Another 'Survey' on EHRs - Affinity Medical Center (Ohio) Nurses Warn That Serious Patient Complications "Only a Matter of Time" in Open Letter

I've written previously about substantial problems nurses at Affinity Medical Center, Ohio (<a href="http://www.affinitymedicalcenter.com/">http://www.affinitymedicalcenter.com/</a>) and other organizations are having with EHRs, and how hospital executives were ignoring their complaints.  The complaints have been made openly, I believe, in large part due to the protection afforded by nurses' unions.<br /><br />See for example my July 2013 post<b> "RNs Say Sutter’s New Electronic System Causing Serious Disruptions to Safe Patient Care at East Bay Hospitals"</b> at <a href="http://hcrenewal.blogspot.com/2013/07/rns-say-sutters-new-electronic-system.html">http://hcrenewal.blogspot.com/2013/07/rns-say-sutters-new-electronic-system.html</a> (there are links there to still more examples), and my June 2013 post  "<b>Affinity RNs Call for Halt to Flawed Electronic Medical Records System Scheduled to Go Live Friday"</b> at <a href="http://hcrenewal.blogspot.com/2013/06/affinity-rns-call-for-halt-to-flawed.html">http://hcrenewal.blogspot.com/2013/06/affinity-rns-call-for-halt-to-flawed.html</a>, along with links therein to other similar situations.<br /><br />Particularly see my July 2013 post "<b>How's this for patient rights? Affinity Medical Center manager: file a safety complaint, and I'll plaster it to your head!"</b> at <a href="http://hcrenewal.blogspot.com/2013/07/hows-this-for-patient-rights-affinity.html">http://hcrenewal.blogspot.com/2013/07/hows-this-for-patient-rights-affinity.html</a>, where a judge had to intervene in a situation of apparent employee harassment for complaints about patient safety risks.<br /><br />Here's the latest at Affinity Medical Center - an open letter to the Chief Nursing Officer (CNO) dated August 15, 2013.  Images and text below:<br /><br /><br /><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/AVvXsEhNZ-FVI6yOi6hzHqgyu1v0xQ66Ur33TUGeYYQ1WxrjwfDtDaHq0FZT49Ifs2gDJV7cOKk19pjmGlSkWErY-onGyNoIgZBxjK7moDu912SBF-3CteKp60XUgswug_ZUZdFAPKSoWfBoMiBp/s1600/affinity_page1.jpg" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" height="400" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhNZ-FVI6yOi6hzHqgyu1v0xQ66Ur33TUGeYYQ1WxrjwfDtDaHq0FZT49Ifs2gDJV7cOKk19pjmGlSkWErY-onGyNoIgZBxjK7moDu912SBF-3CteKp60XUgswug_ZUZdFAPKSoWfBoMiBp/s400/affinity_page1.jpg" width="307" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;">Page 1 - <b>click to enlarge </b>(text is below)<b><br /></b></td><td class="tr-caption" style="text-align: center;"><br /></td><td class="tr-caption" style="text-align: center;"><br /></td></tr></tbody></table><br /><br /><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/AVvXsEjJq3QEnDSUGKCbaNAVv4MmaUcRUmTfAq8x5C8fTNcZcSCHccvXACji_yBjfHDfGHUZNMNu0SuXW4AwwFt4XJPFxcwgrYvrvnFQHLNgCiYfnL76YcOVrsNaWFZhTnhVIInNHzTQdzt0AUJo/s1600/affinity_page2.jpg" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" height="400" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjJq3QEnDSUGKCbaNAVv4MmaUcRUmTfAq8x5C8fTNcZcSCHccvXACji_yBjfHDfGHUZNMNu0SuXW4AwwFt4XJPFxcwgrYvrvnFQHLNgCiYfnL76YcOVrsNaWFZhTnhVIInNHzTQdzt0AUJo/s400/affinity_page2.jpg" width="308" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;">Page 2 - <b>click to enlarge </b>(text is below)<b><br /></b></td></tr></tbody></table><br />The letter to the CNO states (emphases and comments in red italics are mine):<br /><br /><blockquote class="tr_bq">August 15, 2013<br /><br />Mr. Osterman,<br /><br />Nurses at Affinity Medical Center are pleased to see that you have responded to our request and provided additional Cerner education classes, but education was only one of many concerns. <span style="color: red;"><i><b>[I note that education cannot compensate for the toxic effects of bad health IT that is poorly designed and/or poorly implemented, and that it's legally the responsibility of a hospital to ensure all apparatuses implemented and the environment of care are themselves safe - ed.]</b></i></span><br /><br />Since the implementation nurses throughout the hospital have brought many serious concerns to the attention of both yourself and other supervisors.  When nurses have reported these concerns they have been either ignored or dismissed. It is distressing that Affinity would so blatantly disregard the concern of their RN staff surrounding issues that concern patient safety.  It is clear to direct-care RNs that many of the problems that exist with Cerner are a direct result of the failure to include nurses in the planning stages. <span style="color: red;"><i><b>[Exclusion of enduser domain experts from health IT development, in 2013, is grossly negligent IMO - ed.]