Thursday, August 28, 2008
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INFECTION CONTROL REPORT Sterilization failure When sterilization stops The whys of sterilization failure and what do when it happens. Last month’s issue of Dental Products Report described ways to monitor the sterilization process; but what do you do when the recommended mechanical, chemical, or biological monitoring tells you that sterilization has failed? Determine the cause First, one should understand the reason behind a failure episode. See “Top 5 faults” (below, right) for a quick list of the potential causes of sterilization process problems.1 Most of these causes can be blamed on human, not mechanical, error; and all are described in detail in this article. Remember, for heat sterilization to occur, a sterilizing agent such as steam, dry heat, or hot chemical vapor must exist at a minimum temperature, must directly contact the surface of the item being processed, and must have a minimum contact time with those items. Any aberrations can result in sterilization failure.
1. Improper cleaning of instruments Organic debris from the patient’s mouth or dental materials on instruments can insulate the underlying microbes from direct contact with the sterilizing agent. Although some penetration of the agent through these materials may occur, we never know how successful this penetration may be. Thus, cleaning as a first step is extremely important to reduce the bioburden and help ensure direct contact of the killing agents with the microbes. By the way, this particular interference caused by inadequate cleaning cannot be detected using the standard sterilization monitoring methods—mechanical, chemical, or biological procedures. In other words, although all monitors could indicate that sterilizing conditions have been met, any improperly cleaned instruments still could contain live microbes. Thus, cleaning must not only be thorough, it also must involve proper procedures.
2. Improper packaging Sterilization packaging materials must withstand sterilizing conditions, allow sterilizing agents to penetrate and reach the items inside, and maintain the sterility of the packaged items inside after the package’s removal from the sterilizer and during subsequent storage. Because packaging materials are considered medical devices, the Food and Drug Administration (FDA) calls for manufacturers to prove that their packaging materials meet the above-mentioned requirements. Therefore, FDA-cleared sterilization packaging materials, including paper bags, nylon-plastic tubing, paper/plastic peel pouches, and sterilization wrap, must be used as directed by manufacturers to ensure sterility. What’s more, packaging materials must be used only in the specific type of sterilizer they’re made for. For example, using paper/plastic peel pouches (normally used in a steam autoclave1) in a dry heat sterilizer can cause the seal between the paper and plastic to separate. Also, non-FDA-cleared packaging material such as plastic freezer bags may not allow the sterilizing agent to penetrate through to the items inside. In fact, any non-FDA-cleared closed container, including metal boxes or glass tubes with tops, will prevent steam and hot chemical vapors from reaching the items inside. But being too open is not always ideal, either. Using woven cloth as a wrapping material may allow penetration of a sterilizing agent, but it does not maintain an inner sterile environment, because the loose weave does not prevent the entrance of microbes from the surrounding atmosphere, spatter, or dust. In addition, the packaging procedure used must follow manufacturer’s directions. For example, using too many layers of wrapping material can delay sufficient penetration of the sterilizing agent. Use of chemical and biological monitoring can detect many problems with packaging materials and procedures. As discussed in last month’s Infection Control Report, sterilization indicators should be placed inside packages to measure sterilizing agents’ penetration.2
3. Improper loading All the hard work of instrument cleaning and proper packaging can be eradicated if the sterilizer is not loaded correctly. Leave some “air” space around each package, tray, or cassette to facilitate exposure to the sterilizing agent. Packing the chamber too tightly or layering the packages by stacking one atop another can impede penetration of steam, dry heat, or chemical vapor. If the sterilizer comes with loading racks, use them. If not, load the packages upright and aligned on their edges. Using chemical and biological monitoring methods can indirectly detect problems with sterilizer loading because these monitoring indicators are placed inside of packages. All packages loaded should include internal chemical indicators. Placement of a package containing a biological indicator should follow the sterilizer manufacturer’s directions, which frequently state this package should be placed near the drain, where the temperature may be the lowest. Another way to assess proper loading is to place the package containing the indicator in the center of the load. 4. Improper operation Follow the sterilizer manufacturer’s directions for proper machine operation. Make the operator’s manual required reading for your practice’s sterilization assistant. If you have lost your manual, contact the manufacturer for a new one. Although most sterilizers are automatic, the correct cycle must be selected, depending upon the items processed. In addition, for some older dry heat sterilizers, the timing must be set manually. Also, mechanical, chemical, and biological monitoring methods can detect potential problems with sterilizing conditions, but they cannot determine whether the correct cycle has been reselected for the particular items processed.2
5. Sterilizer malfunction Nothing lasts forever, not even a sterilizer. Longevity can depend upon the machine’s periodic maintenance. Keep the door, reservoir, chamber, drain, and air filter of steam sterilizers clean and well maintained to ensure proper operation. Some units provide a visible prompt on the read-out screen when maintenance is needed. One steam sterilizer manufacturer offers the following maintenance schedule: • Clean the door seal weekly to help ensure no steam leakage; • Clean the chamber weekly to prevent debris from accumulating on processed items. Keep drains and steam ports clean; • Clean the water tank weekly to keep biofilm from accumulating in the water tank and within the chamber; • Replace the air filter every 3 months (This unit’s air is drawn in at the end of the drying cycle, so it must be filtered to prevent recontamination of the packages.); • Replace the door seal every year to ensure maintenance of proper chamber pressure; • Have general service by a qualified technician every 3 years. Have a plan B Prepare for sterilization failure. Have a back-up sterilizer on hand or know where you can quickly get a loaner unit. The CDC recommends specific procedures after a sterilization problem is detected.3 (See “Spore test results", below) Collective process Pay close attention to approved procedures for sterility assurance. These include proper cleaning and packaging of instruments, proper loading and operation of the sterilizer, appropriate monitoring of the sterilization process, and proper storage and distribution of sterile packages. Collectively, these help ensure instrument safety. Photos courtesy of Chris H. Miller, PhD Chris H. Miller, PhD, is Professor Emeritus of Oral Microbiology and Executive Associate Dean Emeritus at Indiana University School of Dentistry, Indianapolis. Reach him at either chmille@iupui.edu or c/o ewhite@advanstar.com. If spore test results are positive… The CDC recommends following specific steps after a sterilization problem is detected (indicated by a positive spore test)3: 1. Remove the sterilizer from service and review sterilization procedures (e.g., work practices and use of mechanical and chemical indicators) to rule out operator error as a cause of the test results. 2. Retest the sterilizer by using biological, mechanical, and chemical indicators after correcting any identified procedural problems. 3. If the repeat spore test is negative, and mechanical and chemical indicators are within normal limits, put the sterilizer back in service. The following are recommended if the repeat spore test is positive (i.e., shows there are unkilled microbes): 1. Do not use the sterilizer until it has been inspected or repaired, or the exact reason for the positive test has been determined. 2. Recall (to the extent possible) and reprocess all items processed since the last negative spore test. 3. Before placing the sterilizer back into service, rechallenge the sterilizer with biological indicator tests in three consecutive empty chamber sterilization cycles after the cause of the sterilizer failure has been determined and corrected. Source: CDC’s Guidelines for Infection Control in Dental Health-Care Settings, 2003. References upon request.
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