iryc-KRA_e-toY6ak2nFKFtijMIOvXB0W2PE8xMQe8IX6Pbbs42QmR4cTSR9swsk-IG3i371ljixE3-GSUn7QbQXzqZ/s1600/bizzaroworld.jpg" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" height="200" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEh0BV8P-O5io5HPCOYJHdjddYwVGrOt4Fj_vfeeLDGHu1cvrn3-1iryc-KRA_e-toY6ak2nFKFtijMIOvXB0W2PE8xMQe8IX6Pbbs42QmR4cTSR9swsk-IG3i371ljixE3-GSUn7QbQXzqZ/s1600/bizzaroworld.jpg" width="200" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;">Bizarro World (<a href="http://en.wikipedia.org/wiki/Bizarro_World">http://en.wikipedia.org/wiki/Bizarro_World</a>).</td></tr></tbody></table> Note that ECRI Concerns #2 and #3 also may involve electronic medical records systems. CONCERN #2: Poor Care Coordination with Patient’s Next Level of Care (page 8): <blockquote>... Electronic health records (EHRs) can facilitate communication about a patient’s care among providers, but organizations must establish procedures that address accessing, reviewing, and acting on the findings in those records. For example, what happens if a provider who is viewing a patient’s record discovers that results of tests ordered by another provider have not been acted upon? EHRs could become a barrier “if physicians are second-guessing one another,” says Possanza. Organizations might find it helpful to develop a policy specifying procedures for a provider who finds an abnormal laboratory or pathology result with no indication that the abnormal result was acted upon.</blockquote><ul></ul> CONCERN #3: Test Results Reporting Errors (page 10): <blockquote class="tr_bq">... Callahan observes that breakdowns in test results reporting, particularly in physician practices, typically have one of three causes or a combination of them: (1) technology limitations, such as an inadequate interface between an EHR system and a laboratory system that provides the results electronically; (2) provider-to-provider communication gaps, such as those that occur when no backup plan is in place to designate a provider to review test results for another provider who is unavailable or on vacation; and (3) staffing and training failures, such as requiring a staff member to periodically check an EHR system for test results but not informing the person of what to expect in terms of the volume of test results typically reported to the practice. As more healthcare organizations adopt EHR systems, Callahan warns against being lulled into thinking the systems are a panacea and can prevent test reporting failures. “It’s another tool,” she says. “It won’t improve test results reporting if it’s not used correctly.”</blockquote> I was involved as consultant in a related scenario, in a case that settled out of court, where an ordered lab test was never performed (probably due to an EHR-lab interface failure!) and automatically "expired" in the EHR after a year.  However, no subsequent provider acted upon the expired order, with disastrous results. -- SS

In ECRI Institute's new 2014 "Top 10 Patient Safety Concerns for Healthcare Organizations", Healthcare IT is #1. (FDA: E-cigarettes are REALLY dangerous.)

The ECRI Institute in Pennsylvania (https://www.ecri.org/About/Pages/default.aspx) has had health IT as among the "Top Ten Healthcare Technology Risks" for several years running. Search this blog on …

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27 Apr 2014

Hypocrisy at the FDA: Let's regulate E-cigarettes ... E-medical records, E-medical ordering and related Bad Health IT? They get a gentleman's pass.