</b></i></span><br /><br /><span style="color: red;"></span>Some of the concerns that nurses have brought to the attention of management include:<br /><br /><ul><li>Medication errors/scanning issues - perhaps the biggest concern of all RNs </li><li>RNs unable to access patient records for hours at  a time</li><li>Incorrect descriptors and inaccurate drop-down menus</li><li>Incorrect calculations in the I&O <span style="color: red;"><i><b>[fluid input and output, especially important in very ill patients - ed.]</b></i></span> and MAP <span style="color: red;"><i><b>[mean arterial pressure, used to calculate drip rates of potent drugs that raise or lower blood pressure in critical care, among other things - ed.]</b></i></span> portions of the chart  </li><li>Inaccurate medication times and the inability of RNs to ensure medications are scheduled correctly</li><li>Endless loops of computer prompts that are unable to be dismissed by RNs in an emergency<i><b><span style="color: red;"></span></b></i> <i><b><span style="color: red;"> </span></b></i></li></ul><br /><i><b><span style="color: red;">[It should be apparent that these 'issues' - some due to fundamental design flaws - are quite serious in terms of the harm they can cause, even with the exceptional and stressful RN hyper-vigilance their presence necessitates- ed.]</span></b></i><br /><i><b><span style="color: red;"> </span></b></i> <br /><i><b><span style="color: red;"></span></b></i>These threats to patient safety cannot continue.  <b>It is only a matter of time before a communication error or a medication error lead to a serious complication for a patient.</b> <span style="color: red;"><i><b> </b></i></span>These types of errors have the ability to harm every patient and must be addressed immediately.<span style="color: red;"><i><b> </b></i></span><br /><br /><span style="color: red;"><i><b>[This is not theoretical or unlikely.  Such an error led to my own mother's crippling injuries and death, and to injuries and deaths in numerous other cases of which I am aware through my legal work - ed.]</b></i></span><br /><br /><span style="color: red;"></span>We ask that you set up a meeting with a delegation of RNs from our Facility Bargaining Council to discuss the concerns that nurses have documented on 'Technology Despite Objection' forms <span style="color: red;"><i><b>[complaint forms about use of technology with objections - ed.]</b></i></span> and <b>make a plan to fix these life-threatening problems</b>.<br /><br />You may set up a meeting by contacting Pam Gardner, RN at [redacted] or our National Representative  Michelle Mahon, RN.  <i><b><span style="color: red;">[For the National Nurses United labor union, </span></b><a href="http://www.nationalnursesunited.org/">http://www.nationalnursesunited.org/</a>,<b> <span style="color: red;">with close to 185,000 members nationwide - ed.]</span></b></i>  We look forward to hearing from you.</blockquote><br />The letter is followed by the signatures of about 70 nurses. <br /><br />I am informed by a Union rep in mid-November 2013, 3 months after the date of this letter, that (emphasis mine):<br /><br /><blockquote class="tr_bq"><div class="MsoNormal">Nurses there are continuing to document the problems and concerns that they are experiencing.  I have attached a letter sent to the CNO at Affinity signed by nearly 70 RNs.  This is a pretty significant number of nurses <b>especially in light of the fact that managers stole the circulating letter two times to prevent nurses from signing on.</b>  The response to this letter was…….nothing.  The nurses have been ignored yet again. <span style="color: red;"><i><b>[Ellipsis in the original, I did not redact - ed.]  </b></i></span> </div></blockquote><div class="MsoNormal"></div><br />It is clear the administration of this healthcare system has been explicitly put on notice of likely if not imminent danger to patients by multiple qualified experts, its own RNs.  If they do not act and patient harm occurs, it is my belief criminal negligence charges could be merited.<br /><br />I also highly doubt patients are informed of these EHR system 'issues' and have been afforded the opportunity to give informed consent to the use of these computer systems in their care, or to go elsewhere for treatment.<br /><br />These problems are repeating themselves over and over across this country and others, but many clinicians, especially those not protected to some degree by a labor union, do not speak out due to fear of retaliation.<br /><br />Let's hope the nurses who signed this letter don't get their complaints plastered to their foreheads, as some were threatened with as in the aforementioned post.<br /><br />-- SS<br /><br />

Another 'Survey' on EHRs - Affinity Medical Center (Ohio) Nurses Warn That Serious Patient Complications "Only a Matter of Time" in Open Letter

I've written previously about substantial problems nurses at Affinity Medical Center, Ohio ( http://www.affinitymedicalcenter.com/ ) and...

