A list of the main documents covering the work of Decontamination can be found on the Publications page.
Endoscope Decontamination Document System
HFS was tasked with producing this document system for decontamination and management of flexible endoscopes. EDDS is a set of generic documents that may be used in Endoscope Decontamination Units within NHSScotland. The set comprises of a decontamination policy, a set of decontamination standard operating procedures and their associated record forms. At the back of the policy document a contents list provides links to each of the individual EDDS standard operating procedures & record forms.
The policy document can be found below:
http://www.hfs.scot.nhs.uk/publications/1498138821-EDDS Policy -v1.0 with EDDS list.pdf
NHSScotland Guide to the Carriage of Dangerous Goods Regulations with respect to Used Medical Devices can be downloaded on the Publications page.
Logbooks
These logbooks consist of testing and validation templates covering decontamination equipment used within decontamination units and laboratories.
Please note: Logbooks may be amended at any time to ensure consistency with latest standards and guidance. It is the responsibility of the users to download the latest versions. We can notify users of any changes if subscribed for updates - to register for this service, please contact nss.hfsdeconteam@nhs.net, and state which logbooks you are interested in.
Ultrasonic Cleaner
Ultrasonic Cleaner Logbook
Small Steam Sterilizer with Type B or S Cycles
Small Steam Sterilizer with Type B or S Cycles
Porous Load Sterilizer
Porous Load Sterilizer Logbook V1
Small Steam Sterilizer with Type N Cycle Only
Small Steam Sterilizer Type N Cycle Logbook V1
Thermal Washer Disinfector
Thermal Washer Disinfector Logbook V2
Laboratory Sterilizer
Laboratory Sterilizer Logbook V1
Endoscope Washer Disinfector
Endoscope Washer Disinfector Logbook v1
New in 2018 Publication of the first release of the SHTM 01-01 series.
The best practice guidance Scottish Health Technical Memorandum (SHTM) 01-01 Decontamination of medical devices in a Central Decontamination Unit (CDU) replaces some parts of SHTM 2010, SHTM 2030 and SHTM 2031 guidance published in 2001. SHTM 01-01 provides more detailed guidance to assist in the compliance with parts of the HFS guidance GUID 5014 ‘Requirements for compliant CDUs’ published in 2016.
The SHTM 01-01: 2018 series comprises of seven parts as follows:
• 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
The SHTM 01-01 series parts are concerned with decontamination of medical devices in a Central Decontamination Unit (CDU). 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.
SHTM 01-01 Part A content includes quality management, the decontamination process, general validation of equipment, health and safety, infection control precautions, regulatory framework, reporting incidents outbreaks and distribution of safety alerts, repair, refurbishment and quarantine of medical devices, functional roles and responsibilities, permit-to-work system, medical devices potentially contaminated with Transmissible Spongiform Encephalopathy (TSE) infectivity, disposal and metal recycling and procurement. A glossary for the series is provided in Part A. The European Union (EU) Regulation 2017/745 on medical devices and standard EN 17664: 2017 ‘Processing of health care products - information to be provided by the medical device manufacturer for the processing of medical devices’ are also considered in Part A.
Archiving of GUID 5015
Interim Guidance Roles and Responsibilities of NHSScotland Decontamination Engineering Staff in the Acute Sector Guidance – GUID 5015 published 2017 is now superseded by SHTM 01-01. The document remains available on the archive page.