These documents are being provided in response to our customer’s request for 3rd party guidance/reference information which may be useful in developing internal practices/procedures for: Defining Immediate Use Steam Sterilization (IUSS), Shelf Life/Storage (Event Related or Expiratory Dating), Instructions For Use (IFU) for: Sterilizer, Packaging System, Medical Devices
Internal practices/procedures are useful when they are used in conjunction with other sources of information and in the context of professional experience and judgement.
Sample Policy 1
There are two approaches to policy development, you can have a separate policy on ONE TRAY® or you can add the specifics about ONE TRAY® in a general policy on steam sterilization. Here is an example.
SAMPLE POLICY 2
During the storage and transportation steps of the sterilization process, the integrity of the sterile barrier must be maintained. Develop a policy on the handling, storage, and transport of the sterile tray.
SAMPLE POLICY 3
This example defines immediacy or IUSS. A policy should be developed to explain the when, how, why and rationale for using IUSS.
SAMPLE POLICY 4
During the storage and transportation steps of the sterilization process, the integrity of the sterile barrier must be maintained. Develop a policy on the handling, storage, and transport of the sterile tray.
SAMPLE POLICY 5
There are two approaches to policy development, you can have a separate policy on ONE TRAY® or you can add the specifics about ONE TRAY® in a general policy on steam sterilization. Here is an example.
SAMPLE POLICY 6
There are two approaches to policy development, you can have a separate policy on ONE TRAY® or you can add the specifics about ONE TRAY® in a general policy on steam sterilization. Here is an example.
Sample Policy 7
This example provides a sample competency on the use of ONE TRAY® - once you determine who is using the tray in your organization, make sure that all job roles are addressed in your competency.
Sample policy 8
During the storage and transportation steps of the sterilization process, the integrity of the sterile barrier must be maintained. Develop a policy on the handling, storage, and transport of the sterile tray.
Sample policy 9
There are two approaches to policy development, you can have a separate policy on ONE TRAY® or you can add the specifics about ONE TRAY® in a general policy on steam sterilization. Here is an example.
Sample POlicy 10
There are two approaches to policy development, you can have a separate policy on ONE TRAY® or you can add the specifics about ONE TRAY® in a general policy on steam sterilization. Here is an example.