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Affinity RNs Call for Halt to Flawed Electronic Medical Records System Scheduled to Go Live Friday

At my May 30, 2013 post "<b>Marin General Hospital's Nurses are Afraid a Defective EMR Implementation Will Harm or Kill Patients ... CEO Cites Defective HHS Paper and Red Herrings As Excuse Why He Knowingly Allows This To Continue</b>" at <a href="http://hcrenewal.blogspot.com/2013/05/marin-general-hospitals-nurses-are.html">http://hcrenewal.blogspot.com/2013/05/marin-general-hospitals-nurses-are.html</a>, I lamented that hospital management felt they could ignore clinicians calling for implementation postponement of what they viewed as bad health IT, dangerous to patients, with impunity.<br /><br /><b>Finally, </b>medical professionals stand up to imperial hospital management that, in a perhaps criminally negligent fashion (e.g., see my post on the <b>ECRI Deep Dive Study on Health IT harm</b> at <a href="http://hcrenewal.blogspot.com/2013/02/peering-underneath-icebergs-water-level.html">this link</a>), ignores its clinicians over too-rapid deployment of health IT.<br /><br />Also see newspaper article at <a href="http://www.cantonrep.com/news/x393137745/Affinity-nurses-seek-delay-on-electronic-records#axzz2WcOMZpvF">http://www.cantonrep.com/news/x393137745/Affinity-nurses-seek-delay-on-electronic-records#axzz2WcOMZpvF</a>.<br /><br />(The hospital management is extolling the safety of the new Cerner system.  What could <i><b>possibly</b></i> go wrong?  -- I'd bet the executives, despite their fiduciary duties towards maintaining a safe hospital environment, have no idea about Cerner defects such as at the FDA MAUDE database; see "<b>MAUDE and HIT Risks: What in God's Name is Going on Here?</b>" at <a href="http://hcrenewal.blogspot.com/2011/01/maude-and-hit-risk-mother-mary-what-in.html">http://hcrenewal.blogspot.com/2011/01/maude-and-hit-risk-mother-mary-what-in.html</a> or are familiar with "<b>Medical center has more than 6000 'issues' with Cerner CPOE system in four months" </b>at <a href="http://hcrenewal.blogspot.com/2010/10/medical-center-has-more-than-6000.html">http://hcrenewal.blogspot.com/2010/10/medical-center-has-more-than-6000.html</a>.  Instead, unpaid bloggers do their work for them to protect patients....)<br /><br /><b>See this: </b><br /><br /><div style="text-align: center;">-----------------------------</div><blockquote class="tr_bq"><div class="MsoNormal"><b><span style="font-family: "Times New Roman","serif"; font-size: 14.0pt;">For Immediate Release - June 18, 2013</span></b></div><div class="MsoNormal"><i><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt;">For more information: Michelle Mahon, RN, 234-207-6706 or Liz Jacobs, RN, 510-273-2232</span></i></div><div class="MsoNormal"><br /></div><div align="center" class="MsoNormal" style="text-align: center;"><span style="font-size: large;"><b><span style="font-family: "Times New Roman","serif";">Affinity RNs Call for Halt to Flawed Electronic Medical Records System Scheduled to Go Live Friday</span></b></span></div><div class="MsoNoSpacing"><br /></div><div class="MsoNoSpacing"><br /></div><div class="MsoNoSpacing"><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt;">Affinity Medical Center RNs in Massillon, Ohio are calling on hospital officials to delay the planned June 21 implementation of the Cerner electronic medical records (EMR) system, until the hospital bargains with the nurses and proceeds in a safe manner. </span></div><div class="MsoNoSpacing"><br /></div><div class="MsoNoSpacing"><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt;">The direct-care RNs, represented by the National Nurses Organizing Committee (NNOC) in Ohio, an affiliate of National Nurses United (NNU), say that nurses, the primary users of the complex system, have had insufficient training, which will put patients at risk. The implementation, which has been done without bargaining with NNOC, reflects yet another violation of federal labor law by Affinity, nurses say.</span></div><div class="MsoNoSpacing" style="margin-bottom: 12.0pt;"><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt;"><br />Nurses have documented their concerns in a detailed letter to hospital officials. Those concerns <b>include woefully inadequate training, short staffing in the first days of the roll out, and the subsequent risk of harm to their patients</b>.  