A Sign of the Times

Every now and then, I venture out to go shopping at mainstream chain clothing stores.  Although I find it onerous, there are certain things I can't get at thrift stores.  For example, I can never find nice jeans.

The last time I set foot in these stores was about two years ago.  It was tough to find pants my size at that time-- many stores simply didn't sell pants with a 30 inch waist.  This year, it was even harder, since some of the stores that formerly carried 30W pants no longer did.  I managed to find my usual 30W 30L size in two stores, but I had a bizarre experience in both cases.   I put them on, and they were falling off my waist.  Since my waist size hasn't changed in two years, and my old 30W 30L pants of the same brand still fit the same as they did when I bought them two years ago, I have to conclude that both stores have changed their definition of "30 inches".  My new size is 28W 30L, which is tough to find these days.
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FDA Recalls Draeger Health IT Device Because "This Product May Cause Serious Adverse Health Consequences, Including Death"

More health IT madness, in the form of an actual FDA recall:

FDA Recall notice

Draeger Medical Inc., Infinity Acute Care System Monitoring Solution (M540)
Recall Class: Class I [the most serious type of recall, see below - ed.]
Date Recall Initiated: October 18, 2011
Product: Infinity Acute Care System Monitoring Solution (M540), Catalog number MS25510
All serial numbers are affected by this recall.

This product was manufactured from March 1, 2011 through September 30, 2011 and distributed only to the Rush University Medical Center (Chicago, Illinois) from July 1, 2011 through September 30, 2011.

Use: This product is a networked solution system used to monitor a patient’s vital signs and therapy, control alarms, review Web-based diagnostic images, and access patient records. The number of monitored vital signs can be increased or decreased based on the patient’s needs.

Recalling Firm: Draeger Medical, Inc. 3135 Quarry Rd., Telford,
Pennsylvania 18969-1042

Manufacturer: Draeger Medical GmbH, Moislinger Allee 53-55_23558, Lubeck, Germany

Reason for Recall: The weight-based drug dosage calculation may indicate incorrect recommended values, including a drug dosage up to ten times the indicated dosage. Additionally, there may be a 5-10 second delay between the electrocardiogram and blood pressure curves (waveforms) at the Infinity Central Station.

This product may cause serious adverse health consequences, including death.

Public Contact: Draeger Medical, Inc. 3135 Quarry Road Telford, Pennsylvania 18969-1042_215-660-2349

FDA District: Philadelphia

FDA Comments: On October 17, 2011, the company sent the Rush University Medical Center a letter stating that users should enter the patient’s weight by way of the admin/demographics screen to ensure the drug dosage is calculated as intended.

Additionally, the company’s letter states that users should follow the instructions for Use of the Infinity Acute Care System Monitoring Solution. The Instructions for Use includes, "For primary monitoring and diagnosis of bedside patients, use the bedside monitor. Use the Infinity Central Station only for remote assessment of a patient's status." [That is, clinicians should work around the device's defects, which would seem to hold the computer's rights over the patients' rights -- rather than taking the device out of service immediately and having the vendor fix it - ed.]

Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX.

I find a software company advising clinicians to make sure to "work around" blatant IT defects in "acute care environments" the height of arrogance and contempt for patient safety. Yes, acute care environments are not unpredictable, chaotic environments often moving a mile a minute. They are precisely the environment where everyone can sit around on their butts and leisurely hold, over pizzas and cokes, a committee meeting where each and every move can be discussed, just like in a software development shop ...

I also find the statement that this medical device was "distributed only to the Rush University Medical Center" remarkable. If true, it raises a number of issues that make me very uncomfortable:

• How did the company's letter to Rush make its way to FDA? Whistle blower?

• What testing was done by the manufacturer of this medical device before release to a live-patient environment?

• Who approved this software "going live?" What due diligence was performed?

• Was this a software beta test of experimental software on live subjects?

• Did Rush University Medical Center have some sort of quid pro quo (e.g., financial arrangement) with the software company?

• Did Rush seek IRB approval of this device?

• Were patients presented with an informed consent process regarding its use in their care?

• Were any patients actually injured or did any die as a result of this software?

The answers to these questions need to be sought by FDA.

-- SS

The EHR Mission Hostile User Experience, Part 10: Cerner Powerchart - via FDA's MAUDE Database

"You should not have to work around something that is not in the way" - SS
Some time ago, I'd written an eight part (later expanded to nine part) series on health IT mission hostile user interfaces and experiences.

(Note: Part 1 of this series is here, part 2 is here, part 3 is here, part 4 is here, part 5 is here, part 6 is here, part 7 is here, and part 8 is here. 2011 addendums: a post that can be considered part 9 is here, part 10 is here.)

