Sterilization Module 10 PDF

STERILIZATION Module10 Presented by: Noha Almalki  INTRODUCTION Sterilization is the complete Sterilization methods: destruction of microorganisms Have rapid throughput including bacterial spores. Are easily validated This level of decontamination Are capable of proce...

STERILIZATION Module10 Presented by: Noha Almalki  INTRODUCTION Sterilization is the complete Sterilization methods: destruction of microorganisms Have rapid throughput including bacterial spores. Are easily validated This level of decontamination Are capable of processing is required for all reusable wrapped items to enable storage invasive medical devices after processing without the risk (RMD). of environmental contamination of processed items.  WHEN IS STERILIZATION REQUIRED? Spaulding classification  METHOD OF STERLILIZATION HIGH TEMPERATURE (Thermal sterilization) low Temperature (chemical sterilization) (steam sterilizer) (Moist heat) Dry heat -Ethyllen Oxide Etoh -Hydrogen Peroxide gas plasma H2O2 -Gravity displacement -Vaporized Hydrogen peroxide VH202 -porous load - prevacum- -Ozone sterilization O3 Dynamic air removal we must use the method f sterilization according to (IFU) TYPES OF STEAM STERILIZATION USED IN CSSD 1- TABLETOP STERILIZER 2- -Gravity displacement 3-porous load - pre vacum- Dynamic air removal 4- Immediate use stem sterilizer  Always use moist heat sterilization in preference to other methods : - it is more reliable -can b-e more effectively -monitored -validated. -Choosing the correct sterilization process is important to avoid damage to the item or compromising sterility.  DEVICE COMPATIBILITY The ability of the sterilization system to effectively sterilize the medical device depends on: - the device’s component materials design the level of bioburden (microbes) prior to sterilization. If items are not cleaned and disinfected correctly, effective sterilization may not be achieved. Functionality is the ability of a medical device to withstand the sterilization process and to remain within operating specifications. The device manufacturer will test its functionality after processing through repeated sterilization cycles and provides fully validated IFU on how to process the medical devices they supply (ISO EN 17664).  FACTORS THAT IMPACT STERILIZATON : IMPORTANT FACTORS FOR STERILIZATION: THE TYPE OF MICROORGANISMS PRESENT THE NUMBER OF MICROORGANISMS THE AMOUNT AND TYPE OF SOIL PRESENT THE AMOUNT OF PROTECTION THE MEDICAL DEVICE PROVIDES  STEAM STERILIZATION The process of steam sterilization requires direct contact between the material being sterilized and pure dry saturated steam at the required temperature for the required time in the absence of air. STEAM STERILIZATION CYCLE HAVE THREE PARAMETERS: saturated stem under pressure time temperature  The recommended combinations of time and temperature.are shown below  The higher temperature of 134°C for 3 minutes is the preferred time/temperature for devices that will withstand this temperature and associated pressure. A steam sterilization cycle involves air being displaced and removed by steam entering the chamber. This can be done with -gravity using a gravity displacement sterilizer - or with a vacuum using (aporous load or -PRE vacum orDynamic air removal) assisted sterilizer. Air removal is essential for effective sterilization, as it will affect steam access to all areas of the device or pack.  GRAVITY DISPLACEMENT STEAM STERILIZERS This type of sterilizer has no assisted air removal and is dependent on gravity, so steam penetration is slow and cannot be assured. Cycle times are much longer for this type of sterilizer and load selection is critical. They are not suitable for wrapped items and items with channels (lumens) as they trap air and prevent correct temperatur from being attained.. Gravity displacement steam sterilizers may be used for solid metal items such as non-complex surgical instruments.  POROUS LOAD (VACUUM ASSISTED) STEAM STERILIZERS Porous load sterilizers incorporate a vacuum-assisted air removal stage prior to steam admission  A typical cycle consists of: Conditioning: steam enters the sterilizer chamber and air exits the chamber through the drain Exposure: sterilization of the load occurs at predetermined sterilization parameters (time and temperature). Exhaust: the steam is removed and filtered air is introduced gradually to the chamber Drying: it starts at the end of the exhausting phase. The drying time depends on the device, packaging and the sterilizer’s IFU.  STEAM QUALITY Proper steam quality will prolong the life of RMDs by reducing water impurities that have adverse effects on device materials. Lime, rust, chlorine and salt can all be left as deposits on devices if treated (reverse osmosis) water is not used. These compounds can lead to stress corrosion, pitting and discoloration of the devices and the sterilizer. Pitting, corrosion and precipitates provide areas where organisms can accumulate and be protected from the killing effects of the steam process; increasing the infection transmission risk due to inadequate sterilization.  