Revision 1 - February 2014 - Wales 01-05 Revision 1.pdf · Revision 1 - February 2014. ... NWSSP-FS...

WHTM 01-05Welsh Health Technical Memorandum

Decontamination in primary caredental practices and

community dental services

Revision 1 - February 2014

The amendments made in this revision are:

Acknowledgements

Paragraph 1.13 amended

Diagram on page 20 amended

Paragraph 2.4k amended

Note following paragraph 2.4k added

Note following paragraph 2.4l amended





Appendix 1: First line of the first note amended

Appendix 2: Three bullet points added

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Welsh Health Technical Memorandum 01-05 - Decontamination in primary care dental practices and community dental services Revision 1 - February 2014

Disclaimer

The contents of this document are provided by way of general guidance only at the time of its publication. Any partymaking any use thereof or placing any reliance thereon shall do so only upon exercise of that party’s own judgementas to the adequacy of the contents in the particular circumstances of its use and application. No warranty is given asto the accuracy, relevance or completeness of the contents of this document and NHS Wales Shared ServicesPartnership – Facilities Services shall have no responsibility for any errors in or omissions there from, or any use madeof, or reliance placed upon, any of the contents of this document.

Note: Heath Building Notes (HBNs) and Health Technical Memoranda (HTMs) issued by the Department ofHealth in England are being superseded by specific Welsh editions which will be titled Welsh Heath Building Notes(WHBNs) and Welsh Health Technical Memoranda (WHTMs). Until this process is complete, where a WHBN orWHTM is referred to in the text but has not yet been published, refer to the relevant publications page on the NHSWales Shared Services Partnership – Facilities Services website for the latest approved document.

Intranet: howis.wales.nhs.uk/whe

Internet: www.wales.nhs.uk/whe

Published by NHS Wales Shared Services Partnership – Facilities Services

This guidance is based on the HTM 01-05 Decontamination in primary care dental practices Welsh edition 2011guidance published by Welsh Health Estates which, in turn, was based on the 2009 edition produced by theDepartment of Health

This publication can be accessed from the NHS Wales Shared Services Partnership – Facilities Services websitewww.wales.nhs.uk/whe

ISBN ISBN: 978-1-909899-19-3

© Copyright NHS Wales Shared Services Partnership – Facilities Services 2014

Supersedes Welsh Health Technical Memorandum 01-05 Decontamination in primary care dental practices andcommunity dental services January 2014

Cover image of Neath Port Talbot Primary Care Resource Centre by courtesy of Abertawe Bro Morgannwg.Photograph by Stewart Brooks, NWSSP-FS

Cover designed by Keith James

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http://howis.wales.nhs.uk/sites3/home.cfm?OrgID=254

Patients deserve consistent standards of care every timethey receive treatment. It is essential that they are treatedin a safe and clean environment with minimal risk ofperson-to-person transmission of infections.

This document has been produced after wideconsultation and reflects our commitment to improvingstandards in dental practices.

We believe that, by building on existing good practice,this guidance can help us to deliver the standard ofdecontamination that our patients have a right to expect.

The policy and guidance provided in this WHTM areaimed at establishing a programme of continuousimprovement in decontamination performance. The

guidance suggests options to dental practices withinwhich choices may be made and a simple progressiveimprovement programme established. It is expected thatat publication of this guidance all primary care dentalpractices will be working at or above the requirementsdescribed in my letter of May 2012 CDO(2012)2. (http://wales.gov.uk/topics/health/cmo/professionals/dental/publication/cdo-letters/compliance/?lang=en).

This revised guidance is intended to support andadvance good practice throughout primary care dentistryincluding that delivered by general dental practices,community dental services and where primary care isdelivered in acute settings.

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Foreword by David Thomas, Chief Dental Officer

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Scope, status and structure ofWHTM 01-05Welsh Health Technical Memorandum (WHTM) 01-05is intended to progressively raise the quality ofdecontamination work in primary care dental services bycovering the decontamination of reusable instrumentswithin dental facilities.

The guidance relates to locally conducteddecontamination procedures, which are the mostcommon method of decontamination in primary dentalcare. As such, this includes all work where the end-userand the persons conducting decontamination areemployees of the same organisation working in the sameor related premises. Ordinarily this will be a generaldental practice or community dental services functioningas part of the local health community.

Where practices choose to make use of an externalservice, such as a central sterile services department,which is fully compliant with the Medical DevicesRegulations 2002 and is registered with the Medicinesand Healthcare products Regulatory Agency (MHRA),the guidance contained in WHTM 01-01‘Decontamination of medical devices within acuteservices’ will be appropriate.

The CDO (Wales) letter (2006)1- ‘Decontamination/Sterilisation of Re-usable Instruments in General DentalPractice’ states ‘The Medical Device Regulations 2002require the manufacturer of medical devices to supplyinformation on the appropriate processes to allow reuse,including cleaning, disinfection, packaging and, whereappropriate, the method of sterilization. If correctlyfollowed, these instructions will ensure that the devicewill be safe for another episode of use’. This implies thatdental practices ensure their local policies give rise to theproduction and use of sterilized instruments for use withpatients.

This document is divided into three Sections:

• Section A: Decontamination policy

This section outlines the policy and principles ofdecontamination in dental practices, and explains therequirements for decontamination.

• Section B: Advice to dentists and practice staff

This section gives plain advice to dentists andpractice staff on how to achieve improved goodpractice; how to clean and sterilize instruments; andhow to set up a decontamination area within thepractice.

• Section C: Engineering, technology and standards

This section gives technical advice to engineering andtechnical staff, including the roles and responsibilitiesof staff in the decontamination process. Such as theUser Authorising Engineer (Decontamination)(AE(D)), Authorised Persons (Decontamination)(AP(D)), Competent Persons (Decontamination)(CP(D)) and others.

Reference to guidance and standards provided by theWelsh Government and MHRA is provided andexplained throughout this document.

Where engineering and technical information is provided(Section C), references to source standards and evidenceare given. However, such references are omitted inSection B to aid clarity of presentation and explanation.

It is important to remember that this is a workingdocument; changes to it may be necessary as newevidence around the methodology ofdecontamination becomes available. The user shouldalways seek advice on policies, technical issues andguidance to ensure improvements are maintained.

Who should use WHTM 01-05WHTM 01-05 will be of interest to all staff involved indecontamination in primary care dental services inWales.

It is intended to be used, or referred to, by all membersof a dental team providing primary care dental servicesthat is, dentists and support staff as well as engineeringstaff providing services in key areas. In addition, HealthBoards will find the contents of value.

Reference to other parts of the WHTM 01 series may benecessary on a limited basis only.

Overview

Listed below are the contributors to the originalDepartment of Health Publication on which thisWelsh Edition is based.

Allan Hidderley Medicines & Healthcare productsRegulatory Agency

Christine Arnold British Dental Association

Daniel McAlonan British Dental Association

Esther Dias Infection Prevention Officer andDecontamination Lead, NHS Bromley

Geoff Ridgway Clinical microbiologist

Hugh Bennett Deputy Chief Dental Officer for Wales

Jimmy Walker Health Protection Agency

Ken Toal Health Estates, Northern Ireland

Lesley Derry British Dental Association

Lester Ellman General Dental Practitioner

Margie Taylor Chief Dental Officer for Scotland

Martin Jones Infection Prevention Society

Murray Devine Safety Strategy Lead, HealthcareCommission

Paul Gray NHS Business Services Authority, DentalServices Division

Paul Langmaid Chief Dental Officer for Wales

Stuart Johnston British Dental Association DHWorking Group on Water Quality in Use and

Decontamination of Surgical Instruments. ChairmanNigel Tomlinson

Engineering and Science Advisory Committee on thedecontamination of surgical instruments. ChairmanMike Painter

Internal consulting group

Barry Cockcroft Chief Dental Officer for England

Jerry Read Section Head, Dental and Eye Care Division

Serbjit Kaur Head of Quality and Standards, Dentaland Eye Care Services

Ruth Gasser Department of Health

Ian Rowlan Senior Engineer, Department of Health

Philip Ashcroft Principal Buildings and FacilitiesManagement Services Engineer, Department of Health

Nigel Tomlinson Principal Scientific Adviser,Department of Health

Listed below are the contributors to this Welshedition publication who sit on the WHTM GuidancePeer Group as directed by the Welsh AssemblyGovernment’s All Wales Decontamination Group.

David Thomas Chief Dental Officer, WelshGovernment

Lisa Howells Senior Dental Officer, Welsh Government

Tracey Gauci Nursing Officer, Welsh Government

Mike Simmons Consultant in Public HealthMicrobiology and Service Lead, Public Health Wales

Phillip Flear Sterile Services Manager (Hywel DdaHealth Board)

Eric Thomas Assistant Director, EnvironmentalManagement and Engineering, NHS Wales SharedServices Partnership – Facilities Services

Graham Stanton Senior Decontamination Engineer,NHS Wales Shared Services Partnership – FacilitiesServices

John Prendergast Decontamination Engineer, NHSWales Shared Services Partnership – Facilities Services

Christopher Lewis Environmental ManagementAdvisor, NHS Wales Shared Services Partnership –Facilities Services

Peter Wiles Deputy Director, NHS Wales SharedServices Partnership – Facilities Services

Acknowledgements

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ACDP-TSE: Advisory Committee on DangerousPathogens’ Transmissible Spongiform EncephalopathyRisk Management Subgroup

AE(D): Authorising Engineer (Decontamination)

AP(D): Authorised Person (Decontamination)

BS: British Standards

CAPR: Clinical Audit and Peer Review

CDO: Chief Dental Officer

CE: Conformité Européenne

CPD: Continuing Professional Development

CP(D): Competent Person (Decontamination)

COSHH: Control of Substances Hazardous to Health

DUWL: Dental unit water line

EN: European Norm

EU: European Union

EWC: European Waste Catalogue

HCAI: Healthcare associated infections

IHEEM: Institute of Healthcare Engineering and EstateManagement

ISO: International Standards Organisation

MDD: Medical Devices Directive

MHRA: Medicines and Healthcare products RegulatoryAgency

NWSSP-FS: NHS Wales Shared Services Partnership –Facilities Services

PGMDE: Postgraduate Medical & Dental Education

PPE: Personal Protective Equipment

RO: Reverse osmosis

SSD: Sterile Services Department

TVC: Total viable counts

WHTM: Welsh Health Technical Memorandum

Abbreviations

Contents

Foreword by David Thomas, Chief Dental Officer 4

Overview 5Scope, status and structure of WHTM 01-05Who should use WHTM 01-05

Acknowledgements 6

Abbreviations 7

Section A: Decontamination policy

Chapter 1 Policy 13RegistrationIntroductionThe need for guidanceImprovements and enhancements in practice with the latest guidance,

policy and standardsImprovements and enhancements in practicePrion decontaminationInfection prevention and control policyTraining and educationExclusionsRelationship to other sources of information and guidanceFurther guidance

Section B: Advice to dentists and practice staff

Chapter 2 Improvements and enhancements of the decontamination process 20Decontamination of instruments – an overviewCompliance

Meeting the standards required

Chapter 3 Cleaning instruments 27IntroductionGeneral requirements for cleaning methodsAutomated cleaning: washer-disinfectors

Using a washer-disinfectorRecordsConsiderations for cleaning handpieces

Automated cleaning: ultrasonic cleaningUltrasonic cleaning procedure

Manual cleaningAvoiding instrument damageCleaning procedure summaryRinsing of instruments after cleaning and/or disinfection

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Inspection and care of instruments before sterilizingHandpiece care

Chapter 4 Sterilization 33Types of sterilizerDental handpiecesSmall sterilizers

Use and testing of small sterilizersDaily testing and housekeeping tasks

Packaging and related decontamination strategyStorage of sterilized instruments/devices

Chapter 5 Setting up a decontamination area 39Physical segregation

Chapter 6 General hygiene principles 43Hand hygiene

Drying of handsSkin careFacilities and procedures for hand-washing

Personal protective equipment for decontamination processesGlovesDisposable plastic apronsFace and eye protection for decontamination proceduresFootwareClothing, uniforms and laundryRemoval of PPE

Surface and equipment decontaminationGeneralEnvironmental conditionsSurfaces and equipment – key design issuesDecontamination equipmentCleaning protocols and techniques

Decontamination of treatment areasDental unit water lines (DUWLs)

GeneralDUWLs

Chapter 7 Impressions, prostheses and orthodontic appliances 51

Section C: Engineering, technology and standards

Chapter 8 Regulatory framework and compliance 53BS/EN/ISO StandardsNHS Wales guidelines

Chapter 9 Staff roles and responsibilities in decontamination 54

Chapter 10 Procurement of decontamination equipment and instruments 57Determining the load to be processedDecontamination equipment: washer-disinfectors and sterilizersDecontamination equipment: ultrasonic cleaners

SpecificationsSelecting instrumentsPolicy on new reusable instruments

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Contents

Chapter 11 Decontamination equipment: general guidance on maintenance and testing 61Maintenance and servicingValidation and testingDocumentation

Chapter 12 Installation, validation, maintenance and testing of sterilizers 63Maintenance and servicingValidation and testingPeriodic tests

Chapter 13 Installation, validation, maintenance and testing of washer-disinfectors 65Maintenance and servicingValidation and testingPeriodic tests

Chapter 14 Installation, validation, maintenance and testing of ultrasonic cleaners 67Maintenance and servicingValidation and testingPeriodic tests

Chapter 15 Additional information on test procedures (in addition to those provided in the Standards) 69Automatic control test

MethodUltrasonic activity test

MethodSafety checks

Weekly checksYearly checks

Chapter 16 Approach and protocol for manual cleaning 71Cleaning procedure for dental instruments

Chapter 17 Steam and water quality 73Steam

Quality of input waterConditions of storage and frequency of change

WaterCleaningFinal rinsingDetergents

Chapter 18 The use of lubricants 75

Chapter 19 Hot and cold water systems and dental unit water lines 76Safe hot water temperatureUtilisationFlushing dental unit water lines (DUWLs)Decommissioning of DUWLsRecommissioning of DUWLsMaintenance policyContract maintenanceEmergency actionDocumentationAs-fitted drawingsRecord-keepingWater supply hygiene

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Water treatmentPurging the systemsOzone and ultraviolet treatmentWater storage

Cold water distribution systemDrinking waterInstantaneous water heaters for single or multi-point outletsSafe hot water delivery devicesMaterials and constructionTemperature control regimenPoint-of-use filtration

Summary checklistMicrobiological monitoring

Appendix 1: Waste disposal 85What are the responsibilities of the dental practice?

Appendix 2: Hand-hygiene policy 86

Appendix 3: Examples of logbook pages 89

References 94

Useful links 97

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Contents

Section A: Decontamination policy

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Registration1.1 The registration of dentists providing dental

treatment privately has been in place since 2009.Healthcare Inspectorate Wales will continue tooversee this process and have regulatoryresponsibility to ensure that the requirements forregistration are met. This includes the provision ofa safe, clean environment and appropriatedecontamination of dental equipment.

1.2 The registration scheme will place strong emphasison effective management and self-audit. (Forfurther information, see the Note after paragraph8.10).

Introduction1.3 This document is a guide for those conducting

decontamination at a local level – that is, withinthe dental practice itself. However, this policystatement respects the option to transferinstruments/medical devices to other organisationsfor reprocessing under the Medical DevicesRegulations 2002.

1.4 To help dental practices to improve theirdecontamination procedures, this documentintroduces methods that provide an approved codeof practice for decontamination of devices usedwith dental practices.

1.5 The requirements described in this guidance areintended as a clear indication of good practice anddesigned to promote continuous improvement inthe performance of dental practices. They will helpto demonstrate to patients and those observingquality standards in dentistry that the localprovider of a dental service is capable of operatingin a safe and responsible manner with respect todecontamination of instruments and dentalequipment. Where new practices arecommissioned or new premises contemplated, it isadvised that the full best practice provisions of thisguidance be utilised wherever reasonablypracticable.

1.6 This guidance supports and is in keeping with thestrategic aim of Welsh Government to eliminate all

preventable healthcare associated infections asoutlined in the framework for actions forhealthcare organisations in Wales: ‘Commitmentto purpose: Eliminating preventable healthcareassociated infections (HCAIs)’.http://wales.gov.uk/topics/health/publications/health/guidance/eliminating/?lang=en

It is essential that all staff understand theimpact of infection and infection controlpractices to enable them to discharge theirpersonal responsibilities to service users, otherstaff and themselves.

NoteThe strategy for Wales does not specifically mentionWHTM 01-05, however, the two should be seen ascomplementary.

The need for guidance1.7 This guidance provides a mechanism to comply

with the legislation and relevant regulations. It alsoassists healthcare providers to encapsulate the lateststandards and practice.

Improvements and enhancements inpractice with the latest guidance,policy and standards

NoteService quality improvements will involve keeping upto date with developments and new equipment in thedecontamination field. This guidance may be amendedwhen such new developments are apparent. Seektechnical advice on the latest guidance as issued.

1.8 Every practice should be capable of meeting thequality requirements as stated below:

• Regardless of the technology used, the cleanedinstruments, prior to sterilization, should be freeof visible contaminants when inspected.Instruments should be reprocessed using avalidated decontamination cycle including:cleaning/washing (in terms of manual cleaning,this includes having a written protocol - see

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Chapter 1 Policy

http://wales.gov.uk/topics/health/publications/health/guidance/eliminating/?lang=en


Section C, Chapter 16); a validated steamsterilizer and, at the end of the reprocessingcycle, they should be in a sterilized state.

• Reprocessed dental instruments should bestored in such a way as to ensure restraint ofmicrobiological recolonisation. These measuresshould be backed by careful controls on thestorage times to which instruments that are lessfrequently used are subject.

• Practices should audit their decontaminationprocesses. An audit tool has been developed byPostgraduate Medical & Dental Education(PGMDE), Cardiff University and is availablefrom PGMDE as part of the CAPR process forpractices providing NHS funded services.Wholly private practices can access the audittool but will not be reimbursed.

• Following audit, practices should develop a planto improve those aspects where they could dobetter.

• Use of improvement methodologies in Walesrequires practices to regularly review progressagainst their improvement plans rather thansimply re-audit. However, practices are advisedto review their audit results at least annually, orwhen a decontamination issue arises, to ensurethat good practice is maintained.

1.9 To demonstrate improvements in thedecontamination process, the following main areasshould be constantly reviewed:

• The environment in which decontamination iscarried out should be such as to minimise therisk of recontamination of instruments and thepossibility of generating aerosols, which mayreach patients or unprotected staff. To achieve asgood a practice as possible, the decontaminationfacilities should be clearly separate from theclinical treatment area.

• Where practical the use of a separate room orrooms for the accommodation of clean (output)and dirty (input) work is recommended. Inthese facilities, the room(s) should be used forthis purpose only and access should be restrictedto those staff performing decontaminationduties. The design of such a facility is a matterof scale, depending on use, throughput andlists, plus the space available. Advice should besought for the design and layout(s) for thefacility.

• A well designed single room application couldbe sufficient for the purpose providing theinstrument paths are clearly indicated from use,

cleaning (both manual and automated),sterilization, sorting and recording to storage,and finally use. Again, it is a matter of scale, aslarger units or practices will want to considerseparate rooms for the process.

• Plant and equipment not necessarily used fordecontamination may be located in theserooms, but preferably in the dirty room orsector, provided it can reasonably be shown thatthe devices do not conflict with the requirementfor a clean environment.

• Where possible, reprocessed dental instrumentsshould be stored in a dedicated area/zone thatprovides a dry and clean environment. This maybe an appropriately designed room ordesignated area set aside for storage that isclearly separate from the clinical treatment area.The facility should take account of the need toreduce recolonisation of sterilized instrumentsand also make the identification and selection ofinstruments easy. This storage facility willordinarily be part of the clean area within thedecontamination room(s). It is a requirement tolog and trace this process of instrumentdecontamination, storage and use.

• As part of continuous improvement, practicesshould consider using a validated automatedwasher-disinfector that is compliant with BSEN ISO 15883 for cleaning medical devices.

1.10 The overall aim is to achieve a reprocessed medicaldevice (dental instrument) that is fully compliantwith the requirements of the Medical DevicesRegulations 2002. This implies that theinstrument should be:

• clean and sterilized at the end of thedecontamination process; and

• maintained in a clinically satisfactory conditionup to the point of use.

1.11 Following the guidance in this document will helpto achieve a satisfactory level of risk controltogether with equivalent compliance with theregulatory framework.

“Sterile” and “sterilized”As the environment in which dental instruments areused is not sterile, it follows that dental instrumentswill not be sterile at the point of use. They should,however, be in a sterile state at the end of thedecontamination process when the sterilizer door isopened.

Accordingly, this guidance accepts that dentalinstruments may be defined as “cleaned and sterilized”

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rather than “sterile” at the point and time of use, asomewhat different approach from that in invasivesurgical procedures.

In some instances, the decontamination process maynot generate full sterilization, for example, in thereprocessing of dental handpieces; however, theguidance will nevertheless seek to raise standards andminimise infection risk to patients.

Improvements and enhancements inpractice1.12 Not all practices can meet the recommendations

required to achieve the highest standards andpolicies. Every practice will need to investigateand audit their facility and their way of workingvia a well defined risk assessment. Decisions needto be made on what quality enhancements arerequired to make improvements and meet therecommendations and a detailed plan prepared toimplement the necessary changes.

1.13 The expectation of Welsh Government is that allpractices in Wales have implemented basicimprovements to their facilities since theintroduction of the Welsh version of HTM 01-05in 2011. The Chief Dental Officer (CDO) Walesletter CDO (2012)2 outlined the necessity for alldental practices to comply with the requirements.

1.14 It is recognised that not only are improvements inpremises and equipment required to achieve higherstandards, but also changes in practicemanagement and the culture in which patients aretreated by the dental team.

1.15 This guidance is based upon a principle ofcontinuous improvement in the quality ofdecontamination practices and the environmentused. Where dental practices use the same roomfor patient treatment and decontamination theyneed to develop a plan that facilitates a movetowards suitably designed decontamination area orroom(s). This plan will normally also containstatements on staff training and development tosuit work in a dedicated decontamination room,area or suite.

1.16 In addition, the plan should realistically outlinethe way forward for improvements in relation tomeeting the standards, for example:

• measures to purchase and incorporate a washer-disinfector;

• the separation of decontamination processesfrom the patient treatment area.

Prion decontamination1.17 Recent research has indicated that a low level of

prion contamination may theoretically be presenton some instruments following contact with dentaltissues. This applies if these instruments havepreviously been used in the care of a prion diseasecarrier who may exhibit no symptoms and mayindeed not go on to develop the disease. For thosetissues where evidence suggests this risk is mostpronounced, the CDO for Wales has publishedrequirements for endodontic files and reamers tobe single-use instruments in all cases. Otherinstrument or device types for which a reliablecleaning regime is not available should also beconsidered for replacement by single-use types orby the single use of re-processible instruments e.g.matrix bands. Information regarding risk in thisimportant area is contained in ‘Potential vCJDtransmission risks via dentistry: an interim review’(December 2007).

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The clinical treatment area should be clearly separate from thedecontamination facilities.

1 Policy

Note

Where patients indicate that they are in a high-riskgroup, guidance provided by the Advisory Committeeon Dangerous Pathogens – Transmissible Spongiform(ACDP TSE) Risk Management Subgroup should befollowed https://www.gov.uk/government/publications/guidance-from-the-acdp-tse-risk-management-subgroup-formerly-tse-working-group. The guidancesuggests that special precautions beyond full instrumentdecontamination will not be necessary. However,specific advice is available by contact with thecommittee secretariat.

1.18 For all other instruments used in dentistry, the riskof prion transmission will be usefully reduced bycompliance with the decontamination proceduresdescribed in this WHTM. This statement is basedon various studies conducted on behalf of theDepartment of Health that examined the effect ofsteam sterilization on prion infectivity. Thesestudies showed that the team sterilization methodsdescribed in this guidance provide a useful level ofdeactivation of prion infectivity. While this wouldnot be adequate in high-risk tissue surgery, theeffect is large enough to be of significance indentistry, excluding endodontic procedures asmentioned in paragraph 1.17. In addition, there isa risk of prion transmission through proteincontamination of instruments, hence the measuresoutlined in this guidance to improve washing anddisinfection of dental instruments.

1.19 Currently there is no recognised process that canfully deactivate prion protein in the sense ofremoving any foreseeable level of contamination.In this WHTM, the cleaning process and itsability to remove protein in tandem with avalidated steam sterilization procedure isemphasized, as this is known to at least reduce therisk of prion transmission through dentalinstruments.

Infection prevention and controlpolicy

1.20 All dental practices should have the latest infectionprevention and control policies in place andavailable for external inspection.

1.21 Public Health Wales via the Welsh HealthcareAssociated Infection Programme (WHAIP) havedeveloped a number of model standard andtransmission based precaution policies andprocedures including:

• Hand hygiene

• Respiratory hygiene and cough etiquette

• Personal Protective equipment (PPE)

• Management of care equipment

• Control of the environment

• Safe management of linen

• Management of blood and body fluid spillages

• Safe disposal of waste

• Occupational exposure management (includingsharps safety)

These can be accessed at http://www.wales.nhs.uk/sites3/page.cfm?orgid=379&pid=38960

1.22 The infection prevention and control policystatement for each practice must include all aspectsincluded in paragraphs 2.6–2.7. In addition, awritten assessment of the improvements thepractice needs to make to progress towards meetingthe requirements for best practice should beavailable together with an implementation plan (asoutlined in paragraph 2.25).

Note

This statement is subject to staged implementation andto local constraints, for example, the physical inabilityto provide a separate room.

1.23 Infection prevention and control needs to includeall aspects of the running of a dental practice:from attention to personal hygiene – hand-washing, masks, protective clothing – to thecleaning and sterilization of instruments and themaintenance of the equipment.

1.24 Selective record-keeping on decontamination forinfrequently used instruments is required as a keymeans of avoiding excessively long periods ofstorage for sterilized instruments, during whichmicro-organism recolonisation may occur. Whilelocal implementation may vary, this will ordinarilyinvolve creating a written or computer-basedrecord, which clearly identifies the instrumentsconcerned either directly or by association withtheir container. The record should show the dateof decontamination and also an expiry date forsafe practice (see paragraph 2.4k in Section BChapter 2 ‘Improvements and enhancements ofthe decontamination process’) after which theprocess should be repeated before the instrumentis used.

