Healthcare Hygiene magazine November 2019 | Page 19
➎ Improve information collection and sharing to broaden
the use of best practices in reprocessing.
➏ Improve reprocessing competencies by strengthening
training, education, and certification.
➐ Create a greater sense of urgency and understanding
throughout the healthcare community about the conse-
quences of inadequate reprocessing.
Soon after the workshop, AAMI issued a technical in-
formation report (TIR30:2011) that acknowledged, “There
are few tests that can be used to verify cleaning. To verify
cleaning of a given device, one must have a test soil and
a quantitative test method for detecting residual soil after
cleaning. If cleaning protocols that could be used for verifi-
cation were in wide use today, they could help ensure that
adequate cleaning is accomplished so that a device can be
reliably disinfected and/or sterilized before it is used on the
next patient. The manufacturer must validate the instructions
for reprocessing a reusable device before marketing it. In
addition, manufacturers must consider:
a. that exposure to chemicals, such as cleaning agents,
could alter the material used in the device
b. whether the materials of construction will absorb or
adsorb chemical agents, which could then gradually leach
from the material over time
c. how cleaning processes could affect the function of
the device
d. that cleaning processes and tools must be able to con-
tact all areas of the device that could become contaminated
AAMI TIR30:2011 represented a compendium of pro-
cesses, materials, test methods and acceptance criteria for
cleaning reusable medical devices that remains an essential
roadmap for reaching the destination of “clean” devices.
However, one of the best documents to follow, according
to Susan Klacik, clinical educator at IAHCSMM, is AAMI’s
standard on flexible endoscope processing, ANSI/AAMI
ST91:2015 Flexible and semi-rigid endoscope processing in
healthcare facilities. This standard has been under review
since its original publication, Klacik says, and the committee
hopes to have the revision completed in 2020.
Klacik adds that it is essential for SPDs to double-check
their scopes: “Use a borescope and other cleaning verification
products,” she advises. “Perform competency reviews on
all scopes by all staff members that process the scopes.”
Industry is also wrestling with the recommendation that
scopes should be sterilized going forward. “In 2017 AAMI
held a scope stakeholders meeting with leading experts
in the infection prevention, sterilization, disinfection and
endoscope field,” Klacik says. “The consensus was to
transition semi-critical items to sterilization. This is intended
to be a gradual transition, as it cannot occur quickly since
many processes need to be in place.”
Until then, ANSI/AAMI ST91:2015 Flexible and semi-rigid
endoscope processing in healthcare facilities, remains a
go-to document for guidance.
AAMI TIR30:2011 reminds us that, “Cleaning is normally
accomplished by manual wiping, brushing, or flushing or by
using mechanical aids (e.g., ultrasonic cleaners, washer–de-
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