Mod 10 Part 2 PDF - Sterilization Procedures

at 134oC 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 surgical instruments before...

at 134oC 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 surgical instruments before sterilization Physical layout of the area which ensures direct delivery of sterilized items to the point of use Procedures are developed, followed and audited to ensure aseptic handling and staD safety during transfer of the sterilized items from the sterilizer to the point of use Items are needed for use immediately following IUSS, as soon as the device cools so as not to burn the patient Sterilizers are routinely tested prior to use and appropriate records 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 staD The typical operating theatre is not designed or equipped to wash and clean instruments as reliably and consistently as a properly located and designed CSSD, and there are concerns regarding the adequacy of 253 cleaning and drying of surgical instruments in the operating theatre prior.to using IUSS processing Sterility of sets of instruments can be uncertain following the use of sterilizers designed and intended 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, particularly when.implantable devices are involved Loading It is essential to load the items inside the sterilizer chamber properly to allow for adequate penetration, removal and.contact between the sterilant and items being processed Load steam sterilizers in the following manner to ensure steam contact :and penetration Avoid overloading Place non-perforated trays and containers on their edge Keep packages away from chamber walls Place concave items such as basins on an angle to avoid condensate pooling Load textile packs perpendicular to the sterilizer cart shelf Place pouches on their edge Place multiple packages paper to plastic Do not stack rigid containers unless validated by the manufacturer Unloading 254 :When the cycle is complete, unload the sterilizer in the following manner Place heavier items, trays and containers on lower shelves and lighter items e.g. peel packs on higher shelves :Review the sterilizer printout for the following Correct sterilization parameters Cycle time and date Verify that the cycle number matches the lot control label for the load Verify and initial that the correct cycle parameters have been met :Examine the load items for Any visible signs of moisture, consider wet items contaminated even if.you have not touch them Any signs of compromised packaging integrity Retain printed records of each cycle parameter (i.e., temperature, time) in accordance with the local policy Load Cool-Down :After removing the sterilized load Visually verify the results of the external chemical indicators Allow the load to cool to room temperature before touching or moving sterile packs. The amount of time for cooling depends on the Type of packaging used, type of sterilizer and devices that have been sterilized for example, a heavy item such as an orthopedic mallet may.require a longer cooling time Ensure that cool-down occurs in a traDic-free area without strong warm.or cool air currents 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 moisture is noticed on or in one pack, so the problem is isolated to this pack. However, other packs of the same load should be opened and checked for wetness. If there are several 255 wet packs in one load, the entire load should be rejected and.reprocessed The incident of wet packs must be investigated to identify the -root cause and documented to prevent any future re.occurrence Steam Quality Proper steam quality will prolong the life of RMDs by reducing water impurities that have adverse eDects 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 eDects of the steam process; increasing the infection.transmission risk due to inadequate sterilization Steam Sterilization: Advantages and Disadvantages Advantages disadvantages Highly eDective Inexpensive Rapid process Items may be packaged No toxic residues Moist process Unsuitable for heat sensitive items Dry Heat Sterilization The dry heat method may be used for glassware and metal items, heat stable powders and non-aqueous liquids like paraDin. A typical cycle ,consists of heating the chamber to the required sterilization temperature 256 holding the load at this temperature for a defined time period and then.cooling the load This process does not use steam so the typical times required for :sterilization are much longer. The typical time and temperatures used are (Temperature (o C 120 160 60 170 30 180 Advantages disadvantages Suitable for non-aqueous fluids and glassware High temperatures Unsuitable for heat sensitive items Long sterilization and cooling times Items cannot be wrapped Low Temperature Sterilization Considerations Temperature involved—is the method compatible with the devices being ?processed ?Cycle time—will this fit with the workload/turnaround time of the CSSD ?Will more devices be required Availability of equipment Validation requirements Compatibility with devices being processed Low temperature sterilization methods have been increasingly used in CSSD due to the increase use of delicate sensitive to ,(heat surgical instruments and devices. Ethylene Oxide (EO Hydrogen Peroxide (H2O2) and Ozon are the most commonly.low temperature Sterilizers used in CSSD worldwide Low temperature sterilization involves using chemicals with potential toxic properties. CSSD Specialists most be fully 257 trained on how to use these types of sterilizers in optimum safe.and eDective manner :Types of low temperature sterilization (Ethylene Oxide (EO /1 These sterilizers operate at 37 ºC or 55 ºC and duration time of 8-12 hours 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 Advantages Disadvantages Suitable for heat sensitive reusable medical devices Extremely penetrative—suitable for lumened devices Items may be wrapped Dry process Non-damaging Equipment is expensive Lengthy cycle with aeration and validation ,Ethylene oxide gas is toxic explosive and flammable Separate accommodation is recommended Lengthy aeration required to remove toxic residues Gas plasma /2 This method is also suitable for heat sensitive items such as flexible endoscopes or complex laparoscopic instruments as the operating 258 temperature is 45 less than 55 ºC. The cycle time can vary from 45–75 minutes but no aeration is 75-24 required as the byproducts are non toxic(water vapor and.(oxygen :A typical cycle consists of ,A vacuum to remove air Injection and diDusion of the Hydrogen Peroxide Gas plasma generation via radio (RF) ENERGY for a defined sterilization time Venting of filtered air into the chamber through High EDiciency Particulate Air (HEPA) filter Advantages Disadvantages Suitable for heat sensitive devices Short cycle Non-cellulose wrapping materials required May not be suitable for long narrow lumens Vaporized hydrogen Peroxide /3 It is a sterilization method utilizes hydrogen peroxide to kill wide spectrum of microorganism through oxidization. The cycle -takes 28-55 minutes at less than 50 ºc. lumened and non 259 lumened instruments 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 Hydrogen Peroxide to the chamber for sterilization Aeration Cellulose – containing packaging material can not be used in Hydrogen peroxide sterilizers as the absorb the peroxide and.interrupt eDective sterilization Ozon Sterilization /4 This low temperature sterilization system eliminates the need for purchasing a sterilant by generating O3. The processing cycle takes 4 hours and 30 minutes at 30.8-36 cº. The method 260 must be approved by the medical device manufacturer for.sterilization :Typical cycle consist of Vacuum and humidification Injection of the O3 Sterilization Ventilation Sterilization Validation Validation establishes documented evidence providing a high degree of assurance that a specific process will consistently 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 Proper protocol management