APPENDIX

Asepsis, Cleaning,
Disinfection and
Sterilization
CBIC Certification Preparatory Course

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Asepsis
Asepsis is the use of barriers and practices to
prevent the transfer of microorganisms
Used in any clinical setting (Med or Surg)

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 Asepsis
Medical and Surgical asepsis strategies
Agents to reduce organisms at site
Hand hygiene
Protective/sterile attire
Environmental controls
Engineering controls (ventilation, air flow)
Traffic control
Cleaning practices
Field (clean or sterile)

Asepsis
Medical Asepsis
AKA clean technique
Practice to prevent or reduce the risk of transmission of
organisms from one person to another, or one place to
another
Leads to a decrease in the overall number of
microorganisms present rather than the absence of
organisms as is found in surgical asepsis

Asepsis
Surgical Asepsis
In surgery as well as other areas where invasive
procedures are done such as placement of IV lines,
urinary catheters, chest tubes and any other indwelling
devices

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 Spaulding Classification
Earle H. Spaulding created rational method to
managing pt. care equipment based on
How device used, and
Type of contact device had with pt., such as intact skin,
mucous membrane or sterile tissues
Classification has helped evaluate pt. care practices
and implement best method of cleaning, followed
by disinfection or sterilization

Spaulding Classification
Millions of procedures performed annually where a
pt.s sterile tissue or mucous membranes are
contacted by a medical device or surgical instrument
Major risk is introduction of infection
Essential to achieve disinfection/sterilization
through use of disinfectants or sterilization practices
to ensure instruments dont transmit infectious
pathogens

Spaulding Classification

Level of disinfection of a device/instrument is

determined by its intended use
NON-CRITICAL
Objects that either touch only intact skin (but not mucous
membranes) or do not directly touch the patient
Reprocessing of non-critical devices involves cleaning
and low-level disinfection (e.g., blood pressure cuffs,
stethoscopes)

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Epidemiology, Inc. (CBIC). Any unauthorized use or distribution of this content is considered copyright infringement.
 Spaulding Classification
Level of disinfection of a device/instrument is
determined by its intended use
SEMI-CRITICAL
Objects that touch
Mucous membranes or skin that is not intact, but
ordinarily does not penetrate them
Reprocessing semi-critical devices involves meticulous
cleaning followed by, at a minimum, high-level
disinfection (e.g., respiratory therapy equipment,
transrectal probes, specula)

Spaulding Classification
Level of disinfection of a device/instrument is determined
by its intended use
CRITICAL (high infection risk if device contaminated)
Objects that enter
Normally sterile tissue or
The vascular system or
Through which blood flows
Reprocessing critical devices involves meticulous cleaning
followed by sterilization (e.g., surgical instruments, biopsy
forceps, foot care equipment, dental hand pieces)

Cleaning
Physical removal of foreign material (e.g., dust,
soil) and organic material (e.g., blood, secretions,
excretions, microorganisms)
Physically removes (not kills) organisms; reduces
bio-burden and removes foreign material (organic
residue, inorganic salts) that interferes with
disinfection and/or sterilization

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Epidemiology, Inc. (CBIC). Any unauthorized use or distribution of this content is considered copyright infringement.
 Cleaning
Accomplished with water and detergents or
enzymatic cleaners and mechanical action
Must be performed before high level disinfection
or sterilization
Is to be performed as soon as possible after items
have been used as soiled materials dry onto
instruments

Cleaning
Written procedures for cleaning should include
protocols for containment of contaminated equipment
at point of use, transport to disassembly, sorting,
soaking, physical removal of soil, rinsing, drying,
inspection and wrapping (if necessary)
a. Develop training log; track education & training of each
employee assigned to clean/handle devices
b. Document each persons competency (initially and at
least annually) in cleaning process and use of ultrasonic
cleaner and washer disinfector

Washer/Disinfector
Very effective (>7 log10 reduction) in removing/inactivating
microorganisms
Five Chambers
Pre-wash: water/enzymatic circulated over load
Wash: detergent wash solution sprayed over load
Ultrasonic cleaning: basket lowered into ultrasonic
cleaning tank with detergent
Thermal and lubricant rinse: hot water sprayed over
load; instrument milk lubricant added to water and
sprayed over load
Drying: blower starts in drying chamber

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 Physical Layout of Sterile Processing Area
Logical flow from dirty to clean with soiled and clean work
areas physically separated
Decontamination area should have a negative pressure
relationship to adjacent areas
Pass-through doors and washer/decontaminators deliver items
into clean assembly area
Personnel from the decontamination area should not bring
items to the clean assembly area
Clean Assembly Area should have a positive pressure
relationship to adjacent areas
Sterile Storage should have a positive pressure relationship to
adjacent areas

Pre cleaning:
manual and mechanical
Meticulous cleaning using water with detergents or
enzymatic cleaners must precede sterilization.
Cleaning and decontamination should be done as soon as
possible after the items have been used.
Do not allow material on items to dry.
Ultrasonic cleaners: cavitation (imploding bubbles)
Washer disinfectors
Different cycles, similar to a dishwasher
Monitor the automated washer and instrument
cleaning at least weekly.

