Healthcare Hygiene magazine November 2019 | Page 14

cover story
Defining “Clean”
in Sterile Processing
Patient-Ready Scopes
Remain Contaminated
After Reprocessing
By Kelly M. Pyrek
F
or the last several years, research-
ers have been sounding the
This is the
alarm about processed, presumably
second in
patient-ready endoscopes that have
a series
retained bioburden and pose a risk
of articles
to patients. And the Food and Drug
examining how
Administration (FDA) has been doubling
“clean” is being
down on its scrutiny of scope manufac-
defined in the
turers since high-profile outbreaks and
healthcare
patient deaths linked to contaminated
environment.
scopes have been making headlines.
The discovery of still-contaminat-
ed scopes coming out of sterile processing departments
despite manual cleaning and high-level disinfection (HLD)
cycles in automated endoscopic reprocessors (AERs) has
changed everything we thought we knew about how to
reduce and eliminate risk posed by invasive medical devices
and instruments.
In 2014, Cori Ofstead, MSPH, president and CEO of
Ofstead & Associates, and colleagues, presented a paper
at the annual APIC meeting that alarmed the infection
prevention community by its startling conclusion that
despite guideline adherence by sterile processing techni-
cians, endoscopes remained contaminated with debris and
microorganisms. Furthermore, Ofstead, et al. (2014) found
that visual inspections performed during manual cleaning
did not identify the debris that researchers could visualize
on white swabs during data collection, and rapid-indicator
tests detected contamination on endoscopes with and
without visible debris. Additionally, cultures confirmed viable
microorganisms after manual cleaning and HLD.
In their study, endoscope reprocessing was directly
observed during 60 encounters with 15 used colonoscopes
and gastroscopes at a large tertiary-care medical center.
Researchers documented adherence with guidelines. Surface
swabs were used to sample distal ends, control handles,
ports, caps, and buttons. Water samples were obtained
from suction-biopsy channels and auxiliary water channels.
Samples were tested for protein, blood, carbohydrates, and
adenosine triphosphate (ATP) using rapid indicator tests.
Aerobic cultures were performed, and positive cultures
were sent to a reference lab for species identification.
Researchers visually inspected 500 endoscope components
NOTE
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and conducted 588 rapid indicator tests, including surface
protein, surface ATP, water ATP and dipsticks for protein,
blood, and carbohydrates. Cultures were performed on
88 channel effluent samples. No residue was visible on
endoscopes after manual cleaning. Residue was seen on
swabs or in effluent for 31 percent of post-manual cleaning
samples and zero post-HLD samples. After manual cleaning,
samples exceeded benchmarks for ATP (46 percent biopsy
ports) and protein (75 percent handles). Post-HLD tests
revealed persistent contamination (p<.05). Colony counts
from bedside-cleaned channel samples were higher than
manually cleaned and disinfected counts.
This study came on the heels of a 2013 Ofstead-pro-
duced paper tackling endoscopy-associated infection (EAI)
risk estimates and their implications, which shattered any
remaining complacency about scope-associated infections.
As Ofstead and Dirlam Lang (2013) remind us, “Recent
audits have documented widespread lapses in infection
control involving medical equipment. Inspections of multiple
facilities determined that certain endoscopy equipment was
not properly reprocessed for up to several years. Direct
observation in a multisite study revealed that endoscopes
were virtually never reprocessed in accordance with
guidelines. The implications of these lapses are unknown
because no epidemiologic studies have determined the risk
of EAI associated with reprocessing quality.” In their paper’s
conclusion, they asserted that, “Evidence indicates that
current EAI risk estimates are inaccurate, outdated, based
on flawed methodology, and can have profound effects
on patients. These extremely low risk estimates are used
to justify the lack of reporting, routine monitoring, patient
notification, and laboratory testing following a lapse. In 1993,
researchers recommended prospective studies involving both
patient monitoring and laboratory cultures be conducted to
evaluate the risk of transmitting infections via contaminated
endoscopes. Today, there remains a need for epidemiologic
studies to accurately estimate the risk of EAI and other
complications. Prospective studies should involve observation
of reprocessing practices, microbial testing, and outcomes
assessment. The results could be used to develop criteria
for patient notification and reporting of reprocessing lapses
and assist decision makers in determining what actions to
take when a lapse occurs.”
november 2019 • www.healthcarehygienemagazine.com