PLUS 1173

1 Effective sterilization processing 1.1 Introduction Effective sterilization processing is critical to the successful outcome of the thousands of sterile procedures that are performed daily at health care institutions and clinics throughout North America. This requires that reusable surgical instruments and medical devices be effectively cleaned, inspected, packaged, labelled, sterilized, and transported for reprocessing following their use. Multiple steps are necessary to ensure that each patient receives instruments and supplies that have been processed to the highest standards of care. In order to ensure the delivery of instrumentation that is safe and effective for use, health care professionals should not only adhere to the recommendations of the instrument manufacturer and relevant processing guidelines, but need to also have an understanding of the technology (equipment and processes) used to reprocess surgical instruments and medical devices. This includes an understanding of the basis whereby a given sterilization load is deemed acceptable for use. A key factor in this determination is the results of testing performed with various types of sterilization indicators. 1.2 Cornerstone of sterilization process monitoring The use of a combination of physical monitors and chemical and biological sterilization indicators to monitor the efficacy of a sterilization process has formed the cornerstone of sterilization process monitoring for many years. Physical monitors and chemical indicators generally provide the user with an immediate response, whereas biological indicators (BI) can require a period of incubation ranging from 24 to 48 h following sterilization processing before reliable results are available. As sterilization loads are frequently released to distribution before the results of biological indicator testing are known, the user has to often rely on the results of testing with chemical indicators and information from physical monitors to provide an initial assessment of the adequacy of the sterilization process. 1.3 Rapid sterilization indicators To address the prolonged incubation time required by traditional biological indicators, sterilization indicators have been developed to provide the user with information that is claimed by the manufacturer of the indicator to be equivalent to that provided by a traditional biological indicator either shortly thereafter or immediately following sterilization processing. This technology includes rapid readout biological sterilization indicator systems that provide results within 90 min to 4 h of sterilization processing, and Class 5 and Class 6 chemical indicator systems whose performance is claimed to correlate to that of a biological indicator (Class 5) or respond to all critical variables for a given sterilization process (Class 6). This Guide is intended to supplement the information provided in existing sterilization indicator standards to assist the health care professional in making informed choices regarding the role, capabilities, selection, and application of sterilization indicator systems, including the newer technology sterilization indicator systems. This Guide is not intended to establish requirements regarding the qualification of sterilization indicators or their use.