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April 28, 2005
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Safety Notice: Infection Control Advisory
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- Between 2002-2004, several healthcare
facilities in California
were not cleaning an auxiliary water channel on certain models of
gastrointestinal endoscopes. Over 2000 patients received notifications
regarding inadequate reprocessing and were offered serologic testing
for bloodborne pathogens (HIV, HBV, and
HCV).
- In February of 2003 the
manufacturer circulated a safety notice regarding this potential
reprocessing error and cautioned users to reprocess the channel
whether or not it was used during the procedure. The FDA published a
safety alert on the same subject in April 2003.
- Despite these warnings, a
similar reprocessing failure was recently reported in Pittsburgh in March 2005, resulting
in approximately 200 patient notifications and recommendations for
serologic testing for bloodborne pathogens.
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Endoscopes have several internal tubes
or channels (air, water, and suction/working channels) that are routinely
disinfected in automatic endoscope reprocessors (AERs). Certain channels,
such as the elevator channels of echoendoscopes
and duodenoscopes, may not be disinfected by all types of AERs, and the
user must follow instructions from the manufacturers of the AER and the
endoscope to insure compatibility. The current issue arises from the
presence of an auxiliary water channel on some models of endoscopes. This extra
channel allows the endoscopist to direct a stream of water to clear blood
or debris off the surface of the GI tract to facilitate the procedure.
However, some users have failed to clean and disinfect this auxiliary
channel, either because they were unaware that the channel existed, or they
mistakenly believed that it did not require disinfection if not used.
While these reprocessing failures represent a vanishingly small fraction of
the millions of endoscopic procedures performed annually in the United States,
it is critical that compliance with existing
guidelines be maintained. All channels of the endoscope, whether or not
they are used during the procedure, must be cleaned and disinfected
according to the manufacturer's instructions.
ASGE and SGNA are dedicated to the safety of gastrointestinal
endoscopy, and strongly urge all members to verify their reprocessing
protocols to ensure that all endoscope channels are appropriately
reprocessed.
The American Society for
Gastrointestinal Endoscopy (ASGE), founded in 1941, is the preeminent
professional organization dedicated to advancing the practice of Endoscopy.
ASGE, with more than 8,000 physician members worldwide, promotes the
highest standards for endoscopic training and practice, fosters endoscopic
research, recognizes distinguished contributions to endoscopy, and is the
foremost resource for endoscopic education.
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Source: American Society for Gastrointestinal Endoscopy, Oak Brook, IL
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About ASGE: www.asge.org
630.573.0600
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Patient Information: www.askasge.org
866.305.ASGE (2743)
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The Society of Gastroenterology Nurses
and Associates (SGNA), founded in 1973, is a professional organization of
over 7,000 specialty practice nurses and associates dedicated to the safe
and effective care of patients with known or suspected gastrointestinal
problems who are undergoing diagnostic or therapeutic treatment and/or
procedures. The Society has issued a number of formal Position Statements
and Guidelines on topics related to proper reprocessing, which can be found
at www.sgna.org/Resources/position.cfm.
SGNA carries out its mission by advancing the science and practice of
gastroenterology and endoscopy nursing through education, research,
advocacy, and collaboration, and by promoting the professional development
of its members in an atmosphere of mutual support.
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