1.25 For instruments that are wrapped prior tosterilization in a vacuum sterilizer (i.e. Type B andType S sterilizers), the storage period may beextended to a maximum of one year. Thisprocedure can only be adopted if the vacuumsterilizer used for this process has been correctly

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http://www.wales.nhs.uk/sites3/page.cfm?orgid=379&pid=38960


validated to the requirements of this document,the correct periodic testing regime is in place and arecord of all the correct periodic thermometric andtest reports is maintained. The sterilizer should besubjected to the manufacturer’s maintenanceschedule, complete with log books and records.On cycle completion no water or condensateshould be visible in the packs or on theinstruments before putting into storage, as this cancause microbiological growth and tracking to theinstrument.

Note

The Welsh Government recognises that recolonisationof instruments, particularly those that are wrappedfollowing sterilization, is likely. Accordingly, whilerecommendations are made in respect of maximumstorage times, dental staff should visually check allinstruments prior to use for any obvious deteriorationin their quality.

Note

Vacuum bench top autoclaves do not attain the samelevels of vacuum or air removal as larger porous loadsterilizers utilised in the hospital based departments.Therefore guidance should be sought on the types ofinstrumentation that can be processed through thesemachines, to ensure that the correct procedures, packing,air removal, air performance depression tests, dryingtimes, correct sterilization criteria and thermometric testsare carried out to ensure a sterile instrument is produced.

Training and education1.26 Training and education in the processes of

pathogen control, decontamination, cleaning andhygiene (including hand hygiene), exposure toblood-borne viruses and infection risk reduction,including waste disposal, should be part of staffinduction programmes. They are key aspects ofpatient safety and service quality. Accordingly, theprovision of training and competency records is akey requirement. As part of verifiable continuousprofessional development (CPD), professionalsworking in this area will receive not less than fivehours’ training over a period of five years for bothdentists and dental care professionals.

Exclusions1.27 This WHTM does not cover the following:

• Decontamination in sterile services departments(SSDs). This is covered in Welsh HealthBuilding Note 13.

• Decontamination of laundry and infected linen(covered in the forthcoming WHTM 01-04).

Note

Advice can be sought from NHS Wales Shared ServicesPartnership – Facilities Services (NWSSP-FS) onguidance documentation.

Relationship to other sources ofinformation and guidance1.28 This WHTM was prepared for publication in

Wales during 2013. The main sources ofinformation used in its preparation are listed in theReferences section. Readers should ensure they usethe latest edition of all building legislation, BritishStandards (BS), health and safety regulations, etc.and give first preference to products and servicesfrom sources that have been registered under aquality assurance procedure.

Note

Throughout this guidance, references are made toInternational Standards Organisation (ISO), EuropeanNorm (EN) and BSI Standards. In some instances,these standards have been harmonised so that thecontent of the output for all three standardsinstitutions is the same. These harmonised standardssupport the essential requirements of the medicaldevice directives and their equivalent enactments inUK law.

Where a product or process is stated as compliant witha specified standard this will assist in meeting theappropriate essential requirement of the EuropeanUnion (EU) Medical Devices Directives (MDD).Where manufacturers do not use the harmonisedstandard to state compliance, the technical file for theproduct should identify by what means compliancewith that essential requirement is being met. For somemedical devices the approval of a Notified Body maybe necessary in making the assessment of compliance,with the essential requirements and appropriatestandards coupled to the use of a ConformitéEuropéenne (CE) marking. The Competent Authorityfor the MDD structure in the UK is the Medicinesand Healthcare products Regulatory Agency(www.mhra.gov.uk/). Amongst a range of duties, theagency audits the performance of Notified Bodies.

For low-risk category devices the approach is lesscomplex and the manufacturer is simply registeredwith the Competent Authority.

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1 Policy

Further guidance1.29 This 2014 edition of WHTM 01-05 supersedes the

2011 edition, taking into account amendments toBS EN and ISO standards.

1.30 More information on decontamination for Walesfor Medical Devices is found in WHTM 01-01Parts A, B, C and D. Part E covers non-steamsterilization processes.

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Section B: Advice to dentists and practice staff

19

Decontamination of instruments –an overview

2.1 Decontamination is the process by which reusableitems are rendered safe for further use and for staffto handle. Decontamination is required tominimise the risk of cross-infection betweenpatients and between patients and staff.

2.2 Decontamination of instruments, also known asreprocessing, is a complex process that involvesseveral stages, including cleaning, disinfection,inspection and a sterilization step. The diagrambelow summarises how the individual stages ideallylink together to complete the process ofinstrument decontamination.

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Chapter 2 Improvements and enhancements ofthe decontamination process

Disinfectif a WD is used

Clean

Transport

Inspect Repeat cleaning if necessary

Use

Package

• • •

•

•

•

•

•

Steam-sterilize unwrapped(Type N)

Steam-sterilize in vacuum sterilizer

(Type B or S)

Notes:1. As an alternative to storing instruments immediately after sterilization, instruments that are anticipatedto have a rapid turnover may be put out on sets of individual covered trays. The number of trays shouldcorrespond to the expected number of treatment episodes for that particular working session. This willnegate the need to keep packing and unpacking instruments throughout the day. Each tray should be foruse on a single patient.

2. Any instruments on unused trays at the end of the clinical session – even though they have not beenused – shou

3. Instruments that have remained unused for more than the maximum storage times indicated (that is,1 calendar month for instruments sterilized in a type N sterilizer, and 2 calendar months for instruments sterilized in a type B or S sterilizer) should be subjected to a further cycle of decontamination before being used.

AcquireWith a washer-disinfector (WD);With or without an ultrasonic cleaner;manually

Location

Equipment

Policies and procedures

Management

Facilities

Store(max. 1 year - see

ld be reprocessed before further use.

note below)

Store(max. 1 year - see

note below)

Wrapped and dry

WrapUnwrapped and dry

Store(max.1day-see 2.4j(ii))

Notes:

1. As an alternative to storing instruments immediately after sterilization, instruments that are anticipated to havea rapid turnover may be put out on sets of individual covered trays. The number of trays should correspond tothe expected number of treatment episodes for that particular working session. This will negate the need tokeep packing and unpacking instruments throughout the day. Each tray should be for use on a single patient.

2. Any instruments on unused trays at the end of the clinical session – even though they have not been used –should be reprocessed before further use.

3. Instruments that have remained unused for more than the maximum storage times indicated (referenceparagraph 1.25 for Type B and S sterilizers and paragraph 2.4j(i) for Type N sterilizers) should be subjected toa further cycle of decontamination before being used.

Compliance

The principles identified within this WHTM providean approved code of practice to ensure compliance withthe regulatory framework for the decontamination ofmedical devices used within dentistry.

Guidance contained within this document will assistdental practices in maintaining good operating practicesand developing and constantly improving methodstowards higher levels of achievement. The use of anaudit tool will assist dental practices in reaching thenecessary standards (see paragraph 2.23).

In order to demonstrate compliance to the requirementsof external bodies, for example, the HealthcareInspectorate Wales, Health Boards and WelshGovernment, practices will be expected to provide astatement on plans for future improvement. Details onregistration requirements are given in Chapter 8.

ComplianceMeeting the standards required

2.3 Instruments should be reprocessed using avalidated decontamination process, including awashing process and a steam sterilizer, and at theend of the reprocessing cycle they should besterilized.

2.4 In maintaining and developing dentaldecontamination practices, all the followingshould be included:

a. A local infection control policy subject toregular update, with reference to the all-Walesmodel policies.

b. The above policy should have detailedrequirements and procedures for thedecontamination of instruments.

c. The practice should have a nominated leadmember of staff responsible for infectioncontrol and decontamination.

d. The storage, preparation and use of materialsshould take full account of the requirements ofthe Control of Substances Hazardous to Health(COSHH) Regulations (latest amendmentdocument). Particular care should be taken inthe storage and preparation for use ofdecontamination chemical products.Manufacturers’ instruction sheets should beconsulted for further information. Guidanceon COSHH is available from the Health &Safety Executive (www.hse.gov.uk/coshh).

e. Practices should have a clear procedure forensuring appropriate management of single-useand reusable instruments, which safeguards

their status. (Section C contains detailedguidance on instrument purchase anddisposal.)

f. Reprocessing of dental instruments should beundertaken using dedicated and compliant andvalidated equipment (see Section C).

g. Dedicated hand-washing facilities should beprovided.

h. Cleaning and inspection are key parts ofsatisfactory dental instrument reprocessing.Instruments may be cleaned using anultrasonic bath, but this should be coveredduring use to restrict the release of aerosols.Manual cleaning may also be used as required.To provide practices with a consistent level ofcleaning and disinfection of devices, the use ofautomated and validated washer-disinfectorsdesigned for purpose is stronglyrecommended. Inspection processes shouldensure that the standards of cleaning achievedare visually satisfactory, that is, thatinstruments are free from particulatecontamination, salt deposits or markeddiscoloration. The use of a simple magnifyingdevice with task lighting will improve thevalue of this part of the process.

i. As far as practical, instrument reprocessingprocedures should be kept separate from otheractivities, including clinical work (seeparagraph 5.7 and paragraph 5.8)Decontamination equipment includingsterilizers should accordingly be located in adesignated area or rooms. The layout withinthis area should reflect the progression fromthe receipt of dirty, used instruments towardsclean instruments sterilized in a specificallycontrolled clean area. In the first instance,where practices are meeting the requirementsdefined by this guidance, the designated areafor decontamination may be in, or adjacent to,a clinical room. At a later stage ofdevelopment, more complete separationinvolving the use of a designated room orrooms will become appropriate depending onthe scale of operation and size of practice (seeFigures 1–3 in Chapter 5).

j. Instrument storage and wrappingrecommendations:

The methods used for packing and wrappingof instruments are of prime importance to thequality of the system and safety of the patient:

(i) Where non-vacuum sterilizers (type N) areused, post-sterilization drying using

21

2 Improvements and enhancements of the decontamination process

disposable non-linting cloths should becarried out before the packing ofinstruments; this will improve resistance tocontamination and recolonisation by anappropriate method or storage container.

(ii) Where packing is not applied, instrumentsshould be used within that treatmentsession, usually defined as no more than1 operational day. Unpacked instrumentswill need to be reprocessed within thatspecified period whether used or not.

(iii) Instruments should be dry.

(iv) Instruments should be protected fromcontamination in racks placed incupboards or covered drawer inserts.Instruments should not be stored on openwork surfaces, particularly in clinicalareas. It is important that practices havewell developed protocols and proceduresin place to prevent contamination ofthese instruments by ensuring that thoserequired for a particular patient areremoved from their protectedenvironment before treatmentcommences. This eliminates the need toopen cupboards or drawers during patienttreatment. If an instrument needs to beretrieved from storage during treatment,the practice should have protocols inplace to prevent contamination andensure staff hands are clean and that newgloves are used before handlingunwrapped and sterilized instruments.

(v) All instruments set out for each patientshould be regarded as contaminated afterthe treatment whether or not they havebeen used.

k. Where wrapped instrument storage is used,instruments can be stored up to 1 year. Allstored instruments must be clearly markedwith the date they were processed andwrapped. It is essential that this informationremains clearly readable throughout the storageperiod (see paragraph 1.24). (For qualificationfor this period see following Note).

• Pre-sterilization wrapped and processed in atype B or S validated sterilizer (see paragraph1.24 and paragraph 1.25).

• Post sterilization wrapped if type N validatedsterilizer.

Note

Storage of wrapped instruments processed througha type N sterilizer.

The previous Welsh version of HTM 01-05 statedstorage times of 1 month for post sterilizationwrapped instruments from a type N sterilizer and 2months for wrapped instruments from type B andS sterilizers.

Current guidance in WHTM 01-05 states: ‘Wherewrapped instrument storage is used, instruments canbe stored up to one year’ (see paragraph 2.4k).

However, it is important to recognise that extendedstorage of wrapped instruments processed in type N(non vacuum) sterilizers carries elevated risk topatients and dental personnel. Practices are advisedthat sterilized instruments should only be stored forextended periods where there is a clear need oridentified service requirement. It is recommended thatwrapped instruments stored for more than 1 monthshould be reprocessed.

In general dental practice it is likely that theinstrument stock will have a rapid turnover of use andtherefore the storage of up to 1 year may be irrelevant.

Guidance on formal risk assessments with the use ofmedical device applications refer to BS EN ISO 14971- Medical Devices - Application to risk managementto medical devices.

l. Develop a quality system approach so that thestorage of wrapped instruments does notexceed one year for instruments sterilized in anon-vacuum (type N) sterilizer providing allprocesses are validated and the storagemethod has been audited, inspected and riskassessed.

Subject to local policy and any risk assessmentprocedures carried out, these measures will help toensure stock rotation and will tend to limitrecontamination of stored instruments. Simple butclear record-keeping will be required to make thesemeasures effective.

Note

It is important that sterilized instruments should bedry and clean before wrapping after reprocessing ina type N sterilizer. This procedure carries anelement of risk and should be fully assessed by theuser as it is not to be deemed to be a sterileinstrument, such as an instrument taken from atype B or S, where the instruments are pre-wrappedand have been subjected to an air removal stageprior to sterilization.

22


It must also be noted that both procedures are notas assured as an instrument reprocessed in sterileservices departments operating under the MedicalDirective and inspected by Notified Bodies.

m. Equipment used to decontaminate dentalinstruments should be fit for purpose and fullyvalidated to the test requirements of thisdocument (see Section C for details). Thismeans that the device should be commissioned,maintained and periodically tested by a CP(D),that records of testing and maintenance shouldbe kept, and that correct functioning should bemonitored and recorded in the log book forthat machine.

n. The appropriate and controlled disposal ofwaste is a key aspect of risk control in localdental practices (see Appendix 1).

o. A documented training protocol should be inoperation with individual training records forall staff engaged in decontamination (seeSection C for details). The practice shouldcarry out regular assessments of the changesneeded to continually improve the methods ofworking and the standards required.

p. Staff involved in decontamination must be ableto provide evidence of immunisation in linewith extant guidance, including hepatitis B.Staff must be informed of the benefits, forexample, protection against serious illness,protection against spreading illness, anddrawbacks of vaccination, for example,reactions to the vaccine.

Note

Vaccination is considered additional to, and not asubstitute for, other control measures.

q. It is a requirement that the effective cleaning ofhandpieces is in accordance with manufacturers’guidance. Dedicated cleaning equipment isavailable and may be of value. However,validation in this area is difficult, and the adviceof manufacturers/suppliers should be sought.

r. Separate wash-hand basins for use by staffconducting decontamination should beprovided in the appropriate areas. In addition,two dedicated sinks should be available fordecontamination work, one for washing andcleaning of the instruments, the second forrinsing – including where an automatedwasher-disinfector is in use. (See note below onuse of 2 bowls in single sink) These sinksshould not be used for hand-washing.

Note

Two sinks incorporated into a single unit or, as aninterim solution two bowls, are recommended becauseafter cleaning instruments in the first sink or bowl, theoperator can efficiently rinse the cleaned instrumentsin the second sink or bowl, at a greatly reduced risk ofrecontaminating the instruments with cleansingagents/detergents or previously removed biofilm.

Continual improvement plans should negate the needfor bowls, replacing with dedicated sinks designed forpurpose as facilities develop.

Infection prevention and control policies andprocedures

2.5 This guidance is primarily focused on medicaldevices and instruments used in dentistry.However, local policies must be broad-based andconsider a comprehensive view of hygiene andcleanliness across all aspects of dental practice andassociated facilities.

2.6 All dental practices should have an infectioncontrol policy together with guidelines andprocedures that contain the following information:

• a written policy with regard to minimising therisk of blood-borne virus transmission, withparticular attention to the possibility of sharpsinjuries. The policy should include arrangementsfor access to occupational health advice for allstaff thought to be at risk of blood-borne virusexposure. This is related to risk reduction inblood-borne virus transmission and generalinfection. In addition, a record of all sharpsinjuries must be maintained in accordance withcurrent health and safety legislation;

• a policy on decontamination and storage ofdental instruments, i.e. decontaminationguidelines;

• procedures for cleaning, disinfection andsterilization of dental instruments. This shouldoutline the approach used locally in sufficientdetail as to allow the ready identification of areasand equipment used;

• a policy for the management and disposal ofclinical waste (for further details seeAppendix 1);

• a policy for hand hygiene (see Appendix 2);

• a policy for decontamination of new reusableinstruments (see paragraphs 10.24–10.30);

• local policies and procedures for the use ofpersonal protective equipment (PPE);

• procedures for the management of dental

23


instruments and associated equipment in thecontext of infection control;

• the recommended disinfectants to be usedwithin the practice, their application, storageand disposal i.e. disinfectant guidelines;

• spillage procedure as part of local COSHHarrangements;

• local policies and procedures for environmentalcleaning and maintenance. This should include,as a minimum, the methods used, the frequencyof each procedure and appropriate record-keeping practices. Policy documents may beincorporated into one ‘Standard operatingpolicy’ incorporating all decontaminationpolicies within the practice.

2.7 Dental practices should be aware that Public HealthWales have developed model infection preventionand control policies that can be adopted andadapted for local use. These can be accessed athttp://www.wales.nhs.uk/sites3/page.cfm?orgid=379&pid=38960 (see also Chapter 6, which givesgeneral guidance on cleaning and disinfectionprotocols within the practice).

Use of dental instruments during and aftertreatment on a patient

2.8 The number of instruments provided for eachtreatment should be kept to a minimum – onlythose instruments that are needed should be putout on trays ready for use.

2.9 Care over the process of putting out instrumentsinto trays in relation to the procedures beingperformed will reduce decontamination workload.

2.10 Regard all instruments set out for each patient ascontaminated after the treatment whether or notthey have been used.

Movement of instruments to and from adjacentdecontamination areas

2.11 The object of the measures outlined below is toreduce the risk of cross-contamination betweeninstruments.

2.12 The practice should have safe procedures for thetransfer of contaminated items from the treatmentto the decontamination area.

2.13 Sterilized instruments and single-use instrumentsshould be clearly separated from those that havebeen used and are awaiting decontamination.

2.14 A clean sterilized instrument tray should be usedto transfer sterilized instruments to the treatmentarea. These trays should be of a suitable size to

enable them to be placed in the sterilizer.Alternatively, single-use disposable instrumenttrays may be used, provided these have been storedin a clean and dry environment.

2.15 Instruments for decontamination should betransferred as soon as possible after use to thedecontamination area in order to avoid the risk ofdrying. Prompt decontamination is appropriate.Water immersion or the use of commercial gels orsprays may be considered. These measures reducethe adsorption of proteins to the instrumentsurfaces and makes cleaning easier.

Segregating instruments

2.16 Prior to cleaning, reusable instruments to be cleanedshould be segregated from items for disposal.

2.17 A single-use device should only be used during asingle treatment episode and then disposed of. It isnot intended to be reprocessed and used again –even on the same patient at a later session.

2.18 The re-use of a single-use device has implicationsunder the Medical Devices Regulations. Anyonewho reprocesses or re-uses a device CE-marked foruse on a single occasion bears the responsibilitiesnormally carried by the manufacturer for the safetyand effectiveness of the instrument.

2.19 The symbol that identifies single use items is shownbelow. This will appear on packaging but might notbe present on individual items. If in doubt, furtheradvice should be sought from the manufacturer.

2.20 Where instruments are difficult to clean,consideration should be given to replacing themwith single-use instruments where possible. Indentistry this includes, but is not limited to,instruments such as matrix bands, saliva ejectors,aspirator tips and three-in-one tips.

2.21 Dentists should ensure that all endodontic reamersand files are treated as single-use – regardless of themanufacturer’s designation.

24


2



Quality assurance system and audit

2.22 Dental practices are required to establish andoperate a quality assurance system that covers theuse of effective measures of decontamination andinfection prevention and control. This may best bedemonstrated by undertaking audits andassessments of their infection prevention andcontrol and decontamination practices. Theseaudits should be filed for inspection as part oftheir risk management system.

2.23 This WHTM is regarded as base line guidance andcompliance with its contents is indicative of thepresence of valid quality assurance systems. Auditsshould be carried out in compliance with individualHealth Board policies. As a minimum, practicesmust audit their decontamination processes, with anappropriate review, and demonstrate progressagainst a plan for improvement.

Note

An audit tool has been developed by PGMDE, CardiffUniversity and is available from PGMDE as part of theCAPR process for practices providing NHS fundedservices. Wholly private practice can access the audittool but will not be reimbursed (seehttp://www.walesdeanery.org/index.php/en/dentistry-cpd-programmes/385-clinical-audit-a-peer-review.html).Practices with NHS contract can contact their PGMDEAudit Tutor for further information.

2.24 It is important that the audits are made availableto the auditing body on request and should formpart of the Health Board’s own risk assessment forinspection when required.

2.25 Audit documents should be stored for at least twoyears. They should not be removed from thepremises or destroyed.

Taking instruments to other locations

2.26 The practice should have safe procedures for thetransfer of contaminated items from the treatmentarea to the decontamination facility.

2.27 Transport containers should be such as to protectboth the product during transit and the handlerfrom inadvertent contamination, and thereforeshould be:

• leak-proof;

• easy to clean;

• rigid, to contain instruments, preventing thembecoming a sharps hazard to anyone handlingthe goods and to protect them againstaccidental damage;

• capable of being closed securely;

• robust enough to prevent instruments beingdamaged in transit. Subject to local policy, thecontainers may be labelled to identify the userand/or the contents.

2.28 Without exception, after each use transportcontainers should be cleaned, disinfected anddried, ideally using a washer-disinfector, ordiscarded, as appropriate. If this is not possible,containers should be cleaned with a fresh detergentsolution, then rinsed and dried. Bleach includinghypochlorite solutions should not be used asresidues may damage instruments.

2.29 Where contaminated instruments are to betransported outside the healthcare premises on apublic highway, those responsible for suchtransportation should refer to the requirements ofthe Carriage of Dangerous Goods and Use ofTransportable Pressure Equipment Regulationsand the Health and Safety at Work etc. Act.

2.30 A protocol for transportation that ensures thesegregation of contaminated product from clean orsterilized instruments should be followed.

2.31 Contaminated instruments will be regarded as lowbiohazard materials and must be part of a notedconsignment. This means recording details of thegroup of items transported i.e. dental instruments,the time of dispatch and the intended recipient.Records should be such as to allow eachmovement to be traced and audited if necessary.The consignment note should be positionedprominently within any vehicle used fortransportation and should carry a contacttelephone number, see the Carriage of DangerousGoods and Use of Transportable PressureEquipment Regulations.

2.32 Where instruments travel in a vehicle with adentist or other expert person, record-keeping maybe simplified to cover the date and vehicle usedonly. This rule is applicable to school anddomiciliary visits, for example.

Improvements to meet the standards

Improvements towards achieving approved codes ofpractice in compliance with the latest standardsand guidance should include the following:

• Install a modern validated washer-disinfector ofadequate capacity to remove the need for manualwashing.

• Improve separation of decontamination processesfrom other activities and enhance the distinction ofworkflows of the instruments between dirty and clean.

25


• Provide suitable storage for instruments, whichreduces exposure to air and a possible risk ofmicroorganism contamination. Current standardswill include the development of a local quality systemfocused on safe and orderly storage of instruments.This will ensure that instrument storage is wellprotected in the appropriate clean room or storagefacility against the possibility of exposure of storedinstruments to contaminated aerosols. In addition,the management approach will ensure thatcommonly-used instruments are dealt with on a first-in first-out principle and less frequently usedinstruments are stored for clear identification andreprocessed if not used within the designated storageperiods.

26


Note

Guidance on the installation, validation, maintenanceand testing of ultrasonic cleaners and washer-disinfectors can be found in Section C.

Introduction3.1 The principal methods of cleaning reusable dental

instruments currently available are:

• cleaning using a washer-disinfector;

• manual combined with ultrasonic cleaning;

• manual.

3.2 Effective cleaning of instruments is an essentialprerequisite before sterilization and will reduce therisk of transmission of infectious agents. Whereverpossible, cleaning should be undertaken using anautomated and validated washer-disinfector inpreference to manual cleaning, as a washer-disinfector includes a disinfection stage thatrenders instruments safe for handling andinspection.

3.3 Manual cleaning should be considered only wherethe manufacturer specifies that the device is notcompatible with automated processes, includingultrasonic cleaning, or when the washer-disinfectoris temporarily unavailable, for example, for repairor validation. Exceptionally, where local experienceindicates that removal of tenacious dental materialsrequires manual cleaning, such action may beappropriate before automated cleaning.

3.4 New instruments should be cleaned and sterilizedbefore using for the first time, unless supplied assterile or for single use.

3.5 Instruments cleaned as soon as possible after usemay be more easily cleaned than those left for anumber of hours before reprocessing. Where this isnot possible, water immersion or the use of a foamspray intended to maintain a moist or humidenvironment are thought useful in aidingsubsequent decontamination.

3.6 When working with substances that can harden oninstruments, for example, cements, the

instruments should be cleaned immediately.Instruments that cannot be cleaned should bediscarded.

3.7 Where recommended by the manufacturer,instruments and equipment that consist of morethan one component should be dismantled toallow each part to be adequately cleaned. Membersof the dental team should be appropriately trainedto ensure competence in dismantling, cleaning,sterilizing and reassembling of instruments.Amalgam carriers are an example of instrumentsrequiring this approach.

General requirements for cleaningmethods3.8 Where possible, refer to manufacturers’

instructions relating to instruments, dentalequipment, cleaning devices and cleaningsolutions.

3.9 Whenever possible, cleaning should be undertakenusing an automated and validated process inpreference to manual cleaning. Manual cleaningshould be considered where manufacturer’sinstructions specify that the device is notcompatible with automated processes.

3.10 Ensure that instruments can be cleaned using amethod available to the practice.

3.11 Validation is the means by which an entire processis verified, tested and documented, with the abilityto be consistently reproducible. Ensure thatultrasonic and washer-disinfector cleaningprocedures used in the practice are validated. Thiswill demonstrate that all instruments andequipment cleaned by these methods are reliablyand consistently cleaned using predetermined andreproducible conditions.

3.12 Technical details for validation standards andprocedures are provided in Section C. Theassistance of decontamination specialists will benecessary from time to time in order to ensure thatequipment and procedures remain valid inengineering terms. These services may be available

27

Chapter 3 Cleaning instruments

through the local Health Board, NWSSP-FS or aspart of a commercial package.

Automated cleaning:washer-disinfectors3.13 Each stage of the decontamination process should

contribute to the reduction of bioburden on thedevice being reprocessed. Using a washer-disinfector is preferred for cleaning dentalinstruments because it offers the best option forthe control and reproducibility of cleaning; inaddition, the cleaning process can be validatedunder ENs.

Note

The installation and plumbing of washer/disinfectorsmust comply with the requirements of the WaterSupply (Water fittings) Regulations, see also the WaterRegulations Advisory Scheme www.wras.co.uk.

