New Scottish decontamination guidance: Part A

Following the recent update to decontamination guidance in Scotland, Decon Pete looks at how the management of decontamination processes is changing.

Last month we outlined that Scotland has now received a new SHTM 01-05 document. Therefore, I would like to breakdown the highlights from each section and what this means for dental practices.

This document, unlike the English, Welsh and Northern Irish variant, is made up of three bite-sized publications:

Part A: management – this section focuses on the management of the decontamination process within the local decontamination units (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 and test methods – this 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 – this section 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). For 10 years Scottish dentistry has been working with SDCEP however the new SHTM 01-05 Part C now replaces this.

Let’s dive into Part A on management and outline the key takeaways from the new update.

Brexit

With Brexit now well and truly implemented in the UK, we now have a transition period for the adoption of the new United Kingdom Conformity Assessed (UKCA) marked medical devices in replacement of the longstanding CE mark.

Here is what has changed to the regulatory framework:

From January 2020, the start of the EU-exit transition period, the MDR (medical devices regulations) 2002, as amended by the Medicines and Medical Devices Act 2021, outlines the requirements for medicine and medical device manufacturers that are being placing on the UK market
Although the Brexit transition period has ended, reusable medical devices (RMDs) may continue to use the Conformité Européene (CE) marking until 30 June 2028 (this may be subject to change). However, the new 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.

The latest guidance states:

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
Persons carrying out periodic quarterly/annual testing of decontamination equipment and possibly reviewing/signing off reports require to be suitably qualified, for example a 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 of the new guidelines states that the decon 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 and 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 and cycle logs etc is extremely important to ensure that all aspects of the decontamination process have worked correctly. This is particularly important if an outbreak occurs and the process is brought under scrutiny.

The guidelines state:

Dental and decontamination records, including equipment and process records, should be held securely by the user for the period recommended by the Scottish Government
Records should be retained for the lifetime of the equipment plus 25 years afterwards
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
Where possible in day-to-day decontamination, dental instruments in a LDU should be traced through processing. This 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 look at Part B when we will dive into the equipment and testing requirements.

If you want to know more or require any help and assistance then please do not hesitate to get in touch with me with via email [email protected] or visit the website www.deconpete.co.uk.

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