Sterilization Quality Assurance Control PDF

Sterilization Quality Assurance Control Unit 5 : Quality of Machine Washers Sterilization Indicators Dr. Ibrahim Essa phD. Health Administration / Strategic Planning At the End of this unit the students w...

Sterilization Quality Assurance Control Unit 5 : Quality of Machine Washers Sterilization Indicators Dr. Ibrahim Essa phD. Health Administration / Strategic Planning At the End of this unit the students will be able to: 1.Describe the monitoring process of the cleaning Efficiency of Washer-Disinfector 2. Describe the methods of sterilization monitoring ( mechanical indicators, chemical indicators and biological indicators) 3. Describe the sterilizer maintenance Dr. Ibrahim Essa phD. Health Administration Strategic Planning  CLEANING AREA HERE THE INSTRUMENTS ARE WASHED EITHER MANUALLY OR IN MACHINES. FOR MANUAL WASHING, SINKS WITH WATER SUPPLY AND WORKING COUNTERS ARE ORGANIZED. DETERGENTS AND BRUSHES OF VARIOUS SIZES AND SHAPES ARE REQUIRED IN THIS AREA. Washer-Disinfectors IS A MACHINE USED FOR CLEANING SURGICAL INSTRUMENTS. Dr. Ibrahim Essa phD. Health Administration Strategic Planning  CLEANING Cleaning is the first and most important step in the medical device (MD) reprocessing process. and sterilization can never be achieved without a complete cleaning. Cleaning of every material that is used in the hospital should be carried out prior to the disinfection or sterilization process. The purpose of the cleaning process is to remove as far as possible all soils from the MDs regardless of the chemical nature or volume of soils. Dr. Ibrahim Essa phD. Health Administration Strategic Planning  Cleaning process monitoring In order to prove the efficiency of the cleaning process a validation shall be carried out. Validation means that the process 1. has to be effective and 2. must not change unnoticed later on during daily use, that means, it has to work reproducibly. Therefore in automatic cleaning processes all parameters must be monitored to secure the reproducibility in washer/disinfectors (WDs). The parameters must not change unnoticed. Dr. Ibrahim Essa phD. Health Administration Strategic Planning  Monitoring of the Cleaning Efficiency of Washer-Disinfectors In order to determine the Cleaning Efficiency of Washer-Disinfectors a number of tests were employed. These tests included: visual test; soil test; residual protein test Dr. Ibrahim Essa phD. Health Administration Strategic Planning  Washer - disinfector Dr. Ibrahim Essa phD. Health Administration Strategic Planning  Monitoring of the Cleaning Efficiency of Washer-Disinfectors 1. Soil test:  OSI tests were used in all cycles tested. The test devices are smeared with dried blood or synthetic products that simulate blood, which is more difficult to clean than environmental dirt.  A soil test is considered a pass if no soil remains visible on the test device. The TOSI (Test Object Surgical Instrument) Dr. Ibrahim Essa phD. Health Administration Strategic Planning Soil on instruments after cleaning Soil on instruments before cleaning  Monitoring of the Cleaning Efficiency of Washer-Disinfectors 2. Visual test: The instruments were visually tested for soil using magnification under a microscope. 3. Protein test: Residual protein can be left on instruments , which makes sterilizing the instruments more difficult, as the protein stops the steam condensing on the instruments Dr. Ibrahim Essa phD. Health Administration Strategic Planning  STERILIZATION It is a process of freeing an article from all living organisms including bacteria ,fungal spores and viruses. A material is pronounced sterile if it achieves 99.99% kill of bacterial spores. Dr. Ibrahim Essa phD. Health Administration Strategic Planning  TYPES OF STERILIZATION Dry Heat  Steam High Pressure-Autoclaves operated by Gas, K.oil or Electricity (Flash, Pulse)  Ethylene Oxide Sterilization.  Chemical Sterilization.  