STATUS IN WALES 01 05 Wales ed... · 2015-10-27 · For queries on the status of this document contact [email protected] or telephone 029 2031 5512 2014 HEALTH TECHNICAL MEMORANDUM

For queries on the status of this document contact [email protected] or telephone 029 2031 5512

2014

HEALTH TECHNICAL MEMORANDUM 01-05

Decontamination in primary care dental practices - Update 1

2011

Wales edition

STATUS IN WALES

ARCHIVED

This document was superseded by Welsh Health Technical Memorandum 01-05

Decontamination in primary care dental practices and community dental services

2014

DecontaminationHealth Technical Memorandum 01-05:Decontamination in primary caredental practices

W E L S H H E A LT H ESTATESY S T A D A U I E C H Y D

Welsh edition 2011Update One

Front cover illustration: Washer disinfector

Published by Welsh Health Estates.

This publication is based on the April 2009 editionproduced by the Department of Health for use inEngland. It has been modified, where necessary, for usein Wales under the terms of the Centrally FundedPublications & Associated Contents & Digital RightsManagement Service and Financial FrameworkAgreement between the Department of Health andWelsh Health Estates.

This publication can be accessed from the NHS websitewww.spaceforhealth.nhs.uk

© Copyright Welsh Health Estates 2011.

Updated March 2011: References to Residual air testsdeleted from pages 51, 52 and 86.

Welsh Edition first published in 2010 as a consultationdocument.

Designed by Keith James.

i

DecontaminationHealth Technical Memorandum 01-05:Decontamination in primary caredental practices

Welsh edition 2011Update One

ii

Executive summary

PreambleThis document forms part of the Health TechnicalMemorandum 01 Decontamination series. Other partsinclude:

• Health Technical Memorandum 01-01:Decontamination of reusable medical devices

• Health Technical Memorandum 01-02:Decontamination in laboratories

• Health Technical Memorandum 01-03:Decontamination in pharmacies

• Health Technical Memorandum 01-04:Decontamination of laundry and infected linen

• Health Technical Memorandum 01-06:Decontamination of flexible endoscopes

• Health Technical Memorandum 01-07:Decontamination in primary care NHS trusts.

StructureThis document includes the following three sections:

• Section 1: Decontamination policy and foreword

• Section 2: Advice to dentists and practice staff(local decontamination)

• Section 3: Engineering, technology and standards.

Aim of the guidanceHealth Technical Memorandum 01-05 (Welsh edition) isintended to progressively raise the quality ofdecontamination work in primary care dental services bycovering the decontamination of reusable instrumentswithin dental facilities.

Who should use this guidance?Health Technical Memorandum 01-05 (Welsh edition)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 services(that is, dentists and support staff as well as engineeringstaff providing services in key areas). In addition, LocalHealth Boards (LHBs) will find the contents of value.

Reference to other parts of the Health TechnicalMemorandum 01 series may be necessary (on a limitedbasis only).

This Welsh edition is designed to follow the samestructure and format as its Department of Health‘parent’ document thus providing consistency betweenthe two documents while acknowledging Welsh-specificpolicies and structures.

Acknowledgements

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

DH Working Group on Water Quality in Use andDecontamination 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, Dental andEye 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 HTM GuidancePeer Group as directed by the Welsh AssemblyGovernment’s All Wales Decontamination Group.

Stephen Thomas Welsh Assembly Government

Tracey Gauci Welsh Assembly Government

David Thomas Welsh Assembly Government

Peter Phillips Director, SMTL

Bruce Fisher SMTL

John King Health Solutions Wales

Phillip Flear Sterile Services Manager (Hywel DdaHealth Board)

Eric Thomas Assistant Director, EnvironmenalManagement and Engineering, Welsh Health Estates

Graham Stanton Senior Decontamination Engineer,Welsh Health Estates

John Prendergast Decontamination Engineer, WelshHealth Estates

Christopher Lewis Environmental Management Advisor,Welsh Health Estates

Peter Wiles Deputy Director, Welsh Health Estates

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Contents

Executive summaryAcknowledgements

Section 1: Decontamination policy and foreword

Chapter 1 Policy and foreword (David Thomas, Acting Chief Dental Officer) 2RegistrationIntroductionThe need for guidance“Essential quality requirements” and “best practice”Progression towards best practicePrion decontaminationInfection control policyTraining and educationScope, status and structure of Health Technical Memorandum 01-05ExclusionsRelationship to other sources of information and guidanceFurther guidance

Section 2: Advice to dentists and practice staff

Chapter 2 Essential quality requirements and best practice 10Decontamination of instruments – an overviewCompliance

Essential quality requirements

Chapter 3 Cleaning instruments 16IntroductionGeneral 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 disinfectionInspection and care of instruments before sterilizingHandpiece care

Chapter 4 Sterilization 22Types of sterilizerDental handpieces

iv

Small sterilizersUse 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 28Physical segregation

Chapter 6 General hygiene principles 32Hand hygiene

Drying of handsSkin careFacilities and procedures for hand-washing

Personal protective equipment for decontamination processesGlovesDisposable plastic apronsFace and eye protection for decontamination proceduresClothing, 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 40

Section 3: Engineering, technology and standards

Chapter 8 Regulatory framework and compliance 42BS/EN/ISO StandardsDH guidelines

Chapter 9 Staff roles and responsibilities in decontamination 43

Chapter 10 Procurement of decontamination equipment and instruments 45Determining the load to be processedDecontamination equipment: washer-disinfectors and sterilizersDecontamination equipment: ultrasonic cleaners

SpecificationsSelecting instrumentsPolicy on new reusable instruments

Chapter 11 Decontamination equipment: general guidance on maintenance and testing 49Maintenance and servicingValidation and testingDocumentation

v

Contents

Chapter 12 Installation, validation, maintenance and testing of sterilizers 51Maintenance and servicingValidation and testingPeriodic tests

Chapter 13 Installation, validation, maintenance and testing of washer-disinfectors 53Maintenance and servicingValidation and testingPeriodic tests

Chapter 14 Installation, validation, maintenance and testing of ultrasonic cleaners 55Maintenance and servicingValidation and testingPeriodic tests

Chapter 15 Additional information on test procedures (in addition to thoseprovided in the Standards) 57

Automatic control testMethod

Ultrasonic activity testMethod

Safety checksWeekly checksYearly checks

Chapter 16 Approach and protocol for manual cleaning 59Cleaning procedure for dental instruments

Chapter 17 Steam and water quality 61Steam

Quality of input waterConditions of storage and frequency of change

WaterCleaningFinal rinsingDetergents

Chapter 18 The use of lubricants 63

Chapter 19 Hot and cold water systems and dental unit water lines 64Safe hot water temperatureUtilisationFlushing dental unit water lines (DUWLs)Decommissioning of DUWLsRecommissioning of DUWLsMaintenance policyContract maintenanceEmergency actionDocumentationAs-fitted drawingsRecord-keepingWater supply hygieneWater treatmentPurging the systemsOzone and ultraviolet treatmentWater storage

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Decontamination: Health Technical Memorandum 01-05 – Decontamination in primary care dental practices

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

Summary checklistMicrobiological monitoring

Appendix 1 Waste disposal 73What are the responsibilities of the dental practice?Waste segregation, packaging, classification and labellingWaste transfer and documentation

What is a consignment note?Who completes the consignment note, and when?What is a multiple consignment note?Waste transfer notes

Registrations, records and returnsRegistrationsWhy register as a hazardous waste producer?How to register as a hazardous waste producerWhy register for an exemption from an environmental permit?Hazardous waste – records and returnsConsignee returns to the waste producer or holderWhere should the register be kept?How long should the register be kept?Non-hazardous waste records

Electronic and electrical wastesChemicalsWaste audit and duty-of-care checks

Waste auditPre-acceptance audits

Waste carriersWaste disposal

Appendix 2 Hand-hygiene policy 81

Appendix 3 Examples of logbook pages 84

Appendix 4 Periodic test: small steam sterlizers 89

References 91Acts and regulationsCodes of PracticeBritish, European and International StandardsDepartment of Health publicationsOther publications

vii

Contents

Section 1: Decontamination policy and foreword

Patients deserve consistent standards of care every timethey receive treatment. It is essential that they aretreated in a safe and clean environment with minimalrisk of person-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 toexpect.

The policy and guidance provided in this HealthTechnical Memorandum are aimed at establishing aprogramme of continuous improvement indecontamination performance at a local level. Theguidance suggests options to dental practices withinwhich choices may be made and a simple progressiveimprovement programme established. It is expectedthat by the end of the first year of the implementationof this guidance, all primary care dental practices willbe working at or above the essential qualityrequirements described in this guidance.

This guidance is intended to support and advance goodpractice throughout primary care dentistry includingthat delivered by general dental practices, communitydental services and where primary care is delivered inacute settings.

RegistrationThe registration of dentists providing dental treatmentprivately has recently been introduced. HealthInspectorate Wales (HIW) will continue to oversee thisprocess and have regulatory responsibility to ensure thatthe requirements for registration are met. This includesthe provision of a safe, clean environment andappropriate decontamination of dental equipment.

The registration scheme will place strong emphasis oneffective management and self-audit. (For furtherinformation, see the Note after paragraph 8.11.)

Introduction1.1 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.

1.2 To help dental practices to improve theirdecontamination procedures, this documentintroduces specific benchmarks by whichcompliance with

• Essential quality requirements and

• Best practice

can be achieved and demonstrated.

1.3 The requirements described in this guidance areintended as a clear indication of good practice anddesigned to exert upward pressure on theperformance of dental practices. They will help todemonstrate 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, itis advised that the full best practice provisions ofthis guidance be utilised wherever reasonablypracticable.

1.4 The guidance provided here follows the essentialprinciples given in the “Healthcare AssociatedInfections – A Community Strategy for Wales”(published 2007). This requires that effectiveprevention and control of healthcare-associatedinfection be embedded in everyday practice. Forthis reason, the guidance is written with emphasison practical and readily implemented measures.

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

1.5 Part 1 of the HCAI Community Strategy lists thestrategic objectives that are required to ensure aclean and safe environment and facilities, which

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1 Policy and foreword(David Thomas, Acting Chief Dental Officer)

includes, therefore, the appropriate decontaminationof instruments and other equipment. Thisguidance is designed to assist all primary caredental providers (including salaried dental services)in meeting these requirements, and will extend towholly private practices in due course.

1.6 ‘Clean, safe care – reducing infections and savinglives’ refers to the need for high-qualityenvironmental cleaning and decontamination asvital components in reducing rates of infection.

The need for guidance1.7 As our knowledge of disease transmission has

improved – particularly in relation to thetransmission of variant Creutzfeldt-Jakob disease(vCJD) – it has become timely to reviewdecontamination processes in dental practices.

1.8 A survey of decontamination in general practicesin Scotland (NHS Scotland, 2004) identified howimportant it is to follow procedures correctly inorder to achieve safe standards of infection control.This report found that – even where the correctequipment was available – decontaminationstandards were not always being met satisfactorily.The evidence base for further development in thisguidance will evolve over future years.

“Essential quality requirements” and“best practice”1.9 Every practice should be capable of meeting the

essential quality requirements, that is:

• 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 – seeChapter 16); a validated steam sterilizer, and atthe end of the reprocessing cycle they should bein 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 quarterly. An audit tool produced bythe Infection Prevention Society and DH isstrongly recommended).

• Practices should have in place a detailed plan onhow the provision of decontamination serviceswill move towards best practice.

An expanded list of essential quality requirementsis given in paragraph 2.6.

1.10 To demonstrate best practice, furtherimprovements are required in three main areas:

• A cleaning process that should be carried outusing a validated automated washer-disinfector.

• 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. For bestpractice, the decontamination facilities shouldbe clearly separate from the clinical treatmentarea. This implies the use of a separate room orrooms for the accommodation of clean (output)and dirty (input) work. In these facilities, theroom(s) should be used for this purpose onlyand access should be restricted to those staffperforming decontamination duties. However,plant and equipment not necessarily used fordecontamination may be located in these rooms(but preferably in the dirty room) provided itcan reasonably be shown that the devices do notconflict with the requirement for a cleanenvironment.

• The storage of reprocessed dental instruments ina simple but carefully designed facility clearlyseparate from the clinical treatment area is animportant best practice improvement. Thefacility should take account of the need toreduce recolonisation of sterilized instrumentsand also make the identification/selection ofinstruments easy. This storage facility willordinarily be part of the clean area within thedecontamination room(s).

