CRCST Self-Study Lesson Plan

Sponsored by:
Lesson No. CRCST 133 (Technical Continuing Education - TCE) Patti Koncur, CRCST
IAHCSMM Educational Specialist
and
Scott Davis, CMRP, CRCST, CHMMC
Materials Manager
LEARNING OBJECTIVES
1. Dene biolm
2. Review cleaning processes that
effectively remove biolm
3. Discuss methods to validate cleaning
effectiveness
This series of self-study lessons on CS topics was de-
veloped by the International Association of Healthcare
Central Service Materiel Management (IAHCSMM).
Purdue Universitys Extended Campus and IAHCSMM
both offer grading opportunities.
Earn Continuing Education Credits
Online: You can use these lessons as an in-service with
your staff, or visit www.iahcsmm.org for online grading
at a nominal fee. Each 20 question online quiz with a
passing score of 70% or higher is worth two points
(2 contact hours) toward your CRCST re-certication
of 12 CEs.
Mail: For written grading of individual lessons, send the
completed 20-question quiz and $15 to: PEC Business
Ofce, Purdue University, Stewart Center Room 110,
128 Memorial Mall, West Lafayette, IN 47907-2034.
Each 20 question quiz with a passing score of 70% or
higher is worth two points (2 contact hours) toward your
CRCST re-certication of 12 CE.
Subscription Series: From January 1 to June 30 each
year, Purdue Extended Campus offers an annual mail-in
or online self-study lesson subscription for $75 (six
specic lessons worth 2 points each toward your CRCST
re-certication of 12 CE). Call 800.830.0269 for details.
IAHCSMM provides online grading service for any of
the Lesson Plan varieties. Purdue University provides
grading services solely for CRCST and CIS lesson plans.
For More Information:
Direct any questions about online grading to IAHCSMM
at 312.440.0078, and questions about written grading
to Purdue University at 800.830.0269. To print any
current valid lesson for grading or review, visit
www.distance.purdue.edu/training/cssp/lessons/.
T
HE BEST ATHLETES KNOW THAT TO DEVELOP TEAM STRATEGIES
to defeat their opponents, they must know as much as they can about those
opponents. This includes who they are, what is important and, if possible,
how they will play the game. In sports, the who is easy members of the
opposing team and the what is also known: winning in a sportsman-like manner.
The how can be determined from experience in previous games and/or input from
others who have seen the opposing teams play.
At work, biolm is one of the most important challenges that confront Central Ser-
vice (CS) technicians. Although it was rst identied in the 1600s, its importance to CS
personnel and its impact on the instrument processing cycle have only been identied
and conrmed within the past few years. As with athletes, CS technicians must know as
much as possible about this formidable opponent in order to be victorious over it.
OBJECTIVE 1: DEFINE BIOFILM
Biolm is a collection of microorganisms
that attach to surfaces and each other.
Biolm prevents antimicrobial agents,
such as sterilants, disinfectants, and an-
tibiotics, from reaching microorganisms,
and is difcult to clean from contami-
nated instrumentation and processing
equipment.
Biolm can form on many types of
surfaces, especially those that are moist
and in regular contact with water. Biolm
forms into colonies, which may con-
tain multiple types of microorganisms,
including bacteria, yeast and fungi. As the
colonies grow, they secrete a protective gel
around themselves, which is very difcult
to penetrate.
UNDERSTANDING
BIOFILM
CRCST Self-Study Lesson Plan
Biolm is a generic term that describes
a variety of substances, some with
everyday names found in many places.
For example, helpful types of biolm
include those that assist with treatments
of sewage and contaminated soil, and
others used for the clean-up of oil and
gasoline spills. Dental plaque, pond scum
and the slimy coatings on water pipes and
toilet tanks are examples of not-so-help-
ful forms of biolms. Biolm that has had
uninterrupted time to grow and multiply
when forming pond scum and dental
plaque can be easily seen with the naked
eye; However, biolm usually cannot be
seen on reusable medical devices without
the use of a microscope.
Biolm diseases and infections in hu-
mans, including ear infections, tonsillitis,
and some chronic and implant infections.
Some studies have also reported a link
between biolms and cystic brosis.
1

