Ozone Sterilization

1. BM 500 HOSPITAL CLINICAL ENGR. & MANAGEMENT Ozone Sterilization

2. Content • What is sterilization? • Types of sterilization • The Ozone molecule • Ozone sterilization • Standarts for ozone sterilization • Ozone sterilization equipments BM 500

3. What is sterilization? • A process intended to remove or destroy all viable forms of microbial life, including bacterial spores. • Different than Disinfection. It is less lethal process than sterilization because it destroys most recognized pathogenic microorganisms, but not necessarily all microbial forms such as bacterial spores • Sterilizer: An agent that destroys or eliminates all forms of microbial life in the inanimate environment, including all forms of vegetative bacteria, bacterial spores, fungi, fungal spores, and viruses BM 500

4. Sterilization? • Sterile: absence of all living organisms, particularly microorganisms: • bacteria • yeasts • molds • viruses • Presence of even bacterium renders the component nonsterile • Do not be fooled by the looks: a shiny stainless steel could be nonsterile whereas a rusty nail could be sterile BM 500

5. What is sterilization? • The Sterile Processing Department (Central Supply, or Sterile Supply as it is also known), comprises that service within the hospital in which medical/surgical supplies and equipment, both sterile and nonsterile, are cleaned, prepared, processed, stored, and issued for patient care. • As the number and variety of surgical procedures grew and the types of medical devices, equipment, and supplies proliferated, it became apparent that a centralized processing was needed for efficiency, economy, and patient safety. BM 500

6. Sterilization • 4 Major areas to accomplish the functions: decontamination, assembly and sterile processing, sterile storage, and distribution. • decontamination area, reusable equipment, instruments, and supplies are cleaned and decontaminated by means of manual or mechanical cleaning processes and chemical disinfection. • Clean items are received in the assembly and packaging area from the decontamination area and are then assembled and prepared for issue, storage, or further processing • After assembly or sterilization, items are transferred to the sterile storage area until its time for them to be issued. • Several major functions are carried out in the distribution area: case cart preparation and delivery; exchange cart inventory, replenishment and delivery; telephone-order and requisition-order filling; and, sometimes, patient care equipment delivery. BM 500

7. The Decontamination Process • The Decontamination Process: Used supplies and equipment should be collected and taken to the Decontamination Area in the Sterile Processing Department in a way that avoids contamination of personnel or any area of the hospital. Equipment should be covered and supplies should be moved in covered carts, closed totes or containers, or closed plastic bags. • Attire:Personnel working in the decontamination area should wear protective clothing, which includes a scrub uniform covered by a moisture-resistant barrier, shoe covers, rubber or plastic gloves, and a hair covering. During manual cleaning processes, when splashing can occur, safety goggles and a face mask should be worn. • Sorting:sorting begins at the point of use. Handling of contaminated items should be minimized unless the user of the device is already wearing full personal protective attire, such as following care in the operating room. In areas where workers are wearing no or minimal protective attire, sorting should consist only of removing disposable sharps and discarding other single-use items. BM 500

8. The Decontamination Process • Soaking this is necessary only if you have lumens or other complex designs that are filled with debris or if the devices are very bloody and cannot be rinsed or wiped at the point of use. • Washing detergent - should be compatible with the materials in the device and suited for the type of soil. Consult the recommendations from the device manufacturer • Inspectionafter cleaning, all instruments should undergo inspection before being packaged for reuse or storage. Box locks, serrations, and crevices should be critically inspected for cleanliness Instruments with cutting edges such as scissors, rongeurs, chisels, curettes, etc., should be checked for sharpness. There should be no dull spots, chips, or dents. BM 500

9. The Assembly and Packaging Process • After the instruments have been cleaned and inspected, they are typically assembled into sets or trays according to recipe cards that detail instructions for assembling each set or tray. • Instruments and other items that are prepared for sterilization must be packaged so that their sterility can be maintained to the point of use. The materials and techniques used for packaging must allow the sterilant to contact the device during the sterilization process as well as to protect the device from contamination during storage and handling before it is used. The time between sterilization and use may range from a few minutes to several weeks to many months. The packaging material selected must also permit the device to be removed aseptically. Rigid container systems Textiles Nonwowens Pouch packaging

