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The CIC exam will have a total of fifteen (15) que4stions addressing Cleaning, Sterilization, Disinfection, Asepsis. The content will test knowledge of the following:

Identify and evaluate appropriate cleaning, sterilization, and disinfection practices

Collaborate with others to assess products under evaluation for their ability to be reprocessed

Identify and evaluate critical steps of cleaning, high-level disinfection, and sterilization

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Key Concepts

Disinfection and sterilization are essential to reduce the risk of transmitting infectious pathogens to patients

Failure to comply with scientifically based guidelines has led to numerous outbreaks

Adherence to evidence-based recommendations on the preferred methods for cleaning, disinfection, and sterilization of patient care medical devices and for cleaning and disinfecting the healthcare environment are critical components of infection prevention and control programs

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Definitions

Clean - Remove visible foreign material
Decontamination -Remove pathogenic organisms

and make equipment safe for handling

Sterilization -Kill all microbes
Sanitize - Reduce microbial load on inanimate objects to relatively safe level

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Important Difference

Disinfection-Killing all microbiologic organisms

with the exception of spores

Antisepsis-Kill or reduce microbial load on living tissue
Agents that can kill microorganisms include both disinfectants and antiseptics (cide or cidal)

Disinfectants – inanimate objects
Antiseptics – living tissue

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Regulations

Environmental Protection Agency (EPA)

Disinfectants
Including High Level Disinfectants
Liquid Chemical Sterilants

Food and Drug Administration (FDA)

Antiseptics

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Regulations

Occupational Safety and Health Administration (OSHA)

Bloodborne Pathogen Rule 1991

Require EPA registration
Disinfectant must be tuberculocidal
Rule amended in 1997 - disinfectants must be effective

against HIV & HBV

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Spaulding Classification System

Critical –objects which penetrate sterile tissue or blood must be Sterile
Semi-critical –objects that touch mucous membranes or non-intact skin require High level disinfection
Non-critical –objects that only touch intact skin require Intermediate & Low level disinfection

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4 Methods

Sterilization –all microorganisms & spores
High-level disinfection –all microorganisms

except spores

Intermediate-level disinfection –destroys most virus and most fungi but not spores
Low-level disinfection –destroys vegetative bacteria, some viruses and fungi, but not spores or mycobacteria

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Influencing Factors

Organic and inorganic load
Type and level of microbial contamination
Concentration and exposure

time to germicide

Physical nature of object
Presence of biofilms
Temperature and pH
Relative Humidity

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Attachment

Growth

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Staphylococcus aureus biofilm

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Critical Items

🞂 Objects that enter normally sterile tissue or vascular

system

🞂 Goals

Sterility

Destroy all microorganisms including spores

🞂 Methods

High temp – Steam

Heat tolerant items

Low temp – ETO or H2O2 gas

Heat sensitive items

Liquid chemical sterilants – H2O2, paracetic acid

Heat sensitive items

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Ideal Sterilization Method

Highly effective
Rapid action
Strong penetration
Materials compatible
Non-toxic
Organic material resistance
Adaptable
Monitoring required
Cost-effective

Schneider PM. Tappi J. 1994;77:115-119

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Decontamination of Critical Items

🞂 Dedicated area

🞂 Negative air flow

🞂 Required personal protective equipment

🞂 Presoak to remove load

🞂 Manual cleaning of fragile items

🞂 Automated cleaning

Ultrasonic
Washers

🞂 Detergents (sanitize)

Neutral pH
Enzymes

Decontamination room

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Clean instruments

Dried
Inspected

Cleanliness
Maintenance
Repair

Packed or wrapped

AAMI approved rigid containers or wrappers
Association for the Advancement of Medical Instrumentation

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Sterilization Monitoring

🞂 Mechanical – cycle time, temperature, pressure

(steam)

🞂 Chemical – heat or chemical sensitive inks that change color when germicidal parameters reached

🞂 Biological – Bacillus or Geobacillus spores that directly measure sterilization

Bowie-Dick test is for vacuum and done once a day.

Not a sterilization monitor

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Chemical monitor

Chemical integrator
Used for pack control to monitor conditions

inside each pack or rigid container

Failed indicator – immediately remove pack from procedure and reprocess

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Biological Monitors

Steam biologic monitor

🞂 Daily

🞂 Steam – Geobacillus stearothermophilus

🞂 Dry heat- Geobacillus

stearothermophilus

🞂 ETO – Bacillus atrophaeus

🞂 Low temperature technologies (H2O2 gas) – Geobacillus stearothermophilus

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Failed Biologic Indicator

🞂 Immediately take sterilizer out of service

🞂 Notify director

🞂 Quarantine all loads since failure and reprocess

🞂 Begin investigation

🞂 Verify integrity of biologic indicator

🞂 Verify mechanical indicator (print out)

🞂 Verify operator input

Correct cycle selection

🞂 Verify correct plant operations

Loss of steam
Power loss

🞂 Repeat biologic indicator in 3 consecutive runs

If any positive – call manufacturer for service

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Immediate Use Steam Sterilization

Designed for the steam sterilization of unwrapped

single items designated for immediate use

Decontaminate item
Use rigid covered immediate use container
Do not wrap item
All mechanical, biological and chemical monitors

apply

Never use for any implantable item

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Immediate Use Steam Sterilization

🞂 Weigh costs of more instruments vs. patient safety

🞂 Do not use for convenience or as an alternative to purchasing more instrument sets

🞂 Establish guidelines and monitor use

Date & time
MD, case
Item
Reason

🞂 Use only when there is insufficient time to process instrument completely in wrapped or rigid container

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Low Temperature Sterilization

Used on heat and moisture sensitive equipment

🞂 ETO (ethylene oxide)

Gas concentration, temperature, humidity
Long cycle, aeration required, toxicity

🞂 Hydrogen peroxide gas plasma (Sterrad)

Requires synthetic packaging. No cellulose
Some devices with narrow long lumens cannot be processed (See manufacturer’s recommendations for length and diameter)

🞂 Peracetic Acid (Steris)

Point of use. No storage allowed.
Small loads
Immersible instruments only

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Single Use Device

🞂 FDA issued Single Use Device Guidance in August 2000.

