Wednesday, August 04, 2010

GE: Don't Know Much About Radiation Safety, Don't Know Much About Physics

Don't know much about history

Don't know much biology
Don't know much about a science book
Don't know much about the french I took.
(Wonderful World, sung by Sam Cook)

This is becoming the theme song for executives of health care corporations.  We have posted about a series of cases in which major health care corporations suddenly seemed unable to carry out their core business functions, a phenomenon I am going to start calling "core business incompetence."  Some recent examples:
-  Baxter International apparently failed to check the purity of heparin it bought from a foreign supplier; the contaminated heparin resulted in approximately 81 deaths. (See post here.)
-  A major Genzyme manufacturing facility had multiple quality problems, resulting in the production of a very expensive, but contaminated biologic medication. (See post here.)
-  Three Johnson and Johnson manufacturing facilities had multiple quality problems, resulting in the production of contaminated batches of over-the-counter medications for children. (See post here.)
-  Aetna made mathematical errors in computing the rates it proposed charging; WellPoint made computer errors that exposed sensitive policy-holder information.  (See blog post here.)

Manufacturing pure, unadulterated medicines is a core function of a drug company.  Correctly calculating policy-costs and correctly handling patient data are core functions of health insurance companies.  But in the above cases, three large pharmaceutical companies and two large insurance companies could not perform these core functions competently.

Radiation Sickness from CT Scans
In the last few days, more details of what appears to be another example of core incompetency afflicting a major health care organization has surfaced.  The details were reported by Walt Bogdanich in the New York Times. Here is the summary:
When Alain Reyes’s hair suddenly fell out in a freakish band circling his head, he was not the only one worried about his health. His co-workers at a shipping company avoided him, and his boss sent him home, fearing he had a contagious disease.

Only later would Mr. Reyes learn what had caused him so much physical and emotional grief: he had received a radiation overdose during a test for a stroke at a hospital in Glendale, Calif.

Other patients getting the procedure, called a CT brain perfusion scan, were being overdosed, too — 37 of them just up the freeway at Providence Saint Joseph Medical Center in Burbank, 269 more at the renowned Cedars-Sinai Medical Center in Los Angeles and dozens more at a hospital in Huntsville, Ala.

The overdoses, which began to emerge late last summer, set off an investigation by the Food and Drug Administration into why patients tested with this complex yet lightly regulated technology were bombarded with excessive radiation. After 10 months, the agency has yet to provide a final report on what it found.

But an examination by The New York Times has found that radiation overdoses were larger and more widespread than previously known, that patients have reported symptoms considerably more serious than losing their hair, and that experts say they may face long-term risks of cancer and brain damage.

So not to mince words, in this sad case, many patients seem to have been subject to radiation poisoning from a diagnostic x-ray procedure (not from radiation therapy for cancer.)  Most people (and physicians) may have not previously thought that radiation poisoning was a possible harm from a single diagnostic CT scan.

A Design Failure?

Moreover, it appears that the radiation poisoning did not result from some freak accidents or malfunction:
The review also offers insight into the way many of the overdoses occurred. While in some cases technicians did not know how to properly administer the test, interviews with hospital officials and a review of public records raise new questions about the role of manufacturers, including how well they design their software and equipment and train those who use them.

Also,
None of the overdoses can be attributed to malfunctions of the CT scanners, government officials say.

At Glendale Adventist Medical Center, where Mr. Reyes and nine others were overdosed, employees told state investigators that they consulted with GE last year when instituting a new procedure to get quicker images of blood flow, state records show. But employees still made mistakes.

As a result, hospital officials said, a feature that technicians thought would lower radiation levels actually raised them. Cedars-Sinai gave a similar explanation.

'There was a lot of trust in the manufacturers and trust in the technology that this type of equipment in this day and age would not allow you to get more radiation than was absolutely necessary,' said Robert Marchuck, the Glendale hospital’s vice president of ancillary services.

A GE spokesman, Arvind Gopalratnam, said the way scanners were programmed was 'determined by the user and not the manufacturer.' GE, he added, has no record of Glendale seeking its help setting up the new procedure in 2009.

Most of the known overdoses, including the biggest, occurred on scanners made by GE Healthcare. At two hospitals that use Toshiba scanners — Los Angeles County-U.S.C. and South Lake in Florida — officials said the manufacturer suggested machine settings that ultimately produced too much radiation. Representatives of Toshiba agreed to be interviewed in their California office but abruptly canceled.

