6/28/2012

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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 1.5 contact

hours 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

Objectives

• Review sterile processing activities in a Sterile Processing

Department based on recommended practices/standards.

• Describe how to incorporate sterile processing activities into

an ASC/Clinic setting based on recommended

practices/standards

How much of your formal education focused

on sterilization or sterile processing?

ASC/Clinic Challenges

• Lack of Knowledge

• Space Constraints

• Limited Budgets

• Short Procedures

• Quick Turnaround Times

Where Do We Begin?

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Instrument Cycle

Case Set Up

Procedure Performed

Case Break Down

Soiled Transport

Decontamination Assembly

Sterilization

Instrument Storage

Sterile Transport

Top Areas of Concern

Key Points - Case Set Up Key Points - Point of Use

• Remove Gross Debris

• Flush Lumens

• Keep Moist

Key Points - Case Break Down

• Separate

• Moisten

• Immediate Transport to

Decontamination

Key Points - Soiled Transport

―Containment may be accomplished by any means that adequately prevents personnel contact with contaminated items

during transfer‖ — AAMI ST79:2010

• Bins with lids

• Impermeable color identifier bags

• Closed/covered carts

• Closed sterilization container systems

• Biohazard label

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Key Points – Processing Environment Key Points - Traffic Patterns

Key Points - Work Flow

• Physical separation or

• Procedural barrier separation

―The decontamination area should be physically separated from

all other areas of processing department…‖ — AAMI ST79:2010

Key Points - Controlled Environment

• Temperature &

Humidity

• Air Pressure

• Air Exchanges

Key Points - Lighting Key Points - Work Surfaces

• Floors, walls and ceilings

• Work surfaces

• Compatible with frequent

cleaning

• Compatible with cleaning

chemicals

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Key Points - Housekeeping

• Daily cleaning and disinfection of floors and

horizontal surfaces

• Sequence cleaning from clean → dirty

• Keep separate cleaning supplies

Decontamination area

Prep and pack area

Key Points – Processing Steps

Manufacturer’s Instructions for Use -

IFUs

Key Points - Decontamination

• Cleaning

• Microbicidal Process

• Disinfection

• Sterilization

Decontamination – Manual vs.

Mechanical

• Chemical Dilution Rate

• Chemical Temperature

• 3 Step Process

• No Disinfection

• Splash/Aerosolization

• Automated Dilution

• Automated Process

• Thermal Disinfection

• Washer Testing

Key Points - Assembly

• Inspection

• Lubricants

• Weight

• Lumens

• Open & Disassembled

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Assembly Accessories

• Trays

• Liners

• Peel Pouches

• No Rubber Bands

• Tip Protectors

• Color Code Tape

Assembly Basin & Textiles

• Same Direction

• Non-linting Material

• 7 lbs

• Materials must allow

- Air Removal

- Steam Penetration

- Laundered/De-linted

- Inspect for hole/worn spots

- Maximum weight 12 lbs

- DO NOT IRON

Key Points - Packaging

• Appropriate Type

• Appropriate Modality

• Appropriate Size

Packaging – Peel Pouches

• Small lightweight items

• Correct Modality

• Write on Plastic

• Self, Heat, & Tape Seal

• Double Peel Pouching

- Face same direction

- Do not fold

- Seal both pouches

- CI in inner pouch

• DO NOT PLACE in containers

or wrapped sets

• Manufacturers IFUs

Packaging - Wrap

• Odd size items

• Appropriate Size

• Appropriate Type

• Single Wrap

• One Step

• Woven

• Manufacturers IFUs

Packaging - Containers

• Great Protection

• Costly

• Accessories

• Cleaning Chemicals

• Inspection/Maintenance

• Manufacturer’s IFUs

• Immediate Use

Worn gasket

Lid dented

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Key Points Sterilization

• High Temperature - Thermal

- Traditional Sterilization

- Most common

• Low Temperature - Chemical

- Heat Sensitive Devices

• Manufacturer’s IFUs

Key Points – Sterilization Steam

• Cycle Types

- Flash/Gravity

- Prevacuum

- Express

Key Points - Sterilization

• Loading

- Sets flat

- Basins tilted

- Chamber Walls

- Space appropriately

- Peel pouches;

- Same direction

- Standing up

- Container below wrap

and peel pouches

• Unloading

- Remove carriage

- Allow items to cool on

carriage

- No Carriage;