Here is an addendum, part 10, from the FDA Maude (Manufacturer and User Facility Device Experience) Database. I do not know who wrote it or where it was from. It was received by FDA as indicated on 3 April 2011:

FDA MAUDE REPORT

CERNER POWERCHART

Event Type Other

Event Description

I am writing to report a problem in the design of the cerner powerchart computer provider order entry (cpoe) product. As i will describe below, these design flaws are largely responsible for approximately 100 medication errors per day in our 240 bed hosp. The (b)(6) hosp in (b)(6) is a 240 bed teaching hosp. We are owned by the (b)(6). We have to be one of the only hospitals in the country to fully implement cpoe with two entirely different electronic medical records (emr).

In 2007, we completed a comprehensive cpoe implementation using idx 3. 1 (which was later purchased by general electric). Our self-reported medication error rate was <2 error reports per day. In (b)(6) of 2010, we transitioned our emr to cerner millennium - powerchart (b)(4). This implementation was done as a first step to converge onto a single electronic medical record across the (b)(6) enterprise.

Despite extensive nursing informatics support (approx. 7000 hrs per month for the first six months after implementation), our error rate went from approx. 176 medication errors per day one month after implementation to approx. 100 medication errors per day currently. It has been stable at this level for at least the past 3 months. Many of these errors involve high risk medications (e. G. Heparin, morphine). In order to understand the etiology of the errors, i need to explain how cerner processes cpoe orders.

With cerner, orders are grouped into plans ("powerplans"). These plans can include sub-plans ("phases") and sub-sub-plans ("sub phases"). A typical orders display screen appears as follows: (b)(4). Under the plans is an order tab which displays other orders.

This design allows two distinct sources of error.

First, there is no consistent way to view orders for medications. A medication order can display either in a plan, sub-plan, or under the orders tab. In order to find a given medication, cerner mandates that you click through each and every plan. This facilitates duplication of both medication and non-medication orders (there is a medication checker which is so poorly designed and does little to aid the pharmacists in detecting duplicate medications).

Second and more dangerous, high risk intravenous medications can be run either inside or outside of the plan. Cerner programming [i.e., the user interface design -ed.] does not keep high risk medications in a consistent spot. It is very easy to stop monitoring for heparin (which is included in the heparin plan) while continuing the heparin (which is outside the plan) or vice-versa.

As you can probably guess, we formed multiple interdisciplinary teams to address these deficiencies. [Workarounds - ed.]

I was the lead physician on the orders team. Although we were unable to reduce the error rate, it is not close to an acceptable level. Again, i believe this is because of the design of the cerner product which is why i chose to bring this to your attention. With issues this complex, i am a firm believer that "seeing is believing. " if desired, i would be happy to arrange a web conference to demonstrate my concerns.

Brand Name CERNER POWERCHART COMPUTER
Type of Device NONE
Manufacturer (Section F) CERNER
Manufacturer (Section D) CERNER
Device Event Key 2081342
MDR Report Key 2045867
Event Key 1942844
Report NumberMW5020161
Device Sequence Number 1
Product Code LNX
Report Source Voluntary
Reporter Occupation Other
Type of Report Initial
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received 04/03/2011
Is This An Adverse Event Report? No
Is This A Product Problem Report? No
Device Operator Service Personnel
Was The Report Sent To Manufacturer? No
Is the Device an Implant? No
Is this an Explanted Device?
Page Last Updated: 11/30/2011

I will let the FDA report speak for itself, with only one question:

When will the designers, developers, purchasers and implementers of medical devices like this start to be held criminally liable for patient injuries that occur from the risk these devices pose to patient safety?

criminal negligence - (law) recklessly acting without reasonable caution and putting another person at risk of injury or death (or failing to do something with the same consequences)

It's not as if the issues related to good user interface design are a mystery, nor have those issues been a mystery for at least a few decades.

An EHR design as described, if accurate, while perhaps "nifty" in some way from the computer-techie perspective, would require significant recklessness to design and to actually implement in a life-critical setting.

Those who try to point out these issues internally are sometimes subject to retaliation (for not being a "team player", of course, which in today's parlance means someone who is silent, or silenced, or a co-conspirator regarding managerial mediocrity, malfeasance, or madness). An example is here. We at Healthcare Renewal simply refuse membership on that team.

(Did I mention this deterministic miracle-making technology is slated via the HITECH Act for rollout in the U.S., unless the medical professional or organization is willing to accept progressive cuts to their Medicare reimbursement?)

-- SS

i would be one happy camper if i could dress this well everyday.....i LOVE her outfit....

*images courtesy of sacramento street, marcus design, splendid willow, vt interiors