Friday, January 21, 2011

MAUDE and HIT Risks: What in God's Name is Going on Here?

As I wrote at my last post "Healthcare IT Delirium":
The field of health IT has become delirious.

On top of an irrational exuberance (see this blog query) largely unsupported by the literature (e.g. here), the technology is experimental, its rollout is a grand national experiment in social re-engineering of medicine, there is no patient informed consent, nobody is in control, and nobody is taking responsibility for regulating the domain
despite known risks. The results will very likely reflect the Wild West free-for-all that is now extant.

It's worse.


Some time ago I posted on a number of cases of health IT malfunction from the FDA's MAUDE (Manufacturer and User Facility Device Experience) database of medical device risks. See posts on MAUDE
here and here.


Center for Public Integrity Investigative reporter Fred Schulte had also written on the MAUDE reports and other "glitches" at a Nov. 2009 report "Switch to electronic records getting mixed reviews at hospitals and clinics."

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.


Either I missed a Titanic boatload of cases, or MAUDE has been appended since my posts, because MAUDE links such as this , this
and this are now returning a Mother Lode of cases, at least from one vendor where these events are reported (other vendors' products suffer similar problems).

Examples just from light browsing cause the hair to stand up on my head (there are many, many more at the MAUDE links above):

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1584195
CERNER MILLENIUM CPOE, POWER CHART
Event Type Injury Patient Outcome Life Threatening;
Event Description

The cpoe system serves and documents all transactions of communication pertaining to the patient's care. Orders are entered and delivered to an anticipated recipient and the action ordered is executed. The device-recipient interface has been unreliable with specific etiologies for failure not yet resolved or understood. Examples include orders to transfer patient from icu to a non-icu bed. Patient is moved to another bed but recipient care team does not receive communication and was not aware patient was under their charge. Patient had seizures on floor for hours throughout the night. Other patients had orders for lab tests, chemical tests on body fluids, cytological analysis of body fluids, cultures on body fluids, pathology on or specimen, and others that are not executed by the recipient, leaving the patient undiagnosed after having taken risks for a procedure. Such interface failures have been known by the vendor for years as reported by its own support team.


http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1581240
CERNER MILLENIUM CPOE, POWERCHART Back to Search Results
Event Type Injury Patient Outcome Life Threatening; Hospitalization Disability
Event Description

The displays, formats, layouts, and interfaces of the cpoe tools at this institution contain elevated degrees of user unfriendliness. This toxic effect on the user is manifested by, to mention a few, more than 20 electronic silos in which orders are stored and extensive wordiness using descriptors that are highly irrelevant to the task of the care of pts with critical illness. This manifests itself in several ways, one of which is the ordering of duplicate medications and treatments, some of which get to the pt. These should be reported to pharmacopoeia data bases but often are not. This pt was being infused both total parenteral nutrition and a concentrated dextrose solution, the combined rate of which and cumulative dose caused pulmonary edema.


http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1577753
CERNER MILLENIUM CPOE Back to Search Results
Event Type Injury Patient Outcome Life Threatening; Hospitalization Disability
Event Description

Stress test orders are ambiguous. An example of the order states "stress test adenosine/dobutamine w/imaging nm -stress test adenosine nm-". Order displays on 4 lines on the screen. The type of test that the doctor intended to be performed is unclear, resulting the risk of incorrect pharmacological modalities being used. This caused life threatening acute asthma attack in patient with background asthma who incorrectly received an infusion of adenosine. All patients ordered pharmacological stress tests become subject to said risk.


http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1578421

CERNER MILLENIUM CPOE Back to Search Results
Event Type Injury Patient Outcome Life Threatening; Other
Event Description

When a pt having been in the hospital preoperatively, begins its post-operative course in the recovery room or intensive care unit, post op orders are electronically entered by deleting the unneeded orders that have been active, leaving the orders that are still needed, and adding new ones. There can be upwards of 300 lines of "active" orders on a complicated pt. Precise and safe post-operative ordering requires a time consuming line by line review of each order, counter-intuitively canceling those that are not needed. This does not always occur for any number of reasons, not the least of which is that the task is time consuming and user-unfriendly. The incidence of commingling the pre and post op orders in a hospital with cpoe instruments of care is unk, but not uncommon. At least one pt was placed at risk when the clean post operative abdomen was irrigated based on the pre-op order.


