APIC DFW PROFESSIONAL ADVANCEMENT

CHAPTER 10 REVIEW:

CLEANING, STERILIZATION, DISINFECTION & ASEPSIS

Test Your Knowledge

1. Type of germicidal action required for semi-critical items:
1. Kills all microorganisms except high numbers of bacterial spores
2. Kills all vegetative bacteria, fungi & lipid viruses
3. Kills all microorganisms, including bacterial spores
4. Kills all visible contamination

Test Your Knowledge

2. The first step in the sterilization process is:

• Wrapping of the equipment prior to placing in autoclave
• Pre-cleaning by applying enzymatic cleaner or detergent to the used equipment
• Taking the equipment to the Sterile Processing Dept. via biohazard container
• Cleaning the equipment via manual or mechanical means

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Test your knowledge

3. Types of antiseptics include all of the following except:

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• Iodophors
• Chlorhexidine, 2 & 4% aqueous
• Glutaraldehyde, ≥2.0%
• Alcohols, 60-95%
• PCMX
• Triclosan

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Cleaning, Sterilization, �Disinfection & Asepsis

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CIC exam contains 15 questions on these topics, covering:

1. Identification & evaluation of appropriate cleaning, sterilization & disinfection practices
2. Collaboration with others to assess products under evaluation for their ability to be reprocessed
3. Identification & evaluation of critical steps in cleaning, high-level disinfection & sterilization

Study Resources

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• APIC Test of Infection Control & Epidemiology:

Chapters 7, 30, 31, 32 & 106

• ANSI/AAMI:

ST58: 2013 Chemical sterilization and high-level disinfection in health care facilities

ST91: 2015 Flexible and semi-rigid endoscope processing in health care facilities

ST79: 2017 Comprehensive guide to steam sterilization and sterility assurance in health care facilities

William Dr. Rutala’s website: disinfectionandsterilization.org

Spaulding Classification System

EH Spaulding developed the concept that how an object would be disinfected depended on the object’s intended use.

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• Non-Critical
• Semi-Critical
• Critical

Cleaning

• A process that:
• Renders a surface or device safe to handle
• Reduces the natural bioburden on devices and environmental surfaces
• Removes organic/inorganic contaminants
• Reduces the challenge load posed to a sterilizing or disinfecting process

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• For critical/semi critical devices, items must be pre-cleaned ASAP after use by wiping or irrigating using water with detergents or enzymatic cleaner.

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• Remember: Enzymatic cleaners are NOT disinfectants

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Cleaning cont.

• Transport to decontamination:
• Closed, leak-proof, puncture-resistant container marked BIOHAZARD
• Items must remain moist!
• Accomplished by:
• Manual cleaning: needs friction (scrubbing) and fluidics (fluids under pressure)
• Mechanical cleaning: ex. Ultrasonic, washer-disinfector
• Items must be visually inspected after cleaning to ensure all gross contamination has been removed.
• Cleaning and rinsing are the most important steps in the reusable medical equipment process.

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Washer-Disinfector

Items exit decontaminated/ free of proteinacious materal -- ready for sterilization!

Factors Affecting Sterilization or Disinfection

• Amount of organic material
• # of microorganisms
• Type of organisms (resistance levels)
• Type of germicidal agent
• Concentration of germicidal agent
• Exposure time to germicidal agent
• Temperature of exposure
• pH of solution
• Presence or absence of moisture

Resistance of Microorganisms to Disinfection/Sterilization

Via CDC.gov

�Steam Sterilization �

• Most commonly used type of sterilization
• Six parameters that must be met for sterilization to occur
1. Time
2. Temperature
3. Moisture
4. Direct steam contact
5. Air removal
6. Drying

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Effective Sterilization: Controlled Conditions

• For all physical processes:
• Time, temperature, relative humidity

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• For liquid chemical processes:
• Time, Temperature, pH, concentration

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• For gas or plasma processes:
• Time, Temperature, gas concentration, relative humidity, wrapping

Biological Indicators

• Are standardized preparation of bacterial spores on/in a carrier.
• Purpose: to demonstrate whether sterilizing conditions have been met.
• BI must be placed in most difficult site for sterilant to penetrate.
• BIs should be run at least weekly, but most facilities run daily; they should also be used after servicing prior to use
• A POSITIVE BI indicates a process FAILURE.

Type of Biological Indicators

• Bacillus sterothermophilis
• Moist-heat systems
• Geobacillus stearothermophilus
• Bacillus subtilis
• EO, dry heat systems
• Bacillus atropheus
• Bacillus pumilus
• Radiation-based systems

Chemical and Physical Indicators

Chemical Indicators:

• Measure key parameters of the sterilization process
• Visual change when the desired parameter has been achieved
• Bowie Dick- tests dynamic-air-removal steam sterilizer’s ability to remove air from the chamber and prevent air re-entrainment.

