Shaw's Eco-Logic

Colonoscopies gone bad at the VA

There has been a fair amount of news coverage given to the sad situation at certain VA hospitals, regarding improper disinfection of colonoscopes. Thousands of vets were notified that they might be infected with HIV or Hepatitis B or C, and several cases of infection have already be uncovered.

The official spin on this is "improper assembly" of certain components of the scopes, but there is way more to the story than that.

For one thing, a supplier of equipment used to reprocess (sterilize or disinfect) the scopes was recommending that the wrong tubing connector be used (for cleaning only), to allow automatic reprocessing of the scopes, even though the manufacturer of the scope itself said that these parts had to be cleaned manually.

Unfortunately, the correct connector looks almost identical to the wrong one. Thus, when it is time to reassemble the unit, if the wrong connector stays in place, there could be dire consequences—and apparently there have been.

The VA admits that this improper reassembly could have occurred from April 23, 2003 through Dec. 1, 2008.

Please bear in mind that the scopes and the automatic reprocessors in question are used at many facilities besides the VA. The VA story came out because someone blew the whistle. Generally speaking, there is a good deal less whistle-blowing at private facilities, so we may never know the full extent of the problem.

Perhaps, a victim of this outside the VA, who has none of the common risk factors for the diseases, but did have a recent colonoscopy, might blow his own whistle.

Read my complete HND story.

Protecting you from deadly infections

Infection control guru Larry Muscarella has done it again. Although you might think that a discussion of automated endoscope reprocessors (AER) is really "inside baseball" kind of stuff, the truth is that it is really INSIDE YOU kind of stuff. AERs are used to clean and disinfect the various kind of flexible scopes that are placed deep inside your body for medical procedures.

If they are not processed effectively, you can get an infection, and if you are a sick immuno-compromised patient, you can die. In fact, I have written about such cases.

He took a look at how a supposedly unbiased third-party institute's evaluation of a new AER is anything but unbiased. You might ask: Who is looking out for you? Good question. Right now, it is not the NGOs (so-called non-governmental organizations such as the institute discussed here) or sadly, even the federal regulatory agencies.

Rather, it is independent guys like Larry, who are willing to take on the system. Download Larry's report here (1.2 MB pdf).

No standard for parametric release: Does anyone care?

The classical method of assuring that a load of medical instruments and devices is in fact sterile, after being treated by the sterilizer, is to include a biological indicator (BI). The BI contains a bacterial species deemed difficult to kill by the particular sterilization method employed. The BI is removed after the sterilization cycle, and is cultured to test the cycle. Most BI's require 48 hours for the results to develop.

Best hospital practices, in fact, will specify that the load should not be released until the results of the BI are available.

An alternative is to employ parametric release.

Parametric release is a mechanism for the release of sterilized products to user departments based on the measurement of physical sterilization process parameters in fully validated equipment. It is a broad term used in health care to describes processes which are so well controlled that it becomes possible to release devices immediately after the sterilization cycle, without using biological indicators or end-product sterility testing.

Numerous American and international standards cover best practices for steam and ethylene oxide sterilization (used for heat-sensitive devices), and include the matter of parametric release.

However, few if any hospitals run validated sterilization cycles for steam or ethylene oxide sterilization, since specialized sensors are required, which are more common in so-called "industrial" i.e. large-scale sterilization facilities. That is to say--few if any hospitals use parametric release for steam or ethylene oxide sterilization.

Here's the problem: Another method of sterilization, now deployed in thousands of hospitals, utilizes hydrogen peroxide gas plasma. It has been touted as essentially a replacement for ethylene oxide, and boasts a much faster cycle time.

But, the faster cycle time would be of no benefit if the loads were released on BI, since that would render them no faster--in a practical sense--than ethylene oxide. Thus, many hospitals are releasing the plasma loads parametrically. Unfortunately, no standard exists to validate this process.

Although criteria for a parametric release have been published, this does not constitute a recognized third-party standard. Moreover, the manufacturer has stated that "It is always the hospital's responsibility and decision to implement parametric release."

Does this mean that the hospitals are using patients as the biological indicators?

The docs still don't get it on infection control

A few days ago, this article appeared in the New York Times, and examined the cross-infection hazards of the clothing worn by health care workers.