They can also be found on the inside of
contact lenses and within human organs.
Biolms can be life-threatening to people
with compromised immune systems.
OBJECTIVE 2: REVIEW CLEANING
PROCESSES THAT EFFECTIVELY
REMOVE BIOFILM
Biolm develops in ve stages, beginning
when a planktonic (free-oating) micro-
organism attaches to a surface and ending
when a mature colony releases free-oat-
ing cells to spread in the environment.
The National Institutes of Health
(NIH) states that biolms are very dif-
cult to treat with antimicrobial agents
for reasons that are not fully understood.
Bacteria within biolms can be up to
1,000 times more resistant to a given
agent than their counterparts that are not
part of a biolm colony. This obviously
means that it is easier to clean devices
before biolm can form on them.
Some simple steps to stop or minimize
biolm formation include:
Keep things oiy. Since bioflm likes a
moist environment, it is less attracted
to dry areas. Do not let instruments
remain in solutions longer than recom-
mended by the instrument and solution
manufacturers. Carefully dry instruments
after cleaning; Countertops and work
surfaces, and especially hard-to-reach
surfaces, should be cleaned, disinfected
and dried at the end of each shift;
Ensuie items have been aoequately
rinsed with pure rinse water because
biolms will connect with mineral
residues left on surfaces;
Hang sciub biushes ano cleaning tools
when they are not in use. This keeps
them away from moisture and allows
them to dry, which decreases opportu-
nities for biolm formation;
Do not iefll containeis, especially
those that previously contained lotions
or soaps. Note: although combining
solutions from several partially-lled
containers may seem cost- effective,
this process increases the risk of bio-
lm formation.
Cleaning biolm from instruments is
very difcult because the detergents have
a difcult time penetrating the protective
gel formed around the biolm colony.
Instruments should be cleaned as soon
as possible after use. Removing gross soil
and ushing lumens at the point of use
helps the decontamination process by
decreasing opportunities for biolm for-
mation. Careful observance of cleaning
instructions is the best defense against
biolms.
In May, 2011, the U.S. Food and Drug
Administration (FDA) issued a Draft
Guidance for industry and FDA staff.
2

