Understanding the Sonic Cleaning Process

By Stephen M. Kovach, B.S.

Objectives
After completion of this self-study activity, the learner will be able to:
1. Understand the factors that influence the sonic cleaning process.
2. Describe the role de-gassing plays in sonic cleaning.
3. Test to determine if a sonic cleaner is functioning properly.
4. Design a quality improvement program for sonic cleaning.

Introduction

“Cleaning is critical because residual organic material (e.g., blood, bone,

proteinaceous material) can inactivate disinfectants; moreover, if a device is not
cleaned thoroughly, sterility may not be achieved.”(1)

Surface cleaning is a crucial aspect of any Central Service Sterilization Department’s

(CSSD) cleaning process. Effective cleaning of any surgical instrument is important
regardless of the complexity of the instrument. There is no such thing as “sterile dirt”.

Almost all surgical instrument manufacturers recommend sonic cleaning in their

guidelines for care and cleaning of surgical instruments:

“Ultrasonic cleaners are used to remove soil from joints, crevices, lumens, and other
difficult to access locations. The use of enzymatic detergent in the ultrasonic cleaner is
recommended. Ultrasonic Cleaners should be monitored routinely to ensure that they
are working properly.”(2)

Instruments have become more advanced and complex, so has the sonic cleaning
equipment that can be purchased by hospital CSSD. These advancements have taken a
simple tank with transducers to a level where sonic equipment now can combine the
power of irrigation (pulse / retro flow technology) with sonic energy to clean lumen
instruments better than ever before. Add the advancements that have been made with
cleaning solutions, and today many sonic equipment manufacturers claim they can: (3, 4)
• Improve consistency of cleaning in internal areas of surgical instruments,
• Reduce risk to staff from airborne and blood-borne pathogens created by
manual brushing,
• Improve patient care by reducing risk of exposure to cross-contaminants,
• Reduce time spent trying to manually clean places that cannot be seen or
reached,
• Reduce internal and external instrument damage caused by manually
brushing, tapping, or bending, and
• Reduce instrument-repair budgets.
From an instrument manufacturer’s point of view, ultrasonic cleaning is an essential part
of the cleaning process and should be used as frequently as possible. Today’s CSSD
professionals must understand how sonic cleaning works and are responsible for ensuring
that their department’s ultrasonic equipment is working properly.

Example of various sonic cleaners picture courtesy of UltraClean Systems

What is Sonic Cleaning?

Sonic cleaners are designed for fine cleaning of medical devices, not for disinfection or
sterilization. They are used to remove soil from joints, crevices, lumens, and other areas
that are difficult to clean by other methods. (5)

A sonic cleaner can have a single tank or as many as three tanks in a hospital setting. In a
multi-tank system, the first tank is usually for cleaning, the second is for rinsing and the
third is for drying. In a two-tank system, one tank cleans and the other rinses and dries.

The sonic cleaners used in hospitals work via high-frequency sound waves (usually above
20kH) to produce an effect called cavitation—tiny bubbles of vaporized liquid that
implode (rapidly collapse) and create high pressure shock waves.

Ultrasonic transducers create this high-frequency sound by converting high-frequency

electrical power to mechanical energy (vibrations). See Figure 1. This energy is
transmitted to the cleaning solution via a bank of transducers attached to the underside of
the cleaning tank.
Figure 1 Sonic Cleaner Unit Diagram

Cleaning takes place as the cavitation dislodges soil from the surface, tiny crevices, and
other areas that are difficult to clean on contaminated instruments, which are placed in
the tank with cleaning solution. Cavitation literally sucks soil off the instrument like a
vacuum (Figure 2).

Figure 2 Cavitation

Most sonic cleaners have multiple transducers producing the cavitation energy. If one or
more of these transducers is not functioning, the sonic cleaner tank can have what are
known as “cold spots”—areas within the tank where there is no cavitation. Obviously it
is important to know the location of any cold spots. In a machine with several cold spots
cleaning time will be extended.

