Skip to content
  • About
  • Contact
  • Contribute
  • Book
  • Careers
  • Podcast
  • Recommended
  • Speaking
  • All
  • Physician
  • Practice
  • Policy
  • Finance
  • Conditions
  • .edu
  • Patient
  • Meds
  • Tech
  • Social
  • Video
    • All
    • Physician
    • Practice
    • Policy
    • Finance
    • Conditions
    • .edu
    • Patient
    • Meds
    • Tech
    • Social
    • Video
    • About
    • Contact
    • Contribute
    • Book
    • Careers
    • Podcast
    • Recommended
    • Speaking

Should electronic medical records be considered medical devices?

Wes Fisher, MD
Tech
May 4, 2012
Share
Tweet
Share

In our rush to establish a national electronic medical record (EMR) system as part of the American Recovery and Reinvestment Act of 2009, powerful silos of independent EMR systems have sprung up nationwide.  While most systems are being developed responsibly, like the Wild, Wild West, many have been developed without an objective eye toward quality and the potential  harm they may be causing our patients.

As most readers of this blog are aware, since 2005 the medical device industry in which I work has had widely publicized instances of patient deaths splashed all over the New York Times and other mainstream media outlets from defibrillator malfunctions that resulted in a just a few patient deaths.  The backlash in response to these deaths was significant: device registries were developed, software improvements to devices created, and billions of dollars in legal fees and damages paid to patients and their families on the path to improvement.  In addition, we also learned about the limits of corporate responsibility for these deaths thanks to legal precedent established by the Reigel vs. Medtronic case.

Should electronic medical records be considered medical devices?

This week I received a medical record from a large academic medical center somewhere in the United States (the details are unimportant) that has one of these new pioneering EMR systems manufactured by $13 billion-dollar company, Cerner Corporation.  Now before I go on a rant about Cerner’s EMR system, I should preface my remarks to say that I have never personally used Cerner’s system.  But I am a doctor who received a note composed on Cerner’s system and what I saw was one of the better examples of how EMR’s are contributing to misinformation and confusion when health care is delivered.

I received a copy of an internal medicine consult that was performed on a patient at this outside hospital.  I have extracted the “medications” portion of the internist’s note exactly as it was displayed in the note below (although the list extended over more than one page, so I joined the list together as one figure). Needless to say, I was terrified at what the system had listed as the patient’s medications:

In this example, we see multitudes of medications listed more than once.  We see drugs of similar classes (antihistamines, beta blockers) on the same list.  We see warfarin, one of our most dangerous drugs dispensed, without a dose included.  We see what seems to be outpatient meds listed with inpatient meds, I’m not sure.  Honestly, we really have no idea what medications are actually being taken from this list.  And yet this list of medications is listed by the EMR as the patient’s “Active Medications.”

What the heck have we created?

Certainly, any capable physician who cares for patients would describe this medication list as worthless.  So why is it in there?  (Don’t get me wrong, the fact that any doctor would allow such crap to be displayed in his or her medical note by using an EMR shortcut to enter them uncorrected is beyond me.  Certainly, we as doctors must accept a big portion of the responsibility for this).

But when EMR developers and their hospital administration customers purchase software capable of spewing forth completely useless AND potentially lethal information about our patients that is then transmitted far and wide, (not to mention to local direct caregivers) doctors have an obligation to speak up.

These kinds of documentation problems are the EMR’s Achilles’ heel.  But beyond this, EMR software updates are routinely deployed without real-world real-life testing.  Ever.  And yet, like patients with a defibrillator who die outside the hospital before a root cause of a defibrillator defect can be discovered, I acknowledge that it is  incredibly difficult to prove that the death of an individual was caused by an EMR software problem.

And yet, we must.

So how will we measure problems with EMRs?  It seems industry representatives would rather not address these concerns.  We should ask ourselves, is anyone thinking about this?

Right now, the prevailing belief is that the electronic medical record might be one of the most important medical devices doctors have at our disposal to care for patients.  I tend to agree.  But it’s potential to do harm is also enormous if it is not used responsibly and accurately.  After all, as the above example shows, the potential to introduce unintended yet potentially lethal errors into patient care is huge.  More importantly, since nearly every person in the United States will soon have their medical data housed within these systems, the number of people that could be adversely affected by these systems is much larger than what we’ve seen with our recent defibrillator malfunctions.

Perhaps, like the ICD registry, we should try to to develop an EMR registry of adverse patient outcomes caused by these software systems.  That way, every independent EMR company can learn from the other’s mistakes.  Because, guess what …

ADVERTISEMENT

… like other man-made medical devices, EMR’s are not perfect either.

Wes Fisher is a cardiologist who blogs at Dr. Wes.

Submit a guest post and be heard on social media’s leading physician voice.

Prev

How the Affordable Care Act combats preventable hospital infections

May 4, 2012 Kevin 17
…
Next

Is managed care worth the price of a life?

May 4, 2012 Kevin 14
…

Tagged as: Health IT, Public Health & Policy

Post navigation

< Previous Post
How the Affordable Care Act combats preventable hospital infections
Next Post >
Is managed care worth the price of a life?

ADVERTISEMENT

ADVERTISEMENT

ADVERTISEMENT

More by Wes Fisher, MD

  • How to help physicians end maintenance of certification nationwide

    Wes Fisher, MD
  • When patients tweet their own heart attacks

    Wes Fisher, MD
  • So you failed maintenance of certification. What now?

