Healthcare Hygiene magazine December 2019 | Page 31

In April 2019, the FDA updated the post-market
surveillance study results for duodenoscopes used in ERCP
and reminded healthcare facilities about the importance
of strictly adhering to the manufacturer’s reprocessing and
maintenance instructions, following best practices, and
reporting adverse event information to the FDA.
In August 2019, the FDA updated the post-market
surveillance study results for duodenoscopes used in ERCP
and provided additional recommendations and updates:
 Hospitals and endoscopy facilities should begin
transitioning to duodenoscopes with innovative designs that
facilitate or eliminate the need for reprocessing.
 Issuing new mandated post-market surveillance study
orders to manufacturers of duodenoscopes with disposable
endcaps to gather more data and verify that the new designs
reduce the contamination rate. (Upon completion of these
studies, the FDA expects the labeling on duodenoscopes
with disposable endcaps to be updated with contamination
rate data.)
 Warning healthcare facilities that adenosine triphosphate
(ATP) test strips should not be used to assess duodenoscope
cleaning. To date, the FDA has not evaluated them for
effectiveness for assessing duodenoscope reprocessing.
Manufacturers of ATP test strips are advised to submit data
to support the legal marketing of these strips for this use.
At the November 2019 FDA hearings, IAHCSMM clinical
educator, Susan Klacik, emphasized that exacerbating the
problem was the design of medical devices, particularly that
of scopes. Citing their complex design, Klacik said they are
difficult, if not impossible to clean, and that the materials
used in the manufacturing of the scopes can be difficult
to thoroughly clean if heavily soiled post-procedure. She
explained that internal channels become scratched during
use, creating optimal conditions for microbial growth, and
added that it can be difficult to visualize debris and defects.
Compounding these issues are complex IFUs that require
numerous processing steps.
Klacik further detailed additional challenges, including:
 Lengthy processing time, with the labor time needed
to clean medical devices as being more than an hour
 The technology needed for processing may not be
available in all facilities, including the availability of borescopes
and the use of other cleaning-verification testing methods
 Education and training of sterile processing personnel
is an imperative, yet barriers include the competency levels
of sterile processing techs, ranging from entry to expert
 Repeated motions required in sterile processing may
result in occupational injuries
 Turn-around demands for medical devices are high
and often unrealistic
The consensus of the November panel was that training
of reprocessing personnel was of utmost importance.
The panel recognized that such training falls outside of
FDA’s purview; nonetheless, FDA was encouraged to
collaborate with manufacturers, accrediting organizations,
and other stakeholders to promote correct reprocessing of
duodenoscopes in healthcare settings. Some panel members
commented that the magnitude of the problem did not raise
concerns, and that FDA mandates on strategies to reduce the
risk of infection for duodenoscopes would not be helpful.
www.healthcarehygienemagazine.com • december 2019
The panel recommended that FDA carefully consider next
steps and make deliberate decisions.
The panel discussed FDA’s proposal to standardize
duodenoscope durability testing. Shani Haugen, PhD, a
microbiologist with FDA’s Center for Devices and Radiolog-
ical Health, noted, “The FDA is considering an additional
durability test required for reusable duodenoscopes, as
there are no standardized methods currently -- different
scope manufacturers will use different methods for testing
if their device is durable enough for multiple uses. Labeling
recommends functional tests such as leak testing, and an
optical performance check, as well as visual inspection of
the device to determine whether the scope should continue
to be used. The labelling will request annual inspection
to identify any damage the scope may have sustained.
Studies from manufacturers attribute some damage to the
duodenosocopes from cleaning and high-level disinfection.”
Haugen said the FDA proposal includes the requirement of
250 cycles of simulated use of cleaning, high-level disinfection
and sterilization.
Duodenoscope pre-market submissions have included
different types of mechanical testing, according to the FDA.
Because initial analyses from duodenoscope manufacturers and
reports from the literature have indicated that device damage
may lead to continued contamination of duodenoscopes after
reprocessing, the FDA is seeking to standardize the types
of mechanical and durability tests that are conducted prior
to marketing reusable duodenoscopes, and is requesting
feedback from the committee on the testing to demonstrate
that duodenoscopes can withstand reprocessing cycles,
including sterilization.
Since 2015, FDA has requested that duodenoscope
manufacturers recommend at least annual maintenance of
duodenoscopes. During the maintenance visit, duodenoscope
manufacturers will inspect components of the device and
replace damaged or worn parts, as well as those components
that require periodic replacement. Because duodenoscopes
should undergo at least annual maintenance, durability testing
should include a worst-case simulation of duodenoscope use in
a healthcare facility within a single year. That simulation should
include simulated clinical use and simulated reprocessing.
To identify the number of times a single duodenoscope may
be clinically used in a single year, FDA considered reports from
the literature, conducted informal surveys of healthcare, and
assessed the number of simulated use cycles conducted by
duodenoscope manufacturers in their premarket submissions.
Based on these estimates, the FDA says a minimum of 250
cycles to simulate uses in a single year appears reasonable
for durability testing.
Current durability testing includes simulated clinical use
of the device (repeated insertion of worst-case accessory
instruments, angulation of the bending section of the duode-
noscope while worst-case accessory instruments are within the
instrument channel, and angulation of worst-case accessory
instruments by the elevator) and simulated reprocessing (e.g.,
cleaning and high level disinfection in accordance with the
duodenoscope manufacturer’s reprocessing instructions).
According to the FDA, duodenoscope durability testing
typically has not included a worst-case number of terminal
sterilization cycles, and this may have been a reasonable
31