Like any cleaning process, sonic cleaning is affected by outside factors. Factors that
influence the effectiveness of sonic cleaning are:
1. Energy–created by the mechanical action of the generators and transducers to
produce the cleaner’s cavitation;
2. Target Soil –the type of soil being cleaned;
3. De-gassing–freeing trapped air;
 4. Chemical activity–the type and amount of the cleaning solution chosen;
5. Water quality–hardness and pH;
6. Water Temperature–hot or cold cleaning solution;
7. Time–length of exposure to cavitation;
8. Human factor–training, loading procedures, proper use of equipment;
9. Other issues-such as pre-cleaning and safety
10. Verification of the process

The various combinations of theses factors determine how clean an instrument can or will
be when placed inside the bath/solution of a sonic cleaner.

The first factor, Energy, has been explained above in the section on cavitation. Now let us
look at the other factors:

Target Soil

Sonic cleaning is used primarily on surgical instruments, so the target soil is usually
blood. Many other soils can be present, but blood is a primary concern for the CS
department when cleaning surgical instruments.

“Many types of soil could be present on reusable medical devices, but dried blood is
especially difficult to remove. 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. It must be rehydrated and then washed away.
Blood adheres to surfaces through mechanical and chemical means. Fibrin filaments in
coagulated blood pack themselves into microscopic irregularities in the surface of
instruments and have to be mechanically scrubbed away or chemically treated.”(20)

Several characteristics of blood are important to know for cleaning. The first is that
hemoglobin becomes highly insolvent when it dries out. Secondly fibrin, the coagulating
agent in blood, is inherently water insoluble. Third, blood denatures at temperatures
above 110ºF (45ºC). When blood denatures, it becomes highly insolvent. It bonds
strongly to the substrate (i.e., the surface of the instrument) and dries out, becoming very
resistant to any cleaning action. Thus it is very important to keep Decontamination
Holding Time (the time between when the instruments were last used and the cleaning
process starts) to a minimum. The sooner the cleaning process begins the better.

De-gassing

De-gassing is the process of releasing dissolved air bubbles within the cleaning solution.
In order for the degassing process to work, it must be done with the detergent/enzyme
mixed in the bath solution. It is important to expel these air bubbles because they have a
direct effect on the ability of the equipment to clean. The presence of dissolved air
weakens the cavitation force of the sonic cleaner.
Degassing is done after the cleaning solution has been added. The amount of time will
vary depending on the type of chemical used (e.g. aqueous or solvent), temperature, size
of the tank, and water quality. Generally the process takes as long as one cycle without
any instruments in the filled tank. Consult the ultrasonic cleaner’s Instructions for Use
on the length of time required to de-gas a tank full of solution.

Remember that degassing conditions the bath/solution for maximum efficiency and
should be done for each new fresh bath/solution (change bath as per the manufacturer’s
directions). If the sonic cleaner has not been used for some time, the solution should be
de-gassed because dissolved air can re-enter the cleaner.

Chemical activity

There are many types of cleaning solutions on the market today; each has its plusses and
minuses. When choosing a solution, always consider the following:
• The type of instrument to be cleaned;
• The instrument manufacturer’s recommendation;
• The type of soil to be cleaned;
• Compatibility of the solution with your sonic equipment;
• Use of a low foaming solution to minimize foam settling on instruments;
• Technical data (such as white papers) supporting the claims of the solution
manufacturer. [A material safety data sheet (MSDS) should be provided with any
solution. These can be used to evaluate the key ingredients and their possible
impact on items being cleaned.]

For proper use of the cleaning solution:

• Be aware that excess amounts of certain chemical additives will not support sonic
cleaning. More is not always better; if solution must be added manually, use the
correct amount.
• Many solutions are concentrated and must be diluted with water. In some cases,
distilled water may be required. The best solution concentration is indicated on
the solution container.

Remember not all solutions are created equal. Some solutions need a higher temperature
to work at their optimum efficiency. A solution with many features may not be necessary
in a particular CS department. It’s more important to know which solution will work best
in your department on your instruments.

