26/01/2016. A Day in the Life Steam Sterilization Reprocessing. Welcome! House Keeping. From the GoToWebinar page:

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1 SM 3M Health Care Academy A Day in the Life Steam Sterilization Reprocessing January 27, M All Rights Reserved Welcome! Topic: A Day in the Life Steam Sterilization Reprocessing Facilitator: Susan Flynn, 3M Technical Services Speakers: Dorothy Larson and Susan Flynn For more information: 3M All Rights Reserved 2 House Keeping From the GoToWebinar page: Click on the orange box with a white arrow to expand your control panel (upper right-hand corner of your screen). Type a question in the question box and click send. 3M All Rights Reserved 3 1

2 House Keeping Continuing Education Each 1 hour web meeting qualifies for 1 contact hour for nursing. 3M Health Care Provider is approved by the California Board of Registered Nurses CEP Post webinar Link to Course Evaluation CE Certificate Included Forward to Others in Attendance 3M All Rights Reserved 4 Disclosure Dorothy Larson, Susan Flynn 3M Company Infection Prevention Division Sterilization Technical Services Tech Line option 2 3M All Rights Reserved 5 Learning Objectives 1) Review the daily processing steps in a Sterile Processing Department. 2)Describe the best practices for packaging, preparation, and loading the sterilizer. 3)Describe the recommended practices for Bowie-Dick testing and routine sterilizer efficacy monitoring. 3M All Rights Reserved 6 2

3 Quality control recommended practices Association for the Advancement of Medical Instrumentation (AAMI) Comprehensive guide to steam sterilization and sterility assurance in health care facilities, ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013 (Consolidated Text) Association of Perioperative Registered Nurses (AORN) AORN Guideline for Sterilization (2015) AORN Guideline for Selection and Use of Packaging Systems for Sterilization (2015) 3M All Rights Reserved 7 Polling Question Which department or area of responsibility best describes your role in healthcare? A) Sterile Processing B) Surgery Center C) Operating Room D) Infection Preventionist E) Risk Manager F) Other 3M All Rights Reserved 8 High Level - Sterile Processing Flow OR Patient Case Request CS - Instrments stored in inventory CS - Patient case is picked and sent to OR CS - Instrument set sterilization OR procedure CS - Instrument set assembly Used instrument sets sent from OR to CS CS - Decontamination & wash 3M All Rights Reserved 9 3

4 Cleaning Cleaning is the removal of foreign material (e.g., soil, and organic material) from objects and is normally accomplished using water with detergents or enzymatic products. Thorough cleaning is required before high-level disinfection and sterilization because inorganic and organic materials that remain on the surfaces of instruments interfere with the effectiveness of these processes. Ref: CDC Guideline for Disinfection and Sterilization in Healthcare Facilities W. Rutala, D. Weber and HICPAC. p.36 If the medical device is not effectively cleaned, sterilant cannot penetrate the material contaminating the item and sterilization will not occur. ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2014, Section M All Rights Reserved 10 Functional Workflow Patterns Separation is needed between areas in which decontamination activities occur and areas used for clean activities, such as packaging, sterilizing and storage Ensure that contaminants are contained and employee exposure to bloodborne pathogens and other disease-producing organisms is minimized Move all items progressively from being contaminated to being safe to handle Locate elevators for transport of soiled and clean items, cart holding spaces and sorting spaces to limit environmental contamination Pass-through (between decontamination and the clean processing area) decontamination equipment is recommended A pass-through window is recommended for transport of manually processed items ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013 Section M All Rights Reserved 11 Personal Protective Equipment (PPE) for Decontamination Head and facial hair covered Eye protection protects against liquid splashes/microorganisms/and chemicals Goggles or full-length face shields Masks - Fluid-resistant to protect from splash or splatter Gowns - Protect from splash and splatter Liquid-resistant covering with sleeves Gloves - Prevent punctures, contact with microorganisms, decrease cross-contamination General purpose heavy-duty, water-proof, long and cuffed Shoes clean, non-skid soles and sturdy - to prevent injury from dropped items CDC Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008 pp ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013, Section M All Rights Reserved 12 4