🞂 Hospital or third party reprocessor is regulated the same as original equipment manufacturer.

🞂A device labeled for single use is considered a new device if reprocessed. The reprocessor is considered the manufacturer.

🞂As a new device, all federal (FDA) controls regarding the manufacture and marketing of the device apply.

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Storage of Sterile Items

🞂 Event related shelf life – consider the product sterile

until an event causes it to become contaminated. Packaging evaluated before use for integrity

Tear or opening in packaging
Water damage

🞂 Time related shelf life – consider item sterile for set period based on wrapping/packaging material. Once expiration date is passed, item must be removed from service. Discard or reprocess. If manufacturer has placed expiration date on package, item has time related shelf life.

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Storage of Sterile Items

Segregated, protected area
Covered shelving
Solid surface bottom shelf
Temperature control (68-75)
Humidity control (30%-70%)
Air exchange per hour
8-10 inches off floor
18 inches below ceiling
2 inches from outside wall

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Semi-Critical Items

Objects that come in contact with mucous

membranes and non-intact skin

Goals

High level disinfection

Free of all microorganisms except high numbers of spores

Methods

Pasteurization
Liquid chemical sterilants – heat sensitive items

Gluteraldehyde
OPA (ortho-pthaldehyde)

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Semi-Critical Items

Pasteurization

– 70⁰C (158⁰F) for 30 minutes

Not just for food and drink
Used on respiratory therapy and

anesthesia equipment

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High Level Disinfection

Endoscopes
Bronchoscopes
Laryngoscope Blades
Tonometers
Cryosurgical instruments
Endocavitary probes

Transesophageal
Transvaginal
Nasopharyngoscopes

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High Level Disinfection

>2.0% Glutaraldehyde
45 minute process
Well ventilated area with covered containers
Deactivator required before disposal
OSHA limit of 0.05ppm
Strong odor
$

0.55% OPA
12 minute process
Well ventilated area with covered containers
No deactivator required
No OSHA limit
Weak odor
3x$
Contraindicated for urological instruments used on patients with history of bladder cancer

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Scopes

🞂 Pre clean

Remove visible soiling

🞂 Disinfect

Manual
Automated

🞂 Rinse

Fresh water

No recommendation for sterile vs. potable

Manually rinse lumens
Flush with 70% isopropyl alcohol

🞂 Dry

Air dry

🞂 Store

Hanging freely (no touching)
In ventilated cabinet

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Emerging Pathogens

“Standard disinfection and sterilization procedures for patient care equipment are adequate to sterilize or disinfect instruments or devices contaminated with blood and other body fluids from persons infected with emerging pathogens.”

(Rutala, W. A, Ph.D., MPH., 2004)

One exception – Creutzfeldt-Jakob Disease

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Non-Critical Items

🞂 Objects that will not come in contact with
mucous membranes and non-intact skin
🞂 Goals
Intermediate and low level disinfection

Free of all vegetative bacteria and some fungi and viruses

🞂 Methods
EPA registered hospital disinfectant

Chlorine-based
Phenolics
Quaternary ammonium
Hydrogen Peroxide
70-90% alcohol

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Non-Critical Items

Environmental Surfaces

Medical equipment
Furniture
Building environment

Risks

High touch areas

Door handles
IV poles
Phones
Computers

Low touch areas

Toilet seats

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Room Disinfection Technologies

EPA registered
Sanitize specific surfaces

Copper alloy

Sanitize entire room

UV irradiation
Ozone

Some can sanitize room and contents of

supply drawers

Hydrogen peroxide vapor

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Bacteria per square inch

3,295

25,127

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Survival Rates

Influenza 24-48 hrs
MRSA 63 days
VRE 58 days

•

Acinetobacter

C. diff spore

Pseudomonas

33 days

5 months

7 hours

Hepatitis B
Norovirus
SARS
Candida sp.

•

7 days

12 days

24-72 hrs

3 days

Parainfluenza

10 hrs

COVID 19 has been shown to live up to 5 days (glass), 4 days (wood), 3 days (plastic & stainless steel), 24 hours (cardboard), 4 hours (copper surfaces)

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Staff Competencies

Provide comprehensive training for all staff

assigned to process medical/surgical instruments

To achieve and maintain competency

Hands on training
All work supervised until documented competency
Includes review of written instruction to assure compliance and uniformity
Conducted at hire and annually
Competency must by someone who has documented competency

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Infection Prevention Role

Periodic review of policies and procedures
Annual review of disinfectants
Regular review

Expired items
Flash sterilization logs
Sterilization monitor logs
HLD logs
Observations

Hand hygiene
Proper personal protective equipment