Although blood is the usual target soil on surgical instruments, a different, somewhat
slimy soil is commonly found on orthopedic instruments and is hard to clean. It could be
synovial fluid; if so, a product that can remove it must be chosen. I can’t stress enough
the importance of knowing what type of soil is being removed and choosing the
appropriate product or products in each case. In some situations two solutions may be
required.
Water Quality

Water quality is a broad concept covering several key characteristics of water. For the
CS professional the relevant measurable characteristics are pH level and hardness.

pH is the measurement of the acidity or alkalinity of a liquid. The scale goes from 1,
which is acidic to 14, which is alkaline. The mid-point, 7, is neutral. The pH scale is
logarithmic; meaning each number in the scale represents a 10-fold increase over the
previous number. For example, water with a pH level of 4 is ten times more acidic than
water at pH 5.

The pH level can affect detergent/enzyme performance; thus it is important to know the
optimum pH value for the cleaner being used.

Water hardness is 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/enzyme solutions and prevent them from reacting with the soil on instruments.
Water that is too hard (containing too many minerals) can cause spotting and filming on
instruments, and cause unsatisfactory cleaning outcomes.

The pH and hardness values of water can fluctuate over time. These fluctuations will
affect the performance of the solution in a sonic cleaner. Therefore it is important to test
and monitor water quality to ensure that optimum values are present.

Water Temperature

Equally important to knowing water quality is to understand and know the temperature of
the bath/solution in the ultrasonic cleaner. Each solution has a temperature at which it
functions best. The solution must be kept at this optimum temperature in order to clean
most effectively. The sonic process itself creates heat, and over time this heat can raise
the temperature of the bath/solution to a point where it reduces the cleaning efficacy of a
particular solution. Remember, “Hotter is not always better.” Achieving the proper
temperature and maintaining it throughout the cleaning cycle is key to effective cleaning;
thus CS professionals would be wise to monitor temperature during the cycle.

Time

Cleaning times can very depending on the type of soil, the solution used, water
temperature, and the degree of cleanliness desired. Instruments should be visibly cleaner
almost immediately after they are placed in a sonic cleaner.

The tray / basket used in the machine can affect the cavitation energy the instruments
receive. (6) The type of tray and the density of the load (number of instruments placed in
the tray) is directly proportional to length of cleaning time. With certain trays and loads a
standard cycle time might not do the job.

Many sonic cleaners have a variable time setting. This is important, because it allows a
CS department to adjust for the many variables associated with sonic cleaning.

Cleaning time is the easiest (and often the wrong) factor to adjust to compensate for
process variables. An experienced operator can approximate cycle duration for a certain
instrument load, but should validate by actual use with the chosen solution and the actual
soiled instruments. An easy way to do this is to test a few instruments at a time.

CS staff should ask for the instrument and sonic cleaner manufacturers’
recommendations regarding cleaning time for their products. This information provides
Central Service with a starting point from which timing adjustments for particular
instruments or soils can be made.

Proper Loading of Instruments

Loading instruments into a sonic cleaner is very important, so one must:

• Separate instruments to avoid electrolytic action between different metals
(stainless steel instruments should not be mixed with their aluminum, brass or
copper counterparts).
• Remove gross soil from instruments by pre-rinsing prior to sonic cleaning.
• Do not place chrome-plated and ebonized instruments or items made of cork,
wood, or glass in the sonic cleaner.
• Rinse any pre-foam or spray off the instruments; such materials may not be
compatible with the cleaning agent used in the tank’s bath/solution;
• Place all box locks in the open position.
• Fill lumen items with fluid so the cavitation power can work inside the lumen.
• Spread instruments out over the tray to allow maximum exposure to the cavitation
power.
• If using an irrigation/sonic cleaner, use the correct ports and close off any unused
ports. This will allow for maximum flow into the lumen items.
• Completely submerge instruments in the bath/solution.
• Make sure the tray/basket is properly located inside the tank. This allows for
maximum exposure to the cavitation power.
• Rinse all instruments after cleaning them in a sonic unit that has only one tank.
This is important because residual detergent/enzymes on an instrument are
undesirable.
• Follow manufacturer’s directions for the proper rinsing of the instrument. Consult
the manufacturer of the instruments to be cleaned and the sonic cleaner
manufacturer for any special instructions.
Human Factors

CSSD staff should understand how the sonic equipment works; such knowledge is key to
ensuring that instruments are safe to assemble and then sterilize.
Staff training should involve the following:
• Demonstration of proper use of sonic equipment by a manufacturer’s
representative. All shifts must attend a demonstration.
• Documentation of the in-service/training.
• Minimum yearly review of the sonic cleaning process for all staff.