Prominently mentioned was the oft-spoken, but hardly ever enforced policy of not wearing scrubs outside of the hospital, or better yet keeping them only in an active clinical setting.  My son—who is in med school—e-mailed me about this piece, and about his clueless classmates who were wearing their scrubs on the bus, and then coming back into the hospital for clinical rotations.

His exact comments...

Not at all surprised.  Many doctors have no clue/concern about germ transmission.  And the cycle perpetuates itself...Take for example, the multiple dipsh__s in my class that despite being told not to wear scrubs to the hospital (but rather change into them upon arrival), are seen touting them on the buses.

Clearly, in a allopathic world, prevention barely gets a second thought.

Who cares about the blood supply? Apparently not the Red Cross.

Credit the NY Times' Stephanie Strom with breaking the story:  "Problems persist with Red Cross Blood services.

Did you know that for 15 years, the American Red Cross has been under a federal court order to improve the way it collects and processes blood?  Me neither.

Problems cited in the many FDA reports include:

• Improper screening of donors
• Poor blood-drawing technique
• Failures to test for syphilis
• Failures to discard deficient blood

Strom's story has everything, including a whistle-blower who was later fired, incredible financial and database mismanagement, falsified records, and hints of a sadly typical non-profit culture in which most people don't make any money, while the incompetent top execs are grossly overpaid.

Who knows what damage has been done to patients?  After all, the Red Cross controls 43 percent of the nation's blood supply, and much of what goes wrong can be conveniently hidden...

As a former CEO of the Red Cross put it, "Patients who get blood transfusions tend to be pretty sick. If they spike a fever post-transfusion, no one is likely to suspect that the blood caused it."

Of course, that's the "problem" when attempting to judge health care outcomes.  People who are admitted to hospitals are, uh, sick--and sick people sometimes die.  So, how can it be our fault?

Are the chickens finally coming home to roost for the Steris System 1?

Regular readers of this blog know that I am big on improving infection control in hospitals.  Beyond the fact that hospital-acquired infections produce about 100,000 mostly preventable deaths every year in this country, the whole notion of this goes along with one precept of my basic philosophy.

That is, take care of the big problems first--especially the big problems that have relatively simple solutions!

What good does it do a patient to have the highest-tech medical care, if he is only to die of the same sort of infection he could have received in the hospitals of ancient Rome?

Classical, time-proven methods of sterilization include steam and ethylene oxide (a low-temperature process, perfect for the flexible scopes used in many of today's less-invasive surgical techniques).  However, ethylene oxide (EtO) is toxic (it kills germs, after all) and the sterilization cycle can take up to 16 hours.

Since the very most important consideration in health care these days is cost, sterile processing departments of hospitals have long been searching for alternatives to EtO.  And, sure enough, in the late 1980s-early 1990s two techniques did come on the market.  As it happens, their names are quite similar:  Steris System 1, and Sterrad.

In an earlier post, we detailed some of the issues with the Sterrad,  Now, Steris is on the hot seat.

On May 15, 2008, The FDA issued a Warning Letter to Steris, citing multiple violations of their 510(k) premarket approval.  The 510(k) provision is much sought-after by medical device manufacturers, since it streamlines the approval process by likening the product in question to a similar device (predicate device) that has already been approved.

Several authorities, including Lawrence Muscarella, have raised questions about the Steris System 1 since its introduction, asking how tap water can be rendered sterile simply by its passage through a filter.  In addition, the device has been implicated in patient deaths.

You will note that the Warning Letter claims that the System 1 is "adulterated" and "misbranded."  Thus, it can no longer be considered safe and effective without further agency review.  These claims usually prompt swift draconian action, but so far, we have not seen this.  Granted, with 16,000 plus units in the field, a full-blown recall could be messy, but then again, so are dead patients.

At this point, the silence is deafening from the company, the agency, and numerous non-governmental organizations (NGOs) that should be far more involved.

Muscarella is hopping mad now, and is seriously questioning the labeling of the device from the get-go, but he is most upset at the silence of the NGOs, and posits a conflict of interest--inasmuch as the NGOs rely on funding from device manufacturers.

Finally, there are even those who suggest that this Warning Letter might be the first blow in a death of a thousand cuts strategy, intended to remedy an errant 510(k) approval, dating back to 1989.

In the meantime, exactly what are sterile processing departments supposed to do?