5 SM 26/01/2016 Mechanical Cleaning Equipment Performance Daily and preventive maintenance is vital to the proper function of all mechanical cleaning equipment: - Descaling, cleaning strainer and spray arms and nozzles, checking pumps - Check to ensure correct chemical and lubricants are being used - Check the chemical feed rate and detergent feed lines (mark container to know use patterns) Understanding how to correctly operate equipment in the decontamination area is vital to efficiency and worker safety and to the successful outcome of the process ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013 Sections , M All Rights Reserved 13 Steam Sterilization Approximately 85% of medical device sterilization in healthcare facilities is achieved with saturated steam under pressure Fast Highly effective Reliable Relatively low cost Easy to use Readily available Technology well understood No toxicity or hazardous residues 3M All Rights Reserved 14 Bowie-Dick Testing 3M All Rights Reserved 15 5

6 Chemical Indicators Class 2: Indicators for Specific Tests Testing sterilizer performance Bowie-Dick Test monitors efficacy of air removal and steam penetration in F vacuum assisted sterilizers Bowie-Dick tests can detect: Air leaks, Inadequate air removal, Inadequate steam penetration, the presence of noncondensable gases (air or gases from boiler additives) ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013, Section M All Rights Reserved 16 Bowie-Dick Test 3M All Rights Reserved 17 Bowie-Dick Test Uniform color change Use If not uniform, shut down and report to supervisor -Remain in use -Retest -Call for repair Re-qualify if major repair 3M All Rights Reserved 18 6

7 SM 26/01/2016 Instrument Inspection Assembly Internal Chemical Indicators Packaging 3M All Rights Reserved 19 Instrument Inspection Instruments are inspected for flaws or damage - E.g., rust, pitting, corrosion, burrs, nicks, etc. - Lighted magnifying glass available for instrument inspection Cutting edges are sharp Moving parts move freely without sticking Instruments are cleaned and dried before packaging - Using filtered, medical-grade, compressed air Instruments needing repair are taken out of service for repair or replacement Follow Medical Device Mfrs. instructions for instruments requiring lubrication after cleaning or prior to sterilization 3M All Rights Reserved 20 Instrument Sets Sterilize in perforated or wire-mesh-bottom trays or containment devices (rigid organizing trays or rigid sterilization containers) Remove excess moisture from cleaning and rinsing using filtered, medical-grade, compressed air Remove and replace disposable items (e.g., towels, gauze) ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013, Section M All Rights Reserved 21 7

8 Instrument Sets Jointed instruments should be open or unlocked with ratchets not engaged -Racks, pins, stringers and other devices can be used to hold instruments in the open position Multipart instruments should be disassembled Position to allow sterilant to come into contact with all surfaces and water to drain from concave surfaces Heavy instruments placed so do not damage delicate items ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013, Section M All Rights Reserved 22 Methods to Hold Small Items Small, perforated mesh-bottom baskets with lids (to contain small items in sets) 100% medical grade paper bags Absorbent, single-layer flat wrap Appropriate foam product Laparoscopic sealing caps being placed in medical grade bags 3M All Rights Reserved 23 Instrument Sets When using a rigid container system, contain all items in the basket or tray within the container system ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013, Section M All Rights Reserved 24 8

9 Rigid Sterilization Containers Follow medical device manufacturer s IFU for set preparation and assembly ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013, Section M All Rights Reserved 25 Instrument Sets Tray liners or other nonlinting absorbent material can be placed into trays to alleviate drying problems Containment devices can keep items in place to ensure adequate sterilant contact Check with the manufacturer of both to see if they are FDAcleared and appropriate to use ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013, Section M All Rights Reserved 26 Internal CIs (AAMI ST79) An internal CI should be used within each package, tray, or rigid sterilization container system to be sterilized The CI should be placed in that area of the package, tray, or containment device considered to be least accessible to steam penetration This location might or might not be the center of the package, tray, or containment device. For a containment device, the manufacturer s written IFU for placement of the CI should be consulted. This location might or might not be the center of the package, tray, or containment device. ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013, Section M All Rights Reserved 27 9

