Real-World,
Though Limited, Examples of Healthcare IT Malfunction From the FDA MAUDE
Database
Healthcare
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].
Case 1:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=64345
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.]
Case 2:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=722614
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.]
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Case 3: |
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http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=946706
|
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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.] |
Case 4:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=888215
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
Case 5:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=920819
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.]
Case 6:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=700117
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.]
Case 7:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=715963
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.]
Case 8:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=753029
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:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=695436
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=688925
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=996685
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1075747
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=574578
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1288623
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1370640
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=834678
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.