This document is designed for manufac-
turers of reusable medical devices, and
it outlines test soils and an acceptance
protocol for the cleaning process. Once
the instrument manufacturer has validat-
ed an effective cleaning process, it should
always be followed.
Instruments with lumens, such as
suction tubes and exible endoscopes, are
more difcult for CS technicians to clean
than many other instruments, and biolm
can develop quickly. Therefore, it is im-
portant to ensure these items are properly
Bacillus subtilis biolm
Cleaning biolm from
instruments is very
difcult because the
detergents have a
difcult time pene-
trating the protective
gel formed around
the biolm colony.
Instruments should
be cleaned as soon as
possible after use.
CRCST SELF-STUDY LESSON PLAN
cleaned. Insulated instruments that have
not been properly maintained are also a
cleaning concern because damaged insu-
lation encourages biolm formation.
Always follow the manufacturers In-
structions for Use (IFU) for each instru-
ment being cleaned. IFU contain import-
ant information relating to water quality
and appropriate types of cleaning solu-
tions with proper dilution instructions.
Recommended water temperature, soak
times, and cleaning and rinsing instruc-
tions are also included in the IFU. Note:
IFU should always be kept in each area of
the department where instruments will
be handled. The IFU should be easy to
access, especially in the decontamination,
assembly, and sterilization areas.
Meticulous manual preparation prior
to mechanical cleaning is essential for
most instruments. Always use the proper
brush when cleaning lumens and ensure
that the brush is the proper length (it
should be able to pass through the entire
lumen). Also, ensure the brush is the
proper diameter. If it is too small, it will
not properly clean all inner surfaces of
the lumen; if it is too large, it may damage
the lumen.
After cleaning, the IFU procedures for
proper inspection, lubrication and assem-
bly should be followed. Storage instruc-
tions should also be followed, especially
for lumened instruments, such as exible
endoscopes. If the manufacturers IFU
are not clear, seek clarication. Do not
assume that the cleaning instructions are
the same as those for a similar instrument
made by another manufacturer.
Instruments are not the only place
biolms may develop in the CS depart-
ment. For example, mechanical equip-
ment, such as washer decontaminators,
can become colonized and contaminate
instruments during the cleaning process.
As with instruments, always follow the
manufacturers IFU for the proper
cleaning and descaling of all decontami-
nation equipment.
OBJECTIVE 3: DISCUSS METHODS
TO VERIFY CLEANING
EFFECTIVENESS
After items have been cleaned, it is im-
portant to verify that the cleaning process
was effective. While CS technicians
should know the importance of visual
inspection, they must also remember to
use a magnifying glass or other visual en-
hancing equipment to inspect serrations,
box locks, ratchets, and other hard-to-see
areas on instruments.
Even with the use of most visual en-
hancing tools, microorganisms will still
not be seen, and other tests have been
developed to help verify that cleaning
quality standards have been attained. Ex-
amples of tests that can be used to verify
lumen cleanliness include:
Cameias ano othei oevices. Note: while
this verication method is one of the
most effective, it is also the most
expensive.
Fleece-type pipe cleaneis maoe foi
instrument inspection. If organic soil is
present on the pipe cleaner as it exits
the lumen, the instrument must be
returned to the decontamination area
for re-cleaning.
The ush methoo. Theie aie seveial
ways to inspect instruments using this
inexpensive process. For example, the
lumen or cannulated item can be
ushed with 3% hydrogen peroxide. If
bubbling is seen, this means the device
is not clean. If no bubbling is present,
the instrument will still need to be re-
cleaned to remove the residual hydro-
gen peroxide. It is important to check
the instruments IFU to determine if
it can be tested in this manner because
hydrogen peroxide can damage the
nish of some instruments.

Commonly-prepared tests can be used
to verify instrument cleanliness and the
potential presence of biolm colonies.
Two of the most common used in hospi-
tal protocols are protein tests and adenos-
ine triphosphate (ATP) bioluminescence
tests, both of which test for residual soils
and for biolm.
Protein tests use the ush method.
Lumens are ushed with sterile water,
which is captured as it exits the lumen.
A commercially-prepared test strip is
then used to test the solution for
various organic soils, such as blood
and protein. This process may help
detect the presence of biolm and
assess instrument cleanliness.
A swab method can also be used to test
for organic soils, such as blood or protein,
and this process is also an effective and
easy way to check for cleanliness and
biolm on many types of instrumen-
tation. Like the ush method, several
commercial products are available. For
example, kits may be purchased to test
for either blood or protein matter, and
the testing method is the same for either
residue. First, a commercially-prepared
swab is passed through a lumen or over
an instrument. The swab is then placed
in a vial of solution supplied with the kit.
The vial is then capped and shaken and,
if residual blood or protein is present, a
color change will be seen on the swab.
ATP bioluminescence tests use the
swab method to detect ATP found in
animal, plant, bacterial, yeast, and mold
cells. Note: ATP is a substance that is the
primary source of energy for all cellular
reactions. Residues, such as blood and
bioburden (microorganisms on a con-
taminated object), contain large amounts
of ATP. After cleaning, all sources of ATP
should be signicantly reduced.
After swabbing the lumen or outside of
an instrument, the swab is either placed
into a cartridge or is combined with a
CRCST Self-Study Lesson Plan
reagent; the test swab is then placed into
a meter or is read by a hand-held monitor
to determine the presence of ATP.
Monitoring mechanical cleaning
equipment is also important to ensure
optimum cleaning efciency. AAMI ST79
states that mechanical cleaning equip-
ment should be tested at least weekly,
and the test should involve more than
one function.
All mechanical equipment should be
tested for water quality, pH level and
temperature. Ultrasonic cleaners should
be tested for cavitation action, and washer
decontaminators should be tested for
protein removal. Other tests that may be
run include those for detergent levels and
cycle times. Ensuring that mechanical
equipment works efciently helps ensure
instruments will be properly cleaned
and that biolm will not have a friendly
growth environment.

