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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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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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