1/22/2012

Continuing Education Contact Hours

• Participants must complete the entire presentation/seminar to achieve successful

completion and receive contact hour credit. Partial credit will not be given.

• All of the presenters are employees of STERIS Corporation and receive no direct
compensation other than their normal salaries for participation in this activity.

• STERIS Corporation is an approved provider of continuing nursing education by

the California Board of Registered Nursing, provider number CEP 11681 for 1
contact hour along with IAHCSMM and CBSPD.

• STERIS Corporation is providing the speakers and contact hours for this activity.
However, products referred to or seen during this presentation do not constitute a
commercial support by the speakers.

Learning Objectives Importance of Sterile Processing

After completing this continuing education activity, the participant

• Central hub of healthcare facility
should be able to:

• Describe the various activities performed by healthcare professionals • Efforts effect virtually every patient in facility
working in sterile processing departments

• Review the key steps that should be performed when conducting an

assessment of sterile processing activities in a healthcare facility

Challenges of Sterile Processing

When is it a good time

• Low priority and misunderstood
to learn about sterile
• Time demands
processing in your
• Intimidation facility?
• No formal sterile processing education

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Setting the Stage Start Now

• The phone call… • Gather information

• Suspected sterilization failure • Standardization (P&Ps, products, practices)

• Ask questions
• Physician notification

• Patient surveillance

Understand the Flow Point of Use

• OR, L&D and Clinics

• At point of use
Separate disposable from
reusable, including sharps
Keep instruments moist

Decontamination Delay Containment During Transport

• Delays in transport ―Containment may be accomplished by any means that adequately

prevents personnel contact with contaminated items during
Dried debris difficult to clean
transfer‖ — AAMI ST79:2010
Development of biofilm

Damage to passivation layer

of surgical instruments

Biofilm Development

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Remote Decontamination Physical Environment

Perform decontamination activities only in areas that can support Traffic Patterns
good work practices

• Personal Protective Equipment (PPE)

• Appropriate equipment/space

• Separation of dirty and clean processes

Lighting Ventilation

Controlled Environment Controlled Environment

Work Area Temperature Humidity

• Monitor temperature and humidity
60°F and 65°F
Decontamination 30 – 60%
(16°C and 18°C)
• Out of range leads to:
68°F and 73°F
General Work Areas 30 – 60% Noncompliance with PPE
(20°C and 23°C)

68°F and 73°F Promotion of bacterial growth

Preparation & Packaging 35 – 50%
(20°C and 23°C)

May be as high Altered performance of sterilization monitoring products

Sterile Storage & Personnel Support Areas ≤ 70%
as 75°F (24°C)

75°F and 85°F

Equipment Access Rooms 30 – 60%
(24°C and 29°C)

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Smooth Surfaces Work Flow

―The decontamination area should be physically separated from

• Floors, walls, ceilings all other areas of processing department…‖ — AAMI ST79:2010

• Work surfaces

• Compatible with cleaning

chemicals

Emergency Eyewash Equipment Emergency Eyewash Equipment

• Accessible within 10 seconds of potential exposure • Hands free

– Bottle type not recommended
• Strong chemicals: unit should be immediately adjacent
to the hazard • 15 minutes of continuously free-
flowing water

• Check and log eyewash equipment once/week

• Disable hot water

American National Standards Institute document EMERGENCY EYEWASH & SHOWER EQUIPMENT, 1998
OSHA 29CFR 1910.133 – Eye & Face Protection, and CFR 1910.151 – Medical & First Aid Standard

Hand Washing Housekeeping

• Hand washing sink separate from decontamination sinks • Daily cleaning/disinfection of

floors and horizontal surfaces
• Hands-free equipment
• Sequence cleaning from
• Alcohol waterless agents clean → dirty

• Keep separate cleaning

supplies

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Decontamination Decontamination Process

Two step process Cleaning

• Begins with cleaning • First and most important step

• Followed by microbicidal process • Thorough cleaning can remove of bioburden
– Disinfection

– Sterilization

Microbicidal Processes Personal Protective Equipment

• Designed to provide a particular level of lethality (kill)

• Depending on the level of decontamination disinfection or

sterilization may be used

Manual vs. Automated Cleaning Manual Cleaning

Manual Cleaning
• Heat and moisture sensitive devices
• First: soak
• Not a disinfection process
• Second: wash
• Third: rinse/treated water • Wear gloves in prep and pack

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Cleaning Brushes Mechanical Washers

• Quantity in sizes

• Replace when worn

• Cleaned/disinfected daily

• Metal bristle brushes

Open, Disassemble Instruments Organize Instruments

Instrument Detergents, Disinfectants Ultrasonic Cleaning

• Compatible with devices

• Sonic energy creates tiny bubbles
Bubbles become unstable, then implode
• Remove inappropriate chemicals
Dislodges soil from instrument crevices
• MSDS

• Follow manufacturer instructions

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Instrument Lubrication Assembly Area

• Automated • Instrument Inspection

• Manual Clean

Follow manufacturers instructions Working order

Label and date

Assembly Area Packaging

Instrument tray assembly

• Peel pouches
• Count sheets
• Sterilization wrap
• Content distribution
• Rigid sterilization containers
• Weight limits

Peel Pouches Peel Pouches

• Seals
• Light weight
• Double pouching
• Materials appropriate for sterilization technologies Inside pouch smaller than outside pouch
Inner pouch should not be folded over onto itself
Steam – paper
• Written labels on plastic side only
Hydrogen peroxide gas plasma and Ethylene Oxide

Ozone

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Sterilization Wrap Rigid Containers

