![]() The sterilizer must be operated according to the manufacturer's recommendations. All repaired or replacement sterilizers must be spore tested before being placed into service. ![]() Step Three - Retest and observe operational parameters. However, sometimes the review does not determine an obvious cause of a BI test failure. If a review indicates potential areas of concern they should be addressed. ![]() A review of the practice's BI monitoring process would also be appropriate. Confirm that all involved people are aware of and routinely practice the proper procedures and use the correct materials. The review should include both candid discussion and direct observation. This would include procedures used by all personnel that recycle instruments. The sterilizer's operations manual as well as the practice's written instrument sterilization policies should be reviewed. All monitoring records, including printouts of operational parameters, chemical indicator results, and spore testing since the last negative BI test should be examined. Step Two - Review sterilization procedures. All unused items need to be collected and processed again in another sterilizer. Items processed since the last spore test may not have been sterilized. After receiving the second positive spore test, immediately take the sterilizer out of service until the cause of the problem has been determined and proper changes made. Following is a list of four steps that are recommended after a spore test failure. However, all potential causes of sterilization failure - including mechanical breakdown - must be investigated. Overloading, improper wrapping or packaging, and insufficient exposure times are common operator mistakes. Many are due to some type of human error. A second failure indicates the likelihood of a mechanical or procedural problem.Ī number of factors may be involved with a sterilization failure. However, the spore test should be immediately repeated. If operational (for example, time, temperature, and pressure) and chemical (internal and external) indicators suggest that the sterilizer is functioning properly, then a single spore strip failure likely does not indicate sterilizer malfunction. In such cases, proper processing and interpretation of the results must be carefully completed. Some practices use monitoring systems that allow in-house incubation. The list of questions in the box at right is to be asked of the practice's compliance coordinator and to the practice's monitoring service in the event of a positive spore test. A review of the monitoring process would be useful. Failure to kill the spores (a "positive" test, bacterial growth) is a significant event that requires immediate action. The results of a "negative" test indicate sterilization. The desired outcome of biological testing is the killing of the spore challenge. At least weekly spore testing is recommended. Also, spore testing is an essential part of the evaluation of any repaired sterilizer prior to placing it back into use. This is especially valuable when new types of packaging are selected or when different loading procedures are employed. Monitoring evaluates both sterilizer and office personnel performance and the materials that are used. Regular use of spore tests helps to support the primary goal of sterilization - patient safety through the universal delivery of sterile instruments chairside. Biological indicators (BI) are the most valid method for monitoring the sterilization process.
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