1.11 The overall aim is to achieve a reprocessed medicaldevice (dental instrument) that is fully compliantwith the “essential requirements” of the MedicalDevices Regulations 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.

1.12 Following the guidance in this document will helpto achieve a satisfactory level of risk controltogether with equivalent compliance with the“essential requirements” of the regulations.

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1 Policy and foreword (David Thomas, Acting Chief Dental Officer)

“Sterile” and “sterilized”As the environment in which dental instruments areused is not sterile, it follows that dental instruments willnot 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 “sterilized” rather than“sterile” at the point and time of use (a somewhatdifferent approach from that in invasive surgicalprocedures).

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.

Progression towards best practice1.13 Not all practices will, at present, be in a position

to adopt best practice recommendations.However, every practice will need to assess theimprovements they need to undertake to movetowards these and prepare a plan to implement thechanges.

1.14 While a period of 12 months is seen as appropriatefor the attainment of essential qualityrequirements, no schedule for attainment of bestpractice is provided in this guidance for thepresent. Findings from the 2009 National Surveyof Dental Decontamination will be used to guidethe Department of Health (DH) and the dentalcommunity in terms of reasonable timescales.

Wales will review the findings and assess theirapplication to Wales. It is recognised that not onlyare improvements in premises and equipmentrequired to achieve higher standards, but alsochanges in practice management and the culture inwhich patients are treated by the dental team arenecessary.

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(essential quality requirements), they need todevelop a plan that facilitates a move towards aseparate and controlled decontamination room.This plan will normally also contain statements onstaff training and development to suit work in adedicated decontamination room or suite.

1.16 In addition, the plan should realistically outlinethe way forward in relation to best practicerequirements, 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 Chief Dental Officer for Waleshas published requirements for endodontic files

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For best practice, the clinical treatment area should be clearlyseparate from the decontamination facilities

Decontamination: Health Technical Memorandum 01-05 – Decontamination in primary care dental practices - Welsh edition

and reamers to be single-use instruments in allcases. Other instrument or device types for whicha reliable cleaning regime is not available shouldalso be considered for replacement by single-usetypes or by the single use of re-processibleinstruments e.g. matrix bands. Informationregarding risk in this important area is containedin ‘Potential vCJD transmission risks via dentistry:an interim review’ (December 2007).

Note

Where patients indicate that they are in a high-riskgroup, guidance provided by the Advisory Committeeon Dangerous Pathogens – Transmissible SpongiformEncephalopathy Working Group (ACDP-TSE WG)should be followed (www.dh.gov.uk/ab/ACDP/TSEguidance/index.htm). The guidance suggests that specialprecautions beyond full instrument decontaminationwill not be necessary. However, specific advice isavailable by contact with the committee 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 Health Technical Memorandum.This statement is based on various studies(conducted on behalf of DH) that examined theeffect of steam sterilization on prion infectivity.These studies showed that the steam sterilizationmethods described in this guidance provide auseful level of deactivation of prion infectivity.While this would not be significant in high-risktissue surgery, the effect is large enough to be ofsignificance in dentistry (excluding, that is,endodontic procedures as mentioned in paragraph1.17). In addition, there is a risk of priontransmission through protein contamination ofinstruments, hence the measures outlined in thisguidance to improve washing and disinfection ofdental 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 Health Technical Memorandum, thecleaning process and its ability to remove proteinin tandem with a validated steam sterilizationprocedure is emphasized, as this is known to atleast reduce the risk of prion transmission throughdental instruments.

Infection control policy1.20 All dental practices should have an infection

control policy in place and available for externalinspection. The Welsh Healthcare Associated

Infection Subgroup has work underway to helpproduce model guidelines that may be adapted asappropriate. A number of relevant guidelines havebeen published by Public Health Wales. Theseinclude:

• Control of the Environment

• Hand hygiene policy

• Personal Protective equipment policy

• Occupational Exposure Management includingneedlestick ( sharps injuries)

• Management of Spillages of Body fluids

• Management of Linen

1.21 The infection control policy statement for eachpractice should indicate full compliance with theessential quality requirements (as outlined inparagraphs 2.6–2.7). In addition, a writtenassessment of the improvements the practice needsto make in order to progress towards meeting therequirements for best practice should be availabletogether with an implementation plan (as outlinedin paragraph 2.25).

Note

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

1.22 Infection control needs to include all aspects of therunning of a dental practice: from attention topersonal hygiene – hand-washing, masks,protective clothing – to the cleaning andsterilization of instruments and the maintenanceof the equipment.

1.23 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 (amaximum of one calendar month) after which theprocess should be repeated before the instrumentis used.

1.24 For instruments that are wrapped prior tosterilization in a vacuum sterilizer, the storageperiod may be extended to two calendar months.

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Note

The Welsh Assembly Government (WAG) recognisesthat recolonisation of instruments – particularly thosethat are wrapped following sterilization – is likely.Accordingly, while recommendations are made inrespect of maximum storage times, dental staff shouldvisually check all instruments prior to use for anyobvious deterioration in their quality.

The Department of Health (England) has commissionednew research with regard to contamination rates. Initialfindings support an extended time for storage forinstruments that are wrapped prior to sterilization; theydo not at present, support longer periods of storage forpost-sterilization wrapping.

Training and education1.25 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 in this area over a period of fiveyears.

Scope, status and structure of HealthTechnical Memorandum 01-051.26 Health Technical Memorandum 01-05 (Welsh

Edition) relates to locally conducteddecontamination procedures, which are the mostcommon method of decontamination in primarydental care. As such, this includes all work wherethe end-user and the persons conductingdecontamination are employees of the sameorganisation working in the same or relatedpremises. Ordinarily this will be a general dentalpractice or salaried primary care dental servicesfunctioning as part of the local health community.

1.27 Where practices choose to make use of an externalservice – such as a central sterile servicesdepartment – which is fully compliant with theMedical Devices Regulations 2002 and isregistered with the Medicines and Healthcareproducts Regulatory Agency (MHRA), theguidance contained in Health TechnicalMemorandum 01-01 will be appropriate to thatservice.

1.28 The CDO (Wales) letter 2006 (‘Decontamination/Sterilisation of Re-usable Instruments in GeneralDental Practice) states The Medical DeviceRegulations 2002 require the manufacturer ofmedical devices to supply information on theappropriate processes to allow reuse, includingcleaning, disinfection, packaging and, whereappropriate, the method of sterilization. Ifcorrectly followed, these instructions will ensurethat the device will be safe for another episode ofuse. This implies that dental practices ensure thattheir local policies give rise to the production anduse of sterilized instruments for use with patients.

1.29 This document is divided into three sections:

• Section 1: Decontamination policy andforewordThis section outlines the policy and principlesof decontamination in dental practices, andexplains the essential quality requirements andbest practice requirements.

• Section 2: Advice to dentists and practice staffThis section gives plain advice to dentists andpractice staff on how to meet essential qualityrequirements and achieve best practice; how toclean and sterilize instruments; and how to setup a decontamination area within the practice.

• Section 3: Engineering, technology andstandardsThis section gives technical advice toengineering and technical staff, includingAuthorised Persons (Decontamination) andCompetent Persons (Decontamination).

1.30 Reference to guidance and standards provided byWAG and MHRA is provided and explainedthroughout this document.

1.31 Where engineering and technical information isprovided (Section 3), references to sourcestandards and evidence are given. However, suchreferences are omitted in Section 2 to aid clarity ofpresentation and explanation.

1.32 It is important to remember that this is a workingdocument; changes to it may be necessary as newevidence around the methodology ofdecontamination becomes available.

Exclusions1.33 This Health Technical Memorandum does not

cover the following:

• Decontamination in sterile services departments(SSDs). This is covered in Health BuildingNote 13.

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• Decontamination in laboratories (covered in theforthcoming Health Technical Memorandum01-02).

• Decontamination in pharmacies (covered in theforthcoming Health Technical Memorandum01-03).

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

• Decontamination of flexible endoscopes(covered in the forthcoming Health TechnicalMemorandum 01-06).

Relationship to other sources ofinformation and guidance1.34 This Health Technical Memorandum was prepared

for publication in Wales during 2009-2010. Themain sources of information used in its preparationare listed in the References section. Readers shouldensure they use the latest edition of all buildinglegislation, British Standards, health and safetyregulations etc. and give first preference to productsand services from sources that have been registeredunder a quality assurance procedure.

Note

Throughout this guidance, references are made to ISO,EN and BSI Standards. In some instances, thesestandards have been harmonised so that the content ofthe output for all three standards institutions is thesame. These harmonised standards support the essentialrequirements of the medical device directives (and theirequivalent enactments in UK law).

Where a product or process is stated as compliant witha specified standard this will assist in meeting theappropriate essential requirement of the EU MedicalDevices Directives. Where manufacturers do not usethe harmonised standard to state compliance, thetechnical file for the product should identify by whatmeans compliance with that essential requirement isbeing met. For some medical devices the approval of aNotified Body may be necessary in making theassessment of compliance, with the essentialrequirements and appropriate standards coupled to theuse of a CE marking. The Competent Authority forthe MDD structure in the UK is the Medicines andHealthcare products Regulatory Agency(www.mhra.gov.uk/index.htm). Amongst a range ofduties, the agency audits the performance of NotifiedBodies.

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

Further guidance1.35 Professional advice has previously been available

within ‘A12: Infection control in dentistry’ (2003).As with the content of the earlier Health TechnicalMemoranda 2010, 2030 and 2031, A12 (2003)has been superseded in part by this document.However, the BDA have published a revised A12(2010) which takes into account the guidancecontained in HTM 01-05 published by DH foruse in England and which also takes full account ofrecently published EN/ISO Standards.

1.36 The continued improvement of decontaminationservices for reusable medical devices follows onfrom the successful accreditation of all hospitalsterilization and decontamination services in Walesand the work now underway by theDecontamination Subgroup of the WAG HealthProtection Committee.

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8


Section 2: Advice to dentists and practice staff

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.

10

2 Essential quality requirements andbest practice

Disinfectif a WD is used

Clean

Transport

Inspect Repeat cleaning if necessary

Use

Package

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 calendar

ld be reprocessed before further use.

month)

Store(max. 2 calendar

months)

Compliance

Compliance definitions

Compliance – Essential quality requirements

This terminology is used within this Health TechnicalMemorandum to define a level of compliance expectedas a result of its implementation. Guidance containedwithin this document will assist dental practices inmaintaining these requirements and developing towardshigher levels of achievement in this area over time. Theuse of an audit tool will assist dental practices inreaching the necessary standards (see paragraph 2.23).

In order to demonstrate compliance with essentialquality requirements to external bodies (for example,the HIW, LHBs and WAG practices will be expectedto provide a statement on plans for futureimprovement. Details on registration requirements aregiven in Chapter 8.

Compliance – Best practice

Best practice refers to the full level of compliance thatmay be achieved immediately or via a documentedimprovement from essential quality requirements.

Essential quality requirements

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/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 2002. Particular careshould be taken in the storage and preparationfor use of decontamination 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 safeguardstheir status. (Section 3 contains detailedguidance on instrument purchase anddisposal.)

f. Reprocessing of dental instruments should beundertaken using dedicated equipment (seeSection 3).

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. Practicesshould plan for the introduction of washer-disinfectors. Inspection processes should ensurethat the standards of cleaning achieved arevisually satisfactory – that is, that instrumentsare free from particulate contamination, saltdeposits or marked discoloration. The use of asimple magnifying device with task lightingwill improve the value of this part of theprocess.

j. The separation of instrument reprocessingprocedures from other activities, includingclinical work, should be maintained by physicalor temporal means. Decontaminationequipment including sterilizers shouldaccordingly be located in a designated area.The layout within this area should reflect theprogression from the receipt of dirty, usedinstruments towards clean instrumentssterilized in a specific controlled clean area. Inthe first instance, where practices are meetingthe essential quality requirements defined bythis guidance, the designated area fordecontamination may be in, or adjacent to, aclinical room. At a later stage of development,more complete separation involving the use ofa designated room or rooms will becomeappropriate (see Figures 1–3 in Chapter 5).

k. Instrument storage and wrappingrecommendations:

11

2 Essential quality requirements and best practice

http://www.hse.gov.uk/coshh/

(i) where packaging is not applied,instruments may be stored on coveredtrays and used within that treatmentsession (usually defined as approximately3.5 hours). Instruments will need to bereprocessed if not used within thattreatment session;

(ii) alternatively, if instruments are wrappedeither before or immediately afterdecontamination, storage in accordancewith (m) below should be applied.

m. Develop a quality system approach so that thestorage of wrapped instruments does notexceed 1 calendar month for instrumentssterilized in a non-vacuum (type N) sterilizeror 2 calendar months if sterilized in a vacuum(type B or S) sterilizer (see paragraph 4.31):

(i) Where non-vacuum sterilizers (type N –see paragraph 4.5) are used, post-sterilization drying using disposable non-linting cloths should be supplemented bythe packaging of instruments – this willimprove resistance to contamination andrecolonisation in storage.

