Low Temperature Sterilization Using Hydrogen Peroxide - Week 7 Tagged PDF

Low Temperatu re & Steris System MDR 111 Low temperature sterilization using Hydrogen Peroxide Hydrogen Peroxide (H2O2) is an EXTREMELY powerful oxidant that is capable of effectively killing a wide range of microorganisms – including resistant spore-forming bacteria.  It is a low-temp sterilizat...

Low Temperatu re & Steris System MDR 111 Low temperature sterilization using Hydrogen Peroxide Hydrogen Peroxide (H2O2) is an EXTREMELY powerful oxidant that is capable of effectively killing a wide range of microorganisms – including resistant spore-forming bacteria.  It is a low-temp sterilization that DOES NOT require aeration after the sterilization process.  This sterilization method allows temperature-sensitive devices, such as small diameter endoscopes, telescopes, light cords, batteries, etc. to be sterilized in a SHORTER timeframe than EtO and it does not have a long aeration time before patient procedure use. Examples of Low- Temperature Instruments  Terminally-sterilized items can be used after the cycle is completed Low temperatur Process: the liquid H2O2 is vaporized into the chamber that has been taken to a negative pressure e sterilization During this stage: vaporized H2O2 is drawn using through lumens, and contacts ALL surfaces of medical devices – killing all microorganisms Hydrogen Peroxide Certain sterilizer model changes the H2O2 vapour into a PLASMA state – during the sterilization process – which ensures that there is no residual H2O2 left on the devices at the end of the cycle   Plasma is the fourth state of matter distinct to solid, liquid and gas. Low  It is created when gas is energized to the point where electrons are temperatur stripped away from their atoms. e  In low-temperature sterilization using sterilization Gas-Plasma, an electromagnetic field using is created in which the electrons are stripped away from the vaporized Hydrogen H2O2. Peroxide  This process forms free radicals which are used for sterilization.  There are several H2O2 sterilizer manufacturers that make models and Low cycles – it is important to ensure that temperatur the devices being sterilized in a certain model are approved and validated by e the medical device manufacturer sterilization using Validation document – MUST be specific Hydrogen to the sterilizer make, model and Peroxide specific cycle that is being used for sterilization MIFU Referen ce 1st Generation: 2ND Generation: STERRAD ® 100NX / 4 cycles Express Cycle (24mins) Flex Cycle (42mins) Standard Cycle (47mins) Duo Cycle (60mins) VHP Sterilizers Steris (AMSCO) V-PRO ® maX / 3 Cycles STERRAD® 100S Non-lumen (30mins) Flexible Cycle (40mins) Lumen Cycle (60mins)  Latest Technology: VHP  STERIZONE ® VP4 Sterilizer Sterilizers  1 Cycle for all devices, 75 lb load capacity   A variety of cycle lengths is available – ranging from 24 to 75 minutes  Cycle length depends on which system is being used and the type of device being Low sterilized temperature  There is no room air monitoring and no post- sterilization aeration required since only harmless sterilization by-products of water and oxygen remain after the using completion of the cycle Hydrogen  Straightforward installation specifications and sterilant supply do not require external venting Peroxide - lines, gas hookup, or plumbing  The only thing required is a dedicated Features electrical outlet and space for machine access  Sterilant is provided in cassettes or disposable containers Low temperature sterilization using Hydrogen Peroxide - Features A variety of different cycle types are available with each model – it is important to be knowledgeable on the differences such as the materials compatibility and limitations for each cycle. Low temperature sterilization using Hydrogen Peroxide- Limitations Materials compatibility: Only specific materials and devices have been validated – check the medical device manufacturer to see which devices have been validated in each type of machine and each cycle No powders, liquids, or cellulose-based materials Some manufacturers have lumen restrictions – check before purchase No dead-end lumens are allowed Depending on the sterilizer manufacturer – boosters are sometimes required on lumen devices of a specific length and diameter All medical devices placed into the sterilizer must be completely DRY or the cycle could