IN CONCLUSION
CS technicians have always had an im-
portant job in instrument processing. As
instruments become more sophisticated
and complex, the cleaning and assembly
tasks have become much more difcult
and time consuming. Biolm has added
to this complexity as they are invisible,
and the gel-like substance they secrete for
protection is very resistant to cleaning
and disinfection chemicals.
Biolm has been linked to many types
of hospital-acquired and surgical site
infections, and there is a growing concern
regarding the ability to consistently and
effectively destroy their colonies. Manu-
facturers IFU for cleaning must be
available and closely followed at all times.
Shortcuts cannot be taken, work areas
must be kept as clean and dry as possible,
and meticulous manual and mechanical
cleaning is a constant necessity. Other
requirements include the need to test
cleaned instruments for cleanliness and
ensure that instruments are properly
dried, assembled and, in some cases,
stored.
REFERENCES
1. See, for example: http://mpkb.org/home/
pathogenesis/microbiota/biolm
2. FDA. Processing/Reprocessing Medical
Devices in Health Care Settings: Validation
Methods and Labeling.
ADDITIONAL REFERENCES
ANSI/AAMI ST79:2010 & A1:2010. Compre-
hensive guide to steam sterilization and sterility
assurance in health care facilities. Association
for the Advancement of Medical Instrumentation.
National Institute of Health. Research of Microbi-
al Biolms. 2002.
http://grants.nih.gov/grants/guide/pa-les/PA-03-
047.html
http://www.cdc.gov/hicpac/Disinfection_Steriliza-
tion/3_0disinfectEquipment.html.
Centers for Disease Control and Prevention.
Types of Healthcare-Associated Infections. http://
www.cdc.gov/HAI/infectionTypes.html.
http://www.cdc.gov/hicpac/Disinfection_Steriliza-
tion/4_0efcacyDS.html#7.
CDC (HICPAC) Guideline for Disinfection and
Sterilization in Healthcare Facilities. 2008.
SCOTT DAVIS, CMRP, CRCST, CHMMC
Materials Manager, Surgical Services
Las Vegas, NV
SUSAN KLACIK, ACE, CHL,
CRCST, FCS
CSS Manager, St. Elizabeth Health
Center, Youngstown, OH
PATTI KONCUR, CRCST,
CHMMC, ACE
Educational Specialist, IAHCSMM
NATALIE LIND, FCS, CRCST, CHL
Educational Director, IAHCSMM
DAVID NARANCE, RN, BSN, CRCST
Reprocessing Manager/Clinician
Med Central Health System,
Manseld, OH
CAROL PETRO, RN, BSN, CNOR,
CRCST, CIS
OR Educator and Sterile Processing
Educator, Indiana University Health
North Hospital, Carmel, IN
TECHNICAL EDITOR
CARLA MCDERMOTT, RN, CRCST
Clinical Nurse III, South Florida Baptist
Hospital, Plant City, FL
SERIES WRITER/EDITOR
JACK D. NINEMEIER, PH.D.
Michigan State University
East Lansing, MI
ADVISORY COMMITTEE FOR
SELF-STUDY LESSONS
Lesson No. CRCST 133 (Technical Continuing Eoucation - TCE) Lesson expiies Nov. 2016
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CRCST Self-Study Lesson Plan Quiz - Biolms
OBJECTIVE 1
1. What is biolm?
a. Multiple types of microorganisms that form
into colonies correct
b. A group of plaque-causing algae and fungi
that attach to each other
c. A residue left on instruments that cannot
be removed from dry surfaces
d. A colony of microorganisms that cannot be
removed from moist surfaces
2. How does biolm impact the cleaning process?
a. It encourages rust and stains
b. It prevents antimicrobial agents from
reaching microorganisms
c. It can contaminate the air in Central
Service areas
d. All the above statements are correct
3. Biolm ______ be seen without magnication
on reusable medical devices.
a. Can
b. Cannot
4. Which is true about biolm?
a. It is difcult to clean from contaminated
instruments
b. Once developed, it cannot be removed
without sterilization
c. Biolm likes dry surfaces because it is
easier to attach onto them
d. All the above statements are correct
5. Which is true about biolm?
a. It does not cause disease in humans
b. It is used in the treatment of contaminated soil
c. It can cause diseases and infections in
humans
d. b and c are correct
OBJECTIVE 2
6. Which is the best tactic to help reduce biolm
colonization?
a. Decontaminate cleaning tools daily
b. Use enzyme spray immediately after the
instruments are used
c. Keep surfaces dry
d. Clean instruments within four hours of use