    Wes Fisher, MD

More in Tech

  • Key strategies for smooth EHR transitions in health care

    Sandra Johnson
  • Why flashy AI tools won’t fix health care without real infrastructure

    David Carmouche, MD
  • Why innovation in health care starts with bold thinking

    Miguel Villagra, MD
  • How self-improving AI systems are redefining intelligence and what it means for health care

    Harvey Castro, MD, MBA
  • How blockchain could rescue nursing home patients from deadly miscommunication

    Adwait Chafale
  • How AI is revolutionizing health care through real-world data

    Sujay Jadhav, MBA
  • Most Popular

  • Past Week

    • Why tracking cognitive load could save doctors and patients

      Hiba Fatima Hamid | Education
    • What the world must learn from the life and death of Hind Rajab

      Saba Qaiser, RN | Conditions
    • How medical culture hides burnout in plain sight

      Marco Benítez | Conditions
    • Why flashy AI tools won’t fix health care without real infrastructure

      David Carmouche, MD | Tech
    • How the 10th Apple Effect is stealing your joy in medicine

      Neil Baum, MD | Physician
    • Why Medicaid cuts should alarm every doctor

      Ilan Shapiro, MD | Policy
  • Past 6 Months

    • Why tracking cognitive load could save doctors and patients

      Hiba Fatima Hamid | Education
    • Make cognitive testing as routine as a blood pressure check

      Joshua Baker and James Jackson, PsyD | Conditions
    • The silent toll of ICE raids on U.S. patient care

      Carlin Lockwood | Policy
    • The broken health care system doesn’t have to break you

      Jessie Mahoney, MD | Physician
    • How dismantling DEI endangers the future of medical care

      Shashank Madhu and Christian Tallo | Education
    • How scales of justice saved a doctor-patient relationship

      Neil Baum, MD | Physician
  • Recent Posts

    • What led me from nurse practitioner to medical school

      Sarah White, APRN | Education
    • Why local cardiac CT scans could save your life

      Benjamin Cohen, MD | Conditions
    • Reassessing the impact of CDC’s opioid guidelines on chronic pain care [PODCAST]

      The Podcast by KevinMD | Podcast
    • Key strategies for smooth EHR transitions in health care

      Sandra Johnson | Tech
    • How proposed NIH budget cuts could derail Alzheimer’s research

      Tamer Hage, Tejas Sekhar, and Swapna Vaja | Conditions
    • Removing vaccine advisers could jeopardize lives

      J. Leonard Lichtenfeld, MD | Physician

Subscribe to KevinMD and never miss a story!

Get free updates delivered free to your inbox.


Find jobs at
Careers by KevinMD.com

Search thousands of physician, PA, NP, and CRNA jobs now.

Learn more

View 2 Comments >

Founded in 2004 by Kevin Pho, MD, KevinMD.com is the web’s leading platform where physicians, advanced practitioners, nurses, medical students, and patients share their insight and tell their stories.

Social

  • Like on Facebook
  • Follow on Twitter
  • Connect on Linkedin
  • Subscribe on Youtube
  • Instagram

ADVERTISEMENT

ADVERTISEMENT

ADVERTISEMENT

ADVERTISEMENT

  • Most Popular

  • Past Week

    • Why tracking cognitive load could save doctors and patients

      Hiba Fatima Hamid | Education
    • What the world must learn from the life and death of Hind Rajab

      Saba Qaiser, RN | Conditions
    • How medical culture hides burnout in plain sight

      Marco Benítez | Conditions
    • Why flashy AI tools won’t fix health care without real infrastructure

      David Carmouche, MD | Tech
    • How the 10th Apple Effect is stealing your joy in medicine

      Neil Baum, MD | Physician
    • Why Medicaid cuts should alarm every doctor

      Ilan Shapiro, MD | Policy
  • Past 6 Months

    • Why tracking cognitive load could save doctors and patients

      Hiba Fatima Hamid | Education
    • Make cognitive testing as routine as a blood pressure check

      Joshua Baker and James Jackson, PsyD | Conditions
    • The silent toll of ICE raids on U.S. patient care

      Carlin Lockwood | Policy
    • The broken health care system doesn’t have to break you

      Jessie Mahoney, MD | Physician
    • How dismantling DEI endangers the future of medical care

      Shashank Madhu and Christian Tallo | Education
    • How scales of justice saved a doctor-patient relationship

      Neil Baum, MD | Physician
  • Recent Posts

    • What led me from nurse practitioner to medical school

      Sarah White, APRN | Education
    • Why local cardiac CT scans could save your life

      Benjamin Cohen, MD | Conditions
    • Reassessing the impact of CDC’s opioid guidelines on chronic pain care [PODCAST]

      The Podcast by KevinMD | Podcast
    • Key strategies for smooth EHR transitions in health care

      Sandra Johnson | Tech
    • How proposed NIH budget cuts could derail Alzheimer’s research

      Tamer Hage, Tejas Sekhar, and Swapna Vaja | Conditions
    • Removing vaccine advisers could jeopardize lives

      J. Leonard Lichtenfeld, MD | Physician

MedPage Today Professional

An Everyday Health Property Medpage Today
  • Terms of Use | Disclaimer
  • Privacy Policy
  • DMCA Policy
All Content © KevinMD, LLC
Site by Outthink Group

Should electronic medical records be considered medical devices?
2 comments

Comments are moderated before they are published. Please read the comment policy.

Loading Comments...