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M Infection Prevention Solutions M Sterile U Network M Sterile U Web Meeting October 7, 0 Today s meeting times: 9:00 a.m., :00 a.m., and :00 p.m. Central Standard Time To hear audio, call 800-97-004 and enter access code 76 Phone lines are muted. Audio will commence when the webinar begins. Introducing the M Learning Connection: New Name, Same Great Courses It s an educational resource bringing you M Sterile U and other Infection Prevention courses. You ll soon see some exciting new benefits as our program evolves! Improved features: Add to my Calendar feature added this month! Other M courses will be more accessible as we expand our offerings. What do you need to do? Nothing. Your current registrations remain and our Sterile U offerings have not changed. Welcome! Topic: Ask the Experts: An Industry Panel Answers YOUR Questions Facilitators: Diane Koch, M Dorothy Larson, M Housekeeping Questions Mute feature (*7 = unmute; *6 = mute) Chat feature Technical difficulties Post session follow-up For more information: www.m.com/msterileu

How do I get a CE Certificate? Next week, all of today s meeting participants will be sent an email containing instructions for obtaining a CE Certificate for today s meeting. The email will be sent to the email address you provided when you logged-in to today s meeting. If there are others listening with you today who did not log-on, you may forward the CE certificate email to them. 4 4 Learning Objectives Discuss critical issues and challenges facing CS departments Discuss programs and initiatives that contribute to CS reprocessing excellence 5 5 M 0. All All Rights Reserved. Meet the Expert Panelists David JaGrosse, CSS Manager Middlesex Hospital, Middlesex, CT CRCST Educational consultant to M Jeff O Brien, Sterile Processing 8 years Officer of IAHCSMM Cascade Chapter, Portland, OR CRCST Educational consultant to M Cynthia Spry, Independent Consultant MA, MS, RN, CNOR, CBSPDT Educational consultant to M 6 6

Cleaning Verification A whole process Not just a slice of Pie David JaGrosse, CSS Manager CRCST Middlesex Hospital, Middlesex, CT Education consultant to M 7 7 Cleaning Verification - ANSI/AAMI ST79 Section 0 Quality Control Annex D User-verification of cleaning processes 0. Monitoring of mechanical cleaning equipment Frequency of testing - Upon installation, weekly (preferably daily) during routine use, and after major repairs. Review and initial mechanical washer cycle printouts Document results Table D. Tests to assess efficacy of cleaning medical devices Expose cleaned device to % hydrogen peroxide solution, observe whether solution bubbles. Important to wash or remove after process. Table D. Tests to assess efficacy of washer disinfectors Metal coupon with pre-applied blood test soil 8 Ref: AAMI ST79:00 & A:00 & A:0 & A:0, Sections 7.5 and 0., Annex D 8 AORN Perioperative Standards and Recommended Practices (0) Recommended Practices for Cleaning and Care of Surgical Instruments and Powered Equipment, Recommendation XXII.a Cleaning Verification Test mechanical instrument washers: Before initial use Weekly during service After major maintenance Evaluate manual cleaning When new instruments are reprocessed, and periodically 9 9

The Big - Steps employed for Cleaning Verification. People. Policy; Consistency; Documented process; Access to IFU and tools for the job; Knowledge and education P.Process Mechanical aspects; Sonics; Washers; Cart washer; Hand cleaning process. Post wash tests/inspections ATP Protein detection, etc.; measuring the performance of the process 0 0 Steps employed for Cleaning Verification. Standardized policies and training/education Check List for visual inspection (per shift). Automated and manual Cleaning Performance Verification including washer print outs (if available); Water Quality; Processing Temperatures. Post cycle tests (AAMI Table D) ATP/Swabs/Hydrogen Peroxide Ref: AAMI ST79:00 & A:00 & A:0 & A:0, Annex D Documented Visual Inspection Cycle settings and correct programs on washing equipment. Detergent levels (Sharpie marks) Tools for the job. Supplies for decontam and performing the tasks ahead of you. Cycle printouts and other dirty tests" can be documented or QI checked by Tech. They are in Decontam and you may not want them to leave that area. 4

Automatic Cleaning Observations of Machine Operations / Condition - Occlusion of Spray Arms - Nozzle Directions - Freedom of Movement of Spinner Arms - Instrument rack Coupler alignment - Staining, scaling of insider of chamber - Clean screens, wipe down equipment - Make sure the light in the washer is working - Is the cleaning solution being delivered properly - Daily, weekly, monthly, quarterly, monitoring needs to be done Keep a Record of all results / Record in a book Document the Best cycle settings Keep a copy if they change Testing Devices Temperature / Sonics Temperature - Stick on single use thermometer or digital With modern washers, water temperature is typically the key source of thermal disinfection The level of disinfection, time & temperature to achieve that level differs between brands of Washers Sonics - Tests Cavitation When the ultrasonic cleaner is working correctly SonoCheck will change color Other devices on market also Varying color indicates a possible bad generator; you can go old school and use a piece of aluminum foil 4 4 Testing Devices: Washers Follow IFU for use and what to do if they do not pass 5 5 5