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Physical Indicators:

• Equipment monitors that are engineered to detect any of these parameters:

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Used EVERY load

Disinfection

Eliminates many or all pathogenic microorganism, except bacterial spores, on inanimate object.

High-Level Disinfectants for �Semicritical Objects

Exposure Time > 8m-45m (US), 20^oC

Germicide Concentration__

Glutaraldehyde > 2.0%

Ortho-phthalaldehyde 0.55%

Hydrogen peroxide* 7.5%

Hydrogen peroxide and peracetic acid* 1.0%/0.08%

Hydrogen peroxide and peracetic acid* 7.5%/0.23%

Hypochlorite (free chlorine)* 650-675 ppm

Accelerated hydrogen peroxide 2.0%

Peracetic acid 0.2%

Glut and isopropanol 3.4%/26%

Glut and phenol/phenate** 1.21%/1.93%___

*May cause cosmetic and functional damage; **efficacy not verified

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ENDOSCOPE REPROCESSING�

1. PRECLEAN: point-of-use (bedside) remove debris by wiping exterior and aspiration of detergent through air/water and biopsy channels-transport to scope cleaning area in safe manner

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• LEAK TEST: Dry and/or Wet leak testing
• MANUAL CLEAN: water and enzymatic cleaner
• HLD/STERILIZE: immerse scope and perfuse HLD/sterilant through all channels for exposure time (>2% glut at 20m at 20^oC). If AER used, review model-specific reprocessing protocols from both the endoscope and AER manufacturer
• RINSE: scope and channels rinsed with sterile water, filtered water, or tap water. Flush channels with alcohol and dry
• DRY: use forced air to dry insertion tube/channels and lint-free cloth to dry exterior.
• STORE: hang in vertical position to facilitate drying; stored in a manner to protect from contamination.
• Hang time

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HLD workflow and QA

• Workflow: dirty clean with no opportunity for cross-contamination
• Monitoring of HLD chemical:
• Minimum effective concentration (MEC) or minimum recommended concentration (MRC) must be tested when:
• New HLD bottle is opened
• Each time a scope is cleaned (cycle in AER)

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Must have opened date on bottle!

FEATURES OF ENDOSCOPES THAT PREDISPOSE TO DISINFECTION FAILURES

• Require low temperature disinfection
• Long narrow lumens
• Right angle turns
• Blind lumens
• May be heavily contaminated with pathogens (9-10 logs inside)
• Cleaning (4-6 log₁₀ reduction) and HLD (4-6 log₁₀ reduction) essential for patient safe instrument

ENDOSCOPE REPROCESSING: CHALLENGES

Complex [elevator channel]-10⁹ bacteria

Surgical instruments-<10² bacteria

Laryngoscopes Blades�The Joint Commission, FAQ, October 24, 2011

• How should we process and store laryngoscope blades?
• Processed via sterilization or HLD
• Packaged in some way to prevent from contamination
• Also stored in a way that prevents recontamination. Examples of compliant storage include, but are not limited to, a peel pack post steam sterilization (long-term) or wrapping in a sterile towel (short term)
• Should not place unwrapped blades in an anesthesia drawer (or anywhere, for that manner)

Protocol for Exposure Investigation after Failure to Follow Disinfection & Sterilization Principles

1. Confirm reprocessing failure
2. Embargo any improperly disinfected/sterilized items
3. Do not use equipment in question until assured functioning
4. Inform key stakeholders
5. Conduct thorough evaluation of cause
6. Prepare line list of potentially exposed patients
7. Assess whether failure risk for infection

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8. Inform expanded list of stakeholders of issue
9. Develop hypothesis for failure and initiate corrective action
10. Develop method to assess potential adverse patient events
11. Consider notification of State/Federal authorities
12. Consider patient notification
13. If patient notified, consider if medical evaluation or post exposure therapy is appropriate
14. Develop long-term prevention plan
15. Perform after-action report

Noncritical items: Low-level disinfection

• 2 Categories of items:
• Patient care equipment (eg stethoscopes, bedpans, BP cuffs)
• Environmental surfaces (e.g. Counters, sinks, bedside tables)
• In contrast to critical/semicritical items, most noncritical items may be cleaned and disinfected at point-of-use.
• Environmental contamination plays important role in transmission of several key HA pathogens.
• Antibiotic susceptibilities do NOT correlate with resistance to disinfectants.

