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    The FDA has begun enforcing standards for steam sterilization cycle parameters outlined in ANSI/AAMI ST79. Previously, manufacturers could validate extended cycle times, but the FDA no longer accepts these. Manufacturers may need to revalidate devices and trays to ensure proper steam penetration based on the standard cycle parameters, which include having devices in an open position, sufficient steam penetration in trays, larger lumen sizes, and no dead legs on devices. The document provides the specific cycle parameters from the standards that manufacturers must now follow.

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    New Microsoft Office Word Document

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    arvinddhotre3131
    104 views2 pages
    The FDA has begun enforcing standards for steam sterilization cycle parameters outlined in ANSI/AAMI ST79. Previously, manufacturers could validate extended cycle times, but the FDA no longer accepts these. Manufacturers may need to revalidate devices and trays to ensure proper steam penetration based on the standard cycle parameters, which include having devices in an open position, sufficient steam penetration in trays, larger lumen sizes, and no dead legs on devices. The document provides the specific cycle parameters from the standards that manufacturers must now follow.

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    The FDA has begun enforcing standards for steam sterilization cycle parameters outlined in ANSI/AAMI ST79. Previously, manufacturers could validate extended cycle times, but the FDA no longer accepts these. Manufacturers may need to revalidate devices and trays to ensure proper steam penetration based on the standard cycle parameters, which include having devices in an open position, sufficient steam penetration in trays, larger lumen sizes, and no dead legs on devices. The document provides the specific cycle parameters from the standards that manufacturers must now follow.

    Copyright:

    Attribution Non-Commercial (BY-NC)
    Download as DOCX, PDF, TXT or read online from Scribd
    Download as docx, pdf, or txt
    104 views2 pages

    New Microsoft Office Word Document

    Uploaded by

    arvinddhotre3131
    The FDA has begun enforcing standards for steam sterilization cycle parameters outlined in ANSI/AAMI ST79. Previously, manufacturers could validate extended cycle times, but the FDA no longer accepts these. Manufacturers may need to revalidate devices and trays to ensure proper steam penetration based on the standard cycle parameters, which include having devices in an open position, sufficient steam penetration in trays, larger lumen sizes, and no dead legs on devices. The document provides the specific cycle parameters from the standards that manufacturers must now follow.

    Copyright:

    Attribution Non-Commercial (BY-NC)
    Download as DOCX, PDF, TXT or read online from Scribd
    Download as docx, pdf, or txt
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    Steam Sterilization Cycle Parameters: Revalidate Reusable Medical Devices

    By Emily Mitzel, Laboratory Manager, MS Recently the Food and Drug Administration (FDA) began mandating and enforcing steam sterilization cycle parameters of the ANSI/AAMI ST79:2006 and A1:2008, A2:2009 (The comprehensive guide to steam sterilization and sterility assurance in healthcare facilities) for reusable medical device manufacturers. Previously, the process was to validate to the device type. If there was growth of the Biological Indicator(s) (BI) placed on or in the device at a certain time parameter the exposure time was increased. The FDA has now specified that sterilization cycles validated for medical devices/trays must follow the standards. The extended cycles with increased times and temperatures are no longer accepted. This means manufacturers may need to make changes to the devices, trays, or both to ensure better steam penetration and be validated with the sterilization cycles outlined in the standards. Some items that should be changed include: All devices should be in an open and unlocked position. The tray must allow for sufficient steam penetration and removal. Lumens may need to be made larger as to allow for proper steam penetration. No dead legs should be located on any device.

    Keep in mind the standards arent new, the FDA has started enforcing the standards by not accepting the extended cycle parameters. Manufacturers may want to validate the specific cycle parameters for the standards if they currently have extended cycles validated. The specific cycle parameters to be utilized are as follows: ANSI/AAMI ST79 tables 4 and 5 Minimum Cycle Times for Gravity-Displacement Steam Sterilization Cycles Item Exposure time At Exposure time At Exposure time At Drying Times 121C (250F) 132C (270F) 135C (275F) Wrapped Instruments Textile Packs Wrapped utensils Unwrapped nonporous items (e.g. instruments) Unwrapped nonporous and porous items in a mixed load 30 minutes 30 minutes 30 minutes 15 minutes 10 minutes 25 minutes 10 minutes 15 minutes 10 minutes 3 minutes 10 minutes 3 minutes 10 minutes 15-30 minutes 30 minutes 15 minutes 30 minutes 30 minutes 15-30 minutes 0-1 minute 0-1 minute

    Item

    Minimum Cycle Times for Dynamic-Air-Removal Steam Sterilization Cycles Exposure time At 132C Exposure time At 135C Drying Times (270F) (275F) 4 minutes 3 minutes 4 minutes 3 minutes 4 minutes 3 minutes 3 minutes 3 minutes 20-30 minutes 16 minutes 5-20 minutes 3 minutes 20 minutes 16 minutes N/A

    Wrapped Instruments Textile packs Wrapped utensils Unwrapped nonporous items (e.g. instruments0 Unwrapped nonporous and porous items in a mixed load

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