(ii) For vacuum sterilizers (type B or S – seeparagraph 4.24), pre-wrapping will extendstorage life to 2 calendar months.

(iii) Subject to local policy choice, thesemeasures will help to ensure stock rotationand will tend to limit recontamination ofstored instruments. Simple but clearrecord-keeping will be required to makethese measures effective.

n. Equipment used to decontaminate dentalinstruments should be fit for purpose andvalidated. This means that the device should becommissioned, maintained and periodicallytested by a Competent Person(Decontamination) or service engineer, thatrecords of maintenance should be kept, andthat correct functioning should be monitoredand recorded (see Section 3).

p. The appropriate and controlled disposal ofwaste is a key aspect of risk control in localdental practices (see Section 3).

q. A documented training protocol should be inoperation with individual training records forall staff engaged in decontamination (seeSection 3 for details). Until such time as formaltraining schemes are fully developed, it isrecommended that protocol-specific training isgiven and, where required, the advice of

equipment manufacturers/suppliers and HealthBoard staff should be sought.

r. The practice should carry out an assessment ofthe changes needed to move from compliancewith essential quality requirements tocompliance with best practice requirements.

s. Staff involved in decontamination shoulddemonstrate current immunisation for hepatitisB and, subject to local policy, tetanus. Staffmust be informed of the benefits (for example,protection against serious illness, protectionagainst spreading illness) and drawbacks (forexample, reactions to the vaccine) ofvaccination.

Note

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

t. The effective cleaning of handpieces inaccordance with manufacturers’ guidance.Dedicated cleaning equipment is available andmay be of value. However, validation in thisarea is difficult, and the advice ofmanufacturers/suppliers should be sought.

u. Separate wash-hand basins for use by staffconducting decontamination should beprovided. In addition, two dedicated sinksshould be available for decontamination work– including where an automated washer-disinfector is in use. These sinks should not beused for hand-washing.

Note

Two sinks or two bowls incorporated into a single unitare recommended because, after cleaning instrumentsin the first sink, the operator can efficiently rinse thecleaned instruments in the second sink at a greatlyreduced risk of recontaminating the instruments withcleansing agents/detergents or previously removedbiofilm.

Essential infection-control policies and procedures

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 followinginformation:

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• 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 (decontaminationguidelines);

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

• a policy for the management and disposal ofclinical waste (waste disposal policy) (forfurther details see Appendix 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 dentalinstruments and associated equipment in thecontext of infection control;

• the recommended disinfectants to be usedwithin the practice, their application, storageand disposal (disinfectant guidelines);

• spillage procedure as part of local COSHHarrangements;

• local policies and procedures for environmentalcleaning and maintenance. This shouldinclude, at a minimum, the methods used, thefrequency of each procedure and appropriaterecord-keeping practices.

2.7 Dental practices should be aware that model policydocuments are being developed for Wales by theWelsh Healthcare Associated Infection Subgroupwhich will assist the writing of local policies, withinthe framework provided here, and the design oflocal procedures together with guidanceimplementation planning (see also Chapter 6,which gives general guidance on cleaning anddisinfection protocols 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.

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.

Note

Dental handpieces should be cleaned and sterilizedafter each patient treatment.

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 toenable 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.

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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 Shown below is the symbol that identifies single-use items. This will appear on packaging butmight not be present on individual items. If indoubt, further advice should be sought from themanufacturer.

2.20 Where instruments are difficult to clean,consideration should be given to replacing themwith single-use instruments where possible. Indentistry this will include, 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 – in order to reducethe risk of prion transmission in dentistry.

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 control. This may best be demonstratedby undertaking audits and assessments of theirinfection control and decontamination practices.These audits should be filed for inspection as partof their risk management system.

2.23 Compliance with this Health TechnicalMemorandum will be seen as indicative of thepresence of valid quality assurance systems. Auditsshould be carried out in compliance withindividual Local Health Board (LHB) policies. Ata minimum, practices should audit theirdecontamination processes quarterly, with anappropriate review dependent on audit outcomes.

Note

The Infection Prevention Society/DH audit toolparallels the guidance provided in this document. Inaddition, a number of other safety-related topics areincluded in the tool.

The audit tool is included on the CD-ROM thataccompanies this document.

2.24 It is important that the audits are made availableto the auditing body on request and should formpart of the LHB’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, the containers may belabelled to identify the user and/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 of 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 Regulations 2007and the Health and Safety at Work etc Act 1974.

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2

2.30 A protocol for transportation that ensures thesegregation of contaminated product from clean/sterilized 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 (that is, dentalinstruments), the time of dispatch and theintended recipient. Records should be such as toallow each movement to be traced and audited ifnecessary. The note should be positionedprominently within any vehicle used fortransportation and should carry a contacttelephone number.

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, for example, schooland domiciliary visits.

Best practice

Progress towards achieving best practice should includethe 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 distinctionbetween clean and dirty workflows.

• Provide suitable storage for instruments, whichreduces exposure to air and a possible risk of micro-organism contamination. Best practice will includethe development of a local quality system focusedon safe and orderly storage of instruments. This willensure that instrument storage is well protected inthe appropriate clean room against the possibility ofexposure of stored instruments to contaminatedaerosols. In addition, the management approach willensure that commonly-used instruments are dealtwith on a first-in first-out principle and lessfrequently used instruments are stored for clearidentification and reprocessed if not used within thedesignated storage periods.

15


Guidance on the installation, validation, maintenanceand testing of ultrasonic cleaners and washer-disinfectors can be found in Section 3.

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 that rendersinstruments safe for handling and inspection.

3.3 Manual cleaning, governed by an appropriateprotocol, is acceptable within the essential-quality-requirements framework. Within the best-practiceframework, however, manual cleaning should beconsidered only where the manufacturer specifiesthat the device is not compatible with automatedprocesses (including ultrasonic cleaning) or whenthe washer-disinfector is temporarily unavailable(for example, for repair or validation).Exceptionally, where local experience indicates thatpre-washing may be helpful (for example, in theremoval of tenacious dental materials), such actionmay be appropriate before automated cleaning.

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

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), theinstruments 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 ofinstrumentation requiring 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. Thisis to 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 3. Theassistance of decontamination specialists will benecessary from time to time in order to ensure thatequipment and procedures remain valid in

16

3 Cleaning instruments

engineering terms. These services may be availablethrough the local LHB, Welsh Health Estates 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 the preferred method for cleaningdental instruments because it offers the bestoption for the control and reproducibility ofcleaning; in addition, the cleaning process can bevalidated under European Norms (ENs).

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. Latest standards indicate that a watertemperature of less than 45oC is used toprevent protein coagulation and fixing of soilto the instrument.

• 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 ofensuring 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, orspotting is observed on instruments, then finalstage RO water can be used for the process.Note: Advice on potable water supplied can besought from local supplier (e.g. Welsh Water).

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Using a washer-disinfector is the preferred method for cleaning dental instruments because it offers the best option for the control andreproducibility of cleaning.

Note

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

• 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.

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 European norm (EN) requirements forCE (Conformité Européenne) marking and areconsidered 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 3).

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 magnifyingdevice with task lighting will improve the value ofthis part of the process.) The satisfactorycompletion of this step means that theseinstruments may be clearly designated as ready forsterilization.

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 thehandpieces.

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 cleaning thehandpiece, 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 3).

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 WelshHealth Estates or your local infection control team.

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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 thewater/fluid is maintained, cleaned and changed atsuitable intervals (see paragraph 3.30(k)). Thebath should also be kept free of dirt released inthe cleaning process. Good maintenance is alsoessential. The appearance of instrumentsfollowing ultrasonic cleaning should be checkedto ensure that the process is operating effectively(see also Section 3).

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 cleaning method– including being used as an extra cleaning stageprior to an automated washer-disinfector process.This may be particularly helpful for instrumentswith hinges and/or intricate parts.

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 3.

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

3.29 The ultrasonic cleaner should be tested quarterlyto ensure that it is fully functional (see Section 3).

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 are

fully 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 as per theultrasonic cleaner manufacturer’s instructions.Close the lid and do not open until the cycle iscomplete.

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

k. Change the solution when it becomes heavilycontaminated or otherwise at the end of everyclinical session, because the build-up of debriswill reduce the effectiveness of cleaning. Ensurethat staff are aware of the need to assess when achange of solution is necessary as advised in theoperational requirements.

m. After ultrasonic cleaning, rinse and inspectinstruments for cleanliness, and, wherepossible, check for any wear or damage beforesterilization.

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.

19


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, RO or freshly distilled water willbe necessary as a precaution. When potable water isused, a water softener maybe needed. Consult the localwater advisor 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/or microbial growth). Forinstruments processed in a vacuum sterilizer,before being wrapped, instruments should be driedusing a disposable non-linting cloth.

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

method to set up, but it is difficult to validatebecause it is difficult to ensure that it is carried outeffectively on each occasion.

3.34 Compared with other cleaning methods, manualcleaning presents a greater risk of inoculation injuryto staff. However, despite the limitations of manualcleaning, it is important for each practice to havethe facilities, documented procedures and trainedstaff to carry out manual cleaning as a backup forwhen other methods are not appropriate.

3.35 For dental services that are working to the bestpractice requirements outlined in this document,manual cleaning (acceptable under the essentialquality requirements) should only be used forequipment that cannot be cleaned by automatedmethods.

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 3, 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(for example a washer-disinfector). Aim to phasein instruments that can be cleaned in a washer-disinfector.

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 the

surface. 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 before reprocessing.

3.44 Instruments should be transferred from the pointof use to the decontamination areas as soon as ispractical to ensure that processing takes place assoon as possible after use. Gathering evidenceindicates that keeping instruments moist after useand prior to decontamination improves proteinremoval and overall 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 remainon instruments for any length of time. Dentalprofessionals should consult with the suppliers/manufacturers of decontamination agents toensure that the products used are appropriate andunlikely to cause significant long-term corrosion(refer to COSHH for further advice).

3.46 Always check packaging for the single-use symbolbefore use, and note that it might be difficult tosee (see also paragraphs 2.16–2.21).

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

addition by hand) should be rinsed thoroughly ina dedicated sink or bowl (separate from the oneused for the original wash) using satisfactorypotable water RO or distilled water in order toremove residual soil and detergents with minimumrisk of salt deposition.

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.

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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.

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.

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 (that is, preventing the steam cominginto contact with the instrument surface) with thesterilization process.

3.54 Instruments may become damaged during use orsuffer from general wear and tear over their lifespan.If devices are found to be faulty or damaged duringinspection and function-testing, or if users identifythat they are faulty, they should be taken out of useand either repaired or replaced. Instruments forrepair should be decontaminated, labelled toidentify 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.

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Guidance on the installation, validation, maintenanceand testing of sterilizers can be found in Section 3.

4.1 This chapter should be read in conjunction withSection 1.

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). Sterilization,when properly validated, is effective in reducing

prion infectivity. In the case of newer machines,the parameters monitored for each cycle of use willbe stored and/or available as a print-out to providea short-term record. The use of automated data-loggers or interfaced small computer-basedrecording systems is acceptable provided therecords are kept securely and replicated. Theserecords should be photocopied, as the quality ofthe print-out fades over time. Manual recordingusing a logbook is also acceptable and, in any case,will be a necessity if a machine does not have anyautomatic print-out function (see paragraph 4.16for further details on manual recording). Therecord should, at minimum, document theabsence of a failure warning or the temperature/pressure achieved as appropriate to the indicationsprovided. It is recommended that records bemaintained for not less 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:

Note

For the decontamination of handpieces, advice shouldbe sought from the manufacturer as to which of thefollowing sterilization cycle types is most suitable.

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

• 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 sterilizermanufacturer and the instrumentmanufacturer(s). Users should be aware that

22

4 Sterilization

Sterilization process data can be recorded by an automatic printer.

Type B Benchtop sterilizers can incur financialimplications. These units require maintenanceand also require a full validation regime inaccordance with current guidance.

• 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.

Types B and N are most frequently used in dentalpractices.

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.