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LOW-LEVEL DISINFECTION FOR �NONCRITICAL EQUIPMENT AND SURFACES

Exposure time per manufacturer recommendations

Germicide Use Concentration

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Ethyl or isopropyl alcohol 70-90%

Chlorine 100ppm (1:500 dilution)

Phenolic UD

Iodophor UD

Quaternary ammonium UD

Improved hydrogen peroxide (HP) 0.5%, 1.4%

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UD=Manufacturer’s recommended use dilution

ENVIRONMENTAL SURVIVAL OF KEY PATHOGENS ON HOSPITAL SURFACES

Adapted from Hota B, et al. Clin Infect Dis 2004;39:1182-9 and

Kramer A, et al. BMC Infectious Diseases 2006;6:130

�Surface Disinfection�Rutala, Weber. www.cdc.gov�

• Noncritical Patient-Care Items
• Process noncritical patient-care equipment with a EPA-registered disinfectant at the proper use dilution and a contact time of at least 1 min. Category IB
• Ensure that the frequency for disinfecting noncritical patient-care surfaces be done minimally when visibly soiled and on a regular basis (such as after each patient use or once daily or once weekly). Category IB

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• Environmental Surfaces in HCF
• Disinfect (or clean) housekeeping surfaces (e.g., floors, tabletops) on a regular basis (e.g., daily, three times per week), when spills occur, and when these surfaces are visibly soiled. Category IB
• Use disinfectant for housekeeping purposes where:
• Uncertainty exists as to the nature of the soil on the surfaces (blood vs dirt)
• Uncertainty exists regarding the presence of multi-drug resistant organisms on such surfaces. Category II

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PROPERTIES OF AN IDEAL DISINFECTANT �Rutala, Weber. Infect Control Hosp Epidemiol. 2014;35:855-865

• Broad spectrum: wide antimicrobial spectrum
• Fast acting: should produce a rapid kill
• Remains Wet: meets listed kill/contact times with a single application
• Not affected by environmental factors: active in the presence of organic matter
• Nontoxic: not irritating to users
• Surface compatibility: should not corrode instruments and metallic surfaces
• Persistence: should have sustained antimicrobial activity
• Easy to use
• Acceptable odor
• Economical: cost should not be prohibitively high
• Soluble (in water) and stable (in concentrate and use dilution)
• Cleaner (good cleaning properties) and nonflammable

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Scoring Considerations for Selecting the Ideal Disinfectant for Your Facility�Rutala, Weber. Infect Control Hosp Epidemiol. 2014;35:855-895

Note: Consider the 5 components shown, give each product a score (1 is worst and 10 is best) in each of the 5 categories, and select the product with the highest score as the optimal choice (maximum score is 50).

EPA Lists of Registered Germicides

• List A- sterilants
• List B- tuberculocides
• List C- HIV1
• List D- HIV-1, HBV
• List E- HIV-1, HBV and Mycobacterium tuberculosis
• List F- HCV
• List G- norovirus
• List H- MRSA, Vre
• List J- medical waste treatment

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New technologies: “No touch” methods �for room decontamination�See APIC Chapter 31: pros/cons

• UV light:
• At certain wavelengths will break molecular bonds in DNA=Destroying the organism
• Efficacy is function of many parameters (intensity, exposure time, lamp placement, air movement patterns/humidity, etc.)
• Hydrogen peroxide (HP) systems:
• HP vapor, Aerosolized dry mist HP
• Are highly effective method for eradicating various pathogens from rooms, furniture, and equipment
• Effective, but takes 4x longer than traditional cleaning
• Copper surface technology:
• Copper-infused surfaces can inhibit bacterial growth on environmental surfaces and decrease the accumulated bioburden over time in patient rooms

MONITORING THE EFFECTIVENESS OF CLEANING�Cooper et al. AJIC 2007;35:338

• Visual assessment-not a reliable indicator of surface cleanliness
• ATP bioluminescence-measures organic debris (each unit has own reading scale, <250-500 RLU)
• Microbiological methods-<2.5CFUs/cm²-pass; can be costly and pathogen specific; ENVIRONMENTAL CULTURING NOT ROUTINELY RECOMMENDED
• Fluorescent marker- is transparent & easily cleaned, environmentally stable marking solution that fluoresces when exposed to an ultraviolet light (applied by IP/EVS manager unbeknownst to EVS worker; after EVS cleaning, markings are reassessed) GREAT TEACHING TOOL!

“The goal of preoperative patient skin antisepsis is to reduce the risk of the patient developing a surgical site infection (SSI) by removing soil and transient microorganisms at the surgical site.¹ Reducing the amount of bacteria on the skin near the surgical incision lowers the risk of contaminating the surgical incision site.¹ As part of preparing the skin for antisepsis, preoperative bathing and hair management at the surgical site contribute to a reduction of microorganisms on the skin.^2–4 Effective skin antiseptics rapidly and persistently remove transient microorganisms and reduce resident microorganisms to subpathogenic levels with minimal skin and tissue irritation.”