Radiation Sterilization. Infra Red Radiation – Syringes  Ultra Violet Radiation – Decontamination of Air  Ionizing Radiation / Gamma Radiation Dr. Ibrahim Essa phD. Health Administration Strategic Planning Dr. Ibrahim Essa phD. Health Administration Strategic Planning  Sterilization Process Monitors STERILIZATION INDICATORS When monitoring any sterilization process, there are several indicators we rely on to assure that sterile products will be delivered to the operating room. Mechanical indicators are the digital readings on the sterilizer, print-out, alarms, etc.. that provide the first indication that everything is cool or that there is a problem. Dr. Ibrahim Essa phD. Health Administration Strategic Planning  Sterilization Process Monitors STERILIZATION INDICATORS Mechanical Monitors: Devices that record time, temperature & pressure.  Sterilization Process Monitors STERILIZATION INDICATORS Chemical Indicators: These are more practical means & detect problems immediately. The CDC & all major U.S organizations standards & guidelines advocate that a chemical indicator be attached to every package that goes through a sterilization cycle & within each package to be sterilized in what is expected to be the most difficult-to-sterilize location. These are divided into 6 classes, higher the class, more sensitive the indicator Class -1 These are Internal & External Process Indicator These inform that item has been exposed to sterilization process. E.g. External Process Indicator – Autoclave Tape.  Sterilization Process Monitors STERILIZATION INDICATORS Class 2 E.g. Bowie-Dick test for vacuum steam sterilizer. They only access Vacuum Pump efficiency & detect the presence of air leaks &/or gases in steam. Class 3 E.g. Temperature Tube. Contains chemicals that melts & sometimes changes color when the appropriate temp is attained. Class 4 Respond to one or more sterilization parameters. Contains Ink that changes color when exposed to correct combination of sterilization parameters. Dr. Ibrahim Essa phD. Health Administration Strategic Planning  Sterilization Process Monitors STERILIZATION INDICATORS Class 5 Known as Integrating Indicators or Integrators Respond to all parameters of sterilization over a specified range of temperatures. Class 6 These are emulating indicators. These are designed to react to all critical parameters over a specified range of sterilization cycles for which the stated values are based on the settings of the selected sterilization cycles Dr. Ibrahim Essa phD. Health Administration Strategic Planning  Sterilization Process Monitors STERILIZATION INDICATORS Biological Indicators:  They are standardized preparation of spores.  A positive biological indicator is indicative of possible sterilization process failure.  They should be used at least once a week but Time needed for incubation is long.  E.g. spores of Bacillus Sterothermophilus. Biological indicators are used to verify the microbial killing power of the sterilization process. Dr. Ibrahim Essa phD. Health Administration Strategic Planning  Sterilization Process Monitors Methods of Monitoring/ STERILIZATION INDICATORS 1. Mechanical Indicators - Equipment control 2. Chemical Indicators - Exposure/Process control - Pack control 3. Biological Indicators - Load control Dr. Ibrahim Essa phD. Health Administration Strategic Planning  Sterilization Process Monitors Mechanical Indicators Equipment control consists of monitoring sterilizers prior to and during daily use to determine if the sterilizer is operating to the set conditions of time, temperature, pressure, air removal, moisture conditioning and sterilant exposure. These are your mechanical indicators and are a permanent part of the sterilizer. They indicate what is happening in the sterilizer from moment to moment. They do not tell you what is happening in the load only that the sterilization equipment is functioning or not. They tell you whether or not the conditions for sterilization are being met. Dr. Ibrahim Essa phD. Health Administration Strategic Planning  Sterilization Process Monitors Mechanical Indicators Mechanical techniques for monitoring sterilization include assessing the cycle time, temperature, and pressure of sterilization equipment by observing the gauges or displays on the sterilizer. Some tabletop sterilizers have recording devices that print out these parameters. Correct readings do not ensure sterilization, but incorrect readings could be the first indication that a problem has occurred with the sterilization cycle. Dr. Ibrahim Essa phD. Health Administration Strategic Planning Sterilization Process Monitors Mechanical Indicators Mechanical Indicators show:  what is happening in the chamber  whether conditions are being met  