4.6 In each case, practice staff should consult with themanufacturer/supplier of the sterilizer(s) toascertain the status of the machine in respect ofvalidation/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 and

23

4 Sterilization

Sterilizer with automatic printer.

bioburden. Accordingly, progress towards bestpractice may be seen as a further risk reductionmeasure in this context.

Note

This guidance document recognises the uncertaintiesregarding current dental-handpiece decontaminationtechniques in terms of both reproducibly achievingsterility and also generating prion contaminationreduction, should prions be present. Particularly withinthe essential-quality-requirements framework, theemphasis is on risk reduction rather than elimination.As new knowledge and technologies that are aimed atfurther risk reduction become available, so amendmentswill be made to this guidance (see Section 3).

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 3);

• 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/manufacturer forrefurbishment.

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

Pre-wrap instruments only where this isrecommended by the manufacturer and where thesterilizer is vacuum-assisted. The sterilizer shouldbe validated for the intended load and is likely tobe of type B or S. The use of a type N sterilizeris not appropriate for wrapped instruments.

4.12 All steam sterilizers are subject to the PressureSystems Safety Regulations 2000 and must beexamined periodically by a Competent Person(Pressure Vessels).

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 approach

should be adopted using good operationalpractice as with previous healthcare guidance(e.g HTM 2031). The use of ‘water forirrigation’ is used to meet the requirements for‘clean steam’. Sterile water for irrigation is non-pyrogenic distilled water that has been sterilized.It has an Endotoxin level less than 0.25Eu/mland is readily available from pharmacies forbulk supply. Alternative water supplies can beRO if there is a problem sourcing water of therequired standard (see Chapter 17 for furtherguidance). (The use of water for irrigation ispreferable to distilled water as the quality ofdistilled water cannot be guaranteed).

At the end of the day or whenever the sterilizeris to be unused for several hours, the chambershould be drained after the water has cooledand all internal surfaces that are accessibleshould be rinsed with suitable quality water,dried and left empty with the door kept open.For single-shot types, which do not store waterbetween cycles of use, these rules still apply interms of the water quality to be used.

When the sterilizer reservoir is to be replenished,it should be refilled with suitable water qualityto the level recommended by the manufacturer.

2. Validation is necessary to demonstrate that thephysical conditions required for sterilization(temperature, pressure, time) are achieved.Consultation with appropriately qualifiedengineers through the Local Health Board orcommercial arrangements will be necessary inthis area.

A Competent Person (Decontamination) orservice engineer will be able to ensure thatvalidation is achieved and that theinstrumentation used for parametric release isfunctioning and calibrated appropriately. TheCompetent Person (Decontamination) orservice engineer will be needed to validate orrevalidate the equipment (see Section 3).

Parametric release is defined as the release of abatch of sterilized items based on data from thesterilization process. All parameters within theprocess have to be met before the batch can bereleased 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).

24


4. A schedule for periodic testing should thereforebe planned and performed in accordance withSection 3. The schedule should provide detailsof daily, quarterly and yearly testing or be inaccordance with manufacturers’ guidelines. Eachsterilizer should have a logbook (file) in whichdetails of the following are recorded:

• maintenance;

• validation;

• faults;

• modifications;

• routine tests (see Appendix 3).

4.14 Welsh Health Circular 2000 (071) providesguidance on the length of time for which recordsshould be retained. Reference should be made tothe time period of legal rights of patients, and allrelevant documentation should be retained for thepractice to meet any request within these rights.The code requires that these records be maintainedfor not less than two years, although longerperiods may be applicable subject to local policy-making at Health Board level.

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, the print-out should be retained or copied to a permanentrecord. If the sterilizer does not have a printer, theuser will have to manually record the followinginformation in the process log:

• date;

• satisfactory completion of the cycle (absence offailure light);

• temperature/pressure achieved;

• signature of the operator.

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:

25

4 Sterilization

The outcomes of daily tests should be recorded in the logbook

• a steam penetration test – Helix or Bowie-Dicktests (vacuum sterilizers only);

• an automatic control test (all small sterilizers)in line with manufacturers’ instructions.

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

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.

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).

• dpower 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 and/or maintenance contractor.

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 purpose-designed 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 2 calendarmonths (see paragraph 1.24). Note:instruments need to be dry before they arepackaged.

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. In

addition, the entire tray may be placed withina sealed pack for storage purposes. In both ofthese instances, storage for up to 1 calendarmonth is recommended.

c. Products from a type N sterilizer may also betransferred for use within the current session.In this instance, while covering the instrumentsis essential to protect against dust and aerosols,wrapping is not required. However, theinstruments are not regarded as “stored” andshould therefore be used or streamed for afurther decontamination process within onesession. Instruments should be dry beforebeing transferred for clinical use.

Note

BS EN ISO 11607-1:2006 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 containdental instruments during the sterilization processand in subsequent 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 suchas form/fill/seal (FFS) or four-side-sealing products

may also be used.

The choice of system used will depend on thedecontamination, sterilization and storage optionschosen by the practice. The manufacturers of each ofthe products should be consulted on the standardsapplied and compatibility with the other productsemployed.

26


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(s) should therefore bemaintained between the instruments and thegeneral practice environment. This may beachieved by ensuring that instruments are storedin an environment where they are protectedagainst excessive heat and where conditions remaindry.

4.28 With a view to minimising recolonisation(infection risk), the storage of wrappedinstruments requires thorough control. Thisimplies the rigorous maintenance of records, clearidentification of instrument packs in terms of theircontent, and controls (storage times) on wheninstruments are used. For the majority ofcommonly-used instruments, a first-in first-outprinciple will be helpful.

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. Itshould be kept free of clutter and wiped cleanby the use of detergent and and/or antimicrobialwipes at sessional 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 essential qualityrequirements, this will require that the

instruments be as far from the dental chair asreasonably practicable. Best practice requiresthat instruments not scheduled for use with thecurrent patients 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 useful.

• 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/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 the pack hasbeen subjected to an appropriate sterilizationprocess (if a type B sterilizer is used);

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

• visible contamination is absent (this is tocomply with EN Standards).

4.31 As part of essential quality requirements,instruments that have remained unused for morethan 1 calendar month and are not in a validatedsterile pack (processed by a vacuum sterilizer)should be subjected to a further cycle ofdecontamination before being used. Wherevacuum sterilizer packs are in use, the limitationon storage may be extended to 2 calendar months.

Note

The storage criteria outlined in paragraph 4.31 (andthroughout this guidance) will be the subject of furtherresearch which will be designed to provide evidencethat either substantiates, or will ultimately lead to arevision of, the specified storage times. The main aimsof stipulating such storage times in this document areto ensure stock rotation and improve on currentpractice.

27

4 Sterilization

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. As dental practicesprogress towards higher standards, removing thedecontamination process from the treatment roomshould be a priority. For example layouts, seeFigures 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 well-developed routine for surface cleaning/decontamination within the facilities:

28

5 Setting up a decontamination area

Figure 1: Example layout for essential quality 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, enhanced dirty–clean separation should be a priority in design andoperation.

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/sterilized instruments that are to be placedin 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 operation distinction between clean and dirty.

5.6 Irrespective of the specific layout, a tidy workingenvironment makes carrying out decontaminationeasier. Therefore, the working environment shouldbe decluttered. 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).

29


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)

Physical segregation5.7 Physical segregation within essential quality

requirements means using different areas fordifferent activities. A decontamination area shouldbe set up which preferably comprises a single runof sealed, easily cleaned worktops. The followingkey 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 (where available) and/orwashing and rinsing sinks or separate bowlswithin a single sink unit should be installedadjacent to the receiving area. Where necessary,

30


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

usually owing to space constraints, it isacceptable to use a single sink unit(incorporating two bowls with common supplyand taps) for the functions described here.

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

• Where a washer-disinfector is used, this may belocated adjacent to an ultrasonic cleaner and/ora rinsing sink/bowl but well away from thereceiving area.

• After washing and disinfection (whereapplicable), the instruments and devices requireinspection. A dedicated clean area of benchingwith good task lighting should be provided.

• The sterilizer should be situated well awayfrom the other activities/facilities in order topromote staff safety and good decontaminationpractice.

• 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.

• Where a double-ended washer-disinfector isused, the input door in the dirty area and thatused to empty the clean instruments should beseparated by a barrier. Alternatively, thewasher-disinfector should be built directly intothe separating wall between the dirty and cleanareas.

5.8 This guidance recognises that, because of physicallimitations on space, it may take longer for somepractices to meet the best practice requirements.In areas where building alterations to existingpremises are restricted and/or purpose-builtpremises may be difficult or impossible to acquire,best practice may not be achievable.

31


Hand hygiene6.1 The term hand hygiene covers not only hand-

washing, but also alternative and additionalmeasures such as hand disinfection usingantibacterial-based hand-rubs/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 essential quality requirements, trainingin hand hygiene should be part of staff inductionand be provided to all relevant staff within dentalpractices periodically throughout the year. Adviceis available from the National Patient SafetyAgency’s (NPSA) website (www.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 soap should be used when washing hands.Bar soap should not be used. Apply the liquid soap

to wet hands to reduce the risk of irritation, andperform hand-washing under running water.Ordinarily, the hand-wash rubbing action shouldbe maintained for about 15 seconds. After theexercise, the hands should be visibly clean. Wherethis is not the case, the hand hygiene procedureshould 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 staff thatdevelop 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 wearnail varnish and false fingernails.

6.10 Rings, bracelets and wristwatches should not beworn by staff undertaking clinical procedures. Staffshould remove rings, bracelets and wristwatchesprior to carrying out hand hygiene. A weddingring is permitted but the skin beneath it should bewashed and dried thoroughly, and it is preferableto remove the ring prior to carrying out dentalprocedures.

Facilities and procedures for hand-washing

6.11 In accordance with the advice above, a separatewash-hand basin should be provided. Practices are

32

6 General hygiene principles

encouraged to replace existing wash basins that donot comply with 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 lever-operated 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. It should beensured that the nozzle is kept clean. Refillablehand-wash containers should not be used asbacteria can multiply within many of theseproducts and are therefore a potential source ofcontamination.

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 3).

Personal protective equipment fordecontamination processes6.14 The local infection control policy should specify

when personal protective equipment (PPE) is to beworn and changed. PPE training should beincorporated into staff induction 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 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;

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

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

6.18 Used gloves should be replaced before performingactivities that require strict aseptic precautions orwhen touching equipment that is difficult toclean.

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,bracelets etc.) may damage the integrity of theglove and may pose an infection risk.

6.24 The following additional guidance is provided:

• Long or false nails may also damage the glove,so keep nails 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 the barrier.

• 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.Replace these gloves weekly or more frequentlyif worn or torn or if there is any difficulty inremoving soil.

33


Disposable plastic aprons

6.25 These should be worn during all decontaminationprocesses.

6.26 Aprons should be used as a single-use item anddisposed of as clinical waste (see Appendix 1).Plastic aprons should be changed at thecompletion of each procedure.

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.

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. Overall guidance is providedin DH’s (2010) ‘Uniforms and workwear:Guidance on uniform and workwear policies forNHS employers’.

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/uniforms can become contaminated withmicroorganisms during procedures. It is importantthat freshly laundered uniforms are worn everyday.Sufficient uniforms for the recommended laundrypractice should be provided, as staff who have toofew uniforms may be tempted to reduce thefrequency of laundering.

6.36 Machine-washing clothing for ten minutes with asuitable detergent at a minimum temperature of60oC will reduce any potential microbialcontamination. For guidance relating to contactwith chemical substances, see the Health & SafetyExecutive’s guidance on COSHH –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 should be removed first (so that thegloves end up inside-out). Make sure hands donot get contaminated when removing gloves.Wash hands thoroughly, if visibly contaminated,before removing the rest of the PPE.

b. Plastic disposable apron. The plastic apron isremoved by breaking the neck straps andcarefully gathering the apron together bytouching the inside of the apron only. Avoidtouching the outer contaminated area.

c. Face mask. Remove the mask by breaking thestraps or lifting over the ears and dispose ofinto a clinical waste receptacle (see Appendix 1).Avoid touching the outer surface of the maskand do not crush the mask before disposal.Masks should never be left to hang around theneck and should be disposed of immediatelyafter use.

d. Face and eye protection. Take care not to touchthe outer surfaces. Single-use eye protectionshould be disposed of into the clinical wastereceptacle.

e. Wash hands thoroughly again.

Surface and equipment decontaminationGeneral

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

34


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 3) 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 of free-standing or ceiling-mounted fan units, however, isnot 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 HTM 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 andwhere possible jointless. Health Facilities Note 30– ‘Infection control in the built environment’states that the use of carpets is not advised withinany clinical or associated (decontamination) area.Attractive vinyl flooring materials are availablewhich can provide aesthetic appeal.