In particular,
To this day, no one at Cedars-Sinai knows who programmed the scanners that delivered the overdoses, officials there say. But in written statements to The Times, hospital officials said they had figured out how they might have occurred.

Normally, the more radiation a CT scan uses, the better the image. But amid concerns that patients are getting more radiation than necessary, the medical community has embraced the idea of using only enough to obtain an image sufficient for diagnosis.

To do that, GE offers a feature on its CT scanner that can automatically adjust the dose according to a patient’s size and body part. It is, a GE manual says, 'a technical innovation that significantly reduces radiation dose.'

At Cedars-Sinai and Glendale Adventist, technicians used the automatic feature — rather than a fixed, predetermined radiation level — for their brain perfusion scans.

But a surprise awaited them: when used with certain machine settings that govern image clarity, the automatic feature did not reduce the dose — it raised it.

As a result, patients at Cedars-Sinai received up to eight times as much radiation as necessary, while the 10 overradiated at Glendale received four times as much, state records show.

GE says the hospitals should have known how to safely use the automatic feature. Besides, GE said, the feature had 'limited utility' for a perfusion scan because the test targets one specific area of the brain, rather than body parts of varying thickness. In addition, experts say high-clarity images are not needed to track blood flow in the brain.

GE further faulted hospital technologists for failing to notice dosing levels on their treatment screens.

But representatives of both hospitals said GE trainers never fully explained the automatic feature.

In a statement, Cedars-Sinai said that during multiple training visits, GE never mentioned the 'counterintuitive' nature of a feature that promises to lower radiation but ends up raising it. The hospital also said user manuals never pointed out that the automatic feature was of limited value for perfusion scans.

A better-designed CT scanner, safety experts say, might have prevented the overdoses by alerting operators, or simply shutting down, when doses reached dangerous levels.

Summary: Core Incompetence
To summarize, GE diagnostic CT scan machines apparently were designed so that they could deliver so much radiation that their use could cause radiation sickness. The machines had no built in safeguards to limit the dose of radiation. Users, that is, X-ray technicians, could program the machine so as to deliver dangerous radiation doses, but GE did not warn them that this was the case, nor provide a machine feature that would give a real-time warning of incipient overdose.

Thus it appears that GE, which has been described as "the world’s biggest maker of health care imaging and information technology systems," failed in its core function of designing and manufacturing safe diagnostic x-ray machines. (Presumably the same might be said of Toshiba, but the NY Times report does not include so much detail about problems with its machines.)

A straightforward explanation of the magnitude of the core incompetence was provided by one of the patients who got radiation sickness:
To Mr. Heuser, it is unconscionable that equipment able to deliver such high radiation doses lacks stronger safety features.

'When you are in a car and it backs up, it goes beep, beep, beep,' he said. 'If you fill the washing machine up too much, it won’t work. There is no red light that says you are overradiating.'

It really seems like we are seeing an epidemic of core incompetence by major US health care corporations.

I can only speculate about why this occurring. One explanation is that the organizations may be lead by people who do not understand the health care context, and do not understand the scientific, engineering, and technical issues involved with core competence. Many health care corporations have come to be lead by people with no experience or background in relevant areas.

For example, the current, and often acclaimed CEO of GE is Jeffrey Immelt, who "earned a B.A. degree in applied mathematics from Dartmouth College in 1978 and an M.B.A. from Harvard University in 1982." The leader of GE Healthcare is John Dineen, who "is a graduate of the University of Vermont where he earned Bachelor's degrees in biology/genetics and computer science," and "joined GE in 1986 as a telecommunications engineer."

Another, even more speculative explanation is that many major US and global health care organizations seem to have been infected with the virus of putting short-term financial results ahead of everything else, leading to cutting of costs and particularly human expertise in the areas most core to the organizations' functions, and pushing for hurried results even at the expense of clear thinking, carefully engineering, and consideration of the effects on patients and other humans of the resulting mistakes.

Hopefully, further investigation will reveal more about what went wrong in this case. Meanwhile, I say again, again, again,...

