Continuing from last month’s article where we highlighted the key points from Part A lets take a look at Part B and see what the key points of reference are.
Just to recap 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.
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
· 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.
2.1. 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
2.5. Maintenance should be carried out under the Local Decontamination Unit (LDU) quality management system (QMS) and any Original Equipment Manufacturer (OEM) parts/ spares fitted to decontamination equipment (for example WDs and sterilizers) should be sourced from manufacturer authorised agents
2.11. All maintenance, servicing and testing of equipment should be carried out by suitably qualified competent persons. All Staff and CP(D) 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 that they are, firstly, fully qualified to undertake the work, secondly, have been fully trained by the manufacturer of the equipment that they are working on, and thirdly 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:
2.22. 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
2.23. Installation and validation tests must follow current guidance included within SHTM 01-05 part B, which is aligned with the standards and guidance for benchtop sterilizers British Standards (BS) EN 13060:2014 + A1 2018, and for WDs BS EN ISO 15883 Parts 1, 2 and 5
2.28. 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.
2.29. 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 outlines with the EN’s should be followed. It does also state the following regarding the testing:
4.81. As per Section 2, manufacturer’s 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 below should be considered
Washer Disinfectors
As WD’s 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, entering the mains water supply. This is outlined as follows and will follow WRAS (Water Regulations Approval Scheme):
4.32. All WDs and associated equipment should be connected to the main drain in a manner that provides backflow protection and be consistent with Building (Scotland) Regulations 2004 and Sewerage (Scotland) Act 1968 (as amended 2002)
4.44. 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 detergents ability to clean effectively. If water is hard then the fitting of an water treatment unit may be required:
4.65. Where the local water supply is >125mg/l of CaCO3, some form of water treatment system may be required
4.68. 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 unit
4.70. 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 Regulation. The 3 classifications of Steam steriliser are outlines as N, B and S with the following mentioned regarding N class being made:
type N: air removal in type N sterilizers is achieved by passive displacement with steam. They are non-vacuum sterilizers designed for non-wrapped solid instruments. These sterilizers 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:
7.11. Where a sterilizer 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 sterilizers are used.
When having a new autoclave fitted a Written Scheme of Examination should be provides in accordance with the PSSR 2000 and any cycles that are not to be used should be removed to not only avoid any unnecessary use but also to reduce any testing and validation requirements.
These are the key take aways from Part B and next month we will start to break down Part C where we delve into the whole Process.
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