ABORT No vacuum-sensitive devices allowed  Packagi Only validated containers, pouches, or ng polypropylene wrappers No cellulose materials – cloth, towels, paper or cotton General No paper labels Considerati Hydrog Solutions are process-specific ons en peroxid e Different containers, concentrations, and solution amounts for each technology Solution cassettes or disposable containers are barcoded to ensure its not expired  Low- Temperature Sterilization Materials Conditioning Exposure H2O2 Charge phase Vent phase: phase phase eliminated (injection)- filtered air Vacuum – air (diffusion): for phase: plasma H2O2 added introduced removal 5-20 minutes or evacuation Sterilization Phases   The vacuum phase – chamber is evacuated to remove air and other gases to create low pressure inside the chamber  The injection phase – liquid H2o2 is injected into the chamber. Water is removed from the liquid H2o2 until the concentration reaches 90%  The diffusion phase – Vaporized h2o2 is then transferred to the chamber and diffuses throughout Sterilization surrounding the items to be sterilized. Phases  The plasma phase – an electromagnetic field is created in which the H2o2 vapor breaks apart, producing a low-temp plasma that contains free radicals  INJECTION, DIFFUSION AND PLASMA phases are then repeated for added efficacy  The Vent phase – the chamber is brought back to atmospheric pressure by introducing HEPA-filtered air and the cycle completed Temperature 4 Critical Time process variables for H2O2 Concentration low temperatur Plasma (if applicable) e H2O2 sterilization The required parameters are PROCESS-SPECIFIC and essential to the sterilization process 2 low temperatur e H2O2 sterilization PLASMA IS USED BY STERRAD AND VACUUM IS USED BY REMOVAL HUMAN MEDITEK SYSTEM – THE CHARGE BREAKS DOWN H2O2 TO THE V-PRO SYSTEM – WATER AND OXYGEN, LEAVING NO RESIDUAL H2O2 ON THE MEDICAL STERILANT IS DEVICES REMOVED UNDER VACUUM   Internal conditions are monitored during the cycle and will be aborted if any issues arise  Devices must be dry before sterilization  If a liquid/powder-like substance is Sterilization seen on or inside the package after Safety the cycle is complete- appropriate PPE must be worn  PPE must be worn for all cancelled cycles  Always refer to sterilizers MI for preparing, loading, and operating  All systems and processes have the same requirements:  Biological indicators Sterility  Chemical indicators (internal and Assurance external)  Sterilizer displays and cycle Monitoring printouts  What is Ozone? Ozone When the oxygen that is all around us rises to the upper atmosphere, and is exposed to the sun’s ultraviolet rays, that oxygen will naturally turn into Ozone. That is the ”ozone layer” that protects us from the sun’s UV rays Requires a supply of oxygen to create ozone Oxygen tanks and concentrators Ozone need to be CSA compliant Features Hospital facility oxygen line cannot be used – goes against the CSA HARMLESS by-products of water and oxygen – no requirements for monitoring or aerations Ozone No external venting or plumbing Features Can sterilize lumens up to 3.5m long- such as flexible gastroscopes, colonoscopes, and flexible multi- channel endoscope  Ozone  The cycle length is 45-110 minutes Features  Pre-conditioning (warm air injection)  Humidification  Injection  Vent First, a vacuum is created within the chamber. Followed by a humidification phase. Ozone is then injected into the chamber and the sterilization process begins. After the half-cycle is reached, the previous steps are repeated. A Final ventilation phase is used to remove ozone from the chamber and the packaging.  01 02 Steris STERIS SYSTEM 1 consists of the STERIS SYSTEM 1 PLUS and SYSTEM 1 EXPRESS Systems SYSTEM 1 processor sterile processing and STERIS 20 systems consists of sterilant concentrate the STERIS SYSTEM 1 PLUS/EXPRESS processor and STERIS 40 sterilant concentrate   SYSTEM 1/PLUS/EXPRESS are tabletop, point-of-use sterilization systems intended to sterilize temperature-sensitive medical devices such as rigid and flexible endoscopes, light Steris cords, minimally invasive Systems surgery (MIS) instruments, and video cameras  The SYSTEM achieves this through immersion in STERIS 20 or STERIS 40 sterilant concentrate   The Systems are a point-of-use technology and do not follow medical device storage. Devices approved by STERIS that are processed in these sterile