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

[Glenys Harrington]

Dear All,

This warning from the FDA in the USA will be of interest to those following
the outbreaks of CRE related to ERCP procedures and possible design features
of the duodenoscopes which make meticulous cleaning difficult.

The information will be of interest to your colleagues in gastroenterology
settings.

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

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

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MedWatch – The FDA Safety Information and Adverse Event Reporting Program

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

UPDATED 03/04/2015: The Safety Communication has been updated. Please refer
to the FDA Safety Communication
for details. Updated Information for Healthcare Providers Regarding
Duodenocopes is provided.

UPDATED 02/23/2015. The Safety Communication has been updated. Please refer
to the FDA Safety Communication
for details.

[Posted 02/19/2015]

Engineering, Patient

including those working in reprocessing units in health care facilities,
that the complex design of ERCP endoscopes (also called duodenoscopes) may
impede effective reprocessing. Reprocessing is a detailed, multistep process
to clean and disinfect or sterilize reusable devices. Recent medical
publications and adverse event reports associate multidrug-resistant
bacterial infections in patients who have undergone ERCP with reprocessed
duodenoscopes, even when manufacturer reprocessing instructions are followed
correctly. Meticulously cleaning duodenoscopes prior to high-level
disinfection should reduce the risk of transmitting infection, but may not
entirely eliminate it.The FDA is closely monitoring the association between
reprocessed duodenoscopes and the transmission of infectious agents,
including multidrug-resistant bacterial infections caused by
Carbapenem-Resistant Enterobacteriaceae (CRE) such as Klebsiella species and
Escherichia coli. In total, from January 2013 through December 2014, the FDA
received 75 medical device reports encompassing approximately 135 patients
in the United States relating to possible microbial transmission from
reprocessed duodenoscopes. It is possible that not all cases have been
reported to the FDA. The agency is continuing to evaluate information about
documented and potential infections from multiple sources, including medical
device reports submitted to the FDA, the medical literature, the health care
community, professional medical societies, and the Centers for Disease
Control and Prevention (CDC). The FDA is actively engaged with other
government agencies, including CDC, and the manufacturers of duodenoscopes
used in the United States to identify the causes and risk factors for
transmission of infectious agents and develop solutions to minimize patient
exposure.The FDA continues to actively monitor this situation and will
provide updates as appropriate.

through the mouth, throat, stomach, and into the top of the small intestine
(the duodenum). They contain a hollow channel that allows the injection of
contrast dye or the insertion of other instruments to obtain tissue samples
for biopsy or treat certain abnormalities.

for additional information and recommendations for facilities and staff
that reprocess ERCP duodenoscopes.

Recommendations for Health Care Providers:

*Inform patients of the benefits and risks associated with ERCP
procedures.
*Discuss with your patients what they should expect following the
ERCP procedure and what symptoms (such as fever or chills, chest pain,
severe abdominal pain, trouble swallowing or breathing, nausea and vomiting,
or black or tarry stools) should prompt additional follow-up.
*Submit a report to the manufacturer and to the FDA via MedWatch, as
described below, if you suspect that problems with reprocessing a
duodenoscope have led to patient infections.

Recommendations for Patients:

*Discuss the benefits and risks of procedures using duodenoscopes
with your physician. For most patients, the benefits of ERCP outweigh the
risks of infection. ERCP often treats life-threatening conditions that can
lead to serious health consequences if not addressed.
*Ask your doctor what to expect following the procedure and when to
seek medical attention. Following ERCP, many patients may experience mild
symptoms such as a sore throat or mild abdominal discomfort. Call your
doctor if, following your procedure, you have a fever or chills, or other
symptoms that may be a sign of a more serious problem (such as chest pain,
severe abdominal pain, trouble swallowing or breathing, nausea and vomiting,
or black or tarry stools).

Healthcare professionals and patients are encouraged to report adverse
events or side effects related to the use of these products to the FDA’s
MedWatch Safety Information and Adverse Event Reporting Program:

*Complete and submit the report Online: http://www.fda.gov/MedWatch/report

*Download form
or call 1-800-332-1088 to request a reporting form, then complete and
return to the address on the pre-addressed form, or submit by fax to
1-800-FDA-0178

Read the MedWatch safety alert, including links to the Safety Alert at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMed
icalProducts/ucm434922.htm

You are subscribed to MedWatch Safety Alerts for U.S. Food & Drug
Administration (FDA). This information has recently been updated, is now
available
.

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problems to FDA MedWatch at http://www.fda.gov/medwatch/report.htm

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