Sterilization, Biological, Chemical Monitoring and Documentation

Guidelines:

• Perioperative team members must review the manufacturer’s instructions for cleaning, packaging, and sterilizing to determine the correct sterilization process.
  • Records of sterilization monitoring (mechanical, chemical, and biological) should be maintained long enough to comply with state and local regulations
  • The CDC does not maintain information on time limits for every state
  • The Joint Commission uses a 3 year time frame for record maintenance
  • Follow facility policies for documentation requirements including record maintenance

Considerations:

• Documentation of Sterilization Monitoring:
  • Service/Maintenance records of sterilizing equipment
  • Chemical Indicators (CIs)
    • Respond to one or more of the physical conditions within the sterilizing chamber
    • Used to routinely monitor the process parameters of sterilization
    • Bowie Dick
      • Air-removal testing for prevacuum steam sterilizers
      • Daily when in use
      • After servicing and after moving equipment
  • Biologic Indicators (BIs)
    • Spore strips and indicator tape
    • Provide a direct measure of the lethality of the sterilization process
    • Used to routinely monitor sterilizers
    • Bacterial spores are the microorganisms primarily used in BIs
      • Bacillus atrophaeus (BA)
      • Geobacillus stearothermophilus (GS)
      • At least weekly and with every load with an implantable device
  • Physical
    • Provides report of sterilization cycle conditions

Nurse’s role:

• Perioperative nurses should use facility policies and procedures to provide evidence of compliance with regulations, guidelines, and best practices for surgical instrument processing
  • Use and interpretation of CIs and BIs according to manufacturers’ IFU
  • Interpretation of sterilizer physical monitor results
  • Requirements of maintaining records of sterilization
  • Quality assurance measures for sterilization
  • Team communication and a patient safety culture
  • Processes for reporting adverse events
    • Malfunctions, failed BIs/CIs

Pitfalls:

• Factors impacting sterilization cycle:
  • Operator experience
  • Load preparation
  • Sterilizer condition

Examples:

• Process challenge Devices (PCDs)
  • PCDs are challenge test packs containing a BI or BI and a CI
  • Assess the effective performance of a sterilization process by providing a challenge to the process that is equal to or greater than the challenge posed by the most difficult item routinely processed
  • AORN and AAMI recommend a PCD with the appropriate BI should be used at least daily, but preferably in every sterilization cycle or load.
  • Follow facility policies/procedures

Linchpins (Key Points):

• Follow manufacturers’ IFU for sterilization, biological, and chemical monitoring
• Bowie Dick for air-removal testing for prevacuum steam sterilizers and should be done daily when in use
• PCDs contain BI or BI+CI and should be used at least daily, preferably with every load
• Physical monitors for record of sterilization cycles and detecting malfunctions