MODULE 1 Sterilization RPN 20231.pdf

MODULE 1: Sterilization Suggested Readings Alexander’s Care of the Patient in Surgery (2022) Chapter 4 p. 53 - 86 Tighe (2015) Instrumentation for the Operating Room p. 5 - 16 ORNAC Standards 2...

MODULE 1: Sterilization Suggested Readings Alexander’s Care of the Patient in Surgery (2022) Chapter 4 p. 53 - 86 Tighe (2015) Instrumentation for the Operating Room p. 5 - 16 ORNAC Standards 2023 p. 2-59 – 2-69, 2-71 – 2-94 Learning Outcomes Understand sterilization terminology. Apply best practices to confirming the sterility of packages, instruments and sterilization containers Compare and contrast sterilization and High-level disinfection methods. Understand CJD and sterilization protocol. Sterilization and desired patient outcomes for any surgical procedure is “Freedom from infection.” All sterilization and disinfection methods are monitored by Infection Control (I/C) within the Hospital. The Perioperative Nurse needs to be aware of the Policies that govern these methods within the hospital that they are working. Terminology and Sterilization Sterile (Aseptic)- Free from all microorganisms, including spores. Bioburden- Viable microorganisms on a product i.e. instruments and identified before and after the sterilization process has occurred (blood, bone, tissue). If bioburden is not removed in the cleaning process it remains on the instrument. Any bioburden left on an instrument after sterilization renders that instrument not sterile and must be discarded. Spore- An inactive or dormant, but viable state of an organism that is difficult to kill. Sterilization methods are monitored by their ability to kill a known population of resistant spores. Common spore forming bacteria include: Clostridium perfingens, Clostridium botulinum, Clostridium tetani, and Bacillus anthracis. Shelf Life: How long an item is sterile? There are expiry dates on most items. However, all items before opening must also be checked for, wrapper condition with no breaks in the integrity of the packages including tears or moisture and an indicator if applicable. Commercially prepared items without an expiry date are considered sterile provided the package is intact as mentioned above. A date that has passed on an item renders it unsterile and will not be used. Biological Indicator- A sterilization monitor consisting of a known population of resistant spores that is Module 1: Sterilization used to test the sterilizer’s ability to destroy spores and therefore ensure the item is sterile. This is also dependent on the instruments being packed properly, placed in the Sterilizer correctly and use of the correct packaging materials. Bowie Dick test- An air removal test that tests the ability of the Autoclave to remove air from the chamber and ensure that steam is able to penetrate all surfaces loaded onto the auto clave. This is run daily in all vacuumed Autoclaves that use steam under pressure. Chemical Indicator- A device used to monitor the process parameters in the sterilization cycle. They are specific to the process of sterilization used. They start the process the indicator tape or arrow with one colour. Immediate Use Steam Sterilization (IUSS) or Flash Sterilization- A steam sterilization process for sterilizing items that are needed immediately in an OR. Disinfection vs. Antisepsis Remember that Disinfection and Antisepsis are very different from sterilization. These processes do not kill all living organisms as sterilization does. They are microcidal substances, generally liquids that reduce the number of microorganisms. Disinfectants are bactericidal/antimicrobial agents used to destroy microorganisms on inanimate objects (surface equipment). Time needed is dependent on microorganism. Examples are alcohol and chlorine compounds (Javex), Virox, Alcohols Chlorine compounds (javex based), Virox Glutaraldehyde/orthophthaldehyde Hydrogen peroxide (Cavitron Wipes) Disinfection- Process that kills all living microorganisms with the exception of high numbers of spores. These are divided into 3 categories: Low - Level Disinfection: Kills vegetative forms of bacteria, lipid viruses and some fungi Intermediate - level disinfection: Kills vegetative bacteria, viruses, and fungi (NOT Spores) High - level disinfection (as above Intermediate plus some spores) Gluteraldahyde, hydrogen peroxide, peracetic acid, cidex are some High-Level disinfectants. *This will be further discussed under the heading High Level Disinfection Antiseptics are bactericidal/antimicrobial agents that can