6.47 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 machines) may require cleaning anddecontamination processes that are purpose-designed. 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 Competent Person(Decontamination) employed by the equipmentprovider or local sterile services department (SSD).In the latter case, it should be possible to contactthe local Competent Person (Decontamination)via the Health Board.

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.

For floor and general surface cleaning, the NPSA haspublished a guidance package backed by a colour-coding system for use with materials and equipment.

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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 room(s) used for decontamination. Insome instances, full training of personnel will beneeded.

6.56 If instruments become contaminated (through,for example, being dropped or being placed in adirty area), they should be sent for furtherreprocessing.

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 CE-marked 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 (England) hassponsored research on the use of both microfibrecloth and steam-cleaning technology in clinicaland support-service areas. This work suggests that,provided deep cleaning is performed as an initialexercise, the subsequent use of microfibre-basedtechniques, essentially involving dry or wet wiping

with microfibre cloth, can be helpful in achievingsatisfactory removal of infectious agents fromsurfaces. Essentially 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.

Detailed information is provided in ‘An integratedapproach to hospital cleaning: microfibre cloth andsteam cleaning technology’ (available from Space forHealth at www.spaceforhealth.nhs.uk

6.59 Local provision of steam cleaning from practiceresources is unlikely to be economic. Instead theuse of a contractor 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;

• curing lamps;

• inspection lights and handles;

• hand controls including replacement of covers;

• trolleys/delivery units;

• spittoons;

• aspirators;

• X-ray units.

Note

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

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

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

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. This should be regarded as auseful priority.

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 shouldaccordingly not be provided within practices.

6.74 For blood spillages, care should be taken toobserve a protocol that ensures protection againstinfection. The use of 1% sodium hypochlorite isrecommended with a yield of at least 1000 ppmfree chlorine (unless Health Board policy suggestsotherwise). Contact times should be reasonablyprolonged (not less than five minutes). A higherfree chlorine yield of up to 10,000 ppm is useful,particularly for splash contamination. The processshould be initiated quickly and care should betaken to avoid corrosive damage to metal fittingsetc. The use of alcohol within the samedecontamination 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 3 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.

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. Approved

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Code of Practice & Guidance’ (also known as L8)and Health Technical Memorandum 04-01 – ‘Thecontrol of Legionella, hygiene, “safe” hot water,cold water and drinking water 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 importantin that 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 suchthat the practice can continuously achievecompliance with the requirements of theseregulations. Registration with the LegionellaControl Association 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 neccessary, as part of theirservice level agreement with the Public HealthWales NHS Trust (PHW) or Health ProtectionAgency (HPA).

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 3).

6.81 With regard to Legionella and other water-bornepathogenic agents, the HCAI Code of Practice(2009) states:

“Premises should be regularly reviewed forpotential sources of infection and a programmeshould be prepared to minimise any risks. Priorityshould be given to patient areas although theexact priority will depend on local circumstances”.

6.82 Guidance from L8 advises that at-risk systems,particularly those used with the patient, be draineddown at least at the end of each working day.Where manufacturers provide protocols for dailycleaning, 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 3). 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, a Type Aair gap should separate the DUWLs from the mainswater supply. Such arrangements should be subject toconsideration of local water quality, particularly wherehard water is used.

6.85 DUWLs should be flushed for at least twominutes at the beginning and end of the dayand after any significant period when they havenot been used (for example, after lunch breaks).In addition, they should also be flushed for atleast 20–30 seconds between patients. Whilstthese actions have been shown to have only asmall effect on biofilm build-up within theDUWL system, they do usefully reducemicrobiological counts in the water delivery

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tube during the period when patients are likelyto be exposed. Some water-purification systemsare capable of supplying DUWLs and may beable to reduce microbiological 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.

Notes

(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 orthe use of bottles – should consult with theirappointed Competent Person in respect of localwater 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, ultrasonicscalers and/or water lines (see Section 3).Responsible persons should ensure these arefitted where required. They must be regularlymonitored and maintained.

6.88 Examples of dental equipment requiring backflowprotection are:

• dental spittoons;

• three-in-one syringes;

• wet-line suction apparatus; and

• self-filling automatic radiographic processors(where still used).

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.

See Section 3 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 single-use 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,any device should be rinsed under cleanrunning water. This process should continueuntil the device 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 a supplier/laboratory or in some other fashion sent out ofthe practice, a label to indicate that adecontamination process has been used shouldbe affixed to the package.

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7 Impressions, prostheses and orthodonticappliances

Section 3: Engineering, technology andstandards

42

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 (BSEN 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 orderto bring their content in line with that of theBS/EN/ISO Standard portfolio.

8.4 A list of these Standards is provided in theReferences. It is in the light of these changes thatthis Health Technical Memorandum is published.Reference to the content of a relevant Standard ismade where necessary but the content of thatStandard is not included in this document.

DH guidelines8.5 Guidance produced by the Welsh Assembly

Government for decontamination has evolved inrecent years.

8.6 Advice on decontamination of medical devices wasissued in HSC 2000/032 and in‘Decontamination of reusable medical devices inprimary, secondary and tertiary care sectors (NHSand Independent providers)’ 2007.

8.7 The Chief Dental Officer’s letter (April 2007)advised the single-use of all endodontic files andreamers, as well as any other instruments forwhich effective decontamination was difficult.This was reinforced by the release of ‘PotentialvCJD transmission risks via dentistry. An interimreview’ (December 2007).

8.8 Health Technical Memorandum 01-05 Welshedition has drawn upon all guidance issuedpreviously, including HSG (93)40 ‘Protectinghealth care workers and patients from hepatitis B’.

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

8.10 For Secondary care, the Welsh AssemblyGovernment commissioned the decontaminationproject which successfully saw all hospitalsterilization and decontamination units in Walesachieve 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;

• Use of single-use devices;

• Outsource decontamination to an accreditedHSDU;

• A combination of the above.

8.11 Health Technical Memorandum 01-05 sets out therequirements for the first of the above options.

Healthcare regulation and standards

The new Local Health Boards must ensure that theprovision of health services meets Wales’ healthcarestandards. Infection prevention and control, includingdecontamination, is a requirement that will apply to allNHS 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 HIW in accordance with regulatoryrequirements.

For 2010, the registration requirements for infectioncontrol and prevention, including decontamination, aresupported by the Private Dentistry (Wales) Regulations2008. This Health Technical Memorandum will bereferenced in revised national minimum standards andenforced through the above regulations. Adherence tothe Health Technical Memorandum will, with regard todecontamination, contribute towards evidence ofcompliance with registration requirements.

8 Regulatory framework and compliance

9.1 It is essential that all staff involved indecontamination are suitably trained and havetheir roles and responsibilities defined and thateveryone is aware of each other’s responsibilities.

9.2 Health Technical Memorandum 01-01 Part Aprovides general advice – for the acute sector – onthese responsibilities along with the experience,qualifications and training required. However, thatadvice is based on a universal application todecontamination in complex systems which areprobably inappropriate to primary care dentalpractices.

9.3 Each practice can, therefore, establish its ownsystem concerning staff responsibilities but will beexpected to demonstrate the same degree ofunderstanding, competency and management asrequired by Health Technical Memorandum 01-01Part A. The following may be used as a guide tothese roles. The terminology of Part A is used forclarity but it is likely that local personnel may havediffering titles.

It should be borne in mind that it is likely that oneindividual may carry out two, or possibly more, of thefollowing roles.

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 providor, 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 directlyemployed by the practice or provided as a serviceby the Health Board.

Designated Person: this role acts as the interfacebetween the practice and support services supplied

externally, including service, maintenance andtesting. This could be the Dental PracticeManager. The Decontamination Lead could alsoact as the Designated Person.

Authorising Engineer (Decontamination): this isan external role that provides guidance and adviceon the compliance issues of decontamination,including the implementation of this HealthTechnical Memorandum and associated guidancedocumentation. A list of suitable persons isavailable from the voluntary register held by theInstitute of Healthcare Engineering and EstateManagement (IHEEM) (www.iheem.org.uk/Decontamination).

Authorised Person (Decontamination): TheAuthorised Person provides technical support tothe Competent Person and liaises with theAuthorising Engineer. The Authorised Person maybe either directly employed by the practice, orprovided as a service by the Health Board or by athird party.

Competent Person (Decontamination): TheCompetent Person is responsible for the servicing,testing and maintaining of the decontaminationequipment within the practice. The CompetentPerson may be either directly employed by thepractice, or provided as a service by the HealthBoard or by a third party.

Competent Person (Pressure Vessels): eachpractice will have a legal responsibility for thesafety of its decontamination equipment,particularly the sterilizers that are pressure vessels.The need for insurance and a Written Scheme ofExamination is a legal liability and can beprovided by the Competent Person (PressureVessels). This is likely to be provided by aninsurance company.

Service engineer: A person provided under aservice level agreement or contract who is certifiedby the service agent or equipment manufacturer tobe competent to both service and test specifieddecontamination equipment. This person may,among other duties, perform validation tests inaccordance with the EN standards cited in this

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9 Staff roles and responsibilities indecontamination

document. The service engineer may give anopinion on the outcomes of validation testing aswell as providing data to an Authorising Engineer(Decontamination) or Authorised Person(Decontamination) for validation approval.

User: This person has day-to-day responsibility forthe management of the decontaminationequipment and processes. A likely overlap maymean that this role is duplicated, but theresponsibility must be demonstrated. Animportant function of the User is to ensure thatanyone operating and testing decontaminationequipment (that is, an Operator) is suitablytrained and competent.

The User should seek advice from manufacturers orthe service engineer on how to carry out the testingof equipment and daily tasks.

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 besought 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 NHSTrusts and Health Boards, pathology departmentsand Public Health Wales laboratories.

9.5 The Registered Manager should ensure that allpersonnel fulfilling the roles defined above shouldreceive appropriate training, that they can

demonstrate 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 infectioncontrol and all relevant infection controlpolicies and procedures;

• an understanding of, and an ability to perform,periodic testing where appropriate.

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:

• an owner understanding of legal liabilities andcurrent best practice;

• it has obtained professional advice, wherenecessary, in equipment purchase,maintenance, testing and operation;

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

• it can demonstrate compliance with thePressure Systems Safety Regulations 2000.

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 the roles abovewill be provided by a number of entities/organisations. All roles should thus be identifiedand all individuals aware of each other. Thesystematic approach to these roles should ensurethat they function correctly and that they are notindividual-based but can withstand changes ofpersonnel without affecting the systematicapproach. Advice on relevant training programmesis available from the Authorising Engineer(Decontamination). In addition, the local HealthBoard may also be able to 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 which is usedin the national contract in Scotland (www.scottishdental.org/?o=2403).

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 air-removal process and therefore the type of sterilizerchosen (vacuum or displacement).

10.2 For the cleaning process, instrument design willalso affect the choice of cleaning process,particularly regarding loading carriages for thermalwasher-disinfectors.

10.3 If cannulated devices are to be cleaned, ultrasonicirrigators (that is, ultrasonic 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 – reasonabletime during the normal working day should beset aside for these procedures;

• all capacity planning should be documented.

Note

Periodic testing for washer-disinfectors, sterilizers andultrasonic cleaners can take up to a full session.Accordingly, Registered Managers should plan schedulesto allow for this, particularly if the equipment is locatedclose to clinical areas. (The process effectively takes amachine out of use for that session.) Times will bedifferent for sterilizer types N, B and S. Removal, ordisablement, of unwanted cycles on multi-cyclemachines can help to reduce this.

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

against the relevant Health Technical Specification(formerly, Model Engineering Specification).These 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/irrigators isavailable from the Authorising Engineer(Decontamination).

Note

All Model Engineering Specifications are beingprogressively revised and retitled as Health TechnicalSpecifications (HTS).

10.6 New decontamination equipment should display aCE mark (see below) to demonstrate compliancewith the Medical Devices Regulations 2002.

45

10 Procurement of decontamination equipmentand 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/operator training and cleaning, andwill 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 ongoingcosts?

10.9 The following will also need consideration:

• testing: there will be a need to identify who isto perform the testing, and where and whentesting is to be performed;

• service response: there is a need to be clearabout service-response times in the event ofbreakdown;

• process data capture (that is, chart recorder/data recorder/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.