Post wash Tests What is ATP? ATP (adenosine triphosphate) is present in all organic material, and is the universal unit of energy used in all living cells. ATP is produced and/or broken down in metabolic processes In all living things. The luminometer uses bioluminescence i to detect t residual ATP as an indicator of surface cleanliness. The presence of ATP on a surface indicates improper cleaning and the presence of contamination. This implies a potential for the surface to harbor and support bacterial growth. 6 6 Infection Prevention and Doing the Right Thing Discuss Infection Prevention and the critical role of the Sterile Processing professional Discuss the importance of record keeping and Joint Commissions expectations Discuss Doing the Right Thing: Morals and Ethics Jeff O Brien, CRCST Sterile Processing -8 years Officer of IAHCSMM Cascade Chapter, Portland, OR Education consultant to M 7 7 Infection Prevention Healthcare-associated infections (HAIs) account for an estimated.7 million infections and 99,000 associated deaths each year. The number one way to prevent these infections is hand hygiene, according to the CDC and the World Health Organization (WHO). Use of soap and water is the best method if heavily soiled. Use of antiseptic hand rub is appropriate if not heavily soiled, per AORN and AAMI standards. 8 8 M 0. All All Rights Reserved. 6

Infection Prevention Record keeping - Immediate-Use Steam Sterilization (IUSS) and conventional sterilization methods Ensures accuracy of items produced for load recalls Sterility assurance Legal documents for subpoenas Joint Commission Expectations Following Policies and Procedures 0 Findings AAMI Standards (recording biological Indicator test and control results) Sterilization Records 9 9 M 0. All All Rights Reserved. Doing the Right Thing Morals Definition: A lesson concerning what is right and prudent that can be derived from a story, a piece of information, or an experience. Relates to principals of right and wrong in behavior Our own internal ideals and principals Ethics Definition: The discipline dealing with what is good and bad and with moral duty and obligation. To be ethical our actions need to conform to accepted and professional standards of conduct Individual beliefs, knowledge, culture, and religious beliefs often impact our decisions 0 0 M 0. All All Rights Reserved. Infection Prevention / Doing the Right Thing Honesty and Transparency Is this item sterile or not? Chemical Integrator (CI) and Biological Integrator (BI) pass? Wet loads and load recalls Holes, tears, and missing filters Contaminating the sterile field or back table To whom does the staff owe their primary allegiance? Organization Themselves M 0. All All Rights Reserved. 7

Infection Prevention / Doing the Right Thing Team Work - Surgical team and Sterile Processing team MUST be united - Removal of the "US vs. THEM" Mentality Positive Outcomes from Collaboration - Improved patient safety - Increased physician and staff satisfaction - Increased efficiencies M 0. All All Rights Reserved. Infection Prevention / Doing the Right Thing "Real integrity is doing the right thing, knowing that nobody's going to know whether you did it or not." Oprah Winfrey M 0. All All Rights Reserved. Resources The Joint Commission. 0 Hospital Accreditation Standards (HAS) Association of Perioperative Registered Nurses (AORN), 0 Recommended Practices for Hand Hygiene in the Perioperative Setting Association for the Advancement of Medical Instrumentation (AAMI) Comprehensive guide to steam sterilization and sterility assurance in health care facilities, ANSI/AAMI ST79:00 & A:00 & A:0 & A:0 (Consolidated Text) Centers for Disease Control and Prevention (CDC) Guideline for Disinfection and Sterilization in Healthcare Facilities, 008 4 4 8

Immediate Use Steam Sterilization (IUSS) What s Happening? Cynthia Spry Independent Consultant MA, MS, RN, CNOR, CBSPDT Education consultant to M 5 5 IUSS What is new? Name change Position paper The focus - More CS involvement - New practice initiatives 6 6 IUSS What is not new? Little documented correlation to surgical site infection Appropriate use guidelines - AAMI -AORN - CDC 7 7 9