IUSS SYSTEM Immediate use steam sterilization (IUSS) or flash sterilization is a common term that describes the practice of fast sterilization of surgical instruments at the point of use. often associated with dropped instruments Flash sterilization is for non-porous and/or non-hollow surgical instruments in an unwrapped condition. These gravity-type steam instrument sterilizers are usually located in the operating room, in order to process instruments for extremely urgent use, for example a dropped instrument when no alternative is available. These sterilizers operate at 134o C for 3–10 minutes, resulting in wet and very hot medical devices in the operating room environment.  Indications for Use of IUSS An IUSS sterilizer must be used only after all of the following conditions have been met: Proper cleaning, inspection, and arrangement of Items are needed for use surgical instruments before sterilization. immediately following IUSS, as soon as the device cools so as not to burn the patient. Physical layout of the area which ensures direct delivery of sterilized items to the point of use. Procedures are developed, followed and audited Sterilizers are routinely to ensure aseptic handling and staff safety during tested prior to use and transfer of the sterilized items from the sterilizer to appropriate records the point of use. maintained.  THERE IS NOW A STRONG MOVEMENT TOWARDS THE ROUTINE PREPARATION OF STERILE INSTRUMENTS IN A DEDICATED AREA LIKE THE CSSD FOR THE FOLLOWING REASONS: Immediate advantages of case-by-case organization of sterile instruments by operating theatre staff The typical operating theatre is not designed or equipped to wash and clean instruments  Sterility of sets of instruments can be uncertain following the use of sterilizers designed only for single dropped instruments; they should not be used for routine sterilization of instrument sets The sterilizer may not be located in an area immediately adjacent to the operating theatre; so the delivery of IUSS- sterilized devices to their point of use compromises their sterility  IUSS RECOMMENDATIONS Restrict use to emergencies, such as unexpected surgery, or dropped devices In most emergency situations, the risk/benefit ratio is low enough to justify the use of IUSS sterilized devices IUSS sterilizers must never be used for implants, suction tubing or cannulae or any other product not specifically validated for the IUSS process. In non-emergency situations, the risk/benefit ratio is higher, especially when implantable devices are involved Alolow for proper steam penetration Loading Place non- and Avoid perforated trays overloading and containers on (allow steam Load steam their edge circulation) sterilizers in the following manner to ensure steam contact and penetration: Keep packages Place concave away from devices on an angle chamber walls Place heavier to avoid condensate items, trays and pooling containers on lower shelves e.g. peel packs on higher shelves  Loading Load textile packs Load steam Stand paper sterilizers in the /plastic peel perpendicular to following manner pouches on edge the sterilizer cart shelf to ensure steam using abasket or contact and rack. penetration: Do not stack rigid Place multiple containers unless packages paper to When combining loads validated by the plastic ,place hard goods on the manufacturer bottom to prevent condensation from dripping onto lower packs.  Unloading Review the sterilizer printout for the Verify that the following: cycle number matches the lot When the cycle is - Correct sterilization control label for parameters. complete, unload - Cycle time and date. the load the sterilizer in the following manner: Verify and initial that the Examine the correct cycle load items for: parameters have Any visible signs been met of moisture  Unloading When the cycle is complete, unload the sterilizer in the following manner: Retain printed Any signs of records of each cycle compromised parameter (i.e., temperature, packaging time) in accordance integrity with the local policy  Load Cool-Down After removing the sterilized load: Allow the load to cool to room temperature before touching or moving sterile Visually verify packs. The amount of Ensure that cool- the results of the time for cooling depends down occurs in a on the devices that have traffic-free area external been sterilized for without strong chemical example, a heavy item warm or cool air indicators. such as currents an orthopedic mallet may require a longer cooling time TROUBLESHOOTING—WET PACK PROBLEMS Packages are considered wet when moisture in the form of dampness, droplets or puddles are found on or within a package. There are two types of wet packs; those with external wetness and those with internal wetness. When wet packs are found, either on removal from the sterilizer or upon opening in the operating theatre, sterility is considered to be compromised and the package contents may be contaminated. Wet packs should be rejected and re-processed according to the local policy. If a shelf liner is used, it should only be made of absorbent material  Advantage of Steam sterilization process: - Low cost - Rapid sterilization process -Simple technology -Non-toxic process as there is no chemical required DRY HEAT STERILIZATION The dry heat method may be used for glassware and metal items, heat stable non-aqueous liquids like paraffin. A typical cycle consists of heating the chamber to the required sterilization temperature, holding the load at this temperature for a defined time period and then cooling the load. Heating Holding Cooling This process does not use steam so the typical times