Education & Training
Improving the Performance of
Your Medical Automatic Washer
by Stephen M. Kovach, BS, CSPDT
Objectives
After completion of this self-study activity, the learner
will be able to:
1. Discuss the variables that influence the automatic
washing process.
2. Design a quality improvement program for a medical
automatic washer.
3. Describe the various guidelines and recommendations
concerning monitoring the automatic washing process.
4. List the differences between various types of medical
automatic washers.
Test Questions
True or False
1. Blood cells colored with hemoglobin are fairly easy to
wash off instruments; clear fibrin material is much more
difficult to remove.
2. Moist alkaline detergents dissolve dry proteins and cause
fibrin to break, mimicking enzyme action.
Many thanks to the team at 3M Health Care for
working with Managing Infection Control to provide
the following accredited course. IAHCSMM has
awarded one and one-half (1.5) contact points for
completion of this continuing education lesson
toward IAHCSMM recertification. The CBSPD has
preapproved this inservice for one and one-half (1.5)
contact hours for a period of five (5) years from the
date of publication, and to be used only once in a
recertification period. This inservice is 3M Health
Care Provider approved by the California Board of
Registered Nurses, CEP 5770 for one (1) contact
hour. This form is valid up to five (5) years from the
date of publication. Instructions for submitting
results are on page 103.
Managing Infection Control and 3M Health
Care will be working collaboratively to provide
continuing education courses in monthly editions of
Managing Infection Control.
78 MANAGING INFECTION CONTROL
3. In general, the harder the water, the more cleaning
solution will be needed in the cleaning process.
4. American Society of Testing and Manufacturing (ASTM)
has recently established a new standard D7225Guide
for Blood Cleaning Efficiency of Detergents and Washer
Disinfectors.
5. Association for the Advancement of Medical Instrumentation
(AAMI) and Joint Commission for Accreditation of
Healthcare Facilities (JCAHO) support implementation of
Quality Improvement Processes in the Sterile Processing
department.
6. Cleaning is the removal of all visible dust, soil, other
foreign material and some microorganisms.
7. A solution with a pH of 9 is an acidic solution.
8. Following the manufacturers instructions is not important
in the cleaning process.
9. The prewash cycle temperature should be colder than 113
degrees Celcius.
10. Staff should have at least yearly training on the operation
of the automatic washing equipment.
Introduction
The reliability of sterilization is affected negatively by
the number, type, and inherent resistance of microorganisms,
including biofilms, on the items to be sterilized. Soils, oils,
and other materials may shield items from contact with the
sterilant or combine with and inactivate the sterilant.1
Providing a properly assembled sterile instrument to the
operating room is paramount to the success of any surgical
procedure. Doing so is not an easy task, however. Hospitals
that implement a Quality Improvement Program for their
medical automatic washer help ensure that patients enjoy the
best possible outcome of surgery.
One only has to think of the circle of life from the
movie The Lion King to begin to understand the complex
process of providing a properly assembled sterile instrument to
the OR (see Figure 1 on page 79). Providing instruments
sterile and ready for use requires many steps. Each step
depends on successful completion of the previous step. For
example, a hospital can clean and sterilize items properly; but
if instruments are transported improperly, the effort made to
sterilize them is wasted (see Figure 2 on page 79).
February 2007

Figure 1. Automatic cleaning is part of the circle of life in
sterile processing.
Figure 2. Improper transportation of item under the arm.
Cleaning is one of the first steps to providing a workable
and sterile instrument to the operating room. Cleaning has three
major objectives:
Remove visible soil.
Remove invisible soil.
Remove as many harmful microorganisms as possible.
Manual or mechanical processes or a combination of the two
can be used to achieve these objectives.
Cleaning involves many steps, each of which influences the
outcome. This article will focus on the medical automatic washer
and the variables that influence its effectiveness.
February 2007
Education & Training
A properly functioning medical automatic washer is
vital to the process of providing a clean item for staff to
assemble and prepare for sterilization, and eventually use
on a patient. Staff must understand the variables that affect
the medical automatic washers performance and must
monitor and correct any deviations from the washers
target parameters in order to assure that the process works.
Note: The author realizes that much is being done
within the global community with regard to verifying the
effectiveness of medical automatic washers. This article
deals with practices within the United States only. It does
not address flexible automatic scope washers (automatic
endoscope reprocessors), only washers intended for
cleaning surgical instruments.
What is a medical washer/disinfector?
What does it do?
A medical washer or washer-disinfector is a medical
device intended to process medical devices. The FDA
regulates the introduction of medical devices in interstate
commerce. A medical washer-disinfector intended to clean
and provide high level disinfection of medical devices
must have a FDA cleared pre-market notification [510(k)]
submission before it can be sold. A medical washer
intended to clean medical devices or a medical washer-
disinfector intended to clean and provide either low or
intermediate level disinfection of medical devices is
exempt from 510(k) requirements.2
The majority of medical automatic washers used
in U.S. hospitals today deliver low- to intermediate-
level disinfection and are exempt from the 510(k)
submission requirements.
Medical automatic washers (also known as washer-
decontaminators, washer/disinfectors or automatic
instrument washers) initially developed from commercial
dishwasher technology and have adapted to todays
science-based requirements. Maybe this is the reason
that, even today, many institutions regard the medical
automatic washer as nothing more than a dishwasher,
when in fact it is one of the most vital pieces of equipment
in the fight to reduce healthcare-acquired infections.
The simple definition of a medical automatic washer
is a piece of equipment that cleans and decontaminates
dirty surgical instruments so they can be handled safely,
repackaged and sterilized for a future procedure. Some
medical automatic washers can process only bedpans,
while others can process a variety of items, including
s u rgical instruments with and without lumens. Some
washer manufacturers offer racks specially designed for
lumen-type and minimally invasive surgery instruments
(see Figure 3 on page 80 ).
MANAGING INFECTION CONTROL 79
 Education & Training

Figure 3. Special rack for lumen items. Figure 4. Batch washerbasic design
(coupler system can be located on the side wall in
some models).

