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  2. 2. What is Sterilization??  Sterilization is the process used to render a product free from all forms of viable micro-organisms (bacteria, spores, fungi, and viruses)  Sterilization is required because not all micro-organisms have been completely destroyed during the decontamination process.  Within the SPD, the sterilization area is where sterilizers (steam, and/or low temperature processes), are located including the space for loading, unloading, and cooling. This can be accommodated by a two or three zone system. Variables that affect sterilization are: The dryness of devices to be processed The temperature and humidity of the processing area Whether or not the devices were properly prepared and loaded into the sterilizer Whether or not the sterilant is properly delivered into the system The sterilizer’s condition and maintenance protocol Whether or not the correct sterilization method and cycle were used 1/22 STERILIZATION:PROCESS&MANAGEMENTT SPEAKER: ATAULLA KHAN
  3. 3. 2/22 Types of sterilization Sterilization falls into the following three categories: A. High temperature/pressure sterilization (autoclave) B. Chemical sterilization C. Radiation sterilization STERILIZATION:PROCESS&MANAGEMENTT SPEAKER: ATAULLA KHAN
  4. 4. 3/22 Steam autoclave is the oldest, safest, and most cost effective method of sterilization in the medical equipment industry.  The steam reaches 121-148°C  The pressure chamber at 15 PSL.  The sterilization period is 10-60 minutes. When steam enters the sterilization chamber under pressure; It condenses upon contact with cold items. This condensation frees heat, simultaneously heating and wetting all items in the load, thus providing heat and moisture. A. Steam Autoclave Application: Used mostly for surgical Instruments. Not well suited for heat sensitive materials and instruments. STERILIZATION:PROCESS&MANAGEMENTT SPEAKER: ATAULLA KHAN
  5. 5. Low Temperature Hydrogen Peroxide Plasma  It is a low temperature, non-toxic, but fairly expensive sterilization method.  Hydrogen peroxide is activated to create a reactive plasma or vapor.  Temperature range from 45-50°C.  Operating cycle times range from 45-70 minutes. Best suited to sterilize heat sensitive medical equipment such as endoscopic equipment. 4/22 Ethylene Oxide Gas:  It is an effective, low temperature chemical sterilization method.  Temperatures reached are usually in the 50-60°C range.  It takes longer than steam sterilization, typically, 16-18 hours. Used to sterilize items that are heat or moisture sensitive. B. Chemical Sterilization STERILIZATION:PROCESS&MANAGEMENTT SPEAKER: ATAULLA KHAN
  6. 6. 5/22 C. Radiation Sterilization VHP, (Vaporized Hydrogen Peroxide):  it only uses hydrogen peroxide in vaporized form for sterilization.  In the VHP process, hydrogen peroxide vapour is injected into the chamber via a series of pulses to sterilize packaged medical and diagnostic devices.  The cycle time is 2 hours.  The operating temperature ranges from 30-40°C. A. E-Beam Radiation E-beam generator delivers a high dose of electrons in a narrow beam at the items to be sterilized. B. X-Ray Sterilization This is the process that is based on obtaining X-rays through conversion of electron beams. X-rays offer excellent product penetration in sterilization, thoroughly treating the surface and interior of a product. STERILIZATION:PROCESS&MANAGEMENTT SPEAKER: ATAULLA KHAN
  7. 7. 6/22 A. Gamma, Beta Sterilization  The product to be sterilized is exposed to radiation for 10 to 20 hours, depending on the strength of the source. The highest temperatures reached in gamma sterilization are usually 30-40°C. The result is ionic energy that becomes converted to thermal and chemical energy. This energy kills microorganisms by disruption of the DNA molecule, therefore preventing cellular division and propagation of biologic life. STERILIZATION:PROCESS&MANAGEMENTT SPEAKER: ATAULLA KHAN
  8. 8. 7/22 The sterile processing department (SPD)… THEY DIVIDE EACH OF THE CLEANING STAGES INTO SEPARATE ZONES Decontamination Prep and Pack Sterilization  The SPD is the department within a healthcare facility that processes and controls medical supplies, devices, and equipment, for patient care areas of the facility.  The SPD plays an integral role within a healthcare facility by providing sterile surgical instrumentation to the OR as well as all other areas that require sterile goods. STERILIZATION:PROCESS&MANAGEMENTT SPEAKER: MOHAMMAD ZUBAIR
  9. 9. 8/22 Decontamination Prep and Pack Sterilization Soiled Return Sterile Storage STERILIZATION:PROCESS&MANAGEMENTT SPEAKER: MOHAMMAD ZUBAIR