http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1574909

CERNER MILLENIUM CPOE Back to Search Results
Event Type Injury Patient Outcome Life Threatening;
Event Description

This cpoe product allows doses to be ordered that are not a multiple-s- of the pill size. A representative example is 20mg atenolol po daily. Pill size is 25mg. This feature facilitates dosing errors and enables dangerously absurd dosing without warning. When the reports such dose having been given, the clinician is left to wonder, what dose was given, actually.


http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1570802
CERNER MILLENIUM CPOE, POWER CHART Back to Search Results
Event Date 07/11/2006
Event Type Injury Patient Outcome Life Threatening; Hospitalization Required Intervention
Event Description

Hospital wide breakdown of system of electric charts and electric order gadgets resulted in confusion, neglect, failed communications and delayed treatments in the days immediately following the surgery, leaving patient with permanent musculoskeletal disability and mental anguish. Breakdowns of this magnitude endanger hundreds of patients simultaneously.


http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1665473
CERNER MILLENIUM CPOE, POWER CHART Back to Search Results
Event Date 10/09/2006
Event Type Malfunction Patient Outcome Other;
Event Description

It has been discovered that the medication review screen consisting of a list of the medications on the left most column and a grid indicating the number of doses administered in each time period. The defect manifests itself in the representation of exactly what medication was administered. For pts who are taking two or more forms of the same pharmacological agent, eg nitroglycerin in the paste form, sub lingual form, and pill form, the name of the medication is represented as "nitroglycerin" on the list. The number of times it was administered is confusingly listed as a number in parentheses without clarity on which form of the medication was administered, creating confusion in the clinician and risk to the pt.


http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1726923
CERNER MILLENIUM CPOE, POWER CHART
Event Date 04/03/2010
Event Type Injury Patient Outcome Life Threatening; Other
Event Description

The computerized physician order entry instruments were deployed. Pleural fluid specimen were obtained. Chemical and cytological analysis was ordered on the specimen using the cpoe instruments. The specimen was not analyzed as ordered. Cytology results did not become available. Similar dysfunction appeared in more than 6 patients. The hospital has resorted to paper forms to clarify the dysfunction of this cpoe instrument. The patients may have cancer causing the fluid build up. This will not be known until time passes. There may be resultant delay in diagnosis of chest organ cancer.


http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1766892
CERNER MILLENIUM CPOE
Event Date 07/08/2010
Event Type Injury Patient Outcome Life Threatening;
Event Description

The active and active prn medication list had 7 potassium doses and routes, 2 tylenol doses and routes, 3 magnesium doses, 3 narcotic medications and doses, and 6 sodium chloride and sodium phosphate orders. The defects in the device and human factors at the interface enabled duplicate, triplicate, and more medications, enabling the nurse to potentially decide the treatment for this pt. The exact incidence of medication duplication from (b)(4) systems is unk, but common.


Some examples of mere "malfunctions", again just from random browsing of the MAUDE data:


http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=358222
Model Number RELEASE 500
Event Date 10/03/2001
Event Type Malfunction Patient Outcome Other;
Event Description

Please see initial report.

Event Description

A user entered an order during the order entry process, with a frequency of every 8 hours and then used the ad hoc scheduling feature to modify the defaulted administration times for that frequency. After this was done, the user changed the frequency of the order to a 12-hour frequency without modifying the ad hoc administrations times. The software did not clear the previously entered ad hoc administration times to adjust to the default times for the new frequency. This resulted in a patient receiving a medications 3 times a day as opposed to 2 times a day. The drug was carbamazepene. This incorrect order frequency was repeated for 3 days, ultimately resulting in the patient receiving of total of 3 extra doses over a 3-day period (1 extra dose per day). On the fourth day, the nurse caring for the patient noticed the inconsistency in the order and conducted a further investigation with the pharmacist. The patient was discharged on time; no extended stay was necessary as a result of the overmedication. The patient's carbamazepene levels were checked during a follow-up visit that occurred 5 days after discharge, and were noted as normal at that time.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1365512

Model Number 2007.01 - 2007.17
Event Date 12/30/2008
Event Type Malfunction Patient Outcome Other;
Event Description

The issue involves cerner millennium powerchart message center inox. When the results folder is filtered by event set and the event set display and event set name are different, result filtering may not function correctly. If the result filter is in message center and is an inclusive filter, results may be filtered out incorrectly. The impact associated with this issue is that patient care may be delayed or missed as follow-up may not occur. Cerner has not received communication on any adverse patient events as a result of this issue.


http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1247673
Model Number 2007
Event Date 10/30/2008
Event Type Malfunction
Manufacturer Narrative

Cerner distributed a priority review flash notification on nov 13, 2008 to all potentially impacted client sites. The software notification includes a description of the issue and an interim workflow adjustment to prevent the malfunction. A software modification is being developed to address the issue for all sites that could be potentially impacted. Cerner corporation will provide a follow-up report when the software correction is available.

