Decontamination of medical devices in a Central Decontamination Unit (SHTM 01-01)

This series parts are concerned with decontamination of medical devices in a Central Decontamination Unit (CDU). Examples of medical devices would include surgical instruments and robotic arm instruments which are sterilized using low temperature sterilization processes. This guidance covers decontamination of medical devices processed through a CDU. Examples of medical devices would include surgical instruments and robotic arm instruments which are sterilized using low temperature sterilization processes. The term medical device as used in the SHTM 01-01 series applies to those that are processed through a CDU. The supplement GUID 5017 considers preparation of soiled medical devices in the clinical area prior to their transport to the CDU.

• Part A: Management
• Part B: Test equipment/methods
• Part C: Sterilization by steam
• Part D: Automated cleaning and disinfection equipment
• Part E: Sterilization by Hydrogen Peroxide or Ethylene Oxide
• Part F: Inspect, Assemble and Package
• GUID 5017 supplement: Guidance for Service Users
• GUID 5019: addendum for new NICE IPG 666:2020 recommendations

This series replaces some parts of SHTM 2010, SHTM 2030 and SHTM 2031 guidance published in 2001 but provides more detailed guidance to assist in the compliance with parts of the HFS guidance GUID 5014 ‘Requirements for compliant CDUs’ published in 2016.

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