processing systems will be sterile and ready for immediate use in Steris patient procedures. Systems  SYSTEM 1: Cycle time is about 30 minutes  SYSTEM 1 PLUS: Cycle time is about 23 minutes  SYSTEM 1 EXPRESS: cycle time is about 18 minutes  The advantages of the SYSTEM 1/PLUS/EXPRESS include  rapid sterile processing of delicate instruments  the use-dilution is safe to discharge into the regular Advantages hospital drainage  Single-use Chemistry ensures reproducible results  highly water soluble  Free rinsing and no toxic residuals  The disadvantages of SYSTEM 1/ PLUS/ EXPRESS include:  Only suitable for items that can be immersed  items cannot be stored sterile  Although devices are processed in a Disadvanta container, they are wet and must be ges used immediately  They are Just-In-Time sterilizers and must be located close to the point of use.  Incoming water temperature and pressure may affect(i.e., extend) Cycle time  When considering reprocessing devices, SYSTEM 1/PLUS/EXPRESS have applications in these areas/ departments: Operating Room Steris Outpatient Surgery Systems Endoscopy Urology  For use in rigid devices Pre-clean and rinse per manufacturer's Steris recommendations Systems Ensure all surfaces can be contacted by use dilution Disassemble to the smallest part Ensure devices are in open position allowing flow. Steris Systems For use in flexible endoscopes 1. Leak first 2. Pre-clean and rinse per manufacturer's recommendations 3. Place in appropriate tray/container per processing instruction manual 4. Utilize required Quick Connect following the reprocessing instruction manual 5. Review placement and connections before initiating cycle  STERIS 20/ STERIS 40 Sterilant This sterilization process is used for sterilizing Temperature- sensitive devices, but they must be able to be immersed in the solution. It sterilizes via a chemical reaction with proteins and nucleic acids in microorganism cells. The "cup-within-a-cup" design and chemical delivery STERIS 20/ system allows for the safe sterilization of delicate devices. STERIS 40 It is the use of dilution, not peracetic acid concentration Sterilant that is exposed to instruments. 0.2% Concentration of percetic acid in use dilution. The use Dilution has a neutral pH of 6.4.  THE SYSTEM 1/PLUS/EXPRESS controls include: 1. Power Switch: Turns the machine on or off 2. Start: begins a cycle once the sterilizer is loaded with the appropriate container or Operating tray Controls 3. Cycle Status Indicator: LED display provides real-time dual-line display of cycle phases, operator alerts or cancelled cycles, as well as cycle countdown 4. Cancel: To interrupt the cycle at any time or after a sterile processing cycle  5. Diagnostic Cycle: conducts a self-test of the electromechanical components and the sterile water filter. 6. Printer Feed: Advances the printer paper Operating Controls 7. Enter: to complete a function when using the numeric keypad 8. Change/Save values options for sterilization cycle preparation Steris System Operating Control   The following steps must be taken to prepare the system for the sterilization cycle: 1. Position the appropriate tray in the SYSTEM 1/PLUS/EXPRESS Operating 2. Check the drain screen to be sure it Controls is free of debris 3. The device is prepared and positioned in a tray/container 4. Preparing for the sterilization cycle  5. If required, attach the appropriate Quick Connect (QC) 6. Refer to QC instructions/identification tag (do not remove tag or QC configuration) 7. Place a single cup of SERTIS 20 sterilant for SYSTEM 1 processors or a single cup of SERTIS 40 sterilant for SYSTEM 1 PLUS/EXPRESS processors  Inspect the cup to ensure within the expiration date Operating and buffers are not hard Controls 8. Check for aspirator probe damage and proper positioning of the cup 9. Place a chemical indicator into every load using the orange Vascu-Stat clip 10. For the first cycle- per CSA- place the biological indicator and then follow the MI for preparation, placement, labelling, incubation, and reading of the biological indicator Steris System Operatin g Control   As the cycle status indicator shows, the SYSTEM 1/PLUS/EXPRESS processor has 3 phases  Conditioning phases  1. water enters chamber through a series Cycle of pre-filters and circulates throughout – mixing powders and buffers contained in Phases the bottom of cup and diluting the 35% peracetic