Not egregious enough, I guess

I waited a couple of weeks for more reaction before I posted on this topic, BUT--it got lost in coverage of political campaigns and celebrity scandals.  Silly me, I thought this one would be a big deal.

I'm talking about medical malpractice bad enough to cause the biggest patient notification in US history:  At least six cases of hepatitis, traced back to nurse anesthetists at the Endoscopy Center of Southern Nevada in Las Vegas reusing syringes to draw up medicine from single-use vials—for multiple patients.

This is medical practice below what one might imagine in a mobile hospital in a third world civil war, and is one flagrant reason why the US public hates our health care system.

"I find it baffling, frankly, that in this day and age anyone would think it was safe to reuse a syringe," said Michael Bell, associate director for infection control at the Centers for Disease Control and Prevention.  It isn't all that "baffling," though when one considers that sick mind of the guy who ran the place, and how he could save maybe $30 a week doing this.

The harder part to understand is how the nurse anesthetists could have gone along with it...

Check out my Health News Digest piece.

Larry Muscarella's guide to avoiding a hospital-acquired infection

There is no one better than Lawrence Muscarella, Ph.D. on the subject of infection control.  He's the guy the public health authorites go to when they're faced with a crisis.

Larry weighed in on the widely publicized article "15 steps you can take to reduce your risk of a hospital infection," that is posted at www.hospitalinfection.org

While Larry agrees with much of what is noted there, he does have some serious issues with a few of their points...

Read all about it here

Hospital infection control woes continue

Readers of this blog will note that I have much concern over infection control.  After all, what's the point of all that great high-tech medicine, if you're just going to die from a hospital-acquired infection?

CDC figures peg the number of these infections at about 2 million per year, with nearly 100,000 deaths.  So, yeah, it's a very big deal.

A few weeks ago, I posted an article to Health News Digest, mirrored here, talking about yet another problem that has come up.  This one has to do with a much-touted "alternative" sterilization method.  Hydrogen peroxide gas plasma—introduced by a division of Johnson & Johnson—was quickly embraced by thousands of hospitals, to replace ethylene oxide.

Although there were always doubts about its efficacy, it is quicker, and supposedly safer for the employees using it.  Since it is a new method, and some issues were known about using peroxide in the past, it was incumbent upon the manufacturer of the new sterilizer to put together a list of medical devices that could be sterilized in its machine.

But, in November, 2007, the J&J division (called Advanced Sterilization Products) notified its customers that all prior lists are inoperative.  One can assume that something pretty nasty must have happened to have caused this wholesale abandonment of its customers.  As it is, ASP is advising its customers to check with the device manufacturer for further guidance.  NICE...

But, what's the device manufacturer supposed to say--to customers who have already been using the ASP unit for several years?  He HAS to say it's OK if he wants to keep selling product.  The only thing that will break this Mexican standoff is for the ASP unit to destroy a particular device, as it has done with certain scopes made by Olympus.

Sure, ASP can blame it on a faulty device or bad employee, but if that occurs often enough, it just won't wash.

Meanwhile, the only one who gets screwed is the patient, since you can bet that the devices will get sterilized less often, and so-called high-level disinfection—totally inappropriate for some of these devices—will creep in.

I have my spies poised to report on how all this is playing out in various SPDs (Sterile processing departments) around the country.  You'd think there would be outrage, but, so far at least, you would be wrong.

More confusion means more deaths

That's half of the title of a piece I did recently.  The full title is  "Infection Control:   More Confusion Means More Deaths."

Lest you think the title is overkill, we make the case for confusion causing at least the deaths of two preemies in Los Angeles last year.  We relate actual correspondence between doctors and an infection control expert.  The doc is confused by conflicting standards, and the expert has to make his recommendations in an environment of regulatory malfeasance.  This would include the miserable influence of an NGO  (Non-Governmental Organization) that has WAY too much say-so in these matters.

As you will see, the FDA does not exactly have clean hands in this case, either.

At least the state of California finally overruled the absurd recommendations of AORN.  Of course, we understand that even then, the state relied very heavily on the free advice of this same expert.  That's fine, I guess, but you would think that they would have a bit more courage in their convictions.

Read all about it here, and bear in mind that despite this very public bitch-slapping, AORN has not changed anything in their best practices for the particular medical device involved.

Don't think for a moment that confusion in infection control is limited to this one case.