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 …
… like other man-made medical devices, EMR’s are not perfect either.
By Dr. Westby G. Fisher
Dr. Westby G. Fisher is a cardiologist at NorthShore University HealthSystem who writes regularly at Dr. Wes.Visit website | More posts by Author
Given the potential for lethal harm and the number of "junk" programs, EHRs should definitely be regulated as Class III medical devices - and Human Factors engineering should be an absolute requirement of the system development. HFE would probably eliminate the "configuration error" described by Mr. Voran. Yeah, yeah, we've heard it a million times, ...the certification process is so brutal, expensive and time consuming. Try working with some of these programs, they are hedious.
Classifying EMRs as a medical device would not be advisable for reasons stated previously. HOWEVER, EMR products should be subject to controls and regulatory oversight to ensure that public safety is not compromised but lousy software development practices. EMRs is fast becoming safety critical as Dr. Fisher's story clearly relates. The clear issue Dr. Fisher highlights is the need for controls ensuring public safety regardless of whether EMRs should be classified as a medical devices, or subject to 21 CFR Part 11, or UL 1998, or some additional standard designed to ensure that these kinds of software companies meet an evidentiary standard for maintaining practices which uphold public safety. I would advice EMR companies to get together and establish their own best practices, evidentiary standards, and regulating body before the Federal Government does it for them.
KLAS is an organization that's doing good work tracking customer feedback and tracking issues and rating EMR/EHR software: Their website is here: http://www.klasresearch.com/ I aggree with David's points and would add that EMRs are about a hundred times more complex than any single medical device and the desire of hospitals and clinics and specialists and individual providers to customize the build of the EMR system they buy makes it impossible to define the EMR in a way that would be amenable to treating it as a medical device.
This suggestion would be disastrous. The huge additional cost and delay that would impose in getting all of the 1,000 or so EMRs certified as medical devices would eliminate all of the best, small vendors and prevent just about any EMR vendor from improving their product until those improvements were certified. Couldn't agree more about the junk that EMRs spit out. In the case above whoever chose to print that report selected all medications including discontinued ones and reflects a configuration error by not selecting only current and active medications. Warfarin is tricky as the dosages are often adjusted weekly and sometimes managed by the patients. You're going to get the same issue with insulin as the current dosage of one or more of the products prescribed are mixed and changed frequently. Having yet figured out a good way to get this out of our system either but more often than not I see people not even taking the time to document the current warfarin dosing schedule. But back to the original pretext. Be very careful of what you ask. The medical device approach is paralyzing the mobile devices to record heart tones, ultrasounds, etc. in the sleeves that can fit over an iPhone or other smart phone. As a result they will probably be released as consumer products since the certification process is so brutal, expensive and time consuming.