• Woven wrap • Durable packaging

Launder and inspect • Plastic composite or anodized aluminum

• Non-woven • Variety of designs

Single layer
One-step wrap

Rigid Containers Instrument Sets Placed Flat

YES
• Inspect for damage
NO
• Cleaned after each use
Compatible chemistries

• Stacking

Loading the Sterilizer Cart Sterilization

• Testing requirements
• Do not overload
• Monitoring practices
• Basins positioned for drainage
• Record keeping practices
• Packages should never contact
sterilizer chamber walls • Failure investigation

• Extended cycles

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Equipment Monitoring Routine Monitoring

• Routine maintenance • Bowie-Dick air removal test

Prevacuum cycles
• Preventative/breakdown maintenance

• Maintenance records • Biological testing

• Other testing
Following installation, relocation or major repairs

Bowie-Dick Test Conventional Biological Indicator Strips

Spore Suspension
Air Removal Test
Glassine Envelope
• Test results must be negative Adhesive Seal

Filter Paper Carrier

Spore Suspension

Glassine Envelope
Adhesive Seal

Filter Paper Carrier

Filter Paper Carrier

Spore Suspension

Conventional Self-Contained Biological Indicator Enzyme-Based Early-Readout

Cap
Cap

Vial
Media containing Alpha Glucosidase
Vial with attached 4-Methylumbelliferyl
Media Ampoule
Media Ampoule

Spore Suspension Filter Paper Carrier

Spore Bar
Filter paper carrier with spores

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Comparison Biological Monitoring

Conventional
Waste builds
Utilizes nutrients, changing pH making • Conventional BI can be used for all monitoring
grows and replicates media turn yellow
BI challenge test pack
Self-contained BI test

Enzyme-based Early-readout • Enzyme response cannot be used for verification

Installation/major repair monitoring
Periodic product testing

Spore Enzyme works Bacteria replicates Waste builds changing pH

on modified nutrient, making media turn yellow
by-product glows

Chemical Indicators Chemical Indicator

• Visual identification of processed packs • Six classes

• Verification of sterilant penetration • FDA recognizes only Classes 1, 2 and 6

• Air removal verification of prevacuum sterilizers

• Each class has different performance specifications
• Load monitoring and load release

Chemical Indicators Chemical Indicators

Class 1:
Class 2:
• External indicators
• Indicators used in specific tests
• Shows exposure to sterilization
Bowie-Dick Test
process

• Indicates processed and

unprocessed items

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Chemical Indicators Chemical Indicators

Class 3:
Class 4:
• Internal indicators
• Single-parameter indicators • Internal indicators
• Not frequently used for steam sterilization cycles • React to two or more critical parameters

Chemical Indicators Chemical Indicators

Class 5 – Integrators: Class 6 – Emulating Indicator:

• Internal indicators and challenge packs • Internal indicators and challenge packs

• Respond to all critical parameters • Respond to all critical parameters

• Performance correlated to the BI • Performance correlated to sterilization cycle – tighter tolerance

• For gravity and pre-vacuum cycles • For gravity and pre-vacuum cycles

Pack Control Process Control

Internal Monitoring Lot control label

• Placed into every set/pack/container

• Placed in most difficult area

• Confirm penetration of sterilant

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Load Release (Non-Implant Loads) Load Release (Loads with Implants)

At the end of the cycle At the end of the cycle

• Review cycle print out tape • Review cycle print out tape
• Review external chemical indicator • Review external chemical indicators

• Review BI results

• Quarantine load until the results of the BI testing are available

(AAMI, 2010)

Early Release and Exemption Form Record Keeping

Post Sterilization Storage of Sterile Items

• Place loading carts:

Low traffic areas

• Handle when completely cool

• Inspect package integrity

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Handling and Distribution Product Recalls

Transport sterile/clean in controlled environments

• In the event of a recall
Recall all items from affected loads
Reprocess all items

• Clear, written policies and procedures

Action Plan Evaluation and Registration

• Survey sterile processing departments routinely • Thank you for attending this CE activity
Standards compliance
• Please complete and submit the evaluation form
Industry recommended practice compliance
• For more information on the CE credentialed programs
• Approach systematically offered, go to http://university.steris.com

• Collaboration between departments

References References

• Association for the Advancement of Medical Instrumentation (AAMI), Comprehensive Guide
to Steam Sterilization and Sterility Assurance in Health Care Facilities, ANSI/AAMI
ST79:2010. Arlington (VA): AAMI, 2010. American National Standard
• Association for the Advancement of Medical Instrumentation (AAMI), Containment Devices for
Reusable Medical Device Sterilization, ANSI/AAMI ST77:2006. Arlington (VA): AAMI, 2006.
American National Standard
• American National Standards Institute document, ―Emergency Eyewash & Shower
Equipment,‖ 1998
• Occupational Safety and Health Administration (OSHA). Medical & First Aid Standard. Code
of Federal Regulations, Title 29, Part 1910.133
• Perkins, John J., Principles and Methods of Sterilization in Health Sciences, Second Edition,
eighth printing, 1983, p. 246-248
• Preparing Instruments, Utensils, and Textiles for Sterilization and Wet Pack Problem Solving
Guide, STERIS Corporation, 2003
• Sterilization of Health Care Products – Chemical Indicators – Part 1 General Requirements,
EN ISO 11140-1:2005
• International Association of Healthcare Central Service Materiel Management, Central Service
Technical Manual. 4th, Chicago IAHCSMM, 2008

• Occupational Safety and Health Administration (OSHA), Eye and Face Protection Standard.
Code of Federal Regulation,. Title 29, Part 1910. 151

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