Wednesday, June 9, 2010

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.

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