Real-World, Though Limited, Examples of Healthcare IT Malfunction From the FDA MAUDE Database
IT such as electronic medical records (EMR/EHR) and computerized physician order
entry (CPOE) systems are a perfected, safe technology, one might think, from
the almost hagiographic and entirely uncritical P.R. about HIT, all the way up
to the President of the
Paraphrasing Capt. Chesley Sullenberger in a recent WSJ article, however, I'm a long term optimist about HIT, but a short term realist. Healthcare cannot be 'transformed' by a technology that itself has major problems and needs transformation. These issues should have been substantially remediated before forced national rollouts, I feel.
That's especially true given the inherent dangers in medicine. You can't be a wishful thinker. You have to know what you know, and perhaps more importantly in medicine, what you don't know (this is especially true both for those in IT who lack formal clinical or biomedical backgrounds, and for those in medicine who lack formal biomedical informatics or computer science backgrounds). You also need to know what your tools can and can't do. Sticking one's head in the sand is no way to approach HIT.
That said, here are some sample voluntary reports on HIT malfunctions from just one vendor, taken from the FDA Medical Devices database, the Manufacturer and User Facility Device Experience (MAUDE) database, links included. These are production systems used on real, live patients, not prototypes:
MAUDE data represents reports of adverse events involving medical devices. The data consists of voluntary reports since June 1993, user facility reports since 1991, distributor reports since 1993, and manufacturer reports since August 1996. MAUDE may not include reports made according to exemptions, variances, or alternative reporting requirements granted under 21 CFR 803.19.
Emphases below are mine. My comments are in [red italic].
Cerner Millennium RadNet Auto Launch Study and Auto Launch Report software functionalities. Defects in the Auto Launch functionality make it possible for a mismatch of patient data. [That is, in radiology reports. The dangers of transpositions is obvious.]
The issue involves powerchart local access medication administration task, used when certain cerner millennium solutions are not available. At powerchart local access sites that utilize coordinated universal time (utc) functionality, medication administration tasks might be displayed with incorrect times. When a pt download occurs from cerner millennium servers to powerchart local access, and there is no cerner millennium application session active, powerchart local access adds or subtracts the number of hours equal to the time zone difference from greenwich mean time. Scheduled medication administration tasks may show an incorrect administration time and the possibility exists for a pt to receive medications earlier or later than intended. [As just one example of the dangers with this type of defect, an elderly patient with sepsis might get an early dose of aminoglycoside, causing peak levels to rise to nephrotoxic and ototoxic levels - ed.]
Patient care delay. The issue involves functionality in cerner millennium powerchart office and powerchart core and affects users that utilize the powerchart inbox and message center inbox. In results to endorse or sign and review, if the user clicks ok and next multiple times in quick succession [e.g., a busy clinician with sick patients, waiting for the computer to respond - ed.] while attempting to sign a result or a document, the display could lag behind the system's processing of the action [that is to say, the human-programmed and supposedly tested and validated computer "system" -ed.], and multiple results or documents could be signed without the user's review. In message center, when clicking ok and next or accept and next, or when deleting or completing messages and moving to the next task, a document could be signed or a message could be deleted without the user's review. Results could be endorsed or documents could be signed without physician review, which could impact patient care. Cerner received communication that a patient's follow-up care was delayed as a result of this issue. [Luck prevailed that no injury occurred - in this reported case. One wonders if that is true of all the users who experienced this problem. Also, I do not recall such errors happening on paper order forms due to, say, a busy clinician tapping his pen on the paper - ed.]
The issue involves the pharmacy medmanager functionality. If the user performs a modify action on an order with an existing duration and duration unit, the order's stop date might not be recalculated. Specifically, this occurs when only the duration value is changed prior to entering the original duration unit. Pt care could be adversely affected, as medication therapy could be concluded prematurely or could last longer than intended based on the order details prior to the modification. This issue can be avoided if the user performs a renew action instead of a modify action to change an order's duration. If performing a modify action is required, users can manually set the stop date and time during the modify action. Cerner received communication that a pt's surgery required rescheduling as a result of this issue. [Again, was the lack of patient harm due to careful clinicians who at that moment just happened to not be distracted or cognitively overloaded or overworked or exhausted from on-call, or an act of
The issue involves the results to endorse (rte) inbox functionality in powerchart, powerchart office and firstnet and affects users that use the rte inbox to view radiology reports that have been created in radnet. Radiology results might fail to be displayed in the ordering provider's results to endorse folder in the inbox. Treatment or diagnosis decisions could be delayed if the clinician is relying on the display of a result in the inbox results to endorse folder to initiate patient follow-up. Note: the final results are posted to the flowsheet and are available on the patient's chart. Cerner received communication that a patient's follow-up care was delayed as a result of this issue. [Were any diagnoses of, say, cancer missed by other organizations affected? -ed.]