Key Points to know about

Disinfectants
Key points
Efficacy against pathogens
Use Dilution
Safety and Efficacy for patient populations,
healthcare personnel or device/equipment
Environmental requirements for ventilation, etc.

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Epidemiology, Inc. (CBIC). Any unauthorized use or distribution of this content is considered copyright infringement.
 Ideal Surface Disinfectant Properties
Broad spectrum
Should have a wide antimicrobial spectrum, including kill
claims for all pathogens that are common causes of HAIs and
outbreaks
Fast acting
Should have a rapid kill and short kill/contact time listed on
the label
Remains wet
Should keep surfaces wet long enough to meet listed
kill/contact times with a single application or meet wet times
recommended by evidence-based guidelines (60 seconds)

Ideal Surface Disinfectant Properties

Not affected by environmental factors
Should be active in the presence of organic matter (e.g.,
blood, sputum, feces) and compatible with soaps,
detergents, and other chemicals encountered in use
Non-toxic
Should not be irritating to user, visitors, patients
Should not induce allergic symptoms (especially asthma
and dermatitis).
Toxicity ratings for disinfectants are danger, warning,
caution, and none. Ideally choose products with the
lowest toxicity rating

Ideal Surface Disinfectant Properties

Surface compatibility
Should be proven compatible with common healthcare
surfaces and devices
Persistence
Should have sustained antimicrobial activity or residual
antimicrobial effect on the treated surface
Easy to use
Should be available in multiple forms, such as wipes
(large and small), sprays, pull tops, and refills; directions
for use should be simple and contain information about
PPE as required

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Epidemiology, Inc. (CBIC). Any unauthorized use or distribution of this content is considered copyright infringement.
 Ideal Surface Disinfectant Properties
Acceptable odor
Should have an odor deemed acceptable by users and
patients
Solubility
Should be soluble in water
Economical
Costs should not be prohibitively high, but when
considering the costs of a disinfectant one should also
consider product capabilities, cost per compliant use, etc.

Ideal Surface Disinfectant Properties

Stability
Should be stable in concentrate and use dilutions
Cleaner
Should have good cleaning properties
Non-flammable
Should have a flash point above 150F/65.6C

Quaternary ammonium compounds

(e.g., didecyl dimethyl ammonium bromide,
dioctyl dimethyl ammonium bromide)
Rutala, Weber. Am J Infect Control 2013;41:S36-S41

Advantages
Bactericidal, fungicidal,
virucidal against enveloped
viruses (e.g., HIV)
Good cleaning agents
Surface compatible
Persistent antimicrobial
activity when undisturbed
Inexpensive (dilutable form)
Not flammable
Disadvantages
Not sporicidal
Genearlly not tuberculocidal and
virucidal against non-enveloped viruses
High water hardness and cotton/gauze
can make less microbicidal
A few reports documented asthma as
result of exposure to benzalkonium
chloride
Affected by organic matter
Multiple outbreaks ascribed to
contaminated benzalkonium chloride

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Epidemiology, Inc. (CBIC). Any unauthorized use or distribution of this content is considered copyright infringement.
 Sodium Hypochlorite
Rutala, Weber. Am J Infect Control 2013;41:S36-S41

Advantages
Bactericidal, tuberculocidal,
fungicidal, virucidal
Sporicidal
Fast acting
Inexpensive (dilutable form)
Not flammable
Unaffected by water hardness
Reduces biofilms on surfaces
Relatively stable (e.g., 50%
reduction in chlorine concentration
in 30 days)
Disadvantages
Reaction hazard with acids and ammonias
Leaves salt residue
Corrosive to metals (some RTU products
may be formulated with corrosion
inhibitors)
Unstable active (some RTU products may be
formulated with stabilizers to achieve
longer shelf life)
Affected by organic matter
Discolors/stains fabrics

Used as disinfectant in water Potential hazard is production of

treatment trihalomethane
Odor (some RTU products may be
formulated with odor inhibitors)
Irritating at high concentrations

Alcohol
Rutala, Weber. Am J Infect Control 2013;41:S36-S41

Advantages Disadvantages
Bactericidal, Not sporicidal
tuberculocidal, fungicidal, Affected by organic matter
virucidal
Slow acting against non-enveloped
Fast acting viruses (e.g., norovirus)
Non-corrosive No detergent or cleaning properties
Non-staining Damage some instruments (e.g., harden
Used to disinfect small rubber, deteriorate glue)
surfaces such as rubber Flammable (large amounts require
stoppers on medication special storage)
vials
Evaporates rapidly making contact time
No toxic residue compliance difficult
Not recommended for use on large
surfaces
Outbreaks ascribed to contaminated
alcohol