Proper in-serving of the staff will help ensure that instruments are properly exposed to the
cavitation power of the sonic cleaning process.

Other Issues—Safety, Bath Changes, Solution Levels

Safety is always important when dealing with any powered equipment, including sonic
cleaners. All staff should be aware of safety procedures, should be properly attired in the
appropriate personal protective equipment (PPE), and should be aware of these safety
procedures:
• When the equipment is being used for cleaning (not testing) the lid must always
be closed to prevent excess emission of noise and aerosols.
• No part of the operator’s body should be submerged into the bath/solution during
operation.
• The sonic cleaner should be off when inserting or removing trays/baskets from
the tank.
• Carefully lower trays (do not drop quickly) into the bath/solution. This will
minimize or reduce the amount of air introduced into the bath/solution.

Professional opinions vary regarding the need to change the bath/solution in the sonic
cleaner. The majority of manufacturers recommend immediate replacement of water
once it is heavily contaminated. Contaminated solution can result in a loss of cavitation
power. My recommendation is to change the solution as often as needed, preferably after
each use. After each change of bath/solution, check the screen or trap and clean off any
debris, such as bone chips or paper. Many automatic machines will refresh the bath after
each use (some also degas before each use, it is a programmed cycle). Again, the key to
effective sonic cleaning is cavitation power. Frequent bath changes help maximize this
power, ensuring a better cleaning process.

Maintaining the proper level of solution in the tank is also important; sonic cleaning is a
“fine tuned system.” Improper solution levels can negatively affect the sonic cleaning
process and can damage the cleaner. Sonic cleaning systems were tested with specific
volumes of solution. Insufficient solution volume can reduce the cavitation effect power.
Verification of the Sonic Cleaning Process

Verification is supported in the present guidelines and standards found in AAMI, AORN,
Joint Commission, as well as all of the professional groups that support quality
improvement programs.

AAMI does list a sonic cleaner as a piece of medical equipment in ST 79 section 7.5.3.3;
there are other references that support the minimum of weekly testing of all types of
sonic equipment with or without “retro flow pulse adapter”.

ST 79 - Section 10.2 and ANNEX D states“…Health care personnel may perform

verification tests as part of the overall quality assurance program. This verification may
include the use of test devices that monitor the functionality of the cleaning equipment in
cleaning surfaces and that ensure adequate fluid flow in equipment that has adaptors for
lumened devices…”

ST 79 - Section 7.5.3.3 states“…Mechanical cleaning equipment should be tested upon

installation, weekly (preferably daily) during routine use, and after major repairs. A
major repair is a repair that is outside the scope of routine preventive maintenance and
that significantly affects the performance of the equipment. Examples include
replacement of the water pump(s), detergent delivery system, heating system, water
delivery system, water treatment system, computer control or an upgrade to software...”

The 2010 AORN RP for Cleaning and Care of Surgical Instruments and Powered
Equipment Recommendation XXII –Quality section is supporting the testing of
mechanical instrument washers before initial use, weekly during service, and after major
maintenance.

The Joint Commission in standard E.C.6.20 states that medical equipment be maintained
tested and inspected. (7)

So in accordance with ANSI/AAMI ST79-2010; ANSI/AAMI TIR12-2005; Joint

Commission EC6.20-2005, and AORN, testing at least weekly, monitoring the cleaning
efficacy of any sonic cleaning unit should take place and be used as quality improvement
program.

The following statements support the need for a quality improvement program for the
sonic cleaning process.