Medical automatic washers fall into two distinct categories of

operation. In North America, machines rely on high impingement
and softer chemistry; in Europe, machines rely on low impinge-
ment, high water volume, and more aggressive chemistry. There
are two basic types of medical automatic washers:
1. Batch-type:
This washer has a closed cabinet that is linked to the water
supply and drainage system. The machine is loaded with the
soiled instruments/utensils, and the doors are locked before the
cycle commences. All stages are performed in one chamber
(see Figure 4 right).

2. Indexed/rack conveyor washers (tunnel washers):

This type operates as a continuous-feed system in which soiled
instruments are loaded on one end and reprocessed instru-
ments are ejected on the other. Soiled instruments/utensils are
transported from chamber to chamber in which different stages
of the process are performed (i.e., rinse-wash-disinfect-dry)
(see Figure 5 Tunnel washer below).
Regardless of the model or the theory behind a
medical automatic washer, if it is maintained (preventa-
tive maintenance by a qualified person), properly
calibrated, variables monitored, and used accordingly, it
is capable of effective cleaning.

Figure 5. Basic tunnel washer.

80 MANAGING INFECTION CONTROL February 2007

 Education & Training

Variables that impact cleaning

A washers effectiveness depends on several variables that are equally
important in achieving the desired resultclean instruments that are safe to
handle and then sterilize. These variables include:
Target soiltype of soil to be cleaned;
Instrument designitem to be cleaned;
Water quality (e.g., hardness, pH);
Temperature and time;
Chemical activitythe ability of the cleaning solution to hydrolyze
target soils;
Mechanical actionthe energy needed to clean (agitation);
Human variables and intangibles (e.g., staff training, loading methods).

The final variable is active monitoring of these input parameters and of

the final outcome: instrument cleanliness. This can only be done via a quality
improvement program in which a Sterile Processing department maintains and
improves the medical automatic washing process (following the equipment
manufacturers instructions) and its staff understands the variables and how
they interact. A good quality improvement program should be based on these
variables. Let us examine them individually.

Target soil
Many types of soil could be present on reusable medical devices, but
dried blood is especially difficult to clean. As a liquid, blood tends to flow over
and into joints, hinges, grooves, and other difficult-to-clean locations. It then
coagulates and dries to create a significant challenge to cleaning.4
Blood is the soil most often found on surgical instruments. Thus it is blood
that is the residual soil one most often looks for when making sure items are clean.
Dried blood on instruments is hazardous to the employees of the hospital
and to the next surgical patient upon which the instruments are used. The
danger of handling instruments contaminated with blood is obvious in this age
of hepatitis and HIV. The procedures for sterilizing instruments are based on
years of scientific testing of clean instruments. If surgical instruments are not
clean, the procedures are ineffective.
Cleaning dried blood is much more difficult than cleaning other soils.
Blood coagulates, which means it goes from a free-flowing liquid to a solid that
contains tough, microscopic fibers called fibrin. Fibrin is formed as the blood
coagulates. The fibers jam themselves into microscopic irregularities in the
surface of the stainless-steel instrument. This is a physical attachment to the
surface through mechanical means, not just chemical means as with traditional
adhesives. The action is similar to the roots of plants growing into cracks in
rocks, anchoring themselves to the surface.
Hemoglobin (the red-colored cells of blood), when wet, is fairly easy to
wash off instruments. However, should hemoglobin dry it becomes highly
insoluble and very difficult to clean.
Removing blood from a surgical instrument can be difficult. Ensuring that
no residual blood remains after cleaning is critical to the sterilization process.

Instrument design
The complexity of an instruments design is directly proportional to
the complexity of cleaning it and the difficulty of verifying cleanliness.