The system, they say, has the potential of violating the Ohio Nursing Practice Act because it doesn’t permit RNs to communicate individualized, potentially life-saving information about their patients. </span></div><div class="MsoNormal"><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt;">The letter, which RNs attempted to deliver to hospital officials on Friday, cites nationally recognized experts in health information technology who reinforce the RNs’ concerns. Most notably, the Institute of Medicine (IOM) has concluded that the failure to include RNs in all steps of this transition is one of the most significant barriers to successful, safe implementation of electronic health records systems. </span></div><div class="MsoNormal"><b><br /></b></div><div class="MsoNormal"><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt;"><b>Hospital officials have continued to refuse to meet with nurses, and would not accept the letter.  <span style="color: red;"><i>[Willful ignorance? - ed.]</i></span></b> Without bargaining with the union or acknowledging the nurses’ concerns, the hospital added a few more trainings late Friday, but the RNs say that remains far from adequate.</span></div><div class="MsoNormal"><br /></div><div class="MsoNormal"><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt;">Over the last few years, American healthcare corporations have invested heavily in information technology (IT) systems, which make up a multi-billion dollar market. </span></div><div class="MsoNormal"><br /></div><div class="MsoNormal"><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt;">“RNs who actually use these systems day in and day out have found that the kind of care they can provide with this new technology is limited,” said NNOC Co-president Cokie Giles, RN. <b>“The programs are often counterintuitive, cumbersome to use, and sometimes simply malfunction. Nurses are finding that the technology is taking time away from patients and fundamentally changing the nature of nursing.” </b></span></div><div class="MsoNormal"><br /></div><div class="MsoNormal"><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt;">NNOC/NNU has successfully negotiated clauses in its contracts that allow RNs to play a greater role in reviewing and approving new technologies before they are introduced, and that the new technologies will not supersede RN professional judgment.  </span></div><div class="MsoNormal"><br /></div><div class="MsoNormal"><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt;">“I have been chosen as a ‘super-user,’ said Amy Pulley, an RN who works in the endoscopy unit of the hospital. “I’m not sure what makes me ‘super’ with the limited training for this complex system that I’ve received. I’m concerned that the manner in which this technology is being implemented may pose serious disruptions in patient care.”</span></div><div class="MsoNormal"><br /></div><div align="center" class="MsoNormal" style="text-align: center;"><b><span style="font-family: "Times New Roman","serif"; font-size: 14.0pt;">Highlights of RN Concerns on the Implementation of the Cerner Electronic Medical Records System at Affinity Medical Center</span></b></div><div align="center" class="MsoNormal" style="text-align: center;"><br /></div><div class="MsoNormal"><b><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt;">Inadequate Staffing</span></b></div><div class="MsoListParagraph" style="margin-left: .25in; text-indent: -.25in;"><span style="font-family: Symbol; font-size: 12.0pt;">·<span style="font: 7.0pt "Times New Roman";">        </span></span><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt;">Several units will be severely short staffed for the transition, despite the fact that the hospital has been planning on the “go live” date for several months. </span></div><div class="MsoListParagraph" style="margin-left: .25in; text-indent: -.25in;"><span style="font-family: Symbol; font-size: 12.0pt;">·<span style="font: 7.0pt "Times New Roman";">        </span></span><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt;">The entire hospital and all portions of the system will go live at once, referred to as the “big bang” approach, which has a very low rate of success, rather than implementing it in trial, pilot stages.