Thursday, August 5, 2010

Are Electronic Health Records Medical Devices? Who Is Monitoring Their Safety?

I see it's been more than a year since I posted about Electronic Health Records (EHRs):

--so maybe it's time for an update. Those of you unsure what EHRs have to do with ethics and the pharmaceutical industry, please hang on for a second, and all shall be revealed.

This week's New England Journal of Medicine offers two perspectives on the EHR. David Blumenthal, the Obama administration's lead EHR advocate, and Marilyn Tavenner talk about "meaningful use" regulations for EHRs, while Surgeon General Regina Benjamin tells how she became an EHR believer after her rural clinic was first washed away by a hurricane and then burned down. Do these cheerleading articles tell us the full story about the EHR? I wish.

First you can consult a recent post on our friends, the Health Care Renewal blog:

"MedInformaticsMD" provides us with some telling clinical insights about what happens when a hospital or clinic buys EHR software off the shelf and then tries to go live with it with minimal time and effort devoted to staff preparation and training. He happened to be in the hospital with a sick relative when the prescription order-entry system "went live," and he observed at first hand the ensuing pandemonium, making careful note of the impact this could easily have had on the safety of the patients then hospitalized. None of them, he noted, gave their informed consent to be experimented on in this way; is that ethical, he asks?

MedInformaticsMD knew whereof he spoke because he had described in detail how his mother had suffered from a similar mishap-- but let him talk:

A newly-admitted patient who needed urgent heparinization did not receive the medication promptly. The patient's physician could not order it, as nursing had not yet "admitted" the patient and entered data such as weight. Physicians found no way to override, despite calls to the help desk, attempts by on site IT people and users from the parent hospital, etc. In the end, the pharmacist simply provided the med using a weight estimate despite no "official" order having been entered into CPOE.
This story sticks in my mind as it was due to disappearance of an anti-arrhythmic med on my mother's ED admission med list at the parent hospital, without any alerts that a medicine she'd been on for years was somehow removed as an 'active medication', that led to her needing heparin acutely. The iatrogenic need for heparinization then led to an iatrogenic cerebral hemorrhage and emergency craniotomy, followed by many complications.

So here is an anecdotal example of one patient (the author's mother) having a stroke caused by a screw-up in an EHR, and another patient being put at risk of a serious event, including a possible stroke, due to a screw-up in an EHR. Are these rare events? No, says the Huffington Post:

This little slide show illustrates how, despite an increased number of warnings from sensible and authoritative people about safety issues in EHRs, the political juggernaut to adopt EHRs universally presses forward, aided and abetted by a corporate lobby that is trying to ward off any significant government safety oversight.

What does this have to do with Pharma and ethics? Regular readers of this blog may be surprised that I'd be holding the pharmaceutical industry up as a paragon of virtue; but at least Pharma recognizes that at some level, it has a moral corporate responsibility to submit to appropriate oversight to make sure its products don't kill people. This level of understanding that human health is at stake here appears thus far to have escaped the software firms that now make up the EHR Industrial Complex.


Anonymous said...

I like your post. Tis a travesty that HIT devices are getting a pass from the rigors of regulation. The usability of these devices is poor. The defects are widespread. Patients are dying prematurely from errors associated with these devices. The best thing for the industry would be establishing the accountability which comes from getting a medical device approved.

Michael Kirsch, M.D. said...

Our office will transition to EMR later this month, with trepidation and anxiety. We are more concerned with mastering the mechanics and achieving some level of efficiency, than we are about safety concerns. The latter, particularly in hospitals, is unavoidable during the learning and implementation phases. Hopefully, this vulnerable phase will be brief. In addition, EMR promises to reduce many safety risks that exist in the conventional paper system. The potential advantages are obvious, but there will be a cost as well.

Anonymous said...

Basically It's a usually a computerized legal medical record created in an organization that delivers care,basically it's a tend to be a part of a local stand-alone health information system that allows storage, retrieval and manipulation of records.if we are talking about safety Some systems automatically monitor clinical events, by analyzing patient data from an Electronic Health Record to predict.

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