CRCST Self-Study Lesson Plan

Sponsored by:

Lesson No. CRCST 133 (Technical Continuing Education - TCE) Patti Koncur, CRCSTIAHCSMM Educational Specialist

andScott Davis, CMRP, CRCST, CHMMC

Materials Manager

LEARNING OBJECTIVES1. Define biofilm2. Review cleaning processes that effectively remove biofilm3. 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 University’s Extended Campus and IAHCSMM both offer grading opportunities.

Earn Continuing Education CreditsOnline: 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-certification of 12 CEs.

Mail: For written grading of individual lessons, send the completed 20-question quiz and $15 to: PEC Business Office, 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-certification 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 specific lessons worth 2 points each toward your CRCST re-certification 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/.

THE 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, biofilm is one of the most important challenges that confront Central Ser-vice (CS) technicians. Although it was first identified in the 1600s, its importance to CS personnel and its impact on the instrument processing cycle have only been identified and confirmed 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 BIOFILMBiofilm is a collection of microorganisms that attach to surfaces and each other. Biofilm prevents antimicrobial agents, such as sterilants, disinfectants, and an-tibiotics, from reaching microorganisms, and is difficult to clean from contami-nated instrumentation and processing equipment.

Biofilm can form on many types of surfaces, especially those that are moist and in regular contact with water. Biofilm 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 difficult to penetrate.

UNDERSTANDING

BIOFILM

CRCST Self-Study Lesson Plan

Biofilm is a generic term that describes a variety of substances, some with everyday names found in many places. For example, helpful types of biofilm 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 biofilms. Biofilm 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, biofilm usually cannot be seen on reusable medical devices without the use of a microscope.

Biofilm diseases and infections in hu-mans, including ear infections, tonsillitis, and some chronic and implant infections. Some studies have also reported a link between biofilms and cystic fibrosis.1 They can also be found on the inside of contact lenses and within human organs. Biofilms can be life-threatening to people with compromised immune systems.

OBJECTIVE 2: REVIEW CLEANING PROCESSES THAT EFFECTIVELY REMOVE BIOFILMBiofilm develops in five stages, beginning when a planktonic (free-floating) micro-organism attaches to a surface and ending

when a mature colony releases free-float-ing cells to spread in the environment.

The National Institutes of Health (NIH) states that biofilms are very dif-ficult to treat with antimicrobial agents for reasons that are not fully understood. Bacteria within biofilms can be up to 1,000 times more resistant to a given agent than their counterparts that are not part of a biofilm colony. This obviously means that it is easier to clean devices before biofilm can form on them.

Some simple steps to stop or minimize biofilm formation include:

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;

rinsed with pure rinse water because biofilms will connect with mineral residues left on surfaces;

when they are not in use. This keeps them away from moisture and allows them to dry, which decreases opportu- nities for biofilm formation;

those that previously contained lotions or soaps. Note: although combining solutions from several partially-filled containers may seem cost- effective, this process increases the risk of bio- film formation.

Cleaning biofilm from instruments is very difficult because the detergents have a difficult time penetrating the protective gel formed around the biofilm colony. Instruments should be cleaned as soon as possible after use. Removing gross soil

and flushing lumens at the point of use helps the decontamination process by decreasing opportunities for biofilm for-mation. Careful observance of cleaning instructions is the best defense against biofilms.

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 flexible endoscopes, are more difficult for CS technicians to clean than many other instruments, and biofilm can develop quickly. Therefore, it is im-portant to ensure these items are properly

Bacillus subtilis biofilm

Cleaning biofilm from instruments is very difficult because the detergents have a difficult time pene-trating the protective gel formed around the biofilm 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 biofilm formation.

Always follow the manufacturer’s 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 flexible endoscopes. If the manufacturer’s IFU are not clear, seek clarification. 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 biofilms 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 EFFECTIVENESSAfter 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:

this verification method is one of the most effective, it is also the most expensive.

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.

ways to inspect instruments using this inexpensive process. For example, the lumen or cannulated item can be flushed 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 instrument’s IFU to determine if it can be tested in this manner because hydrogen peroxide can damage the finish of some instruments.

