New Scottish decontamination guidance: Part B

Following the updates to decontamination guidance in Scotland, Decon Pete looks at how the decontamination equipment and test methods are changing.

Continuing from last month’s article where we highlighted the key points from Part A, let’s take a look at Part B and see what the key points of reference are.

Just to recap, unlike the English, Welsh and Northern Irish variant, this document is made up of three bite size publications as outlined:

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.

Part B takes a detailed look at all of the equipment that is used within the local decontamination unit (LDU) and outlines the exact testing/validation and maintenance procedures that are required to be adopted.

Maintenance and servicing

The following equipment is described and full maintenance and servicing requirements are outlined:

Washer disinfectors (WDs)
Ultrasonic baths
Lubricators and heat sealers
Sterilisers.

Maintenance and servicing is a crucial part of ensuring that all medical devices are working in accordance to the manufacturers instructions and as intended.

The guidelines state:

A programme of planned preventative maintenance (PPM) should be in place for all decontamination equipment to ensure the required standards of performance and safety are met and maintained
Maintenance should be carried out under the LDU quality management system (QMS) and any original equipment manufacturer (OEM) parts/spares fitted to decontamination equipment (for example washer disinfectors and sterilisers) should be sourced from manufacturer authorised agents
All maintenance, servicing and testing of equipment should be carried out by suitably qualified competent persons. All staff undertaking these duties should be knowledgeable in the correct use and wearing of personal protective equipment (PPE) as outlined in the National Infection Prevention and Control Manual (NIPCM).

It is important that whoever you employ to maintain your equipment, they are fully qualified to undertake the work, have been fully trained by the manufacturer of the equipment that they are working on, and only use genuine manufacturer parts to complete the work.

Validation and periodic testing

Validation is a way of ensuring and showing that the equipment is working as it was intended to the day it came out of the factory. Any new equipment that is purchased must be fully validated before use to ensure that nothing has changed during transit.

The key takeaways here are:

Validation is required for new equipment at installation with additional periodic monitoring thereafter (daily, weekly, quarterly and annually) to ensure all decontamination equipment is fit for purpose. It will also be necessary to re-validate equipment after any major repairs have been carried out
Installation and validation tests must follow current guidance included within SHTM 01-05 Part B
A testing protocol should be agreed in advance prior to purchase and included in the procurement contract. The responsibility for performing works tests will normally rest with the manufacturer. The responsibility for testing once installed on site is dependent upon contractual agreements and/ or purchaser preferences
Failure to employ testing protocols or retain evidence of their performance may indicate non-compliance of the decontamination process.

Within each of the equipment sections, SHTM outlines the periodic tests that are required in accordance with the various EN regulations. The individual manufacturers will outline what tests they require.

However, in the absence of this, the tests outlined in the EN regulations should be followed. It also states the following regarding testing:

As per section two, manufacturers’ instructions for use (IFU) should be followed, however periodic testing protocols will vary between manufacturers and therefore a risk assessment should be taken to assess if the testing being carried out is adequate. For example, if the manufacturers recommended testing frequency is inadequate to highlight a potential issue, then the recommended tests should be considered.

Washer disinfectors

As WDs are mandatory in Scotland as the primary method for cleaning all dental instruments, they are subject to more stringent requirements.

When having a WD installed, it is important that the unit is fitted with ‘backflow’ protection to prevent any contaminated water within the WD from entering the mains water supply. This is outlined as follows and will follow WRAS (Water Regulations Approval Scheme):

All WDs and associated equipment should be connected to the main drain in a manner that provides backflow protection and is consistent with the Building (Scotland) Regulations 2004 and Sewerage (Scotland) Act 1968 (as amended 2002)
A ‘type A’ air gap is required at the point of use or an interposed cistern. This applies to all WDs and water softening treatment plant, other than those regenerated only by means of sodium chloride solutions, which should be protected by a ‘type B’ air gap.

Water quality also pays an important part in the effectiveness of the WD and the detergent’s ability to clean effectively. If water is hard then the fitting of a water treatment unit may be required:

Where the local water supply is >125mg/l of CaCO3, some form of water treatment system may be required
If the input water quality, for example, hardness, is higher than recommended levels, then the following water treatment methods may be considered as an option: water softener or RO (reverse osmosis) unit
When considering the purchase of process chemicals and accessories, the ‘NP187 framework for decontamination consumables’, should be considered as the first option.

Sterilisers

All small benchtop sterilisers must conform to EN13060 and will be clearly CE/ UKCA marked in line with the Medical Device Regulations. The three classifications of steam steriliser are outlined as N, B and S.

Regarding N class being made, the following is stated: air removal in type N sterilisers is achieved by passive displacement with steam. They are non-vacuum sterilisers designed for non-wrapped solid instruments. These sterilisers are not designed for reprocessing instruments with a lumen.

It is also important that every cycle that your steriliser is able to perform must be validated and periodic tested in accordance with the guidance:

Where a steriliser is installed with multiple cycle options, it is important to note that all the cycles configured within the control memory require periodic validation to current guidance. If there are cycle options that are configured and not used, they should be deleted or disabled to prevent unauthorised use. Single cycle options are preferred where benchtop sterilisers are used.

When having a new autoclave fitted, a written scheme of examination should be provided in accordance with the PSSR 2000. Any cycles that are not to be used should be removed to not only avoid any unnecessary use but also reduce any testing and validation requirements.

These are the key take aways from Part B, and next month we will break down Part C where we delve into the whole process.

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

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