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 installationand warranty requirements;

• an explanation of the purpose of theequipment and the cycles;

• suitable chemicals to be used with theequipment;

• optimum working temperatures;

• cleaning instructions (stipulating suitabledetergents) for the user;

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

• explanation of warning indications (cyclefailure etc. and fault-finding (diagnostic)procedures;

• all maintenance requirements (easily copiedso that it can be displayed and undertaken byan operator) including frequencies etc;

• monthly maintenance requirements;

• yearly testing and validation requirements/procedures;

• 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 equipment(this 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 (inWatts) or electrical demand (in Amperes) of theultrasonic transducers.

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.

46


10.20 An ultrasonic cleaner needs to be maintained by aCompetent Person (Decontamination) or asuitably 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/corners to aid in the cleaningprocess;

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

• a reservoir drainage facility that does not affectperformance and does not leave pools of fluidin the reservoir, which allows the tank to beemptied without the need for operatives to puttheir hands in 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, also reducing 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 (this canbe integrated) that records:

– time and date,

– cycle type,

– unique cycle number,

– duration of cycle,

– equipment serial number,

– minimum/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/minimum temperatures,

– ultrasonic activity,

– cycle failure indication,

– lamp warning indicators;

• lower-level fluid sensor/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;

• degas requirements (prior to use);

• optimum working temperatures;

• cleaning instructions (stipulating suitabledetergent) for the user;

• safety instructions;

• explanation of warning indication (cycle failureetc.);

• all maintenance requirements;

• monthly maintenance requirements or as permanufacturers’ recommendations;

• yearly testing and validation requirements/procedures;

• 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 used– will the instruments selected be fit for thispurpose?

• Is it compatible with other instruments in use?

• Is there an appropriate single-use device thatwould meet the requirements?

47

10 Procurement of decontamination equipment and instruments

• If reusable, how easy will it be maintained?

• Does the instrument need dismantling beforecleaning?

• Are there instructions from the manufacturerdescribing how this can be done?

• Does the instrument have a limited lifecyclespecified by the manufacturer?

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

• Will the instrument withstand automatedwasher-disinfector processes?

• 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 (134–138°C for aminimum of three minutes) appropriate for theinstruments?

• If another time/temperature range isrecommended, can this be undertaken?

• Is training required? Will the manufacturerprovide it?

• What commissioning and validation is requiredfor the equipment? What are the ongoingcosts?

Note

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

Policy on new reusable instruments10.24 Before being put into use, new dental instruments

should 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.

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.

48


Maintenance and servicing11.1 All decontamination equipment should be

subjected to validation, maintenance and servicingas recommended by the manufacturer/supplier. Allrecords of these procedures should be retained foraudit/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 non-compliance of the decontamination process.Alternative protocols of maintenance should beequal to, or exceed, the manufacturer’sspecification and must be 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 (optionA) is as follows:

a. The Competent Person (Decontamination) orservice engineer should test or validate theequipment.

b. The Competent Person (Decontamination) orservice engineer should then submit thevalidation/service report to the RegisteredManager in order to bring the equipment intoservice.

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

d. Welsh Health Estates undertakes the roles ofAuthorising Engineers for the NHS in Walesand provides advice and guidance on periodicvalidation regimes.

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

11.6 The second option (option B) for steam sterilizers– and the standard approach for washer-disinfectors and ultrasonic cleaners – is as follows:

a. The service engineer produces a service reportcontaining a validation statement declaringthat the equipment manufacturer candemonstrate that the product complies withthe CE-marking process under the terms of theMedical Devices Regulations.

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

11.7 This should be performed in full prior toequipment use, then periodically as advised inChapters 12–14.

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 of thelocal Health Board would also be useful. Inaddition, where available, an Authorising Engineer(Decontamination) will also be able to advise.

11.11 Periodic inspections/testing logs will need to besigned by the Competent Person(Decontamination) or service engineer and becountersigned by the Registered 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 CompetentPerson (Decontamination) or service engineer).

49

11 Decontamination equipment: general guidanceon maintenance and testing


Lack of a User signature may well indicate non-compliance.

Note

The User is defined as the person designated by theRegistered Manager to be responsible for themanagement of the decontamination equipment andprocess. For a dental practice, this would normally bedentists themselves.

11.13 The validation schedules for sterilizers outlined inparagraph 11.5 and Chapter 12 are part of theessential quality requirements. However, in termsof testing schedules for washer-disinfectors andultrasonic cleaners, manufacturers’ guidanceshould be sought. In the absence of manufacturers’guidelines, the testing schedules in Chapters 13and 14 should be followed.

Documentation11.14 Documentation provides the only evidence of

completed work. Absence of documentation forany work item will indicate omission of that item.It is important that all documentation relating todecontamination equipment is up-to-date and isretained locally for audit/inspection purposes.

11.15 The following documentation should be retainedfor the equipment and be readily/freely available atany time:

• specification;

• validation report, where the preferred option(option A) is selected – independentlymonitored by the Authorising Engineer(Decontamination). Where option B isfollowed, a service report (validation) signed bythe service engineer or Competent Person(Decontamination) on behalf of themanufacturer’s agent;

• performance qualification details – loadingpatterns and required parameter values;

• logbook of periodic testing;

• logbook of plant history, componentreplacement etc;

• process log;

• training and competency records;

• documentation for Pressure Systems SafetyRegulations 2000 including written scheme ofexamination and examination reports;

• list of all named designated responsiblepersons;

• other relevant documentation.

50

51

12 Installation, validation, maintenance andtesting 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 testing12.2 The specification will include a protocol for

validation. 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

EuropeanTest Type Performed by Norm (EN)

reference

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

Note: Immediately after installation, the air leakage and emptychamber tests should be undertaken by the CompetentPerson (Decontamination) or service engineer.

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

Periodic tests12.5 The following testing protocol is recommended.

Additional tests as defined by the manufacturershould 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 liaise with theequipment manufacturer with regard to training.

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

* The Device Bulletin MDA DB 9804 has been withdrawn from circulation. However, for the purposes of theThermometric tests and the Steam generator overheat cut-out tests this document is still considered to be ‘bestpractice’ until the proposed HTM 01-07 Decontamination in primary care document is published.

(See table included in Appendix 4)

For further information refer to the Medical and Healthcare Products Regulatory Agency publications accessiblethrough the current decontamination document page of the Welsh Health Estates website.

52

Decontamination: Health Technical Memorandum 01-05 – Decontamination in primary care dental practices - Welsh edition 2011 Update One

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.


53

13 Installation, validation, maintenance andtesting 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

54



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

55


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.


14 Installation, validation, maintenance andtesting of ultrasonic cleaners

56



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, items should be rinsedas a normal procedure before these tests are carried out, otherwise the tests could return false positives.

57

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 Health TechnicalMemorandum 01-01 Part A for further guidanceon training and certification), it will not benecessary for the practice to possess copies of theseStandards. It will, however, be necessary that anycontracted test performance include reference tothe requirements of these Standards.

15.2 The following tests are additional to those shownin the referred Standards. These additional testprocedures are compliant with EN Standards andshould be applied where necessary and if relevantto the type of decontamination equipment beingused.

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.

15 Additional information on test procedures(in addition to those provided 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 send it for repairor replace it.

Wand meters

15.13 Ultrasonic energy meters are now available tomonitor 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 Competent Person (Decontamination) orservice engineer should conduct a series of safetychecks before proceeding. Advice on the yearlyprogramme of safety checks may be sought fromthe Authorising Engineer (Decontamination).

15.17 The validation checks and tests may be used as abasis for yearly safety checks, paying particularattention to those factors affecting safety andparticularly those which may have changed sincethe previous annual safety check or validation test.

15.18 The Competent Person (Decontamination)/service engineer should ensure verification of theadequacy and safe connection of engineeringservices.

58


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. Wherepossible, manual cleaning should be replaced withautomated cleaning. However, where manual cleaning isnecessary (for example, as advised by the manufacturer)and where the practice is operating under the essentialquality requirements, the critical parameters should becontrolled as much as possible to reduce the variabilityin cleaning performance. The following advice aims toenable this control as much as possible.

16.1 A dirty-to-clean workflow should be maintainedthroughout the cleaning procedure. Two sinks orbowls should be provided – one for manualcleaning and one for rinsing. In addition, separatesetting-down areas should be used for dirtyinstruments and for clean instruments.

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. Ordispose 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.

16 Approach and protocol for manual cleaning

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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 aerosolsshould be avoided at all times.

Remember: Maintaining a dirty-to-clean workflow procedure will assist in the cleaning process.

• Wash hands.

• Wear personal protective clothing (PPE).

• 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(specified for the purpose). Note: ensure correct temperature as recommended by the detergentmanufacturer is maintained.

• 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 andin good condition.

• 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.

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17.1 For the purposes of this document, either one ofthe following types of water is considered suitable:

• 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;

• 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;

• conditions of storage of feed-water;

• period between changes of feed-water.

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.While both are acceptable, there is some advantagein using the water once only in that there is nobuild-up of contamination 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.

17.9 Current recommendations are for the reservoir tobe drained down and cleaned at the end of eachworking day or daily shift. The machine shouldnot be left for any lengthy period, especiallyovernight, with water in the reservoir.

The possibility of pyrogens accumulating in thereservoir is of particular concern. Some pyrogenswill be washed down from load items, while othersmay arise from bacterial growth, especially wherethe sterilizer is unused for long periods betweenrefills. Even if such bacteria are subsequently killedby the sterilization process, pyrogens will not beinactivated and will be deposited on the next load.The levels of pyrogens in the steam may exceedthe permitted maximum even though sterilizedwater for irrigation was used as the originalfeedwater.

WaterCleaning

17.10 Cleaning and rinsing (either manual orautomated) can be performed with potable wateras long as the water hardness is low enough andother aspects of the water quality are satisfactory.It is recommended that water for cleaning shouldhave a suitable hardness level. This is part of theconsideration 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 should 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.

17 Steam and water quality

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Final rinsing

17.12 The final rinsing of instruments – those washedmanually, in an ultrasonic bath or in a washer-disinfector – should be carried out usingsatisfactory potable water, RO or freshly distilledwater.

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.

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

• Health Technical Memorandum 04-01 – ‘Thecontrol of Legionella, hygiene, “safe” hot water,cold water and drinking water systems’.

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 as anillustration of good practice.

Compliance with Health Technical Memorandum04-01 and this guidance document 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 ControlAssociation).

• 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 etc.). The riskassessment should be carried out by aCompetent Person.

• The Registered Manager should ensure that anoperational plan is in place for each site underhis/her control. This document shouldcomprise:

– up-to-date as-fitted drawings, schematicdiagrams and descriptions of all the supply,storage and distribution systems within thosepremises;

As-fitted drawings can be obtained from third partiessuch as architects.

– step-by-step instructions to operate, maintain,control and shut down the water supply, storageand distribution 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 asto their competency. It is also essential that theyhave an overall appreciation of the practicesaffecting water hygiene and safety, and that theycan interpret the available guidance and performtheir tasks in a safe and technically competentmanner.

Safe hot water temperature

19.4 To reduce the risk of scalding, thermostatic mixingdevices 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.

Utilisation

19.6 One of the critical factors affecting the quality ofwater 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.

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.

19 Hot and cold water systems and dental unitwater lines

Flushing dental unit water lines (DUWLs)

19.8 For procedures on flushing DUWLs betweentreatment sessions and at the beginning/end ofeach working day, see paragraphs 6.84–6.86.

Decommissioning of DUWLs

19.9 Follow the manufacturer’s guidance for thetemporary 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 DUWLs

19.12 In the absence of manufacturers’ guidance, flushthe DUWL for at least three minutes, disinfect theDUWL with a suitable disinfectant (asrecommended by the manufacturer for routinedisinfection of the DUWL), then flush 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 isroutinely 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 ofdental equipment requiring backflow protectionare:

• 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 the manufacturer’s recommended chemicals, is arequirement for medical devices such as thoselisted above.

Maintenance policy

19.18 The Registered Manager is ultimately responsiblefor the provision of a wholesome water supply inthe premises under his/her authority.

Contract maintenance

19.19 When selecting subcontractors, particularly inrelation to the control of Legionella, theircompetence should be established beforehand (forexample, companies/individuals who are membersof the Legionella Control Association).

Emergency action

19.20 Contingency plans should be available in the eventof 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.

b. A mains-water failure that could last beyondthe period for which storage capacity has beendesigned:

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19 Hot and cold water systems and dental unit water lines

– 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/washrooms;

The emergency action to be taken during an outbreakof healthcare-associated legionellosis is covered inHealth Technical Memorandum 04-01 Part BAppendix 1.

Documentation

19.21 It is essential to have comprehensive operationalmanuals 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 drawings

19.23 The availability of accurate as-fitted drawings isessential 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 thewritten scheme, since much of the information is anintegral part of the written scheme itself.