“A problem analysis should be completed for any aspect of decontamination that

can pose a risk to personnel or patients. The problem analysis should define and
resolve the problem and the system should be monitored to ensure that the
problem has been corrected.”(8)
 “Ultrasonic Cleaners should be monitored routinely to ensure that they are
working properly. Recommended monitoring methods are:
1) Sonocheck monitoring vials (from Healthmark Industries Co., 33670 Doreka,
Fraser, MI 48026 USA) which change color when the ultrasonic cleaner is
supplying sufficient energy and conditions are correct.
2) Aluminum Foil Test (Reference: The Aqueous Cleaning Handbook: A Guide to
Critical-Cleaning Procedures, Techniques, and Validation, Alconox, Inc. 2002,
3rd Edition, White Plains, NY, pps.110-111.” (9)

The Organization for Safety and Asepsis Procedures (OSAP) is a global dental safety
organization and this organization recommends routine testing of sonic cleaners within
the dental practice.

The FDA considers the sonic cleaner a Class 1 medical device. The cleaner must be
maintained in proper working order, and CSSD staff must know whether or not it is
working properly. One of the best ways to ensure that the machine is functioning
properly is to establish a quality improvement program for the sonic cleaning process. A
quality improvement process helps ensure adherence to Joint Commission, AORN and
AAMI standards and guidelines.

Testing is a key component of a quality improvement program. Tests provide a means of

monitoring the variables that affect the effectiveness of sonic cleaning (i.e., water quality,
time, detergent/enzymes, temperature, agitation, speed, initial temperature, chemical
concentration, equipment failure). Ultrasonic cleaners should be tested at least weekly,
and the results of the test should be documented. Tests fall under two categories: periodic
functional tests and routine tests.

A periodic functional test is performed for initial set-up and then quarterly or after
repairs. Its purpose is to verify uniform distribution of cavitation in the sonic cleaner.
Uniform distribution of sonic cavitation within the bath ensures satisfactory performance
by the cleaner and allows performance of routine testing. A periodic functional test can
be used to fine-tune the ultrasonic cleaning process if results are found to be
unsatisfactory. It also helps identify “cold spots” in the tank. (See Figure 3 for placement
of testing devices for the periodic functional test.)

x x x

x x x x x
x
x x x x x
Small Large

Figure 3 Periodic Functional Tests (Size of Tank)

X=Location of Various Testing Devices
A routine test is performed weekly to verify that proper cavitation is taking place. Such
parameters as water level, de-gassing, instrument load, and energy supplied by the
transducers can cause variations in the process that affect performance. Only routine
testing will detect ultrasonic performance deterioration and prevent ineffective ultrasonic
cleaning. The routine test is performed under normal conditions in an empty tank. (See
Figure 4 for placement locations for individual test devices). You need to place at least
one test in the middle of the tank (depending on the size of the tank you can place more;
sometimes 3 tests are placed in a larger tank).

x x x x

Figure 4 Routine Test ( Center of a Tank)

X = Location of Testing Device

The following is a simple program for monitoring the sonic cleaning process. CSSD
should include it as part of their Joint Commission process improvement program.

Inspection & Testing

Daily:
• Follow manufacturer’s guidelines for daily inspection of equipment (wipe down
tank at end of day, check gaskets, clean screens, etc.…).
• Inspect the level of detergent (cleaning solution). Each day, mark the date on the
solution container at the level of solution remaining. This will allow staff to see
how much solution is being used.
• Log all observations in a report.
• Report any concerns to the proper management staff.

Weekly:
A complete test of all inputs of the ultrasonic process should be run each week.
Observations and test results should be entered in a log/report.

Step 1--Equipment Inspection: Inspect equipment (screens, gaskets, etc.)

according manufacturer instructions. Record the results.

Step 2--Water Quality Inspection: Measure hardness and pH of the tank

bath/solution before adding cleaning solution (A simple dip stick method can be
used. Record results, and report any concerns to the proper management staff).

Step 3--Water Temperature Inspection: Measure the tank bath/solution

temperature with a liquid reversal thermometer. The thermometer should be
 applied to the inside of the tank wall just below the water line. Record results on a
log sheet, and report any concerns to the proper management staff.

