Do EHRs Kill People?

Do EHRs Kill People?


Back in the times when EHRs were just EMRs, they had a very simple and humble mission. The software was supposed to help providers of health care services better manage their business. EMRs were supposed to help physicians adhere to CMS documentation rules, automate patient flow management and get rid of all the mountains of paper floating around a typical medical office or hospital. It was assumed that EMR software will increase reimbursement rates, streamline workflow and even make the doctor more efficient. After all, every other industry that switched to computerized business management realized bottom line improvements.

Along the way, bolder statements started appearing, mainly from EMR vendors trying to sell their wares. EMRs could also reduce medical errors. The most common argument was for the benefits of replacing the notoriously illegible physician hand writing. Prescription errors would be reduced if only pharmacists and nurses could get a nice legible script. Then came the frequently misplaced paper charts. If the chart resides in the computer, it cannot be misplaced, it is always available to all and it is complete. All the information you need right at your fingertips, regardless of your physical location. It could save lives or at the very least, it could save time. The EMR was nothing more than an electronic chart. One vendor went so far as to create a computerized image of a yellow manila folder with tabbed pockets for various items in the electronic chart.

Nobody thought the electronic chart needed to be regulated by the FDA any more than the paper chart was. After all, the EMR was not providing medical care; it was just a more effective place to record administered care. Or was it? There is a funny thing about computers. They have a mind of their own, a mind created by programmers, a mind which makes them interactive. A paper chart is passive. If you want to see all lab results in a paper chart, you have to decide where to look and actively flip the pages. If you missed one page, it’s your omission, not the chart’s mistake. If you want to see all lab results in an EMR, you click a button and the software does all the paging returning a convenient list for you to look at. If the software missed a page, it’s the software’s fault, not yours. The software is controlling what you see and how you see it. This small fact renders the electronic chart a full partner in delivering health care; it is now a medical instrument.

And then the EMR grew up and became an EHR. The EHR performs tasks for you, like calculating dosage for medications or just simple BMI. The more advanced EHRs presume to give you advice on what to order for a certain condition, or what not to order based on what it knows about your patient. There are EHRs now, and there will be more in the future, which communicate with other software and automatically, bring in medical data and place it in the chart. This sophisticated software makes decisions regarding patient identities and about schedules for preventive care and disease management. Computers are not infallible. Their mistakes are called “bugs” or “software glitches” and just like the nurse or the medical records clerk sometimes placed the wrong piece of paper in the chart, EHRs can, and do, corrupt medical records. Incorrect, incomplete and indecipherable medical records can lead to injury and even death. But does it really happen?

Do EHRs actually kill people?

The Huffington Post has been investigating this exact question. Between January 2008 and February 2010, the Huffington Post identified 237 reports in the voluntary incident reporting FDA database related to HIT, including 6 deaths and 43 injuries. However, a closer looks reveals that only a small fraction of these reports are actually related to EHRs per se. Most reports involve PACS, medication dispensing systems, blood banks and other FDA regulated equipment. Out of the 6 reported deaths (2 of which occurred in 2006), one was related to a PACS system latency, another to human error in labeling an x-ray cassette and another to a hospital pharmacy system. 2 deaths were attributed to system wide failures of CPOE and one to lack of intuitiveness in display of notes. As to injuries, out of the 43 reported, I could only count 17 directly related to EHR software and most have to do with CPOE.

Is this the tip of the iceberg, as some contend? Are there many more unreported deaths caused by EHR software? There may be, but frankly, the evidence of massive numbers of adverse events is not there. It does, however, stand to reason that voluntary reporting would be incomplete and the fact that only a couple of EHR vendors are represented in the FDA database is suspicious to say the least. On the Health Care Renewal blog they are engaging in what I think they know are rather creative mathematics, to project hundreds of thousands of injuries per year if, and when, EHR adoption really takes off.

If EHRs become as pervasive in everyday medicine as ONC is proposing, every patient will eventually be touched by an EHR.  It is very likely, that some errors will be prevented by the sheer existence of an EHR, but new and unfamiliar errors will also be introduced as side effects. Of course, the potential benefits must be shown to significantly outweigh the hazards, and we already have accepted mechanisms for such assessments.