Record-keeping

19.25 The User should ensure that an accurate record ofall 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 recordsshould be updated to reflect the modificationscarried 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 entries,and that there is an audit trail in place.

Water supply hygiene

19.32 After any installation work, all piping, fittings andassociated services used for the conveyance ofwater 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 806-2:2005, BS EN

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806-3:2006 and BS 6700:2006 (see also HealthTechnical Memorandum 04-01 Part A Chapter17) and under the direct supervision of anominated 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/cisterns);

• backflow (back-siphonage) of contaminatedwater into systems conveying potable water(mains and storage structures).

Water treatment

19.34 In a properly installed and commissioned hotwater system, it should be possible to maintain atemperature of at least 55oC at the furthest draw-off point in the circulating system, and 50oC inthe circulating system’s return connection to thecalorifier.

19.35 In older premises, however, this may not bepossible, and in the case of cold water systems it isnot always possible or practicable to maintainwater temperature below 20oC because ofutilisation and complexity. In addition, therefore,it may be necessary to apply a residual biocidalwater treatment that has been shown to destroyand remove biofilm. Information on thesetechniques, which include chlorine dioxide andcopper and silver ionisation, can be found inHealth Technical Memorandum 04-01 Part 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 ofbiofilm. 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 of

Legionella is not generally recommended.Treatment using chlorine dioxide or copper/silverionisation can be used. Advice should be soughtfrom the Local 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 HealthTechnical Memorandum 04-01 Part A for moreguidance on water treatment regimens.)

Purging the systems

19.40 Where chemical treatment is introduced, it isessential 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 treatment

19.42 Whereas treatments such as chlorine dioxide andcopper 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 Health Technical Memorandum04-01 Part A).

Metal contamination

19.43 See Health Technical Memorandum 04-01 Part AChapter 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.

Water storage

19.46 For general information on water storage, seeHealth Technical Memorandum 04-01 Part A

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(paragraphs 7.1–7.2) and Health TechnicalMemorandum 04-01 Part B (paragraphs7.54–7.61).

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 806-2:2005 and BS6700:2006. (See Chapter 8 of Health TechnicalMemorandum 04-01 Part A for furtherinformation.)

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 Health TechnicalMemorandum 04-01 Part A (paragraphs 8.13and 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 relevantparts of BS EN 806-2:2005, BS EN 806-3:2006and BS 6700:2006. The hot water system may beof either the vented or the unvented type. (SeeHealth Technical Memorandum 04-01 Part AChapter 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.

Notes

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 draw-off 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 ofdebris;

• whenever dismantled for statutory inspection,or every year in the case of indirect calorifiers,calorifiers should be thoroughly cleaned toremove sludge, 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 Health Technical Memorandum 04-01 Part Bparagraphs 7.74–7.76 for further advice on calorifiers.

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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 806-2:2005, BS EN 806-3:2006 and BS 6700:2006. In essence:

• 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 Health Technical Memorandum04-01 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 that isfor drinking etc. should comply with BS 6920-1:2000 and be listed in the latest edition of the‘Water Fittings and Materials Directory’ publishedby WRAS.

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 opposite 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 alsoHealth Technical Memorandum 04-01 Part Aparagraph 5.16).

Summary checklist19.65 A summary checklist for hot and cold water

services showing recommended frequency ofactivity is given in Table 2.

The checks/tasks outlined in Tables 1 and 2 could becarried out by trained user or contracted-out to a thirdparty (for example, an LHB).

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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

Notes:

† Sentinel outlets are normally those that – on a hot water service – are the first and last outlets on a recirculatingsystem. On cold water systems (or non-recirculating hot water systems), they are the closest and furthermost fromthe storage tank (or water heater). The choice of sentinel taps should also include other outlets that are consideredto represent a particular risk, for example, those installed in accommodation in which particularly susceptiblepatients are treated, or others identified in the risk assessment and temperature mapping exercise as having the leastsatisfactory temperature performance.

‡ Representative outlets include conventional and mixed-temperature taps; 20% of the total number installedthroughout the premises would be tested annually on a rotational basis: that is, all taps checked every five years.

1. The Health & Safety Commission’s (2000) Approved Code of Practice L8 permits a period of two minutes toachieve an equilibrium temperature below 20°C. Achieving this minimum requirement would be indicative of anexceptionally underutilised water system. (At a typical flow to a wash-hand basin of 4.5 L/m, 2 minutes to achievetemperature would indicate a 50 m dead-leg of 15 mm pipe.)

2. The Water Supply (Water Quality) Regulations 2000 permit water undertakers to supply water to premises attemperatures up to 25°C. In practice, the water temperature is likely to be below this maximum value, typicallybelow 10°C in winter and 20°C in summer. If, during prolonged periods of high environmental temperature, thewater temperature starts to exceed 20°C, the water undertaker should be asked to see whether remedial actioncould be undertaken. Within the curtilage of the premises, the aim should be to ensure that the temperaturedifference between the in-coming supply and most distal parts of the distribution system is below 2°C.

3. The Health & Safety Commission’s (2000) Approved Code of Practice L8 permits a period of 1 minute to achievean equilibrium temperature of 50°C. A minimum of 55°C may be required for the operation of suitable mixingdevices required to provide “safe” hot water at the upper limit of the recommended range. Hot water at 55°C isrequired in many cases for reasons of food hygiene or decontamination requirements, for example, in kitchens andsluice rooms etc. In a properly balanced hot water circulating system, with the circulation taken close to the draw-off point, achieving temperature should be virtually instantaneous. (At a typical flow to a wash-hand basin of 4.5L/m, 1 minute to achieve temperature would indicate a 25 m dead-leg of 15 mm pipe.)

Table 1: Tests for temperature performance

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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

Notes:

* See paragraph 182 in the Health & Safety Commission’s Approved Code of Practice L8 for further guidance ontasks that should be undertaken.

1. For effective operation of hot water services, the minimum equilibrium temperature should be 55°C and beachieved within seconds.

2. For thermostatic mixing devices, temperatures should be measured at the inlet.

3. For satisfactory operation of cold water services, temperature equilibrium to below 20°C should be achieved wellwithin one minute.

4. Temperatures should be continuously monitored by the BMS.

5. Additional checks should be made on the hot water circulating system and systems using trace heating at distalpoints.

6. Risk assessment may indicate the need for more frequent flushing of outlets. It is preferable that this form part ofthe daily cleaning routine where appropriate. Alternatively, self-purging showers that discharge water to a drainprior to use and without the release of aerosols can be considered.

Table 2: Summary checklist for hot and cold water services

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 the

absence 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 by UnitedKingdom Accreditation Service (UKAS)-accreditedlaboratories. Dip slides are not acceptable.

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Dental practitioners should read Health TechnicalMemorandum 07-01 – ‘Safe management of healthcarewaste’, which provides a good-practice framework forthe management of healthcare waste, helping healthcareorganisations such as dental practices to meet legislativerequirements.

The guidance includes:

• a unified approach to identifying and classifyinginfectious and medicinal waste to comply with healthand safety, transport and waste regulations;

• a revised colour-coded waste segregation andpackaging system to allow standardised identificationof 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?The Registered Manager is solely responsible forensuring 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 staff aretrained and aware of the waste procedures.

The Hazardous Waste Regulations require that dentalamalgam waste is kept separate from other waste andconsigned to an appropriate waste management facility.To comply with these requirements, RegisteredManagers need to fit amalgam separators and consignthe amalgam to an appropriate facility for disposal orrecovery (see also Figure A1). See Defra’s guidance ondental amalgam(http://www.defra.gov.uk/environment/waste/topics/hazwaste/documents/amalgamguidance2005.pdf )

Waste segregation, packaging,classification and labellingDental practices will produce a wide range of bothhazardous and non-hazardous wastes. Figure A1 outlinessome key dental waste streams, including an explanationof each stream, what waste containers should be used,what can be placed in these containers, how wasteshould be classified and described and advice on wastedisposal.

Waste transfer and documentationAs the producer of the waste, the dental practice bearsthe legal responsibility of ensuring that wastedocumentation is complete and accurate.

There are two different types of documentation requiredfor waste transfers:

• consignment notes that are used for hazardouswastes;

• waste transfer notes that are used for non-hazardouswastes.

What is a consignment note?

A consignment note is used to track the movements andensure the safe disposal of hazardous wastes. It is alsodesigned to ensure the information accompanying thewaste is sufficient to enable its safe disposal. A newconsignment note must be completed for each individualcollection of hazardous waste. Each note will consist ofproducer, carrier and consignee copies.

Figure A2 provides a completed example of a standardconsignment note for a number of dental waste streams.

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Appendix 1 – Waste disposal

http://www.defra.gov.uk/environment/waste/topics/hazwaste/documents/amalgamguidance2005.pdf

Who completes the consignment note, and when?

Before the waste is removed from the dental practice:

• Part A contains details of the dental practice and thedestination of the waste. This must be completed bythe practice.

• Part B contains details about the waste, its propertiesand its packaging. This must be completed by thepractice.

• All three copies should then be provided to the wastecarrier.

• Part C contains details of the waste carrier, the driver,the vehicle and a declaration that the carrier hasverified key information in sections A and B. Thismust be completed by the carrier.

• The paperwork is then passed back to the producer.Only after section C is completed can the dentalpractice complete section D to verify sections A to C(as this includes a record of the number plate of thevehicle onto which the waste was loaded).

• Once parts A to D are complete, the carrier mayremove the waste.

On arrival at the destination (consignee) site, theconsignee completes Part E to verify what they havereceived.

Further guidance on this is provided by the EnvironmentAgency at www.environment-agency.gov.uk/hazwaste.

What is a multiple consignment note?

A multiple consignment note (MCN) is a type of noteused by waste carriers to collect hazardous waste from anumber of small producers in the same journey.

An “M” on the end of consignment note numberidentifies that this collection is part of a larger collectionround.

A MCN contains the same information as a standardconsignment note; however, the layout is slightlydifferent. The waste carrier must provide the dentalpractice with two documents:

• a multiple collection note that contains informationcommon to all the collections (for example, thecarrier details, the destination site, and the Part Econsignee information); and

• an annex that is specific to the practice, which looksvery much like a standard consignment note (withoutPart E); section B should be identical to the standardnote.

Waste transfer notes

Waste transfer notes are used for the collection of non-hazardous wastes. The dental practice completes a waste

transfer note. The legal responsibility for describing thewaste rests with the dental practice.

Registrations, records and returnsRegistrations

There are two key waste registrations:

• registering as a hazardous waste producer;

• seeking an exemption from an environmental permitfor transporting and storing waste.

Why register as a hazardous waste producer?

All dental practices that produce 500 kg or more ofhazardous waste in any 12-month period need to registertheir premises annually, as decreed by the HazardousWaste Regulations 2005.

If the practice produces less than 500 kg in any12-month period, it is exempt.

This information is used to track hazardous wastes andensure that they are safely managed.

How to register as a hazardous waste producer

Apply for registration from the Environment Agencyvisit http://www.environment-agency.gov.uk/apps/hazwaste/registrationwelcome.jsp

When the premises are registered, the practice will begiven a hazardous waste producer registration numbercalled a premises code. This code must be used on allconsignment notes where hazardous waste is removedfrom those premises.

Registration is only valid for 12 months, so must berenewed annually.

Why register for an exemption from anenvironmental permit?

Usually a waste treatment, recovery or disposal operationneeds to be authorised by a permit. A waste exemption is avery specific type of low risk waste handling operation thatdoes not require a permit although exemptions usuallyneed to be registered with the Environment Agency.

Previously, dental practices that stored waste returned bypatients applied for a “paragraph 39 exemption” for suchactivities. The exemption meant that the practice did notneed a full permit as long as it complied with theconditions of the exemption.

In April 2010 new Environmental PermittingRegulations were introduced affecting waste exemptions.The existing list of exempt operations was changed, andunder the new regulations the “paragraph 39 exemption”no longer exists and there is no longer a requirement toregister or renew existing paragraph 39 exemptions.

74


https://www.environment-agency.gov.uk/apps/hazwaste/registrationwelcome.jsp

https://www.environment-agency.gov.uk/apps/hazwaste/registrationwelcome.jsp

For further details of environmental permittingrequirements and exemptions, visit the EnvironmentAgency guidance at http://www.environment-agency.gov.uk/business/topics/permitting/default.aspx

Hazardous waste – records and returns

Dental practices are required to keep a register thatcontains their hazardous waste records. This requirementis usually met by keeping copies of both:

• standard or multiple consignment notes (includingannexes); and

• consignee returns to the producer or holder.