Bad health IT is defined at my Medical Informatics academic site (<a href="http://cci.drexel.edu/faculty/ssilverstein/cases/">http://cci.drexel.edu/faculty/ssilverstein/cases/</a>) as follows: <blockquote class="tr_bq">Bad Health IT ("BHIT") is health IT that is ill-suited to purpose, hard to use, unreliable, loses data or provides incorrect data, is difficult and/or prohibitively expensive to customize to the needs of different medical specialists and subspecialists, causes cognitive overload, slows rather than facilitates users, lacks appropriate alerts, creates the need for hypervigilance (i.e., towards avoiding IT-related mishaps) that increases stress, is lacking in security, compromises patient privacy or otherwise demonstrates suboptimal design and/or implementation. </blockquote> Health IT is unregulated, and Bad Health IT results in patient injuries and deaths.   This is unarguable from the data cited in this post and related posts I've linked to.  The levels of harm are unknown. At my April 9, 2014 post "FDA on health IT risk:  "We don't know the magnitude of the risk, and what we do know is the tip of the iceberg, but health IT is of 'sufficiently low risk' that we don't need to regulate it" (<a href="http://hcrenewal.blogspot.com/2014/04/fda-on-health-it-risk-reckless-or.html">http://hcrenewal.blogspot.com/2014/04/fda-on-health-it-risk-reckless-or.html</a>) I observed how the FDA bent over backwards to avoid regulating Electronic Medical Records systems and other healthcare IT systems: To recap that post: Out of one side of their mouth FDA wrote this: <blockquote class="tr_bq">... products with health management heath IT functions, includes software for health information and data management, medication management, provider order entry, knowledge management, electronic access to clinical results and most clinical decision support software. Products with health management health IT functions are of sufficiently low risk and thus, [even] if they meet the statutory definition of a medical device, FDA does not intend to focus its oversight on them.</blockquote> While out of the side of their mouth that was not intended for public viewing, discovered by investigative reporter Fred Schulte, they wrote this: <div style="margin-left: 40px;">...In summary, the results of this data review suggest significant clinical implications and public safety issues surrounding Health Information Technology. The most commonly reported H-IT safety issues included wrong patient/wrong data, medication administration issues, clinical data loss/miscalculation, and unforeseen software design issues; all of which have varying impact on the patient’s clinical care and outcome, which included 6 death and 43 injuries. The absence of mandatory reporting enforcement of H-IT safety issues limits the number of relevant MDRs [device reports] and impedes a more comprehensive understanding of the actual problems and implications.   </div>FDA is thus claiming "we know what we non-publicly concluded it is not possible to know, and Health IT is not worth regulating ... even in face of dangers we do know" (e.g., see the alarming ECRI Institute data at <a href="http://hcrenewal.blogspot.com/2013/02/peering-underneath-icebergs-water-level.html">http://hcrenewal.blogspot.com/2013/02/peering-underneath-icebergs-water-level.html</a>). Note that everyone who needs medical care (which is. essentially, everyone) is increasingly exposed to these electronic products with health management heath IT functions, against their will and without any informed consent processes.  The only people exposed to E-cigarettes are those who willingly buy and consume them. With E-cigarettes, however:  <blockquote class="tr_bq">CBS/AP  April 24, 2014  FDA: Ban sales of electronic cigarettes to minors  <a href="http://www.cbsnews.com/news/fda-ban-sales-of-electronic-cigarettes-to-minors/">http://www.cbsnews.com/news/fda-ban-sales-of-electronic-cigarettes-to-minors/</a> WASHINGTON -- The federal government wants to ban sales of electronic cigarettes to minors and require health warning labels and approval for new products under regulations being proposed by the Food and Drug Administration. </blockquote> Wonderful.  How thoughtful.  (E-cigarettes are plastic or metal tubes, usually the size of a cigarette, that heat a liquid nicotine solution instead of burning tobacco. That creates vapor that users inhale.) <blockquote class="tr_bq"> While the proposal being issued Thursday won't immediately mean changes for the popular devices, the move is aimed at eventually taming the fast-growing e-cigarette industry. The agency said the proposal sets a foundation for regulating the products but the rules don't immediately ban the wide array of flavors of e-cigarettes, curb marketing in places like TV or set product standards. Any further rules "will have to be grounded in our growing body of knowledge and understanding about the use of e-cigarettes and their potential health risks or public health benefits," Commissioner Dr. Margaret Hamburg said.