February 2007 MANAGING INFECTION CONTROL 81

 Education & Training
Twenty years ago surgical instruments were simpler in design.
Today we have:
Long narrow lumens;
Tiny serrations;
Multiple parts;
Higher quality stainless steel;
Various metals and plastics.
But even traditional instruments pose a challenge. One of
the most challenging areas to clean is an instrument box lock
(see Figure 6 below). This tiny narrow area is often found
with dried blood inside. The dried blood not only damages the
instrument itself but also is a place where microorg a n i s m s
hide and are protected during the sterilization process.
The cannulated areas of instruments also can harbor hard-to-
clean blood. After surgery box locks should be opened and
instruments with removable parts should be disassembled.
This will limit drying of blood on instruments, which may
cause corrosion.5
Figure 6. Box locks.
Water quality
Water as a variable in the cleaning process is sometimes
underappreciated. Failure to recognize poor quality water,
failure to treat water as needed, or failure to monitor and
take action on poor water quality places patients at risk. The
relevant measurable characteristics of water in the cleaning
process are hardness, pH-level, temperature and purity (micro-
bial contamination).
Hardness
Hardness is usually defined as the concentration of
calcium and magnesium ions expressed in terms of
calcium carbonate. These and other minerals bind with the
cleaning agents in detergents, preventing them from
82 MANAGING INFECTION CONTROL
binding with the target soil. Dissolved solids in water
present obstacles to good cleaning. Hardness minerals
can also cause spotting and filming on instruments. They
must be effectively tied up or sequestered if the cleaning
results are to be satisfactory. The harder the water, the
more concentrated the cleaning solution will need to be.
Water hardness thus can diminish product efficacy and
efficiency. Routine monitoring of water hardness helps to
ensure the optimum performance of equipment and
cleaning solutions (see Figure 7 below).
Figure 7. Water hardness chart.
pH
The pH level indicates the acidity or alkalinity of
water on a scale from 0 to 14. A solution is considered
neutral if it has a pH-level of 7. One to 6 on the scale is
considered acidic; 8 to 14 on the scale is called alkaline
or a base. Improper pH can compromise the effectiveness
of cleaning solutions. Knowing the waters pH helps
ensure optimum performance of the cleaning solution.
Temperature and time
These two parameters are interdependent at almost
every stage of the automatic washer process. A low
temperature at the start (to prevent denaturing) and higher
temperature later (to maximize enzymatic solution or
detergent) are crucial for thorough instrument cleaning.
Monitoring the temperature at all stages of the process is
important because improper temperature can cause adverse
reaction and poor performance.
Water temperature is the key to thermal disinfection
in a medical automatic washer. The level of disinfection
d i ffers between brands of medical washers, as does the
time and temperature required to achieve the specified
disinfection level. One must remember that the target of
thermal disinfection is the surface of the instrument. Thus, it
is key to monitor the surface temperature of instruments to
know whether disinfection has occurred. Water temperature
February 2007
 Education & Training
needs to be monitored and documented independently of the
machine for two reasons:
1. Washers only monitor the temperature of water in the sump, not
at the instrument surface level.
2. Thermal couplers and heaters can fail.
With enough time, simple water will remove all types of blood
and other soils (the Grand Canyon is evidence of this). Of course,
surgical services do not operate on geologic time scalesmore like
supersonic. As a result chemical solvents (e.g., enzymes, soaps) are
required to speed the hydrolysis of target soils. The contact time for
the various cleaning solutions needs to be optimized so they can
work as intended. Cleaning solutions should be applied for at least
the minimum time specified on the product label. More contact time
between the cleaning solution and the target soil might be needed to
completely clean some instruments.
Decontamination holding time (DHT)
DHT is the duration of time between an instruments last
surgical use and the moment the cleaning process begins. DHT
can vary in length from just a few minutes to hours or even
days. The longer the time before the cleaning process begins,
the greater chance instruments will arrive for assembly dirty on
the clean side. Thus, it is important to keep soiled instruments
moist after use. This can be done by placing a wet towel
over the instruments or by using one of the many sprays now
available to keep instruments moist. Sterile Processing staff
should remind their colleagues in the Operating Room of the
importance of wiping down instruments during surgery and
sending them back to the decontamination area in the best
condition possible (see Figure 8 below).
Figure 8. Decontamination area with supplies coming back
from the Operating Room.
Chemical activitycleaning solutions
The two types of cleaning solutions normally used in
medical automatic washers are enzymes and detergents. Studies
84 MANAGING INFECTION CONTROL
have demonstrated clear differences between
cleaning agents.6
Enzymes are biological agents that break down
t a rget soils, making them more soluble through a
process called hydrolysis. Time is needed for this action
to take place. The time needed to act depends on factors
such as concentration, temperature, pH, and the type
and amount of soil to be removed. Four basic types of
enzymes are used to clean surgical instruments:
Lipasebreaks down fats and greases;
Proteasebreaks down protein;
Cellulasebreaks down cellulosic materials such
as wood, cotton and paper;
Amylasebreaks down carbohydrates and starches.
D e t e rgents are chemicals that reduce surface
tension during cleaning so that water can spread and
wet surfaces. These chemicals are also called surface-
active agents, or surfactants. Surfactants perform
other important functions in cleaning, such as
loosening, emulsifying (dispersing in water), and
holding soil in suspension until it can be rinsed away.
Similar to protease enzymes, high alkaline surfactants
hydrolyze proteinaceous soils.7 Foaming is also a
factor; low-foaming detergents are preferable for
medical automatic washers.
Note: Remember no two enzymes or detergents are
exactly alike. Knowing the difference between them and
what they can do gives the Central Sterile Processing
professional a better understanding of the cleaning
process and his/her particular needs.
The effectiveness of any cleaning solution depends
on certain factors, including dosing, concentration,
storage conditions, age, decontamination room environ-
ment and adherence to label instructions.
According to Martin We i d e r, a major washer
concern is the dosage and control mechanisms for
dispensing cleaning solutions.18 These variables
should be validated and monitored because they are a
significant cause of poorly cleaned instruments.
Blocked or kinked feed tubing may limit the amount of
chemicals being pumped into the washer. Broken
pumps, incorrect temperature, misaligned coupling
mechanisms and compromised spinner arms, all play a
role in delivering the proper dosage of chemical agents.
The length of the tubing from the source (cleaning
solution) to the pump is also important. Inherently,
pumps are capable of delivering solution at a maximum
distance. Sterile Processing staff should know the
maximum length of tube their machines pump is
designed to work with (see Figure 9 on page 86).
February 2007
 Education & Training