Step 4--Test sonic cleaner performance: CSSD staffs have traditionally chosen
one of four methods--a pencil load test, an aluminum foil test, an ultrasonic
activity detector, or a SonoCheckTM to test sonic activity in the cleaning tank. (10)

Procedures for Testing Sonic Activity

Each test will be described in this section. In each case, test results should be recorded
and then compared with results of the same test conducted when the cleaner was
originally installed. In case of unsatisfactory test results, refer to the troubleshooting
guide supplied by the manufacturer of the particular test being used. Any concerns should
be reported to the proper management staff to address.

Pencil Load Test

In a pencil load test (also known as the ceramic disc test), the surface of an unglazed
ceramic disc or plate having a matte finish and a diameter of approximately 50 mm
(thickness is not critical) is rubbed with a standard HB lead pencil and then immersed in
the cleaning tank. Consistent, equal application of the lead onto the disc every time is
very important. (The Steris ® Company has recommended this method in the past, but
the disks are no longer available.) (11)

A ground glass stopper, a sheet of ground glass, or an aluminum sheet with a thickness of
2-3mm may be substituted for the ceramic disc. The ultrasonic cleaner should
completely remove the pencil lead within three minutes. If this type of test is being
recommended by a sonic manufacturer, they should provide you with a trouble shooting
guide for easy interruption so the proper trouble shooting can be done in case of a failure
or decrease in removing the lead.

Strip of Aluminum Foil

A strip of aluminum foil can also be used to test a sonic cleaner. Several tests using
aluminum foil have been described in the literature (12). Recommendations vary
regarding the thickness of the foil strip, but it should be at least 0.025mm. One test
recommends suspending nine strips of aluminum foil, 15mm to 20mm wide, within
10mm of but not touching-the bottom of the tank. Another method is to take three pieces
of foil, each measuring 10-20cm, and fold them over rods suspended in various areas of
the tank. The presence of significant pitting and a uniform pattern of dents and holes in
the foil strips after cleaning indicate the unit is working. If a manufacturer of a sonic is
suggesting using the aluminum foil test, make sure they provide you with a chart for easy
interruption of the results so proper trouble shooting and result interruption can be done
by the user of the test.

Ultrasonic Activity Detector

Testing can also be done with an ultrasonic activity detector, a device developed to
determine ultrasonic activity levels (13). The device consists of a stainless steel probe
with a plastic handle and connecting cable. The cable plugs into a hand-held instrument
that indicates and monitors ultrasonic activity. The probe is placed into various sections
of the tank and measurements are taken for each spot tested.

SonoCheckTM
The fourth testing method is the SonoCheckTM (14) (See Figure 5 & 6), a chemical
indicator vial that verifies the cavitation capability of the ultrasonic bath. The test device
is a closed vial containing fluid and glass beads. The vial is placed in the sonic bath,
which then is switched on. When effective cavitation is achieved, the color of the fluid in
the vial changes from blue/green to yellow. The length of time it takes to change color is
proportional to the cavitation power of the sonic cleaner. The person conducting the test
records the amount of time that elapses prior to the color change. If using this type of test,
make sure a trouble shooting guide is provided for ease of interpretation.

Figure 5 and 6 SonoCheck™ Results

Yellow= Positive Change/Effective Cavitation
Blue/Green=No Change/Ineffective Cavitation

Each of these test methods has its pluses and minuses. A CSSD department must
determine which test is best suited for its particular needs, and then use the chosen test as
part of a quality improvement program. Criteria for selecting a test include:
• Ease of use and interpretation of results--results should be objective.
Subjective results can lead to misinformation about the equipment.
• Availability and cost.
• Correlation to cavitation.
• Reliability and reproducibility of the test results.

Information gleaned from running the sonic performance test should help resolve
concerns about whether the sonic process is working.

Procedures for Testing Sonic Cleaning Effectiveness (Soil Test)

Recently a new type of test has become available as an option for evaluating the sonic
cleaner’s effectiveness; namely, a soil test. A soil test contains a soil sample that must be
completely removed by the sonic cleaning process.

As stated previously in this article, blood is a primary target soil for the sonic cleaner.
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 available today–a paint-on type such as
an Edinburgh soil, and the TOSI™, a prepared test object.