Event Description

This issue involves the overview with reminder functionality on powerchart and affects sites that use cerner millennium powerchart (powerchart. Exe). If a currently open pt chart is replaced with another pt chart, and reminders are subsequently viewed in the detail pane of this visit, the incorrect patient's reminder may de displayed. Pt care could be adversely affected, as clinical decisions could be based on the wrong pt info. Cerner has not received communication of any adverse pt events as a result of this issue.


http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1097561

Model Number 2007.13
Event Date 06/30/2008
Event Type Malfunction
Event Description

The issue involves the task list functionality in carenet, and affects users that utilize the task list to view and document pt activities. When encounter security is turned on and the user documents an activity in task list, utilizing the previous or next arrows to select another pt chart, the single pt task list displays tasks for incorrect pt. Clinicians may view and document a pt's activity in another pt's record. Pt care may be affected as clinical decisions could be based on incomplete, invalid, or inappropriate info. Cerner has not received communication of an adverse pt event as a result of this issue.

Cerner has distributed a priority review flash notification july 30, 2008, to all potentially impacted client sites. The software notification includes a description of the issue and an interim workflow adjustment to prevent the malfunction. A software modification is being developed to address the issue for all sites that could be potentially impacted. Cerner corporation will provide a follow-up report when the modification is available. Additional model #: 2007. 16.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1051313
Model Number 2001 THROUGH 2007
Event Date 04/23/2008
Event Type Malfunction
Manufacturer Narrative

Cerner has distributed a priority review flash notification may 23, 2008 to all potentially impacted clients sites. The notification includes a description of the issue and an interim workflow adjustment to prevent the malfunction. User documentation is being updated to address the issue for all sites that could be potentially impacted. Cerner corporation will provide a follow-up report when the documentation is available.

Event Description

The issue involves the order entry formats in powerorders and affects sites that use powerorders and medication profile. When creating the volume dose detail in the order entry formats (oef), the strength order formats require the volume dose to have an "=" sign as a prefix label. Failure to adhere to this build can result in an inpatient prescription order converted to produce an outpatient prescription that may be misleading. This only occurs when the inpatient order used is verified with a pharmacy product and the formulation used does not exactly match the dose. A formulation factor of more or less than one is used to achieve the volume and the order is then converted to a prescription. For example, 500 mg = 1 tab or 250 mg times 2 tabs = 500 mg. Patient care could be adversely affected, as a patient could receive either more or less of a medication therapy than intended. Cerner has received communication of order discrepancies discovered during a chart review as a result of this issue.

Again, there are many, many more examples like these in MAUDE, and I haven't even looked for data from other mfg's yet.
My relative was nearly killed last year by this technology due to issues like these, the risks of which I've been writing about for more than ten years now.


Alert to Sarah Palin: "Death panels?" Who needs death panels when technology like this is mediating our care and is planned for "urgent" national rollout with "meaningful use" rules and Medicare-penalty extortion - er, gentle coercion - directed towards healthcare organizations and clinicians?

I repeat, from the title of this post:

What in God's Name is Going on Here?

and:

U.S. government, regulatory agencies and consumer watchdogs: where are you?

-- SS


Jan. 21, 2011 addendum:

One wonders if the EHRevent site I wrote about at "
EHRevent.org: Web Site to Collect EHR Safety Reports" and at "EHRevent: survey amateurism, bias, or something else?" will be as frank as MAUDE.

2 comments:

Anonymous said...

The government apparently believes that healthcare information technology that kills and injures is better than no technology at all. Sort of like dyspareunia is better than no-pareunia.

Scot M Silverstein MD said...

The government apparently believes that healthcare information technology that kills and injures is better than no technology at all.

Not just (certain sectors of) government. See my May 2009 post Harvard's EMR Justification: We Just Have To Do Something.

-- SS