3.14 Washer-disinfectors are used to carry out theprocesses of cleaning and disinfectionconsecutively in an automated cycle. A typicalwasher-disinfector cycle for instruments includesthe following five stages:

• Flush – removes “difficult” grosscontamination, including blood, tissue debris,bone fragments and other fluid and soliddebris. The latest standards indicate that awater temperature of less than 45oC preventsprotein coagulation and fixing of soil to theinstrument.

• Wash – removes any remaining soil.Mechanical and chemical processes loosen andbreak up contamination adhering to theinstrument surface. Detergents used in thisprocess must be specified by the manufactureras suitable for use in a washer-disinfector.They should also be compatible with theinstruments being processed and supplied so asto perform correctly and avoid instrumentdegradation including discoloration, staining,corrosion and pitting.

• Rinse – removes detergent used during thecleaning process. This stage can contain severalsub-stages. The quality of the water used forthis stage is an important consideration inensuring a clean, unmarked product aftersterilization. Good quality potable water directfrom the mains supply exhibits satisfactory lowendotoxin levels which are unlikely to harmhealth in this application. However, where thelocal potable water is unsatisfactory forprocessing, not compatible with process

chemicals or spotting is observed oninstruments, then final stage purificationsystems should be considered to improve theprocess, e.g. high level filtration, RO. Note:Advice on consistency of potable watersupplied can be sought from local supplier,e.g. Welsh Water.

• Thermal disinfection – the temperature of theload is raised and held at the pre-setdisinfection temperature for the requireddisinfection holding time, for example, 80oCfor 10 minutes; or for 90oC for 1 minute.

• Drying – Purges the load and chamber withheated air to remove residual moisture.

Note

Some systems with a water capacity and delivery ratespecially suited for use in this and other dentalapplications are available. The supply arrangements willfrequently include a comprehensive package so thatwater is supplied as a service.

Using a washer-disinfector

3.15 For details of all operational aspects of using awasher-disinfector, follow the manufacturer’sinstructions. This will include details of both thewater quality/type to be used and directions onthe detergents and/or disinfectants recommendedfor use with the device. These instructions formpart of the EN requirements for CE marking andare considered to be part of the regulated product.

3.16 Ensure that staff are trained in the correctoperation of a washer-disinfector, including howto perform daily tests and housekeeping tasks.Records of training and the achievements of staffshould be maintained (see Section C).

28


Using a washer-disinfector is the preferred method for cleaningdental instruments because it offers the best option for the controland reproducibility of cleaning.

3.17 It is crucial to load a washer-disinfector correctly,as incorrectly loaded instruments will not becleaned effectively. Therefore, follow aninstrument-loading procedure that has beenshown to achieve effective cleaning in the washer-disinfector used in the practice. To do this:

• do not overload instrument carriers or overlapinstruments;

• open instrument hinges and joints fully;

• attach instruments that require irrigation tothe irrigation system correctly, ensuring filtersare in place if required, for example, forhandpieces if specified by the manufacturer.

3.18 After cleaning, inspect instruments for cleanlinessand check for any wear or damage beforesterilization. The use of a simple magnifying devicewith task lighting will improve the value of thispart of the process. The satisfactory completion ofthis step means that these instruments may beclearly designated as ready for sterilization.

Records

3.19 Washer-disinfector logbooks and records should bekept by the designated “user”, an identifiedmember of the practice staff. Cycle parametersshould be recorded together with details of routinetesting and maintenance of the equipment used.The use of automated data-loggers or interfacedsmall computer-based recording systems isacceptable, provided the records are kept securelyand replicated. It is recommended that records bemaintained for not less than two years.

Considerations for cleaning handpieces

3.20 Check with the handpiece manufacturer that awasher-disinfector can be used to clean them.

3.21 Certain types of washer-disinfector can beadapted to clean handpieces, and these can bevalidated independently as being effective.

3.22 Where a handpiece manufacturer does notrecommend a washer-disinfector for cleaningthem, use of a dedicated handpiece-cleaningmachine may be considered. This uses apressurised system to clean and lubricatehandpieces. However, unlike a washer-disinfector,it does not disinfect.

3.23 Always consult the washer-disinfectormanufacturer for operating details (for example,whether filters are required) and running costsbefore purchase.

3.24 Washer-disinfectors might remove all lubricantsduring the cleaning cycle; therefore, handpiecesmight require further lubrication after cleaning.

Follow the handpiece manufacturer’srecommendations for lubrication (see alsoparagraphs 3.55–3.57 and Chapter 18 inSection C).

Note

1. Some washer-disinfectors that have a handpieceirrigation system require that a special filter be fittedto protect the internal mechanism of the handpiecefrom extraneous debris during the operating cycle.These filters need to be replaced at regular intervalsin accordance with the manufacturer’s instructions.

2. There are certain commercial products that claim tobe able to sterilize as well as wash and disinfectdental handpieces. Please seek advice from NWSSP-FS or your local infection prevention and controlteam.

Automated cleaning:ultrasonic cleaning3.25 Evidence on the effectiveness of ultrasonic

cleaning gives support to its use in dentistry.However, it is important to ensure that the wateror fluid is maintained, cleaned and changed atsuitable intervals (see paragraph 3.30(j)). Theultrasonic bath should also be kept free of dirtreleased in the cleaning process. Goodmaintenance is also essential. The appearance ofinstruments following ultrasonic cleaning shouldbe checked to ensure that the process is operatingeffectively (see also Section C).

3.26 Ultrasonic cleaning in a well-maintained machineenhances removal of debris. Thus, although awasher-disinfector is preferred and should beincorporated into new plans or upgrades, anultrasonic cleaner can be used as a cleaningmethod, including being used as an extra cleaningstage prior to an automated washer-disinfectorprocess, i.e. a pre-cleaning process. This may beparticularly helpful for instruments with hinges orintricate parts. When using these baths, it isessential that the water is changed frequently (seeparagraph 3.30).

3.27 To enable consistent cleaning of instruments,follow the manufacturer’s operating instructionsand ensure that all staff use a specified anddocumented operating procedure. Details onvalidating ultrasonic cleaners are supplied inSection C.

3.28 The use of ultrasonic cleaners to clean dentalhandpieces should not be undertaken withoutconfirmation from the manufacturer that thedevices are compatible.

29

3 Cleaning instruments

3.29 The ultrasonic cleaner should be tested quarterlyto ensure that it is fully functional and operates inaccordance with the manufacturer’s specification(see Section C).

Ultrasonic cleaning procedure

3.30 The following procedures should be followed:

a. Instruments should be briefly immersed in coldwater, with detergent, to remove some of theblood and other visible soil before ultrasoniccleaning. Care should be taken to minimiseaerosol production in this process and tosafeguard against inoculation injury. The use ofa purpose-designed container with sealing lid isrecommended.

b. Follow the manufacturer’s recommendationsfor the safe operating procedure of theultrasonic cleaner and follow the pointsoutlined below regarding loading andunloading the cleaner.

c. Ensure that joints or hinges are opened fullyand instruments that need taking apart arefully disassembled before they are immersedin the solution.

d. Place instruments in a suspended basket andfully immerse in the cleaning solution,ensuring that all surfaces are in contact withthe solution. The solution should be made upin accordance with the manufacturers’instructions.

e. Do not overload the basket or overlapinstruments because this results in poorcleaning and can cause wear to theinstruments.

f. Do not place instruments on the floor of theultrasonic cleaner because this results in poorcleaning and excessive instrument movement,which can damage the instruments.

g. To avoid damage to delicate instruments, amodified basket or tray system might also benecessary depending on operationalrequirements.

h. Set the timer to the correct setting according tothe ultrasonic cleaner manufacturer’sinstructions. Close the lid and do not open ituntil the cycle is complete.

i. After the cycle is complete, drain the basket ofinstruments before rinsing.

j. Change the solution either when it becomesheavily contaminated or at the end of everyclinical session, because the build-up of debriswill reduce the effectiveness of cleaning and

could be a source of cross contamination.Ensure that staff are aware of the need to assesswhen a change of solution is necessary asadvised in the operational requirements.

k. After ultrasonic cleaning, rinse and inspectinstruments for cleanliness, and, wherepossible, check for any wear or damage beforeplacing in the washer-disinfector and sterilizer.

3.31 Instruments cleaned in an ultrasonic cleaner or byhand should be rinsed thoroughly to removeresidual soil and detergents. A dedicated sink orbowl, separate from the one used for the originalwash, should be used and the instrumentsimmersed in satisfactory potable water or, wherethis is not available, in RO or freshly distilledwater. Wash-hand basins should not be used. Thisstep may be omitted if the local policy andprocedure involves the use of a washer-disinfectoras the next stage in the decontamination process.Note: Advice on potable water supplied can besought from local supplier.

Note

Hard-water contamination of wet instruments, whichthen go on to sterilization, can compromise the properfunction of a small steam sterilizer. Rinsing satisfactory,soft, potable water or other purified source will benecessary as a precaution. When potable water is used,a water softener maybe needed. Consult the local wateradvisor at not less than annual intervals.

3.32 Instruments should be sterilized as soon as possibleafter cleaning to avoid air-drying, which can resultin corrosion and microbial growth. Instrumentsprocessed in a vacuum steriliser should be driedusing a disposable non-linting cloth before beingwrapped.

Manual cleaning3.33 In principle, manual cleaning is the simplest

method to set up, but it is difficult to validatebecause it is not easy to ensure that it is carriedout effectively on each occasion.

3.34 Compared with other cleaning methods, manualcleaning presents a greater risk of inoculationinjury to staff. However, despite the limitations ofmanual cleaning, it is important for each practiceto have the facilities, documented procedures andtrained staff to carry out manual cleaning as abackup for when other methods are notappropriate.

3.35 For dental services that are working towards therequirements outlined in this document, manual

30


cleaning should only be used for equipment thatcannot be cleaned by automated methods.

3.36 This method should have systems in place to avoidrecontamination of clean instruments.

3.37 An effective system for manual cleaning should beput in place, as outlined in Section C, and all staffshould follow an agreed written procedure. Avisual inspection for cleanliness, wear and damageshould be carried out.

3.38 Consider routinely using an automated method,such as the recommended washer-disinfector, andaim to phase in instruments that are suitable forcleaning in this way.

Avoiding instrument damage3.39 Most dental instruments are made of high-quality

materials designed to minimise corrosion ifreprocessed correctly. The corrosion resistance isbased on their alloy composition and structure,which forms a protective passivation layer on thesurface. The ability of the instruments to resistcorrosion depends on the quality and thickness ofthis layer.

3.40 It is important to avoid damage to the passivationlayer during cleaning. Accordingly, methods suchas the use of wire brushes, which may give rise tosurface abrasion, should be avoided.

3.41 Any instruments that have rust spots should beremoved.

Cleaning procedure summary3.42 Effective cleaning of dental instruments before

sterilization is of the utmost importance to reducethe risk of transmission of infectious agents.

3.43 Research suggests that instruments cleaned as soonas possible after use are more easily cleaned thanthose left for a number of hours beforereprocessing.

3.44 Instruments should be transferred from the pointof use to the decontamination areas as soon aspractical to ensure they are processed as soon aspossible after use. Evidence indicates that keepinginstruments moist after use and prior todecontamination improves protein removal andoverall decontamination outcomes.

3.45 It should be noted that certain solutions arecorrosive to stainless steel instruments and willcause pitting and then rusting if allowed to remainfor any length of time. Dental professionals shouldconsult with the suppliers and manufacturers ofdecontamination agents to ensure that theproducts used are appropriate and unlikely to

cause significant long-term corrosion (refer toCOSHH regulations for further advice).

3.46 Always check packaging for the single-use symbolbefore use and note that it might be difficult to see(see also paragraphs 2.17–2.21).

Rinsing of instruments after cleaningand/or disinfection3.47 Instruments cleaned in an ultrasonic cleaner or

manually should be rinsed thoroughly in adedicated sink or bowl, separate from the one usedfor the original wash, using satisfactory potablewater, high level filtration systems or other methodof purifying the supply in order to remove residualsoil and detergents with minimum risk of saltdeposition.

Note

This step may be omitted if the local policy andprocedure involves the use of a washer-disinfector asthe next stage in the decontamination process.

3.48 Instruments should be sterilized as soon as possibleafter cleaning to avoid air-drying which can resultin corrosion and/or microbial growth. However,where instruments are to be wrapped prior tovacuum sterilization, the instruments should bedried using non-linting cloth.

Inspection and care of instrumentsbefore sterilizing3.49 All instruments that have been through any

cleaning procedure, including processing by awasher-disinfector, should be inspected to ensurethey are clean, functional and in good condition.

3.50 Any instruments that are blunt, bent or damagedor show any signs of pitting or other corrosionshould be discarded. An illuminated magnifier isrecommended because it makes it much easier tosee residual contamination, debris or damage.

3.51 Dental staff should ensure that:

• there is free movement of all parts and thatjoints do not stick;

• the edges of clamping instruments meet withno overlap and that teeth mesh together;

• scissor edges meet to the tip and move freelyacross each other with no overlap or burrs(rough edges);

• all screws on jointed instruments are tight andhave not become loose during use.

31

3 Cleaning instruments

3.52 Instruments should be inspected for any visiblesoiling such as blood or dental materials. It isespecially important to check joints, hinges or theserrated surfaces of jaws, which are difficult toclean. If there is any residual contamination, theinstrument should be rejected and should undergoanother cycle of the cleaning process.

3.53 Occasional use of a lubricant may be requiredwhere hinged instruments are found to be stiff. Anon-oil-based lubricant should be used to avoid itinterfering with the sterilization process, that is,preventing the steam coming into contact with theinstrument surface.

3.54 Instruments may become damaged during use orsuffer from general wear and tear over theirlifespan. If devices are found to be faulty ordamaged during inspection and function-testing,or if users identify that they are faulty, they shouldbe taken out of use and either repaired or replaced.Instruments for repair should be decontaminated,labelled to identify they have been through thedecontamination process and then returned toeither the manufacturer or a reputable repaircompany.

Handpiece care3.55 Handpieces should be lubricated according to the

manufacturer’s instructions. Those that have beenprocessed in a washer-disinfector might have hadthe lubricant removed and require lubricationagain before going into the sterilizer.

3.56 A separate canister of lubricant should be used forcleaned instruments. The canisters should belabelled so that it is clear which canister is used forunclean instruments and which is used forinstruments that have been cleaned in a washer-disinfector. Another canister for use withhandpieces after sterilization might be required ifthe manufacturer recommends it.

3.57 Inadequate lubrication can lead to unnecessarydamage to the internal mechanism.

32


Guidance on the installation, validation, maintenanceand testing of sterilizers can be found in Section C.

4.1 This chapter should be read in conjunction withSection A.

Types of sterilizer4.2 Saturated steam under pressure delivered at the

highest temperature compatible with the productis the preferred method for the sterilization ofmost instruments used in the clinical setting.

4.3 To facilitate sterilization, load items should first bethoroughly cleaned (and disinfected where awasher-disinfector has been used). In the case ofnewer machines, the parameters monitored foreach cycle of use will be stored and/or available asa print-out to provide a short-term record. The useof automated dataloggers or interfaced smallcomputer-based recording systems is acceptableprovided the records are kept securely on a reliablenetwork and replicated. These records should bephotocopied, as the quality of the print-out fadesover time. Manual recording using a logbook isalso acceptable and, in any case, will be a necessityif a machine does not have any automatic print-out function (see paragraph 4.16 for further detailson manual recording). The record should, as aminimum, document the absence of a failurewarning or the temperature and pressure achieved,as appropriate to the indications provided. Recordsare required for every sterilization cycle. It isrecommended that records be maintained for notless than two years.

4.4 It is likely that steam sterilizers used in dentalpractices will have a chamber volume of less than60 L and thus be considered to be small deviceswithin the standards applied by national andinternational bodies.

4.5 Standards describe three types of small sterilizerused within the healthcare setting:

• Type N: air removal in type N sterilizers isachieved by passive displacement with steam.They are non-vacuum sterilizers designed for

non-wrapped solid instruments. Thesesterilizers are not designed for reprocessinginstruments with a lumen.

• Type B (vacuum): type B sterilizers incorporatea vacuum stage and are designed to reprocessload types such as hollow, air-retentive andpackaged loads. A number of different cyclesmay be provided. Each cycle should be fullyvalidated and used in accordance withinstructions provided by both the sterilizer andthe instrument manufacturer. Users should beaware that Type B benchtop sterilizers canincur financial implications in comparison witha Type N design, as the technical nature ofdesign will require additional maintenance, andalso require an in-depth validation regime inaccordance with current guidance to includeregular steam penetration and air testing.

33

Chapter 4 Sterilization

Sterilization process data can be recorded by an automatic printer.

• Type S: these sterilizers are specially designedto reprocess specific load types. Themanufacturer of the sterilizer will define exactlywhich load, or instrument, types arecompatible. These sterilizers should be usedstrictly in accordance with these instructions.

Advice can be sought from NWSSP-FS.

Types B and N are most frequently used indental practices.

Where a sterilizer is installed with multiple cycleoptions it is important to note that all the cyclesconfigured within the control memory requiresperiodic validation to current guidance. If thereare cycle options that are configured and not used,they should be deleted or disabled to preventunauthorized use. Single cycle options arepreferred where bench top sterilizers are used.

Note

All cycles to be used on the sterilizer must be validatedand periodically tested, with written reports and chartsfor audit.

4.6 In each case, practice staff should consult with themanufacturer and supplier of the sterilizer toascertain the status of the machine in respect ofvalidation and verification and the recording ofparameters achieved during sterilization cycles.

Dental handpieces4.7 Dental handpieces are constructed with a number

of internal channels and pathways. These featuresare often difficult to clean, although the use of avalidated automated washer-disinfector may besuccessful provided that handpiece and washer-disinfector are of known compatibility. Where thisis established, sterilization using a type B or type Ssterilizer is likely to be useful, although it should beaccepted that it is unlikely that sterility will beachieved, whatever sterilizer is used, due to thepresence of lubricating materials.

4.8 If no validated and compatible washer-disinfector isavailable, steam sterilization will still be of value ingenerating a reduction in contamination levels andbioburden.

34


Sterilization process data should be recorded for each cycle by an automatic printer.

Small sterilizers4.9 Small sterilizers should be operated to ensure that:

• they are compliant with the safetyrequirements stated in this guidance and in themanufacturer’s notes;

• they are installed, commissioned, validated andmaintained appropriately in compliance withthe manufacturer’s instructions (see Section C);

• they are operated in accordance with theequipment manufacturer’s instructions.

4.10 Where sterilization equipment has been used forsignificant periods, water quality can influencecalcification build up. Under these circumstances,the machine should be inspected by an engineer orreturned to the supplier or manufacturer forrefurbishment.

4.11 Users should be aware of this cautionary noterelating to the improper use of small sterilizers:

Note

Pre-wrap instruments only where this is recommendedby the manufacturer and where the sterilizer is vacuum-assisted. The sterilizer should be validated for theintended load and is likely to be of type B or S. Theuse of a type N sterilizer is not appropriate forwrapped instruments.

4.12 All steam sterilizers are subject to the PressureSystems Safety Regulations and must be examinedperiodically by a Competent Person (PressureVessels).

Use and testing of small sterilizers

4.13 To ensure the safety of this device, the followingpoints should be adhered to:

1. Each sterilizer will have a reservoir chamberfrom which the water is delivered for steamgeneration; this should be filled daily usingwater of a suitable quality. A practical approachshould be adopted using good operationalpractice as with previous healthcare guidance,e.g. WHTM 01-01 Parts A, B and C. The useof ‘water for irrigation’ is used to meet therequirements for ‘clean steam’. Sterile water forirrigation is nonpyrogenic distilled water thathas been sterilized. It has an endotoxin level lessthan 0.25Eu/ml and is readily available frompharmacies for bulk supply. Alternative watersupplies can be RO if there is a problemsourcing water of the required standard (seeChapter 17 for further guidance). The use ofwater for irrigation is preferable to distilled

water as the quality of distilled water cannot beguaranteed. At the end of the day or wheneverthe sterilizer is to be unused for several hours,the chamber should be drained after the waterhas cooled and all internal surfaces that areaccessible should be rinsed with suitable qualitywater, dried and left empty with the door keptopen. For single-shot types, which do not storewater between cycles of use, these rules stillapply in terms of the water quality to be used.When the sterilizer reservoir is to bereplenished, it should be refilled with suitablewater quality to the level recommended by themanufacturer.

2. Validation is necessary to demonstrate that thephysical conditions required for sterilization(temperature, pressure and time) are achieved.Consultation with appropriately qualifiedengineers through the Health Board orcommercial arrangements will be necessary inthis area. A CP(D) or service engineer will beable to ensure that validation is achieved andthat the instrumentation used for parametricrelease is functioning and calibratedappropriately. The CP(D) or service engineerwill be needed to validate or revalidate theequipment (see Section C).

Parametric release is defined as the release of a batch ofsterilized items based on data from the sterilizationprocess. All parameters within the process have to bemet before the batch can be released for use.

3. Testing is an integral part of ensuring that asmall sterilizer consistently performs tooperating parameters set during the machine’scommissioning. Failure to carry out routineperiodic tests and maintenance tasks couldcompromise safety and have legal andinsurance-related implications for the RegisteredManager (see paragraph 9.3).

4. A schedule for periodic testing should thereforebe planned and performed in accordance withSection C. The schedule should provide detailsof daily, quarterly and yearly testing or be inaccordance with manufacturers’ guidelines. Eachsterilizer should have a logbook in which detailsof the following are recorded:

• maintenance;

• validation;

• faults;

• modifications;

• routine tests (see Appendix 3).

35

4 Sterilization

4.14 Every organisation must have a recordsmanagement policy which is promulgatedthroughout the organisation and of which all staffare aware. Equally important are the adoption ofretention and disposal schedules which give clearguidance on how long records, including HealthRecords, should be maintained. The requirementsfor NHS Wales are set out in WHC (2000)71.More recent guidance for the Department ofHealth England is available athttp://www.gov.uk/government/publications/records-management-nhs-code-of-practice.

4.15 The logbook should contain all informationpertaining to the lifecycle of the equipment, frompurchasing through to disposal.

4.16 If the sterilizer has an automatic printer, theprintout should be retained or copied to apermanent record. If the sterilizer does not have aprinter, the user will have to manually record thefollowing information in the process log:

• date;

• satisfactory completion of the cycle (absence offault recognition indicator);

• temperature/pressure achieved;

• signature of the operator.

It is a recommendation that, where possible,sterilizers are upgraded to include printers or data-recording devices to provide automated methodsof recording the sterilization process.

Daily testing and housekeeping tasks

4.17 Some small sterilizers require a warm-up cyclebefore instruments can be processed. Themanufacturer’s instruction manual should beconsulted to find out whether this is the case.

4.18 The daily tests should be performed by theoperator or user and will normally consist of:

• a steam penetration test – Helix or Bowie andDick tests for vacuum sterilizers only;

• an automatic control test for all smallsterilizers in line with manufacturers’instructions;

• a record of temperature and pressure achievedat the daily test, to ensure this is satisfactorybefore the autoclave is used for sterilization ofinstruments.

4.19 These outcomes should be recorded in thelogbook together with the date and signature ofthe operator.

36


The outcomes of daily tests should be recorded in the logbook.

4.20 The tests may be carried out at the same time.

4.21 Sterilizers should not be used until the daily testsand housekeeping tasks have been carried out andthe results found to be satisfactory. Correctloading of instruments and equipment is essentialto ensure effective sterilization. Reference shouldbe made to the instructions and illustrationsincluded in the manufacturer’s handbook to ensurecorrect loading every time.

4.22 Before carrying out the daily tests, the user should:

• clean the rubber door seal with a clean, damp,non-linting cloth;

• check the chamber and shelves for cleanlinessand debris;

• fill the reservoir with water of a suitable quality(e.g. water for irrigation) or RO if no alternativeis available (see paragraph 4.13);

• turn the power source on.

4.23 If the sterilizer fails to meet any of the testrequirements, it should be withdrawn from serviceand advice should be sought from themanufacturer or maintenance contractor. Anyinstruments processed in an unsuccessful cycleshould not be used.

Packaging and relateddecontamination strategy4.24 There are three combinations of steam-sterilization

and instrument-wrapping strategies that can beused within dental practices:

a. With a type B vacuum steam sterilizer,instruments will be pre-wrapped usingpurpose-designed materials that are compatiblewith the sterilizer. With a type S sterilizer,instruments may be placed in purposedesigned cassettes. In both cases, instrumentsshould be dry before they are placed in thepurpose-designed packaging. Wrapping shouldtake place with a dry product shortly afterwashing and disinfection. Once the wrappedinstruments have been sterilized satisfactorily,the product may be stored for up to one year(see section B paragraph 2.4).

b. With a displacement steam sterilizer (type N),the instruments will not be wrapped prior tosterilization. Immediately after removal fromthe sterilizer, instruments may be wrappedusing suitable sealed view-packs. Instrumentsshould be dry before being packed. Inaddition, the entire tray may be placed withina sealed pack for storage purposes. In both of

these instances, where wrapped instrumentstorage is used, instruments can be stored upto 1 year. (For qualifications for this periodsee note after paragraph 2.4k).

c. Products from a type N sterilizer may also betransferred for use within the current session.In this instance, while covering theinstruments is essential to protect against dustand aerosols, wrapping is not required.However, the instruments are not regarded as“stored” and should therefore be used orstreamed for a further decontaminationprocess within one session. Instruments shouldbe dry before being transferred for clinical use.

Note

BS EN ISO 11607-1 Annex A provides a usefulsummary of “sterile barrier systems”. In practice, theseare sealable trays or wrappings, which may be of valuein dental practices. In summary, the systems referred toare:

a. Flexible peel pouch (sealed view pack). This istypically supplied sealed on three sides with theremaining side open for the insertion of dentalinstruments. This packaging, subject tomanufacturers’ advice, may be used to post-wrapinstruments after steam sterilization in order toprotect against recontamination.

b. Pre-formed rigid tray with die-cut lid. The lid maybe permeable or impermeable. These trays arepotentially suitable for use with displacement orvacuum sterilizers. Subject to manufacturers’instructions, the trays may be used to contain dentalinstruments during the sterilization process and insubsequent storage.

c. Sterilization bag. This is constructed from porousmedical paper and sealed before sterilization of thecontents. The bag is essentially designed for use withvacuum sterilizers.

d. Header bag. This is manufactured as a sealed bag witha heat-sealed permeable closure, which can be peeledoff. This type is suitable for storage of larger items.

e. In larger-scale operations, automated systems such asform/fill/seal (FFS) or four-side-sealing products mayalso be used. The choice of system used will dependon the decontamination, sterilization and storageoptions chosen by the practice. The manufacturersof each of the products should be consulted on thestandards applied and compatibility with the otherproducts employed.

BS EN ISO 11607-2: Sets out the validationrequirements for forming, sealing and assembly processes.

