1231 CE Online (1)

Figure 17 – Rigid Endoscope Ready for Final Packaging and Sterilization

Figure 18 – Flexible Endoscope in Sterilization Tray

The manufacturer validates an endoscope for terminal sterilization based on two criteria: material compatibility (ie, whether or not the material will tolerate the sterilization method) and sterilization efficacy (ie, whether or not the item can be rendered sterile using a particular method). An autoclave, or steam sterilizer, uses high heat under pressure and is the oldest and most reliable sterilization method. However, some endoscopes cannot tolerate the high heat and will need to be processed in a low-temperature alternative. A variety of low-temperature sterilization machines use a gas for the sterilant agent: Ethylene Oxide (EO), Hydrogen Peroxide Gas Plasma or Hydrogen Peroxide Gas Vapor. EO is the oldest and most effective low-temperature gas sterilization method but requires a long aeration time (up to 14 hours), which may delay surgery schedules. Hydrogen peroxide gas is a newer method for low-temperature sterilization. The entire cycle time for hydrogen peroxide sterilization is quick, with a complete sterilization cycle as short as 35 - 45 minutes. The machine used for this method quickly converts hydrogen peroxide gas to plasma (STERRAD) or to vapor (STERIS® V-PRO) and has no residue, doesn’t need any aeration time, and doesn’t require any special venting or drains.

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