CONTENTS Section Title 2 Disinfection, Packaging and Sterilization 3 Validation of Sterilization (Physical, Chemical and Biological) 4 Sterilizer Requalification 5 Sterile Package Shelf Life 6 Acquisition of Supplies 7 Recall of Sterile Items Available 1
DOCUMENT TITLE: DISINFECTION, PACKAGING, AND STERILIZATION REFERENCE VERSION: 1.0 NUMBER: CSSD-002 EFFECTIVE DATE: 01 SEP 2017 2. Disinfection, Packaging and Sterilization. 2.1. Policy. 2.1.1. Dental instruments are classified into three categories depending on the risk of transmitting infection. The classifications of critical, semi-critical and noncritical are based on the following criteria: 2.1.1.1. Critical instruments are those used to penetrate soft tissue or bone, or enter into or contact the bloodstream or other normally sterile tissue. They should be sterilized after each use. 2.1.1.2. Semi-critical instruments are those that do not penetrate soft tissues or bone but contact mucous membranes or non-intact skin, such as mirrors, reusable impression trays and amalgam condensers. These devices also should be sterilized after each use. 2.1.1.3. Non-critical instruments are those that come into contact only with intact skin such as external components of x-ray heads, blood pressure cuffs and pulse oximeters. Such devices have a relatively low risk of transmitting infection; and, therefore, may be reprocessed between patients by intermediate-level or low-level disinfection. 2.2. Procedures. 2.2.1. Disinfection of Environmental Surface. 2.2.1.1. At the completion of work activities, countertops and surfaces of the dental chair that may have become contaminated with blood or saliva should be wiped with absorbent toweling to remove extraneous organic material, and then disinfected with a suitable chemical germicide approved by the Organization and HAAD. 2.2.1.2. Caution should be exercised, since some disinfectant is corrosive to metals, especially aluminum. 2.2.2. Disinfection of Dental Instrument. 2.2.2.1. Before sterilization or high-level disinfection, instruments should be cleaned so that any debris is removed. 2.2.2.2. Hold instruments in solution to make them easier to clean later. 2.2.2.3. Use enzymatic or non-enzymatic pre-soak or cleaning solutions to facilitate instrument cleaning. 2.2.2.4. Do not use a sterilant/high-level disinfectant as a holding solution. (Glutaraldehydes can bind protein to surfaces.) 2.2.2.5. Do not soak in hypochlorite (bleach) or saline solutions as chloride ions corrode instruments. 2
2.2.2.6. Heavy duty gloves should be worn when handling and cleaning contaminated instruments. 2.2.2.7. Before sterilization, all items to be sterilized must be scrupulously cleaned to remove any debris. 2.2.2.8. Instrument cassettes and mechanical cleaning (e.g., ultrasonic cleaners) is also used to reduce direct handling of contaminated instruments. 2.2.2.9. Applying rust inhibitors is also recommended to protect instruments from corrosion that may result from sterilizing. 2.2.3. Packaging. 2.2.3.1. After thoroughly cleaning, drying and inspecting dental supplies, assemble them into sets or trays for wrapping or packaging. 2.2.3.2. Packaging materials should be held at room temperature (20 C to 23 C [68 F to 73 F]) and at a relative humidity ranging from 20% to 60% for a minimum of 2 hours. 2.2.3.3. All packaging materials, woven or nonwoven, should be examined regularly for defects and extraneous matter. Procedures for packaging techniques and should be consistent with the manufacturer s recommendations. 2.2.3.4. Double-wrapping is recommended for terminal sterilization in acute care settings, and double-wrapping may be prudent for some dental items depending upon strength and barrier requirements. 2.2.3.5. Some small individual items may be placed into peel pouches. Always place critical and semi-critical instruments that will not be used immediately into sterilization packaging. 2.2.3.6. It is not appropriate to re-use pouches or wraps that have been designated single-use. 2.2.4. Secure package with Sterilization Indicator Tape. 2.2.4.1. Securing a wrapped package with a sterilization indicator tape is mandatory. 2.2.4.2. Do not use tapes other than sterilization indicator tape. 2.2.4.3. Also do not use safety pins, paper clips, staples, or other sharp objects. 2.2.4.4. There are different indicator tapes available for use on different materials. 