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Compliance FAQ's:

Q  What is Rapid Processing?
A  Rapid Processing usually means terminal sterilization of a wrapped item (or items) resulting from 4 to 25 minutes of exposure to saturated steam at 270° F.

How does Rapid Processing differ from Flash Sterilization?
A  Flash Sterilization was originally developed to process a single instrument for immediate use in an open tray.

Why use “Rapid sterilization?
A  “Rapid” sterilization allows for the routine processing of multiple instruments, supplies or devices for immediate use.

Q  What are some of the primary concerns that are solved by proper Rapid Processing?
A  According to AAMI:

  • Work practices that ensure proper cleaning, decontamination, inspection and organization of instruments.
  • Accurate documentation and consistent protocol.
  • Potential contamination during transport and handling of  “unwrapped” Flashed items.

Q  How can these concerns be adequately addressed?
A  Properly decontaminate, clean and inspect before placing items in ONE TRAY®. As a sealed container, ONE TRAY® provides for safe handling and transport as recommended by AAMI.

Q  How do I know sterilization was achieved?
A  Place a Class 5 Multi-Parameter Steam Sterilization Integrator (such as SteriScan) on the top of the contents and enter all of the required information on the ONE TRAY® Load Record Card. Upon opening, visually check the Steam Sterilization Integrator to confirm the conditions for sterility were achieved inside the ONE TRAY® container before accessing the contents.

Q  How long will the contents remain sterile?
A ONE TRAY® has a 510(k) cleared shelf life of 30 days.

Q How does ONE TRAY® compare to specialized 'Flash' containers?
A ONE TRAY has no moving parts, daily maintenance requirements or operator involvement; while conveniently accepting instruments safely protected in their modular organizing trays.

Q How does ONE TRAY® compare to standard sterilization containers?
A ONE TRAY utilizes the proven filtered vent design of standard containers to provide the same convenience and reliability for the protection of surgical instrumentation.

Q How does ONE TRAY® differ from specialized 'Flash' containers and standard sterilization containers?
A As a sealed container, ONE TRAY allows for the "Just-In-Time" terminal sterilization and safe transport of temperature tolerant surgical instrumentation and supplies using either Prevac or Gravity Displacement Cycles.

Q Why is this important?
A ONE TRAY® offers the safety of FDA cleared technology for the "Just-In-Time" terminal sterilization of instrumentation; while improving workflow and saving time whenever necessary by processing entire sets of instruments in their modular organizing trays.

 

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