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 the
manufacturer’s instructions regarding length of drying time), and the instruments are
loaded into the sonic cleaner using a normal loading pattern. A visual inspection of the
instruments is required after the sonic cleaning process. Results are recorded and
interpreted according to the soil manufacturer’s guide (15).

The TOSI (Test Object Surgical Instruments; see Figure 7) has three components: blood
soil, a stainless steel plate, and a clear plastic holder. The soil is composed of blood
components mixed and applied in a precise manufacturing process, which provides a
consistent challenge to the effectiveness of the sonic cleaner. 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 (14).

Figure 7 TOSI™ (Test Object Surgical Instrument)

During the test one TOSI is placed inside an empty approved tray/basket for one cycle
length. Users should follow the manufacturer’s instructions and refer to the
troubleshooting guide in case of unsatisfactory results. Results of the test are recorded,
and concerns reported to the appropriate staff for follow-up.

Just as with the sonic energy tests described above, CSSD staff must determine the best
test method for their particular facility, and then use the chosen test in their quality
improvement program. Criteria for selection include:
• Ease of use and interpretation of results;
• Consistency of application of the test;
• Availability and cost;
• Correlation of test soil with human blood;
• Reliability and reproducibility of the test results; and
• Ability of the test to identify and resolve concerns regarding cleaning
effectiveness
Procedures for Testing Sonic Cleaning Effectiveness for Hollow/Lumen Instruments
(Soil Test)

Many of today’s advanced sonic cleaners have the ability to irrigate (with a pulse flow /
retro-flow technology) lumen/hollow instruments (like suctions), allowing the CSSD
department to better clean lumen/hollow items. Alfa and Nemus wrote an excellent
article entitled “Manual versus automated methods for cleaning reusable accessory
devices used for minimally invasive surgical procedures” (16). This article goes into
great detail on why you should be using a sonic cleaner with this irrigation (pulse / retro-
flow technology) for cleaning any lumen/hollow instrument such as suctions, minimally
invasive surgery instruments, robotic arms…

Example of a sonic that cleans lumens (this is only one of the many types available to
CSSD)

One example of the retro flow / pulse technology courtesy of Geddis Inc.

In the article entitled “Cleaning efficacy of medical device washers in North American
healthcare facilities” (21) Alfa pointed out the importance of testing with the proper type
of soil, “...the TOSI was reflective of the protein and/or hemoglobin levels found on
surgical instruments pre and post cleaning in an automated instrument washer and
whether reduced fluid flow conditions in a narrow lumen washer could be detected by
the TOSI- Lum-Chek… the TOSI Lum-Chek and regular TOSI devices do provide a
readily available method for monitoring washers that facilitates ongoing cleaning
assessment in the healthcare setting…” The article also stated the reason the TOSI™
were used in this peer reviewed study is that it best represented what is actually found on
surgical instruments and others tests that just had dye on them did not represent what was
being found on surgical instruments.(21)

Having a standardized challenge for the cleaning efficacy of a sonic cleaner with an
irrigation system is important because you want to make sure the cannulated/lumen items
are getting clean. The LumCheck™ test kit (17)(see figure 8) allows you to do this, it
includes a reusable stainless steel holder (analogous to a lumened instrument) which
opens to allow easy insertion of a blood soil test (TOSI™) which correlates to dried
blood on a stainless steel instrument. Complete removal of the blood soil (with visual
inspection) indicates that the irrigation system is working properly. Users should read the
manufacturer’s instructions for connecting lumen/hollow instruments to the equipment,
and use the same procedure to connect the test device. Run a complete, empty cycle and
record the results. If soil remains, the inputs for cleaning need to be checked, including
water quality, water temperature, detergent concentration and the pump system. Report
any concerns to the appropriate management staff for follow-up.

Figure 8 LumCheck™

As of this publishing, the author was not aware of methods other than the LumCheck™
available to medical facilities for testing lumens that use blood soil as the test soil. There
are some other tests, but they are not blood soil based tests and thus do not represent what
is actually being cleaned in a CSSD. Authors note: “Our data demonstrates that the
lumen TOSI is a relatively easy challenge and if residual material remains, it indicates
that the lumen cleaning ability of the washer has been severely impaired (less than ½
usual conditions)(18).