cycle, time, temperature and pressure Dr. Ibrahim Essa phD. Health Administration Strategic Planning  Sterilization Process Monitors Chemical Indicators Chemical Indicators :  monitor one or more of requirements -time, temp, and sterilant  can be external and Internal  give instant results  indicate proper conditions for sterilization were present Dr. Ibrahim Essa phD. Health Administration Strategic Planning  Sterilization Process Monitors Chemical indicators Chemical indicators, internal and external, use sensitive chemicals to assess physical conditions such as temperature during the sterilization process. Dr. Ibrahim Essa phD. Health Administration Strategic Planning  Sterilization Process Monitors External Chemical Indicator/ Exposure Control External Chemical Indicator: Exposure Control process indicator - autoclave tape distinguishes processed from unprocessed medical devices secures pack labels pack If indicator did not change, do not use Dr. Ibrahim Essa phD. Health Administration Strategic Planning  Sterilization Process Monitors External Chemical Indicator/ Exposure Control Provides a way to distinguish processed from unprocessed medical devices without opening the packages. For example, steam autoclave tape placed on the outside of a package. All recommended practices state that an external chemical indicator should be printed or affixed on each package except if the internal CI is visible from the outside. Peel pouches usually have the external indicator built in to the packaging. Double pouching does not make the external indicator an internal indicator. External indicators is a safeguard against distribution of items that have not been sterilized. Dr. Ibrahim Essa phD. Health Administration Strategic Planning Dr. Ibrahim Essa phD. Health Administration Strategic Planning  Sterilization Process Monitors Internal Chemical Indicator/ Pack Control Internal Chemical Indicator Pack Control  inside each package, tray or container  paper strips or cards  validates sterilant penetration  color change strip or moving front format  can measure all process parameters (Integrators) Dr. Ibrahim Essa phD. Health Administration Strategic Planning  Sterilization Process Monitors Internal Chemical Indicator/ Pack Control Pack control is the monitoring and issuing of packs for use based on the readout of the chemical indicator inside the package. Chemical indicator can be multi-parameter or integrating. The CSA standards indicate that an internal indicator be placed inside all packages. Dr. Ibrahim Essa phD. Health Administration Strategic Planning Dr. Ibrahim Essa phD. Health Administration Strategic Planning  Chemical Indicators Bowie-Dick Test Uniform color change If not uniform, shut down and report to supervisor Remain in use Retest Call for repair Re-qualify if major repair Bowie-Dick Test Uniform color change – Use Not uniform color change (e.g., center of test sheet paler or a different color than the edges) – report to supervisor who will decide to use sterilizer, retest, or call for repair. Re-qualify if major repair Dr. Ibrahim Essa phD. Health Administration Strategic Planning  Chemical Indicators Bowie-Dick Test Bowie-Dick test: Used for high-vacuum autoclaves, Done every day: – In the middle of a test pack of towel, a paper on to which a strip of a specific tape is put, for testing. – Uniform development of dark color indicates that the steam has passed freely and rapidly to the center of the load. Dr. Ibrahim Essa phD. Health Administration Strategic Planning  Chemical Indicators Bowie-Dick Test Bowie-Dick tests can detect: Air leaks Inadequate air removal Inadequate steam penetration Presence of non-condensable gases: air or gases from boiler additives Used for routine daily testing and qualification testing Dr. Ibrahim Essa phD. Health Administration Strategic Planning Sterilization Process Monitors Biological Indicators/Load Control Biological Indicators Load Control  Confirm the ability of the sterilization process to kill microbial spores  large number of spores  Integrate all the parameters of the sterilization process  Most critical test of the sterilization process Dr. Ibrahim Essa phD. Health Administration Strategic Planning  Sterilization Process Monitors Biological Indicators/Load Control Load control or biological indicator monitoring is the foundation of a successful