Healthcare Hygiene magazine November 2019 | Page 17

The FDA’s Role
CLICK HERE FOR THE DIRTY SCOPES GALLERY
New and pristine endoscope channels (images
1-3) are contrasted with endoscopes that are
damaged: crushed and pinched channel (image 4);
dirty channel (image 5); debris in channel (image
6); water drops left inside a channel (image 7);
damaged distal ends (images 8-9). All images
courtesy of Healthmark Industries Co.
However, the complexity of endoscopes
requires rigorous adherence to currently
accepted reprocessing guidance. The
endoscope features that challenge the
reprocessing procedures, according to
Lichtenstein and Alfa (2019), include:
• Complex endoscope design with
several long, narrow internal channels
and bends that make it difficult to
remove all organic debris and micro-
organisms (e.g., elevator channel and
elevator lever cavity of duodenoscopes).
• A large variety of endoscope man-
ufacturers require different cleaning
procedures and devices and materials.
• Occult damage (e.g., scratches,
crevices) to the endoscope can se-
quester microorganisms and promote
biofilm formation.
Human factors is an undeniable
component of the narrative around
lack of compliance with reprocessing
guidelines. For example, Ofstead, et al.
(2010) demonstrated that compliance
with all the reprocessing steps occurred
for only 1.7 percent of flexible endo-
scopes reprocessed when cleaning
steps were performed manually and
disinfection was automated, compared
to 75.4 percent compliance when
both cleaning and disinfection were
automated. As the researchers note,
“Until recently, the only aspect of this
process that was monitored was to test
the MEC of the high-level disinfectant
to ensure it contained a sufficient con-
centration of the active ingredient …
Often staff are not aware of additional
channels in new models of endoscopes
and are not trained on specific cleaning
requirements. The use of different sizes
and types of channel brushes for the
various channel sizes, the fact that
some channels cannot be brushed,
and the multitude of different types of
cleaning brushes available makes du-
odenoscope reprocessing a confusing
process prone to human error.”
R
isk management related to scopes
was placed on everyone’s radar
when the FDA began to step up its
oversight. In fall 2013, the Centers
for Disease Control and Prevention
(CDC) alerted the FDA to a potential
association between multidrug-re-
sistant bacteria and duodenoscopes.
Upon further investigation, it became
clear that these cases of infection
were occurring despite confirmation
that the users were following proper
manufacturer cleaning and disinfection
or sterilization instructions.
In mid-May 2015, the FDA con-
vened the Gastroenterology-Urology
Devices Panel of the Medical Devices
Advisory Committee to seek expert
scientific and clinical opinion from
healthcare, consumer and industry
representatives related to reprocessing
of duodenoscopes based on available
scientific information. Following two
days of presentations, testimony and
other input, panel participants were
asked to answer questions focused
on duodenoscope and AER safety
and effectiveness, notably strategies
to promote adherence to reprocessing
instructions, the CDC’s Interim Duode-
noscope Surveillance Protocol, and risk
communication. Potential strategies
emerged in the following areas:
➊ Manual Cleaning and
Human Factors
Manual cleaning prior to disinfection
or sterilization is critical to effective
reprocessing. To ensure that manual
cleaning is performed consistently and
accurately, the panel recommended
strengthening competency training for
reprocessing staff in healthcare facility
reprocessing departments and incor-
porating human-factors testing when
developing reprocessing instructions. It
is important to consider the device, end
user and use environment when devel-
oping reprocessing instructions. Thus,
human-factors testing ensures that
end users will be able to understand
and correctly follow the reprocessing
instructions in the labeling.
➋ Device Design
Duodenoscopes should be designed
to enable meticulous cleaning
and disinfection or sterilization;
www.healthcarehygienemagazine.com • november 2019
Continued on page 18
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