8/23/2012. Continuing Education Contact Hours. How much of your formal education focused on sterilization or sterile processing?

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1 Continuing Education Contact Hours The presenter is an employee of STERIS Corporation and receives no direct compensation other than normal salary for participation in this activity. STERIS Corporation is providing the speaker for this activity. However, products referred to or seen during this presentation do not constitute a commercial support by the speaker. Objectives How much of your formal education focused on sterilization or sterile processing? 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 ASC/Clinic Challenges Where Do We Begin? Lack of Knowledge Space Constraints Limited Budgets Short Procedures Quick Turnaround Times 1

2 Instrument Cycle Case Set Up Instrument Storage Procedure Performed Top Areas of Concern Sterile Transport Case Break Down Sterilization Soiled Transport Assembly Decontamination 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 2

3 Key Points Processing Environment Key Points - Traffic Patterns Key Points - Work Flow Key Points - Controlled Environment The decontamination area should be physically separated from all other areas of processing department AAMI ST79:2010 Physical separation or Procedural barrier separation 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 3

4 Key Points - Housekeeping Key Points Processing Steps Daily cleaning and disinfection of floors and horizontal surfaces Sequence cleaning from clean dirty Keep separate cleaning supplies Decontamination area Prep and pack area 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 4

5 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 Lid dented Worn gasket 5

6 Key Points Sterilization Key Points Sterilization Steam High Temperature - Thermal - Traditional Sterilization - Most common Cycle Types - Flash/Gravity Low Temperature - Chemical - Heat Sensitive Devices Manufacturer s IFUs - Prevacuum - Express Key Points - Sterilization Key Points Cool Down 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 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 6

7 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 Key Points #2 Load/Cycle Release Control Biological Frequency daily with BI Purpose Live Spores/Incubator Functioning Same lot Non-Sterilized Yellow Positive Control failure - repeat both test and control Purpose Cycle parameters achieved Mode Physical monitoring Chemical indicators Biological indicators Process Challenge Devices 7

8 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 Class 6 Emulating indicators Respond to all critical parameters Key Points Process Challenge Device PCD Challenge Packs Process challenge Biological challenge device Performance correlated to the BI For gravity and prevacuum cycles Performance correlated to a specific sterilization cycle For use in gravity, prevacuum and SFPP Class 5 integrator challenge device Class 6 Emulator challenge device BI with class 5 integrator Key Points Release of Implants Sample Early Release Documents 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 8

9 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 Key Points - #6 Packaging Following test cycle: Retrieve and incubate BIs No evidence of moisture in packs Document spore results Investigate BI failures Reprocess test sets/items 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 9

10 Key Points #7 Record Keeping Key Points 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 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 Key Points Sterile Transport Understand the steam sterility assurance process Know correct methods for monitoring Carry out all phases of steam sterility monitoring Visual inspection Cleanliness Functionally 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 10

11 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 Key Points Sterile Storage Environment Excessive handling Dropped Tears in package Peel pouch seals not smooth Clean/dirty awareness 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 11

12 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 Eye & Face Protection, and CFR 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 12

13 Key Points - Education Action Plan Device Manufacturer Equipment Manufacturer Clinical Specialists Facility Policy & Procedures Competencies Regulatory Agencies/Guidelines Online Learning Conferences/Seminars 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 Questions? 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 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, 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, 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 Occupational Safety and Health Administration (OSHA). Eye and Face Protection Standard. Code of Federal Regulation,. Title 29, Part Perkins, John J., Principles and Methods of Sterilization in Health Sciences, Second Edition, eighth printing, 1983, p 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 :2005 International Association of Healthcare Central Service Materiel Management, Central Service Technical Manual. 4th, Chicago IAHCSMM,