For some time now the various areas of the UK have been working towards relatively outdated 01-05 documents. This has now changed with the introduction of a brand new SHTM 01-05 for Scotland which was published in April of this year.
Over the coming articles we will be breaking down the key changes to the document and outlining what it means for Scottish dentistry. However this month we will take a look at what each section of the document will cover.
This document, unlike the English, Welsh and Northern Irish variant, is made up of three bite-sized publications as outlined:
Part A – management: focuses on the management of the decontamination process within the LDU. Applies to dental instruments that are processed by the user or a third party to be made ready for use
Part B – decontamination equipment/test methods: covers decontamination equipment used to carry out processing of dental instruments. It details the maintenance, periodic testing and test equipment requirements for decontamination equipment. This is in line with the Chief Dental Officer Letter (2010) and current guidance
Part C – process: provides practical guidance on the whole instrument decontamination process. It is presented in a form designed to be readily understandable by members of the dental team, written in collaboration with the Scottish Dental Clinical Effectiveness Programme (SDCEP)
For 10 years Scottish dentistry has been working with SDCEP however the new SHTM 01-05 Part C now replaces this.
Why has decontamination guidance been updated?
This new SHTM has been developed with an aim of facilitating a greater alignment with other UK documents. It also aligns itself to the Medical Device Regulations 2002 (MDR) and supersedes parts of SHTM 2010, SHTM 2030 and the SDCEP decontamination into practice series.
Although the new guidance is designed for all NHS and private practices it does also state the following:
Note 1: dental services using equipment such as porous load sterilisers and pass-through washer disinfectors (WDs) should refer to:SHTM 01-05:2024 parts A and C for the decontamination management and processSHTM 01-01:2018 parts B, C and D for guidance for decontamination equipment and testing. (Part B of SHTM 01-05:2024 does not apply.)
As dental services are referred to as those access centres within the hospital setting the SHTM 01-05 part B does not apply as the main testing/ validation etc will be carried out by facilities estates. This will be in accordance with ’01-01 Decontamination of medical devices in a central decontamination unit’.
Part A contents
The contents of this part include:
Regulatory framework and national requirements
Staff training
Health and safety
Infection prevention and control
Functional roles and responsibilities of all staff and external companies
Documentation and traceability
Reporting incidents, outbreaks and distribution of safety alerts
Repair, refurbishment and quarantine of medical devices
Disposal, decommissioning and procurement
The MDR and information provided by the medical device manufacturer for the processing of dental instruments.
Part B contents
Part B is intended as a guide for management, technical personnel with appropriate training and experience. It additionally outlines the users responsible for the operational management of all decontamination equipment. It will also be of interest to microbiologists, infection control managers, estates managers, supplies officers, contractors, suppliers, and others in both the public and private sectors.
This guidance covers all aspects of ultrasonic cleaners (UCs), automated WDs, sterilisers (type N, B and S), lubricators and their accessories used for processing medical devices in an LDU.
Part C contents
Part C is based on and replaces the extensively used SDCEP decontamination into practice guidance series, which was completed in 2014.
Building on the success of the SDCEP guidance series, SHTM 01-05 part C presents practical, up-to-date advice on each aspect of decontamination within dental practice. Reference to parts A or B may be necessary for more detailed technical guidance.
Environmental sustainability should be considered whenever possible when updating processes. See SHTM 01-05 part A, section eight.
Over the coming articles we will delve deeper into the key changes of each section, starting with part A.
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