Any package that has fallen or been dropped on the floor must be inspected for damage to the packaging and
75 Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008
contents (if the items are breakable). If the package is heat-sealed in impervious plastic and the seal is still intact, the package should be considered not contaminated. If undamaged, items packaged in plastic need not be reprocessed.
Monitoring. The sterilization procedure should be monitored routinely by using a combination of mechanical, chemical, and biological indicators to evaluate the sterilizing conditions and indirectly the microbiologic status of the processed items. The mechanical monitors for steam sterilization include the daily assessment of cycle time and temperature by examining the temperature record chart (or computer printout) and an assessment of pressure via the pressure gauge. The mechanical monitors for ETO include time, temperature, and pressure recorders that provide data via computer printouts, gauges, and/or displays814. Generally, two essential elements for ETO sterilization (i.e., the gas concentration and humidity) cannot be monitored in healthcare ETO sterilizers.
Chemical indicators are convenient, are inexpensive, and indicate that the item has been exposed to the sterilization process. In one study, chemical indicators were more likely than biological indicators to inaccurately indicate sterilization at marginal sterilization times (e.g., 2 minutes)847. Chemical indicators should be used in conjunction with biological indicators, but based on current studies should not replace them because they indicate sterilization at marginal sterilization time and because only a biological indicator consisting of resistant spores can measure the microbial killing power of the sterilization process.847, 974. Chemical indicators are affixed on the outside of each pack to show that the package has been processed through a sterilization cycle, but these indicators do not prove sterilization has been achieved. Preferably, a chemical indicator also should be placed on the inside of each pack to verify sterilant penetration. Chemical indicators usually are either heat-or chemical-sensitive inks that change color when one or more sterilization parameters (e.g., steam-time, temperature, and/or saturated steam; ETO-time, temperature, relative humidity and/or ETO concentration) are present. Chemical indicators have been grouped into five classes based on their ability to monitor one or multiple sterilization parameters813, 819. If the internal and/or external indicator suggests inadequate processing, the item should not be used815. An air-removal test (Bowie-Dick Test) must be performed daily in an empty dynamic-air-removal sterilizer (e.g., prevacuum steam sterilizer) to ensure air removal.
Biological indicators are recognized by most authorities as being closest to the ideal monitors of the sterilization process 974, 975 because they measure the sterilization process directly by using the most resistant microorganisms (i.e., Bacillus spores), and not by merely testing the physical and chemical conditions necessary for sterilization. Since the Bacillus spores used in biological indicators are more resistant and present in greater numbers than are the common microbial contaminants found on patient-care equipment, the demonstration that the biological indicator has been inactivated strongly implies that other potential pathogens in the load have been killed844.