--2016 AORN GUIDELINE

Antisepsis: the removal of pathogens from living tissue

Pre-op Skin Antisepsis: �The Basics�

• Preoperative bathing and hair removal
• Patients should bathe or shower with either soap or skin antiseptic (eg. CHG) at the least the night before or day of surgery
• Hair at surgical site should be left in place, & only when necessary, removed via a method that minimizes trauma to skin (clipping or depilatory) OUTSIDE of the OR
• Selecting skin antiseptics
• One skin antiseptic has NOT been proven to be more effective in preventing SSIs; a facility multidisciplinary team should select safe, effective antiseptics for pre op antisepsis based on each patient’s need.
• Current choices are:
• Iodophors , Chlorhexidine, 2 & 4% aqueous, Alcohols, 60-95%, PCMX & Triclosan.

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Pre-op Skin Antisepsis: �The Basics

• Applying, handling, and storing skin antiseptics
• Skin should be free of dirt, debris, creams, cosmetics & alcohol-based products prior to application
• Antiseptics should be applied per manufacturer recommendations via aseptic technique; sterile gloves are worn if the caregiver’s hands could touch the patient’s skin during prep
• Antiseptic dry times should be followed without fail
• FDA rules recommend single-use applicators/bottles (one time/one patient)
• Antiseptic solutions should not be diluted
• Antiseptic solutions should be stored/disposed of per local, state & federal regulations in a manner that decreases fire risk.

Current Issues: TASS

• Toxic Anterior Segment Syndrome (TASS)
• Acute, noninfectious inflammatory reaction of anterior chamber/segment of eye that typically occurs 12-48 hours after an uneventful cataract surgery
• Possible causes: detergent residue, topical ophthalmic ointments & salt solutions, anti-septic agents, talc from gloves, water bath contaminates, impurities of autoclave steam , heat stable endotoxin, & intraocular surgical instruments
• Recommendations:
• Keep used intraocular surgical instruments moist
• Cleaning in separate designated area from other surgical instruments

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Current issues: HPV

• Human Papilloma Virus (HPV)
• Extremely common sexually acquired infection
• Considered cause of cervical cancer (70% attributed to 2 types of HPV: HPV-16, HPV-18
• Endovaginal ultrasound probes-
• Semi critical(covered/uncovered); require HLD
• Studies showed common agents (OPA, Glut) had minimal activity against HPV-16 & HPV-18.
• However, 35% sonicated hydrogen peroxide had completely inactivated both. (e.g. Trophon)

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Colonoscope vs endovaginal probe

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Current Issues: Inactivation of Creutzfeldt-Jakob Disease (CJD)

• Degenerative neurologic disorder of humans with incidence in the US of ~1-1.5 cases/million population/year
• Causes by proteinaceous infectious agent or prion
• High-risk tissue (e.g. brain, spinal cord, eye tissue)
• High-risk patients (e.g. known/suspected infection with CJD or prion disease)
• Recommendations for items contaminated with high-risk tissue from high-risk patients:
• Critical and Semicritical items require special prion reprocessing.
• Items impossible/difficult to clean should be discarded.
• Noncritical surfaces should be cleaned then spot decontaminated with 1:10 hypochlorite solution.

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Test Your Knowledge

1. Type of germicidal action required for semi-critical items:
1. Kills all microorganisms except high numbers of bacterial spores
2. Kills all vegetative bacteria, fungi & lipid viruses
3. Kills all microorganisms, including bacterial spores
4. Kills all visible contamination

Test Your Knowledge

1. Type of germicidal action required for semi-critical items:
1. Kills all microorganisms except high numbers of bacterial spores
2. Kills all vegetative bacteria, fungi & lipid viruses
3. Kills all microorganisms, including bacterial spores
4. Kills all visible contamination

Test Your Knowledge

2. The first step in the sterilization process is:

• Wrapping of the equipment prior to placing in autoclave
• Pre-cleaning by applying enzymatic cleaner or detergent to the used equipment
• Taking the equipment to the Sterile Processing Dept. via biohazard container
• Cleaning the equipment via manual or mechanical means

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Test Your Knowledge

2. The first step in the sterilization process is:

• Wrapping of the equipment prior to placing in autoclave
• Pre-cleaning by applying enzymatic cleaner or detergent to the used equipment
• Taking the equipment to the Sterile Processing Dept. via biohazard container
• Cleaning the equipment via manual or mechanical means

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Test your knowledge

3. Types of antiseptics include all of the following except:

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• Iodophors
• Chlorhexidine, 2 & 4% aqeuous
• Glutaraldehyde, ≥2.0%
• Alcohols, 60-95%
• PCMX
• Triclosan

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Test your knowledge

3. Types of antiseptics include all of the following except:

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• Iodophors
• Chlorhexidine, 2 & 4% aqeuous
• Glutaraldehyde, ≥2.0%
• Alcohols, 60-95%
• PCMX
• Triclosan

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Dr. William Rutala �“Mr. Clean” & one of the nicest guys you will ever meet!!

Much of the material for this presentation prepared from his website: disinfectionandsterilization