Equipment Maintenance

After any maintenance is done on the sonic equipment, all tests should be conducted to
ensure that the equipment is 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 necessary
adjustments can be made immediately. It is also very important that the person repairing
and doing the maintenance is qualified and has experience with that particular equipment.
Summary

A quality improvement program for the sonic cleaning process should include: (19)
• Measuring pH and water hardness
• Monitoring the bath/solution temperature
• Performing a cavitation test on the equipment
• 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
• Training of staff on a continuous basis
o De-gassing procedure
o Loading of instruments
o Selection of trays
o Other key factors/inputs relevant to each hospital’s process
• Record all results of tests and observations in a log/book
• In case of unsatisfactory results refer to the troubleshooting guide for the
tests and equipment used
• Report any concern to the proper management staff within the department
to follow up.

Today’s Central Service Sterilization Departments are very active and dynamic. Surgical
instrumentation and processes change constantly, and the cleaning equipment needed to
process these instruments safely is evolving as well. It only makes sense to have a well-
qualified and trained staff to process these surgical instruments.

A sonic cleaner, like any piece of equipment, can malfunction at any time. Knowledge of
when and why the cleaner is malfunctioning is key to ensuring properly cleaned surgical
instruments. A quality improvement program helps ensure that staffs are protected and
patients are receiving the best possible care. It enables CSSD staff to know that their
equipment (in particular, the sonic cleaner) is working properly. Then staff can be sure
that the instruments are clean and ready for the next stage of the reprocessing cycle.

SonoCheck™, TOSI™, and LumCheck™ are trademarks of Healthmark Industries

Fraser, MI
References
1. http://www.zimmer.com/web/enUS/pdf/Surgical_Cleaning_Instructions_Final.pdf
; page 8.
2. http://ortho.smith-nephew.com/us/node.asp?NodeId=3248 ;page 1.
3. http://www.ultracleansystems.com/products.htm
4. http://www.medisafeuk.co.uk
5. ANSI/AAMI ST79:2010, p. 57.
6. Coatesworth, Kovach. The importance of tray selection on Sonic Cleaning.
Managing Infection Control. Nov: 2005.
7. Standard EC.6.20: JCAHO Standards 2006.
8. ANSI/AAMI ST79:2010, Section 11
9. http://ortho.smith-nephew.com/us/node.asp?NodeId=3248
10. Coatesworth, Kovach. The importance of tray selection on Sonic Cleaning;
Managing Infection Control. Nov: 2005.
11. Steris Maintenance Manual Sonic Energy Systems P-47162-091: 4/30/91: pp. 3-5.
12. http://www.efhss.com/html/educ/sbasics/sbasics0102_en.php#sbasics_cleaning_0
8_03_05
13. http://www.sentry-products.co.uk/categories.cfm -search sonic testing
14. http://www.healthmark.info/proformance.html
15. http://www.medisafeuk.co.uk/sgjlib/default.asp?src=item&id={0F71E4BE-4BE7-
4A30-AB6C-301A28D1ACEE}&title=Washer%2FDisinfector+Test+Soil
16. Alfa, Nemus; Journal of Hospital Infection 1720-1/6/2004-09:05-
DMESSENGER-106432-MOEDL6-pp.1-9
17. http://www.healthmark.info
18. Alfa, Nemus; Manual versus automated methods for cleaning reusable accessory devices used for
minimally invasive surgical procedures: YJHIN 1720—1/6/2004: pp. 1–9
19. Basile, Kovach; The Cleaning Process. Managing Infection Control. July: 2003.
20. 2010 Association for the Advancement of Medical Instrumentation ■ ANSI/AAMI ST79:2010
;Section 7.5.2
21. Alfa MJ et al., Cleaning efficacy of medical device washers in North American healthcare facilities,
J Hosp Infect (2009), doi:10.1016/j.jhin.2009.06.030