10 Internal CIs (AORN) CI should be placed in area within package presenting a challenge for air removal and sterilant contact. (V.a.2, V.b) More than one CI may be required for multilayered trays Place according to tray manufacturer s IFU. (V.a.3) Appropriate number/placement of internal CIs (V.b) Consult CI Mfr., device Mfr., and containment device Mfr. for additional information. AORN 2015 Guideline for Selection and Use of Packaging Systems for Sterilization, Rec. V AORN 2015 Guideline for Sterilization, Rec. VII.f.1 3M All Rights Reserved 28 Internal CIs (AORN) Immediate Use Steam Sterilization A Class 5 chemical integrating indicator or a class 6 indicator should be used within each sterilization container or tray used for IUSS. Class 6 indicators are cycle-specific and should be used only in the specific cycles for which they are labeled. When IUSS of an implant is unavoidable, cycle selection should be determined by the manufacturer s written instructions for use, and a biological indicator and a class 5 chemical integrating indicator should be run with the load. AORN 2015 Guideline for Sterilization, Rec. VII.c.3 3M All Rights Reserved 29 Chemical Indicator Placement Wrapped fabric packs Wrapped instrument sets Place CI in geometric center, not on the top 3M All Rights Reserved 30 10

11 Chemical Indicator Placement Rigid container Place two CIs inside rigid containers Place one in each of two opposite corners For rigid container systems, ask the manufacturer where the greatest challenge is 3M All Rights Reserved 31 Chemical Indicator Placement Multi-layer rigid container Place two CIs in each level of multi-level rigid container Place one in each of two opposite corners on each level For rigid container systems, ask the manufacturer where the greatest challenge is 3M All Rights Reserved 32 Chemical Indicator Placement Multi-level container Supplied by the manufacturer Holes in tray Has to be wrapped Place a CI in center of each level For all these trays, ask the medical device manufacturer where the greatest challenge is 3M All Rights Reserved 33 11

12 Packaging Options Reusable woven textile Disposable nonwoven materials Peel pouches Reusable rigid sterilization containers ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013, Section 8.3 3M All Rights Reserved 34 Plastic-Paper Pouches Contain small, lightweight, low profile items (1 or 2 clamps, or Army-Navy instruments) If double pouching, outer package must be larger; paper side faces paper and plastic side faces plastic Double packaging in paper-plastic pouches should not be performed without documentation from the manufacturer that the paper-plastic pouch has been validated for this use. ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:201 & A4:2013, Section Reprinted from ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 with permission of Association for the Advancement of Medical Instrumentation, Inc AAMI 3M All Rights Reserved 35 Package Closures Closures (do not restrict air removal, steam penetration or steam removal) Use sterilization indicator tape or latch on the rigid container NO pins, paper clips, rubber bands, staples, etc. (can puncture material and compromise the sterile barrier) Use elastomer bands if recommended by the packaging manufacturer If not stretchy enough, will tear packaging Tip protectors should be steam-permeable, fit loosely and used according to the manufacturer s IFU ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013, Section 8.3 3M All Rights Reserved 36 12

13 SM 26/01/2016 Chemical Indicators Class 1: Process Indicators Exposure Control (e.g., indicator tapes) Use with individual units to indicate that the unit has been directly exposed to the sterilization process Distinguish between processed and unprocessed units Designed to react to one or more of the critical process variables ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013, Section M All Rights Reserved 37 Labeling on product Lot or load control number Date of processing Sterilizer number Cycle number Expiration date or statement: Contents sterile unless package is open or damaged. Please check before using. If using a marking pen (nontoxic ink) For wrapped items, write only on the attached label or indicator tape On peel pouches, write on the plastic side ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013, Section and M All Rights Reserved 38 Loading the Sterilizer Routine Sterilizer Efficacy Monitoring Process Challenge Devices Steam Sterilization Processes 3M All Rights Reserved 39 13

14 Instrument Trays Place instrument trays flat To maintain distribution of metal mass Allow air removal Sterilant penetration Condensate drainage Drying Keeps instruments in orderly arrangement and from getting damaged ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013, Section M All Rights Reserved 40 Paper-Plastic Pouches ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013, Section Reprinted from ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 &A3:2012 with permission of Association for the Advancement of Medical Instrumentation, Inc AAMI 3M All Rights Reserved 41 Basins Place basins sets tilted on edge and oriented in the same direction for: Displacement of air Rapid, even distribution of steam throughout the load Prevention of condensate pooling ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013, Section M All Rights Reserved 42 14