While ONC is exploring collaboration with the FDA, and the FDA seems willing to engage, the customary counterargument is that FDA processes will stifle innovation and make EHRs unaffordable. There is validity to such arguments, but as long as money seems to be no object for HITECH, maybe we can spend some of it on devising reasonable and affordable methods of testing patient safety, both pre- and post-market. Innovation will take care of itself and the alternative is unconscionable.

Margalit Gur-Arie blogs frequently at her website, On Healthcare Technology. She was COO at GenesysMD (Purkinje), an HIT company focusing on web based EHR/PMS and billing services for physicians. Prior to GenesysMD, Margalit was Director of Product Management at Essence/Purkinje and HIT Consultant for SSM Healthcare, a large non-profit hospital organization.

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63 Comments on "Do EHRs Kill People?"


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Jun 26, 2010

You may be interested in this related post on eMRs and FDA regulation
Dave Marcinko


Great post. Glitches and bugs in software will always exist. There is no way around it. The nice thing about software is that once a bug is discovered it is just a one time fix. Once the bug is fixed, that particular bug “should” never occur in the future.
That cannot be said about human error. Sure if you’ve made an error in past, you’ll be less likely to repeat that same error in future, however you can be guaranteed to never repeat that error.
Computers are logical and follow a specific set of instructions and will always perform the same task given the same input. Humans are less logical than that thus raising the margin for errors.

Jun 15, 2010

tsuris, she may have blurted that off the record and I cannot blame her. It’s not usability per se that we need to certify. It’s patient safety that needs to be looked at first and foremost.

Jun 14, 2010

Yes , yes. The words ring true. This is what its come to : an electronic healthcare circus complete with Doctors rationalizing death by the megabyte, Clancey the Clown in a cheerleader outfit and vendors serving cocktails. Hello Earth, are you there, is everyone brain dead?

Jun 14, 2010

Marg, HIStalk reported that about Judy F, from his usually reliable sources.
You are insightful__”I don’t see why out of all HIT products EHRs are the only ones that cannot stand scrutiny.”
I would add that CPOE evaded assessment of safety and efficacy. This has highly dangerous ramifications.
The HIT vendor community schemed the regulatory avoidance strategy for years, and recruited academicians (see earlier comment by someone about Tang) to whore for them, as long as their departments and “education societies” got industry funds. Some truly liked the kool aid, produced it and served it.
To wit, the Miller Gardner paper of circa 1998. There was never any self scrutiny which the authors assured. The Tang prsentation mentioned earlier is another example. He was not conflicted at all, now was he then and is he now??
Sham scrutiny evolved to seduce government officials. They did not vet the c$hit certification (was and still is a sham) and HIMSS infiltrated the government with shills.
With direct lines to the White House and Congress, this white collar crime syndicate has been successful at accessing $ billions of taxpayers’ dollars. The crap they are selling is scandalous. Does anyone recall Teapot Dome?

Jun 14, 2010

Not Exactly Death,
I have listened to most of ONC committee meetings, and I don’t have a recollection of Ms. Faulkner ever saying such thing on record. Maybe somewhere in a hallway or by the water cooler.
In any case I don’t think attaching “usability” to certification of EHRs will even begin to address the problem discussed here. EPIC got 5 stars usability ratings from CCHIT very recently and so did most vendors that applied (see my previous post here on EHR Usability – ).
Usability is just one factor affecting patient safety and it cannot easily be “tested” in a couple of hours. Pre and post market lengthy observations would be much better, and a place to report adverse events is a must. If drug manufacturers and other HIT product vendors can live with such constraints, I don’t see why out of all HIT products EHRs are the only ones that cannot stand scrutiny.

Not Exactly Death
Jun 14, 2010

Not exactly death. Your blog readers could be the judge:
It seems to me that this is an experiment by the vendors, partner hospitals, and HIMSS for which the patients and physicians have not signed consent.
There is not a place to report adversity. There are “do not disclose” requirements according to Koppel and Kreda (JAMA).
There are intimidating and bullying coercion tactics by hospital administrators. There is sham legitimacy given by HIMSS’ CCHIT non profit in the form of a “certifiacte”. What gives?