2.2.4.5. If you are using an SMS polypropylene wrap you may need to use a sterilization indicator tape specifically designed for this material, often referred to as: Steam Indicator Tape for Disposable Wraps and typically it is a bluish color (as opposed to a beige-tan). 2.2.5. Sterilization of Special Dental Devices. 2.2.5.1. All critical and semi-critical dental instruments that are heat stable should be sterilized after each use by Oven-type dry heat sterilizer. (Uses dry heat at 320 F for 1-2 hr). 2.2.5.2. Sterilization is recommended for all high-speed dental handpieces, lowspeed handpiece components used intraorally and reusable prophylaxis angles. 3
2.2.5.3. It is important to follow the manufacturers instructions for cleaning, lubrication and sterilization procedures to ensure the effectiveness of the sterilization process and the longevity of these instruments. 2.2.6. Sterilization of Dental Instrument. 2.2.6.1. Refer to the Appendix 2.3.1. Sterilization Table. 2.2.6.2. Any soiling, whether organic or inorganic debris left on devices, can prevent the sterilant from gaining access to the device surface beneath. Thus, if tissue, blood, mineral deposits, etc., are seen on the device after sterilization, the device must be considered non-sterile. 2.2.6.3. Load the sterilizer according to the manufacturer s instructions. Only use devices that are cleared by the HAAD for sterilization. Do not overload the chamber; sterilant must be able to contact all sides of the package. Place concave items downward so they will drain. 2.2.7. Unloading the Sterilizer. 2.2.7.1. The door may be opened slightly at the end of the cycle and the items left inside for a period of time in order to reduce the potential for condensation formation. 2.2.7.2. The time allowed for cooling should take into account the type of sterilizer being used, the design of the device being sterilized, the temperature and humidity of the ambient environment and the type of packaging used. 2.2.7.3. Avoid directly touching the items while they are hot. A minimum cooling time of 10 minutes is recommended. Check to be sure items or packs removed from the sterilizer are dry, cool and undamaged. 2.2.8. Storage. 2.2.8.1. Clean supplies and instruments should be stored in closed or covered cabinets, if possible. 2.2.8.2. Supplies and instruments should not be stored under sinks or other locations where they might become wet. 2.2.8.3. Be very careful that packages are stored correctly and not stacked several high or deposited into drawers and the drawer slammed shut. 2.2.8.4. In general, the temperature in the storage area should be between 18-22 C and the relative humidity should be between 30-60%. 2.2.9. Use. 2.2.9.1. Always thoroughly inspect sterile packages prior to use. 2.2.9.2. If the package is moist, torn, breached or otherwise compromised, clean the contents, repackage using new packaging and sterilize the package again. 2.2.9.3. If packages are to be used immediately, distribute to chair side and leave packaging intact until instruments are ready to use. 2.3. Appendix. 2.3.1. Sterilization Table. 4
DOCUMENT TITLE: VALIDATION OF STERILIZATION (PHYSICAL, CHEMICAL AND BIOLOGICAL) REFERENCE VERSION: 1.0 NUMBER: CSSD-003 EFFECTIVE DATE: 01 SEP 2017 3. Validation of Sterilization (Physical, Chemical and Biological). 3.1. Policy. 3.1.1. In order to be assured that sterilizer is working properly and to indicate that the proper parameters for sterilization were achieved., all sterilization cycles must be monitored utilizing: 3.1.1.1. Physical monitors. 3.1.1.2. Chemical monitors. 3.1.1.3. Biological monitors. 3.2. Procedures. 3.2.1. Physical Monitors. 3.2.1.1. The vacuum test is used to detect any pressure losses in the sterilization chamber. 3.2.1.2. This test should be carried out on an empty machine, prior to starting other sterilization cycles. 3.2.1.3. The cycle cannot start if the temperature inside the sterilization temperature is >40 C. 3.2.1.4. Select Vacuum Test and start the cycle. 3.2.1.5. The autoclave reaches the selected vacuum degree and will hold it for 15 minutes. 3.2.1.6. The test result is given by the End Cycle message appearing on screen and by the relevant print out. 3.2.2. Chemical Monitors. 3.2.2.1. The Bowie and Dick cycles verifies that the steam penetrates properl;y inside a porous load. 3.2.2.2. Carry out the test cycle after removing all trays from the autoclave chamber but the central one: place the test pack without any other instrument on this tray. 3.2.2.3. Select the Helix/B&D cycle and start the cycle. 3.2.2.4. The result is confirmed by the test-pack result. 3.2.3. Biological Monitors. 3.2.3.1. Contains bacterial spores which are very hard to kill. 3.2.3.2. BI needs to be run at least weekly and with every load that contains an implantable device. 3.2.3.3. It is also recommend that a BI also be run every time something is changed in the instrument preparation procedure or sterilization process, 5