be used on LIVING tissue (i.e. patients). Examples are: Chlorhexidine (Hibitane) based and Iodophors (Betadine) based. These are used by the scrub team and on the patient for prepping. Processing Instruments and Equipment In 1972 Spalding classified items and divided them into 3 groups. How items are processed depends on its intended use: Module 1: Sterilization  1. Critical 2. Semi critical 3. Non critical Critical- Items coming into contact with the sterile tissue, vascular system (i.e. devised introduced beneath a mucus membrane). Critical Items must be sterile and if they are not there is a high risk that an infection will occur. This is why we use sterile/aseptic technique. This includes surgical instruments, cardiac catheters, and all implants. (This may include bronchoscopes, cystoscopes that are processed using Sterris) Semi Critical- Items that come into contact with unbroken mucus membranes. These may be sterile but must at least be disinfected (high level Disinfection) Colonoscopes, gastroscopes, thermometers, (bronchoscopes, cystoscopes in some hospital settings) Non-Critical- Items contact intact skin Low level disinfection is required. These include BP Cuffs, stethoscopes, SPO2 probes, ECG lead cords. (You will see these cleaned in between cases in the OR). Instrument Care- Instrumentation for the Operating Room Pages 5 – 16 Instruments should be kept as free as possible from gross debris during the surgical procedure itself. Instruments should be wiped routinely with sponges moistened with sterile water during surgical procedure. Before sterilization can occur, all instruments and equipment need to be washed. This is called the decontamination phase. The Sterilization Process Types of Sterilization Steam sterilization (Autoclave) Chemical Sterilization Methods (EO, Gas Plasma Sterilization (Sterrad), Peracitic Acid, (Sterris) Radiation High Level Disinfection Method of Choice for Sterilization is dependent upon What the item is Safety factors Packaging of item Length of time the process takes Cost involved Process Decontamination: Pre sterilizing…. (Staff wear PPE) The used surgical instruments and case carts travel from the OR to the Decontamination area of the Medical Device Reprocessing Department (MDRD). All instruments are disassembled, rinsed/washed and then placed in the ultrasonic washer if appropriate where they are washed again so that all bioburden is removed. They are then dried (if appropriate), reassembled in the “open position,” and packed in the appropriate instrument container. Once instruments are washed (decontaminated), they are checked again for cleanliness, for functionality and then reassembled into the sterilization tray. They are then placed in the appropriate sterilizing machine. Module 1: Sterilization Once the instrument has been decontaminated, they are reassembled into the instrument containers or wrapped with wrappers specific to the Sterilization method used to package the products to be sterilized - this allows for sterilant to move in and out of the instrument containers or packages during the sterilization process. Staff wear OR scrubs to do this, including OR hats. Instruments are reassembled (if appropriate), checked against the inventory list to ensure all correct instruments are going into the correct instrument tray, counted, and placed in the “opened position so that all areas can be sterilized. Reassembly, Wrapping and Packing Module 1: Sterilization  Inspecting and Packing the Instruments Wrapping a basin Set for the Operating Room Wrappers and Containers There are 4 types of wrappers commonly used: Muslin - economical, reusable, has NO memory but can be linty and is labor-heavy. Must have a specific thread count. Non disposable gown packs are wrapped this way. Paper - not linty, quite light, but expensive because it’s disposable. Plastic/paper peel backs - very popular, seals easily by heat, is disposable, but expensive. (Picture of the instrument above) Synthetic nonwoven polypropylene wraps (spunguard) or Tyvek/Mylar pouches are suitable for Sterrad sterilizing. Reusable Rigid Container Systems – re-usable container that instruments are packed in (see photo below). Module 1: Sterilization Once any item is wrapped the shelf life sterility is event-related, not time-related. (Dependent on what happens to the package after the item is sterilized) Maximum weigh per pack is limited to 12 lbs (4.3 kg) or steam cannot penetrate. Parts with screws and stylets must be disassembled. (Note: rubber is separated from instruments