Special Edition on Sterile Processing Imperatives Special Edition- Sterile Processing Imperatives | Page 10

shortening or disabling AER cleaning and rinsing cycles
in order to save time and improved turnaround. During
previous studies, we discovered that AER manufacturers’
representatives had disabled AER cleaning cycles in two other
hospitals. Incidents where AERs were disabled or cycles were
improperly programmed have also been reported to the FDA.
Ofstead, Hopkins and Buro, et al. (2020) observe, “We
are troubled by mounting evidence demonstrating that HLD
effectiveness is suboptimal in real-world settings. Previous
research has established that multiple factors contribute
reprocessing failures … Clearly, these long-standing barriers
to adherence and overall reprocessing effectiveness must be
addressed however the groundbreaking research described
in this manuscript identified additional problems specific to
the high-level disinfection step and MEC testing that ensures
the chemistries are strong enough to reliably eliminate
microbes. As Rutala and Weber stated, the margin for error
with high-level disinfection is simply not large enough to
tolerate any deviations from optimal practices. They have
recommended a shift towards sterilization, and we agree that
sterilization may be necessary for improving patient safety.
In the meantime, high-level disinfection will continue to be
used by many institutions and it is essential to address the
quality issues described in this paper.”
The researchers recommend that researchers undertake
the following endeavors:
● Conduct multi-site studies and ongoing surveillance
to assess real-world practice patterns and determine
the nature and prevalence of breaches related to the
high-level disinfection step and MEC testing.
● Conduct research to establish realistic usage periods for
reusable HLD chemistries in real-world settings.
● Assess the ability of technological solutions such as
automation and engineered safeguards such as an
AER that shuts down when anything does not need
manufacturer criteria, to overcome shortcomings that
have been attributed to human error.
As the researchers emphasize, “For these technological
innovations to be successful it is essential that manufacturers
and their representatives be partners in striving for excellence
in the field. Neither company representatives nor customer
should seek to deviate from if you or to shorten automated
Cycles to save time. Before implementing time-saving or
cost-cutting measures, infection prevention and reprocessing
managers should review evidence provided by the manufac-
turer that reprocessing is still effective when these steps are
skipped or processes are truncated. Ideally, manufacturers and
facility personnel will provide mutual support and account-
ability for ensuring that practices align with guidelines and
IFUs.” They add, “Given the current situation, it is essential
for infection preventionists to leverage this momentum
and take the lead in coordinating efforts of endoscopists,
reprocessing personnel, and others to implement robust
quality management programs that address all of the factors
that impact HLD effectiveness.”
As we have seen, a recent survey of sterile processing
technicians confirmed ongoing challenges to performance,
with IFU adherence at the top of the list of concerns.
Damien Berg, BS, BA, CRCST, regional manager of sterile
10
processing for UC Health in Aurora,
Colo. and immediate past-president
(2019-2020) of IAHCSMM, reminds us
All these
that issues of concern “vary from facility
errors can
to facility and the size of the department
lead to
(as well as number of items processed)
and, of course, what is reported by the
surgeon and OR staff
customer about mistakes (errors can be
frustration, but more
very subjective and under reported),”
importantly, they can
Berg says. “I have the unique viewpoint
of being an active manager in two
jeopardize patient safety,
large hospitals and one surgery center. cause case delays, or
I not only deal with the real day-to-day
infections.”
operations, but I also travel the world —
— Damien Berg, BS, BA,
visiting many departments and talking
to sterile processing professionals who
CRCST
share these and other issues that impact
the everyday SPD. I see some of the top errors ranging from
missing integrators, holes in wrap and missing instruments
to some type of foreign debris remaining in the tray or on
the instruments. All these errors can lead to surgeon and OR
staff frustration, but more importantly, they can jeopardize
patient safety, cause case delays, or infections).”
“The top mistakes that I see in sterile processing are related
to the inability to, or decision not to, follow the manufacturer’s
instructions for use,” says Bob Marrs,
CRCST, CIS, CHL, vice president of
organizational development for Beyond
Because
Clean. “Because sterile processing staff
sterile
typically are concerned with keeping
pace with the OR schedule, steps
processing
often get circumvented. On a perfect
staff typically are
day, following the manufacturer’s IFU
concerned with keeping
is challenging. Trying to do it for every
instrument, every time, is pretty much pace with the OR
impossible. These short cuts can be schedule, steps often get
related to improper cleaning and dis-
circumvented.”
infection. Sometimes staff will choose
— Bob Marrs, CRCST,
manual cleaning over the validated
CIS, CHL
process of thermal disinfection. With
thermal disinfection the patient receives the same level of
cleaning with each cycle. Manual cleaning is different, much
like washing your dishes at home. Everyone has their own idea
about how to clean their dishes. The typical sterile processing
staff member is no different. What is clean to one person
may not be considered clean to another.”
Marrs continues, “At times, sterile processing staff
will completely bypass the inspection of the instruments
prior to assembly. This allows bioburden, foreign material,
broken and non-functioning instruments to make their way
into the operating room. When this happens, the surgeon
becomes the quality manager often discovering the error
while operating on their patient. This takes the focus away
from the patient and places it on the instrument. This is
never a good position for the surgeon. I’ve also seen staff
shorten the sterilization cycle and not follow the prescribed
instructions. The manufacturer’s instructions for use were
developed and designed to ensure that proper procedures
are followed. When these procedures are not followed, the
patient will ultimately pay the price.”
Sterile Processing Imperatives 2020 • www.healthcarehygienemagazine.com