Do EHRs Kill People?

Do EHRs Kill People?

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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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bev M.D.
Jun 11, 2010

What a great post, Margalit. And fair warning to all those who post here that EHR’s kill people – if you have seen that happen, then report it! Or you will get the kind of unsupportive data shown here. Medicine no longer is run by anecdote.
I was also unaware of your link, which at least shows the FDA is considering it. It would be a massive job and require more staffing, no doubt.
I would like to add, however, the factor of injuries/deaths caused during the implementation of an EHR, particularly a difficult or failed one (all of us have examples of that). When my hospitals implemented our new lab system some years ago and it initially failed (due to our own mistakes as well as the vendor’s), I am positive that we killed some people during that time – but it was way too chaotic to identify and report individual cases. The FDA can’t regulate poor planning and implementation, unfortunately. I think enough bad things have happened that hospitals are getting wise now in terms of implementation, but it is still an issue. Doctors’ offices beware – you need a real, specific plan.

Guest
Anon
Jun 11, 2010

“Does surgery kill people?”
Why, yes, it sometimes does.
But medicine is much better off for having it.
Same with EHRs.

Guest
Jun 11, 2010

See “FINDING A CURE: THE CASE FOR REGULATION AND OVERSIGHT OF ELECTRONIC HEALTH RECORD SYSTEMS”
http://jolt.law.harvard.edu/articles/pdf/v22/22HarvJLTech103.pdf
Sharona Hoffman and Andy Podgurski looked at the case for FDA regulation of EHRs, and decided it was not viable. They argued that either CMS do it, or that a new federal regulatory entity be established. The latter would be a very tough sell politically, and would take too long to get up to speed.
Tough issue.

Guest
John
Jun 11, 2010

After a dozen plus years working in health information technology, I have yet to see any vendor or any hospital thoroughly test an EMR. I doubt this experience is unique to me.

Guest
Anon
Jun 11, 2010

Do EHRs kill people? Of course they do! The question is do EHRs kill more people than no EHR. How do you write this post without mentioning the increased mortality seen at Childrens Hospital of Pittsburg after EHR implementation? And not a small increase – from 2.8% to 6.6%. Until more hospitals report their data, I will conclude that EHRs kill more people than no EHR.

Guest
Jun 11, 2010

Anon (second Anon), the Pittsburgh study was done in 2005 after a hospital wide CPOE system was installed in 6 days (?!). That’s a long time ago. For every Pittsburgh style study there is a Stanford style study, this one much more recent – 2010), showing contradictory results, i.e. CPOE decreased mortality.
Personally, I don’t have much confidence in either one, since the results cannot be directly linked to the CPOE system while completely eliminating all other factors. This is particularly true for increased mortality rates with no individual CPOE errors reported, or at least documented.
The point here is that research needs to be done and regulatory bodies, whether FDA or CMS or something new, as BobbyG points out, need to be involved on some level.
And Anon 1, instruments and devices used in surgery are regulated.
Pittsburgh Study – http://pediatrics.aappublications.org/cgi/content/abstract/peds.2009-3271v1
Stanford Study – http://pediatrics.aappublications.org/cgi/content/abstract/peds.2009-3271v1

Guest
Jun 11, 2010

Sorry, wrong link for Pittsburgh.
Here is the correct one: http://pediatrics.aappublications.org/cgi/content/abstract/116/6/1506

Guest
Robert Forster
Jun 11, 2010

Great article Margalit. I have an itch that does not go away with scratching. I ask, does a box (check list) format for physicians seeing elder or complex patients with more than 1 disease improve or hinder quality physician decision making. Being an old internist I am biased that guidelines can be great for single disease persons/events. Yet almost non relevant when other diseases are present, e.g. CHF, and renal insufficiency. The integration of complex diseases is the essesence of problem solving–yet a check the box format may hinder that inguizitive/intuitive physician thinking process. Last time I saw my doc he spent 8 minutes looking at the computer (making sure each box was checked=I call “euboxic”) and 1 minute at me. I guess non verbal clues are no longer important (we know that is not true). So, EMRs/EHRs will have some unintented consequences-not all good in my mind. Maybe it is just the transition–but I miss and now appreciate the physician/patient visual exchange and relationship. RobMD