required for sterilization are much longer. The typical time and temperatures used are:  METHOD OF STERLILIZATION HIGH TEMPERATURE (Thermal sterilization) low Temperature (chemical sterilization) (steam sterilizer) (Moist heat) Dry heat -Ethyllen Oxide Etoh -Hydrogen Peroxide gas plasma H2O2 -Gravity displacement -Vaporized Hydrogen peroxide VH202 -porous load - prevacum- -Ozone sterilization O3 Dynamic air removal we must use the method f sterilization according to (IFU)  ETHYLENE OXIDE (EO) These sterilizers operate at 37 C or 55 C so are suitable for heat sensitive items. They are used commercially and in some hospitals, but are banned in hospital settings in many countries due to the costly health and safety requirements for operating and housing these machines. The EO process works well for heat sensitive equipment such as invasive flexible endoscopes, and cardiac and ophthalmic devices, but requires very long cycle durations to allow of adequate aeration.  A typical cycle consists of: Load pre-conditioning—vacuum and humidification Sterilizing gas exposure Gas exhaust and air purge HYDROGEN PEROXIDE GAS PLASMA H2O2 This method is also suitable for heat sensitive items such as flexible endoscopes or complex laparoscopic instruments as the operating temperature is 45 C. The cycle time 45–75 minutes but no aeration is required. Kills by oxidization  A typical cycle consists of: a vacuum to remove air injection and diffusion of the hydrogen peroxide generation of the plasm aradio (RF) ENERGY for a defined sterilization time venting of filtered air into the chamer through High- efficiency particulate air (HEPA) filter Cellulose Containing packing material can not be used in hydrogen peroxide sterilizer as the absorb the peroxide and interrupt effective sterilization VAPORIZED HYDROGEN PEROXIDE VH2O2(VHP) it is a sterilization method utilizes hydrogen peroxide to kill wide spectrum of micro organism though oxidization.The cycle takes 28-55 minutes less than 50 c. lumen and non lumen instrument can be sterilized in these machines based on the program you select.  TYPICAL CYCLE CONSIST OF: -Conditioning to remove air and moisture -Leak test -injection of H2O2 -The VHP is exhausted from the chamber through a catalytic converter that converts the VHP to.water and oxygen -Aeration Cellulose Containing packing material can not be used in  OZON STERILIZATION This low temperature sterilization system eliminates the need for purchasing a sterilant by generating O3. The processing cycle takes 4 hours and 30 min at 30-.8-36c.The method most be approved by medical device manufacturer for sterilization. Kills by oxidization TYPICAL CYCLE CONSIST OF: -VACUM AND HUMIDIFACATION -INJECTION OF THE O3 -STERILIZATION -VENTILATION  Biological Test PCD Physical Monitring -printout -Documenttion Chemical Test 6 TYPES TEST AND MONITORING  STERILIZATION VALIDATION Validation establishes documented evidence providing a high degree of assurance that a specific process will produce an end result meeting specifications and quality attributes by: Measuring the critical parameters of the process such as temperatures, time and pressure, load configuration (contents) and documentation of the results. Assuring all components of the process such as proper cleaning, functionality, packing, wrapping are met Steam Sterilizer Testing Routine testing of sterilizers should be performed daily, weekly, quarterly and yearly as per ISO 17665.  Daily Bowie-Dick test for steam penetration (also known as air removal test). Weekly Yearly Safety checks All the above plus Vacuum leak test Steam quality tests Air detector function test (if equipped) - Non-condensable gas Automatic control test - Steam superheat Bowie-Dick test - Steam dryness Quarterly - Endotoxins All the above plus Testing of dry heat sterilizers Thermometric test, Thermocouple test Surgical instrument Biological indicators calibration verification Chemical indicators Ethylene Oxide Sterilizer Testing Physical parameters i.e. temperature, pressure and humidity. Biological indicators. Chemical indicators. Gas Plasma Sterilizer Testing Physical parameters i.e. temperature, pressure and humidity. Biological indicators. Chemical indicators. Chemical Indicators for Sterilization ISO 11140 classifies chemical indicators into six types, according to their intended use. They are further subdivided by their indicated sterilization process.  TYPES TYPE 1 Use to show that the pack has been process indicattors process TYPE 2 use in specific test procedures, such indicators for use in specific test as the Bowie-Dick test for air removal. TYPE3 React one of the critical sterilization Single variable indicators variables e.g Time or Temperature  TYPES Type 4 designed to react to two or more of Multivariable the critical sterilization variables, e.g., indicators (time and temperature) These indicators are designed to react to all critical Type 5 variables of the sterilization process, e.g., time, Integrating temperature and presence of moisture Meets or indicators exceeds the performance requirements of a biological indicator These indicators are designed to react to all critical Type 6 variables of the sterilization process, e.g., time, temperature Emulating indicators and presence of moisture, and are intended to match the critical variables of specified sterilization cycles Examples of indicators