As long as "imperial CEOs" can continue to get extremely rich while presiding over incompetence and stupidity, if not worse), we can expect the foolishness to continue. Meanwhile, the foolishness drives up costs and drives down quality of health care for the poor suffering patients, let alone the physicians and other health care professionals who must deal with it.

To really reform health care, we need to provide incentives for competent, honest leadership, and make that leadership accountable for its shortcomings.

Postscript - Why the Rush to Aggressive Treatment?

The NY Times article described the rush to get one of the afflicted patients to the CT scan:
on the morning of July 4, when a 52-year-old executive producer of films, H. Michael Heuser, arrived in the emergency department with stroke symptoms.

A 'code brain' was immediately called, signaling a life-or-death situation. A blood clot in the brain can be dissolved with medicine, but doctors must do it within several hours, before brain cells die from a lack of oxygen. So Mr. Heuser was rushed into a room with several CT scanners, where he underwent one brain perfusion study and at least one more later. A CT perfusion scan, which lasts about 45 seconds, can identify a stroke through a series of blood flow images.

Mr. Heuser did have a stroke, from which he would recover. But other parts of his body inexplicably began to break down.

However, there is no clear evidence that such a rapid and drastic approach is really that good for patients. A recently updated Cochrane review concluded: "In patients with acute ischaemic stroke, immediate anticoagulant therapy is not associated with net short or long-term benefit. Treatment with anticoagulants reduced recurrent stroke, deep vein thrombosis and pulmonary embolism, but increased bleeding risk. The data do not support the routine use of any the currently available anticoagulants in acute ischaemic stroke." However, many physicians seem to advocate the drastic approach based on some controlled trials that showed at best small improvements in average neurological function for patients receiving rapid anti-coagulation (and which were done before anyone thought about radiation sickness as a possible harm of the approach.) Once again, an aggressive, technological, expensive approach, possibly advocated by people who stood to gain financially from it, may not be as advantageous as it appears.

5 comments:

Marilyn Mann said...

Roy

The Cochrane review was of anticoagulants for acute ischemic stroke ("The anticoagulants tested were standard unfractionated heparin, low-molecular-weight heparins, heparinoids, oral anticoagulants, and thrombin inhibitors."). The "medicine" the NYT article is referring to, OTOH, is Tissue plasminogen activator (tPA), which is different.
There is debate about the value of tPA, but I'm not going to try to weigh in on that.

Marilyn

Roy M. Poses MD said...

Marilyn -
Yes, you are probably right that the article was referring to thrombolytics rather than anticoagulants.

Here is the summary of the results of the Cochrane review on thrombolytics in acute ischemic stroke:
http://www.ncbi.nlm.nih.gov/pubmed/19821269

"Thrombolytic therapy, mostly administered up to six hours after ischaemic stroke, significantly reduced the proportion of patients who were dead or dependent (modified Rankin 3 to 6) at three to six months after stroke (odds ratio (OR) 0.81, 95% confidence interval (CI) 0.73 to 0.90). Thrombolytic therapy increased the risk of symptomatic intracranial haemorrhage (OR 3.49, 95% CI 2.81 to 4.33) and death by three to six months after stroke (OR 1.31, 95% CI 1.14 to 1.50)."

So in summary, at 3-6 months, patients who got thrombolytics were more likely to die, but less likely to be dependent.

It doesn't seem to me that this means that thrombolytics provide benefits that outweigh the harms (and that is setting aside the harm discussed above, that is, radiation sickness from the CT scan.)

Mike M said...

There may be plenty of blame to point at corporate leadership, but don't forget that there are highly trained and credentialed physicians and technologists involved. They were responsible for prescribing and administering these imaging procedures, yet did not notice that there was a problem. An analogy that may be more appropriate than the backup up beep, is a driver who runs over a patient while backing out of their reserved hospital parking space and says "there should have been a beep, so I didn't need to look behind me."

MedInformaticsMD said...

Mike M:

CT scan areas are frequently a madhouse.

Can we agree it was simply stupid, or maybe even brain dead no pun intended), of the GE engineers and management not to make cognitive support for workers (clinicians, technicians) in such environments a top priority?

Or should their devices be labeled, Clint Eastwood style, "Do You Feel Lucky Today, Punk?"

-- SS

MedInformaticsMD said...

Alse see my followup post at

http://hcrenewal.blogspot.com/2010/08/few-comments-on-ge-radiation-debacle.html