Guest
Jun 11, 2010

@Robert Forster –
I hear you. Let me re-post a comment I made the other day on another blog:
___
“I would just observe that, absent significant payment reform (I won’t be holding my breath), there’s a very real problematic barrier to effective EHR use if we don’t change the basic paradigm. For example, fundamental to the concept of the “patient-centered medical home” trial initiatives now getting underway is the argument that primary care docs should properly be seeing no more than 8-10 patients per day (e.g., think about the typical hour attorney consult visit), that the customary 25-30 pts/day is driven by the need to bill, to keep the doors open; that roughly half of outpatient visits are of marginal to nil clinical value.
I and one of my REC colleagues did a clinic assessment visit the other day. We interviewed 4 docs, one of whom was a severe “Dr. NO!” on the topic of HIT. His beef was basically a “productivity loss” complaint, i.e. that seeing mostly older, complex problem list pts (he’s Internal Med) made it nigh impossible to effectively chart electronically within the scheduling constraint.
Now, perhaps with a lighter, more rational daily patient load (and more extensive EHR training) he might come around and truly “adopt.”
I consulted with an attorney a couple of years ago regarding legal guardianship over my dementia-addled (now late) Dad. The initial hour cost me $300. The entire deal ended up costing about $4,000.
A physician, however, is supposed to take in myriad data and make a comparably expert decision in 15-30 minutes — and hope he/she can eventually get reimbursed a relative pittance.
It’s crazy.
So, OK, where are we? We’re facing a current and projected shortage of perhaps 40-50,000 primary care docs, and under PCMH theory we propose to cut their pt volumes in HALF or more so they can provide better care? All while bringing tens of millions of the previously uninsured into the (non-ER) system under Obamacare reform.
Right.
I don’t have a good answer for the skeptical docs who argue that the EMR gold rush is more about billing imperatives and vendor welfare, that the docs’ pt care-analytic needs are a distant 3rd at best.
It’s a vexing circumstance.”
___
Absent a coherent, comprehensive systems view, we can just expect more pain and frustration and failure.

Guest
James
Jun 11, 2010

Ambulance crashes kill patients every year:
http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5208a3.htm
However, the alternative of not using ambulances for emergency transit is clearly one that results in more fatalities.
We are told repeatedly that the status quo of medicine (IOM Report most frequently cited) is 100,000 preventable deaths a year. This is occuring under our largely paper-based world.

Guest
Jun 11, 2010

It seems that although there may be significant growing pains with EHR the current system is not the answer. It seems we must move forward as quickly as possible.

Guest
Jun 11, 2010

Yes James, ambulances kill people and cars in general do too and airplanes and trains and faulty surgery and diagnostic equipment as well.
But all these things are tested for safety and are under the supervision of regulatory bodies. There will always be accidents even with the best regulated systems. However, as your article clearly indicates, one hopes that safety regulations significantly decrease the likelihood of such accidents. Why should we take a different and completely unsupervised approach with EHRs?
At the very least we should have some post market research done and if it shows that there are no significant hazards associated with HIT then we will know that nothing needs to be done. We don’t have such research.
bev brings up a very important aspect as well. The biggest danger is probably during implementation. Maybe, at the very least, there should be some best practice guide lines on how to introduce HIT safely.

Guest
bev M.D.
Jun 11, 2010

BobbyG;
I have tried on 3 different computers to access the article you cited, and can’t get in. I can’t even access the jolt.law.harvard.edu site at all. Is anyone else having this problem? I’d really like to read the article. Why did they say the FDA was not a viable choice?

Guest
rbar
Jun 11, 2010

Interesting discussion that omits one point: there is great effort going into implementation of EHR – is that a worthwhile effort? I believe it is, at least in large institutions (for instance, academic system or large MSG; probably the biggest bang for the buck is at the VA that has a nationwide system, although my knowledge is limited as I did not work there since residency). A randomized will never happen (and I am not sure whether it was feasible at all, or its results generizable).
The biggest problem I see is drowning in poorly managed data, a problem that will obviously increase over the years. For instance, problem lists that, for the same patient, contain duplications like osteoarthritis, DJD, joint pain, knee arthritis, joint pain. Or records that list 120 notes for a given patient, but the highly valuable ones (e.g. 1st time consultation) are hard to separate from the insubstantial ones (pt calls and asks for off work note). Some systems are doing better with regards to the latter then others.

Guest
e-dollar Bill
Jun 11, 2010

Don’t criticize the FDA MAUDE database. The injuries and deaths are real. Doctors and others should be reporting. They experience retaliation if they do. Health Care Renewal estimates are representative. The HIT industry has used HIMSS and C$HIT to deceive the Executive and Legislative Branches of the US Government.