Figure 9. Examples of poor administration Users should be aware that, although most washers
of cleaning solution. are designed to alarm when the volume of cleaning solution in
the storage barrel is low, most washers will not warn when
detergent is not being delivered. For instance, a washer will
continue to run even if it is pumping only air. It is important
to ensure that the dosage pump is properly functioning and
calibrated. A simple way to monitor the pump is to mark the
barrel of solution daily (see Figure 10 left).
Each cleaning solution has a minimum concentration for
potency. The ratio between the target soil (contaminant) and
the applied cleaning solution is important. Follow label
requirements for concentration levels; they vary according to
the water quality and amount of target soil present.
Cleaning solutions should always be stored according
to the manufacturers directions. Some cleaning solutions
(particularly enzymes) can be deactivated by heat, so it is
important to store and transport them at the proper temperature
Air in line. (see Figure 11). Likewise, relative humidity of the decontami-
nation room can affect the solutions penetration, so the rooms
relative humidity should be monitored and documented. This
can be done with simple wall monitors or electronic devices that
can store the data for later retrieval. Temperature and humidity
levels should be documented at least every shift.

Figure 11. Temperature on the barrel.

Figure 10. Barrel marked.

Cleaning solutions that have passed the manufacturers

usage date will not clean as validated by the manufacturer. Staff
should know their solutions expiration dates and be sure to
rotate product.
Always follow the manufacturers guidelines and label
instructions. No two products or pieces of equipment are the
same, and instructions can vary:
Do not use on anodized aluminumautomatically feed at
1/4 to 2 fluid ounces per gallon of water depending on soil
load and water conditions...8

86 MANAGING INFECTION CONTROL February 2007

 Education & Training

May be used in manual or ultrasonic/automated cleaning
systems... Do Not use for cleaning spinal syringes or
needles...9
...works in all water temperatures10
Central service staff should understand how each piece of
equipment works, which cleaning solutions are best for their
equipment, and the limitations of those solutions. Choosing the
wrong cleaning solution can cause problems down the line.
Staff should read all labels and product safety information
(e.g., Material Safety Data Sheets [MSDS]), as well as any
white papers the company provides for its product. A file on
each product should be located in the department for easy
reference. The more information available, the better prepared
the staff.
optimum exposure to the cleaning solution and spray
action. Stringing instruments is an excellent way to
expose all the areas of an instrument to the cleaning action
of a medical automatic washer (a five-inch stringer will
keep instruments open and exposed) (see Figure 12). A
blocked spray nozzle decreases cleaning power. If two
holes are blocked on a 10-hole spray arm, the spray is
only 80 percent efficient. Such a blockage affects not only
the cleaning power but also the effective rinsing of the
cleaning solutions. Verifying that spray arms achieve full
rotation and that the nozzles are clean will help ensure
effective cleaning action (see Figure 13 below).
Figure 13. Spray arm concerns.

Mechanical action
The mechanical efficiency of a washer is vitally important
to performance. Each washer has its own cycle setting
(prewash, rinse, enzymatic/detergent, sonic, disinfection,
drying), which must be matched with the cleaning solution and
the instruments to be cleaned (general instrument, micro,
orthopedic). Other important variables include the length of the
cycle, agitation, instrument loading, tray and rack selection,
rinsing and staff training regarding proper use of the machine.
Agitation
Physical agitation from water spray brings fresh
cleaning solution to the soiled area and washes away used
Yuck! Two holes blocked.
detergent. Spray impulses loosen blood through physical
impact. Spray from different angles helps prevent
blocking from instruments piled on top of one another.
Instruments must not be stacked or overloaded in any tray.
Evenly spreading instruments within the tray provides

Figure 12. Stringing instruments.

Side holes blocked.

Loading
If instruments are not loaded properly they will not
come clean, even in a properly performing washer. Thus,
staff must know proper loading techniques (see Figure 14
on page 89).

88 MANAGING INFECTION CONTROL February 2007

 Education & Training

One washer manufacturers guide to operation includes a basket; do not allow items to protrude outside of the
the following instructions for loading instruments: Open all rack. Wire mesh baskets are better than perforated trays.
instruments, especially clamps; keep spray arms free from Avoid solid side trays or trays with limited perforations on
obstructions; keep instruments in a basket; avoid overloading the bottom.11

Figure 14. Improperly loaded instrumentsHow clean do you think these instruments will be when they come out
of the medical automated washer regardless of how well the washer is performing?

