Last month we outlined that Scotland has now received a new SHTM 01-05 document and that I would start to breakdown the highlights from each section and what this means to dentistry.
This document, unlike the English, Welsh and N.I variant, is made up of 3 bite size publications as outlined:
· Part A - Management - Focuses on the management of the decontamination process within the LDU and 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 in line with the Chief Dental Officer (CDO) letter (2010) and current guidance
· Part C - Process - Provides practical guidance on the whole instrument decontamination process, presented in a form designed to be readily understandable by members of the dental team and has been written in collaboration with the Scottish Dental Clinical Effectiveness Programme (SDCEP)
o For 10 years Scottish dentistry has been working with SDCEP however the new SHTM 01-05 Part C now replaces this.
We will start with Part A – Management – and outline the key take aways from the new update.
Brexit
With Brexit now well and truly implemented and the UK now a separate Island we now have a transition period for the adoption of the new UKCA marked Medical Devices in replacement of the longstanding CE mark. Section 2 outlines the Regulatory Framework and states:
2.2. From January 2020, the start of the EU-exit transition period, the MDR 2002 (SI 2002 No 618, as amended) (UK MDR 2002) as amended by the Medicines and Medical Devices Act, 2021, outlines the requirements for medicine and medical device manufacturers placing on the Great Britain market.
2.3. Although the BREXIT transition period has ended, Reusable Medical Devices (RMDs) may continue to use the Conformité Européene (CE) marking until 30th June 2028 (may be subject to change). However, the new United Kingdom Conformity Assessed (UKCA) mark (a new UK product marking) may also now be used for RMDs being placed on the UK market.
Training
Staff training is of the utmost importance to ensure that all of the equipment used is being done so in the correct manner. It is also important that all members of the team are adequately trained on the latest guidance to ensure that they stay safe. Section 6 of Part A states:
6.3.: staff undertaking decontamination duties should access training in section 6 of the ‘Framework to support staff development in the decontamination of re-usable medical devices’ for courses and in-practice training which cover infection prevention and control, including decontamination
6.3: persons carrying out periodic quarterly/ annual testing of decontamination equipment and possibly reviewing/ signing off reports require to be suitably qualified, for example City and Guilds certificate
Decontamination Lead
It is so important that all practices, not just in Scotland, have a nominated Decon Lead to ensure and maintain staff/ patient safety and that all aspects of effective decontamination are adhered to. Section 6 outlines:
6.11. Every healthcare organisation for example the NHS Health Board should have a nominated Decontamination Lead.
The Decontamination Lead is responsible for:
• providing effective and technically compliant decontamination services
• implementing an operational policy for decontamination
• ensuring that the operational policy clearly defines the roles and responsibilities of all personnel who may be involved in the use, installation, and maintenance of decontamination equipment
• monitoring the implementation of the operational policy for decontamination services; delegating specific responsibilities to key personnel; the extent of such delegation should be clearly set out in the operational policy together with the arrangements for liaison and monitoring
Record keeping and Traceability
Keeping effective records of servicing, testing, cycle logs etc. is extremely important to ensure that all aspects of the decon process have worked correctly. This is particularly important if an outbreak occurs and the process is brought under scrutiny. Section 7 outlines:
7.2. Dental and decontamination records, including equipment and process records should be held securely by the User for the period recommended by the Scottish Government in Scotland Government Records Management Health and Social Care Code of Practice (Scotland) 2020.
Section 3.2, (page 84) of the Code of Practice indicates that records should be retained for the lifetime of the equipment plus 25 years afterwards.
7.3. Some types of printouts are known to fade quickly, therefore special action is required to preserve these records (for example photocopying, or electronic scanning) and it is acceptable to backup original paper records with electronic versions in this way
7.4. Where possible in day-to-day decontamination, dental instruments in a LDU should be traced through processing, which may include:
• operational cycles involved in processing a particular dental instrument, or set of dental instruments should be traceable
These are the key take aways from Part A and next month we will start to break down Part B where we delve into the equipment and testing requirements.
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