Healthcare Hygiene magazine December 2019 | Page 32

approach when duodenoscope sterilization was uncommon.
However, given the need to provide an adequate margin of
safety to mitigate the risk of infection for patients, the FDA
says it is considering a recommendation that durability testing
include a worst-case number of terminal sterilization cycles (i.e.,
the same number of sterilization cycles as cleaning/high-level
disinfection). Alternatively, duodenoscope manufacturers may
identify the number of sterilization cycles that the device is
compatible with and use the labeled number of sterilization
cycles in the durability testing.
The November panel’s consensus was that standardized
durability testing was appropriate, because damage to the
duodenoscopes was not often
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recognized by healthcare
rendering of the
personnel. The panel noted
duodenoscope distal tips
that the details of the durability
testing should be further discussed and refined with industry.
The panel discussed the potential of new designs to reduce
duodenoscope contamination rates and the urgency with
which the transition should be made.
Haugen emphasized that the distal end of scopes poses
a significant challenge to cleaning and high-disinfection,
and explained that since 2017, two scopes with disposable
components have been cleared by the FDA.
“The disposable cap improves access for cleaning,”
Haugen said at the November hearings. “From media
reports, we’ve learned that manufacturers are considering
more disposable components and developing completely
disposable duodenoscopes. Device design is a key factor that
contributes to reprocessing challenges. In agreement with
conclusions from the 2015 panel convened by the FDA, the
best solution to reduce the risk of infection by duodenoscopes
is through innovative device designs that make reprocessing
easier more effective or unnecessary. In August, the FDA
recommended the transition to disposable components
and asked duodenoscope manufacturers to transition from
fixed caps to reduce or eliminate the need for reprocessing.
FDA recognizes that a transition away from conventional
duodenoscopes to the newer, innovative models will take
time, due to costs and market availability. We encourage
healthcare facilities purchasing new duodenoscopes to begin
developing a transition plan and work to replace conventional
duodenoscopes with newer models.”
The panel’s consensus was that there is a potential that
the new designs could reduce contamination, but there is
insufficient data to demonstrate that reduction. The panel
commented that additional modifications to the device design
and reprocessing instructions, education, and practices could
be made.
“New designs are predicted to improve reprocessing
outcomes,” Haugen said at the November hearings. “Upon
completion of manufacturers’ new post-market surveillance
studies of duodenscopes with disposable end caps to verify
that the new designs reduce the contamination rate, we expect
the labeling to be updated with contamination rate data.”
The panel also was asked to comment on the appropriate
balance between obtaining data premarket versus post-market
for devices that are intended to reduce the risk of infection
from duodenoscopes. The panel noted that there is a need to
demonstrate effectiveness of designs intended to reduce the
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risk of contamination prior to those devices being available
for use, however the challenges associated with generating
such data prior to marketing were also noted.
In late August, the FDA recommended that duodenoscope
manufacturers and healthcare facilities transition to different
types of duodenoscopes that may pose less risk to patient
safety. Specifically, because of challenges with cleaning these
devices for reuse (reprocessing) and persistent high levels
of contamination, the agency is recommending moving
away from using duodenoscopes with fixed endcaps to
those with disposable components that include disposable
endcaps—or to fully disposable duodenoscopes when they
become available. Disposable designs simplify or eliminate the
need for reprocessing, which may reduce between-patient
duodenoscope contamination as compared to reusable, or
fixed endcaps.
“We recognize that a full transition away from conventional
duodenoscopes to innovative models will take time and imme-
diate transition is not possible for all healthcare facilities due to
cost and market availability,” said Jeff Shuren, MD, JD, director
of the FDA’s Center for Devices and Radiological Health, in
a recent statement. “This is why we’re communicating with
healthcare facilities now—so they can begin developing a
transition plan to replace conventional duodenoscopes—and
those facilities that are purchasing duodenoscopes with fixed
endcaps can invest in the newer, innovative models. We are
also encouraging the manufacturers of these duodenoscope
models to assist healthcare facilities with their transition plans.
We continue to work with manufacturers to increase the
supply of disposable cap duodenoscopes and the development
of other new and innovative device designs that will further
minimize or eliminate the risk of patient infection. Duodenos-
copes remain critical to life-saving care for many patients in the
U.S. While the risk of infection from inadequate reprocessing
is relatively low, we are taking action because of continuing
elevated levels of contamination in duodenoscopes.”
Also in late August, the FDA announced additional steps it is
taking, including ordering new post-market surveillance studies
on duodenoscopes with disposable endcaps, requesting the
inclusion of real-world contamination rates in duodenoscope
labeling, and issuing letters to manufacturers of certain test
strips used to assess duodenoscope cleanliness that have not
been through proper FDA premarket review.
Reprocessing of duodenoscopes involves cleaning outside
surfaces, interior channels and the elevator recess to remove
tissue and fluids, followed by high-level disinfection to reduce
harmful microbes so that the device is reasonably assured to
be free of the risk of disease transmission. Failure to correctly
reprocess a duodenoscope could result in tissue or fluid from
one patient remaining in a duodenoscope and potential
for disease transmission. Information from post-market
surveillance human factors studies indicate that many steps
in the reprocessing instructions cannot be reliably followed
by healthcare facilities.
The FDA says it is concerned about the results of
post-market human factors studies it required of each U.S.
duodenoscope manufacturer (Fujifilm, Olympus and Pentax)
to evaluate whether healthcare facility staff could understand
and follow the manufacturer’s reprocessing instructions in
real-world healthcare settings.
december 2019 • www.healthcarehygienemagazine.com