February 2007 MANAGING INFECTION CONTROL 89

Education & Training
When loading the washer, staff must separate multilayer
trays so that cleaning solutions can have direct contact with the
instruments. The Sterile Processing staff should also follow
these rules for loading an automatic washer:
Open hinged instruments and place on stringer if possible
(at least 5 inches).
Disassemble sets and instruments according to manufac-
turers instructions.
Place concave instruments on their side or upside down.
Use specialty baskets/trays when available (e.g., basins).
Separate stainless-steel instruments from other metals. To
avoid electrolysis, place different metals in their own
tray/basket if possible.
Put the heaviest instruments at bottom of the basket. Do
not place them on top of delicate instruments (see Figure
15 below).
Figure 15. Properly loaded trays (5-inch stringer).
Notice how wide the instruments are open to get
maximum exposure to the cleaning process.
MANAGING INFECTION CONTROL
Tray and rack selection
Trays for washing can be different than trays for
sterilization. It is important to pick and use the correct
type of tray in order to optimize cleaning results. In his
paper And then there was Decontam, a paper
authored by Richard Schule, Director, Clinical Sterile
Processes at Clarian Health, he notes that loading
racks have variations and should be numbered. If a
problem arises, staff can track back to a specific rack for
follow up.19
Metal racks are subjected to strenuous conditions
that can cause them to warp and break down. Couplings
may show fatigue; spray arm bushings may break and
fail. Such failures indicate that the correct water pressure
(cleaning power force) is not being delivered.
Rinsing
Thorough rinsing is needed at various stages of the
washing cycle. The quality of the rinse may differ from
stage to stage. Rinsing between stages prevents residuals
from being transmitted from one stage to the next. The
final rinse after cleaning is extremely important because
any residuals after this stage will likely remain on the
instrument and could detrimentally affect disinfection
and sterilization, and/or cause adverse reactions in
the patient. Some medical automatic washers are
programmed with only 15 seconds of rinse time. Sterile
Processing staff should verify that the rinse time is long
enough to remove all residue. Quality of the rinse water
should be monitored as well.
Biofilm
Biofilms are a concern with medical automatic
washers. Biofilms are produced by microorganisms
and consist of a sticky rigid structure of organic
contaminates. A slime layer anchors firmly to a surface
and provides a protective environment for microorgan-
isms to grow. The chamber walls inside medical
automatic washers are an area that staff should check
routinely for any biofilm build up. Some companies
recommend using a de-scaler to clean the chamber walls
on a routine basis. Poor water quality, poor rinsing and
too much cleaning solution are possible reasons for a
build up of biofilm inside the medical automatic washer
(see Figure 16 on page 91).
Washer features
When purchasing a washer, staff should know
which optional features are most important. For
example, a washer with a window allows the user to
view what is going on inside the chamber. Staff should
February 2007
 Education & Training

Figure 16. Biofilm example.

Yellow film on wall. White and red film on wall.

February 2007 MANAGING INFECTION CONTROL 91

 Education & Training
be able to print out the cycle parameters for each machine.
If more than one machine is in use, each should have its
own alarm system for detecting low levels of each
cleaning solution. Features such as a window and an alarm
help staff identify and solve problems in the automatic
washer cleaning process.
Always follow the manufacturers guidelines for
replacement of parts and service. Factory-trained technicians
should perform replacement and servicing of the equipment.
For example, temperature variations in a washer can be caused
by a faulty thermostat or heating element. The dosage pump
must be calibrated regularly to ensure delivery of the correct
amount of cleaning solution. Review the preventative mainte-
nance manual with the repair technician. Involving the
hospitals biomedical department in this review can help ensure
that the proper work is being done.
Staff training
The most critical component in any cleaning process is
the human one. The staff working in the decontamination
area must understand the importance of their work and how
they affect not only patient health and safety, but also that of
themselves and their fellow staff. Regular, professional staff
training will help ensure that instruments are clean. Training
should include, but not be limited to, cleaning solutions,
equipment and personal protective apparel. Training should be
mandatory for new employees, and conducted annually for all
s t a ff. A certified Sterile Process staff only enhances the
outcome of the facilitys cleaning process. Certification
ensures a level of understanding of the cleaning process that is
continually updated and enhanced through recertification.
It takes time and dedication to keep the medical automatic
washer functioning properly. Running instruments through a
washer does not guarantee that they will be fully cleaned; all
of the variables mentioned in this article must be working at
their optimum for the process to be complete and for staff to
have confidence in their equipment. A quality improvement
program takes time to implement but will prevent future
headaches, such as additional manual cleaning and reduced
s t a ff productivity. It allows staff to better understand the
cleaning process and to solve problems more easily when they
do occur.
The importance of monitoring
Testing a medical automatic washer to ensure it is properly
calibrated is vital to any hospitals infection control program.
Washers fail to clean for many reasons. Independent testing
provides a means of monitoring the variables that influence
the effectiveness of an automatic washer. Professional
o rganizations and government agencies including JCAHO,
92 MANAGING INFECTION CONTROL
FDA, AORN, IAHCSMM, ASHCSP, ASTM, CDC and AAMI,
as well as equipment manufacturers, recommend that Sterile
Processing departments have a quality improvement program
in place to reduce the incidence of dirty instruments resulting
from a poorly functioning washer.
The following statements from professional organizations
support implementation of quality improvement programs:
JCAHO Standard E.C.6.20: Medical equipment is
maintained, tested and inspected.(2005)
AAMI ST79:2006, 7.5.5 Verification of the cleaning
process: . processing personnel are increasingly aware
of the need to control and standardize the steps taken to
ensure the sterility of devices for patient use. Because
disinfection and sterilization cannot be assured unless the
cleaning process is successful, professionals in the field
ought to seek out whatever means are available and
practical to verify this function. A quality system would
call for monitoring and documenting decontamination
processing parameters, whether the process is accom-
plished by hand or mechanically.
AAMI ST79:2006, Annex D User verification of cleaning
processes: Ideally, cleaning verification by users should
include visual inspection combined with other verification
methods that allow the assessment of both external
surfaces and inner housing and channels of medical
devices. Manufacturers should strive to provide users with
such tests so that medical devices can be tested directly
after cleaning in a way that will not damage the device or
require recleaning
IAHCSMMs Central Service Technician Manual 6th
(2003) edition contains a section on ways to verify the
cleaning process.
AAMI TIR12:2004 defines verification and validation for
the user and the manufacturer:
1. 2.38 user verification: Documented procedures,
performed in the user environment, for obtaining,
recording and interpreting the results required to
establish that predetermined specifications have
been met.
2. 2.39 validation: Documented procedures for
obtaining, recording and interpreting the results
required to establish that a process will consistently
yield product complying with predetermined specifi-
cations.
The Getinge Company offers a performance monitoring
program that allows users to independently verify the key
February 2007