It is important that a risk assessment should be carried

37

4 Sterilization

out in accordance with BS EN ISO 14971 ‘Applicationof risk management to medical devices’ to identify anyhazards associated with the medical devices beingsterilized and the ongoing storage thereafter. If carriedout correctly a number of hazards could be identified,i.e. staff training, storage, validation of the equipment,etc. which may require the Dentists to investigate usingan accredited Sterile Services Unit for their reprocessing.

4.25 In all three cases, if the instruments are damp, theyshould be dried using disposable non-lintingcloths and be appropriately handled. It is essentialto ensure that the cloth is adequately dry and freefrom contamination. Accordingly, the cloth shouldbe disposed of after each sterilizer load.

4.26 Regardless of the packaging used, whereinstruments are to be stored, the date by whichthey should be used or by which they are subjectto a further decontamination cycle should beclearly indicated on the packaging.

Storage of sterilized instruments/devices4.27 Regardless of the approach described above, it is

essential that stored instruments are protectedagainst the possibility of recontamination bypathogens. A barrier should therefore bemaintained between the instruments and thegeneral practice environment. This may beachieved by ensuring that instruments are stored inan environment where they are protected againstexcessive heat and where conditions remain dry.

4.28 There should be control of storage of wrappedinstruments, including maintenance of records,clear identification of content of instrumentspacks, if not visible and storage times. For themajority of commonly-used instruments, a first-infirst-out principle will be helpful.

Note

Where packs are non-transparent, it may be useful touse a simple coded label to indicate the contents.

4.29 As a general rule:

• The storage of reprocessed surgical instrumentsshould ensure restraint of recolonisation. Thiswill often mean protection against aerosols andsundry contact with other equipment. The areain which the packaging of sterilized instruments,that is, those reprocessed in a type N sterilizer,takes place should be an open bench area. It

should be kept free of clutter and wiped cleanby the use of detergent or antimicrobial wipes atsessional intervals.

• The storage area should be dedicated for thepurpose. It is recognised that some practicearrangements will involve storage ofinstruments within rooms that are also used forclinical work. In meeting the requirements ofthis document, this will require that theinstruments be as far from the dental chair asreasonably practicable. Where practical,instruments not scheduled for use with thecurrent patient should be stored in a separateenvironment, ideally in the clean area of theseparate decontamination room. Whereinstruments need to be stored within theclinical area, the use of a purpose-designedstorage cabinet that can be easily cleaned willbe required.

• The storage area should be appropriatelydesigned to prevent damage to instruments andto allow for the strict rotation of stocks.

• Cupboards should be capable of being easilycleaned and used in conjunction with sealedview-packs or covered or sealed trays.

• Products should be stored above floor levelaway from direct sunlight and water in asecure, dry and cool environment.

• Although air movement is often difficult tocontrol in non-purpose-designed premises,whenever possible, airflow should be from theclean to dirty areas.

4.30 Before being used, the instruments should bechecked to ensure that:

• if packed, including the use of view-packs, thepackaging is intact;

• the sterilization indicator confirms that thepack has been subjected to an appropriatesterilization process, if a type B sterilizer isused;

• if a covered container is used, the instrumentshave remained covered;

• visible contamination is absent; this is tocomply with BS EN Standards.

4.31 It is a requirement that the practice has a strictpolicy on the reprocessing of unused instrumentsin line with the statements given in 2.4 k and thenote on wrapping and storage.

38


5.1 There is a clear need to maximise the separation ofdecontamination work from clinical activitywithin the constraints of space and roomavailability. Where instruments are reprocessed inthe same room as the patient treatment area, thereprocessing area should be as far from the dentalchair as practicality allows. Dental practices shouldmake every practical effort to progress towardshigher standards, removing the decontaminationprocess from the treatment room. For examplelayouts, see Figures 1–3.

5.2 If decontamination has to be carried out in apatient treatment room, to minimise the risks bothto the patient and of cross-contamination of

instruments, appropriate controls should be inplace. Uncontrolled procedures that generate therisk of exposure to aerosol dispersion or splashes,such as manual washing, the use of an ultrasoniccleaner without a sealed chamber or lid or theopening of decontamination equipment, shouldNOT take place while the patient is present.

5.3 Regardless of the choice of location used for thereprocessing facilities, a dirty-to-clean workflowshould be maintained so that used instruments areat a lower risk of coming into contact withdecontaminated instruments. This requires a welldeveloped routine for surface cleaning anddecontamination within the facilities:

39

Chapter 5 Setting up a decontamination area

Figure 1: Example layout of facility for basic decontamination requirements

OUT

Deliver

Rinsingsink

Wash-handbasin

(optional)

Wash-handbasin

CLEANZONE

DIRTYZONE

Inspection and storage

Inspect and, where applicable,

pack

Ventilationinput

Ventilation extraction or

output

Notes1. The use of an ultrasonic cleaner is optional.

by combining both sinks through the installation of a double-bowl sink assembly.

2. Practices may increase the number of sterilizers if capacity and service continuity dictates.

Ultrasonic cleaner

(optional)

WashingsinkKey

INOUT

(optional, dependent upon space and layout)

Where such a cleaner is not provided,handling difficulties will be reduced by siting the washing sink near to the rinsing sink or

Instrument flow

Airflow

Sterilizer

• the decontamination area should be wipeddown carefully after each decontaminationcycle is completed;

• for clinical areas, a similar wipe-clean isrequired after each patient procedure andbefore the next patient is admitted. Proceduresfor the wipe-down processes are described inChapter 6.

5.4 Where a dedicated decontamination area has beendeveloped, separated from the patient treatmentarea in another room or rooms, enhanceddirty–clean separation should be a priority indesign and operation.

5.5 When setting up new premises or planningsignificant modification to existing premises, theseparation of the decontamination area from theclinical area is recommended. The provision oftwo separate rooms is the preferred option as itprovides for a higher degree of separation between

dirty instruments awaiting decontamination andcleaned or sterilized instruments that are to beplaced in trays, packs or containers for use:

• one room for dirty activity (cleaning andpreliminary inspection of instruments); and

• one room for clean activity (inspection,sterilization and wrapping instruments).

The clear intention is to reduce the risk and extentof recontamination as well as providing for a veryclear operational distinction between clean anddirty.

Note

The final design of any decontamination room orrooms must be clearly risk assessed and investigated bya consultation process to ensure the correct facility isbuilt specifically for the needs of that practice andmeets the requirements of this document. The main factors that will need to be included are

40


Figure 2: Example layout for single decontamination rooms

OUT

Deliver

Rinsingsink

Wash-handbasin

Wash-handbasin CLEAN

ZONEDIRTYZONE

Single-ended washer-disinfector



pack

Ventilationinput


output

Notes1. The use of an ultrasonic cleaner is optional. Where such a cleaner is not provided,


2. Practices may increase the number of washer-disinfectors and sterilizers if capacity andservice continuity dictates.

Ultrasonic cleaner

(optional)

WashingsinkKey

INOUT

(optional, dependent upon space and layout)

Instrument flow

Airflow

handling dificulties will be reduced by siting the washing sink near to the rinsing sink or

Sterilizer

(optional)

available space, depending on an upgrade of existing ora new build, frequency of use with patient workloadsessions, staffing levels for good working practice,numbers of washer disinfectors and sterilizers required.The following questions should be addressed:

• What type of room is required?

• Is segregation needed or a well designed single roomapplication?

5.6 Irrespective of the specific layout, a tidy workingenvironment makes carrying out decontaminationeasier. Therefore, the working environment shouldbe uncluttered. The decontamination processshould be carried out by ensuring that a dirty-to-clean workflow is maintained (as outlined inparagraph 5.7). This is a one-way process that canbe achieved by physical segregation or temporalseparation (see paragraph 5.2). In some cases

41

5 Setting up a decontamination area

Figure 3: Example layout for two decontamination rooms

INOUT

Washingsink

CLEAN DIRTY

Deliver

Wash-handbasin

Wash-handbasin

Ultrasonic cleaner

(optional)

Rinsing sink



pack

Double-ended washer-disinfector

Notes1. An alternative is to have a single-ended washer-disinfector in the dirty area. The

risks of manual handling.

guidance provided it is validated.)

2. The use of an ultrasonic cleaner is optional. Where such a cleaner is not provided,


3. Practices may increase the number of washer-disinfectors and sterilizers if capacity andservice continuity dictates.

Key

Ventilationinput


output


output

Ventilationinput

AirflowInstrument flow

provision of a transfer hatch between the two rooms would be beneficial in reducing the

While double-ended washer-disinfectors offer advantages in reducing the risks of manual

handling, the use of a single-ended washer-disinfector will fulfil the objectives of this

handling difficulties will be reduced by siting the washing sink near to the rinsing sink or

Sterilizer

Figure 3: Example layout for two decontamination rooms

where there is sufficient space, a physical screensuch as glass or acrylic can be used as a splashbarrier for decontamination processes insegregating of areas.

Physical segregationNote

A two room decontamination facility with both dirtyand clean rooms is designed for larger practices withlarge patient throughputs, such as a Health Centre.

5.7 Physical segregation within the decontaminationrooms can be a physical barrier, as in the twinroom layout, or by the good management of spaceand flow in a single room design by using differentareas for different activities. A decontaminationarea should be set up which preferably comprises asingle run of sealed, easily cleaned worktops. Thefollowing key design points should be observed:

• The dirty zone will be used to receivecontaminated instruments. An area ofbenching should be clearly designated for thispurpose and used for no other activity.

• The washer-disinfector, washing and rinsingsinks or separate bowls within a single sinkunit should be installed adjacent to thereceiving area. Where necessary, usually owingto space constraints, it is acceptable to use asingle sink unit incorporating two bowls withcommon supply and taps for the functionsdescribed here.

• The ultrasonic cleaner, where used, should beseparated from the receiving area and adjacentto the rinsing sink/bowl.

• After washing and disinfection the instrumentsand devices require inspection. A dedicatedclean area of benching with good task lightingshould be provided.

• Adequate space should be provided for thewasher-disinfector for loading and unloading aswell as access for maintenance and testing. Thewasher-disinfector could be a pass through unitof bench top or under bench design dependingon the room layouts.

• The sterilizer should be situated well awayfrom the other activities and facilities in orderto promote staff and patient safety and gooddecontamination practice. Adequate spaceshould be provided for the sterilizer for goodmaintenance and testing.

• After sterilization, the sterilizer will need to beunloaded into another clean, well-lit area.Ensure that this area is kept clean, particularlyjust before the sterilizer is emptied.

• Where possible, air movement should be fromclean to dirty areas (see paragraphs 6.41–6.42).

• A wash-hand basin should be provided for useby staff at the completion of each stage in thedecontamination process. Where this work isconducted adjacent to the treatment area, it isacceptable for a single wash-hand basin to beused for this and clinical hand-washing.However, this basin should be distinctlyseparate from the sinks used indecontamination. A screen could be utiliseddepending on space.

• Where a double-ended washer-disinfector isused in a pass through facility, the input doorin the dirty area and that used to empty theclean instruments should be separated by abarrier. Alternatively, the washer-disinfectorshould be built directly into the separating wallbetween the dirty and clean areas.

5.8 This guidance recognises that, because of physicallimitations on space and costs, some practices maynot meet the required standards and policies. Inareas where building alterations to existingpremises are restricted or purpose-built premisesmay be difficult to upgrade, progress to improvestandards may prove difficult and a full riskassessment should be carried out highlighting theproblems and formulating an action plan toimprove the facility and working practices.

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Hand hygiene6.1 The term hand hygiene covers not only

handwashing, but also alternative and additionalmeasures such as hand disinfection usingantibacterial-based hand-rubs and gels.

6.2 Hand hygiene is crucial in preventing the spreadof infection and the recontamination of surgicalinstruments and devices. Clean hands are anessential counterpart to the use of gloves. Neithermeasure is a substitute for the other.

6.3 As part of the constant improvement in delivery ofthe service, training in hand hygiene should bepart of staff induction and be provided to allrelevant staff within dental practices periodicallythroughout the year. Advice is available fromwww.npsa.nhs.uk/cleanyourhands .

6.4 There are three different levels of hand hygiene(see Appendix 2). The level required depends onthe potential for contamination of the hands andthe risk factors related to the process to beundertaken. For the decontamination of devices,as described here, good levels of social handhygiene will be sufficient. Accordingly, the aim isto render the hands physically clean and to removetransient microorganisms encountered in theperformance of normal duties.

6.5 Hand hygiene should be practised at the followingkey stages in the decontamination process so as tominimise the risk of contamination:

• before and after each treatment session;

• before donning and after the removal of PPE;

• following the washing of dental instruments;

• before contact with instruments that have beensteam-sterilized, whether or not theseinstruments are wrapped;

• after cleaning or maintaining decontaminationdevices used on dental instruments;

• at the completion of decontamination work.

6.6 Mild liquid soap should be used when washinghands. Bar soap should not be used. Apply theliquid soap to wet hands to reduce the risk of

irritation and perform hand-washing underrunning water. Ordinarily, the hand-wash rubbingaction should be maintained for about 15 seconds.After the exercise, the hands should be visiblyclean. Where this is not the case, the hand hygieneprocedure should be repeated.

Drying of hands

6.7 Effective drying of hands after washing is importantbecause wet surfaces transfer microorganisms moreeasily than when they are dry and inadequatelydried hands are prone to skin damage. To preventrecontamination of washed hands, disposable papertowels should be used.

Skin care

6.8 Hand cream, preferably water-based, should beused to avoid chapped or cracking skin.Communal jars of hand cream are not desirable asthe contents may become contaminated andsubsequently become an infection risk. Ideally,wall-mounted hand cream dispensers withdisposable cartridges should be used. Any staffwho develop eczema, dermatitis or any other skincondition should seek advice from theiroccupational health department or generalpractitioner (GP) as soon as possible.

6.9 Fingernails should be kept clean, short andsmooth. When viewed from the palm side, no nailshould be visible beyond the fingertip. Staffundertaking dental procedures should not wear nailvarnish or false nails. Do not use abrasive spongesor nail brushes because these can cause abrasion ofthe skin where microorganisms can reside.

6.10 Rings, bracelets and wristwatches should not beworn by staff undertaking clinical procedures. Staffshould remove these prior to carrying out handhygiene. A wedding ring is permitted but the skinbeneath it should be washed and dried thoroughly,although it is preferable to remove the ring priorto carrying out dental procedures.

Facilities and procedures for hand-washing

6.11 A separate wash-hand basin should be provided(see paragraph 5.7). Practices are encouraged to

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Chapter 6 General hygiene principles

replace existing wash basins that do not complywith the following:

• The basin should not have a plug or anoverflow and be fitted with a remote runningtrap, that is, the U-bend is not directly underthe plughole.

• It should have a sensor-operated or leveroperated mixer tap.

• Taps should not discharge directly into thedrain aperture as this might generate aerosols.

6.12 Wall-mounted liquid hand-wash dispensers withdisposable cartridges should be used and thenozzle kept clean. Refillable hand-wash containersshould not be used as bacteria can multiply withinmany of these products and are therefore apotential source of contamination.

6.13 Hand hygiene is an essential part of preventinginfection in the practice. A cleanable posterdepicting a six- or eight-step method should bedisplayed above every clinical wash-hand basin inthe practice (see Section C).

Personal protective equipment fordecontamination processes6.14 The local infection prevention and control policy

should specify when personal protectiveequipment (PPE) is to be worn and changed. PPEtraining should be incorporated into staffinduction programmes.

6.15 Appropriate PPE should be worn duringdecontamination procedures. PPE includesdisposable clinical gloves, household gloves, plasticdisposable aprons, face masks, eye protection andadequate footwear. PPE should be stored inaccordance with the manufacturers’ instructions.

6.16 When used appropriately, and in conjunction withother infection control measures, PPE forms aneffective barrier against transmission of infection.

Gloves

6.17 Gloves are needed to:

• protect hands from becoming contaminatedwith organic matter and microorganisms;

• minimise the risks of cross-infection bypreventing the transfer of organisms from staffto patients and vice-versa;

• protect hands from certain chemicals that willadversely affect the condition of the skin.Particular care should be taken when handlingcaustic chemical agents, particularly those usedin disinfection and for washer-disinfectors.

6.18 A new pair of gloves must be worn for everypatient and, if necessary, changed duringtreatment. Used gloves should be replaced beforeperforming activities that require strict asepticprecautions or when touching equipment that isdifficult to clean.

6.19 It is important that gloves fit properly if they areto produce the level of protection against theexpected contaminants. The use of latex gloves issubject to a Health & Safety Executiverecommendation, which calls for local riskassessment. This is partly attributable to reports oflong-term allergy development in some users. Theuse of vinyl or nitrile gloves may be a satisfactorysubstitute and should be made available to staffwithin the practice.

6.20 Powdered gloves should not be used. Individualswho are sensitised to natural rubber latex proteinsand/or other chemicals in gloves should takeadvice from their GP or occupational healthdepartment for an alternative to latex gloves.

6.21 All disposable clinical gloves used in the practiceshould be CE-marked and should be:

• low in extractable proteins (<50 µg/g);

• low in residual chemicals;

• powder-free.

6.22 Gloves, other than domestic household types, aresingle-use only. They should be discarded asclinical waste.

6.23 Jewellery, for example, watches, dress rings andbracelets may damage the integrity of the gloveand may pose an infection risk.

6.24 The following additional guidance is provided:

• Long or false nails may also damage the glove,so nails should be kept short and clean.

• Glove integrity can be damaged if in contactwith substances such as isopropanol or ethanol;therefore, alcohol rubs/gels should not be usedto decontaminate gloves.

• Gloves, except household gloves, should not bewashed as liquids may be absorbed into theglove and compromise the efficacy of thebarrier.

• Storage of gloves should follow manufacturers’recommendations.

• Domestic household gloves, if used, should bewashed with detergent and hot water and leftto dry after each use to remove visible soil.Gloves should be replaced weekly or morefrequently if worn or torn or if there is anydifficulty in removing soil.

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Disposable plastic aprons

6.25 These should be worn during all decontaminationprocesses.

6.26 Aprons should be changed at the completion ofeach procedure, be used as a single-use item anddisposed of as clinical waste (see Appendix 1).

Face and eye protection for decontaminationprocedures

6.27 During cleaning procedures, there is a risk ofcontaminated fluids splashing onto the face andinto the eyes. Therefore, the dental team shouldensure protection of their mucosa from splashesand other contaminated fragments that may escapeduring these procedures.

6.28 Face masks are single-use items and should bedisposed of as clinical waste.

6.29 Spectacles do not provide sufficient eye protectionunless specifically designed for the purpose. It isadvisable to wear a visor or face shield overspectacles; this gives added protection forprescription glasses.

6.30 Eye protection may be reusable but is oftendifficult to clean. It may be reused if cleanedaccording to manufacturers’ instructions. Thisshould take place when it becomes visibly dirtyand/or at the end of each session. Disposablevisors are available and may be used.

Footwear

6.31 Footwear should be fully enclosed, in good orderand comply with health and safety guidance.Particular care should be taken concerning the riskof chemical or hot water spillage onto feet.

Clothing, uniforms and laundry

6.32 A wide variety of clothing is worn in dentalsurgeries and in many practices is used to reinforcethe corporate image.

6.33 Clothing worn to undertake decontaminationshould not be worn outside the practice. Adequatechanging and storage facilities that are accessiblefrom the decontamination area should beprovided. A similar approach is recommended forclinical clothing.

6.34 Short sleeves allow the forearms to be washed aspart of the hand hygiene routine. Dental staff needto be aware of the hazards that may beencountered in the decontamination process andmay wish to wear long-cuffed gloves or disposallong-sleeved gowns to protect their arms.

6.35 Clothing and uniforms can become contaminatedwith microorganisms during procedures. It is

important that freshly laundered uniforms areworn every day. Sufficient uniforms for therecommended laundry practice should beprovided, as staff who have too few uniforms maybe tempted to reduce the frequency of laundering.

6.36 Uniforms and clothing should be washed at thehighest temperature suitable for the fabric, e.g.10 minutes with a suitable detergent at aminimum temperature of 60oC, to reduce anypotential microbial contamination. For guidancerelating to contact with chemical substances, seethe Health & Safety Executive’s guidance onCOSHH – www. hse.gov.uk/coshh.

Removal of PPE

6.37 Depending on the type of PPE worn, items ofPPE should be removed in the following order:

a. Gloves. Gloves should be removed first so thatthey end up inside-out. When removing them,make sure hands do not become contaminated.Hands should be washed thoroughly, if visiblycontaminated, before removing the rest of thePPE.

b. Plastic disposable apron. The apron is removedby breaking the neck straps and carefullygathering together by touching only the inside,avoiding touching the outer contaminated area.

c. Face mask. The mask is removed by breakingthe straps or lifting over the ears and disposinginto a clinical waste receptacle (see Appendix 1).Touching the outer surface should be avoidedand the mask should not be crushed beforedisposal. Masks should never be left to hangaround the neck and should be disposed ofimmediately after use.

d. Face and eye protection. Care should be takennot to touch the outer surfaces. Single-use eyeprotection should be disposed of into theclinical waste receptacle.

e. Wash hands thoroughly again.

Surface and equipmentdecontaminationGeneral

6.38 Surfaces and equipment used in thedecontamination of dental instruments should becleaned carefully before and after eachdecontamination process cycle. The procedureused should comply with written local policies.

6.39 All surfaces should be such as to aid successfulcleaning and hygiene. Wherever possible, surfaces,including walls, should be continuous and free

45

6 General hygiene principles

from damage and abrasion. They should be freefrom dust and visible dirt.

Environmental conditions

6.40 The environmental conditions in decontaminationfacilities should be controlled to minimise thelikelihood of recontamination of sterilizedinstruments. Key considerations include thecleanability of surfaces, fittings and equipment.

6.41 Ventilation and air quality are importantconsiderations. In non-purpose-built facilities, thecontrol of airflow is a challenging issue.Responsible Persons (see Section C) will need toconsider how good standards can be achievedwithout resorting to unreasonably complex orexpensive ventilation systems. Through-wall fan-based ventilation and extraction units will often beuseful in this context. In particular, cassette-basedsystems can be simple to install and produce abalanced airflow at low cost. The use offreestanding or ceiling-mounted fan units,however, is not recommended.

6.42 Mechanical ventilation systems may beadvantageous, particularly where best practicerequirements are being pursued. However, thesesystems can be expensive in terms of both capitaland running costs. Accordingly, designs that makebest use of natural ventilation in clinical areas maybe advantageous, while the use of simple fan-basedsystems in decontamination areas will be helpful.It should be remembered that protecting againstrecontamination of instruments is always a keyaim.

Detailed guidance can be found in WHTM 03-01 -‘Specialised ventilation for healthcare premises’.

6.43 The ventilation system in the decontaminationarea or room(s) should be designed to supplyreasonable quantities of fresh air to the positionswhere persons work and to remove excess heatfrom equipment and processes.

6.44 Where used, mechanical extract units should beceiling- or wall-mounted. Care should be taken toensure that airflow is from clean to dirty.

6.45 Where full mechanical ventilation solutions areused, the extract system should be located andsized to draw about one-third of the air across thedecontamination benches in the clean-to-dirtydirection. Mechanical ventilation equipmentshould include coarse air filtration on the inputside. This will require periodic maintenance.Practices are advised to consult a heating andventilation engineer if choosing to install amechanical ventilation system.

Surfaces and equipment – key design issues

6.46 All surfaces and equipment should be imperviousand easily cleanable. Work surfaces and floorcoverings should be continuous, non-slip and,where possible, jointless. Welsh Health BuildingNote 00-09 – Infection control in the builtenvironment states that the use of carpets is notadvised within any clinical or associateddecontamination area. Attractive vinyl flooringmaterials are available which can provide aestheticappeal.

6.47 Flooring in clinical care and decontaminationareas should be impervious and easily cleanable.Carpets, even if cleanable, should not be used.There should be coving between the floor and thewall to prevent accumulation of dust and dirt incorners and crevices.

6.48 Any joints should be welded or sealed where theyare unavoidable. Sealing prevents damage due towater ingress under the flooring.

6.49 It should be ensured that surfaces:

• can be easily accessed;

• will dry quickly.

6.50 Manufacturers’ advice should be sought in termsof the compatibility of detergents and disinfectantswith the surface materials used.

Decontamination equipment

6.51 Specialist items of equipment, for example,ultrasonic baths, washer-disinfectors, sterilizers andRO or water treatment plant, may require cleaningand decontamination processes that are purposedesigned. Although information will be providedby manufacturers it is recommended that, whenwriting local protocols, assistance is sought from aqualified decontamination engineer or othertrained person. This may be a CP(D) employed bythe equipment provider or local SSD manager. Inthe latter case, it should be possible to contact thelocal AP(D) via the Health Board or contactNWSSP-FS for the AE(D) or DecontaminationEngineers (Wales) for advice.

6.52 Planned cleaning programmes will have links topreventive maintenance and the validation process.Local policies should reflect these requirementsand clearly state the intervals at which actions areto be taken and a procedure for the keeping ofrecords.

6.53 It is often during cleaning work that minordefects, wear or damage to equipment will bedetected. Local policies should ensure that suchdefects are reported to the responsible person.

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Note

For floor and general surface cleaning, NHS Englandhas published a guidance package backed by a colourcoding system for use with materials and equipment.

This system should also be useful for dental practices(visit http://www.nrls.npsa.nhs.uk/resources/?entryid45=59810).The colour codes used in primary care are:

• red – for wash-rooms;

• blue – for offices;

• green – for kitchens;

• yellow – for clinical and decontamination areas.

Cleaning protocols and techniques

6.54 The dental practice should have a local protocolclearly outlining surface and room cleaningschedules. The cleaning process will be mosteffective if the more contaminated areas arecleaned first. Materials and equipment used toclean clinical areas and other higher-risk areasshould be stored separately from those used forgeneral and non-clinical areas. Simple recordsshould be maintained.

6.55 Cleaning staff should be briefed on the specialmeasures to be observed in cleaning of patient careareas or rooms used for decontamination. In someinstances, full training of personnel will be needed.

6.56 If instruments become contaminated through, forexample, being dropped or placed in a dirty area,they should be sent for further reprocessing.

6.57 Evidence suggests that the use of commercialbactericidal cleaning agents and wipes is helpful inmaintaining cleanliness and may also reduce viralcontamination of surfaces. Care should be taken inthe use of alcohol wipes which, though effectiveagainst viruses on clean surfaces, may fix proteinand biofilm. However, the careful use of waterwith suitable detergents, including those CEmarked for clinical use, is satisfactory provided thesurface is dried after such cleaning.

Note

Alcohol has been shown to bind blood and protein tostainless steel. The use of alcohol with dentalinstruments should therefore be avoided.