</span></div><div class="MsoListParagraph" style="margin-left: .25in; text-indent: -.25in;"><span style="font-family: Symbol; font-size: 12.0pt;">·<span style="font: 7.0pt "Times New Roman";">        </span></span><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt;">They are utilizing the ‘super-user’ model which will pull nurses from direct-care so they can be available to teach, leaving several units without enough nurses to care for patients.</span></div><div class="MsoListParagraph" style="margin-left: .25in; text-indent: -.25in;"><span style="font-family: Symbol; font-size: 12.0pt;">·<span style="font: 7.0pt "Times New Roman";">        </span></span><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt;">The hospital refuses to decrease the number of elective procedures or provide additional staff during the transition time.</span></div><div class="MsoNormal"><br /></div><div class="MsoNormal"><b><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt;">Lack of training </span></b></div><div class="MsoListParagraph" style="margin-left: .25in; text-indent: -.25in;"><span style="font-family: Symbol; font-size: 12.0pt;">·<span style="font: 7.0pt "Times New Roman";">        </span></span><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt;">Some nurses have received only one day of training.</span></div><div class="MsoListParagraph" style="margin-left: .25in; text-indent: -.25in;"><span style="font-family: Symbol; font-size: 12.0pt;">·<span style="font: 7.0pt "Times New Roman";">        </span></span><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt;">Super-users have received no education or training in the system beyond what is provided to the other users. </span></div><div class="MsoListParagraph" style="margin-left: .25in;"><br /></div><div class="MsoNormal"><b><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt;">Design flaws</span></b></div><div class="MsoListParagraph" style="margin-left: .25in; text-indent: -.25in;"><span style="font-family: Symbol; font-size: 12.0pt;">·<span style="font: 7.0pt "Times New Roman";">        </span></span><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt;">Placement of the workstations are ill conceived—RNs must turn their back to patients while documenting. </span></div><div class="MsoListParagraph" style="margin-left: .25in; text-indent: -.25in;"><span style="font-family: Symbol; font-size: 12.0pt;">·<span style="font: 7.0pt "Times New Roman";">        </span></span><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt;">During one education session, the system crashed because 17 users at one time overloaded it.</span></div><div class="MsoNormal"><br /></div><div class="MsoNormal"><b><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt;">Failure to consult nurses</span></b></div><div class="MsoListParagraph" style="margin-left: .25in; text-indent: -.25in;"><span style="font-family: Symbol; font-size: 12.0pt;">·<span style="font: 7.0pt "Times New Roman";">        </span></span><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt;">Several concerns were brought to management’s attention which they were unable to answer. One example— how will RNs override the system in the event of an emergency? </span></div><div class="MsoListParagraph" style="margin-left: .25in;"><br /></div><div class="MsoNoSpacing"><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt;">Affinity is one of five hospitals in California, Ohio, and West Virginia that are part of one of the nation’s largest for-profit hospital chains, Tennessee-based Community Health Systems where affiliates of NNU are pursuing federal action for significant violations of RN rights. </span></div><div class="MsoNormal"><br /></div><div class="MsoNormal"><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt;">The National Labor Relations Board held a five-day hearing in May in a complaint filed by the nurses and NNOC over Affinity’s refusal to bargain a first contract and retaliation against RNs for advocating for their patients and their colleagues. A decision by an NLRB administrative law judge is pending. CHS affiliated hospitals in West Virginia and California are facing similar sanction from federal officials. At one of the California hospitals last week, a U.S. District Court judge issued an injunction ordering the hospital to return to negotiations with the RNs.