variables of the medical automatic washing process. This is
exactly what AAMI TIR12:2004 calls for: that companies
provide a way to verify their equipment is working properly.
Ideally, when the washer is serviced a test object is used to
verify the machine is operating at the same level as when it was
originally installed. The user has proof the equipment is
working properly and has been independently verified. At this
writing Getinge is the only company of which the author is
aware that is providing this service as part of its documented
service program.
Setting up a quality improvement program
Proper cleaning then is very critical to the sterilization
process. A quality improvement program with an independent,
objective test for the variables that affect the automatic
cleaning process allows the Sterile Processing professional to
monitor and ensure that proper cleaning is being done.
Because no two Sterile Processing departments have the
same cleaning process, the quality improvement program
outlined below is necessarily generic, but does include many of
February 2007
Education & Training
the variables mentioned earlier in this article. The program
assumes the following:
Appropriate facilities are provided;
Appropriate equipment is used;
Equipment is fit for its purpose, properly maintained and
calibrated, and properly monitored and validated;
Staff are properly trained and supervised;
Single use medical devices are not reused;
Records of decontamination are kept.12
A quality improvement program should be based on staff
observations and on data obtained by monitoring the key
variables. The process should be ongoing; tests can be
conducted each shift, weekly, monthly, quarterly or yearly
depending on the variable monitored.
Water quality testing
Water quality in a hospital can change from when it
enters the building to when it is used. Water can be easily
monitored by using a dipstick test. Staff should monitor
and document at least the basic parameters (pH, hardness,
MANAGING INFECTION CONTROL 93
 Education & Training
alkalinity) at least weekly. Documenting the results
over time allows staff to discern trends. When trouble
arises staff can use this data to help solve the problem.
Many cleaning solution manufacturers will provide a free
water-quality analysis. Sterile Processing staff can also ask
the hospital maintenance department for the records they
keep on the quality of water entering the hospital.
Temperature monitoring
Proper temperature at the various stages of cleaning is
vital to the successful function of an automatic washer.
Water temperatures must not exceed certain levels at
certain cleaning stages. Temperatures at the various stages
should be monitored and documented at least weekly.
A simple irreversible thermometer can be used to verify
and document the highest temperature reached during
a cycle or stage of a process. Alternatively, a temperature
data logger can be used to record and store the full
temperature profile of an automatic washer cleaning cycle.
The data can then be downloaded and stored for future
reference. Either way, recording and documenting the
data is key to ensuring the washer runs at the correct
temperature for each cycle or stage of the process.
Instrument and target soil testing
As stated previously, blood is the primary target soil for
the medical automatic washer. Logically, therefore, a soil
test should contain a sample of this target soil. Two types
of test kits containing blood or a blood substitute are avail-
able todaya paint-on type such as an Edinburgh soil13,
and the TOSI14, a prepared test object.
The Edinburgh soil is made up in the department by
s t a ff. The paint-on soil is spread over the instruments
being tested. The soil must be applied consistently each
time the test is performed. The soil is allowed to dry
(follow manufacturers instructions regarding length of
Figure 17. Blood soil testsTOSI and LumCheck.
94 MANAGING INFECTION CONTROL
drying time), and the instruments are loaded into the
medical automatic washer using a normal loading pattern.
A visual inspection of the instruments is required after the
washing process is complete. Results are recorded and
interpreted according to the soil manufacturers guide-
lines.
The TOSI (Test Object Surgical Instruments) (see Figure
17 below) has three components: the blood soil, a stainless
steel plate and a clear plastic holder. The soil is comprised
of blood components that have been mixed and applied in
a precise manufacturing process. The stainless steel plate
is scratched or grooved, replicating the uneven surface
of surgical instruments. The plate is mounted in the plastic
holder at an angle, providing a gradually more difficult
cleaning test from one end to the other. This mimics a box
lock of a surgical instrument (see Figure 6). The TOSI is
made in a quality-controlled environment (International
Standards Organization [ISO] certified facility), ensuring
consistency among individual tests.
During the test, one TOSI is placed inside an empty tray/
basket for one complete cycle. In some washers, one
TOSI test goes on each level. Users should follow manu-
facturers instructions and refer to the troubleshooting
guide in case of unsatisfactory results. Results of the test
are recorded, and problems are addressed. The result of a
TOSI test help staff to diagnose problems and address the
root cause(s).
The American Society of Testing and Manufacturing
recently established a new standard D7225Guide for
Blood Cleaning Efficiency of Detergents and Washer
Disinfectors. The design of the TOSI complies with
D7225, providing the user with the means to implement
this method. Following D7225, the user performs a quali-
tative evaluation of the cleaning efficiency of their
medical automatic washer. Hospitals and equipment
manufacturers can use available test methods to help
February 2007