6.58 The Department of Health in England hassponsored research on the use of both microfibercloth and steam-cleaning technology in clinicaland support-service areas. This work suggests that,provided deep cleaning is performed as an initial

exercise, the subsequent use of microfibre-basedtechniques, essentially involving dry or wetwiping with microfibre cloth, can be helpful inachieving satisfactory removal of infectious agentsfrom surfaces. The special fibre is capable ofentangling and thus removing a wide range ofpathogenic particles from surfaces to which theyare otherwise adherent. However, as infectivematerial is efficiently transferred to themicrofibre, its reprocessing or disposal must takeaccount of the infection risk. Reprocessing takesthe form of washing through a conventionallaundry process. This should take place at the endof each session or when obviously contaminated.The life of the cloth is likely to allow for repeateduse on many occasions. The materials are availableat relatively modest cost from infection controlcompanies.

Note

Detailed information is provided in ‘An integratedapproach to hospital cleaning: microfibre cloth andsteam cleaning technology’ available from theDepartment of Health’s website.

6.59 Local provision of steam cleaning from practiceresources is unlikely to be economic. The use of acontractor may be advantageous.

6.60 Cleaning equipment should be stored outsidepatient care areas.

Decontamination of treatment areas6.61 The patient treatment area should be cleaned after

every session using disposable cloths or cleanmicrofibre materials even if the area appearsuncontaminated.

6.62 Areas and items of equipment local to the dentalchair that need to be cleaned between each patientinclude:

• local work surfaces;

• dental chairs;

• dental inspection light;

• hand controls including replacement of covers;

• trolleys and delivery units;

• spittoons;

• aspirators;

Other equipment that is not directly attached tothe dental chair, such as curing lamp and x-rayunit, must be wiped down if it has been used.

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http://www.nrls.npsa.nhs.uk/resources/?entryid45=59810

http://www.nrls.npsa.nhs.uk/resources/?entryid45=59810

Note

Dental chairs should be free from visible damage, forexample, rips and tears.

6.63 Areas and items of equipment that need to becleaned after each session include:• taps;

• drainage points;

• splashbacks;

• sinks.

In addition, cupboard doors, other exposedsurfaces (such as dental inspection light fittings)and floor surfaces, including those distant fromthe dental chair, should be cleaned daily.

Note

Spittoons and aspirating units need to be washedthrough at the end of a session according tomanufacturers’ instructions.

6.64 Items of furniture that need to be cleaned atweekly intervals include:

• window blinds;

• accessible ventilation fittings;

• other accessible surfaces such as shelving;

• radiators and shelves in cupboards.

6.65 Purpose-made disposable single-use covers areavailable for many of the devices mentioned above,including inspection light handles and headrests.The use of these is encouraged but should not betaken as a substitute for regular cleaning. Coversshould be removed and surfaces should be cleanedafter each patient contact.

6.66 Computer equipment in clinical areas can readilybecome contaminated. Solutions are available tominimize risks, e.g.

• purpose designed covers over computerkeyboards.

• “easy-clean” waterproof keyboards.

Where covers for conventional keyboards areprovided, care should be taken to ensure thatcovers are changed or that washing is performed atfrequent intervals.

6.67 Cleaning centres on simple techniques usingdisposable cloths wetted with clean water and adetergent.

6.68 Damp dusting is preferable to dry dusting, whichshould be avoided wherever possible as this mayresult in dust suspension.

6.69 Care should be taken to keep water well awayfrom electrical devices, even though many of thoseprovided in dentistry will have water-resistanthousings.

6.70 After some clinical procedures it is necessary tostart cleaning as soon as care of the individualpatient is complete. In these cases, staff should notwait until the end of the session to start cleaningthe area.

6.71 Portable aspirators with reservoir bottles are notrecommended. They are not fitted with filters andpose a considerable hazard when disposing of thecontents.

6.72 Intra-oral radiology film and devices used indigital radiology imaging are potential sources ofcross-infection. Accordingly, where reusabledevices are used, they should be decontaminatedin accordance with the manufacturer’s instructions.For intra-oral holders this will require the use ofsteam sterilization following washing anddisinfection.

6.73 Soft toys are often difficult to clean and shouldnot be provided within practices.

6.74 For blood spillages, care should be taken toobserve a protocol that ensures protection againstinfection. The use of hypochlorite at 1000 ppmavailable chlorine is recommended unless HealthBoard policy suggests otherwise. Hypochloriteshould be made up either freshly usinghypochlorite generating tablets or at least weeklyin clean containers. Contact times should bereasonably prolonged, not less than five minutes.A higher free chlorine yield of up to 10,000 ppmis useful, particularly for splash contamination.The process should be initiated quickly and careshould be taken to avoid corrosive damage tometal fittings, etc. The use of alcohol within thesame decontamination process is not advised.

Dental unit water lines (DUWLs)Note

In view of the expertise required in this specialised field,practices (through the Registered Manager) shouldengage with an external specialist to assist in meetingthe recommendations given in Section C of thisguidance. This may be a locally-based engineeringconsultant with specialist knowledge of legionella andother water-borne organisms.It is likely that Health Boards and representatives fromprofessional organisations, such as the LegionellaControl Association, will be able to recommend asuitable contractor.

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General

6.75 Best practice guidelines on the control oflegionella are provided in the Health & SafetyCommission’s ‘Legionnaires’ disease – the controlof legionella bacteria in water systems. ApprovedCode of Practice and guidance on regulations’ L8,HSG 274 Legionnaires disease- Technical guidanceand WHTM 04-01 – ‘The control of Legionella,hygiene, “safe” hot water, cold water and drinkingwater systems’.

Note

The Health & Safety Commission’s Approved Code ofPractice L8 gives practical advice on how to complywith UK health and safety law with respect to thecontrol of legionella bacteria. This Code is important inthat it has a special legal status. If a healthcareorganisation is prosecuted for a breach of health andsafety law, and it is held that it did not follow therelevant provisions of the Code, that organisation wouldneed to demonstrate that it had complied with the lawin some other way or a court would find it at fault.

6.76 The use of water in dentistry must comply with aseries of regulations which are designed to ensurethe safety of patients, staff and the public. Theapplication of these regulations and codes iscovered in detail in Chapter 19 of this guidance.

6.77 The Registered Manager (see paragraph 9.3)should ensure that arrangements are made so thatthe practice can continuously achieve compliancewith the requirements of these regulations.Registration with the Legionella ControlAssociation or other recognised body isrecommended.

Microbiological monitoring

6.78 Apart from situations where there are indicationsfrom taste or odour, microbiological monitoringusing dip slides for total viable counts (TVCs) isnot considered essential. However, somecompanies and other institutions offercomprehensive water-purification services thatinclude periodic microbiological samplemonitoring. Such services, provided they arequality-controlled, may contribute usefully to riskreduction in this area.

6.79 Where taste or odour problems are encountered,advice may be sought from the local authorityenvironmental health department. They canarrange for testing, if necessary, as part of theirservice level agreement with Public Health Walesor alternative commercial services.

Note

This is a complex procedure and the use of in-housetest kits is not recommended.

DUWLs

6.80 No currently available single method or device willcompletely eliminate biocontamination ofDUWLs or exclude the risk of cross-infection. Toreduce contamination risk, a combination ofmethods is applicable (see also Section C).

6.81 With regard to legionella and other water-bornepathogenic agents, the Health and Social Care Act2008: Code of Practice on the prevention andcontrol of infections and related guidance (2009)states: “Premises should be regularly reviewed forpotential sources of infection and a programme shouldbe prepared to minimise any risks. Priority should begiven to patient areas although the exact priority willdepend on local circumstances”. Whilst the Code ofPractice does not apply in Wales, the statementreferred to above is considered to provide soundguidance.

6.82 Guidance from HSG 274 Part 3 advises that at-risk systems, particularly those used with thepatient, be drained down twice daily (typically atthe start and finish of each working day). Wheremanufacturers provide protocols for daily cleaning,these should be applied.

6.83 Self-contained water bottles (bottled water system)should be removed, flushed with distilled or ROwater and left open to the air for drying overnight.They should be stored inverted.

6.84 Where visual contamination is present, flushingwith a suitable disinfectant followed by thoroughwashing is necessary. The manufacturer’sinstructions will specify the disinfectant to be usedand may also require the continuous presence ofantimicrobial agents to prevent the build-up ofbiofilms.

Note

The self-contained water supplies used with dental caresystems should be freshly distilled or RO water (seeSection C). Certain systems recycle water back to astorage facility. Where this is done, repurification willbe necessary at each cycle.

If self-contained water bottles are not used, anappropriate air gap (Type A) should separate theDUWLs from the mains water supply. Sucharrangements should be subject to consideration oflocal water quality, particularly where hard water isused.

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6.85 DUWLs should be flushed for at least twominutes at the beginning and end of the day andafter any significant period when they have notbeen used, for example, after lunch breaks. Inaddition, they should also be flushed for at least20–30 seconds between patients. Whilst theseactions have been shown to have only a smalleffect on biofilm build-up within the DUWLsystem, they do usefully reduce microbiologicalcounts in the water delivery tube during theperiod when patients are likely to be exposed.Some water-purification systems are capable ofsupplying DUWLs and may be able to reducemicrobiological risks.

Note

Care should be taken to minimise the occurrence ofsplashing and aerosol formation.

6.86 Disinfection of DUWLs should be carried outperiodically. In all cases the manufacturer’sinstructions should be consulted. Sodiumhypochlorite and isopropanol and a number ofother agents have been shown to be effective in theremoval of biofilm as well as the reduction ofmicrobacterial contamination. However, theseagents should only be used where recommendedby manufacturers. If they are used, care should betaken to ensure that DUWLs are thoroughlyflushed after disinfection and before beingreturned to clinical use.

Note

(1) There is disagreement within the scientific literatureconcerning the effectiveness of water-based flushingof DUWLs, particularly in respect of biofilmcontrol. For systems making use of potable water,that is, where the water supply is drawn from amains water system, the nature of the building’swater-supply arrangements may be an importantconsideration. This is particularly so where storagetanks are used. Where delivered water quality is indoubt, dental practices should consider adoptingcontinuous dosing systems if permitted by theDUWL manufacturer’s recommendations. If dosingis used, it is important to ensure that the dose ratesdelivered are within the recommended safe limitsfor the product used. Dental practices that use apotable water option, through air-gap supply or theuse of bottles, should consult with their appointedCompetent Person (Decontamination) in respect oflocal water quality and suitability.

(2) For those using purified water, such as freshlydistilled or RO, possibly with UV treatment, therate of biofilm build-up is likely to be low, providedthat water lines are regularly disinfected andmaintained.

(3) Particular caution should be taken with regard todental handpieces where dosing is applied, as anumber of instances of damage have been reported.

6.87 Dental equipment requiring protection againstbackflow should have anti-retraction valvesincorporated on all handpieces, ultrasonic scalersand water lines (see Section C). ResponsiblePersons should ensure these are fitted whererequired. They must be regularly monitored andmaintained.

6.88 Examples of dental equipment requiring backflowprotection are:

• dental spittoons;

• three-in-one syringes;

• wet-line suction apparatus; and

• self-filling automatic radiographic processorswhere still used.

Note

Adherence to the equipment manufacturer’srecommended cleaning procedures, including the useof the manufacturer’s recommended chemicals, is arequirement for medical devices such as those listedabove.

6.89 Where in-line filters are used, these will requiretreatment using an appropriate cleansing solutionat intervals recommended by the manufacturer –but always at the end of each session. This stepshould be performed after first flushing theDUWL.

6.90 If the DUWL has disposable filters, they should bereplaced daily.

Note

See Section C for further guidance on DUWLs.

6.91 For dental surgical procedures, surgical flaps orother access into body cavities involvingirrigation, the use of sterile water or sterileisotonic saline provided from a separate singleuse source is recommended.

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7.1 Decontamination of these devices is a multi-stepprocess to be conducted in accord with the deviceor material manufacturer’s instructions. In generalterms, the procedure will be as follows:

a. Immediately after removal from the mouth anydevice should be rinsed under clean runningwater. This process should continue until thedevice is visibly clean.

b. All devices should receive disinfectionaccording to the manufacturer’s instructions.This will involve the use of specific cleaning

materials noted in the CE-markinginstructions. After disinfection the deviceshould again be thoroughly washed. Thisprocess should occur before and after anydevice is placed in a patient’s mouth.

c. If the device is to be returned to asupplier/laboratory or sent out of the practice,a label to indicate that a decontaminationprocess has been used should be affixed to thepackage.

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Chapter 7 Impressions, prostheses andorthodontic appliances

Section C: Engineering, technology and standards

52

53

BS/EN/ISO Standards8.1 BS EN Standards for sterilization were first

published in 1994. They included:

• BS EN 285 on larger steam sterilizers;

• BS EN ISO 17665 on the monitoring of steamsterilization; and

• BS EN 556 on the definition of sterilization.

8.2 Subsequent standards covered small sterilizers(BS EN 13060).

8.3 Reviews and rewrites of the above Standardscoupled with the production of new Standards hasled to a revision of the content of Health TechnicalMemoranda, including this document, in order tobring their content in line with that of the BS ENISO Standard portfolio.

8.4 A list of these Standards is provided in theReferences. It is in the light of these changes thatthis WHTM is published. Reference to the contentof a relevant Standard is made where necessary butthe content is not included in this document.

NHS Wales guidelines8.5 Guidance produced by the Welsh Government for

decontamination has evolved in recent years.

8.6 The CDO letter Advice for dentists on re-use ofendodontic instruments and variant Creutzfeldt-Jakob Disease (vCJD) (April 2007) advised thesingle-use of all endodontic files and reamers, aswell as any other instruments for which effectivedecontamination was difficult. This was reinforcedby the release of ‘Potential vCJD transmission risksvia dentistry. An interim review’ (DH - December2007).

8.7 WHTM 01-05 has drawn upon all guidanceissued previously.

8.8 It is issued specifically to improve standards indecontamination for primary care dental practices,where decontamination is carried out locallywithin the practice.

8.9 For secondary care, the Welsh Governmentcommissioned the decontamination project which

successfully reviewed and reported that all hospitalsterilization and decontamination units in Walesachieved accreditation to the standards required bythe Medical Device Regulations. Accreditationstatus allows HSDUs to undertakedecontamination for third parties, includingprimary care. This allows primary care in Wales toconsider:

• In-house decontamination to the correctstandards and policies;

• Use of single-use devices as advised and wherepossible;

• Outsource decontamination to an accreditedHSDU;

• A combination of the above.

8.10 WHTM 01-05 sets out the requirements for thefirst of the above options.

Healthcare regulation and standards

Health Boards must ensure that the provision of healthservices meets Doing well, doing better - Standards forHealth Services in Wales. Infection prevention andcontrol, including decontamination, is a requirementthat will apply to all NHS healthcare providers.

All private primary care dental services have beenregulated in Wales since 1 January 2009. All providersof private dental services activities will continue toregister with the Healthcare Inspectorate Wales inaccordance with regulatory requirements.

For 2013, the registration requirements for infectioncontrol and prevention, including decontamination,are supported by the Private Dentistry (Wales)Regulations 2008. This WHTM will be referenced inany National Minimum Standards for Private DentalServices and enforced through the above regulations.Adherence to the WHTM will, with regard todecontamination, contribute towards evidence ofcompliance with registration requirements.

Chapter 8 Regulatory framework and compliance

Note

WHTM 01-01 Part A outlines roles andresponsibilities and structure of decontamination forthe Welsh Health Service.

9.1 It is essential that all staff working in the dentalpractice/service understand the importance of cross-infection control. Staff involved in decontaminationmust be suitably trained, have their roles andresponsibilities defined and everyone must be awareof each other’s responsibilities.

9.2 WHTM 01-01 Parts A, B, C and D provideadvice for the acute sector on the decontaminationprocesses and standards to meet the directive.

9.3 Each practice can, therefore, establish its ownsystem concerning staff responsibilities but will beexpected to demonstrate the same degree ofunderstanding, competency and management,regulatory compliance as required by WHTM 01-01 Parts A and B. The following may be used as aguide to these roles. The terminology of Part A isused for clarity but it is likely that local personnelmay have differing titles.

Note

It should be borne in mind that it is likely that oneindividual may carry out two, or possibly more, of thefollowing roles depending on the structure and size ofthe organisation and the numbers of staff involved inthat process.

Registered Manager (Executive Management):this will be the individual with ultimateresponsibility for decontamination equipmentownership and the definition and appointment ofthe following staff. In a dental practice, this couldbe the NHS provider, practice owner or a personof similar authority.

Decontamination Lead: Healthcare AssociatedInfections – A Community Strategy for Walesmakes it a requirement that an individual is giventhe responsibility for infection control anddecontamination. This person should have theexperience and authority to perform this task andshould be accountable to the Registered Manager.The Decontamination Lead may be either directly

employed by the practice or provided as a serviceby the Health Board.

Designated Person: this role acts as the interfacebetween the practice and support services suppliedexternally, including service, maintenance andtesting. This could be the Dental PracticeManager. The Decontamination Lead could alsoact as the Designated Person.

User: This person has day-to-day responsibility forthe management of the decontaminationequipment and processes for the practice. A likelyoverlap may mean that this role is duplicated, butthe responsibility must be demonstrated. Animportant function of the User is to ensure thatanyone operating and testing decontaminationequipment, that is, an Operator, is suitably trainedand competent.

Note

The User should seek advice from manufacturers andNWSSP-FS, the AP(D) or AE(D) or the appointedCP(D) on how to carry out the testing of equipmentand daily tasks as stated in this document. The serviceengineer can advise on maintenance schedules andspecific requirements of the machines.

Authorising Engineer (Decontamination)(AE(D)): this is a role that provides guidance andadvice on the compliance issues ofdecontamination, including the implementation ofthis WHTM and associated guidancedocumentation. A list of suitable persons isavailable from the register held by the Institute ofHealthcare Engineering and Estate Management(IHEEM) (www.iheem.org.uk/Decontamination).

Decontamination Engineer (Wales): This role,fulfilled by NWSSP-FS, can advise the User on alltechnical issues within this document (see WHTM01-01 Part A).

Authorised Person (Decontamination)(AP(D)): The Authorised Person providestechnical advice to the Competent Person andUser and liaises with the Authorising Engineer.The AP(D) can offer advice to the practice andUser, or Health Boards / Trusts.

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Chapter 9 Staff roles and responsibilities indecontamination

Competent Person (Decontamination)(CP(D)): The Competent Person is responsiblefor servicing, testing and maintaining thedecontamination equipment within the practice.The Competent Person may be either directlyemployed by the practice as a contractor, orprovided as a service by the Health Board or by athird party. The CP(D) should have attended thespecific training courses on testing of washer-disinfectors and sterilizers and have certificationfor quality assurance of the process.

Competent Person (Pressure Vessels): eachpractice will have a legal responsibility for the safetyof its decontamination equipment, particularly thesterilizers that are pressure vessels. The need forinsurance and a Written Scheme of Examination isa legal liability and can be provided by theCompetent Person (Pressure Vessels). This is likelyto be provided by an insurance company.

Service engineer: A person provided under aservice level agreement or contract who is certifiedby the service agent or equipment manufacturerto be competent to both service and possibly actas the CP(D) to test specified decontaminationequipment. This person may, among other duties,perform validation tests in accordance with theEN standards cited in this document. The serviceengineer may give an opinion on the outcomes ofvalidation testing as well as providing data to anAE(D) or AP(D) for validation approval.

Operator: This is the person with authority tooperate decontamination equipment. This personwill also carry out daily and weekly periodic tests.

Manufacturer: the manufacturer, supplier or agentof any decontamination equipment.

Purchaser: the purchaser of any decontaminationequipment, likely to be the practice.

9.4 In addition to these roles the practice may requirespecialist clinical advice and guidance and shouldpossess the ability to source the followingresponsibilities, either within the practice orexternally.

Control of Infection Officer: advice regardinginfection prevention and control and the ability toaudit and implement relevant advice.

Microbiologist (Decontamination): while mostdecontamination processes are a matter ofparametric management and control, that is,ensuring that values of key measurements orindicators are within a specified range fordecontamination, advice from a Microbiologist(Decontamination) may be required for certainprocedures and practices. This advice should be

sought where the practice is in doubt about itsrelevance. Access to a Microbiologist can be madevia the local Health Board. Institutions thatemploy such professionals would include theHealth Boards, pathology departments and PublicHealth Wales laboratories.

9.5 The Registered Manager should ensure that allpersonnel fulfilling the roles defined above shouldreceive appropriate training, that they candemonstrate competency in their duties and thatindividual training records for all staff are retained.Training should always be supported by definedlearning outcomes and competencies and mayinclude, where appropriate, the following:

• an understanding of the wholedecontamination process;

• an understanding of their roles and those ofothers;

• an understanding of the need for infectionprevention and control and all relevantinfection prevention and control policies andprocedures;

• an understanding of, and an ability tounderstand the need for periodic testing ofdecontamination equipment whereappropriate;

• an understanding of auditing ofdecontamination processes and facilities.

9.6 It is likely that small practices will be unable toappoint all these responsible posts and a localdecision regarding them will need to be made.Essentially, a practice should be able todemonstrate the following responsibilities:

• the owner has an understanding of legalliabilities and current best practice;

• it has obtained professional advice, wherenecessary, in equipment purchase,maintenance, the validation, testing andoperation activities;

• it can evidence the performance of all relevantmaintenance and testing duties;

• it can demonstrate compliance with thePressure Systems Safety Regulations.

9.7 Full identification of the individuals fulfilling theseroles should be documented. It may be acceptableif staff of other titles fulfil the responsibilities aslong as the post-holder’s authority and experienceis sufficient for their full implementation.

9.8 It is likely in a dental facility that some of the rolesabove will be provided by a number ofentities/organisations. All roles should thus be

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9 Staff roles and responsibilities in decontamination

identified and all individuals aware of each other.The systematic approach to these roles shouldensure that they function correctly and that theyare not individual-based but can withstandchanges of personnel without affecting thesystematic approach. Advice on relevant trainingprogrammes is available from NWSSP-FS. Inaddition, the local Health Board may also be ableto provide advice.

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Note

In addition to the guidance given in this chapter,readers may also find Scottish Dental’s website useful.On its decontamination page, it has included a list ofdecontamination equipment that has been tested andapproved for use in dental practices, and is used in thenational contract in Scotland (www.scottishdental.org/).

Determining the load to be processed10.1 In order to ensure full compatibility of the

equipment with the decontamination process, theneed for packaging and storage should beconsidered, as this will affect the type of airremoval process and therefore the type of sterilizerchosen (vacuum types B or S or downwarddisplacement type N).

10.2 Instrument design will also affect the choice of thecleaning process, particularly regarding the designsand types loading carriages for thermal washer-disinfectors.

10.3 If cannulated devices are to be cleaned, ultrasonicirrigators, that is, ultrasonic pre-cleaners with theadditional ability to clean and flush internalchannels of cannulated devices, or loadingcarriages with lumen connections may be required.

10.4 In addition to the types of load items:

• their quantities should also be assessed. Thiswill enable the number of equipment items tobe determined;

• realistic cycle times should be assumed whencapacity planning is calculated;

• it should be remembered that alldecontamination equipment will requiremaintenance, servicing and testing andreasonable time during the normal workingday should be set aside for these procedures. Itmust be stated that service and testing areseparate functions and responsibilities;

• all capacity planning should be documented.

Note

Periodic testing for washer-disinfectors, sterilizers andultrasonic cleaning baths take up a specified time,especially a type B sterilizer. Accordingly, RegisteredManagers should plan schedules and time to allow forthis important function, particularly if the equipmentis located close to clinical areas. The process effectivelytakes the machines out of use for that specified timescale, depending on the machine and type. Times willbe different for sterilizer types N, B and S. It is highlyrecommended that removal, or disablement, ofunwanted cycles on multi-cycle machines is carried out,as all cycles available on a machine have to be testedand verified. Therefore the minimal cycles in operationwill reduce the testing time and reduce costs.

Decontamination equipment:washer-disinfectors and sterilizers10.5 Decontamination equipment should be procured

against a formal specification. Such specificationtemplates are currently available for washer-disinfectors and sterilizers. Advice on completingthe specifications for sterilizers and washer-disinfectors and on the production of aspecification for ultrasonic cleaners and irrigatorsis available from the AE(D) and NWSSP-FS

Note

All Model Engineering Specifications are beingprogressively revised and retitled Technical SpecificationTemplates and are available through NWSSP-FS.

10.6 New decontamination equipment should display aCE mark (see below) to demonstrate compliancewith the Medical Devices Regulations.

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Chapter 10 Procurement of decontaminationequipment and instruments

10.7 When selecting new equipment, the size, modeland type should be considered against workloadand throughput requirements, together with theavailability of space and the service infrastructureavailable.

10.8 Further consideration should also be given to thefollowing:

• What are the delivery and acceptancerequirements?

• Will the equipment selected be fit for purposeand is it compatible with other equipment inuse?

• What are the manufacturer’s recommendationsfor staff and operator training and cleaning,and will they be achievable in practice?

• Does it have an automated cleaning process?

• What cleaning agents are recommended andwill they comply with COSHH and health andsafety requirements?

• What commissioning and validation is requiredfor the equipment?

• What are the ongoing costs?

10.9 The following will also need consideration:

• testing: there will be a need to identify who isto perform the testing and where and when itis to be performed;

• service response: there is a need to be clearabout service-response times with appropriatecosts in the event of breakdown;

• process data capture, that is, chart recorder,data recorder, and printer: this information isneeded to clarify the audit process on productrelease. Manual recording of displayedparameters at the end of a cycle should berecorded to an appropriate log and stored.

Note

In general terms, as primary-care dentists may not havein-house engineering staff, robust contractualarrangements to ensure breakdown cover, routinemaintenance and continuity of validation will be needed.

10.10 The equipment should come with an easily-readable operating, maintenance and technicalmanual that includes:

• make, model, serial number and installation andwarranty requirements with an explanation of thepurpose of the equipment and the cycles requiredfor the medical devices to be reprocessed;

• suitable and type tested chemicals to be usedwith the equipment;

• optimum working temperatures and times;

• cleaning instructions for the user, stipulatingsuitable detergents;

• safety instructions, including lifting andhandling, PPE requirements etc;

• explanation of warning indications such ascycle failure and fault-finding (diagnostic)procedures;

• all maintenance requirements, easily copied sothat it can be displayed and undertaken by anoperator including frequencies etc;

• monthly maintenance requirements;

• yearly testing and validation requirements andprocedures;

• consumable parts list and spares componentslist incorporating identification numbers.

10.11 Information on periodic testing protocols can befound in Chapters 12–14. These chapters alsoprovide advice on the required actions if testsindicate unacceptable results.

