Healthcare Hygiene magazine November 2019 | Page 20

contaminators, washer-sterilizers) in conjunction with water
and detergents to remove foreign material.”
The document adds, “In the past, a device was consid-
ered ‘clean’ if the person who was performing the cleaning
task observed no visible foreign material. Today, however,
more devices have long or narrow opaque lumens, crevices,
hinges, acute angles, serrated edges, junctions between
insulating sheaths, coils, or other designs that make it diffi-
cult or impossible to rely on the traditional visual endpoint.
In addition, visual observation might not be adequately
sensitive to detect levels of soil that could interfere with
subsequent reprocessing.”
And as Grein and Murthy (2018) remind us, “… semi-crit-
ical medical devices are far more likely to be associated with
disease transmission compared with critical or non-critical
devices. Semi-critical devices such as endoscopes are often
contaminated with a high degree of bacterial bioburden,
possess long channels or intricate designs that are challenging
to clean, and are prone to biofilm production when moisture
is present. Also, as described by Rutala and Weber, any
breach in the reprocessing protocol can lead to significant
contamination. Specifically, the cleaning step may reduce the
bacterial burden by 2 to 6 log10, and HLD may reduce it by an
additional 4 to 6 log10, for a total of 6 to 12 log10. Because
GI endoscopes may contain 107 enteric microorganisms after
use, the margin of safety in HLD of GI endoscopes is low to
nonexistent, in stark contrast with the 17 log10 margin of
safety in sterilization of surgical equipment.”
They add that, “Prompt bioburden removal before HLD
is the most important step of reprocessing, because the
presence of bioburden impedes the effectiveness of the
high-level disinfectant. The cleaning procedure includes
precleaning, a leak test, and manual cleaning and reduces
the number of microorganisms and organic debris by 4 logs
or 99.99 percent.”
However, they acknowledge that the complexity of
cleaning places a significant burden on technicians and
their supervisors to ensure that every step is done correctly
before HLD: “Some AERs currently on the market perform
automated cleaning in addition to HLD, although they do
not replace the initial immediate cleaning step performed at
bedside. Although automation provides greater standard-
ization and reduces the risk of human error, the reliability
of these devices is yet to be confirmed through indepen-
dent peer-reviewed studies in clinical settings.” They add,
“Endoscope reprocessing requires meticulous attention to
detail and rigid compliance with reprocessing instructions.
Unfortunately, lapses are common and frequently implicated
in exposure events or outbreaks.”
Recently updated multi-society guidelines provide current
recommendations for critical steps in reprocessing flexible GI
endoscopes and incorporates guidance specific to duodeno-
scopes. Experts emphasize that strict compliance with HLD
processes is a critical requirement for all endoscopes. For
duodenoscopes, all personnel must additionally be trained
and knowledgeable in new recommendations for additional
flushing and cleaning steps for the elevator channel. Experts
advise healthcare facilities to implement recent interim
guidance from the FDA for duodenoscope reprocessing and
ensure compliance with updated recommendations as they
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become available. In response to the multiple duodenos-
cope outbreaks, the FDA and CDC outlined four optional
additional enhanced disinfection measures for consideration
by healthcare providers to decrease the risk of infection
and include microbiologic testing of duodenoscopes after
processing, ethylene oxide (ETO) sterilization, use of liquid
chemical sterilants for HLD, and repeat HLD.
Regarding sterilization of certain scopes, Grein and Mur-
thy (2018) note, “ERCP endoscopes and reusable accessories,
such as biopsy forceps, are used in sterile body cavities and
as such, many experts consider that they should be classified
as critical devices.”
The future remains unwritten, but as Grein and Murthy
(2018) acknowledge, “Many issues remain unresolved in
the current guidelines owing to the lack of robust data to
develop specific recommendations. However, it is clear that
compliance with accepted guidelines for the reprocessing
of GI endoscopes between patients is critical to the safety
and success of their use and that, when these guidelines
are followed, pathogen transmission can be minimized.
Increased efforts and resources should be directed to
improve compliance with these guidelines and to future
research in prevention of GI endoscope related infections.
In the meantime, health care facilities should improve their
own internal quality control processes, regularly reinforce
necessary competencies, and consider performing post-pro-
cedure infection surveillance. Until methods to sterilize these
devices can be implemented to ensure optimal patient safety
from infection risks associated with GI endoscopy, continued
vigilance is required to ensure strict adherence to current
reprocessing guidelines and to detect infrequent infections
that may signal breaks in adherence to current processes,
design flaws that increase risk, or damaged equipment.”
Despite the chorus of voices echoing the criticality of
proper reprocessing, investigators looking into the kinds of
contamination and defects found in processed scopes has
uncovered a host of alarming discoveries. Guidelines are
increasingly recommending the use of lighted magnification
and visualization following reprocessing to identify any
residual contamination, as studies comparing visual and
microscopic analysis have demonstrated that visual inspection
alone is insufficient to determine cleanliness.
Researchers have confirmed that what technicians
can’t see with the naked eye can hurt their patients.
Ofstead, Wetzler and Heymann, et al. (2017) conducted
a study involving visual inspections with a borescope,
microbial cultures, and biochemical tests for protein and
ATP to identify endoscopes in need of further cleaning or
maintenance. Three assessments were conducted over a
seven-month period; the control group endoscopes were
reprocessed using customary practices and were compared
with intervention group endoscopes subjected to more
rigorous reprocessing. At final assessment, all endoscopes
(N = 20) had visible irregularities. Researchers observed fluid
(95 percent), discoloration, and debris in channels. Of 12
(60 percent) endoscopes with microbial growth, four had
no growth until after 48 hours. There were no significant
differences in culture results by study group, assessment
period, or endoscope type. Similar proportions of control
and intervention endoscopes (about 20 percent) exceeded
post-cleaning biochemical test benchmarks. ATP levels
november 2019 • www.healthcarehygienemagazine.com