ensure that medical automatic washers are performing
properly, thereby reducing healthcare-acquired infections
that result from using dirty instruments.
Testing for hollow/lumen instruments
Many of todays advanced medical automatic washers
have the ability to irrigate hollow instruments, allowing
the Sterile Processing department to better clean lumen
items. Refer to the article Manual versus automated
methods for cleaning reusable accessory devices used for
minimally invasive surgical procedures.15 A new test,
the LumCheck15 (see Figure 17) can be used to evaluate
the cleaning performance of washers that irrigate lumen
items. The test consists of a capsule with lumens on
either end, into which a TOSI test strip is inserted. The
dimensions of the test capsule are similar to those of long
hollow instruments. Users should read the manufacturers
instructions for hooking up lumen/hollow instruments to
the equipment, and use the same procedure to hook up the
February 2007
Education & Training
test device. Run a complete cycle and record the results. In
case of unsatisfactory results, refer to the troubleshooting
guide for the LumCheck. Report any concerns to the
appropriate management staff for follow-up.
Sonic testing
Some medical automatic washers have a sonic cycle. This
cycle can be monitored using any of three methods:
a foil test, a sonic probe test or a SonoCheck. The sonic
probe test and the foil test are somewhat difficult to
perform in a washers sonic chamber. The SonoCheck is
easy to use and read. Proper use of the SonoCheck was
discussed in the article Improving the Quality of the
Sonic Cleaning Process, which appeared in the July 2006
issue of Managing Infection Control.
Picking the right test
The Sterile Processing staff must determine the best test
method for their particular facility. Some tests are subjec-
MANAGING INFECTION CONTROL 95
 Education & Training
tive in nature, and consistency (repeatability) is a concern.
Criteria for test selection should include:
Ease of use and interpretation of results;
Consistency of application of the test;
Availability and cost;
Correlation of test soil with the actual target soil(s);
Reliability and reproducibility of the test results;
Ability of test results to indicate the source of
problem(s);
Scientific data supporting use of the test.
Training
Proper staff training is vital to the process. Document
all in-services, and have competencies for the various
activities performed.
Equipment maintenance
After any maintenance is done on the washer, all tests
should be conducted to ensure that the equipment is
Figure 18. Working with your Automated WasherWork Flow (Duties)
96 MANAGING INFECTION CONTROL
functioning properly. The type of maintenance done and
the results of all tests should be documented and recorded.
The person who performs the maintenance should not
leave until the tests have been completed so that any
necessary adjustments can be made immediately.
Summary
Simply running a test through the automatic water is not
enough to ensure that the process is working properly. The
Sterile Processing department should implement a quality
improvement program for the washer that includes:
Measuring pH and water hardness;
Monitoring the temperature of the water at various stages;
Performing a target soil cleaning test;
Performing an appropriate lumen test on cannulated/lumen
type cleaning equipment;
Daily/weekly visual inspection of equipment (observations
of machine operation/conditions);
Constant daily visual inspection of all instruments;
continued on page 102
February 2007
 Education & Training

Figure 19. Sample quality improvement program form.

February 2007 MANAGING INFECTION CONTROL 97

 Education & Training

continued from page 96

Training of staff on a continuous basis; AAMI ST79:2006 states, Sterile processing personnel are
Degassing procedure if the washer has a sonic increasingly aware of the need to control and standardize the
cycle; steps taken to ensure the sterility of devices for patient use.
Proper loading of instruments; Because disinfection and sterilization cannot be assured unless
Appropriate tray selection; the cleaning process is successful, professionals in the field
Other key factors/inputs relevant to each hospitals ought to seek out whatever means are available and practical to
process; verify this function. A quality system would call for monitoring
Recording all test results and observations in a and documenting decontamination processing parameters,
log/book; whether the process is accomplished by hand or mechanically.
Referring to the equipment manufacturers trou-
bleshooting guide in case of unsatisfactory results.16 JCAHOs (2005) standard E.C.6.20 says, Medical equipment
is maintained, tested and inspected.
Figure 18 illustrates a sample flow diagram for
a quality improvement program in a hospital Sterile An ineffective automatic washer compromises sterilization
Processing department. Figure 19 (page 97) is an and places both employee and patient at risk. Improperly cleaned
example of a quality improvement program checklist items can result in patient infections, delayed cases (need to
provided by Healthmark Industries. re-set up room) and even death!14 A hospital that does not have a
The Sterile Processing management team is quality improvement program (see Figure 20) in place for the
ultimately responsible for providing clean, properly washer risks not meeting the fundamental goal of to do no harm.
functioning sterile instruments. Part of that process in Regular testing of the key variables just makes Common Sense
the majority of hospitals is making sure the medical for Sterile Processing.
automatic washer is working properly. Issues concerning
the operation of a medical automatic washer and the Figure 20. Quality improvement program cycle.
cleaning process in general, and results of monitoring
should be reported routinely to the infection control
committee and to risk management. Incorporating these
reports as part of a monthly quality management meeting
is an effective way to achieve and document this type of
communication. Audits of practice (e.g., observations,
random conversations with staff at work) will help
ensure that all staff are following policy and procedure
and can identify situations where changes might need to
be made. A quality improvement program will assure
compliance with regulations and will help to prevent the
incidence of unclean, unsterile instruments.