Decontamination equipment:ultrasonic cleaners

10.12 The following are more specific considerationswhen procuring ultrasonic cleaners.

10.13 Ultrasonic cleaners can be freestanding or integralto the washer-disinfector.

10.14 They should comply with the electrical safetyspecifications given in BS EN 61010-1.

10.15 Consideration should be given to the:

• voltage (V) supply of the equipment (single230 V or three-phase 400 V) to help establishwhether the electrical infrastructure needsmodification;

• power (kW/h) consumption of the equipmentthis will help to establish running costs.

10.16 Ultrasonic cleaners may be designed to operate ata single frequency, across a frequency range, and/orwith a controlling system to adjust the frequencyin response to the loading conditions.

10.17 An active ultrasonic sensor indicator should beprovided to show the power consumption in Wattsor electrical demand in Amperes of the ultrasonictransducers.

10.18 Siting of the ultrasonic cleaner within theworkplace should be in a defined area, following astrict dirty-to-clean workflow.

10.19 It should be easy to wipe down and disinfect theultrasonic cleaner.

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10.20 An ultrasonic cleaner needs to be maintained by aCP(D) or a suitably qualified person.

Specifications

10.21 When procurement of ultrasonic cleaners ispursued, the following specification points shouldbe considered:

• a reservoir or tank large enough toaccommodate the required throughput;

• a reservoir that should be of a polishedstainless-steel construction with internalrounded edges and corners to aid in thecleaning process;

• the maximum and minimum fluid levels clearlyvisible to the user marked on the reservoir;

• a reservoir drainage facility that does not affectperformance, does not leave pools of fluid inthe reservoir and allows the tank to be emptiedwithout the need for operatives to put theirhands into the fluid;

• an integral purpose-built holding basket, whichenables all equipment to be held within theultrasonic bath in the optimum position, sothat micro-dental instruments or instrumentswith fine points are not blunted by the impactsresulting from fine mechanical shaking;

• a hinged auto-locking lid that preventsinteraction with the load once the ultrasonicequipment is in use and also reduces the risk ofaerosols and noise. If not interlocked, theequipment should be clearly labelled, warningusers not to put their hands in the device whenit is activated;

• a means to control the detergent’sconcentration;

• an automatic printer and data-logger whichcan be integrated and records:

– time and date,

– cycle type,

– unique cycle number,

– duration of cycle,

– equipment serial number,

– minimum and maximum temperatures,

– a sensor recording ultrasonic activity,

– electrical demand in Watts or Amperes,

– cycle failure indication;

• a display indicator integral to the unit clearlydisplaying:– time and date,

– elapsed cycle time,

– maximum and minimum temperatures,

– ultrasonic activity,

– cycle failure indication,

– lamp warning indicators;

• lower-level fluid sensor and auto cut-off;

• thermostatic control;

• over-temperature sensor, with automatic cut-offand warning indication;

• a cleaning cycle ideally identified by a uniquecycle number.

10.22 Ultrasonic equipment should come with an easily-readable operating, maintenance and technicalmanual that includes:

• installation requirements;

• suitable chemicals, for use as agreed by themanufacturer;

• degas requirements, prior to use;

• optimum working temperatures;

• cleaning instructions for the user, stipulatingsuitable detergent;

• safety instructions;

• explanation of warning indication, cycle failureetc.;

• all maintenance requirements;

• monthly maintenance requirements or as permanufacturers’ recommendations;

• yearly testing and validation requirements andprocedures;

• consumable parts list;

• spares components list incorporatingidentification numbers;

• make, model and serial number;

• lifting and handling requirements;

• staff training;

• appropriate PPE.

Selecting instruments10.23 When selecting new instruments, the following

should be considered:

• For what purposes will the instruments be usedand will the instruments selected be fit for thispurpose?

• Are they compatible with other instruments inuse?

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10 Procurement of decontamination equipment and instruments

• All instruments must be inspected whenpurchased to ensure the quality, and that nodefects are apparent before use such as joints,burrs and finishes.

• Are there any appropriate single-use device thatwould meet the requirements?

• If reusable, how easy will they be maintained?

• Do the instruments need dismantling beforecleaning and do they have manufacturers’instructions?

• Do the instruments have a limited lifecyclespecified by the manufacturer?

• What are the manufacturer’s recommendationsfor cleaning and will they be achievable inpractice?

• Will the instruments withstand automatedwasher-disinfector processes and are theycompatible with the chemicals andtemperatures?

• What cleaning agents are recommended? Dothey comply with COSHH and health andsafety requirements? Are these cleaning agentscompatible with the washer-disinfector,ultrasonic cleaner and instruments already usedin the practice?

• Is steam sterilization (134–137°C for aminimum of three minutes at temperature)appropriate for the instruments?

• If another time/temperature range isrecommended, is there a validated cycleavailable on the sterilizer?

• Is training required? Will the manufacturerprovide it?

• Ensure commissioning and validation is carriedout for the equipment to the schedules given inthis WHTM.

• Evaluate and obtain costs for the maintenanceof all the machines, servicing and testingschedules.

• Obtain costs for all consumables, printers,chemicals and spares.

Note

Difficult-to-clean serrated handles should be avoidedand it should also be ensured that hinges are easy toclean.

Policy on new reusable instruments

10.24 Before being put into use, new dental instrumentsshould be inspected carefully to ensure there is noevidence of manufacturing defects. They should befully decontaminated before their first use. Themanufacturer should provide instructions fordecontamination.

10.25 Reusable dental instruments should be separatedinto:

• those that can withstand either processing in awasher-disinfector or ultrasonic cleaning; and

• those that will require manual cleaning,although practices should aim to phase ininstruments that can be cleaned via automatedprocesses.

10.26 Some instruments consisting of more than onecomponent will need to be dismantled forcleaning. The manufacturer’s instructions shouldalways be followed.

10.27 Personal training records should show that:

• staff have been appropriately trained;

• staff are competent to decontaminate thereusable dental instruments presently in use;and

• training is updated for any new instrumentsintroduced into the dental environment.

10.28 Items that cannot be immersed in water, forexample, electrical and electronic equipment,should be cleaned in accordance with themanufacturer’s instructions.

10.29 If recommendations include wiping with adetergent solution, then a clean non-linting clothplus the recommended detergent solution to wipethe instrument should be used. This should befollowed by wiping with a clean damp non-lintingcloth to remove residues. The instrument shouldbe dried thoroughly using a clean non-lintingcloth. Advice on these issues can be sought fromthe infection prevention and control team.

10.30 If disinfection with alcohol is advised, the advicegiven in paragraph 10.29 should be followed.While this procedure may be advised, it should beunderstood that alcohol may have the property offixing certain contamination.

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Maintenance and servicing11.1 All decontamination equipment should be

subjected to validation, maintenance and servicingas recommended by the manufacturer andsupplier. All records of these procedures should beretained for audit and inspection.

11.2 All equipment should also be periodically tested asadvised in Chapters 12–14. An unsatisfactory testresult indicates that the decontaminationequipment should not be used until the fault hasbeen rectified.

11.3 Failure to perform these tasks or retain evidenceof their performance may indicate noncomplianceof the decontamination process. Alternativeprotocols of maintenance should be equal to, orexceed, the manufacturer’s specification and mustbe justified.

Validation and testing11.4 All pieces of decontamination equipment will need

a protocol for validation at installation.

11.5 For steam sterilizers, the preferred protocol is asfollows:

a. The CP(D) or service engineer who has carriedout a certified testing course should test orvalidate the equipment.

b. The CP(D) or service engineer should thensubmit the validation or service report to theRegistered Manager for audit and acceptancebefore the equipment is put into service. Thereport should clearly state the test methods andstandards that have been applied with allresults and recommendations.

c. The Registered Manager should retain a copyof the report and make it available to theHealth Board on request.

d. NWSSP-FS undertakes the role of AE(D) forthe NHS in Wales and provides advice andguidance on periodic validation regimes.

e. Periodic audit of the reports will be carried outusing the online QAS system and RDS function.

11.6 Work carried out on the equipment:

a. The service engineer produces a service reportwith the work carried out in accordance withmanufacturers’ recommendations.

b. By this process, the contract between theRegistered Manager, the equipmentmanufacturer and the service engineer acts as aform of record.

11.7 This should be performed in full prior to Chapters12–14.

11.8 The validation report provides auditable evidenceof testing (see paragraph 11.5).

11.9 These protocols will require full implementationand all results need recording in a logbookdedicated to individual equipment. Standardlogbooks summarising all required tests areavailable for most types of decontaminationequipment. Manufacturers should be consulted onthe contents of the logbook (see also Appendix 3).

11.10 If local or in-house documentation is used, itssuitability should be discussed and agreed with thedecontamination equipment manufacturer.Consultation with the responsible officers, such asthe Primary Care Dental lead of the Health Board,would also be useful. In addition, where available,NWSSP-FS and the AE(D) would also be able toadvise.

11.11 Periodic inspections, testing and service logs willneed to be signed by the CP(D) or the appointedservice engineer and be countersigned by theRegistered Manager.

11.12 Daily and weekly records should be signed by theUser before equipment is returned for use. Thissignature acts as a “certification of fitness for use”based on information and advice from themanufacturer, often represented by the CP(D). TheUser signature will indicate acceptance for use.

Note

The User is defined as the person designated by theRegistered Manager to be responsible for themanagement of the decontamination equipment and

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Chapter 11 Decontamination equipment:general guidance on maintenanceand testing


process. For a dental practice, this would normally bedentists themselves.

11.13 The validation schedules for sterilizers outlined inparagraph 11.5 and Chapter 12 detail the testingrequired. However, in terms of testing schedulesfor washer-disinfectors and ultrasonic cleaners,manufacturers’ guidance should be sought. In theabsence of manufacturers’ guidelines, the testingschedules in Chapters 13 and 14 should befollowed.

Documentation11.14 Documentation and signatures provide the only

evidence of completed work. Absence ofdocumentation for any work item will indicateomission of that item. It is important that alldocumentation relating to decontaminationequipment is up-to-date and is retained locally foraudit and inspection purposes.

11.15 The following documentation should be retainedfor the equipment and be readily available at anytime:

• specification(s) of purchased equipment;

• validation report(s), independently monitoredby the AP(D) or AE(D and signed by theCP(D) on behalf of the manufacturer or agent;

• test results and performance qualificationdetails, loading patterns and requiredparameter values. These results for both thewasher-disinfector)s) and sterilizer(s);

• logbook(s) of periodic testing for both washer-disinfector(s) and sterilizer(s);

• logbook(s) of plant history, componentreplacement, etc;

• process log of items being reprocessed;

• training and competency records of staffoperating the decontamination equipment;

• documentation for Pressure Systems SafetyRegulations including written scheme ofexamination and examination reports;

• list of all named designated ResponsiblePersons;

• other relevant documentation and records onthe decontamination equipment.

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63

Chapter 12 Installation, validation, maintenanceand testing of sterilizers

Maintenance and servicing12.1 The sterilizer should be maintained and serviced

in accordance with the manufacturer’s instructions.However, in the absence of these instructions, theschedules outlined in this chapter should befollowed.

Validation and testingDefinition of validation

A documented procedure for obtaining, recording andinterpreting the results required to establish that aprocess will consistently yield product complying withpredetermined specifications.

12.2 The specification will include a protocol forvalidation. Validation is needed for new equipmentat installation and annually thereafter. It will alsobe necessary to validate equipment after any majorrepairs have been carried out. The followingprotocol is suggested (see paragraph 4.13 (2)).

12.3 The following test results from type-tests or workstests will be required.

EuropeanTest Type Performed by Norm (EN)

reference

Dynamic chamber B S N Manufacturer EN 13060pressure

Air leakage B S Manufacturer EN 13060

Empty chamber B S N Manufacturer EN 13060

Solid load Manufacturer EN 13060Non-wrapped N SSingle-wrapped SDouble-wrapped B S

Small porous items Manufacturer EN 13060Single-wrapped SDouble-wrapped S

Small porous load Manufacturer EN 13060Single-wrapped SDouble-wrapped B S

Full porous load Manufacturer EN 13060Single-wrapped SDouble-wrapped B S

Hollow load B S Manufacturer EN 13060

Solid load dryness Manufacturer EN 13060Non-wrapped SSingle-wrapped SDouble-wrapped B S

Small porous Manufacturer EN 13060items: drynessSingle-wrapped SDouble-wrapped S

Small porous load: Manufacturer EN 13060drynessSingle-wrapped SDouble-wrapped S

Full porous load: Manufacturer EN 13060drynessSingle-wrapped SDouble-wrapped B S

Microbiological test B S N Manufacturer EN 13060optional

12.4 Tests not defined in the referred Standards arefurther defined in Chapter 15.

Periodic tests12.5 The following testing protocol (shown overleaf,) is

recommended. Additional tests as defined by themanufacturer should also be performed.

Note

Users and operators, when delegated, should receive theappropriate training before carrying out any of thesetests. This training should be documented on personaltraining records. The Registered Manager should liaisewith the equipment manufacturer with regard totraining.

Test Type Performed by Reference

DAILY

Steam penetration B S User or, by delegation, Operator MDA DB 2002(06)

Automatic control test B N S User or, by delegation, Operator Paragraphs 15.3–15.5

WEEKLYincluding daily tests plus:

Air leakage B S User or, by delegation, Operator MDA DB 2002(06)

QUARTERLY (or to manufacturers’ recommendations)including weekly tests plus:

Thermometric tests B N S CP(D)/service engineer MDA DB 9804*

ANNUALLYincluding quarterly tests plus:

Steam generator overheat cut-out test B N S CP(D)/service engineer MDA DB 9804*

Thermometric tests B N S CP(D)/service engineer EN 13060

Small load

Large load

Dryness tests B S CP(D)/service engineer EN 13060

Small load

Large load

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* The Device Bulletin MDA DB 9804 has beenwithdrawn from circulation. However, for the purposesof the Thermometric tests and the Steam generatoroverheat cut-out tests this document is still consideredto be ‘best practice’ until the proposed WHTM 01-07Decontamination in primary care document ispublished. (See table included in Appendix 4).

For further information refer to the Medical andHealthcare Products Regulatory Agency publicationsaccessible through the current decontaminationdocument page of the NWSSP-FS website.

Maintenance and servicing13.1 The washer-disinfector should be maintained and

serviced in accordance with the manufacturer’sinstructions. However, in the absence of theseinstructions, the schedules outlined in this chaptershould be followed.

Validation and testing13.2 Validation is needed for new equipment at

installation and annually thereafter. It will also benecessary to validate equipment after any majorrepairs have been carried out. The followingprotocol is suggested in the table shown below.


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Chapter 13 Installation, validation, maintenanceand testing of washer-disinfectors

Test Description Performed by Reference

Verification of calibration The accuracy of indicating and CP(D)/service engineer BS EN ISO 15883:1 andrecording instruments is checked BS EN ISO 15883:2against certificated source instruments

Automatic control test The values of cycle time and CP(D)/service engineer BS EN ISO 15883:1 andtemperature are noted at relevant BS EN ISO 15883:2stages of the cycle so that a fingerprintof the automatic cycle can be made

Rinse-water quality test Indicates acceptable values for all CP(D)/service engineer BS EN ISO 15883:1 andcritical chemical purity parameters BS EN ISO 15883:2

Pipework Ensures free-flowing drainage CP(D)/service engineer BS EN ISO 15883:1 andBS EN ISO 15883:2

Doors and door interlocks Confirms safety to operator and CP(D)/service engineer BS EN ISO 15883:1 andexposure to complete cycle only BS EN ISO 15883:2

Fluid emission Confirms door-seal prevents CP(D)/service engineer BS EN ISO 15883:1 andcontamination to surroundings BS EN ISO 15883:2

Detergent dosing test Confirms repeatable detergent CP(D)/service engineer BS EN ISO 15883:1 andaddition BS EN ISO 15883:2

Cleaning efficacy test Using an artificial soil to clean a CP(D)/service engineer BS EN ISO 15883:1 andworst-case load, chamber walls and BS EN ISO 15883:2load carriers to confirm the exposureto cleaning parameters is sufficientto remove soil

Thermometric test Thermocouples are attached to CP(D)/service engineer BS EN ISO 15883:1 andworst-case load, chamber walls and BS EN ISO 15883:2load carriers to confirm thatdisinfection parameters areacceptable

Load carriers Confirms mechanical alignment of CP(D)/service engineer BS EN ISO 15883:1 andall load carriers BS EN ISO 15883:2

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Periodic tests13.4 The following testing protocol is recommended.

Additionally, any additional tests defined by themanufacturer should also be performed.


DAILY

Remove and clean strainers Ensures filters and User or, by delegation, Operator BS EN ISO 15883:1 andand filters strainers are clean BS EN ISO 15883:2

Cleaning efficacy Visual examination of User or, by delegation, Operator BS EN ISO 15883:1 andall load items BS EN ISO 15883:2


Protein residue test Confirms that cleaning User or, by delegation, Operator BS EN ISO 15883:1 andprocess retains the BS EN ISO 15883:2capability of removingprotein

Safety checks Check condition of User or, by delegation, Operator Manufacturerdoor seal


Safety checks Check safe operation CP(D)/service engineer Paragraphs 15.14–15.18of doors and doorinterlocks

Automatic control test CP(D)/service engineer BS EN ISO 15883:1 andBS EN ISO 15883:2

Cleaning efficacy test CP(D)/service engineer BS EN ISO 15883:1 andBS EN ISO 15883:2

Chemical dosing Confirm delivery of CP(D)/service engineer BS EN ISO 15883:1 anddetergent (and any other BS EN ISO 15883:2additives) is repeatableand the machine reactscorrectly to low levelsof any additive

Thermometric disinfection test Use of thermocouples CP(D)/service engineer BS EN ISO 15883:1 andon worst-case load to BS EN ISO 15883:2confirm disinfectionparameters areacceptable


Completion of all validation CP(D)/service engineer BS EN ISO 15883:1 andtests above BS EN ISO 15883:2

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Verification of calibration The accuracy of indicating and CP(D)/service engineer BS EN ISO 15883:1 andrecording instruments is checked BS EN ISO 15883:2against certificated source instruments

Automatic control test The values of cycle time and CP(D)/service engineer Paragraphs 15.3–15.5temperature are noted at relevantstages of the cycle so that a fingerprintof the automatic cycle can be made

Drainage test (where applicable) Ensures free-flowing drainage CP(D)/service engineer BS EN ISO 15883:1 andBS EN ISO 15883:2

Lid (i.e. door) interlock Confirms safety to operator and CP(D)/service engineer BS EN ISO 15883:1 andexposure to complete cycle only BS EN ISO 15883:2

Fluid emission Confirms door-seal prevents CP(D)/service engineer BS EN ISO 15883:1 andcontamination to surroundings BS EN ISO 15883:2

Chemical dosing test Confirms repeatable detergent CP(D)/service engineer BS EN ISO 15883:1 and(where automated) addition BS EN ISO 15883:2

Cleaning efficacy test Using an artificial soil to clean a CP(D)/service engineer BS EN ISO 15883:1 andworst-case load, the exposure to BS EN ISO 15883:2ultrasonic activity for a sufficienttime period is confirmed

Thermometric test (where Thermocouples are attached to CP(D)/service engineer BS EN ISO 15883:1 andmachine also disinfects) worst-case load to confirm that BS EN ISO 15883:2

disinfection parameters areacceptable

Ultrasonic activity test The use of aluminium foil within CP(D)/service engineer Paragraphs 15.6–15.13the cleaner tank indicates a uniformdistribution of ultrasonic activity.A wand meter may be used as longas points of measurement arecompatible with the foil test andare fully recorded

Maintenance and servicing14.1 The ultrasonic cleaner/irrigator should be

maintained and serviced in accordance with themanufacturer’s instructions. However, in theabsence of these instructions, the schedulesoutlined in this chapter should be followed.

Validation and testing14.2 The specification should include a protocol for

validation. The following protocol is suggested.


Chapter 14 Installation, validation, maintenanceand testing of ultrasonic cleaners

68


Periodic tests14.4 The following testing protocol is recommended.

Additionally, any additional tests defined by themanufacturer should also be performed.


DAILY

Remove and clean strainers Ensures filters and User or, by delegation, Operator Manufacturerand filters strainers are clean

Drain machine at end of day/ Ensures contaminated water User or, by delegation, Operator Manufacturersession is not stored in tank

Cleaning efficacy Visual examination of User or, by delegation, Operator Manufacturerall load items


Safety checks Check condition of User or, by delegation, Operator Manufacturerdoor seal Paragraphs 15.14–15.18

Protein residue test Confirms that cleaning User or, by delegation, Operator BS EN ISO 15883:1process retains thecapability of removingprotein


Automatic control test CP(D)/service engineer BS EN ISO 15883:1

Verification of calibration CP(D)/service engineer BS EN ISO 15883:1

Cleaning efficacy test CP(D)/service engineer BS EN ISO 15883:1

Ultrasonic activity test CP(D)/service engineer BS EN ISO 15883:1


Completion of all validation CP(D)/service engineer As abovetests above

Note

For cleaning efficacy tests and protein residue tests,where the cycle does not have a rinse stage, itemsshould be rinsed as a normal procedure before thesetests are carried out, otherwise the tests could returnfalse positives.

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15.1 Most test procedures are defined in the referencedStandards shown in the testing protocols inChapters 12–14. Unless these tests are to beperformed by suitably-qualified and certificatedpractice staff (see Chapter 5 in WHTM 01-01Part A for further guidance on training andcertification), it will not be necessary for thepractice to possess copies of these Standards. Itwill, however, be necessary that any contracted testperformance includes reference to therequirements of these Standards.

15.2 The following tests are additional to those shownin the referred Standards. These additional testprocedures are compliant with BS EN Standardsand should be applied where necessary and ifrelevant to the type of decontaminationequipment being used.

Automatic control test15.3 This test (see list of tests in Chapters 12–14) is

designed to show that the operating cyclefunctions correctly as shown by the values of thecycle variables indicated and/or recorded by theinstruments fitted to the decontaminationequipment.

Method

15.4 Place the test load, as defined in BS EN 13060,appropriate to the cycle to be tested and the loadto be processed in the chamber. Select and startthe cycle to be tested. If a process-data recording isnot made by the machine, the elapsed time,chamber temperatures and pressures at allsignificant stages of the cycle should be observedand noted.

15.5 At the approximate mid-point of the hold time(disinfection, cleaning, sterilizing), note theelapsed time and indicated critical parameters. Thetest will be considered satisfactory if the followingrequirements are met:

• a visual display of “cycle complete” occurs;

• during the whole of the cycle the values of thecycle parameters, as indicated or shown on theprocess-data record, are within the limits

established as giving satisfactory results eitherby the manufacturer or the validation tests;

• during the hold period, the disinfection/cleaning/sterilizing temperatures are within anappropriate temperature band;

• the time for which the temperatures above aremaintained is not less than that previouslyestablished either by the manufacturer orvalidation tests as necessary;

• the door cannot be opened until the cycle iscomplete. It is not advisable to attempt to openthe door in case the safety devices aremalfunctioning. This test should only beperformed by someone fully trained to do so;

• the person conducting the test does notobserve any mechanical or other anomaly.

Ultrasonic activity test15.6 The ultrasonic activity can be investigated by the

erosion pattern created on aluminium foil exposedin the tank for a short period. This activity maynot be uniform throughout the tank. Validationtests will determine the pattern variation atdefined positions and the time required to producethis pattern.

15.7 The exposure time will depend upon the type offoil used. Standard test foil is now available tomaximise repeatability.

15.8 The following equipment will be required:

• aluminium foil provided for ultrasonic cleanertesting;

• adhesive tape, for example, autoclave indicatortape or masking tape;

• a watch or clock with a second hand;

• a rule or tape measure.

Method

15.9 The following method should be used:

• Cut strips of aluminium foil in lengths120 mm longer than the bath is deep. Roll upone end of the foil so that the foil is now aslong as the bath is deep.

Chapter 15 Additional information on testprocedures (in addition to thoseprovided in the Standards)

• Ensure that:

– the water in the tank is at the required level;

– the required amount of any chemicaladditive specified by the manufacturer hasbeen added; and

– the water in the tank is at the specifiedoperating temperature.

• Carry out the manufacturer’s recommendedstart-up procedure. This will normally includea period of operation to eliminate dissolvedgases from the solution in the bath (thedegassing procedure).

• Using strips of adhesive tape across the top ofthe bath, suspend nine strips of the preparedfoil in the bath in a 3 x 3 grid. Ensure that therolled bottom end of each foil strip is no morethan 10 mm above, but not touching, thebottom of the bath.

• Operate the bath for the predeterminedexposure time. This varies typically between30 seconds and 10 minutes depending on thepower rating of the ultrasonic transducers.

• Remove the strips from the bath, blot-dry andexamine. The strips can be filed convenientlyby sticking them to a sheet of plain paper usinga transparent adhesive tape.

• Drain the bath and clean to remove debris oferoded aluminium foil.

Results and interpretation

15.10 When the foil strips are inspected, the areas thatshow maximum erosion should be at similarpositions on all nine foils and each should beeroded to a similar extent.

15.11 On re-testing the extent of erosion, the erosionpattern should remain consistent. If the zones oferosion are markedly different on the nine foils, itindicates poor uniformity of cleaning. Pooruniformity of cleaning might be due to failure ofone or more of the transducers that produce theultrasonic vibration in the base of the bath.

15.12 A significant change between tests indicates adeterioration or failure in the transducers. If thereis no erosion, this indicates complete failure. Inthe event of any of these findings withdraw theultrasonic cleaner from use and either send it forrepair or replace it.

Wand meters

15.13 Ultrasonic energy meters are now available tomonitor the efficiency and operating frequency ofultrasonic baths. They are much quicker and moreconvenient than the classic foil ablation test butshould be used with care. Precise positioning ofthe wand will need to be noted in order to makethe test repeatable.

Safety checksWeekly checks

15.14 The User should check the following beforeproceeding:

• Examine the door seals.

• Check the security and performance of thedoor safety devices.

15.15 Where the equipment possesses a pressure vessel,the following checks should be performed:

• Ensure safety valves and other pressure-limitingdevices are free to operate.

• Carry out any other checks required by theCompetent Person (Pressure Systems) or thewritten scheme of examination.

Yearly checks

15.16 The CP(D) or service engineer should conduct aseries of safety checks before proceeding. Adviceon the yearly programme of safety checks may besought from the AE(D) or NWSSP-FS.

15.17 The validation checks and tests may be used as abasis for yearly safety checks, paying particularattention to those factors affecting safety and thosewhich may have changed since the previous annualsafety check or validation test.

15.18 The CP(D) or service engineer should ensureverification of the adequacy and safe connection ofengineering services.

