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 The notice from Cedars-Sinai Medical Center of four such infections
and 67 more patients who were at risk coincided with a hospital in
Hartford, Connecticut, reporting a similar outbreak involving at
least five infections and more than 280 potential exposures.
The Cedars-Sinai cases, like the larger number of infections and
potential exposures reported last month at the UCLA Ronald Reagan
Medical Center in Los Angeles, involved a family of germs called
carbapenem-resistant Enterobacteriaceae, or CRE.
The bacteria identified on Wednesday in the Hartford Hospital
outbreak was a drug-resistant strain of E.coli.
But the procedure and instrument implicated at all three hospitals
were the same - an endoscopic retrograde cholangiopancreatography,
or ERCP, performed with a duodenoscope.
The Food and Drug Administration, meanwhile, issued an updated
safety alert for duodenoscopes, urging medical providers to inform
patients of the risks, including possible transmission of infection,
associated with the use of such instruments.
The alert also puts providers on notice to report any infections
they suspect were caused by problems with the scopes to the
manufacturer and the FDA.
The latest flurry of infections has raised new questions about
whether manufacturers' recommendations for disinfecting
duodenoscopes are sufficient to protect patients.
The complex design of the instrument - flexible tubes that are
threaded down the throat and stomach to the top of the small
intestine to drain fluids from blocked pancreatic and bile ducts -
may hinder proper cleaning, the FDA has warned.
A senior FDA official said this week that manufacturers' own tests
of disinfection measures they recommend contained flaws that
rendered those cleaning procedures unreliable.
Makers of the devices include such camera companies as Olympus Corp,
Fujifilm Holdings Corp and Pentax.
Olympus was the maker of the single duodenoscope linked to all 71
patients of concern at Cedars-Sinai, from August 2014 to February
2015, and of two suspect scopes tied to 179 potential exposures
dating back to October at UCLA.
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Seven of UCLA patients were confirmed to have been infected, and two
of them had died.
One of the four infected Cedars-Sinai patients died from "an
underlying disease," not from the bacteria, as the infection had by
then been cleared, the hospital said in its statement.
Hartford Hospital said it found five or six of its patients had
contracted drug-resistant E.coli last year from two duodenoscopes
used in 281 more procedures, leading doctors to conclude that those
additional patients may have been exposed.
Both privately run Cedars-Sinai and UCLA, a public hospital, say
they were offering potentially exposed patients free home-testing
kits. The two facilities also said they have begun using enhanced
disinfection procedures, above and beyond the manufacturer
recommendations.
Duodenoscopes have been associated with episodic infections for more
than a decade. But an increasing number of germs have developed a
resistance to antibiotics, making them potentially more dangerous
and difficult to treat.
(Editing by Eric Walsh, Mohammad Zargham and Ken Wills)
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