This was posted on Feb. 28, 2104 @ HealthNewsDigest.com
(HealthNewsDigest.com) - The title of this piece is taken from a mordant lyric in Richard Fariña's 1966 folkie love song "Children of Darkness."
Yet another stake
has pierced the heart of the ridiculous meme that the biggest problem in
American health care is getting everyone insured. I'm talking about the recent
highly publicized case at UCLA's Ronald Reagan Medical Center in which 179
patients may have been exposed to Carbapenem resistant enterobacteriaceae
(CRE), resulting in two deaths. So far, seven UCLA patients are confirmed to
have been infected with CRE--a dreaded superbug that it is fatal in up to 50
percent of those it infects.
Infection control
guru Lawrence
Muscarella notes that since 2012, there have been at least six other
instances of similar CRE outbreaks, most of which were caused by contaminated
duodenoscopes, used in endoscopic retrograde cholangiopancreatography (ERCP).
No doubt, ERCP is a lifesaving procedure, whereby many diseases of the pancreas
and biliary system can be treated. Prior to ERCP, if treatment were even
possible, open surgery was the only method.
However,
sterilization or high level disinfection of these duodenoscopes can be
difficult. The well-known adage that a device first has to be clean to be
sterile applies, and attention has been focused on a component of the scope
called the "elevator forceps."
Not surprisingly,
in every case of CRE infection, hospitals insisted that they were following the
scope manufacturer's reprocessing instructions. "Reprocessing" is a
curious term used in the industry referring to the validated process of
cleaning, disinfecting, or sterilizing endoscopes and accessories. Inasmuch as
there is an immense difference between cleaning, disinfection and
sterilization, such a collective term seems, at best, counterproductive.
Reaction of
officialdom--our "foul command" if you will--to these CRE outbreaks
has been disheartening--if not depressing. The American Gastroenterological
Association blames the scope manufacturers...
"The problem
of infection transmission lies in the complex design of duodenoscopes where the
elevator channel can allow bacteria to remain after cleansing, even if
reprocessing follows accepted procedures." (from a February 20, 2015 press
release)
"Consider
taking a duodenoscope out of service until it has been verified to be free of
pathogens if a patient develops an infection with a multidrug-resistant
organism following ERCP, and you suspect that there may be a link between the
duodenoscope and the infection." Consider taking it out of service?
(from a February 19, 2015 press release)
And how's this for
world class detachment, courtesy of John Allen, MD, the Association's
president: "This problem (superbug-contaminated duodeonoscopes) has been
known since at least 1987. It certainly is disturbing that a fundamental design
issue with these scopes would cause problems for this long." Amazingly,
the docs who garner big bucks using these scopes assume zero ownership
regarding their problems. Apparently, it's up to those underpaid basement dwellers
in the hospital (Sterile Processing Departments) to sort all this out.
How well would
society tolerate a celebrity chef who showed a similar reaction, if food-borne
illnesses at his restaurant were traced to improper food handling procedures?
Regular readers of
this column are aware that I am no fan of the FDA. Sadly enough, the agency's
posture in this affair confirms my assessment, despite a host of relevant
journal articles and adverse event reports dating back nearly 30 years--for
these and similar scopes. According to William Maisel, MD, MPH, Chief Scientist
and Deputy Center Director for Science at FDA's Center for Devices and
Radiological Health (CDRH): FDA did not recognize the potential problems with
contamination with the scopes until September 2013, when officials were
contacted by the Centers for Disease Control and Prevention with information
about infections. Right, Bill.
But, it gets worse.
UCLA and other
affected hospitals have turned to true sterilization of the duodeonoscopes with
ethylene oxide (EtO). UCLA has been cooperating with Olympus, the scope
manufacturer, who endorses the use of EtO in its reprocessing manual for the
scopes in question. Experts in EtO sterilization tell me that pre-cleaning of
the scope would have to be woefully inadequate to allow bacterial contamination
to survive the process.
In a safety
communication entitled Design of ERCP Duodenoscopes May Impede Effective
Cleaning issued by FDA on February 19, 2015, it is stated in bold letters
to "Follow closely all manufacturer instructions for cleaning and
processing." Fair enough.
Then why is Maisel
quoted in the LA Times on February 23rd as being against the use of EtO?
Although gas treatment "has helped in some cases where there have been
outbreaks," Maisel said, "there can be ethylene oxide residual levels
on the products that can be harmful to patients." An additional problem,
he said, is that using gas "can damage the scopes themselves. And so we
are not, at this time, recommending routine ethylene oxide sterilization."
These statements
are so outrageously stupid as to beggar belief. Residual levels of EtO are
removed during the FDA-required aeration process, and if the gas damages the
scopes, why would Olympus be recommending it?
Insiders have given
me all sorts of reasons why Maisel said what he did. Regardless, the
long-troubled CDRH shows no signs of improvement. On the bright side, Rep. Ted
Lieu (D-CA) called on Congress to investigate what the FDA and device makers
are doing to protect patients from the spread of deadly bacteria. "For the
life of me, I don't understand why the FDA didn't issue this advice until
now," he said. "I want to know what the FDA knew and when did they
know it."
Don't we all,
Congressman, don't we all.
Michael D. Shaw
Exec VP
Interscan
Corporation
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