IUSS Some clarifications Historically IUSS has mostly been accomplished using a gravity sterilization cycle Early OR sterilizers were gravity sterilizers These were used to flash items Came to be called flash sterilizer or flash autoclave More appropriate name would have been gravity sterilizer used to flash items 8 8 IUSS Some clarifications, Cont. Over time gravity sterilizers in ORs were replaced with sterilizers that could be set to run a gravity sterilization cycle OR a dynamic air removal cycle (pre-vacuum) However until recently, gravity cycles mostly used for IUSS - Rapid readout in gravity can be accomplished in hour (now even less time 0 minutes) - Great for implants Many small surgery facilities still have gravity only sterilizers (table top types) 9 9 IUSS Some clarifications, Cont. Joint Commission issued an Update paper about short cycles which led to: - Multiple society endorsed paper on IUSS - Focus on IUSS during JC survey - Initiatives in the practice setting to address IUSS 0 0 0

Available at https://www.aorn.org/news.aspx?id=0 5&terms=Immediate%0use%0steam% 0sterilization OR Google: Multi-Society statement endorses process for immediate-use steam sterilization (formerly flash sterilization Practice Initiatives Some Clarification IUSS can be accomplished in either gravity or dynamic air removal cycles Dynamic air removal cycles are more efficient at air removal Gravity and dynamic air removal cycles must provide the same level of sterility - (one type of cycle does not make something more sterile than another) Practice Initiatives Some Clarifications, Cont. Many facilities had their OR sterilizers switched from running a gravity cycle to running a dynamic air removal cycle. USE OF THIS CYCLE DOES NOT MEAN We are no longer flashing. Joint Commission is concerned with excessive use and improper process, not whether or not you use an IUSS process, if appropriate.

Key Considerations Not as a substitute for inventory Not for convenience Cleaned according to IFU NO SHORT CUTS or inappropriate resources - (only shortcut with IUSS is dry time) If sterilizer permits, use a container not an open pan. - Container FDA clearance for IUSS Run dynamic air removal cycle if possible (check IFU) and follow IFU for cycle parameters 4 4 Key Considerations, Cont. Policy for when appropriate Procedure for the process NO STORAGE: - Not even until end of shift or end of day - Regardless of assurances unless written FDA clearance for limited storage Document, document, document Ensure staff knowledge and staff competency 5 5 Resources Association of perioperative Registered Nurses (AORN) Recommended practices for sterilization. In Perioperative Standards and Recommended Practices (Denver: AORN, Inc., 0) Association for the Advancement of Medical Instrumentation (AAMI). Steam sterilization and sterility assurance in healthcare facilities, AAMI/ANSI ST79 0 (Arlington, VA:0) Centers for Disease Control and Prevention (CDC). Guideline for disinfection and sterilization in healthcare facilities, 008 6 6

An Industry Panel Answers YOUR Questions 7 7 Ask The Expert Panel A Loaner Company is asking that I send trays back Sterile, and their paperwork says this is federal law. Isn t washer decontamination adequate? 8 8 Ask The Expert Panel If a sterile processing area in a surgery center does not have a washer-disinfector, should the staff wear gloves when putting trays together on the clean side? 9 9

Ask The Expert Panel Please advise hospital room requirements (ventilation, negative pressure and separate room) as it relates to High level Disinfection - GUS station with Hood / use of Cidex OPA. Can GUS stations be in patient procedure areas? 40 40 Ask The Expert Panel Peel pouches are not to be placed inside wrapped instrument sets for steam sterilization. Does the same recommendation apply to low temperature gas-plasma? Do you write on the paper or plastic side of a peel pouch? How do you place peel pouches in the autoclave? 4 4 Ask The Expert Panel We have been doing verification of our trays in SPD, including Loaner sets. Do we have to run every tray, or can we just do one similar type tray from each of the companies? 4 4 4

Ask The Expert Panel What is the OSHA standard for transporting contaminated instruments from the operating room and ancillary departments? 4 4 Ask The Expert Panel Should laparoscopic instruments be completely disassembled for sterilization? Can instrument milk be applied in Prep & Pack? Is stacking reusable rigid containers in the sterilizer an acceptable practice? What are the official rules for when to take loads out of the autoclave? 44 44 Ask The Expert Panel In regards to various companies Instructions for Use, are there any steps being taken to encourage manufacturer s to standardize sterilization parameters, whenever possible? 45 45 5

Ask The Expert Panel Where can I get a list of sterilization guidelines for reprocessing single-use devices that have been validated for reuse? Are floor grade (i.e. Pakistan) instruments all single-use devices, and is there any documentation, such as from AAMI or AORN, on reprocessing these instruments? 46 46 Thank you! Next M Sterile U Web Meeting: Date: Thursday, November, 0 Title: The AAMI Benchmarking Tool: An Overview 47 47 6