15 Reusable Rigid Containers Place flat on shelf below absorbent items to prevent wetting of absorbent items by condensate Do not stack unless validated by MDM Do not stack containers from different MDMs because the configurations might not be compatible which could affect air removal and steam penetration ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013, Section M All Rights Reserved 43 Mixed, Terminal Load Loading the Sterilizer 3M All Rights Reserved 44 Routine Sterilizer Efficacy Monitoring Establishing a regular pattern of testing the efficacy of the sterilization process Frequency of using a BI PCD Biological indicators should be used within PCDs for routine sterilizer efficacy monitoring at least weekly, but preferably every day that the sterilizer is in use. ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013, Section M All Rights Reserved 45 15

16 Biological Indicators AAMI ST79 Rationale: The use of BIs provides evidence of efficacy by challenging the sterilizer with a large number of highly resistant bacterial spores. Biological monitoring provides the only direct measure of the lethality of a sterilization cycle. Test each type of cycle with a BI PCD ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013, Definition 2.7, Section M All Rights Reserved 46 Process Challenge Device (PCD) Definition Item designed to constitute a defined resistance to a sterilization process and used to assess performance of the process. * Representative of load and creates the greatest challenge Equal to or greater than the most difficult item to sterilize Placed in most difficult area in sterilizer for the sterilant to penetrate Example: PCD for IUSS Examples of PCDs for Terminal Sterilization *ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013, Section M All Rights Reserved 47 Sterilizers larger than 2 cubic feet Routine Efficacy Testing BI PCD Use a commercially available disposable, FDA cleared BI PCD, or AAMI 16 towel pack Full load on bottom shelf over drain ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013, Section M All Rights Reserved 48 16

17 Table-Top sterilizers Routine Efficacy Testing BI PCD: User assembled Contain items normally present during routine sterilization Full load in cold point (check with sterilizer manufacturer) Representative of package or tray routinely processed and most difficult to sterilize. Examples: If routinely processing: Peel pouches Peel pouches & Wrapped instruments User-assembled BI PCD: BI + CI inside peel pouch BI + CI inside wrapped tray ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013, Section M All Rights Reserved 49 IUSS Sterilization Cycles Routine Efficacy Monitoring with BI PCD Test each type of tray configuration that is used For sterilizers >2 cubic feet - place the BI PCD on bottom shelf over the drain in an otherwise, empty chamber Representative BI PCD using one or more BIs and one or more CIs in the empty tray configuration Rigid sterilization container system Perforated, mesh bottom, open surgical tray Protective organizing case Single-wrapped surgical tray ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013, Section , , M All Rights Reserved 50 Which cycle do we use? Gravity or Dynamic-air-removal? What s the difference? The reusable medical device manufacturer is responsible for ensuring that the device can be effectively cleaned and sterilized. The written IFU of the device manufacturer should always be followed. IUSS Cycles Unless a device manufacturer specifically recommends the use of gravity cycles, dynamic air removal cycles should be the cycle of choice. ( ) ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013, Section 7.2.2, M All Rights Reserved 51 17

18 Types of Steam Sterilization Processes Gravity Displacement Incoming steam displaces air Dynamic-Air-Removal Prevacuum A series of pressure and vacuum excursions Steam-flush pressure-pulse (SFPP) A series of steam flushes and pressure pulses above atmospheric pressure ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013, Section 2.25, M All Rights Reserved 52 Healthcare Facility Responsibility Obtain and adhere to manufacturer s written instructions Cleaning Cycle type Exposure time Temperature Drying time (if recommended) Reconcile cycle parameter differences between the Sterilizer Manufacturer, Device Manufacturer, and Packaging Manufacturer AORN 2015 Guideline for Sterilization, Rec. VI.b and VII.a.2 3M All Rights Reserved 53 Sterilization Cycle - Completed 3M All Rights Reserved 54 18

