(Editor's Note: As usual my friend Mike cuts right into the heart of reality.)
Last week's story on this topic
generated plenty of interest, so we continue our coverage...
Yet another prestigious hospital joins the ranks of those
reporting Carbapenem resistant enterobacteriaceae (CRE) infections, linked to
endoscopic retrograde cholangiopancreatography (ERCP) endoscopes. On March 4th,
Cedars-Sinai Medical Center in Los Angeles discovered that four patients were
infected with CRE, and 67 others may have been exposed.
Lisa McGiffert, director of the Safe Patient Project at
Consumers Union, and a longtime activist regarding hospital-acquired
infections, said that "It's highly likely many hospitals around the
country have had outbreaks, and they haven't been able to connect the dots
until this problem was disclosed at UCLA. It's just a little late--especially
for those who got infections and maybe died as a consequence."
As discussed in last week's piece, the magic bullet to
end this horror seems to be true sterilization of the scopes with ethylene
oxide (EtO). This finding was published on October 8, 2014 in JAMA, in
an article entitled "New Delhi Metallo-β-Lactamase-Producing
Carbapenem-Resistant Escherichia coli Associated With Exposure to
Duodenoscopes."
Notably, EtO is hardly new technology, introduced 70-odd
years ago. So why, people asked me, are these ERCP scopes not being sterilized
with EtO? Good question. In fact, this was one of two questions repeatedly
posed to me, via e-mails, phone calls, and from a Boston-based talk show host.
Regarding the non-use of EtO, the answer is cost. EtO
sterilization is not expensive per se, but its 10-12 hour cycle time means that
more scopes (at nearly $40,000 each) would need to be placed in inventory, to
maintain the production flow of the ERCP procedures. Other reprocessing methods
are quicker, but have proven to be less effective. However, in light of the CRE
outbreaks, EtO sterilization--at least for these scopes--appears to be making a
comeback. Bear in mind that other types of endoscopes are not immune from
superbug contamination, and EtO should strongly be considered for these, as
well.
This column is aware of a three hour cycle EtO
sterilizer, now undergoing FDA 510(k) clearance procedures. More information
will be presented when available.
The second good question concerns the astonishing level
of detachment in this matter, shown by the gastroenterology doctors. Although
official recognition of gastroenterology as a subspecialty of internal medicine
dates back to 1941, the field came into its own with the emergence of endoscopy
in the 1970s. How odd that the devices that virtually put gastroenterology on
the map--not to mention enabling its high fees--are somehow dissociated from
the practitioners, themselves.
And, let's not forget the unsung heroes of each
hospital's central service/sterile processing department (CS/SPD). These are
the people responsible for sterile processing of all devices, including
endoscopes. It is not widely publicized that reprocessing instructions for the
Olympus duodenoscope under fire (TJF-Q180V) comprise a 106-page booklet, along
with a companion 45-page Cleaning and Disinfection Checklist. Similarly
detailed instructions must be followed for dozens of other devices.
Nor is it widely publicized that CS/SPD salaries are
relatively low. Based on recent data, those with manager/director titles can
earn around $70,000/year, while a lead CS/SPD technician makes about $34,000.
For those keeping score at home, GI-docs pull in about ten times the
compensation of the technician. I would hazard a guess that before these CRE
infections, few gastroenterologists had ever seen, let alone read, a
reprocessing manual for an endoscope.
The CRE/ERCP scope matter reveals many flaws of our
health care system, including infection control breaches; soulless detachment
and expediency; regulatory malfeasance; and official cover-ups. It is long past
time to address these problems.
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