Print
E-mailWhat 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.
Joint Responsibilities to Ensure Safe and Effective Sterilization
 |
 |
 |
 |
 |
|
ISO 17664 / TIR 12 STEP 1 : The Medical Device Manufacturer produces a reliable instrumentThe 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 methodASP 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 efficientlyThe 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