before sterilizing in order to ensure the steam to hold them together). Never have solid metal against solid metal or rubber items sticking directly to other rubber surfaces because the steam cannot penetrate these barriers. *The scrub nurse is responsible for ensuring instruments are in the open position when opening their instrument container. Double-wrapping must be sequential. According to ORNAC standards it is recommended that fan folding of drapes along with sequential double-wrapping allows for better protection against microbes. Lumens of instruments must be flushed with water for steam sterilization. Lumens of instruments must be dry for EO or plasma gas sterilization. Quality Monitors: Chemical and Biological Indicators The image below shows the before sterilization chemical indicators on the left-hand side and the after- sterilization indicator on the right-hand side. Notice the change that occurs. It is the chemical indicator that we check to ensure the package has gone through the sterilization process. Module 1: Sterilization Steam/Chemical Indicator - go on the inside and outside of equipment packs. External Sterilization Indicators - go on the outside of every package (unless the package is visible or see through) Internal Sterilization Indicators - go in the center of the packaged item. Chemical indicators do not GUARANTEE sterility. They indicate that certain parameters of heat and moisture were met. (These are checked and verbally confirmed by the scrub nurse). Checking indicators is the role of the scrub and the circulating nurse. This is documented for each case done in the operating room. Biological Indicator Biological controls are the exact method of guaranteeing sterility. They actually test the sterilizer’s ability to kill specific strains of highly resistant organisms. The Biological Indicator goes into the Sterilizer. The sterilizer is run through and then the test strip is examined by the Central Processing Staff to endure the sterilizer is killing all spores and rendering all instruments and pack sterile from that sterilizer. This is monitored by MDRD Staff. Types of Sterilizers The autoclave or steam sterilizers, requires time to heat up. The sterilizing time will be dependent on valves on the doors being properly sealed and closed, steam and heat being introduced and air is evacuated. This ensures proper permeation of steam under the proper conditions that makes the item sterile. Loading the Sterilizer - Bundles and instruments trays are loaded correctly as per manufacturer’s instructions as per weight air flow and size (see image below). Module 1: Sterilization A receipt indicating the pressure, temperature and the total time of the sterilization process is printed and kept as records in MDRD (see image below). Sterilization is complete when all of the microorganisms including spores have been killed. This is what ensures “sterility”. A biological indicator provides confirmation that this has occurred in the sterilizer. The sterilizer is tested daily with a biological indicator in most CPDs. Drying / Cooling - Drying and cooling is an essential part of the process. Hot moisture inside the packs will condense and can possibly leak out of the sterile packages onto the unsterile counter top surfaces and cause contamination. This would be referred to as “wet packs.” This would make the product “unsterile.” Packs dry for at least 15-20 minutes. This is all part of the process within the Autoclave Packs must cool for anywhere between 30-60 minutes, with some variance on open racks to ensure cooling occurs without condensation resulting. Storing Instrument Packs and Trays – Storage provided within MDRD, as sterile supplies are not just specific to the OR. Specific surgical trays are sometimes stored in the Central Corridor of the OR. Quality control monitors the process and can track trays for inventory purposes and maintenance. Module 1: Sterilization  Steam Sterilization Steam sterilization or autoclaving involves the application of steam under pressure. Steam sterilization is the oldest, safest, and the most economical. It is the preferred method for items that are not moisture and heat sensitive. The high pressure ensures that all surgical packages are fully saturated (100% wet). There are three important factors to consider with steam sterilization. They are moisture, heat/temperature and time. High Temperature is required for the destruction of the microorganisms. The pressure allows the temperature to be reached within a certain period of