FDA MAUDE DATABASE:
Patient outcome = death
I present another health IT problem case from the FDA's
voluntary MAUDE
(Manufacturer and User Facility Device Experience) database below.
From FDA's description of MAUDE:
- 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.
- The on-line search allows you to search CDRH
database information on medical devices which may have malfunctioned or
caused a death or serious injury. MAUDE is scheduled to be updated monthly
and the search page reflects the date of the most recent update. FDA seeks
to include all reports received prior to the update. However, the inclusion
of some reports may be delayed by technical or clerical difficulties.
- MAUDE data is not intended to be used either to
evaluate rates of adverse events or to compare adverse event occurrence
rates across devices. Please be aware that reports regarding device trade
names may have been submitted under different manufacturer names. Searches
only retrieve records that contain the search term(s) provided by the
requester.
I somehow missed the following case when I wrote the Oct. 2009 post 'Our
Policy Is To Always Have Unabashed Faith In The
Computer ... Except When It Screws Up, And Then It's The Doctor's Fault'
but I have added it there as well:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1656460
CERNER MILLENIUM
POWERCHART CPOE
Event Date
11/19/2006
Event Type: Death
Patient Outcome: Death
The medication review screen of the subject device does not specify the
exact dose in milligrams of combination medications. For example, narcotics are
combined with tylenol in at least two strengths.
Liquid narcotic tylenol-oxycodone combination is reported in ml, not mg. The
exact dose of tylenol is not specified and requires
knowledge of the combination medication dose in the volume specified.
Certain fields of the grid do not specify the volume, but rather state
"date/time" requiring another click or pop up screen. The immediate
knowledge of tylenol dosage in mg is directly related
to understanding and preventing excessive doses. In the subject, 10 ml of
acetaminophen-oxycodone is indicated as having been given 3 times over 4 hours.
That means that 1950 mg of tylenol was administered in
4 hours while the patient was in a state of starvation and receiving other
medication that increase the effects of tylenol.
This dose would equate to 11,700 mg of tylenol over 24
hours, nearly 3 times the maximum daily dose in otherwise health people. In the
ensuing days, the patient developed acute renal failure, presumably acute
tubular necrosis, and died. In the absence of other etiology, the excess tylenol was the culprit. This was not considered as etiology
ante-mortem. The counterintuitive screen impaired the professionals. The
pharmacist did not recognize and stop the medication, the nurses administered
it, and the excessive dose, clinically meaninglessly listed as a volume of
10 ml -given 3 times in 4 hours- of acetaminophen-oxycodone, was missed by
the physicians. Adverse events have been ascribed to "user error" by
vendors.
The device offers a potent propensity to life endangering oversights. There are
other screens on this device which present information that interfere
with clinically useful visualization of data. [Who
designed these screens, I ask? Clinicians, or business
IT personnel used to designing inventory systems for widget control? - ed.] The data does not flow to the
professionals. It is not represented in a meaningfully useful manner.
The professionals need to hunt for it. As such, the user unfriendly screens
[see this link on mission hostile HIT - ed.] impair safe medical care consistent with the
impediment to expedient professional understanding of what, exactly, is the
dose of medication and how much was administered to the patient. This sentinel
case of death is directly attributed to user unfriendly screens on this device.
How many cases like this related to health IT go unreported,
nationwide and worldwide? Nobody really knows; these devices are unregulated
with no requirements for reporting.
Unfortunately, “let's roll it out nationally anyway, because HIT will
deterministically revolutionize medicine, just ignore the iconoclastic prattle
from writers like
these” seems to be the latest cultural and governmental Tulpenmanie.
Can we safely ignore contrarian research and literature? Will HIT “revolutionize” medicine as per the
definitive certainty of HHS in "The
'Meaningful Use' Regulation for Electronic Health Records", NEJM,
Blumenthal and Tavenner (10.1056/NEJMp1006114, July 13, 2010)?
“The widespread use of electronic health records (EHRs) in
the
[Except for those who haven't - ed.]
And our government's called BP
Energy Company cavalier?
I offer no additional comments.