Closing Comments
Remember, the first goal and focus of any health-
care facility is to do no harm. Delivering the highest
quality of care possible is a key element in achieving
that goal.
Residual of any type (detergent, blood, protein, etc.)
on any instrument can cause harm. The author realizes
that there is much research and debate concerning
the level of detection necessary. However, failure to References
monitor the cleaning process or to implement a quality 1. AORN Journal. Recommended Practices for Sterilization in the
Perioperative Practice Settings. March:2006.
improvement program to provide better patient outcomes 2. http://www.fda.gov/cdrh/ode/guidance/1252.html.
is counter to the concept of to do no harm. 3. Rudin, D. Efficacy Against Infection Prions in Instrument Reprocessing.
The following quotes from two of the best sources Infection Control Technology. March:2006.
4. The Association for the Advancement of Medical Instrumentation. Safe
on the subject sum up why a hospital/clinic should handling and biological decontamination of medical devices in health care
monitor the medical automatic washer cleaning process: facilities and in nonclinical setting. ANSI/AAMI ST35:2003.

102 MANAGING INFECTION CONTROL February 2007

 Education & Training

5. h t t p : / / w w w. b e e r e m e d i c a l . c o m / P r i n t s / p d f /
Guide-Instr.520care.pdf.
6. Australian Infection Control. Relative efficacy Sterile Process and Distribution CEU Information
and activity of medical instrument cleaning CEU Applicant Name _________________________________________________
agents. Volume 7, issue 3, 9:2002.
7. Address_________________ _ _ _ _ _ _____ _ _ _ _ _ _ _ _ _ _ __ ____ _ _ _ _ __ _ _ ________
http://www.cleaning101.com/cleaning/chemistry
8. Criti-Klenz:1479-08:label instructions.
9. MetriWash:10-3300:label claim. City____________________________ State________ Zip Code _______ _ _ _ _ ___
10. Endozyme. AW-triple Plus with a A.P.A.(R);
345A.P.A., label claim. The CBSPD (Certification Board for Sterile Processing and Distribution) has
11. AVENATECDH, INC washer/Decontaminators- pre-approved this inservice for 1.5 contact hours for a period of five years from the
In-Service Training Guide-Operation of the date of publication and to be used once in a re-certification period. Successful
Belimed. SM-100:1998. completion of the lesson and post test must be documented by facility management
12. Basile, Browne, Kovach. Measuring Clean in and those records maintained by the individuals until re-certification is required. DO
Central Service. Managing Infection Control. NOT SEND LESSON OR TEST TO CBSPD.
8:2004. For additional information regarding Certification contact: CBSPD, 2 Industrial
13. http://www.medisafeuk.co.uk/sgjlib/default. Park Road, Suite 3, Alpha, NJ 08865 or call 908.454.9555 or visit Web site at
asp?src=item&id={0f71E4BE-4BE7-4A30- www.sterileprocessing.org.
AB6C-301A28D1ACEE}&title=Washer%2F
Dsinfection+Test+Soil. IAHCSMM has awarded 1.5 contact points for completion of this continuing
14. http://www.healthmark.info/proformance.html. education lesson toward IAHCSMM recertification.
15. Alfa, Nemes. YJHIW 1720-1/6/2004-09: 05-
DMESSENGER-106432-MOEDLG-pp.1-6.
16. Basile, Kovach. The Cleaning Process. Nursing CE Application Form
Managing Infection Control. 7:2003. 3M Health Care provider approved by the California Board of Registered Nurses, CEP
17. Chobin, Nancy. Role of Central Service in 5770 for 1 contact hour. This form is valid up to five years from the date of publication.
Infection Control. Nebraskaland Central
1. Make a photocopy of this form.
Service Meeting. 10/19/2005.
2. Print your name, address and daytime phone number and position/title.
18. ZenSentrile Forum 2004, Martin Weider,
Dosage and Control Mechanisms in Validation of 3. Add your social security number or your nursing license number.
Automated Cleaning and Disinfection Processes. 4. Date the application and sign.
19. and then there was Decontam. Richard W. 5. Answer the CE questions.
Schule; Paper submitted for the Ruth Anne 6. Submit this form and the answer sheet to:
Brooks,RN Past Presidents award IAHCSMM. Workhorse Publishing
Managing Infection Control
PO Box 25310, Scottsdale, AZ 85255-9998
7. Participants who score at least 70% will receive a certificate of completion within
30 days of Managing Infection Controls receipt of the application.
Stephen M. Kovach is the director of
education for Healthmark Industries in
Application
Please print or type.
St. Clair Shores, Mich. He has been in
the hospital field for more than 30 years. Name______________ _ _ _ _ _ _ _ _ _ _ _____ _ _ _ _ _ _ _ __ _ _ _ _ _ _ _______________ ___
Stephen has been active with his state and
national Central Service org a n i z a t i o n s , Mailing Address___________________________________________________ _ __
having held many leadership positions. City, State, Country, Zip _______________________________________________
He also belongs to the Michigan Lakeshore
Chapter #2307 of AORN. He has received Daytime phone ( )_____________________ _ _ _ _ _ _ _ _ _ _ _ _ _ ____ _ _ __
recognition in both his personal and
Position/Title______________________________ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ ____ _ __
business profession.
Stephen is very proud to say he has Social Security or Nursing License Number _________ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _____
WORKED IN CENTRAL SERVICE.
Date application submitted ___________________________ _ _ _ _ _ _ _ _ _ _ ________

Signature _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ ___________________ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ ____ _ _ _

ANSWERS Offer expires February 2012
1. T 6. T On a scale of 1-5, 5 being Excellent and 1 being Poor, please rate this program
2. T 7. F for the following:
3. T 8. F 1) Overall content ___________________
4. T 9. T
2) Met written objectives ______________
5. T 10. T
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February 2007 MANAGING INFECTION CONTROL 103