acid to an in-use concentration of 0.2% - use dilution is heated to the set temperature of 50 degrees Celsius in SYSTEM 1 and 43 degrees Celsius in SYSTEM 1 PLUS/EXPRESS  2. Door is LOCKED and click start   Exposure Phase  1. when the sterilizing temperature of 50 degrees Celsius in SYSTEM 1 or 43 degrees Celsius in the SYSTEM 1 PLUS/EXPRESS is reached, the exposure phase begins  2. Sterilization occurs as devices in the tray/container are exposed to the STERIS 20 Cycle Phases or STERIS 40 sterilant concentrate  3. The STERIS 20 peracetic acid solution at MEC of 1800ppm for 12 minutes  The STERIS 40 peracetic acid solution at MEC of 1800 ppm for 6 minutes  Rinse/Air purge phases 1. At the end of a 12-minute exposure time to STERIS 20 or 6- minute exposure time to STERIS 40 sterilant concentrate – use dilution is sent down the drain 2. 4 sterile water rinses for SYSTEM 1 and 2 sterile water rinses for SYSTEM 1 PLUS/EXPRESS Cycle Phases 3. Air purge 4. cycle complete 5. press “Cancel” and wait for “open” prompt  1. Review Printout Parameters 2. Open lid Post-sterile 3. check STERIS 20 / STERIS 40 container and discard Processing 4. read record and discard chemical Cycle indicator 5. Aseptic transfer of biological transfer – if applicable 6. remove devices/instruments  The SYSTEM 1 printout- once cycle is complete will be produced Records time and date – and Physic three essential parameters Sterility al necessary for sterilization during exposure phase: Assurance Monitors Monito TIME, TEMPERATURE and CONCENTRATION Diagnostic cycle run daily for rs all systems Monitors both electromechanical and the sterile water filter  Chemical Sterility indicators Assurance Chemical indicators When exposed to Monitors (CI) independently peracetic acid of 1800 monitor the effective ppm or greater concentrations of the STERIS 20: colour changes STERIS 20 sterilant from purple to white and STERIS 40 STERS 40: colour changes sterilant during the from blue to pink cycle Sterility Assurance Monitors Biological indicators Utilize Geobacillus Stearothermophilus to verify processor’s capability of killing the most resistant microorganism Vivid red to yellow colour change indicates growth – biological indicator requires 24 hour incubation period  Use 70% isopropyl alcohol to The unit should be wipe inner and outer surfaces of chamber – inner and outer damp-wiped daily surfaces of instrument trays – remove tray holder and wipe Check the drain screen – below sterilant cup Operation Maintenanc Remove residual water from drip pan – e DAILY Change paper reel when red border appears  Change Change sterile water filter every 90 DAYS or as indicated by diagnostic fault code Change Change the sterile air filter every 6 MONTHS – indicate date on top of filter Operation Maintenanc Inspect Inspect trays, containers, and aspirator probes for cracks or damages e Perform Perform daily diagnostic cycle and monitor for fault codes Function Function of pre-filter “A” and “B” can be monitored from the “Fill Time” reported on the printout at the completion of cycle  When handling sterilant cup after cycle completion – dispose gloves after Safety Precautions Aborted loads/unsealed sterilant cups – PPE must be worn and MI followed for safe handling   Liquid PAA is a highly effective anti- microbial agent that maintains its efficacy even in the presence of high levels of organic soil. It is a clear, colourless solution with a pungent odour.  it sterilizes in 30-45 minutes at 50-56°C. The cycle time may vary due to water Peracetic pressure, incoming water temperature, or filter status. Acid  Liquid PAA provides ‘just in time’ sterilization and is used in many endoscopy clinics.  Liquid PAA will kill gram-positive and gram- negative bacteria, fungi and yeasts in < 5 minutes at < 100ppm.  The liquid PAA sterilization process employs chemicals that are not carcinogens, mutagens or reproductive hazards. This process does not require aeration and there are no toxic residues. No special handling requirements are necessary after sterilization. Safety Considerati However, PAA is a strong oxidizing agent and ons concentrated solutions are irritating to skin, eyes and mucous membranes. Vapours can cause inflammation of the respiratory tract. Rubber gloves, safety goggles and protective clothing should be worn when handling concentrated PAA.  Test 1 Coverage Week 1- on July Week 5 13th: Questions?