</span></div><div class="MsoNormal"><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt;">CHS is the second largest for-profit hospital chain in the United States, and one of the wealthiest. Over the past five years, CHS reported over $1.5 billion in profits to the Securies Exchange Commission. </span></div><div class="MsoNormal"><br /></div><div class="MsoNormal"><br /></div><div class="MsoNormal"><span style="color: #1f497d; font-family: "Arial","sans-serif";">Michelle Mahon, RN </span></div><div class="MsoNormal"><span style="color: #1f497d; font-family: "Arial","sans-serif";">National Representative</span></div><div class="MsoNormal"><span style="color: #1f497d; font-family: "Arial","sans-serif";">National Nurses United</span></div><div class="MsoNormal"><span style="color: #1f497d; font-family: "Arial","sans-serif";">mmahon@nationalnursesunited.org</span></div><div class="MsoNormal"><span style="color: #1f497d; font-family: "Arial","sans-serif";">234-207-6706</span></div></blockquote><br />I believe the nurses should strike if their concerns are not heeded.<br /><br />I once worked in a highly-unionized city Transit Authority; I believe the unions would have shut the Authority down in the face of even a fraction of concerns like this that could impact pubic safety - and their own memberships' careers and lives.<br /><br />-- SS<br /><br /><b>6/20/13 addendum:</b><br /><br />I note that this EHR medical device (per FDA) is non-FDA approved, nor vetted by any regulatory agency.  Apparently the hospital believes it has the prerequisite skills and expertise to vet this device for safety.  Who, exactly, will take responsibility for bad outcomes?<br /><br /><div style="font-family: inherit;"><span style="font-size: 100%;">FDA's Chair of the Center for Device and Radiological Health, Jeffrey Shuren, MD JD, stated </span><span style="font-size: 100%;"><span style="font-size: 100%;">explicitly </span>that EHRs were medical devices on Feb. 25, 2010 (see testimony to the HHS Health Information Technology HIT Policy Committee at <a href="http://web.archive.org/web/20120320111030/http://healthit.hhs.gov/portal/server.pt/gateway/PTARGS_0_11673_910717_0_0_18/3Shuren_Testimony022510.pdf" target="_blank">this PDF</a>) that:</span></div><div style="font-family: inherit;"><span style="font-size: 100%;"><br /></span> </div><div dir="ltr" style="font-family: inherit;"><span style="font-size: 100%;"> </span></div><blockquote dir="ltr" style="font-family: inherit; margin-right: 0px;"><div dir="ltr"><span style="font-size: 100%;">... Under the <a href="http://www.fda.gov/regulatoryinformation/legislation/federalfooddrugandcosmeticactfdcact/default.htm">Federal, Food, Drug, and Cosmetic Act</a>, <b><span style="color: red; font-style: italic;">[that regulates all drug, medical devices, etc. in the United States - ed.]</span> HIT software is a medical device</b>. Currently, the FDA mandates that manufacturers of other types of software devices comply with the laws and regulations that apply to more traditional medical device firms. These products include devices that contain one or more software components, parts, or accessories (such as electrocardiographic (ECG) systems used to monitor patient activity), as well as devices that are composed solely of software (such as laboratory information management systems)... </span><span style="font-size: 100%;"><b>To date, FDA has largely refrained from enforcing our regulatory requirements with respect to HIT devices.</b></span></div></blockquote><br /><br />I also note that patient informed consent to its use in their care is likely not being sought.  Should it?  If not, why not?<br /><br />-- SS<br /><br /><b>9/2/2013 addendum</b><br /><br />The comment by "Anonymous August 20, 2013 at 11:24:00" has many characteristics of a sockpuppet (see <a href="http://hcrenewal.blogspot.com/2010/01/more-on-perversity-in-hit-world.html">http://hcrenewal.blogspot.com/2010/01/more-on-perversity-in-hit-world.html</a>) - ignoring everything written in the post and expressing perverse and deranged views.  See it, and my response, in the comment section.  A post about an anti-health IT union dispute such as this is a strong potential sockpuppet magnet.<br /><br />-- SS

Affinity RNs Call for Halt to Flawed Electronic Medical Records System Scheduled to Go Live Friday

At my May 30, 2013 post " Marin General Hospital's Nurses are Afraid a Defective EMR Implementation Will Harm or Kill Patients ....

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