</blockquote><div dir="LTR" id="article-entry"> (Perhaps the E-cigarette industry hasn't figured out who to pay off yet?) <blockquote class="tr_bq">... "By being able to regulate e-cigarettes, we'll get a lot more information about what's in them, how they're made and we're already studying e-cigarettes in terms of how they're being used and what are their implications for health," Hamburg told CBS News. "At the present time, when we can't regulate cigarettes, it's like they wild, wild West" she said. "Companies can do anything they want. They can market in ways that they want. ... Unless they make a therapeutic claim that it is a product for actual cessation of nicotine use, we can't regulate them. If they make a therapeutic claim, we can regulate them as a medical product."</blockquote> The "Wild, wild west" is a perfect descriptor of the health IT market.  And claims of benefits?  How about some 'Words that Work?'  (<a href="http://hcrenewal.blogspot.com/2013/10/words-that-work-singing-only-positive.html">http://hcrenewal.blogspot.com/2013/10/words-that-work-singing-only-positive.html</a>) <blockquote>Hamburg stressed to CBS News that, "Until we have the authority to regulate e-cigarettes, we cannot provide the information that the American public wants about the relative risk and safety of these products. ... We cannot put in place certain restrictions that might be appropriate with respect to how the products are made, the kind of flavorings, the kind of marketing, etc. So we see this as really a crucial first step."</blockquote> The health IT industry has special accommodations in that regard that the E-cigarette company lawyers need to closely examine. <blockquote class="tr_bq">Smokers like e-cigarettes because the nicotine-infused vapor looks like smoke but doesn't contain the thousands of chemicals, tar or odor of regular cigarettes. Some smokers use e-cigarettes as a way to quit smoking tobacco, or to cut down. However, there's not much scientific evidence showing e-cigarettes help smokers quit or smoke less, and it's unclear how safe they are.</blockquote> It's undeniably unclear how safe clinical IT devices are, either.  The ECRI Institute, for instance, found 171 mishaps in 9 weeks at 36 hospitals voluntarily reported, leaving 8 patients harmed and possibly three of them dead.   (A likely far more than serous problem than GM cars with defective ignitions that killed ~13 in a decade...)   The FDA found many injuries and several deaths in their own self-admitted limited dataset as well.  (See FDA Internal Memo on HIT risk at <a href="http://hcrenewal.blogspot.com/2010/08/smoking-gun-internal-fda-memorandum-of.html">http://hcrenewal.blogspot.com/2010/08/smoking-gun-internal-fda-memorandum-of.html</a>). <blockquote class="tr_bq">... Companies also will be required to submit applications for premarket review within two years. As long as an e-cigarette maker has submitted the application, the FDA said it will allow the products to stay on the market while they are being reviewed. That would mean companies would have to submit an application for all e-cigarettes now being sold.</blockquote></div><div style="margin-bottom: 0in;"> </div><div style="margin-bottom: 0in;">There is no premarket review of clinical IT of the types categorized by FDA as "with health management heath IT functions" as above, even if those devices meet the statutory requirements as a medical device that falls under the Food, Drug & Cosmetic Act.  These systems increasingly mediate and regulate every transaction of healthcare.</div><div style="margin-bottom: 0in;"> </div><div style="margin-bottom: 0in;">E-cigarettes, however, are a major concern that are being reviewed in earnest?</div><div style="margin-bottom: 0in;"> </div><div style="margin-bottom: 0in;">Unbelievable.</div><div style="margin-bottom: 0in;"> </div><div style="margin-bottom: 0in;">-- SS DISCLAIMER:  I neither use tobacco products in any form nor E-cigarettes, never did, and have no conflicts of interest of any kind with either the tobacco or E-cigarette industries.</div>

Hypocrisy at the FDA: Let's regulate E-cigarettes ... E-medical records, E-medical ordering and related Bad Health IT? They get a gentleman's pass.

Bad health IT is defined at my Medical Informatics academic site (http://cci.drexel.edu/faculty/ssilverstein/cases/) as follows:Bad Health IT ("BHIT") is health IT that is ill-suited to purpose, hard …

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25 Apr 2014

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