  11. 11. 10/22 What is the Decontamination Process?? The use of physical or chemical means to remove, inactivate or destroy blood borne pathogens on a surface or item to the point where they are no longer capable of transmitting infectious particles and the surface or item is safe for handling, use or disposal. STERILIZATION:PROCESS&MANAGEMENTT SPEAKER: MOHAMMAD ZUBAIR
  13. 13. 12/22 Decontamination Cleaning & Drying Automated Cleaning Manual Cleaning The washer disinfector renders its load, i.e. safe to handle. No automated disinfection of instruments and utensils, increases the risk of contaminations and infections. Disinfection and cleaning of noncritical goods prevents hospital acquired infections. Contamination risk for staff due to exposure to soil and liquids. Staff safety-cleaning process takes place in a closed chamber which means no risk for splashes and thereby contamination. Wet goods may cause re- contamination Correct drying after cleaning can easily be arranged and integrated into the process. STERILIZATION:PROCESS&MANAGEMENTT SPEAKER: MOHAMMAD ZUBAIR
  14. 14. 13/22 This area as being the ‘clean room’ Where- -Instrument sets and trays are assembled, -wrapped -and placed into the sterilizers correctly Prep & Pack? STERILIZATION:PROCESS&MANAGEMENTT SPEAKER: MOHAMMAD ZUBAIR
  16. 16. It is the instrumentation and equipment warehouse. If a product is disinfected and/or sterilized it will have a home in this department or in another sterile storage location. Like a warehouse, orders are packed and sent to other locations for use on specific patients undergoing specific procedures. Sterile storage 15/22 STERILIZATION:PROCESS&MANAGEMENTT SPEAKER: MOHAMMAD ZUBAIR
  17. 17. Sink modules are used for- -manual soaking -hand washing -and rinsing of instrumentation. The sink may include- -a main and treated water faucet -a spray rinser, -air gun -and tubular manifold. Material comes to the SPD decontamination room via a “Dirty Elevator” or door way. First area for processing is the SSS. Usually there are three sinks. The first sink is filled with water and an enzymatic cleaner. Here the surgical items are allowed to soak. The second sink is used for washing and scrubbing of the surgical devices and instruments. The third basin is the rinse sink… Stainless Steel Sink Module 16/22 STERILIZATION:PROCESS&MANAGEMENTT SPEAKER: ATAULLA KHAN
  18. 18. These are used for instruments that are- -heavily covered in bio burden or -have hard to clean surfaces. -This machine creates vibration or cavitations waves that shear soils from instruments. Ultrasonic Cleaner Instruments are submersed in a liquid detergent bath. The passage of Ultrasonic waves cause cavitations (vibration). The vibrations create mechanical energy which removes debris from the surfaces. The detergent traps the loose debris from settling on the instruments. 17/22 STERILIZATION:PROCESS&MANAGEMENTT SPEAKER: ATAULLA KHAN
  19. 19. The washer-disinfectors effectively cleans- -thermally disinfects, -and dries moisture From- -temperature stable utensils, -surgical instruments, -anesthesia materials -and glassware prior to any necessary sterilization. water boils at 212 degrees F . when it boil it means water is turning into steam. At these extreme temperatures most organic organism will meet their demise. Washer Disinfector Accomplish 18/22 STERILIZATION:PROCESS&MANAGEMENTT SPEAKER: ATAULLA KHAN
  20. 20. The sterilizing agent can be steam, plasma, ozone, EO Gas, or other low temperature solutions. Sterilizer Achieve Sterilizers kill the remaining microbial life left on surgical instruments. How do we know if the sterilizer is killing microbial life? Biological indicators monitor the effectiveness of the steam sterilization process.  Sterilizers work by using steam that is forced through valves, channels, chambers, and drains. 19/22 STERILIZATION:PROCESS&MANAGEMENTT SPEAKER: ATAULLA KHAN
  21. 21. Sterilization planning  Sterilizers generate intense heat. Due to these conditions architects and hospitals must make sure the adequate space is giving for cooling of the cart and wrapped instrument trays. 20/22 STERILIZATION:PROCESS&MANAGEMENTT SPEAKER: ATAULLA KHAN
  22. 22. Improved ergonomics Improved throughput Efficient staging of loads to be processed Reduction of labor time Less handling of heavy and hot (temperature) loads Reduction of amount of loading equipment required Benefits of Automation 21/22 STERILIZATION:PROCESS&MANAGEMENTT SPEAKER: ATAULLA KHAN
  23. 23. Sterilization: A review of the basics, By Gayla Tilton and Myrna Kauffman Medical sterilization methods, By mehul patel, Design engineer, Lemo usa, inc. to-kill-superbugs-that-cause-infections/ Bibliography: 22/22 STERILIZATION:PROCESS&MANAGEMENTT Thank You!For listening, joining and cooperating us… SPEAKER: ATAULLA KHAN