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Note

The use of manual cleaning presents particularproblems. Because the process is not automatic, it is notpossible to fully validate the process. Manual cleaning isthus not the preferred method of cleaning and, wherepossible, should be replaced with automated cleaning ina validated washer-disinfector. Where manual cleaningis required or deemed necessary, for example, as advisedby the manufacturer, the practice should be operatingunder the correct parameters and should be controlledas much as possible to reduce the variability in cleaningperformance. The following advice aims to enable thiscontrol.

16.1 A dirty-to-clean workflow should be maintainedthroughout the cleaning procedure. Two sinks, orbowls as an interim measure, should be provided,one for manual cleaning and one for rinsing. Inaddition, separate setting-down areas should beused for dirty instruments and for cleaninstruments.

16.2 If lack of space means that a setting-down area hasto be used for both dirty and clean instruments atdifferent times during the decontaminationprocess, the surface should be thoroughly cleanedbetween stages using a water–detergent solution tominimise the risks of cross-contamination.

16.3 Always use detergents specifically formulated formanual cleaning of instruments.

Note

Do not use chlorhexidine handscrub, for example,Hibiscrub, washing-up liquid, cleaning creams or soap.Chlorhexidine in particular makes proteins stick to steel.

Cleaning procedure for dentalinstruments

a. Measure the volume of water and detergent toachieve the concentration specified by thedetergent manufacturer. A line painted on the

sink is useful to indicate the required volumeof water. The detergent should be designed forthe manual cleaning of dental instruments.

b. Using a mercury-free thermometer, monitorthe temperature of the water throughout thecleaning procedure to ensure the temperatureof the water is 45oC or lower. A highertemperature will coagulate protein and inhibitits removal. The temperature of the fluidshould be as recommended by the detergentmanufacturer.

c. Where manufacturers’ instructions permit,fully submerge items to be cleaned in thedetergent solution.

d. Scrub instruments using long-handled brusheswith soft plastic bristles. To minimise aerosolrisk, fully immerse the instruments in thesolution and keep under water during thecleaning process.

e. Following cleaning, drain the water, avoidingsplashing. If the water is heavily soiled, repeatthe cleaning procedure.

f. Brushes should be single use. Where they arereusable, after each use the brushes should bewashed in hot water, using the manufacturer’srecommended detergent, in order to removevisible soil, and be stored dry and head up.Dispose of brushes if they are single-use.Reusable brushes should be replaced at themanufacturer’s recommended interval or morefrequently if the brush is seen to havesignificantly deteriorated.

g. Carry out a final rinse in the clean sink usingsatisfactory potable water, RO or freshlydistilled water.

h. After rinsing, drain and dry if instruments areto be wrapped.

Chapter 16 Approach and protocol formanual cleaning

71

Protocol for the manual cleaning of dental instrumentsImmersion method

All personnel involved in the decontamination of dental instruments should be trained in the content andapplication of this protocol and associated guidance.

To minimise the risk to personnel undertaking manual cleaning, the splashing and creation of aerosols should beavoided at all times.

Remember: Maintaining a dirty-to-clean workflow procedure will assist in the cleaning process.

• Wash hands.

• Wear personal protective clothing (PPE).

• Always use heavy duty domestic gloves for manual cleaning.

• Prepare sinks, equipment and setting-down areas.

• Dismantle and open the instruments, as applicable, ready for immersion.

• Fill the clean sink, NOT wash-hand basin, with the appropriate amount of water and detergent specifiedfor the purpose. Note: ensure correct temperature as recommended by the detergent manufacturer ismaintained.

• Fully immerse the instruments in the solution and keep under water during the cleaning process toprevent aerosols.

• Agitate/scrub the instruments using long-handled brushes with soft plastic bristles.

• Drain any excess cleaning solution prior to rinsing.

• Rinse in a second sink with freshly distilled or RO water.

• After rinsing, drain and dry if instruments are to be wrapped.

• Visually inspect all items under an illuminated magnifier ensuring they are clean, functional and in goodcondition.

• Lubricate any relevant items prior to sterilization with a non-oil-based lubricant.

• Dispose of cleaning materials safely in accordance with local policy.

• Replace cleaning solution and the rinse-water after each use.

• Complete any relevant documentation.

• Where two separate sinks are not available, two bowls in one sink can be used.

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73

17.1 For the purposes of this document, either one ofthe following types of water are consideredsuitable:

• suitable potable water (see paragraph 3.14)

• sterile water for irrigation. Sterile water forirrigation is a sterile, non-pyrogenic preparationof water for injections BP, containing noantimicrobial agent or other substance;

• freshly distilled water. The quality of the watershould be checked;

• Reverse osmosis water.

Steam17.2 The quality of steam, for example, dryness and

purity, is important for large-scaledecontamination in SSDs.

17.3 Decontamination within a dental decontaminationfacility should ensure that the quality and safety ofthe instruments are not affected by thedecontamination process itself.

17.4 While an SSD utilises steam from an externalsource, most dental facilities generate steam withinthe sterilizer chamber. Factors affecting the qualityof the steam, and thus the safety of theinstruments, include the following:

• material of chamber construction;

• quality of feed-water, including any storagecontainers;

• conditions of storage of feed-water;

• period between changes of feed-water andusage;

• cleanliness and cleaning regimes of water tankand pipework.

Quality of input water

17.5 The quality of input water for small sterilizers isdefined in Annex C of BS EN 13060.

17.6 Care should be taken to observe use-by dates. Anywater unused or left in opened containers at theend of the day should be discarded.

Conditions of storage and frequency of change

17.7 Feed-water may be stored in a reservoir on themachine and can be either reused or used once only,depending on the sterilizer design. While both areacceptable, there is some advantage in using thewater once only in that there is no build-up ofcontamination within the reservoir.

17.8 However, even high-quality water is subject tomicrobial contamination. For this reason,irrespective of whether the water is used once only,the reservoir should be emptied at such afrequency as to eliminate microbiological build-up.This policy must be extended to any portablewater storage containers, and any containersopened should be discarded within a reasonableperiod once they have broken the seal, usually24 hours.

17.9 Current recommendations are for the reservoir tobe drained down and cleaned at the end of eachworking day or daily shift. The machine should notbe left for any lengthy period, especially overnight,with water in the reservoir. The possibility ofpyrogens accumulating in the reservoir is ofparticular concern. Some pyrogens will be washeddown from load items, while others may arise frombacterial growth, especially where the sterilizer isunused for long periods between refills. Even ifsuch bacteria are subsequently killed by thesterilization process, pyrogens will not beinactivated and will be deposited on the next load.The levels of pyrogens in the steam may exceed thepermitted maximum even though sterilized waterfor irrigation was used as the original feedwater.

WaterCleaning

17.10 Cleaning and rinsing, either manual or automated,can be performed with potable water as long as thewater hardness is low enough not to reduce theeffectiveness of any part of the process and otheraspects of the water quality are satisfactory. It isrecommended that water for cleaning should havea suitable hardness level. This is part of the

Chapter 17 Steam and water quality

74


consideration for defining satisfactory potablewater. The local water advisor should be consultedon endotoxins, hardness, silicates, ammoniaconcentrations at not less than annual intervals.

17.11 If the input water has a hardness higher thanrecommended, water softening may be aconsidered option. An ongoing knowledge of thehardness of the incoming water feed is thereforenecessary and the hardness values themselvesshould be documented at intervals recommendedby the local water advisor.

Final rinsing

17.12 The final rinsing of instruments, those washedmanually, in an ultrasonic bath or in a washer-disinfector, should be carried out using satisfactorypotable water, RO or freshly distilled water.

Detergents

17.13 The efficacy of cleaning will depend on therelationship between potable water quality anddetergent performance. The detergent should bechosen not only for its cleaning efficacy but alsofor its compatibility with the potable water qualityand parameters of its use.

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18.1 Lubricants, usually in aerosol form, are often usedduring the decontamination and preparationprocess. This is often required by the manufacturerin order to lengthen the working life of someinstruments. Such instructions should be followed.Any doubts about the relevance of theseinstructions should be checked and confirmed inwriting by the manufacturer.

18.2 It should be noted that using lubricants willinevitably introduce oils into a process designed toremove contamination. Where water is reused inthe sterilizer, this contamination may build upwithin the reservoir and the sterilizer chamber.

However, this effect will be limited if guidancegiven in this document requiring that water bechanged at least once per day is carefully applied.

18.3 There is a limited conflict betweendecontamination and the use of lubricant. Iflubrication is practised in accordance withmanufacturer’s instructions, the consequence ofthis recontamination should be assessed. Thisassessment will require consultation with theequipment manufacturer or service agent whoshould be asked to approve the choice of lubricantused.

Chapter 18 The use of lubricants

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19.1 Registered Managers of dental practices have anoverriding general duty of care under the Healthand Safety at Work etc Act 1974. Therefore, theyshould ensure that the water supply, storage anddistribution services should comply with the bestpractice guidance given in:

• the Health & Safety Commission’s‘Legionnaires’ disease – the control of legionellabacteria in water systems. Approved Code ofPractice & Guidance’ (also known as L8); and

• HSG 274 Legionnaires’ disease: Technicalguidance

• Health Technical Memorandum 04-01 – ‘Thecontrol of Legionella, hygiene, “safe” hot water,cold water and drinking water systems’.

Advice can be sought from NWSSP-FS on thesesystems.

Note

The Approved Code of Practice L8 has a special legalstatus. Health and safety inspectors seek to securecompliance with the law and may refer to L8 andHSG 274 as illustrations of good practice.

Compliance with WHTM 04-01 and this guidancedocument will satisfy L8.

19.2 All premises are required to have a written schemeand a legionella risk assessment for controllingany identified risks in accordance with L8:

• Written schemes, to the required standard, canbe produced by competent persons, generallymembers of the Legionella Control Association.

• A risk assessment for the water services will benecessary to identify potential problems in thesystem, for example, excess storage capacity,temperature distribution problems, low waterusage, inappropriate materials. The riskassessment should be carried out by aCompetent Person.

• The Registered Manager should ensure that anoperational plan is in place for each site undertheir control. This document should comprise:

– up-to-date as-fitted drawings, schematicdiagrams and descriptions of all the supply,storage and distribution systems within thosepremises;

Note

As-fitted drawings can be obtained from third partiessuch as architects.

– step-by-step instructions to operate, maintain,control and shut down the water, storage anddistribution systems within those premises;

– a schedule of possible emergency incidentscausing loss of the water supply from the waterundertaker. Each item in the emergency incidentschedule should include guidance on operationalprocedures to re-establish a stable wholesomewater supply.

19.3 The Registered Manager should implement aprogramme of staff training to ensure that thoseappointed to devise strategies and carry outcontrol measures are appropriately informed,instructed and trained and should be assessed as totheir competency. It is also essential that they havean overall appreciation of the practices affectingwater hygiene and safety and that they caninterpret the available guidance and perform theirtasks in a safe and technically competent manner.

Safe hot water temperature19.4 To reduce the risk of scalding, thermostatic mixing

devices should be installed where applicable. A riskassessment will be necessary to establish the needand type of device to be installed.

19.5 Routine checks are essential to ensure continuedsatisfactory operation.

Utilisation19.6 One of the critical factors affecting the quality of

water within hot and cold water distributionsystems is the extent of utilisation. The RegisteredManager needs to ensure that there is good liaisonbetween staff members in the dental practice toensure that the water services are sufficiently used.

Chapter 19 Hot and cold water systems anddental unit water lines

19.7 L8 recommends that, for sporadically used taps,flushing is carried out once a week. The procedurefor such practice should be fully documented andcovered by written instructions.

Flushing dental unit water lines(DUWLs)19.8 For procedures on flushing DUWLs between

treatment sessions and at the beginning and end ofeach working day, see paragraphs 6.84–6.86.

Decommissioning of DUWLs19.9 Follow the manufacturer’s guidance for the

temporary decommissioning of DUWLs.

19.10 In the absence of manufacturers’ guidance,DUWLs should be flushed, drained and leftdisconnected during any temporary closure of thetreatment room. If this is not practicable, theyshould be flushed on a weekly basis as per theguidance above.

19.11 Self-contained water bottles (bottled watersystems) should be removed, flushed with distilledor fresh RO water and left open to the air fordrying. They should then be stored inverted toprevent contamination during the temporaryclosure.

Recommissioning of DUWLs19.12 In the absence of manufacturers’ guidance, the

DUWL should be flushed for at least threeminutes, disinfected with a suitable disinfectant, asrecommended by the manufacturer for routinedisinfection of the DUWL, then flushed for afurther three minutes.

19.13 Where in-line filters are used, these will requiretreatment using a cleansing solution that has beenrecommended by the manufacturer. This stepshould be performed after first flushing theDUWL.

Note

Care should be taken to minimise the occurrence ofsplashing and aerosol formation.

19.14 If DUWLs have disposable filters, they should bereplaced.

19.15 Self-contained water bottles (bottled watersystems) should be flushed with distilled or cleanRO water. Where visual contamination is present,flushing with a suitable disinfectant followed bythorough washing is necessary. The manufacturer’sinstructions will specify which disinfectant to use.In instances where visual contamination is

routinely detected, it will be necessary to decreasethe interval between flushing operations. If goodpractice is followed, practices should not routinelydetect evidence of visual contamination.

Note

The self-contained water supplies used for dental caresystems should be freshly distilled or RO water (seeChapter 17).

19.16 As part of the recommissioning, dental equipmentrequiring protection against backflow should havethe anti-retraction valves, incorporated onhandpieces or waterlines, checked by theResponsible Person. They should ensure they aresuitably decontaminated, refitted correctly and areoperating in the correct manner. Examples of dentalequipment requiring backflow protection are:

• dental spittoons;

• three-in-one syringes;

• ultrasonic scalers;

• wet-line suction apparatus; and

• self-filling automatic radiographic processors,where still used.

19.17 Adherence to the equipment manufacturer’srecommended cleaning procedures, including useof their recommended chemicals, is a requirementfor medical devices such as those listed above.

Maintenance policy19.18 The Registered Manager is ultimately responsible

for the provision of a wholesome water supply inthe premises under their authority.

Contract maintenance19.19 When selecting subcontractors, particularly in

relation to the control of legionella, theircompetence should be established beforehand, forexample, companies or individuals who aremembers of the Legionella Control Association.

Emergency action19.20 Contingency plans should be available in the event

of the following:

a. A power failure:

– This may result in a failure to maintaintemperature in the hot water system.

– If the dental practice produces its owndistilled water, this will restrict the amountof distilled water that can be produced in aset time period.

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19 Hot and cold water systems and dental unit water lines

b. A mains-water failure that could last beyondthe period for which storage capacity has beendesigned:

– may result in the temporary cessation of theproduction of RO water;

– may require the temporary cessation of sterilesupply activities;

– may result in hygiene issues for patient andstaff WCs and washrooms.

Note

The emergency action to be taken during an outbreakof healthcare-associated legionellosis is covered inWHTM 04-01 Part B Appendix 1.

Documentation19.21 It is essential to have comprehensive operational

manuals for all items of plant; they should includerequirements for servicing, maintenance tasks andfrequencies of inspection.

19.22 This information should be kept together with allcommissioning data.

As-fitted drawings19.23 The availability of accurate as-fitted drawings is

essential for the safe operation of hot and coldwater service systems. The drawings are necessaryto perform the temperature control checks on thesystems and will assist in identifying any potentialproblems with poor hot water circulation and coldwater dead-legs, where flow to sporadically-usedoutlets can be low. Such information shouldidentify all key components in the installations,for example, water meters, storage tanks, filtrationequipment, where fitted, calorifiers and thelocation of isolating valves in the systems. As-fitted drawings can be obtained from third partiessuch as architects.

19.24 In addition to drawings, there should becomprehensive schedules of outlets, lists ofsentinel taps (outlets), other outlets to be testedannually and other components in the system.

Note

The information required above could be compiled bythe Competent Person employed to produce the writtenscheme, since much of the information is an integralpart of the written scheme itself.

Record-keeping19.25 The User should ensure that an accurate record of

all assets relating to the hot and cold waterdistribution systems is set up and regularlymaintained.

19.26 The User should also ensure that records of allmaintenance, inspection and testing activities arekept up-to-date and properly stored. Recordsshould be kept for at least five years. As aminimum, the following items should berecorded:

• the names and positions of those responsiblefor performing the various tasks under thewritten scheme;

• a legionella risk assessment and a writtenscheme of actions and control measures;

• details of precautionary measures that havebeen carried out, including sufficient detail toidentify that the work was completed correctlyand when the work was carried out.

19.27 Planned preventive maintenance will help toensure that systems perform correctly, and anessential element of this process is themaintenance of accurate records.

19.28 Maintenance records should include the following:

• details of remedial work required and workcarried out;

• details of cleaning and disinfection procedures;

• results of any chemical or microbiologicalanalyses of water.

19.29 When alterations to equipment or systems areimplemented, any drawings kept with the records should be updated to reflect themodifications carried out.

19.30 The asset register should be designed to providethe following information:

• an inventory of equipment;

• a basis for identifying equipment details;

• a basis for recording the maintenancerequirements;

• a basis for recording and accessing informationassociated with disinfection and maintenance.

19.31 When completing records, it is essential that theindividual concerned signs and dates the entriesand that there is an audit trail in place.

Water supply hygiene19.32 After any installation work, all piping, fittings and

associated services used for the conveyance of

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water for domestic purposes must be disinfectedbefore being brought into use. The methodgenerally used for disinfection is chlorination.Disinfection using chlorine should be carried outin accordance with BS EN 806-2, BS EN 806-3,BS EN 806-5 and BS 8558 (see also WHTM 04-01 Part A Chapter 17) and under the directsupervision of a nominated person.

19.33 Despite disinfection of systems, some outbreaks ofdisease related to treated water supplies still occur.To reduce the risk of such outbreaks, the designshould eliminate:

• direct contact with the internal parts of waterpipes and structures by people, animals orbirds, for example, ensure covers are in placeon storage tanks and cisterns;

• backflow (back-siphonage) of contaminatedwater into systems conveying potable water(mains and storage structures).

Water treatment19.34 In a properly installed and commissioned hot

water system, it should be possible to maintain atemperature of at least 55oC at the furthestdrawoff point in the circulating system, and 50oCin the circulating system’s return connection to thecalorifier.

19.35 In older premises this may not be possible, and inthe case of cold water systems it is not alwayspossible or practicable to maintain watertemperature below 20oC because of utilisation andcomplexity. In addition, therefore, it may benecessary to apply a residual biocidal watertreatment that has been shown to destroy andremove biofilm. Information on these techniques,which include chlorine dioxide and copper andsilver ionisation, can be found in WHTM 04-01Part B.

Note

In addition to residual biocidal techniques, there areother manufacturer-specified treatments that aredeveloped for use on DUWLs and other associateddental equipment. Refer to the manufacturer’sinstructions for their correct use.

19.36 Where automatic equipment is used fordisinfection, it should indicate any change in theamount or concentration of material injected intothe water so that immediate action can be taken.

19.37 Continuous dosing with appropriate biocides thathave proven efficacy should be considered duringconstruction to prevent the accumulation of

biofilm. A regular flushing programme for alloutlets should also be implemented.

19.38 The continuous chlorination of hot and coldwater service systems to control the growth oflegionella is not generally recommended.Treatment using chlorine dioxide or copper andsilver ionisation can be used. Advice should besought from the Health Board Responsible Person(Water).

19.39 In defining their responsibilities, service providersshould be asked to advise on test methods andanticipated concentrations of residual chemicalswithin the system. (See also Chapter 3 of WHTM04-01 Part A for more guidance on watertreatment regimens.)

Purging the systems19.40 Where chemical treatment is introduced, it is

essential to ensure that all parts of the system arepurged so that adequate concentrations areachieved.

19.41 As temperature monitoring is performed onsentinel and representative outlets on a rollingbasis only, additional draw-off will be required atall points on a regular basis.

Ozone and ultraviolet treatment19.42 Whereas treatments such as chlorine dioxide and

copper and silver ionisation are intended to bedispersive, that is, they result in a residual agentwithin the system; ozone and ultraviolet areintended to be effective close to the point ofapplication. They are not, therefore, necessarilyeffective in hot and cold water service systems (seeChapter 15 of WHTM 04-01 Part A).

Metal contamination

19.43 See WHTM 04-01 Part A Chapter 6.

Filtration

19.44 It is essential for filter cartridge elements to bechanged at appropriate intervals in accordancewith the manufacturer’s recommendations, takinginto account local conditions.

19.45 Filter membranes should also be chemicallycleaned or replaced at the recommended periods,and care must be taken to ensure that the “vessel”or “housing” containing the filter assembly is alsodisinfected appropriately during filter ormembrane maintenance.

79


Water storage19.46 For general information on water storage, see

WHTM 04-01 Part A (paragraphs 7.1–7.2) andWHTM 04-01 Part B (paragraphs 7.54–7.61).Advice can be sought from NWSSP-FS.

Cold water distribution system

19.47 The design and installation of the cold waterdistribution system should comply with the WaterSupply (Water Fittings) Regulations 1999 andrelevant parts of BS EN 806-2, BS EN 806-3 andBS 8558 (See Chapter 8 of WHTM 04-01 Part Afor further information.)

19.48 The control of water temperature in the coldwater service will essentially rely on goodinsulation and water turnover. Cold water servicesshould be sized to provide sufficient flow andshould be insulated and kept away from areaswhere they are prone to thermal gains. This alsoapplies to water supplies for spittoons. Stagnationmust be avoided. Special attention should be givento the maintenance and monitoring of thesesystems.

19.49 Schematic drawings of the system with numberedand labelled valves will reduce confusion and savetime in trying to identify appropriate isolatingvalves and other system components.

19.50 Checks and actions should be carried out to showthat:

• the system components show no sign ofleakage or corrosion;

• the system insulation is in good condition;

• the system filters have been changed and/orcleaned in accordance with manufacturer’srecommendations. Strainers should be checkedand cleaned regularly;

• all isolating valves have periodically beenworked through their full range of travel;

• every water outlet complies with the backflowprotection requirements of the Water Supply(Water Fittings) Regulations 1999.

Drinking water

19.51 If separate drinking water supplies are provided,reference should be made to WHTM 04-01 PartA (paragraphs 8.13 and 8.14).

Hot water storage and distribution

19.52 Hot water services should be designed andinstalled in accordance with the Water Supply(Water Fittings) Regulations 1999 and relevant

parts of BS EN 806-2, BS EN 806-3 and BS8558. The hot water system may be of either thevented or the unvented type. (See WHTM 04-01Part A Chapter 9 for further information.)

19.53 To control possible colonisation by legionella, it isessential to maintain the temperature within thehot water circulating system. To some extent, ifproperly maintained, the calorifier/water heaterwill provide a form of barrier to legionella andother water-borne organisms. The minimum flowtemperature of water leaving the calorifier/waterheater should be 60oC at all times and 55oC atthe supply to the furthermost draw-off point inthe circulating system.

Note

A minimum of 55oC may be required for the operationof suitable mixing devices to provide “safe” hot water atthe upper limit of the recommended range.

In large non-recirculating systems, the minimum of55oC should be maintained by electric trace-heating.

19.54 The minimum water temperature at theconnection of the return to the calorifier/waterheater should be 50oC. To achieve the requiredcirculating temperatures, it will be necessary tomaintain the balance of flows to individual pipebranches and drawoff points.

19.55 Calorifiers, where fitted, should be subjected toregular procedures that include the following:

• cleaning and maintenance;

• quarterly draining to minimise theaccumulation of sludge. This may be extendedto annual draining if, during inspection, it isfound that there is little accumulation of debris;

• whenever dismantled for statutory inspection,or every year in the case of indirect calorifiers,they should be thoroughly cleaned to removesludge, loose debris and scale;

• whenever a calorifier is taken out of service, itshould be refilled, drained, refilled again andthe entire contents brought up to, and held at,the nominal operating temperature of 60oCfor at least an hour. See also WHTM 04-01Part B paragraphs 7.74–7.76 for further advice.

Instantaneous water heaters for single or multi-point outlets

19.56 The general principles and limitations ofinstantaneous water heaters are given in therelevant parts of BS EN 806-2, BS EN 806-3 andBS 8558:

80


• the flow rate is limited and is dependent uponthe heater’s hot water power rating;

• where restricted rates of delivery are acceptable,the heater can deliver continuous hot waterwithout requiring time to reheat;

• they are susceptible to scale formation in hardwater areas where they will require frequentmaintenance;

• this form of hot water heating should only beconsidered for smaller premises or where it isnot economically viable to run hot waterdistribution to a remote outlet.

Safe hot water delivery devices

19.57 Appropriate types of thermostatic mixing deviceare specified in WHTM 04-01 Part A Table 4.

19.58 It is essential to check the temperature settingsand operation of all water mixing devices regularly,preferably every six months, provided that there isno “drift” in excess of 1oC. Other maintenanceshould be strictly in accordance with themanufacturer’s instructions.

19.59 Local water quality will influence the maintenancefrequency for any installation. A relatively smallpiece of debris may restrict the operation of thetemperature control and fail-safe mechanisms.

19.60 The recommendations regarding safe watertemperature apply to all areas to which patientsand visitors have free access.

Materials of construction

19.61 Systems should comply with the requirements ofthe Water Supply (Water Fittings) Regulations1999. Materials used in contact with water thatis for drinking etc. should comply with BS 6920-1and be listed in the latest edition of the ‘WaterFittings and Materials Directory’ published byWRAS.

Temperature control regimen

19.62 Temperature control regimen is the preferredstrategy to maintain systems free from legionellaand other water-borne organisms. This will requiremonitoring on a regular basis. The test frequenciesare listed in Table 1.

Point-of-use filtration

19.63 Point-of-use filters must be changed in accordancewith manufacturers’ recommendations, typically atleast once a month. When changing filters, it isrecommended that water-quality sampling takesplace at outlets identified as sentinel points beforerefitting a replacement filter. Except where takingsamples as above, once point-of-use filtration hasbeen introduced, taps or showers must not be usedwithout a filter in place.

19.64 Where point-of-use filters are no longer required,the outlet and associated pipework must bedisinfected to remove any accumulated biofilmbefore the system is returned to service (see alsoWHTM 04-01 Part A paragraph 5.16).

Summary checklist19.65 A summary checklist for hot and cold water

services showing recommended frequency ofactivity is given in Table 2.

Note

The checks and tasks outlined in Tables 1 and 2 couldbe carried out by trained user or contracted-out to athird party, for example, a Health Board.