The issue involves the direct charting flowsheet and icu flowsheet, used within the powerchart system. When the result details box is accessed for a negative result value in either the icu flowsheet or the direct charting flowsheet in powerchart, either by right-clicking a negative, unsigned result value and selecting chart details from the context menu, or by right-clicking a negative signed result value and selecting modify, the dialog box displays a blank result value. When the user clicks ok in the result details dialog box, the value is changed to zero in the result cell in the flowsheet. [Of all places, health IT in ICU's should be extensively validated before going into production - ed.]
The issue involves the careadmin medication administration wizard used within the carenet system. When scanning a medication in careadmin, the system fails to recognize mckesson identifiers or other miscelaneous identifiers and properly identify the scanned product, which could result in the documentation of an incorrect dose in the careadmini window. In such situations, the system does not display overdose or underdose or route/form compatibility warnings as it should. Patients could receive an inappropriate dose of medication. Cerner has not been made aware of any adverse patient care events that resulted from this issue. [Thank god for that - but were any unreported by other organizations? - ed.]
Microbiology set up a program within the cerner computer system to automate the reporting system for hsv (herpes simplex virus)testing. The system was tested with the assistance of cerner and found to be working appropriately. The new system was operational for approximately 3 weeks when it was determined that the first word of the sentence, "no" was inappropriately dropping off of the following sentence: "no herpes simplex virus type 1 or herpes simplex virus type 2 detected by dna amplification. " as such, two of five patients were incorrectly informed that they had hsv before the error was detected. One had started an antiviral creme treatment. The other three did not have follow-up visits until after the correct results were determined. Cerner has looked at the program and has not provided an answer for the system issue. In the interim, the previous manual review and entry process is being used. [How does the word "no", an essential descriptor in a medical test, simply get "dropped?" Does NORAD's ballistic missile warning system ever do that, i.e., "no ICBM's incoming" reported as "ICBM's incoming"?- ed.]
Additional reported errors can be seen in a file downloadable by clicking on this link (PDF). Some of these are a bit startling.
Still others can be seen at:
Again, these are reports about just one HIT vendor but this piece is not just about them. Other HIT vendor products have similar issues. Health IT remains an experimental technology.
The MAUDE reports are voluntary, however, so the absence of a report does not mean an absence of a problem. (I note MAUDE queries on a number of major HIT vendors produce no results, or results limited to HIT that is closely associated with physical "medical devices" -- as opposed to virtual ones -- such as radiology systems.) For example, while a query on mfg. "Cerner" brings up hits, a query on another vendor shows this result:
No records were found with Manufacturer: Allscripts Report Date From: 10/01/1998 Report Date To: 09/30/2009
... and this:
No records were found with Manufacturer: Nextgen Report Date From: 10/01/1997 Report Date To: 09/30/2009
... while a broader FDA search on "Nextgen" brings up exactly one relevant hit on "Nextgen EMR - Medical Device" -- without specifics as to the "malfunction" noted under product code "HGM" - which on lookup is a perinatal monitoring system.
A broader search on Allscripts only brings up drug related issues such as this curious 2002 warning letter about the marketing of guaifenesin, a cough medicine, from FDA's Center for Drug Evaluation and Research.
Either these vendors are not reporting HIT problems, or are listed under another name. Rather unlikely is that they have no problems to report (latter hyperlink is PDF). As another example, a search on brand name "Centricity" brings up "hits" mostly on specialized GE products such as PACS.
So, is HIT safe, or can "glitches" affect patient care? Should this industry be entirely unregulated, or its products "certified" by groups with conflicts of interest such as those affiliated with industry trade groups? Should vendors be held harmless for HIT defects that harm patients?
I report, you decide.