7. Bacteria within biolms can be up to ______
times more resistant to a given agent than their
counterparts that are not part of a biolm colony.
a. 10
b. 100
c. 1,000
d. 10,000
8. Why is stringent observance to cleaning
instructions necessary when decontaminating
items that contain biolms?
a. The FDA Draft Guidance for processing
medical devices imposes penalties if
cleaning is not successful
b. The colonies on one instrument will grow
on other instruments
c. It eliminates the need to discard expensive
instruments
d. It is the best defense against biolm colonies
9. Manufacturers IFUs should be available and
followed because they
a. Are required by AAMI
b. Contain information about biolm resistance
c. Contain information on correct solutions
and water temperatures for proper cleaning
d. All the above statements are correct

10. How often should counter tops and work
surfaces and hard-to-clean surfaces be
cleaned, disinfected and dried?
a. Hourly
b. Twice each shift
c. At the end of each shift
d. At least once daily
11. Lumened instruments are of concern when
cleaning biolms because
a. These instruments are more frequently
used than any other instruments
b. They are more difcult to clean than many
other surgical instruments
c. Manufacturers IFUs are not always clear
on how to clean lumens properly
d. b and c above are correct
e. All the above are correct
12. Insulated instruments are of concern when
cleaning biolms because
a. There is no way to remove biolm from the
damaged insulation
b. Technicians cannot scrub the insulation
without damaging it
c. Damaged insulation encourages biolm
formation
d. Biolm on damaged insulation must be
removed by external vendors

13. How often should mechanical cleaning
equipment be cleaned to prevent biolm
formation?
a. Daily
b. Weekly
c. As necessary
d. As recommended by the manufacturer
14. Instruments are the only place where biolms
can develop in the Central Service department.
a. True
b. False

OBJECTIVE 3
15. Verifying the cleaning process can be done using
a. Cameras
b. Pipe cleaners
c. Commercially-prepared swab tests
d. All the above

16. Which is true when using Hydrogen Peroxide
to ush-test instruments?
a. The instruments will have to be cleaned
after the test
b. Hydrogen peroxide may damage the
instruments nish
c. Manufacturers IFU should state this
method of testing can be used
d. All the above instruments are correct
17. Which is true about protein tests to verify
instrument cleanliness?
a. They use the ush method
b. A test strip is inserted inside the lumen
c. They can detect the presence of biolm
d. a and c are correct
18. Mechanical cleaning equipment should be
tested for cleaning effectiveness
a. Daily
b. At least weekly
c. As needed
d. After repair
19. A magnifying glass or other visual enhancing
equipment should be used to inspect which of
the following on instruments?
a. Ratchets
b. Box locks
c. Lumens
d. a and b above
e. all the above

20. Protein and ATP bioluminescence tests can
be used to verify instrument cleanliness and
the potential presence of biolm.
a. True
b. False