Product Assessment (Packaging, Sterilization)

Guidelines:

• Use of sterile surgical instruments and supplies is a key component of surgical site infection prevention
  • Sterilization packaging systems:
    • Permit a sterilant to contact the packaged contents
    • Protect the sterile items from contamination during transport and storage until use
    • Enable aseptic delivery of the items to the sterile field
  • Types of packaging systems
    • Reusable woven fabrics
    • Single-use nonwoven materials
    • Rigid containment devices
    • Peel pouches composed of plastic, paper and plastic, or polyethylene and plastic

Considerations:

• Principles of packaging and sterilization: Chemical Indicators (CIs)
  • Follow manufacturer’s IFU for packaging and sterilization
  • Select CIs specific to the sterilization method and cycle
  • Place a CI on both the outside and inside of the package to be processed
    • External CIs show that a package has been processed
    • Internal CIs react to one or more of the critical parameters of sterilization (steam, pressure, temperature, time) or the parameters of a specific sterilization cycle
    • Neither internal or external CIs verify sterility of the contents, but they do verify achievement of one or more of
      the conditions necessary for sterilization

Nurse’s role:

• Perioperative personnel are responsible for verifying package integrity and the appropriate color change of chemical indicators (CIs) before using aseptic technique to deliver items to the sterile field.
  • Acquire needed products
    • Surgical checklist, briefing, nursing process
  • Assess expiration date
    • Team communication
  • Assess package integrity
    • Inspect all sterilization wraps for defects and cleanliness
      • Holes, tears, worn spots

Pitfalls:

• Not all items to be sterilized are compatible with all sterilization packaging systems
• Not all packaging systems are appropriate for every type of sterilizer
• Incompatible packaging systems undergoing sterilization may have inadequate exposure to sterilant and remain unsterile as a result
• Use packaging that is compatible with the device, the planned sterilization method, and cycle length, and is cleared by the US FDA for the planned use.

Examples:

• Let’s talk about peel pouches:
• Peel pouches are for lightweight, low profile items
• Peel pouches should not be used in wrapped instrument sets or rigid containers
• Do not double pouch package contents unless the pouch manufacturer allows this practice in the IFU
• The plastic side of a peel pouch is impervious to sterilant penetration and the paper side permits sterilant penetration, facing the inner pouch in the same direction as the outer pouch results in contact through which the sterilant can penetrate

Linchpins (Key Points):

• Standardized processes prevent human error
• Follow manufacturer’s IFU for packaging and sterilization
• Visually inspect packaging for integrity
• Verify internal and external CIs
• Team communication is key