81



Frequency Check Cold water Hot water Notes

Monthly † Sentinel outlets The water temperature The water temperature These measurements areshould equilibrate below should equilibrate to at applicable to non-mixed20oC after draw-off for least 50oC after draw-off outlets only2 minutes 1,2 for 1 minute 3

Monthly Inlets to sentinel TMVs Temperatures as above Temperatures as above Measurements can be made by means of surface temperature probes

Monthly Water leaving and Also to be monitoredreturning to calorifier continuously by BMS

6-monthly In-coming cold water at The water should be below Also to be continuouslyinlet to building – in the 20°C 2 monitored by BMSwinter and in the summer

Annually ‡ Representative outlets The water temperature The water temperatureshould equilibrate below should equilibrate to at20°C after draw-off for least 50°C after draw-off2 minutes 1,2 for 1 minute 3

Table 1: Tests for temperature performance

82

Notes:

† Sentinel outlets are normally those that, on a hotwater service, are the first and last outlets on arecirculating system. On cold water systems, or non-recirculating hot water systems, they are the closestand furthermost from the storage tank or waterheater. The choice of sentinel taps should also includeother outlets that are considered to represent aparticular risk, for example, those installed inaccommodation in which particularly susceptiblepatients are treated, or others identified in the riskassessment and temperature mapping exercise ashaving the least satisfactory temperature performance.

‡ Representative outlets include conventional andmixed-temperature taps; 20% of the total numberinstalled throughout the premises would be testedannually on a rotational basis: that is, all taps checkedevery five years.

1. The Health & Safety Commission’s HSG274Legionnaires’ disease: Technical guidance permits aperiod of two minutes to achieve an equilibriumtemperature below 20°C. Achieving this minimumrequirement would be indicative of an exceptionallyunderutilised water system. (At a typical flow to awash-hand basin of 4.5 L/m, 2 minutes to achievetemperature would indicate a 50 m dead-leg of15 mm pipe.)

2. The Water Supply (Water Quality) Regulations (latestamendment) permit water undertakers to supplywater to premises at temperatures up to 25°C. Inpractice, the water temperature is likely to be belowthis maximum value, typically below 10°C in winter

and 20°C in summer. If, during prolonged periods ofhigh environmental temperature, the watertemperature starts to exceed 20°C, the waterundertaker should be asked to see whether remedialaction could be undertaken. Within the curtilage ofthe premises, the aim should be to ensure that thetemperature difference between the in-coming supplyand most distal parts of the distribution system isbelow 2°C.

3. The Health & Safety Commission’s HSG274Legionnaires' disease: Technical guidance permits aperiod of 1 minute to achieve an equilibriumtemperature of 50°C. A minimum of 55°C may berequired for the operation of suitable mixing devicesrequired to provide “safe” hot water at the upper limitof the recommended range. Hot water at 55°C isrequired in many cases for reasons of food hygiene ordecontamination requirements, for example, inkitchens and sluice rooms etc. In a properly balancedhot water circulating system, with the circulationtaken close to the drawoff point, achievingtemperature should be virtually instantaneous. (At atypical flow to a wash-hand basin of 4.5 L/m, 1minute to achieve temperature would indicate a 25 mdead-leg of 15 mm pipe.)

83


Service Task* Frequency

Hot water services Arrange for samples to be taken from hot water calorifiers/ Annuallywater heaters in order to note condition of drain water

Check temperatures in flow and return at calorifiers/water heaters Monthly 4

Check water temperature after draw-off from outlets for Monthly 4

1 minute to ensure that 50°C has been achieved in sentinel outlets 1,2,5

Visually check internal surfaces of calorifiers/water heaters for scale Annuallyand sludge. 5

Check representative taps for temperature as above on a rotationalbasis

Manual check to confirm secondary hot water recirculation pumps Monthlyare operating effectively

Cold water services Check tank water temperature remote from in-coming ball valve and 6-monthly 4

mains temperatures. Note maximum temperatures recorded byfixed max/min thermometers, where fitted

Check temperature in sentinel outlets after draw-off for Monthly2 minutes to establish that it is below 20°C 2,3

Visually inspect cold water storage tanks and carry out remedial work Annuallywhere necessary.Check representative taps for temperature, as above, on arotational basis

Dental equipment Drain down and clean At the end of each working day

Emergency eye wash sprays Flush through and purge to drain 6-monthly or more frequently if recommended by manufacturers

Mixed-temperature outlets Check delivery temperature in accordance with D08 6-monthly

Showerheads Dismantle, clean and descale showerheads and hoses Quarterly, or as necessary

Sporadically-used outlets Flush through and purge to drain, or purge to drain immediately At least twice weekly 6

before use without release of aerosols

Table 2: Summary checklist for hot and cold water services

Notes:

* See paragraph 182 in the Health & SafetyCommission’s HSG274 Legionnaires’ disease:Technical guidance further guidance on tasks thatshould be undertaken.

1. For effective operation of hot water services, theminimum equilibrium temperature should be 55°Cand be achieved within seconds.

2. For thermostatic mixing devices, temperatures shouldbe measured at the inlet.

3. For satisfactory operation of cold water services,temperature equilibrium to below 20°C should beachieved well within one minute.

4. Temperatures should be continuously monitored bythe BMS.

5. Additional checks should be made on the hot watercirculating system and systems using trace heating atdistal points.

6. Risk assessment may indicate the need for morefrequent flushing of outlets. It is preferable that thisform part of the daily cleaning routine whereappropriate. Alternatively, self-purging showers thatdischarge water to a drain prior to use and withoutthe release of aerosols can be considered.

Microbiological monitoring19.66 Apart from situations where there are taste or

odour problems, microbiological monitoring fortotal viable counts (TVCs) is not considered to benecessary.

19.67 If performed for these purposes, the detection oflow TVCs is not necessarily an indication of theabsence of legionella, but is an indication of theoverall water quality and signifies a generallyunfavourable environment for bacteria.

19.68 All microbiological measurements should be byapproved methods and/or be carried out byUnited Kingdom Accreditation Service (UKAS)-accredited laboratories. Dip slides are notacceptable.

84


Note

Dental practitioners should refer to Welsh HealthTechnical Memorandum 07-01 – ‘Safe management ofhealthcare waste’, which provides a good-practiceframework for the management of healthcare waste,helping healthcare organisations such as dental practicesto meet legislative requirements. The guidance includes:

• a unified approach to identifying and classifyinginfectious and medicinal waste to comply withhealth and safety, transport and waste regulations;

• a revised colour-coded waste segregation and packagingsystem to allow standardised identification of waste;

• the use of European Waste Catalogue (EWC) codeson all waste documentation;

• a new offensive/hygiene waste stream for non-infectious waste (human hygiene waste and sanpro(sanitary protection) waste);

• items and equipment that do not pose a risk ofinfection, including gowns, gloves, plaster casts.

• Check with the local waste contractor to ensure thatcolour-coded waste containers, labels anddocumentation comply with the latest guidance.

What are the responsibilities of thedental practice?It is the responsibility of the Registered Manager (ornominated other) to ensure that waste is:

• correctly segregated;

• stored safely and securely away from areas of publicaccess within the premises;

• packaged appropriately for transport;

• described accurately and fully on the accompanyingdocumentation when removed;

• transferred to an Authorised Person for transport toan authorised waste site;

• appropriately registered, with necessary records andreturns at premises.

The Registered Manager should also ensure that all staffare trained and aware of the waste procedures andcomply with them.

Note

The Hazardous Waste (England and Wales) Regulationsrequire that dental amalgam waste is kept separate fromother waste and consigned to an appropriate wastemanagement facility. To comply with theserequirements, Registered Managers need to fit amalgamseparators and consign the amalgam to an appropriatefacility for disposal or recovery.

85

Appendix 1: Waste disposal

A hand-hygiene policy must be available within thepractice and should contain, at least, the following:

• Wash hands between each patient treatment, andbefore donning and after removal of gloves.Antibacterial-based hand-rubs and gels can be usedinstead of hand-washing between patients duringsurgery sessions.

• Bar soap must not be used or made available in thepractice.

• Do not use abrasive sponges or nail brushes becausethese can cause abrasion of the skin wheremicroorganisms can reside.

• Nails must be short and clean. Nails should be free ofnail art, permanent or temporary enhancements (falsenails) or nail varnish.

• Nails should be cleaned using a blunt “orange” stick.

• Use good-quality soft paper hand-towels.

• Ensure that paper towels and drying techniques donot damage the skin.

• Use a hand cream following hand-washing at the endof a session to counteract dryness, but do not usehand cream under gloves because this can encouragethe growth of microorganisms.

• Antibacterial-based hand-rubs and gels formulated foruse without water can be used on visibly clean handsin conjunction with a good hand-washing techniquefor invasive dental procedures.

• Follow local infection control guidance ormanufacturers’ instructions on the maximum numberof applications of antibacterial-based hand-rubs andgels that can be used on physically clean hands beforehand-washing is required. Be aware that build-up ofproduct on the hands occurs with repeatedapplication. If hands become “sticky”, they must bewashed as normal using a proper hand-hygienetechnique.

• Alcohol-impregnated wipes used for cleaning surfacesshould not be used in place of hand-rubs and gels, asthey are not effective in hand decontamination.

• Use a foot-operated or sensor-operated waste bin.

• Protective domestic gloves should be worn for allcleaning tasks. These should be sturdy and suitablefor purpose. Gloves should be inspected before use toensure that they are intact. Where the task involvesthe use of chemicals, the gloves should be certified assuitable for chemical resistance and comply with theEuropean PPE Directive (89/686/EEC).

• Gloves should be cleaned regularly between cleaningtasks. Use of gloves does not reduce the requirementfor hand washing.

• Latex free gloves should be available to the abovespecification where a latex allergy has been identified.

86

Appendix 2: Hand-hygiene policy

87

Appendix 2 Hand-hygiene policy

Table A1: Levels of hand hygiene

Level 1: Social hand hygiene Level 2: Hygienic hand hygiene Level 3: Surgical scrub

Why? To render the hands physically clean In addition to level 1, to destroy In addition to level 2, to substantiallyand to remove transient microorganisms and to provide reduce the numbers of residentmicroorganisms, picked up during residual effect during times when microorganisms that normallysocial activities. hygiene is particularly important in live on the skin during times when

protecting yourself and others. surgical procedures are being carriedout.

When? Before: Before: Before:

• commencing/leaving work • aseptic procedures • surgical or invasive procedures, oral

• using computer keyboards • contact with surgery, perio or implant surgery

• eating or handling food or drinksimmunocompromised patients

(Specific policies and procedures on

• carrying out decontamination • before wearing gloves and carryingsurgical preparation should be

procedures out minor surgical or routineavailable at local level)

• preparing or giving medicationsdental procedures.

• direct patient contact where no After:exposure to blood or other bodilyfluids or non-intact skin has • Contact with blood, other bodily occurred. fluids, excretions, secretions,

mucous membranes, non-intactskin, wound dressings, spore-forming organisms.

After:

• becoming visibly soiledvisiting the toilet

• patient contact even whereno exposure to blood or otherbodily fluids, or non-intact skinhas occurred

• carrying out decontaminationprocedures

• using computer keyboard

• handling laundry, equipment orwaste

• blowing, wiping or touching nose.

What hand Mild liquid soap – does not need to An approved antibacterial hand An approved antibacterial handhygiene to be antibacterial or antiseptic. cleanser (for example, 2–4% cleanser (for example, chlorhexidineuse? chlorhexidine, 5–7.5% povidone gluconate 4%, povidone iodine 7.5%).

Antibacterial-based hand-rubs/gelsiodine, 1% triclosan or plain soap

People who are sensitive to antisepticcan be used when hands have not

from a dispenser).cleaners can wash with an approved

been soiled. Antibacterial-based hand-rubs/gels plain liquid soap followed by two

Bar soap should not be used.(for example, when performing applications of an antibacterial-basedaseptic techniques) to provide further hand-rub/gel. Skin problems shouldcleansing and residual effect, and may be reported and discussed with a GPbe used with plain (liquid) soap or occupational health, and a localwhere necessary. procedure followed.

How long 10–15 seconds 15–30 seconds 2–3 minutes, ensuring all areas of for? hands and forearms are covered.

88


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Appendix 3: Examples of logbook pages

Table A2: Summary details

Steam sterilizer details

Dental practice address Room Make

Model Ref. No Serial No.

Contents – the following forms:

Name of form Code No. Copy Purpose Table

Daily test sheet Yes A record of all daily testing A3

Weekly test sheet plant history record No A record of faults/maintenance A4

Quarterly and yearly test sheets Yes Competent Person’s (Decontamination) quarterly –and yearly test sheets

Test history record Yes History of the weekly, quarterly and yearly tests –

Autoclave history record sheet Yes Record of all faults, maintenance and repairs tothe autoclave A5

Process log sheet No Provides a record of every sterilizer load processed A6

Personnel Name/organisation Tel. No.

Registered manager

User

Operator(s)

Decontamination Lead

Designated Person

Authorised Engineer (Decontamination)

Competent Person (Pressure vessels)*

Authorised Person

(Decontamination)

Competent Person

(Decontamination)*

Service engineer

Microbiologist

Review of records by Nominated Person e.g. Designated Person/AP(D)/AE(D)

Date Comments on review Name/signature

*These personnel should have qualifications/training/registration defined in WHTM 01-01 Part A

Pressure Systems Safety Regulations 2000

This section to be filled in by the Competent Person (Pressure vessels)

Written scheme of inspection exists/is suitable

Inspection carried out on Date: Inspected by:

Result of examination/comments

89

90


Table A3: Daily test sheet

Sterilizer location Serial No. Week beginning

Make/model Ref. No.

During sterilizing Sterilizing Automatic Steam penetration Certified fithold period hold time control test result test Pass/Fail/ for use by

Pass/Fail Not applicable user

Cycle Temp Pressure Min : secnumber oC min/ bar

max

Mon P/F P/F/NA

Tue P/F P/F

Wed P/F P/F

Thur P/F P/F

Fri P/F P/F

Sat P/F P/F

Sun P/F P/F

Reservoir water changes (where applicable). Drain, rinse and refill with freshly distilled or RO water.

Cycle number when water changed Comments Water changed by

Monday

Tuesday

Wednesday

Thursday

Friday

Saturday

Sunday

Tests to be carried out in accordance with WHTM 01-05

Faults – new or existing (also enter in plant history record)

91

Appendix 3 Examples of logbook pages

Table A4: Weekly test sheet

Sterilizer location Serial No. Department

Make/model Ref. No.

Week Cycle Automatic air Automatic Steam Weekly safety Certified fitbeginning number leakage test control test penetration checks for use by

result* result test Satisfactory/ userPass/Fail Pass/Fail Pass/Fail/Not Unsatisfactory

applicable

P/F P/F P/F/NA S/U

P/F P/F P/F S/U

P/F P/F P/F S/U

P/F P/F P/F S/U

P/F P/F P/F S/U

P/F P/F P/F S/U

P/F P/F P/F S/U

P/F P/F P/F S/U

* Only where the sterilizer has an in-built self-test programme. Otherwise the test should be carried out by a CP (D) and copies of theCP(D)’s test sheets should be inserted.

Tests to be carried out in accordance with WHTM 01-05

Weekly safety checks (tick if satisfactory)

Week Cycle Door seal Door pressure Door closed Satisfactory/Unsatisfactory Tested bybeginning number interlock interlock

S/U

S/U

S/U

S/U

S/U

S/U

Faults – new or existing (also enter in plant history record)

92


Type

of

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e

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tal p

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5:

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93

Appendix 3 Examples of logbook pages

Den

tal p

ract

ice

Star

t da

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or t

his

shee

t

Dep

artm

ent/

loca

tion

Ref

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)in

itia

ls

Yes/

No

Yes/

No

Yes/

No

Yes/

No

Yes/

No

Yes/

No

Yes/

No

Yes/

No

Yes/

No

Yes/

No

Yes/

No

Yes/

No

Yes/

No

Yes/

No

Yes/

No

Yes/

No

Yes/

No

Yes/

No

Yes/

No

Yes/

No

Yes/

No

Yes/

No

Yes/

No

Yes/

No

Yes/

No

Yes/

No

Yes/

No

Yes/

No

Yes/

No

Yes/

No

Yes/

No

Yes/

No

Yes/

No

Yes/

No

Yes/

No

Yes/

No

Yes/

No

Yes/

No

Yes/

No

Yes/

No

Yes/

No

Yes/

No

Yes/

No

Yes/

No

Yes/

No

Yes/

No

Yes/

No

Yes/

No

Yes/

No

Yes/

No

Yes/

No

Yes/

No

Tabl

e A

6:

Proc

esse

d lo

g sh

eet

– be

ncht

op a

utoc

lave

It should be noted that this list may not be totallyinclusive at the time of reading. Advice should be soughton the currency of these references and the need toinclude new or revised documents.

Acts and regulationsThe acts and regulations shown below can be accessedfrom the www.legislation.gov.uk/ website

Carriage of Dangerous Goods and Use of TransportablePressure Equipment Regulations

Control of Substances Hazardous to Health Regulations(COSHH)

Hazardous Waste (England and Wales) Regulations

Health and Safety at Work etc. Act

Medical Devices Regulations

Pressure Systems Safety Regulations

The Private Dentistry (Wales) Regulations

Water Supply (Water Fittings) Regulations

Water Supply (Water Quality) Regulations

British, European and InternationalStandardshttp://shop.bsigroup.com/

BS 6920-1. Suitability of non-metallic products for usein contact with water intended for humanconsumption with regard to their effect on the qualityof the water. Specification. British Standards Institution,2000.

BS 8558. Guide to the design, installation, testing andmaintenance of services supplying water for domestic usewithin buildings and their curtilages. Complementaryguidance to BS EN 806.

BS EN 285. Sterilization. Steam sterilizers. Largesterilizers.

BS EN 556-1. Sterilization of medical devices.Requirements for medical devices to be designated“STERILE”. Requirements for terminally sterilizedmedical devices.

BS EN 556-2. Sterilization of medical devices.Requirements for medical devices to be designated“STERILE”. Requirements for aseptically processedmedical devices.

BS EN 806-2. Specifications for installations insidebuildings conveying water for human consumption.Design.

BS EN 806-3. Specifications for installations insidebuildings conveying water for human consumption. Pipesizing. Simplified method.

BS EN 806-5. Specifications for installations insidebuildings conveying water for human consumptionOperation and maintenance.

BS EN 13060. Small steam sterilizers.

BS EN 61010-1. Safety requirements for electricalequipment for measurement, control and laboratory use.

BS EN ISO 11607-1. Packaging for terminally sterilizedmedical devices. Requirements for materials, sterilebarrier systems and packaging systems.

BS EN ISO 11607-2. Packaging for terminally sterilizedmedical devicesValidation requirements for forming,sealing and assembly processes.

BS EN ISO 14971. Medical Devices – Application ofrisk management to medical devices.

BS EN ISO 15883-1. Washer-disinfectors. Generalrequirements, terms and definitions and tests.

BS EN ISO 15883-2. Washer-disinfectors.Requirements and tests for washer-disinfectorsemploying thermal disinfection for surgical instruments,anaesthetic equipment, bowls, dishes, receivers, utensils,glassware, etc.

BS EN ISO 17665-1. Sterilization of health careproducts. Moist heat. Requirements for thedevelopment, validation and routine control of asterilization process for medical devices.

94

References

Department of Health (England)publicationswww.gov.uk/government/organisations/department-of-health

Advisory Committee on Dangerous Pathogens –Transmissible Spongiform (ACDP TSE) RiskManagement Subgroupwww.gov.uk/government/publications/guidance-from-the-acdp-tse-risk-management-subgroup-formerly-tse-working-group

An integrated approach to hospital cleaning: microfibrecloth and steam cleaning technology.www.gov.uk/government/uploads/system/uploads/attachment_data/file/143264/Microfibre_report_revised_Mar_08.pdf

Potential vCJD transmission risks via dentistry: aninterim review.webarchive.nationalarchives.gov.uk/20130107105354/http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_081170

European LegislationCOUNCIL DIRECTIVE 89/686/EEC of 21 December1989 on the approximation of the laws of the MemberStates relating to personal protective equipmenthttp://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CONSLEG:1989LO686:LATEST:EN:PDF

Health and Safety Executivewww.hse.gov.uk/

Control of Substances Hazardous to Health Regulations(COSHH).www.hse.gov.uk/coshh/

Legionnaires’ disease -Technical guidance HSG 274.www.hse.gov.uk/pubns/books/hsg274.htm

Legionnaires’ disease – the control of legionella bacteriain water systems. Approved Code of Practice andguidance on regulations L8.www.hse.gov.uk/pubns/books/l8.htm

Healthcare Inspectorate Waleswww.hiw.org.uk/

NHS Wales Shared Services Partnership –Facilities ServicesThe publications below are available from the NHSWales Shared Services Partnership - Facilities Serviceswebsites:Intranet: howis.wales.nhs.uk/wheInternet: www.wales.nhs.uk/whe

Welsh Health Building Note 00-09 – Infection controlin the built environment

Welsh Health Building Note 13 – Sterile servicesdepartment.

Welsh Health Technical Memorandum 00 – Policies andprinciples: best practice guidance for healthcareEngineering.

Welsh Health Technical Memorandum 01-01 –Decontamination of medical devices within acuteservices Part A: Management and environment.

Welsh Health Technical Memorandum 01-01 –Decontamination of medical devices within acuteservices Part B: Common elements.

Welsh Health Technical Memorandum 01-01 –Decontamination of medical devices within acuteservices Part C: Steam sterilization and steam forsterilization.

Welsh Health Technical Memorandum 01-01 –Decontamination of medical devices within acuteservices Part D: Washer-disinfectors.

Welsh Health Technical Memorandum 01-04–Decontamination of laundry and infected linen.

Welsh Health Technical Memorandum 03-01 -Specialised ventilation for healthcare premises.

Welsh Health Technical Memorandum 04-01 – Thecontrol of Legionella, hygiene, “safe” hot water, coldwater and drinking water systems.

Welsh Health Technical Memorandum 07-01 – Safemanagement of healthcare waste.

NHS ScotlandSurvey of decontamination in general dental practice.Sterile Services Provision Review Group, 2004www.scotland.gov.uk/Publications/2004/11/20093/45208

95

References

https://www.gov.uk/government/organisations/department-of-health

https://www.gov.uk/government/organisations/department-of-health

https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/143264/Microfibre_report_revised_Mar_08.pdf

https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/143264/Microfibre_report_revised_Mar_08.pdf

http://webarchive.nationalarchives.gov.uk/20130107105354/http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_081170

http://webarchive.nationalarchives.gov.uk/20130107105354/http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_081170

http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CONSLEG:1989L0686:LATEST:EN:PDF

http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CONSLEG:1989L0686:LATEST:EN:PDF

http://howis.wales.nhs.uk/sites3/home.cfm?OrgID=254

http://www.scotland.gov.uk/Publications/2004/11/20093/45208

http://www.scotland.gov.uk/Publications/2004/11/20093/45208

Public Health Waleswww.wales.nhs.uk/sitesplus/888/home

National Infection Control Policies for Wales.www.wales.nhs.uk/sites3/page.cfm?orgid=379&pid=38960

Welsh Healthcare Associated Infection Programme(WHAIP).www.wales.nhs.uk/sites3/home.cfm?orgid=379

Water Regulations Advisory Scheme(WRAS).Water Fittings and Materials Directory.www.wras.co.uk/directory/default.htm

Welsh Governmentwww.wales.gov.uk/?lang=en

Commitment to purpose: Eliminating preventablehealthcare associated infections (HCAIs).www.wales.gov.uk/topics/health/publications/health/guidance/eliminating/?lang=en

Healthcare associated infections – a community strategyfor Wales.www.wales.gov.uk/topics/health/protection/communicabledisease/publications/community/?lang=en

WHC(2000)71 - For the record - Managing Records inNHS Trusts and Health Authorities.www.wales.nhs.uk/documents/WHC(00)71.htm

Chief Dental Officer.www.wales.gov.uk/topics/health/cmo/professionals/dental/?lang=en

Advice for dentists on re-use of endodontic instrumentsand variant Creutzfeldt-Jakob Disease (vCJD) LetterApril 2007 -.www.wales.gov.uk/topics/health/cmo/professionals/dental/publication/cdo-letters/cjd/?lang=en

PSD/CDO (2006)1-‘Decontamination/Sterilisation ofRe-usable Instruments in General Dental Practice.

CDO(2012)2 Health Technical Memorandum 01- 05:‘Decontamination in primary care dental practices’(Welsh Edition) - Compliance with essentialrequirements.www.wales.gov.uk/topics/health/cmo/professionals/dental/publication/cdo-letters/compliance/?lang=en

World Health Organizationwww.who.int/en/

Guidelines for drinking-water quality, 2011.www.who.int/water_sanitation_health/publications/2011/dwq_guidelines/en/index.html

Water safety in buildings. 2011.www.who.int/water_sanitation_health/publications/2011/9789241548106/en/

Other publicationsMeiller, TF et al (1999), ‘Dental unit waterlines:biofilms, disinfection and recurrence’. The Journal ofthe American Dental Association, Vol 130 No 3, January,pp 65–72.

Pankhurst CL, Johnson NW and Woods RG, Microbialcontamination of dental unit waterlines: the scientificargument. International Dental Journal, Vol 48, 1998,pp 359–368.

Pankhurst CL, Woods RG and Johnson NW, Causes andprevention of microbial contamination of dentalunit water. FDI World, Vol 8 No 1, 1999, pp 6–13.

Smith AJ, To flush or not to flush? Dentistry, 20September 2001.

Walker JT et al, Microbial biofilm formation andcontamination of dental-unit water systems in generalpractice. Applied and Environmental Microbiology,Vol 66, 2000, pp 3363–3367.

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http://wales.gov.uk/topics/health/protection/communicabledisease/publications/community/?lang=en

http://wales.gov.uk/topics/health/protection/communicabledisease/publications/community/?lang=en

http://www.wales.nhs.uk/documents/WHC(00)71.htm

http://wales.gov.uk/topics/health/cmo/professionals/dental/publication/cdo-letters/cjd/?lang=en

http://wales.gov.uk/topics/health/cmo/professionals/dental/publication/cdo-letters/cjd/?lang=en

http://wales.gov.uk/topics/health/cmo/professionals/dental/?lang=en

http://wales.gov.uk/topics/health/cmo/professionals/dental/?lang=en

http://www.who.int/water_sanitation_health/publications/2011/dwq_guidelines/en/

http://www.who.int/water_sanitation_health/publications/2011/dwq_guidelines/en/

http://www.who.int/water_sanitation_health/publications/2011/9789241548106/en/

http://www.who.int/water_sanitation_health/publications/2011/9789241548106/en/

Institute of Healthcare Engineering and EstateManagement (IHEEM)www.iheem.org.uk/

Medicines and Healthcare product Regulatory Agencywww.mhra.gov.uk/

Legionella Control Associationwww.legionellacontrol.org.uk/

Scottish Dental Clinical Effectiveness Programme(SDCEP)www.sdcep.org.uk/

97

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