channels. Unique to duodenoscopes, it has microscopic crevices that
standard brushes can't scour. Bacteria can build up in these crevices.
"Meticulously cleaning duodenoscopes prior to high-level disinfection
should reduce the risk of transmitting infection, but may not entirely
eliminate it," states the FDA.
Strains of CRE, which includes Klebsiella and E. coli, naturally and
harmlessly inhabit the colon but spark an antibiotic-resistant infection
when spread to other parts of the body, as by a scope inserted down
the throat, through the stomach and into the small intestine.
Despite its awareness of the hazard, the FDA has not ordered a
recall of duodenoscopes, largely because no other device can do what
they do in the estimated 500,000 ERCP procedures performed in the
United States each year. "The procedure is the least invasive way of
draining fluids from pancreatic and biliary ducts blocked by cancer-
ous tumors, gallstones or other conditions," says the agency, adding
that "the continued availability of these devices is in the best interest
of the public health" and outweighs the potential risks.
Course of action
Lawmakers and safety advocates are criticizing the FDA and duo-
denoscope manufacturers for failing to sufficiently protect patients.
Greater government oversight and a slew of lawsuits are inevitable.
(In the first lawsuit stemming from the superbug outbreak at UCLA,
an 18-year-old patient accused Olympus of negligence for selling a
medical scope prone to spreading deadly bacteria.) But in the mean-
time, what's the best course of action for a facility that hosts ERCPs?
The recommendations in the FDA's safety communication don't
advise a radical change in practices. Scope reprocessors should
strictly adhere to manufacturers' instructions, paying meticulous
attention to the elevator. The "Multisociety Guideline on Reprocessing
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