OR Manager November/December 2021 - 24

Sterilization & infection prevention
BY SUSAN KLACIK
Quality monitoring for decontamination process
T
he foundation of sterilization is
cleaning. How can we be sure that
the mechanical cleaning equipment
being used is producing clean
medical devices?
There are methods available to verify
that the mechanical equipment used
to clean medical devices is functioning
appropriately. ANSI/AAMI ST79:2017
Comprehensive guide to steam sterilization
and sterility assurance in health
care facilities (ST79 Steam sterilization
standard) and 2020 Amendments A1,
A2, A3, A4 provide recommendations
on routine verification testing of decontamination
equipment.
Mechanical cleaning equipment used
in the decontamination room are documented,
reproducible, automated, or
semi-automated systems that use both
automated and manual cleaning processes
and are validated for use. There
are different types of equipment used,
with the typical mechanical cleaning
equipment being washer disinfectors,
ultrasonic washers, and cart washers.
According to ANSI/AAMI ST79, verification
testing should be performed on
all mechanical cleaning equipment as
part of the overall quality assurance program.
Mechanical cleaning equipment
should be tested upon installation,
each day it is used, and after major repairs.
When evaluating or changing to a
new type of cleaning solution, all cycles
used should be tested to ensure that
the cleaning solution and action are
effective. There are different methods
to perform cleaning verification, with the
following being the most common:
* Directly testing individual medical
devices for residual soils (eg, adenosine
triphosphate or ATP, protein,
hemoglobin);
* Using a cleaning verification test device
that provides a consistent and
repeatable challenge to the cleaning
effectiveness of the equipment;
* Monitoring critical parameters (eg,
cycle printout) to evaluate the performance
of the cleaning equipment.
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OR Manager | Nov/Dec 2021
Monitoring and verifying cleaning
processes should be recorded. Some
mechanical washers have digital readouts
and cycle printouts that should be
reviewed for each cycle and initialed by
the operator to indicate an acceptable
cycle. Most commercial cleaning verification
products include record-keeping
methods for use that may demonstrate
the level or type of failure. Key performance
outcomes include clean surfaces
and adequate fluid flow in equipment
that has adaptors for lumened
devices.
Before operating any decontamination
equipment, the manufacturer's written
instructions should be reviewed and followed
for indications for use and operation,
including loading practices such as
having hinged instruments loaded in the
open position; use of accessories; and
cycle selection. Gross debris should
be removed from the medical devices
before undergoing mechanical cleaning;
if not removed, they will circulate
through the washer and deposit onto
other devices, impeding the cleaning.
For automated cleaning to be effective,
all device surfaces should have contact
with the cleaning solutions.
Washer disinfectors
Washer disinfectors are typically used
for handheld instruments and utensils.
Some washer disinfectors include
flushing devices for lumened devices.
A washer disinfector reduces microbial
contamination using a multistep
method consisting of cleaning solutions,
water temperature, rinsing, lubrication
(some cycles), and drying. These
washers clean via impingement, which
is the spray-force action of pressurized
water against instruments being
cleaned to physically remove bioburden.
This impingement is similar to
a dishwasher in that the cleaning is
dependent on a combination of the
water temperature, detergent, and
spray force to remove soil from devices
being processed.
These washers use successive
steps during the wash cycle. The first
step is a cool prerinse to prepare them
for the next cycle (cool water is used to
prevent coagulation of proteins). The
next step is at a higher temperature
with detergent to maximize the effectiveness
of the detergent activity. The
third step rinses the debris and detergents
from the instruments. Again,
some washer cycles may include a
lubrication cycle. It is important that all
cycles perform/function effectively in
order to achieve thorough cleaning.
Instrument washer racks and conveyor
systems should be inspected
daily. A visual
inspection includes
checking the spray arms and washer
jets for obstructions such as debris,
paper, and mineral build up, because
these will hinder spray action and disrupt
cleaning efficacy. Commercial
cleaning verification devices should be
used to confirm this cleaning action. To
ensure all spinning arms are functioning
properly, verification testing devices
should be placed on each level of an
otherwise empty shelf. The cycle is run,
then upon completion of the cycle, the
testing mechanism is evaluated according
to the verification manufacturer's
instructions for use, and these results
are then recorded.
Washer traps/screens at the bottom
of the unit should be visually inspected
for debris at least daily and cleared of
obstructions. The detergent container
should be checked to ensure detergent
is available. The chamber walls should
also be visually checked for any scaling,
such as a white scale.
If a white scale is observed, it should
be immediately removed with a descaler
recommended by the equipment manufacturer.
This white scale can fall on
instruments and clog pumps, motors,
and spray arms. If the washer has a
printout, that printout should be reviewed
and initialed after each use to
ensure that the cycle has reached the
expected parameters.
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OR Manager November/December 2021

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