time. The higher the pressure the quicker the temperature will increase. It is this combination that makes the process effective. There are five phases in this process: 1. Packing and Loading the Sterilizer 2. Heating 3. Destroying 4. Cooling 5. Testing Types of Steam Sterilizers Pre-Vac High vacuum (Bowie Dick Test daily) Gravity Displacement (Bowie Dick Test daily) Steam Flash Sterilizer (Bowie Dick Test daily) Module 1: Sterilization  Immediate Use Steam Sterilizing (Flash Sterilization) – “Flashing” or “just in time sterilization” is not supported by ORNAC and should be used as a last resort when an instrument has dropped or is needed in an urgent situation. It must be used immediately. A sterilization indicator must still be used that is specific to the flash sterilizer. Flashing wrapped items and implants is contraindicated. Daily leak testing (Bowie Dick Leak Test) is also done on this steam auto clave, similar to the Steam Sterilizers in MDRD. Before placing item into the Sterilizer in the Operating Room - The instrument must be prepared as per manufacturer’s instructions. This includes: decontaminating and cleaning the instrument, assembling, inspection, adding chemical indicator, loading into appropriate closed container suitable for “flash sterilizer”, transferring it from the sterilizer to the sterile field in an aseptic manner. The instrument comes out moist as there is not a drying cycle in this type of auto clave and the instrument is extremely hot to handle. Oven mitts are required to deliver the instrument tray from the sterilizer to the OR Table. As per CSA standards an incident report must be completed, in addition to placing the autoclave print out in the patient’s OR record. Chemical Sterilization Methods and Disinfection Chemical Sterilization is used for materials that are delicate and heat sensitive. It is sometimes referred to as cold or low temperature sterilization - maximum temperature is 54-60 degrees Celsius (130-140 degrees Fahrenheit) versus steam at 121-132C (250-270F). Types of Chemical Sterilizers 1. Ethylene oxide (EO)- used to sterilize items that are heat-sensitive. It is a chemical agent that kills microorganisms, including spores. Materials must be aerated after sterilization. EO is no longer in use in many hospitals as it poses a great environmental hazard. Gas Plasma Sterilization - Low-Temperature Hydrogen Peroxide Gas Plasma Sterilization (STERRAD*) requires Hydrogen Peroxide to make a plasma “cloud” around the items to sterilize. It uses lower temperatures than steam. This sterilant is non- toxic and has to a large extent replaced EO gas. Module 1: Sterilization 2. Liquid Chemosterilizers - Peracetic acid (Steris (see photo)) is used to sterilize endoscopes, including bronchoscopes and cystoscopes. The scopes must be used within 1-2 hours of sterilization. They come out “wet” and must be aseptically dried before using. 3. Irradiation – uses gamma rays to sterilize disposable products by companies outside of the hospital, such as gloves and sutures. Items are sterile indefinitely, as long as the wrapper is not torn. High Level Disinfection These disinfectants play a key role in the processing of semi critical medical devices. The disinfectant is a Gluteraldahyde solution that acts as a chemical sterilant. Remember disinfection kills all microorganisms with the exception of spores. This type of sterilant is used on endoscopes. They are prewashed in a processing room, lumens are flushed and then submersed in the solution, processed and rinsed. The fumes are very toxic and a ventilation hood is used over the disinfection washers. They come out wet and are kept in a cupboard for same day use. Prions Creutzfeldt - Jakob Disease (CJD) (Alexander p. 60 - 62) Refer to ORNAC 2021 for procedural protocol - Page 2-17 – 2-18 Prions are a unique class of a protein-based organism with no detectable DNA or RNA. CJD is an infectious, debilitating and fatal neurological disease of the CNS based on this prion. The incubating period is months to years to decades. This prion/protein is highly resistant to conventional sterilization methods. The only positive diagnosis is by a brain tissue sample. Transmission may occur from exposure to tissue or body fluids of an infected person, instrument, or equipment that is contaminated with prions. MDRD will adhere to the Public Health Agency of Canada’s Classic Creutzfeldt-Jakob disease in Canada Reference guide for specific protocols for cleaning and reprocessing non-disposable instruments. Module 1: Sterilization