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What can I sterilize in my STERRAD® and how is it tested?

This page explains the ASP Medical Device Manufacturing Program (MDM) and the STERRAD® Sterility Guide (SSG)

If you just need information on the devices you can sterilize and how, then please go directly to the SSG website

The Medical Device Manufacturing Program (MDM)

The devices within the STERRAD® sterility claims have been tested as part of the Medical Device Manufacturing Program (MDM). The MDM Program involves intense testing of medical devices, which undergo different sterilization cycles in STERRAD® Systems. Each device is tested in a specific test lab, following ISO 14937 standards to reach sterility assurance 10-6, material compatibility and functionality.

Devices that pass the sterility assurance level, material compatibility and functionality tests of the MDM Program are:

  • added to the STERRAD® Sterility Guide - an online resource that provides customers with a list of devices that are within STERRAD® sterility claims.
  • added to the MDM's Instructions for Use (IFU) that specify how to sterilize in STERRAD® Systems.

This gives your Central Sterilization Supply Department (CSSD) a large range of devices approved for STERRAD® Sterilization that meet operation efficiency and surgical schedules.

Functionality Sterility Processing

ISO 17664 / TIR 12

STEP 1 : The Medical Device Manufacturer produces a reliable instrument

The MDM determines the functional compatibility and the methods of sterilization that can be approved
for use in a STERRAD® System.

ISO 14937

STEP 2 : The Sterility Supplier (ASP) provides a reliable sterilization method

ASP evaluates the device for sterile efficacy on the approved materials and lumen clams for a specific STERRAD® system.

MDM IFU / AAMI ST 81

STEP 3 : The Health Care Professional performs the sterilization process efficiently

The HCP should follow the MDM’s recommended Instruction For Use (IFU) for sterilization.

The STERRAD® Sterility Guide (SSG)

The STERRAD® Sterility Guide (SSG) is an online resource that provides customers with a list of devices that are within STERRAD® sterility claims. It can be accessed via the SSG website or via a dedicated Mobile App.

  • Search for your device in the STERRAD® Sterility Guide (SSG)
  • The STERRAD® Sterility Guide (SSG) is our database of over 16,000 devices that have been tested to meet STERRAD® System claims for sterility.
  • SSG is the most comprehensive list of approvals from the device manufacturers.
  • Verify STERRAD® macine compatibility and cycle options for your device.
  • Maintain your own inventory for quick and easy reference.

 

Why Health Care Professionals feel confident using SSG?

  • All medical devices listed in SSG are supported by written authorization from the manufacturer
  • All medical devices listed in SSG fall within approves sterility claims
  • SSG provides link to MDM's website and contains manufacturer's notations to assist customers with any specific instructions for use (IFU)
  • New devices are constantly added to the SSG
  • All medical devices listed in SSG are reviewed on a yearly basis
  • MDMs reach out to ASP during product development for advice on how to design new devices for sterilization in STERRAD® Systems