Healthcare Hygiene magazine November 2019 | Page 22

of residual contamination may be essential to identify sub-
optimal reprocessing and proactively identify endoscopes in
need of repair or refurbishment. Residual fluid found inside
endoscopes indicate that current industry standards do not
effectively dry endoscopes, which is essential to minimize
growth of environmental contaminants and potential
pathogens. The association between visual abnormalities,
biochemical markers of contamination, microbial growth,
and the potential for adverse patient outcomes is not
known. Research is needed to establish optimal methods
and frequency for assessing endoscopes for visual abnor-
malities, residual contamination, and microbial growth, as
well as a schedule for routine maintenance. At this time,
the goal is for every institution to have documented proof
that their endoscopes are in good working order and are
not contaminated in ways that put patients at risk.”
Some researchers disagree that current cleaning and
disinfection methods are adequate, and some have raised the
issue of the contamination and the damage to endoscopes
that accumulate over extended time and use. Ofstead and
Wetzler, et al. (2016) evaluated flexible endoscope damage
and contamination levels at baseline and two months later in
an ambulatory surgery center and found that post-cleaning
test results exceeded benchmarks for all gastroscopes and
no colonoscopes. Microbial growth was found in samples
from 47 percent of fully reprocessed endoscopes at base-
line and 60 percent at follow-up. Borescope examinations
identified scratches, discoloration, debris and fluid inside
endoscopes, and further documented that irregularities
changed over time.
Researchers found that total microbial growth was <10
CFU for every endoscope except a PC (17 CFU) at baseline
and a different PC (24 CFU) at follow-up. Cultures were
more commonly positive for gastroscopes (80 percent) than
colonoscopes (33 percent) at baseline, but not at follow-up
(60 percent for both). Common skin and GI flora and
nonpathogenic soil bacteria were found. Positive controls
(pre-cleaned endoscopes) had very high colony counts and
ATP levels >600 RLU, whereas negative controls (sterile
materials) had ≤2 CFU and ATP <30 RLU.
Irregularities observed during borescope examinations of
patient-ready endoscopes included scratches, discoloration,
surface damage, debris, and residual fluid. Debris retrieved
from one endoscope was later determined to be a fragment
of channel lining. Channel irregularities appeared to change
over time, with additional damage observed in endoscopes
that were reassessed two months after the baseline. Dis-
coloration found in control group channels at baseline was
similar two months later but was reduced in the intervention
group. After the baseline assessment, two endoscopes were
sent out for repair due to borescope examination findings.
During the two-month assessment, one endoscope failed a
leak test and three other endoscopes were quarantined and
sent out for repair based on borescope examinations and
tests for residual contamination. The manufacturer deter-
mined all the endoscopes to have multiple critical defects.
Ofstead and Wetzler, et al. (2016) concluded that their
findings confirmed results from other studies that found
GI endoscopes were frequently contaminated despite
reprocessing in accordance with guidelines: “Our findings
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lend support to new recommendations for enhanced visual
inspections and cleaning verification. ATP tests and borescope
examinations allowed damaged and contaminated endo-
scopes to be identified so they could be re-reprocessed or
repaired as needed to prevent biofilm buildup and potential
transmission of infection.”
In the recent webinar, “Conducting visual examinations
of flexible endoscopes: A focus on channels and ports,”
researcher Cori Ofstead, of Ofstead & Associates, summa-
rized her many inquiries into the contamination of presumed
patient-ready status of contaminated endoscopes. She
reminds us why proper endoscope reprocessing is important:
• Endoscopes are contaminated during procedures
• Contaminated endoscopes transmit pathogens effectively
• Infections and injuries have been linked to every type
of endoscope
• Endoscope-related infections and injuries should be
preventable
• Current reprocessing and maintenance practices are far
below standards
• There are implications for patient safety and public health
The cause-and-effect between damaged and contam-
inated endoscopes is very real. As Ofstead pointed out,
reports to the FDA include endoscope defects contributing
to mucosal trauma and bleeding in the patient, requiring
the procedure to stop. Additionally, debris and bioburden
retained in scopes after reprocessing has been reported to
the FDA. The type of retained material ranges from human
and foreign tissue, to debris from channel shredding.
Ofstead emphasized that when she and her team
examined scopes, most of the so-called “patient-ready”
instruments retained bacteria even after cleaning and HLD.
What’s more, these contaminated scopes were linked to
infectious outbreaks among patients. Ofstead further em-
phasizes that visual inspection could have prevented these
adverse events. AORN, AAMI and SGNA all recommend
this step in their guidelines:
 Perform visual inspection every time a scope is used
 Use good lighting and magnification
 Consider using a borescope for channels
 Evaluate endoscope cleanliness
 Look for any visible damage or defects
Additionally, manufacturers’ IFUs recommend visual
inspection, Ofstead said, advising technicians to look
for any irregularities, including scratches, cracks, chips,
tears, pitting, peeling, stains, discoloration, deterioration,
protruding objects into the channel, and adhesion of any
foreign bodies. Manufacturers advise users to never utilize
a scope with irregularities on a patient, to troubleshoot
from the IFUs, and in the worst-case scenario, to send the
scope out for repair.
In her webinar, Ofstead offered the following
critical insights:
 Routine visual inspections could have identified
the damage and retained debris that harmed patients
 Visual inspection of endoscopes will find prob-
lems; ensure you have a plan for responding to these findings
 Retained moisture fosters the growth of bacteria, mold
and biofilm; scopes should be completely dry before storage
november 2019 • www.healthcarehygienemagazine.com