10. Types of Sterilization • Steam • Ethylene Oxide • Dry Heat • Microwaves • Formaldehyde Gas • Hydrogen Peroxide Plasma • Ozone Gas • Lonizing Radiation BM 500

11. The Ozone Molecule • Ozone or trioxygen (O3) is a triatomic molecule, consisting of three oxygen atoms. It is an allotrope of oxygen that is much less stable than the diatomic O2. Ground-level ozone is an air pollutant with harmful effects on the respiratory systems of animals. The ozone layer in the upper atmosphere filters potentially damaging ultraviolet ligth from reaching the Earth's surface. • Most people can detect about 0.01 ppm in air. Exposure of 0.1 to 1 ppm produces headaches, burning eyes, and irritation to the respiratory passages. • At -112 °C, it forms a dark blue liquid. At temperatures below -193 °C, it forms a violet-black solid. • Ozone is diamagnetic, meaning that it will resist formation of a magnetic field and will decrease the energy stored in the field once the field is established. BM 500

12. The Ozone Molecule BM 500

13. Ozone Sterilization • The method of generation • generated on-site • generated by passing dry air (or oxygen) through high voltage electrodes (ozone generator) • bubbled into the water to be treated. • Ozone • colorless gas • relatively unstable • highly reactive • reacts with itself and with OH- in water BM 500

14. Ozone Sterilization • Generation of Ozone BM 500

15. Ozone Sterilization • Flow Diagram BM 500

16. Principles of Ozone Formation • A high voltage is applied between two concentrically arranged electrodes. The electrodes are separated from each other by a dielectric and two discharge chambers, through which gas flows. Some of the oxygen molecules in the input gas break down in the electric field and immediately attach themselves to free oxygen molecules, forming ozone. BM 500

17. Ozone Formation BM 500

18. Ozone Sterilization • Because ozone is very reactive, it is also unstable. It cannot therefore be stored and has to be produced where and when it is needed. Ozone is produced from oxygen-containing gases in ozone generators by means of a silent electrical discharge. All industrial-scale ozone generators make use of this method. • The effectiveness of the ozone generation is related to a number of factors. Depending on the input gas, the strength of the electric field, cooling and the design of the ozone generator, ozone yields of 1 to 16 percent by weight can be achieved in the production gas. BM 500

19. Ozone Reactivity BM 500

20. Ozone Effectiveness BM 500

21. Advantages and Disadvantages • Advantages • Highly effective against all type of microbes • Disadvantages • Unstable (must be produced on-site) • High toxicity • High chemical hazards • Highly sensitive to inorganic and organic loads • Formation of harmful disinfection by-products (DBP’s) • Highly complicated maintenance and operation • Very expensive MIS 524

22. Advantages and Disadvantages • Advantages • Highly effective against all type of microbes • Used for moisture and heat-sensitive items. • Ozone generated from Oxygen and water • No aeration because no toxic by-producs • Disadvantages • Unstable (must be produced on-site) • High toxicity • High chemical hazards • Highly sensitive to inorganic and organic loads • Formation of harmful disinfection by-products (DBP’s) • Highly complicated maintenance and operation • Very expensive BM 500

23. Sample Sterizers • In 2002, TSO3 Inc., licensed ozone gasrelated sterilization technology from Lynntech. The 125 L - Ozone Sterilizer developed by TSO3 Inc., is marketed to hospital sterilization centers. This device was approved for marketing by Health Canada in May 2002 and received FDA approval in September 2003. The sterilizer is sold in the US through Skytron. MIS 524

24. Sample Sterizers The ozone is killing any bacteria, viruses or mold spores that it contacts. With a half life of approximately 20 minutes, ozone then reverts back to pure oxygen. MIS 524

25. Advantages and Disadvantages • In 2002, TSO3 Inc., licensed ozone gasrelated sterilization technology from Lynntech. The 125 L - Ozone Sterilizer developed by TSO3 Inc., is marketed to hospital sterilization centers. This device was approved for marketing by Health Canada in May 2002 and received FDA approval in September 2003. The sterilizer is sold in the US through Skytron. MIS 524

26. Other Applications • Industrial applications • aquaria, fish disease labs, and aquaculture • cooling towers • pharmaceuticals and integrated circuit processing (ultra-pure water) • pulp and paper industry • Gaseous sterilization • cleaning and disinfection of healthcare textiles BM 500