Phenolics
Rutala, Weber. Am J Infect Control 2013;41:S36-S41

Advantages Disadvantages
Bactericidal, Not sporicidal
tuberculocidal, Absorbed by porous materials and
fungicidal, virucidal irritate tissue
Inexpensive (dilutable Depigmentation of skin caused by
form) certain phenolics
Non-staining Hyperbilirubinemia in infants
Not flammable when phenolic not prepared as
EPA registered recommended

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Epidemiology, Inc. (CBIC). Any unauthorized use or distribution of this content is considered copyright infringement.
 Hydrogen Peroxide
Rutala, Weber. Am J Infect Control 2013;41:S36-S41

Advantages Disadvantages
Bactericidal, tuberculocidal, More expensive than
fungicidal, virucidal most other disinfecting
Fast efficacy actives
Easy compliance with wet-contact Not sporicidal at low
times concentrations
Safe for workers
Benign for the environment
Surface compatible
Non-staining
Not flammable

High-Level Disinfection
Glutaraldehyde, hydrogen peroxide, ortho-
phthalaldehyde, and peracetic acid with hydrogen
peroxide are dependable high-level disinfectants
provided the factors influencing germicidal
procedures are met
Use of glutaraldehyde includes specific safety
requirements (ventilation and measuring exposure of
staff)

High-Level Disinfection of Semi-Critical Objects

Exposure Time > 8m-45m, 20oC
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

All material in this presentation is the intellectual property of the Certification Board of Infection Control and
Epidemiology, Inc. (CBIC). Any unauthorized use or distribution of this content is considered copyright infringement.
 Interim Protocol for Healthcare Facilities
Regarding Surveillance for Bacterial
Contamination of Duodenoscopes after
Reprocessing (CDC)
Response to CRE outbreak
Inspection and manual cleaning
Drying
Supplement manufacturers recommendations
Staff training and competency
Patient information and notification can you identify
which patient had a particular scope?
Culturing of duodenoscopes

References/Resources
AORN. Standards, Recommended Practices, and Guidelines.
Denver, CO: AORN, Inc. Association of periOperative Registered
Nurses at http://www.aorn.org/Guidelines/

ANSI/AAMI ST79. Comprehensive guide to steam sterilization

and sterility assurance in healthcare facilities. Association for
the Advancement of Medical Instrumentation and
ANSI/AAMI ST58. Chemical Sterilization and High Level
Disinfection in Healthcare Facilities at
http://www.aami.org/publications/standards/ster.book1.ht
ml

References/Resources
CDC. Guideline for Disinfection and Sterilization in
Healthcare Facilities, 2008 at
http://www.cdc.gov/hicpac/pubs.html

Immediate-Use Steam Sterilization Multi-

organization position paper at
http://www.aami.org/publications/standards/ST7
9_Immediate_Use_Statement.pdf

All material in this presentation is the intellectual property of the Certification Board of Infection Control and
Epidemiology, Inc. (CBIC). Any unauthorized use or distribution of this content is considered copyright infringement.
 References & Resources

*test comes from references cited in the Candidate

Handbook
http://disinfectionandsterilization.org/

Best Practices in Disinfection and Sterilization.

Rutala. APIC Webinar, November 12, 2014:
http://disinfectionandsterilization.org/files/2012/
12/DSBestPract14.ppt

References & Resources

*test comes from references cited in the Candidate

Handbook
Selection of an Ideal Disinfectant. Rutala.
Association for Healthcare Environment
Conference, September 21, 2014:
http://disinfectionandsterilization.org/files/2012/
12/IdealDisinfectant14.ppt

References & Resources

*test comes from references cited in the Candidate

Handbook
http://www.cdc.gov/hicpac/Disinfection_Sterilizat
ion/2_approach.html

http://www.virox.com/files_docs/content/pdf/ms
ds/reprocessing.pdf

All material in this presentation is the intellectual property of the Certification Board of Infection Control and
Epidemiology, Inc. (CBIC). Any unauthorized use or distribution of this content is considered copyright infringement.
 References & Resources

*test comes from references cited in the Candidate

Handbook
http://www.health.gov.bc.ca/library/publications/
year/2011/Best-practice-guidelines-cleaning.pdf

http://www.hc-sc.gc.ca/dhp-
mps/prodpharma/applic-demande/guide-
ld/disinfect-desinfect/disin_desin-eng.php

References & Resources

*test comes from references cited in the Candidate

Handbook
http://www.cdc.gov/hai/organisms/cre/cre-
duodenoscope-surveillance-protocol.html

All material in this presentation is the intellectual property of the Certification Board of Infection Control and
Epidemiology, Inc. (CBIC). Any unauthorized use or distribution of this content is considered copyright infringement.