- Open door slightly

- Let items sit in chamber

to reduce condensation

- Remove aseptically

- Place on cart to cool

Key Points – Cool Down

• Room Temperature

• Wire Carts

• Low Traffic

• Aseptic Handling

Key Points – Low Temperature

Sterilization

• Chemical

Ethylene Oxide

Peracetic Acid

Gas Plasma

Vaporized Hydrogen

Peroxide

Ozone

• Operator’s Manuals

• Safety

• Device Compatibility

• Packaging

• Accessories

• Sterility Assurance

- CIs

- BIs

- Cycle Printouts

Key Points – Sterility Assurance Goal

• Ensure processed instruments and medical

devices are safe for patient use

- Identifies processed items from those not processed

- Confirms sterilant penetration to the items

- Verifies the proper functioning of sterilizers

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Key Points – Sterility Assurance Key Points – #1 Equipment Control

• Purpose – Verification

- Functionality

- Kill

- Efficacy

- Air Leaks

- Saturated Steam

• Tests

- Bowie Dick

- Biological Indicator

• When

- Installation

- Requalification

- Routine Monitoring

- Periodic Testing

• Where

- Over Drain

• What

- All types of Cycles

Key Points - Testing

• Install/Requalify/Major

Repairs

- 3 consecutive BIs

- 3 consecutive Bowie

Dick Tests

- Empty Load

- No Enzyme

- Flat bottom shelf over drain

• Routine

- Bowie Dick Test (prevacuum)

- BI - each cycle/container

- Minimally weekly preferably

daily

- Prevacuum – Full Load

- Gravity – Empty Load

- Flat bottom shelf over drain

Key Points – Testing Materials

• Bowie Dick Test

• SCBI

• PCD

Key Points – Control BI

Control Biological

• Frequency – daily with BI

• Purpose – Live Spores/Incubator Functioning

• Same lot

• Non-Sterilized

• Yellow – Positive

• Control failure - repeat both ―test‖ and ―control‖

Key Points – #2 Load/Cycle Release

• Purpose

Cycle parameters achieved

• Mode

Physical monitoring

Chemical indicators

Biological indicators

Process Challenge Devices

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Key Points – Load/Cycle Release

Physical Monitors

• Time, temperature

• Pressure recorder

• Displays

• Digital printouts

Key Points – Chemical Indicators

Six Classes of Chemical Indicators (Defined by AAMI, based on specificity)

Class 1 – Process Indicators

- External

- Shows Exposure

Class 2 – Indicators for use in

specific tests (Bowie-Dick)

Class 3 – Single parameter indicators

- Low Temperature

Class 4 – Multi-parameter indicators

- Internal

Key Points – Chemical Indicators

Class 5 – Integrating

indicators

• Respond to all critical

parameters

• Performance correlated to the

BI

• For gravity and prevacuum

cycles

Class 6 – Emulating

indicators

• Respond to all critical

parameters

• Performance correlated to a

specific sterilization cycle

• For use in gravity,

prevacuum and SFPP

Key Points – Process Challenge Device

PCD

Challenge Packs

• Process challenge

• Biological challenge device

• Class 5 integrator challenge device

• Class 6 Emulator challenge device

• BI with class 5 integrator

Key Points – Release of Implants

• Physical monitoring

• External indicators

• Internal indicators (at site use)

• Process Challenge Devices (BI)

• Quarantined until BI

results known

• Emergency implant

cycle release

Document

Traceable to patient

Emergency release exception

Emergency clearly defined

Sample – Early Release Documents

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Key Points – #3 Pack Control

Purpose

• Determine parameters have been reached inside the pack

• Determine the pack has been exposed to the sterilant

Key Points – Pack Control

Internal Monitoring

• Chemical indicator/

integrator

• Every set/pack/container

• Every level

• Placed in the area least

accessible to steam

• Internal CI in each package

• Retrieve and interpret at

time of use

Key Points – #4 Process Control

• Lot control labels

• Visual confirmation of set

sterilization status

• Visual confirmation of pack

integrity

Key Points - #5 Product Testing

Sterilization Verification

• Quality assurance testing of routinely processed items

• Periodic verification determined by each facility

• Performed anytime there is a major change in:

Types or material of packaging

Load configuration

Set weight

• BIs and CIs placed within the test samples

• Should be tested on a full load

Key Points – Product Testing

• Following test cycle:

• Retrieve and incubate BIs

• No evidence of moisture in

packs

• Document spore results

• Investigate BI failures

• Reprocess test sets/items

Key Points - #6 Packaging

• Allows sterilization of contents

• Protects and prevents contamination

• Types of packaging available

• No one packaging system works for all

• Roles of good and appropriate packaging

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Key Points – #7 Record Keeping

AAMI – ST79

• Record Keeping

Epidemiology purposes

Sterilization activities

Tracing instrumentation

Instrument tracking

through to patient use

Maintenance and repair

operations/history

Documentation to be

Maintained:

