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American National Standards
   Sterilization process

   Facility Design

   Staff Training

   Quality Improvement Plan from Point of use
    to the reuse

   Documentation and reporting process
   Seen in all aspects discussed previously
   Environmental Restrictions
   Facility Funding

   Set difficulties Need to allocate resources
   Sterilization Preprogrammed
     The user select the option according med device
      manufacture written Instructions
     Load Configuration (porous material…)
   Items usually Unwrapped
     Single Wrapper may be used IF:
     Rigid Containers IF:
   Items are assumed to be wet
   Items must be transferred immediate to the
    point of use
     Respect aseptic tech
     No storage or half life
   Removal of gross soil is essential before
    any method of sterilization
   Decontamination is to protect the worker
   Documentation is essential
   The transfer tech:
     Worker Safety: hot wet items
     Sterilizer once opened: contamination Occur
      ▪ Recommendation: HEPA Filter + Laminar Flow Area
     Way to deliver the items:
      ▪ Stop Hand Washing / Scrubbing
      ▪ HEPA Filter Area
     If these Not Present: Once Sterilizer Opened, Grap the
      item By Sterile Cloth and put them in the Rigid Container
     Idea: Flash Sterilizer near the Operating Room
 Important Concept: Longer time opened  Greater
  Number of Particles   Contamination
 Infection Control Audit is mandatory
   Implantables Should not be Flash Sterilized
   Risk of failure increase  Greater risk of
    infection
   BI Must be used  even though should not
    be used
Patient In Surgery
   Infectious Dose
     Improper Cleaning
   Complexity of items that need to be
    resterilized
   Manufacture written Instruction
   The Rationale Approach
   The presence of educational Speakers
    (Sterilization Team)

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Aami introductory

  • 2. Sterilization process  Facility Design  Staff Training  Quality Improvement Plan from Point of use to the reuse  Documentation and reporting process
  • 3. Seen in all aspects discussed previously  Environmental Restrictions  Facility Funding  Set difficulties Need to allocate resources
  • 4. Sterilization Preprogrammed  The user select the option according med device manufacture written Instructions  Load Configuration (porous material…)  Items usually Unwrapped  Single Wrapper may be used IF:  Rigid Containers IF:  Items are assumed to be wet
  • 5. Items must be transferred immediate to the point of use  Respect aseptic tech  No storage or half life  Removal of gross soil is essential before any method of sterilization  Decontamination is to protect the worker  Documentation is essential
  • 6. The transfer tech:  Worker Safety: hot wet items  Sterilizer once opened: contamination Occur ▪ Recommendation: HEPA Filter + Laminar Flow Area  Way to deliver the items: ▪ Stop Hand Washing / Scrubbing ▪ HEPA Filter Area  If these Not Present: Once Sterilizer Opened, Grap the item By Sterile Cloth and put them in the Rigid Container  Idea: Flash Sterilizer near the Operating Room  Important Concept: Longer time opened  Greater Number of Particles   Contamination  Infection Control Audit is mandatory
  • 7. Implantables Should not be Flash Sterilized  Risk of failure increase  Greater risk of infection  BI Must be used  even though should not be used
  • 9.
  • 10. Infectious Dose  Improper Cleaning
  • 11.
  • 12. Complexity of items that need to be resterilized  Manufacture written Instruction  The Rationale Approach  The presence of educational Speakers (Sterilization Team)