November 15, 2010: EHRevent.org: 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 "EHRevent.org" for health IT and drug adverse event reporting
November 22, 2010: EHRevent.org 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? www.EHRevent.org 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 EHRevent.org 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?
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 EHRevent.org, a claim that "EHRevent.org 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?
I'm going to go a step further.
I am making the following request: that EHRevent.org 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.