Jun 13, 2010

I have an answer for all of your questions. Haha, its another question.
Why not let HIMSS decide everything for all of us. After all they control so many seats in government with all of there quartering soldiers on the ground and careful eyes on every aspect of the stakeholder battlefield that MAY AFFECT their stakeholder interests, the Electronic Health Records Association. The current situation is much like the movie “IRobot”. For all the help the AMA has given us on the issue, get real people! The Docs hide in closets afraid to speak while playing their favorite game – Who wants to be a millionaire? That game starts in pre-med and should be re-named ” the mushroom that wants to become a millionaire”. Let the rain fall. The mushrooms need a nice dark, moist environment and lots of crap.

Jun 13, 2010

uh-oh, I don’t think we can know if this is the tip of the iceberg or half of the iceberg. Obviously this is not the entire iceberg and it would behoove us to have a mandatory reporting system.
Of course, such reporting would expose hospitals to law suits that were not contemplated before. I am not sure what the solution should be.
The case in the article could have probably happened on paper too, even though I must say that it is less likely to make such error if you just write it down as opposed to typing 1.25, selecting units, and then selecting a frequency from a very long dropdown. Sometimes you think you selected one thing, but if your cursor was a bit lower or higher, you end up with a different selection, and unless you have the luxury of time to go back and recheck, you won’t really know you made a mistake. I don’t know if this is what happened there, but it is a very likely scenario.

May 26, 2011

I teach, install, and program EHR and I am more concerned about providers who document that they did a procedure, such as a rectal exam when it fact it was not done. Like the old axiom, “to err is human, to really mess up requires a computer”……I just don’t see it. The benefits far far far outnumber the problems.

Jun 13, 2010

Dear Margalit,
Dr. Shuren, CDRH Director, stated that the reports on the MAUDE site are the “tip of the iceberg”. Those reports are being sent to MedWatch even though there has not been a formal request or notification to physicians and nurses that adverse events from and dysfunction of CPOE devices and EHRs are to be reported to the FDA.
At present, there is NOT anyplace to report the adversity (to the delight of the vendors and hospitals with whom they partner).
Going further, this is amplified by threats, direct or implied, of reprimand for “disruptive behavior”, to potential health care workers who report HIT injuries and deaths to any agency outside of the hospital.
Just noticed this:
Were there malfunctioning computerized dose checking devices, other electronic instruments involved with ordering, or merely cognitively confused (by the pages of computer gibberish) or decorticated over worked health care workers?
Uh Oh!

Jun 13, 2010

This should have been reported to the FDA database. I don’t see why it wasn’t since it is already in the public domain.
Perhaps “voluntary” reporting for public good is not enough of an incentive, and perhaps, as Dr. Luzerne writes above, this is not specific to HIT issues.

Jun 13, 2010

It takes time to enter data. My hospital EHR boatanchor has every little thing documented by even nursing assistants, such as “patient given water”. The nurses enter everything by check box with short little meaningless notes. When I ask for a piece of information that I specifically requested be gathered the response to me is “I put it in the computer”.
I have to find it!!
Time at the keyboard is time not taking care of anyone, whether by me or by a nurse.
EHR has transformed what it means (to the hospital admin) what it even means to be a good nurse.
Our average length of stay in the ED increase by a full hour when we turned on the boat anchor. The graph was breathtaking. It has been more than a year now, so the transition has aged out of annual graphic presentations.
People sit in the waiting room longer.
Of course not all the data is correct. But it is forever.
Doctors do not document in real time. To try to do so is foolhardy, dangerous and impossible.
Nurses are documenting in real time. This means less care per hour and more garbage per hour. The nurse is on the lookout for punctuation errors more than a change in the patient.
Do I really have to answer the question directly? Of course these devices are killing patients.
The cost of care will climb like a homesick angel just to cover the decreased capacity of care available per unit of time and the value will be greatly decreased.