FW: PRO/EDR> Antibiotic-resistant Enterobacteriaceae – USA (03): (CA,CT) ERCP endoscopes

[Glenys Harrington]

Dear All,

Further to my posting last week in relation to the carbapenem-resistant
Enterobacteriaceae (CRE)/ endoscopic retrograde cholangiopancreatography
(ERCP) outbreaks in the USA this posting on ProMed today will be of interest
– see below.

Thank you to those working in endoscopy unit/s who contacted me advising of
a new design feature (sealing of the forceps elevator wire) that they
believe now makes it very difficult to clean the area around moving parts of
the forceps elevator and the forceps elevator recess.

As per the FDA Alert (Date Issued: February 19, 2015, Updated: February 23,
2015 Updated: March 4, 2015) below:

“The elevator mechanism changes the angle of the accessory exiting the
accessory channel, the moving parts of the elevator mechanism contain
microscopic crevices that may not be reached with a brush. Residual body
fluids and organic debris may remain in these crevices after cleaning and
disinfection. If these fluids contain microbial contamination, subsequent
patients may be exposed to serious infections”.

The instructions for cleaning these types of dueodenoscopes are very
detailed – as an example see the “Olympus Quick Reference Guide for Cleaning
the TJF-Q180V elevator mechanism”, attached.

Please bring this issue and the outbreaks below to the attention of your
endoscopy colleagues to ensure thy are aware of these cleaning requirements.

Find below links to the FDA alerts and an editorial by William A. Rutala,
PhD, MPH and David J.Weber,MD, MPH relating to these outbreaks.
“Gastrointestinal Endoscopes: A Need to Shift From Disinfection to
Sterilization? JAMA October 8, 2014 Volume 312, Number 14”.

FDA Alerts

Endoscopic Retrograde Cholangiopancreatography (ERCP) Duodenoscopes: FDA
Safety Communication – Design May Impede Effective Cleaning

http://www.fda.gov/safety/medwatch/safetyinformation/safetyalertsforhumanmed
icalproducts/ucm434922.htm

Design of Endoscopic Retrograde Cholangiopancreatography (ERCP)
Duodenoscopes May Impede Effective Cleaning: FDA Safety Communication

http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm434871.htm

If anyone would like to discuss this issue with me offline please feel free
to contact me.

Regards

Glenys

Glenys Harrington
Consultant
Infection Control Consultancy (ICC)
PO Box 5202
Middle Park
Victoria, 3206
Australia
M: +61 404 816 434
infexion@ozemail.com.au
ABN 47533508426

—–Original Message—–
On Behalf Of promed@promedmail.org
(CA,CT) ERCP endoscopes

ANTIBIOTIC-RESISTANT ENTEROBACTERIACEAE – USA (03): (CALIFORNIA,
CONNECTICUT) ERCP ENDOSCOPES
****************************************************************************
*****************
A ProMED-mail post

ProMED-mail is a program of the
International Society for Infectious Diseases

Two more hospitals — one in California and one in Connecticut — reported
they’d found drug-resistant “superbugs” on a hard-to-clean type of medical
equipment that’s under federal scrutiny. The devices, called duodenoscopes,
have been modified in a way that allows germs to stick to them, the Food and
Drug Administration [FDA] says.

They’ve been blamed for an outbreak of drug-resistant bacteria that’s killed
at least 2 patients and infected 5 more at UCLA’s [University of California]
hospital. The university has warned about 180 people that they may have had
the same contaminated scope used on them.

Now Cedars-Sinai Medical Center, also in Los Angeles, says it’s found the
same type of carbapenem-resistant Enterobacteriaceae (CRE) in 4 patients who
had procedures using duodenoscopes. The scopes — flexible tubes that carry
a camera and other equipment into the body through the mouth — are
specifically designed for procedures called endoscopic retrograde
cholangiopancreatography (ERCP). They are used to treat patients with
pancreatic cancer and other serious illnesses.

“Despite the fact that Cedars-Sinai meticulously followed the disinfection
procedure for duodenoscopes recommended in instructions provided by the
manufacturer (Olympus Corporation) and the FDA, the medical center’s
infection-control specialists announced today [4 Mar 2015] that their
investigation has identified a total of 4 patients who had a CRE
transmission (carbapenem-resistant Enterobacteriaceae) linked to an ERCP
procedure,” the hospital said in a statement. “The same duodenoscope was
used in all 4 patients, whose ERCPs occurred between August 2014 and January
2015.”

