Healthcare Hygiene magazine November 2019 | Page 18

Predating the CDC’s warning to the FDA by almost two
years, the Association for the Advancement of Medical Instru-
mentation (AAMI) and the FDA held a workshop in 2011 that
actually addressed the definition of “clean” by identifying as
one of its clarion themes the importance of gaining consensus
on ‘how clean is clean’ and on adequate cleaning validation
protocols for reprocessing reusable medical devices. • Research the essential factors to be considered when
defining “clean” for handling and reprocessing medical
devices.
• Develop a common definition or explanation of “clean”
for reprocessed medical devices.
• Standardize test soils for validating the reprocessing
of specific types of medical devices.
The workshop identified three key challenges and barriers
to “clean”:
• Lack of understanding and lack of a consistent definition
for the meaning of “clean” for reprocessed medical devices
• Lack of specific criteria and endpoints for measuring
whether a device is clean
• Lack of standardization of clinically relevant test soils
for validating the effectiveness of reprocessing methods
To address these challenges, AAMI and FDA recommend-
ed three priority actions: At that time, AAMI had established seven clarion themes
➊ Gain consensus on “how clean is clean” and on
adequate cleaning validation protocols for reprocessing
reusable medical devices.
➋ Create standardized, clear instructions and repeatable
steps for reprocessing whenever possible. 3. Pay early,
iterative, and comprehensive attention to reprocessing
requirements throughout the device design process.
➍ Make human factors and work environment factors
priorities when developing reprocessing requirements.
Continued from page 17
manufacturers were urged to design duodenoscopes that
enable thorough cleaning and effective reprocessing through
device disassembly or disposable parts.
➌ Microbiological Culturing of Duodenoscopes
Healthcare facilities may perform microbiologic culturing,
which involves sampling duodenoscope channels and the
distal end of the scope and culturing those samples to
identify any bacterial contamination that may be present
on the scope after reprocessing. The FDA recommended
additional data and validation testing to demonstrate the
methodology is robust and demonstrates consistent and
reliable culturing results before health care facilities can
incorporate as a best practice.
➍ Supplemental Measures to Enhance Duodeno-
scope Reprocessing
Additional strategies can reduce the risk of infection
transmission, such as: microbiological culturing, sterilization,
use of a liquid chemical sterilant processing system and
repeat high-level disinfection as part of strict adherence to
the manufacturer’s reprocessing instructions.
In October 2015, the FDA ordered U.S. duodenoscope
manufacturers (Olympus, Fujifilm and Pentax) to conduct
post-market surveillance studies to better understand how
these devices are reprocessed in real-world settings and their
impact on duodenoscope-transmitted infections.
In February 2018, the FDA, CDC and American Society
for Microbiology (ASM) released voluntary standardized
protocols for duodenoscope surveillance sampling and
culturing. For healthcare facilities that choose to implement
duodenoscope surveillance sampling and culturing, these
protocols are used to help monitor the quality of a facility’s
endoscope reprocessing procedures.
In March 2018, the FDA issued warning letters to all three
manufacturers who make duodenoscopes sold in the U.S.
for failure to provide sufficient data. All three manufacturers
responded to the warning letters and submitted plans that
outlined how study milestones would be achieved including
enrolling new sites and collecting samples.
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In December 2018, the FDA issued interim results from
the ongoing mandated post-market surveillance studies
of duodenoscope reprocessing. Interim results indicated
higher-than-expected contamination rates after duode-
noscope reprocessing. Facilities and staff that reprocess
duodenoscopes are reminded of the importance of manual
cleaning prior to disinfection or sterilization and proper
servicing of duodenoscopes.
In April 2019, the FDA updated the post-market surveil-
lance 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 tran-
sitioning 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 triphos-
phate (ATP) test strips should not be used to assess duode-
noscope 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.
NOTE: Watch for updates from HHM on recommendations
for duodenoscope reprocessing coming out of the November
2019 meeting of the General Hospital and Personal Use
Device Panel of the Medical Device Advisory Committee.
november 2019 • www.healthcarehygienemagazine.com