such as a packaging change, device or package content change, repair of the sterilizer, etc. 3.2.3.4. The BI is placed in its own test pack and placed in the sterilizer. 3.2.3.5. After the sterilizer cycle is complete, the sterilized BI is removed from its test pack and incubated at the proper temperature. 3.2.3.6. An unprocessed BI is also placed in the incubator as a positive control. 3.2.3.7. For the dry heat sterilization, the incubation temperature is 37 C. 3.3. Appendix. 3.3.1. None. 6
DOCUMENT TITLE: STERILIZER REQUALIFICATION REFERENCE VERSION: 1.0 NUMBER: CSSD-004 EFFECTIVE DATE: 01 SEP 2017 4. Sterilizer Requalification. 4.1. Policy. 4.1.1. Sterilizer shall be re-qualified annually and after the following: 4.1.1.1. Major repairs. 4.1.1.2. Construction. 4.1.1.3. Relocation. 4.1.1.4. Unexplained sterility Failures. 4.1.2. Qualification of the sterilizer must include all of the following: 4.1.2.1. Vacuum leak test three times. 4.1.2.2. Bowie-Dick test three times. 4.1.2.3. Biological spore test three times. 4.2. Procedures. 4.2.1. Refer to Section 3: Validation of Sterilization (Physical, Chemical and Biological). 4.3. Appendix. 4.3.1. None. 7
DOCUMENT TITLE: STERILE PACKAGE SHELF LIFE REFERENCE VERSION: 1.0 NUMBER: CSSD-005 EFFECTIVE DATE: 01 SEP 2017 5. Sterile Package Shelf Life. 5.1. Policy. 5.1.1. Sterilized instruments should be stored in a clean, dry environment to maintain the integrity of the package. 5.1.2. It s a good practice to rotate the packages so that those sterilized first are used first. 5.1.3. However, instruments remain sterile until the package is opened or compromised or had reached 30 days unused. 5.2. Procedures. 5.2.1. If packaging is compromised, or had reached 30 days unused, instruments should be re-cleaned, repackaged, and re-sterilized. 5.2.2. It is recommended that all packages be marked with the date of sterilization and the sterilizer that processed the package to facilitate easy identification and recall of affected packages, should there be a sterilization failure. 5.3. Appendix. 5.3.1. Environmental Temperature and Humidity Monitoring. 8
DOCUMENT TITLE: ACQUISITION OF SUPPLIES REFERENCE VERSION: 1.0 NUMBER: CSSD-006 EFFECTIVE DATE: 01 SEP 2017 6. Acquisition of Supplies. 6.1. Policy. 6.1.1. The CSSD layout should be designed for a unidirectional flow. 6.1.2. The CSSD should have four zones for a smooth work flow: 6.1.2.1. The unclean and washing area. 6.1.2.2. The assembly and packing area. 6.1.2.3. The sterilization area. 6.1.2.4. The sterile area. 6.1.3. Acquisition of supplies must be done within the daily normal working hours. 6.1.4. Availability of all needed sterile supplies must always be ensured before working hours closing to be readily obtainable the next day. 6.2. Procedures. 6.2.1. CSSD should be located as close as possible to the major user areas of the Dental Clinic. 6.2.2. The Dental Nurse shall ensure inventory of the sterile supplies daily to ensure supplies do not run out. 6.2.3. Dental Nurses during their free time should and every after procedure should start doing cleaning, disinfecting, packaging and sterilizing dental supplies and instruments. 6.2.4. There should be no any dental instruments left in the dirty and sterilization area left unprocessed for cleaning, disinfection and sterilization. All these process has to be done before working hours end. 6.3. Appendices. 6.3.1. None. 9
