What is the Medical Device Manufacturing Program?

The Medical Device Manufacturing (MDM) Program was designed for one purpose - to provide peace of mind to health care professionals.

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.

Find out more about which devices have been validated for use in STERRAD® here.

Find your device in the SSG Learn more about STERRAD Systems Contact us

Joint Responsibilities to Ensure Safe and Effective Sterilization

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.

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
Find your device in the SSGLearn more about STERRAD SystemsContact us
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