Sterilization and Autoclave Practices

Sterilization Process

• In non-emergency situations, the risk/benefit ratio is higher, particularly when implantable devices are involved.

Loading Sterilizer

• Load sterilizers properly to allow for adequate penetration, removal, and contact between the sterilant and items being processed.
• Avoid overloading and place non-perforated trays and containers on their edge.
• Keep packages away from chamber walls and place concave items, such as basins, on an angle to avoid condensate pooling.
• Load textile packs perpendicular to the sterilizer cart shelf and place pouches on their edge.
• Place multiple packages paper to plastic and do not stack rigid containers unless validated by the manufacturer.

Unloading Sterilizer

• Unload the sterilizer in the following manner:
  • Place heavier items, trays, and containers on lower shelves.
  • Place lighter items, e.g., peel packs, on higher shelves.
• Review the sterilizer printout for correct sterilization parameters, cycle time, and date.
• Verify that the cycle number matches the lot control label for the load.
• Verify and initial that the correct cycle parameters have been met.
• Examine the load items for any visible signs of moisture, compromised packaging integrity, and retain printed records of each cycle parameter in accordance with local policy.

Load Cool-Down

• After removing the sterilized load, visually verify the results of the external chemical indicators.
• Allow the load to cool to room temperature before touching or moving sterile packs.
• Ensure that cool-down occurs in a traffic-free area without strong warm or cool air currents.

Troubleshooting - Wet Pack Problems

• Packages are considered wet when moisture in the form of dampness, droplets, or puddles is found on or within a package.
• If moisture is noticed on or in one pack, the problem is isolated to this pack, but other packs of the same load should be opened and checked for wetness.
• If there are several wet packs in one load, the entire load should be rejected and re-processed according to local policy.
• The incident of wet packs must be investigated to identify the root cause and documented to prevent any future re-occurrence.

Steam Quality

• Proper steam quality will prolong the life of RMDs by reducing water impurities that have adverse effects on device materials.
• Lime, rust, chlorine, and salt can be left as deposits on devices if treated with reverse osmosis water.
• These compounds can lead to stress corrosion, pitting, and discoloration of the devices and the sterilizer.
• Pitting, corrosion, and precipitates provide areas where organisms can accumulate and be protected from the killing effects of the steam process, increasing the infection transmission risk due to inadequate sterilization.

Steam Sterilization: Advantages and Disadvantages

• Advantages: highly effective, inexpensive, rapid process, items may be packaged, no toxic residues, moist process.
• Disadvantages: unsuitable for heat-sensitive items.

Dry Heat Sterilization

• The dry heat method may be used for glassware and metal items, heat-stable powders, and non-aqueous liquids like paraDin.
• A typical cycle consists of heating the chamber to the required sterilization temperature, holding the load at this temperature for a defined time period, and then cooling the load.
• Advantages: suitable for non-aqueous fluids and glassware, high temperatures.
• Disadvantages: unsuitable for heat-sensitive items, long sterilization and cooling times, items cannot be wrapped.

Low Temperature Sterilization Considerations

• Temperature involved: is the method compatible with the devices being processed?
• Cycle time: will this fit with the workload/turnaround time of the CSSD?
• Will more devices be required?
• Availability of equipment and validation requirements.
• Compatibility with devices being processed.

Low Temperature Sterilizers

• Ethylene Oxide (EO): operates at 37 ºC or 55 ºC, suitable for heat-sensitive items, uses chemicals with toxic properties, requires very long cycle durations to allow for adequate aeration.
• Gas Plasma/2: operates at less than 55 ºC, suitable for heat-sensitive items, short cycle, non-cellulose wrapping materials required.
• Vaporized Hydrogen Peroxide/3: utilizes hydrogen peroxide to kill a wide spectrum of microorganisms, operates at less than 50 ºC, lumened and non-lumened instruments can be sterilized.
• Ozon Sterilization/4: eliminates the need for purchasing a sterilant, generates O3, operates at 30.8-36 ºC.