DOCUMENT TITLE: RECALL OF STERILE ITEMS REFERENCE VERSION: 1.0 NUMBER: CSSD-007 EFFECTIVE DATE: 01 SEP 2017 7. Recall of Sterile Items. 7.1. Policy. 7.1.1. The Organization s Dental Clinic must have a policy on recall and should clearly identify all the steps to take including: 7.1.1.1. Circumstances for issuing a recall order. 7.1.1.2. Designate the person authorized to issue a recall order. 7.1.1.3. Designate the person responsible for reporting on the execution of a recall order. 7.1.1.4. A recall order should be in writing and should identify by sterilization Cycle number the items to be recalled. 7.2. Procedures. 7.2.1. Procedure In the event of a positive biological spore test: 7.2.1.1. A determination must be made whether the biological is an actual positive biological or a false positive and whether it is due to Staff error, product fault, Incubator fault or mechanical fault. Steps to be taken are as follows: 7.2.1.2. 7.2.1.2.1. Recall all items from that cycle. Initially, only recalled items should be torn down and re-sterilized. 7.2.1.2.2. Contact the OHSO /ICN. The Dental Staff on duty will be the designated person responsible for item recall. 7.2.1.3. Review all chemical monitors and sterilization mechanical records. 7.2.1.3.1. On the sterilizer load printout: 7.2.1.3.1.1. For a Prevac Cycle, sterilization temperature must be 134 C. Time must be 10 minutes. For a Gravity cycle, sterilization temperature must be 134 C. Time must be 60 minutes. 7.2.1.3.2. Chemical Indicators : 7.2.1.3.2.1. The Indicator Strip on the sterilized packages has turned to black. 7.2.1.3.2.2. For 273 F, 30 minute loads, the Class 4 integrator indicates a PASS. 7.2.1.3.2.3. For 273 F, 55 minute loads, the Class 5 integrator indicates a PASS. 7.2.1.3.2.4. The external chemical indicator on the BI has turned brown. If it has not changed, it has not been run. 10
7.2.1.4. Check the Control BI to assure that it has turned yellow. If it has not, the BI lot may be defective. Obtain another lot and run a 2nd cycle with the new lot. 7.2.1.5. Check the incubator to assure that it is operating properly. If it is not, run a 2nd BI and incubate in another slot. 7.2.1.6. Check with the Plant to determine if there were any changes to steam service. If there has been a disruption or chemical change, the load 7.2.1.7. Follow-up: 7.2.1.7.1. A single positive BI does not indicate a sterilizer malfunction if the mechanical and chemical indicators are acceptable and appear to be functioning properly. 7.2.1.7.2. If all chemical indicators pass and sterilization records show that all parameters have been met, two additional BI s and two Controls should be run (from a new lot number). They will be placed in separate slot. If one or both BI s pass, it can be assumed that the fault lies with the BI or the incubator. This will be reported to the BI manufacturer or biomedical engineer. The entire load must still be rewrapped and re-sterilized and the sterilizer will still be taken out of service for further investigation as an added precaution. 7.2.1.7.3. In the event that both follow-up BI s turn positive, it must be assumed that the sterilizer is faulty, taken out of service and repaired. All items from all cycles up to the last negative BI should be recalled, rewrapped and re-sterilized. The Dental Staff will contact Infection Control at ext.: 372 and provide with all details, including which trays if any were not able to be recalled. Infection control will notify all Dental Physicians as necessary. 7.2.1.7.4. If patient-care items were used before retrieval, the infection control professional should assess the risk of infection in collaboration with central processing and risk management staff. The factors that should be considered include the chemical indicator result: 7.2.1.7.4.1. Nonreactive chemical indicator may indicate temperature not achieved. The results of other biological indicators that followed the positive biological indicator. e.g., positive on Tuesday, negative on Wednesday. 7.2.1.7.4.2. The parameters of the sterilizer associated with the positive biological indicator such as reduced time at correct temperature, the time-temperature chart or print out and the microbial load associated with decontaminated instruments. The margin of safety in steam sterilization is sufficiently large that there is minimal infection risk associated with items in a load that show spore growth, especially if the item was properly cleaned and the temperature was achieved. 11
7.2.1.7.5. Once the sterilizer has been repaired, 3 consecutive BI s must be run followed by 3 consecutive Bowie-Dick tests and 3 consecutive vacuum tests. 7.2.1.7.6. All must pass before placing the sterilizer back into service. 7.3. Appendix. 7.3.1. Instrument Sterilization Recall Log 12