As soon as you can, repeat the spore test in the suspect sterilizer, using proper sterilization and monitoring procedures; be sure to include chemical indicators in the repeat run. If this spore test’s results read negative and the CIs change appropriately, you may return the sterilizer to service. However, if the repeat spore test is positive or the CIs do not properly change, and you have confirmed that the packaging, loading, and operating procedures were performed correctly, contact your sterilizer repair service for unit repair or replacement.
Keep in mind that before either a repaired or a new sterilizer is placed into service, the unit should be spore-tested under normal operating procedures and achieve a negative (spore-free) result.
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When it comes to instrument processing and sterilization, use all three methods of monitoring—mechanical, chemical, and biologic—to help ensure patient safety. Mechanically monitor each sterilizer load and chemically monitor each package in each load. Biologically monitor every sterilizer at least once a week. Be sure to keep accurate records on all monitoring. Of the three methods, biologic monitoring is regarded as the most valid for monitoring the sterilization process, for it uses live, highly resistant bacterial spores. Chemical monitoring uses heat-sensitive or heat-time-steam-sensitive chemicals that change color and may help to immediately detect certain sterilizer malfunctions and help to earmark procedural problems. In addition, use of mechanical monitoring by observing the time, temperature and pressure of sterilizer cycles may provide early detection of a mechanical problem. Keep in mind that effective sterilization helps you reach the ultimate goal of proper instrument processing—delivering sterile instruments to chairside.
A RATIONAL APPROACH TO DISINFECTION AND STERILIZATION More than 30 years ago, Earle H. Spaulding devised a rational approach to disinfection and sterilization of patient-care items and equipment.14 This classification scheme is so clear and logical that it has been retained, refined, and successfully used by infection control professionals and others when planning methods for disinfection or sterilization. 1, 13, 15, 17, 19, 20 Spaulding believed the nature of disinfection could be understood readily if instruments and items for patient care were categorized as critical, semicritical, and noncritical according to the degree of risk for infection involved in use of the items. The CDC Guideline for Handwashing and Hospital Environmental Control 21, Guidelines for the Prevention of Transmission of Human Immunodeficiency Virus (HIV) and Hepatitis B Virus (HBV) to Health-Care and Public-Safety Workers22, and Guideline for Environmental Infection Control in HealthCare Facilities23 employ this terminology. Critical Items Critical items confer a high risk for infection if they are contaminated with any microorganism.