Commonly-prepared tests can be used to verify instrument cleanliness and the potential presence of biofilm 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 biofilm.

Protein tests use the flush method. Lumens are flushed 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 biofilm 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 biofilm on many types of instrumen-tation. Like the flush 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 significantly 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 efficiency. 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 efficiently helps ensure instruments will be properly cleaned and that biofilm will not have a friendly growth environment. IN CONCLUSIONCS 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 difficult and time consuming. Biofilm 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.

Biofilm 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.

REFERENCES1. See, for example: http://mpkb.org/home/

pathogenesis/microbiota/biofilm

2. FDA. Processing/Reprocessing Medical

Devices in Health Care Settings: Validation

Methods and Labeling.

ADDITIONAL REFERENCESANSI/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 Biofilms. 2002.

http://grants.nih.gov/grants/guide/pa-files/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_0efficacyDS.html#7.

CDC (HICPAC) Guideline for Disinfection and

Sterilization in Healthcare Facilities. 2008.

SCOTT DAVIS, CMRP, CRCST, CHMMCMaterials Manager, Surgical Services

Las Vegas, NV

SUSAN KLACIK, ACE, CHL, CRCST, FCSCSS Manager, St. Elizabeth Health

Center, Youngstown, OH

PATTI KONCUR, CRCST, CHMMC, ACEEducational Specialist, IAHCSMM

NATALIE LIND, FCS, CRCST, CHL Educational Director, IAHCSMM

DAVID NARANCE, RN, BSN, CRCSTReprocessing Manager/Clinician

Med Central Health System,

Mansfield, OH

CAROL PETRO, RN, BSN, CNOR, CRCST, CISOR Educator and Sterile Processing

Educator, Indiana University Health

North Hospital, Carmel, IN

TECHNICAL EDITORCARLA MCDERMOTT, RN, CRCSTClinical Nurse III, South Florida Baptist

Hospital, Plant City, FL

SERIES WRITER/EDITORJACK D. NINEMEIER, PH.D.Michigan State University

East Lansing, MI

ADVISORY COMMITTEE FOR SELF-STUDY LESSONS

REQUEST FOR ONLINE SCORING (payment and scoring made directly online at www.iahcsmm.org) REQUEST FOR PAPER/PENCIL SCORING (please print or type information below)

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❍ Check here if you have a change of address

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DETACH QUIZ, FOLD, AND RETURN TO:Purdue UniversityPEC Business OfficeStewart Center, Room 110128 Memorial MallWest Lafayette, IN 47907-2034800.830.0269

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CRCST Self-Study Lesson Plan Quiz - Biofilms

OBJECTIVE 1 1. What is biofilm? 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 biofilm 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. Biofilm ______ be seen without magnification on reusable medical devices. a. Can b. Cannot

4. Which is true about biofilm? a. It is difficult to clean from contaminated instruments b. Once developed, it cannot be removed without sterilization c. Biofilm likes dry surfaces because it is easier to attach onto them d. All the above statements are correct

5. Which is true about biofilm? 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 26. Which is the best tactic to help reduce biofilm 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 biofilms can be up to ______ times more resistant to a given agent than their counterparts that are not part of a biofilm 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 biofilms? 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 biofilm colonies

9. Manufacturers’ IFUs should be available and followed because they a. Are required by AAMI b. Contain information about biofilm 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 biofilms because a. These instruments are more frequently used than any other instruments b. They are more difficult 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 biofilms because a. There is no way to remove biofilm from the damaged insulation b. Technicians cannot scrub the insulation without damaging it c. Damaged insulation encourages biofilm formation d. Biofilm on damaged insulation must be removed by external vendors 13. How often should mechanical cleaning equipment be cleaned to prevent biofilm formation? a. Daily b. Weekly c. As necessary d. As recommended by the manufacturer

14. Instruments are the only place where biofilms can develop in the Central Service department. a. True b. False OBJECTIVE 315. 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 flush-test instruments? a. The instruments will have to be cleaned after the test b. Hydrogen peroxide may damage the instrument’s finish c. Manufacturer’s 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 flush method b. A test strip is inserted inside the lumen c. They can detect the presence of biofilm 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 repair19. 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 biofilm. a. True b. False