Sunday, July 24, 2011 and "The National Database of EHR Errors Being Called For" - Where's the Beef?

At my Nov. 2011 posts on a new entity called "" that is supposed to be a health IT industry watchdog, I expressed various forms of skepticism. See my Nov. 2010 posts at the following HC Renewal links:

November 15, 2010
: Web Site to Collect EHR Safety Reports

November 16, 2010: EHRevent: survey amateurism, bias, or something else?

November 17, 2010: Some answers about new site "" for health IT and drug adverse event reporting

November 22, 2010: CEO Edward Fotsch MD: The Real Challenge with EHRs is -- User Error?

Now, approximately eight months later, I read this in the July 2011 EHREvent newsletter at this link, written by Michael Victoroff, MD, Editor in Chief:

... The media has drawn our attention to the case of Genesis Burkett, a newborn who recently died in a Chicago hospital when an order for intravenous fluids was incorrectly transcribed by a pharmacy technician. Some journalists have characterized this a “computer error” because the ordering physician entered the order (correctly) into an electronic system, and the pharmacy tech re-entered the order (incorrectly) into an automated compounding machine. [If so, perhaps one should wonder how mission hostile - see link - the user experience of that compounding machine might have been, which could have contributed to or caused the error - ed.]

Moreover, a decision support system that should have alerted at the mistake had been disabled. [Disabled by whom, exactly, and why? Perhaps because it, too, was ill conceived and user hostile? - ed.]

This case has been invoked as a warning about hazards of automation. Calls have been made for “mandatory reporting of adverse events related to HIT to a national database.”

Uh, hello? is exactly the “national database” being called for. It is a fully accredited, federal Patient Safety Organization and part of an AHRQ network of error-reporting entities. Reports to are fully confidential, and data that is collected is reportable only in de-identified or collective form.

("Uh, hello?" he writes?)

Uh, hello, Dr. Victoroff ... As in the old Wendy's commercial:

Where's the beef?

Where's the beef???

A search of the website shows no accessible, searchable database that I can find.

If someone knows of such a publicly accessible database at least remotely similar to the FDA's MAUDE (Manufacturer and User Facility Device Experience) database at this link, please let me know.

The best I can find on a Google search on "EHRevent database" is a page of legalese containing these statements:

2.1 PDR Secure will develop a Patient Safety Evaluation System (“PSES”) for the collection, management, and analysis of information received from and/or reported to participating providers, to be accessed through a PDR Secure web portal [but, apparently, not public dissemination, and based on this language it seems dubious that even "participating providers" will get a complete, searchable corpus of reports - ed.]

... 2.4 PDR Secure will assemble a knowledgeable workforce, and in collaboration with its workforce (which may consist of employees, contractors, volunteers, representatives of participating providers and other Patient Safety Organizations, and other individuals as appropriate to the involved Patient Safety Activity), will develop and conduct Patient Safety Activities, including but not limited to data collection, appropriate studies, evaluative activities, reports, and recommendations, including, where feasible, “best practices” recommendations; and will offer the results to participating providers. [In other words, we disseminate what we think is relevant - ed.]

Examples of what the public can find - for free and at will - on the FDA MAUDE site are at the posts here:

January 21, 2011: HC Renewal - MAUDE and HIT Risks: What in God's Name is Going on Here?

Drexel Health IT website
Real-World, Though Limited, Examples of Healthcare IT Malfunction From the FDA MAUDE Database

Drexel Health IT website
FDA MAUDE DATABASE: Patient outcome = death

Unless I am missing some MAUDE analog at, a claim that " is exactly the national database [on EHR medical device problems, dangers, harms etc. - ed.] being called for" raises some questions:

  • Called for by whom: patients and their advocates, or, an industry interested in secrecy and turf protection?
  • If the public does not have unfettered, searchable access to the set of de-identified case reports being submitted to EHRevent, as they do to FDA's MAUDE and other public databases, how can the public know their publications are complete, unbiased, and not selectively preferential towards certain HIT vendors and/or user organizations?
  • Is EHRevent's model based on the watchdog's opinions of what's important for the public to know, or will it allow the public to make its own informed choices?
  • Will EHRevent publicly demand the recall of EHR medical devices repeatedly reported to them to be harmful, as would the FDA or other governmental regulators regarding dangerous products?
At present, the answers to these questions raise little confidence in me that is "the national database" being called for by true watchdogs, e.g., those truly interested in ensuring the safest, most effective EHR medical devices, and the weeding out of dangerous and deficient EHR medical devices.

I'm going to go a step further.

I am making the following request: that make available online, in a de-identified (as to people and organization) and searchable format the event reports about the EHR medical devices they receive.

Finally, regarding infant mortality related to health IT, perhaps Dr. Victoroff should read cases #2 and #3 at the post "Babies' deaths spotlight safety risks linked to computerized systems" at this link.

-- SS


Anonymous said...

With all due respect for the good doctor Victoroff, I can see why he is bleakin mad that EHREvent was ignored in the Chicago Trib and Los AngelesTimes reports about the Baby Burkett fiasco.

On the other hand, his organization is ignored because it is hardly a neutral site to which to report the near misses, injuries, and deaths due to HIT devices. Witness his statement: "Computerized Physician Order Entry (CPOE) systems have been shown both to reduce errors, and also to induce some. On balance, like most medical devices, they produce both good and harm, with the balance heavily on the side of benefit."

"...with the the balance heavily on the side of benefit".

There is not any data to support this HIT vendor favorable bias that was not sponsored by the vendors themselves and their trade group, HIMSS.

Additionally, the elves (his expression) tell me that his reporting is casual and shallow, considering the deaths of patients who died because of HIT, and who would not have died if their care was guided by pre CPOE work flows.

Thus, all readers ought to continue to report the adverse events associated with HIT, EHR, CPOE, CDS (decision support) to the MedWatch, on line.

I agree with the journalists.

Ignore EHREvent until there is beef.

InformaticsMD said...

Anonymous July 24, 2011 7:47:00 PM ED wrote:

On balance, like most medical devices, they produce both good and harm, with the balance heavily on the side of benefit."

In making claims like this, he ignores a growing corpus of literature by reputable sources (such as at the 'reading list' here) that state otherwise.

Even ONC had to really torture the numbers to try to claim modest gains from HIT (see my Mar 2011 post "ONC: The Benefits Of Health Information Technology: A Review Of The Recent Literature Shows Predominantly Positive Results").

IMO such claims that "the balance *IS* heavily on the side of benefit" (as opposed to, for example, "may be" or "hopefully are, but more study is needed") are not neutral, or science.

They're marketing.

-- SS

Anonymous said...

It behooves Dr. Victoroff to read MAUDE of the FDA.

There are already reports there similar to the Burkett case (the same CPOE vendor), in which the CPOE system of devices confusingly alters (elves) the detail of the doctors' ordering screens for view by recipients, whether they be nurses or pharmacists.

The reality of what was ordered is obfuscated by the device. The devices can not be trusted.

There is not any scrutiny for safety, efficacy, and usability, yet Dr. Victoroff likes them thinking they are safe. When did he last use one on patients?

The gibberish laden screens confuse the user, causing injury and death.

Until we see and evaluate the doctors' order screen shot and that which the pharmacy saw, the technician remains as much a victim as the patient.

Hey, Dr. V, post them for all to see. Make your organization fit for purpose, cause right now, it merely legitimizes the industry, and does nothing to protect patients.

Live IT or live with IT said...

Until ehrevent makes its database available, it has no credibility, indeed rather smells like an industry facade.

Let us see Dr. V!