Separately, Hartford HealthCare said it had found a rise in cases of a
different “superbug” but also linked it to the scopes. “A routine monitoring
of cultures done at Hartford Hospital identified an increase in extended
spectrum beta-lactamase _Escherichia coli_ (ESBL), a drug-resistant version
of _E. coli_. After further review, we determined that this increase may
have been associated with having the endoscopic retrograde
cholangiopancreatography (ERCP) procedure,”
the hospital’s chief medical officer Dr Rocco Orlando said in a statement.
At the facility, some 281 patients who underwent certain endoscopic
procedures over the past year were potentially exposed to a drug-resistant
form of _E. coli_, hospital officials said.

“We do not believe any of our patients are in danger, but because safety is
one of our core values, we are reaching out to every patient who has
undergone this procedure and may have come in contact with this version of
_E. coli_. We have been proactive, calling patients this week to alert them,
and asking them to come in for screening,” it added. “We want to assure you
that while the process for cleaning our endoscopes was followed, due to the
same design flaw we are seeing across the country, there is a section of the
scope that is difficult to disinfect. We are no longer using the scopes and
have pulled them from every hospital across our system.”

Cedars-Sinai says it has also removed the suspected device and warned
71 patients who were treated with it.

The FDA says it’s working with the 3 companies that make the devices to get
them approved and to find better ways to clean them. One mechanism at the
tip has microscopic crevices that a brush cannot get into. “Residual body
fluids and organic debris may remain in these crevices after cleaning and
disinfection,” the FDA said in a notice sent out to medical professionals
last month [February 2015]. The 3 companies told FDA they did not know that
the changes they made to the devices meant they needed a new approval from
the agency.

FDA says about 500 000 procedures are done using the devices and says the
small risk of infection is worth the benefit of using the devices.
The patients otherwise would have to have open surgery, which is much
riskier.

Olympus Corp.’s US unit was sued by a Los Angeles hospital patient who says
he was infected. “Olympus continues to monitor and investigate this issue.
We are working with the FDA, relevant medical societies and our customers
regarding these concerns including the consideration of alternative cleaning
and reprocessing methods,” the company said in a statement.

[byline: Maggie Fox]

—
communicated by:
ProMED-mail rapporteur Kunihiko Iizuka

[ProMED-mail has recently reported on outbreaks of infections due to
multidrug resistant _Enterobacteriaceae_ at several hospitals in the US from
contaminated specialized endoscopes used for endoscopic retrograde
cholangiopancreatography, or ERCP (see also’s below). ERCP is a type of
upper gastrointestinal endoscopic procedure. The design of ERCP endoscopes
poses a problem for cleaning and disinfection between reuse.

Hospital staff thoroughly clean ERCP endoscopes manually and then place them
in an automated machine (an automated endoscope reprocessor, or AER) for
high-level disinfection according to manufacturer recommendations. However,
this process may not remove contamination from certain hidden parts of the
apparatus. Some hospitals that have experienced an outbreak have gas
sterilized the instruments using ethylene oxide
().
No new cases have been reported after use of gas-sterilized ERCP endoscopes
().

Ethylene oxide gas is commonly used to sterilize heat-sensitive surgical
items and medical devices. Because ethylene oxide remaining on the endoscope
may be toxic to patients and hospital personnel
(),
the endoscopes must be aerated to remove residual ethylene oxide. The time
this takes increases the instrument’s turn-around-time. However, a
spokeswoman for the UCLA hospital has been reported to have said the
hospital allows time for the gas to wear off to reduce toxicity to patients
and employees and added that Olympus Corp, which manufactures the scopes
used at that hospital, recommends ethylene-oxide gas as an alternative for
sterilization and that it is not harmful to the scopes that UCLA is using
().
– Mod.ML

A HealthMap/ProMED-mail map can be accessed at
.]

[See Also:
Antibiotic-resistant Enterobacteriaceae – USA (02): (CA) fatal, ERCP
endoscopes 20150220.3179359 Antibiotic-resistant Enterobacteriaceae – USA:
(WA) fatal, ERCP endoscopes 20150124.3117058
2014
—
NDM-1 carrying E. coli – USA: (IL) ERCP 20140104.2151607]
………………………………………….ml/msp/sh
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