sterilization process monitoring program. Load is processed and released based on the result of the BI in a test pack. At present, the BI is the best means at our disposal to confirm the sterility of an article or to determine the efficiency of a sterilization process. True sterility testing is destructive and would require opening in the package, culturing onto growth medium and then waiting for microorganisms to grow. Dr. Ibrahim Essa phD. Health Administration Strategic Planning  Sterilization Process Monitors Biological Indicators/Load Control Biological indicators (BIs) are the most accepted means of monitoring the sterilization process because they directly determine whether the most resistant microorganisms (e.g., Geobacillus or Bacillus species) are present rather than merely determine whether the physical and chemical conditions necessary for sterilization are met. Correct functioning of sterilization cycles should be verified for each sterilizer by the periodic (at least weekly) use of BIs. Dr. Ibrahim Essa phD. Health Administration Strategic Planning  Sterilization Process Monitors Biological Indicators/Load Control A biological indicator (BI) is the only type of monitor that provides direct evidence that sterilization process conditions are sufficient to kill spores. It uses microbes that are highly resistant to the type of sterilization process you are monitoring. BIs are considered the "gold standard" of load sterilization monitoring. They are widely recommended as the preferred device for monitoring and releasing loads. Dr. Ibrahim Essa phD. Health Administration Strategic Planning  Sterilization Process Monitors Biological Indicators/Load Control Biological sterilization indicators: Spores of a non-pathogenic organism: Done weekly – They are killed at 121°C after 15 minutes. – Attempts to culture them is subsequently made Dr. Ibrahim Essa phD. Health Administration Strategic Planning  Sterilization Process Monitors Biological Indicators/Load Control Positive BIs: If any of the processed BIs culture positive (show spore growth), then that means the sterilizer is suspect and the following actions should be taken: 1. Report results to supervisor 2. Recall and re-sterilize all "suspected non- sterile" items Dr. Ibrahim Essa phD. Health Administration Strategic Planning  Sterilization Process Monitors Biological Indicators/Load Control 3. Verify spore growth via gram stain 4. Determine cause of failure and correct 5. Retest sterilizer before using again Association for the Advancement of Medical Instrumentation (AAMI) guidelines state: "Until the results of retesting are satisfactory, the performance of the sterilizer must be considered in question." Dr. Ibrahim Essa phD. Health Administration Strategic Planning Load Control Products Dr. Ibrahim Essa phD. Health Administration Strategic Planning  Sterilization Process Monitors Types of Detect controls Physical Mechanical indicators operation Sterilization Chemical Tº; steam; Control indicators exposure time Destruction of Microbiological microorganisms indicators and spores  Sterilizer Maintenance According to AAMI guidelines, all sterilization equipment must receive periodic and routine maintenance to ensure accurate and reliable operations. Dr. Ibrahim Essa phD. Health Administration Strategic Planning  Sterilizer Maintenance The following maintenance procedures are considered the fourth management tool:  Routine Maintenance - daily inspections and cleaning in accordance with the manufacturer's recommendations. This generally includes the cleaning of gaskets, chart pens, chamber drain screens and internal/external surfaces.  Preventive Maintenance - periodic preventive maintenance in accordance with the manufacturer's instructions. Dr. Ibrahim Essa phD. Health Administration Strategic Planning  Sterilizer Maintenance  Scheduled Maintenance : this level of maintenance should include lubrication of appropriate parts and replacement of expendable parts, i.e. steam traps.  Calibration: periodic calibration of items such as pressure and temperature gauges, timers, recording and control devices must be carried out by qualified personnel as specified in the manufacturer's instruction manual. Dr. Ibrahim Essa phD. Health Administration Strategic Planning Dr. Ibrahim Essa phD. Health Administration Strategic Planning