1/22/2012. When is it a good time to learn about sterile processing in your facility? Continuing Education Contact Hours. Learning Objectives

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1 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 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 should be able to: Describe the various activities performed by healthcare professionals working in sterile processing departments Central hub of healthcare facility Efforts effect virtually every patient in facility Review the key steps that should be performed when conducting an assessment of sterile processing activities in a healthcare facility Challenges of Sterile Processing Low priority and misunderstood Time demands Intimidation When is it a good time to learn about sterile processing in your facility? No formal sterile processing education 1

2 Setting the Stage Start Now The phone call Suspected sterilization failure Physician notification Gather information Standardization (P&Ps, products, practices) Ask questions 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 Dried debris difficult to clean Development of biofilm Containment may be accomplished by any means that adequately prevents personnel contact with contaminated items during transfer AAMI ST79:2010 Damage to passivation layer of surgical instruments Biofilm Development 2

3 Remote Decontamination Physical Environment Perform decontamination activities only in areas that can support good work practices Traffic Patterns Personal Protective Equipment (PPE) Appropriate equipment/space Separation of dirty and clean processes Lighting Ventilation Controlled Environment Controlled Environment Work Area Temperature Humidity Decontamination General Work Areas 60 F and 65 F (16 C and 18 C) 68 F and 73 F (20 C and 23 C) 30 60% 30 60% Monitor temperature and humidity Out of range leads to: Noncompliance with PPE Preparation & Packaging Sterile Storage & Personnel Support Areas 68 F and 73 F (20 C and 23 C) May be as high as 75 F (24 C) 35 50% 70% Promotion of bacterial growth Altered performance of sterilization monitoring products Equipment Access Rooms 75 F and 85 F (24 C and 29 C) 30 60% 3

4 Smooth Surfaces Work Flow Floors, walls, ceilings Work surfaces The decontamination area should be physically separated from all other areas of processing department AAMI ST79:2010 Compatible with cleaning chemicals Emergency Eyewash Equipment Emergency Eyewash Equipment Accessible within 10 seconds of potential exposure Strong chemicals: unit should be immediately adjacent to the hazard Check and log eyewash equipment once/week Hands free Bottle type not recommended 15 minutes of continuously freeflowing water Disable hot water American National Standards Institute document EMERGENCY EYEWASH & SHOWER EQUIPMENT, 1998 OSHA 29CFR Eye & Face Protection, and CFR Medical & First Aid Standard Hand Washing Housekeeping Hand washing sink separate from decontamination sinks Hands-free equipment Alcohol waterless agents Daily cleaning/disinfection of floors and horizontal surfaces Sequence cleaning from clean dirty Keep separate cleaning supplies 4

5 Decontamination Decontamination Process Two step process Begins with cleaning Followed by microbicidal process Disinfection Sterilization Cleaning First and most important step Thorough cleaning can remove of bioburden 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 First: soak Second: wash Third: rinse/treated water Heat and moisture sensitive devices Not a disinfection process Wear gloves in prep and pack 5

6 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 Remove inappropriate chemicals MSDS Follow manufacturer instructions Sonic energy creates tiny bubbles Bubbles become unstable, then implode Dislodges soil from instrument crevices 6

7 Instrument Lubrication Assembly Area Automated Manual Follow manufacturers instructions Instrument Inspection Clean Working order Label and date Assembly Area Packaging Instrument tray assembly Count sheets Content distribution Weight limits Peel pouches Sterilization wrap Rigid sterilization containers Peel Pouches Peel Pouches Light weight Materials appropriate for sterilization technologies Steam paper Hydrogen peroxide gas plasma and Ethylene Oxide Seals Double pouching Inside pouch smaller than outside pouch Inner pouch should not be folded over onto itself Written labels on plastic side only Ozone 7

8 Sterilization Wrap Rigid Containers Woven wrap Launder and inspect Non-woven Single layer One-step wrap Durable packaging Plastic composite or anodized aluminum Variety of designs Rigid Containers Instrument Sets Placed Flat Inspect for damage Cleaned after each use Compatible chemistries Stacking NO YES Loading the Sterilizer Cart Sterilization Do not overload Basins positioned for drainage Packages should never contact sterilizer chamber walls Testing requirements Monitoring practices Record keeping practices Failure investigation Extended cycles 8

9 Equipment Monitoring Routine Monitoring Routine maintenance Preventative/breakdown maintenance Maintenance records Bowie-Dick air removal test Prevacuum cycles Biological testing Other testing Following installation, relocation or major repairs Bowie-Dick Test Conventional Biological Indicator Strips Air Removal Test Test results must be negative Spore Suspension Glassine Envelope 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 Ampoule Vial Media Ampoule Media containing Alpha Glucosidase with attached 4-Methylumbelliferyl Spore Suspension Filter Paper Carrier Spore Bar Filter paper carrier with spores 9

10 Comparison Biological Monitoring Conventional Utilizes nutrients, grows and replicates Waste builds changing ph making media turn yellow Conventional BI can be used for all monitoring 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 on modified nutrient, by-product glows Bacteria replicates Waste builds changing ph making media turn yellow Chemical Indicator Visual identification of processed packs Verification of sterilant penetration Air removal verification of prevacuum sterilizers Load monitoring and load release Six classes FDA recognizes only Classes 1, 2 and 6 Each class has different performance specifications Class 1: External indicators Shows exposure to sterilization process Class 2: Indicators used in specific tests Bowie-Dick Test Indicates processed and unprocessed items 10

11 Class 3: Internal indicators Single-parameter indicators Not frequently used for steam sterilization cycles Class 4: Internal indicators React to two or more critical parameters Class 5 Integrators: Internal indicators and challenge packs Respond to all critical parameters Performance correlated to the BI For gravity and pre-vacuum cycles Class 6 Emulating Indicator: Internal indicators and challenge packs Respond to all critical parameters Performance correlated to sterilization cycle tighter tolerance For gravity and pre-vacuum cycles Pack Control Process Control Internal Monitoring Placed into every set/pack/container Placed in most difficult area Confirm penetration of sterilant Lot control label 11

12 Load Release (Non-Implant Loads) Load Release (Loads with Implants) At the end of the cycle Review cycle print out tape Review external chemical indicator At the end of the cycle Review cycle print out tape 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 12

13 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 Standards compliance Industry recommended practice compliance Approach systematically Collaboration between departments 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 ST77:2006. Arlington (VA): AAMI, 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 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 Part 1 General Requirements, EN ISO :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