• Commissioning records

Installation dates

Operational test results

• Sterilization verification

(product verification)

Test protocols

Cycle printouts

Test results

Key Points – Record Keeping

Documentation for CS

Sterilization Cycle:

• Lot number

• Load contents

• Cycle printout

• Initials of operator

• Results of CI test pack (if

used)

• Results of BI (if used)

Documentation for Immediate-

Use Sterilization Cycle:

• Load contents items & quantity

• Cycle Time & Temperature

• Sterilizer identification

• Sterilization location

• Date & time of cycle

• Response of CI

• Results of BI (if used)

• Identification of patient

• Initials of operator

Key Points – Staff Responsibility

Understand the steam sterility assurance process

Know correct methods for monitoring

Carry out all phases of steam sterility monitoring

Visual inspection

• Cleanliness

• Functionally

Key Points – Sterile Transport

Limit Product Handling

To Four Times:

• Sterilizer cart to CS storage

• CS storage to transport

method

• Transport method to user

storage

• User storage to inspection

and opening for use

―First In – First Out‖

Stock Rotation

Key Points – Sterile Transport Key Points – Sterile Transport

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Key Points – Sterile Storage Key Points – Sterile Storage

• Event Related

Sterile indefinite period of

time

Storage/transport

conditions

Handling

Stock rotation

• Time Related

Specific period of time

Defined by hospital policy

and procedures

AORN - Length of time item

considered sterile depends:

Type/configuration of

packaging materials

Number of times handled

Open/closed storage

Use of dust covers

Sealing methods

Key Points – Contaminating Events

• Excessive handling

• Dropped

• Tears in package

• Peel pouch seals not

smooth

• Clean/dirty awareness

Key Points – Sterile Storage Environment

Key Points – Safety OSHA

OSHA Standard Precautions

Assume that ALL blood and body fluids

may contain harmful microorganisms

Protect Yourself from Direct Contact

Personal Protective Equipment

• Appropriate employee attire

Protection from exposure to blood/fluids

Appropriate PPE

• Mask with shield

• Goggles

• Impervious gown

• Gloves

• Head covering

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Appropriate Eye/Face Protection Key Points – Safety Emergency Eyewash

Equipment

• Accessible within 10 seconds travel time of all

chemical usage locations

• Immediately adjacent to use of acid/caustic

• Check eyewash equipment once/week

• Must keep log of weekly testing

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

Key Points – Safety Emergency Eyewash

Equipment

• Hands free

• Must flush both eyes simultaneously

• Must supply 15 minutes of

continuously free-flowing water

• If at hand washing sink, hot water

must be disabled

Key Points – Safety Hand Washing

• Hand washing sink separate from decontamination

sinks

• Hands-free equipment

Sink

Towel

Soap Dispensers

• Alcohol waterless agents

Key Points – Equipment Maintenance

• Preventative Maintenance – PMs

- Recommended manufacturer intervals

- Qualified technicians

- Maintenance records

Key Points – Equipment Maintenance

• Routine - Clean steam sterilizer chamber drain daily

- Check Door Gasket

- Clean chamber per manufacturer’s

recommendations

- Review Manufacturer’s recommendations

- Operator’s Manuals – All Equipment

- Documentation

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Key Points - Education

• Device Manufacturer

• Equipment Manufacturer

• Clinical Specialists

• Facility Policy & Procedures

• Competencies

• Regulatory Agencies/Guidelines

• Online Learning

• Conferences/Seminars

Action Plan

• Survey your sterile processing departments routinely

Standards compliance

Industry recommended practice compliance

• Develop Auditing Checklists

• Document as Quality Performance Improvement Program

• Perform Annual Staff Competencies

Evaluation and Registration

• Thank you for attending this CE activity

• Please complete and submit the evaluation form

• For more information on the CE credentialed programs offered, go

to http://university.steris.com

Questions?

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 ST77:2010. Arlington (VA): AAMI, 2006.

American National Standard

• American National Standards Institute document, ―Emergency Eyewash & Shower

Equipment,‖ 1998

• American Institute of Architects Academy of Architecture for Healthcare. Guidelines for design

and construction of hospital and healthcare facilities. Washington (DC): American Institute of

Architects, 2001

• Occupational Safety and Health Administration (OSHA). Medical & First Aid Standard. Code

of Federal Regulations, Title 29, Part 1910.133

• Occupational Safety and Health Administration (OSHA). Eye and Face Protection Standard.

Code of Federal Regulation,. Title 29, Part 1910.151

References

• 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, 1994.