19 SM 26/01/2016 Pre-vacuum Selected cycle parameters Actual Cycle Parameters Physical Monitors Check the cycle printout to verify cycle parameters were met Recording charts Gauges Tapes Printouts Digital displays ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013, Section 10.4, M All Rights Reserved 55 Polling Question For each sterilizer cycle printout the operator should verify: (Select best response) A) Time and Temperature B) Air removal method C) Both A & B D) None of the above 3M All Rights Reserved 56 Unloading the Sterilizer Biological Indicators Routine Load Release - Implants Sterile Storage Documentation 3M All Rights Reserved 57 19

20 Unloading the Sterilizer Maintain items on sterilizer cart until adequately cooled Do not touch during the cooling process Could wick bacteria from hands into packaging Place sterilizer cart in a low traffic area, no airconditioning or cold-air-vents Do not transfer warm items to a cool cart which could result in condensate forming and contamination May open door slightly at end of cycle to reduce the potential for condensation formation ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013, Sections 8.8, 8.8.3, 8.8.4, and M All Rights Reserved 58 Biological Indicators Conventional BIs Visual color change in hours Example: Processed BIs Example: Positive Control BI 3M All Rights Reserved 59 3M Attest Rapid Readout Biological Indicator Technology - BI Results in 30 minutes to 3 hours 3M All Rights Reserved 60 20

21 Biological Indicator Positive Control Incubate a positive control BI each day a test vial is incubated in each incubator or auto-reader From same lot number as test BI Purpose: To verify that the test system is working and to ensure Correct incubation conditions Viability of spores Capability of media to promote growth Proper functioning of Auto-reader or incubator Good Science ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013, Section M All Rights Reserved 61 Routine Load Release - Implants Physical monitors External process indicator (Class 1) on every package Internal CI (Class 3, 4, 5, or 6) inside every package A PCD containing a BI and a Class 5 integrating indicator Implants should be quarantined until BI results are known, except in emergency situations A Class 6 CI within a PCD may be part of release criteria for implant loads. However, the load release decision is based on the BI, or Class 5 in an emergency. Evaluation of all data by an experienced, knowledgeable person Do not distribute load if any data suggests a sterilization process failure ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 A4:2013, Section , Table 6 and 7 3M All Rights Reserved 62 Implant Load Release Criteria The load should be quarantined until the results of the BI testing are available (CDC, 2008). Releasing implants before the BI results are known is unacceptable and should be the exception, not the rule. ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013, Section M All Rights Reserved 63 21

22 Early Release of Implants If documented medical exceptions dictate release of implant before BI result, use: Implant Log, and Exception Form for Premature Release of Implantable: Name of implant Name of patient Name of surgeon Reason for premature release What could have prevented the premature release AAMI ST79 Annex L ST79 clearly states that premature release of implants should be the exception, not the rule! 3M All Rights Reserved 64 Sterile Storage 3M All Rights Reserved 65 Case Carts ready to send to O.R. 3M All Rights Reserved 66 22

23 3M Comply Sterigage Interpretation Chart 3M All Rights Reserved 67 Documentation Sterilizer and load records Load contents Date and time of cycle Exposure time and temperature Initials of operator Biological results Chemical indicator results Records of sterilizer repair, maintenance and calibration Maintain records for time determined by risk manager ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013, Section M All Rights Reserved 68 IUSS Sterilization AORN Documentation Log or data base to trace sterilized items used on patients should include: Information on each load Item(s) processed Patient receiving the item(s) Cycle type and parameters used (e.g., temperature, duration of cycle) Monitoring results Day and time cycle is run Operator information Reason for IUSS AORN 2015 Guideline for Sterilization VII.g.1 3M All Rights Reserved 69 23

24 How to Purchase AORN Standards for Your Reference Library AORN standards can be purchased through AORN using the following options: Internet: Call: x 1 or x 1 (Monday-Friday, 8AM To 4:30PM MST) Fax: By mail: AORN, Inc., Customer Service/Book Orders, 2170 South Parker Road, Suite 400, Denver, CO 80231, USA 3M All Rights Reserved 70 How to Purchase AAMI Standards for Your Reference Library AAMI documents can be purchased through AAMI by credit card using the following four options: Internet; emnumber=1383 Call: Fax: Mail: AAMI Publications, P.O. Box 0211, Annapolis Junction, MD M All Rights Reserved 71 Thank you 3M All Rights Reserved 24

25 Questions? 3M All Rights Reserved 73 25