Where relevant, the register should also contain recordsof any rejected loads or carrier schedules.

Guidance on consignment notes and their completionis provided in a series of guides to the Hazardous WasteRegulations (www.environment-agency.gov.uk).

Consignee returns to the waste producer or holder

Each consignee (destination site) is required to send tothe dental practice a return each quarter. This return is arecord of what has happened to the waste and must beplaced in the waste producer’s register. These returnsmust be present to ensure the register is legally complete.

Where a waste contractor does not provide returns:

• the producer should formally request one in writing;

• if this is unsuccessful, the waste producer shouldconsider making alternative arrangements for theirwaste disposal until the contractor complies with thelaw and also pass their details to the EnvironmentAgency.

Where the waste is taken to a transfer station beforebeing sent elsewhere, it is recommended that the dentalpractice request copies of the associated completedpaperwork for that onward movement which confirmsthat it was received at the final destination.

Where should the register be kept?

Where the register is kept depends on the number ofpractice branches and whether these are each registeredas hazardous waste producers or not.

• Registered premises – if a practice is registered, theregister for any hazardous waste that is removed fromthat practice must always be kept on the premises.

• Exempt premises – if a practice branch is exemptfrom registration as a hazardous waste producer, theregister for any hazardous waste that is removed fromthat practice should be kept at the principal place ofbusiness. This may be another practice if the practiceis one of several in a company. If a practice wishes tokeep the register anywhere else, this must be agreedin writing with the Environment Agency.

How long should the register be kept?

The register must be kept for at least three years.

The three years commences from the date the waste wasremoved from the practice’s premises by a waste carrier.

Non-hazardous waste records

Waste transfer notes should be kept for a minimum oftwo years.

Where season tickets are used, a record should also bekept of the times when each of the regular collections aremade using the note.

75


http://www.environment-agency.gov.uk/business/topics/permitting/default.aspx

http://www.environment-agency.gov.uk/business/topics/permitting/default.aspx

76


Container type Example Contents Classification Disposalwaste description and EWC

codes

Sharps box (yellow lid) Clinical waste: – Hypodermic needles, syringes and 18 01 03* & Incineration mixed sharps and syringe barrels including those 18 01 09 onlypharmaceutical waste contaminated with medicines Hazardousfor incineration only (not cytotoxic and cytostatic)

– Used medicine vials

– Other sharp instruments or items(Note: orange lids including teeth without amalgam fillingsmust not be used)

Soft clinical wastes Clinical waste: infectious, Body-fluid-contaminated dressings, PPE 18 01 03* Alternative(orange bag) suitable for alternative and swabs, and other waste that may Hazardous treatment or

treatment present a risk of infection incineration

NO medicinally, chemically or amalgamcontaminated wastes

Medicines (rigid Non-cytotoxic and Non-cytotoxic and cytostatic medicines 18 01 09 Incinerationleak-proof container) cytostatic medicines, including used and out-of-date stock Non-hazardous only

clinical waste, forincineration only

Offensive or Offensive/hygiene waste Gowns, gloves, tissues, X-ray film and Non-hazardous Landfillhygiene wastes from dental care suitable other items from dental care which are not 18 01 04

for landfill contaminated with bodily fluids, medicines, chemicals or amalgam

Municipal offensive/ Hygiene waste from toilets only Non-hazardoushygiene suitable for 20 01 99landfill

Amalgam waste Dental amalgam: Teeth with amalgam fillings Hazardous Metal recoveryinfectious, clinical waste, 18 01 10*for recovery

Dental amalgam and Dental amalgam and mercury includingmercury: non- infectious, spent and out-of-date capsules, excessfor recovery mixed amalgam, and contents of amalgam

separators

X-ray fixer (container Photographic fixer Waste photographic fixer from X-ray Hazardous Recoverytype not specified) (must be kept seperate from developer) 09 01 01* (various)

X-ray developer (container Photographic developer Waste photographic developer from X-ray Hazardoustype not specified) (must be kept separate from fixer) 09 01 04*

Lead foils (container type X-ray lead foils from Lead foils from X-ray film packaging Non-hazardousnot specified) dentistry 15 01 04

Municipal waste Mixed municipal waste Domestic type refuse: Non-hazardous Landfill or food packaging 20 03 01 municipalpaper/magazines that cannot be recycled wastepaper towels incinerator(no hazardous wastes)

Figure A1: Waste segregation and classification table (see supporting text)

SHA

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ITE

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INER

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PART A Notification Details

1. Consignment note code: ABC123/AB001 3. Premises code: ABC123

2. The waste described below is to be removed from (name, 4. The waste will be taken to (address and postcode):address, postcode, telephone, e-mail & fax): The Transfer Station, Low Street, Old Town, The ShireThe Dental Practice, High Street, New Town, The Shire, YY12 4XXXX12 3YY 5. The waste producer was (if different from 1) (name, address, Tel 0123 456789, [email protected] postcode, telephone, e-mail & fax)

PART B Description of waste

1. The process giving rise to the waste(s) was: Dental healthcare. 2. SIC for the process giving rise to the waste: 85.13

3. WASTE DETAILS (where more than one waste type is collected all of the information given below must be completed foreach EWC identified).

Description of waste EWC Qty The chemical/biological components of Physical Hazard Containercode (kg) the waste, their concentrations form code(s) type, number

& size

Clinical waste: mixed 18 01 03* 10 kg Sharps, syringe barrels, medicine vials and mixed H3, H4, 2 x 14-litresharps and 18 01 09 ampoules (not cytotoxic and cytostatic) H5, H9, yellow-liddedpharmaceutical waste H14 sharps boxfor incineration only

Clinical waste: 18 01 03* 20 kg Dressings, PPE and swabs, not mixed H9 4 orange bagsinfectious, suitable for contaminated with chemicals or medicinesalternative treatment

Dental amalgam: 18 01 10* 0.5 kg Teeth with amalgam fillings (mercury) solid H6, H9, 1 amalgaminfectious, clinical waste, H14 pot 500mlfor recovery

Dental amalgam and 18 01 10* 0.5kg Dental amalgam and mercury – mixed H6, H14 1 amalgammercury: non-infectious, spent and out-of-date capsules, potfor recovery excess mixed amalgam, and contents of 1 litre

amalgam separators

X-ray fixer solution 09 01 01* 10 kg Acetic acid 1–5% liquid H4 1 x 15-litreSilver 1–2% drum

X-ray developer solution 09 01 04* 10 kg Hydroquinone 5–10% liquid H4, H7, 1 x 15-litreDiethylene Glycol 1–5% H11 drumSodium Carbonate 1–5%

ADR information for each EWC identified above:

EWC UN identification no. Proper shipping UN Special handling requirementscode Name class(es)

18 01 03* UN 3291 Clinical waste, 6.2 II No persons in handling chain to have unspecified, n.o.s direct contact. Waste to be disposed of

at authorised site

etc. etc. etc.

Figure A2: Example: hazardous waste consignment note

78


PART C Carrier’s certificate PART D Consignor’s/holder’s certificate

PART E Consignee’s Certificate (where more than one waste type is collected, all of the information given below must becompleted for each EWC)

Individual EWC code(s) Quantity of each EWC code EWC code accepted/ Waste Management operationreceived received (kg) rejected (R or D code)

I received this waste at the address given in A4 on Name: (please PRINT)

Vehicle registration no (or mode of transport if not by road): On behalf of (name, address, postcode, tel, e-mail

Where waste is rejected please provide details:& fax):

I certify that the waste management licence/permit/authorisedexemption no(s). Signature:

authorises the management of the waste described in B Date:at the address given at A4

Time:

(If more than one carrier is used, please attach a schedule forsubsequent carriers.If a schedule of carriers is attached tick here)

I certify that I today collected the consignment and that thedetails in A2, A4 and B3 are correct & have been advised ofany specific handling requirements:1. Carrier driver name (please PRINT) Brian Jones

2. On behalf of(name, address, postcode, telephone, e-mail & fax)

The Transfer Station, Low Street, Old Town, The Shire,YY12 4XXTel: 0987 654321; email: [email protected]

3. Carrier’s registration no/exemption reason:ABC/012345

4. Vehicle registration no: AB09 FIL

Signature B. JonesTime: 18.00 Date: 29/02/2010

I certify that the information in A, B and C above is correct,that the carrier is registered or exempt and was advised of theappropriate precautionary measures. All of the waste is packagedand labelled correctly and the carrier has been advised of anyspecial handling requirements.

1. Consignor/Holder name (please PRINT)

Mr David Mathews

on behalf of

(name, address, postcode, telephone, e-mail and fax)

The Dental Practice, High Street, New Town, The Shire,XX12 3YYTel 0123 456789, soretooth @hotmail.com

Signature D. MathewsTime: 18.00 Date: 29/02/2010

Electronic and electrical wastesA detailed explanation of the requirements for disposalof electrical waste is beyond the scope of this document.Further information is available from Health TechnicalMemorandum 07-05.

There are four key points to note:

• Many electrical wastes including refrigerators,freezers, fluorescent tubes, televisions, cathode-raytube (CRT) and TFT (flat screen) computermonitors, and certain batteries (lead acid or nickel-cadmium) are hazardous wastes and must thereforebe consigned from the dental practice.

• The local civic amenity site is unlikely to beauthorised to accept commercial electronic waste.Check before taking this waste there, and ensure thata consignment note is used if it is.

• New regulations on the disposal of waste electricaland electronic equipment (WEEE) have beenintroduced.

• When new equipment is purchased, there is anopportunity to make arrangements with the supplierto remove the old one.

For older electrical equipment WEEE (placed on themarket before 13 August 2005) that is not beingreplaced by new equipment serving an equivalentfunction, the dental practice itself is responsible forarranging and financing its collection and treatment inaccordance with the WEEE Regulations.

For all other WEEE from the practice, it may be possibleto call upon a responsible producer compliance scheme(PCS) to take-back and treat the old equipment. TheEnvironment Agency website gives details of the PCSeach equipment producer is a member of.

When new equipment is purchased, the supplier maynot mention take-back, so it is in the practice’s intereststo be proactive.

ChemicalsA detailed explanation of the requirements for disposalof chemical waste is beyond the scope of this Appendix.

There are three key points to note:

• Chemicals should not be disposed of in the clinicalwaste stream. This may cause chemical releases andworker exposure issues during subsequent handlingand disposal.

• Hazardous chemicals (including photochemicals)should not be disposed of to foul sewer or surfacedrains.

• Some chemicals may react to produce fire or toxicgas. These incompatible chemicals should be disposed

of and stored separately. Flammable, corrosive andoxidising chemicals are of particular concern inhealthcare.

Further guidance on the storage of chemicals is availablefrom the Health & Safety Executive (www.hse.gov.uk/chemicals).

Waste audit and duty-of-care checksWaste audit

If asked, the dental practice should be able to providedetailed information on its waste segregation procedures,their effectiveness and therefore the content of eachwaste stream.

Specifically, it should identify those waste streams thatcontain or are contaminated with, in any quantity:

• other medicines;

• amalgam;

• chemicals and photochemicals.

Undertaking such audits will enable the practice todemonstrate that it has discharged its duty of care indescribing and packaging its waste.

Note

The statutory duty of care applies to everyone in thewaste management chain. It requires producers andothers who are involved in the management of the wasteto prevent its escape and to take all reasonable measuresto ensure that the waste is dealt with appropriately fromthe point of production to the point of final disposal. Akey element to the duty of care is the requirement forbusinesses to keep a written description, adequatelydescribing the type and quantity of waste. This shouldaccompany the waste as it is moved from point ofproduction to point of final disposal.

Main responsibilities of the waste producer in line withthe duty of care:

• Describe the waste fully and accurately.

• Complete and sign a waste transfer note (orconsignment note for hazardous waste) prior towaste being transferred to another party.

• Pack waste securely (where appropriate) in line withthe Carriage Regulations.

• Tag and label waste receptacles for identification.

• Store waste safely on-site.

• Register as a waste carrier (if required), and make allreasonable checks on waste carriers.

• Select an appropriate recovery or disposal method.

• Ensure waste falls within the terms of the wastecontractor’s waste management licence, permit orexemption.

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Pre-acceptance audits

Producers of healthcare wastes, including those fromdental practices, are required to undertake regular(usually annually) pre-acceptance audits of theirpremises. The purpose of the audits is to ensure thatwaste is being segregated and disposed of appropriatelyand in line with all legal and other requirements.

Evidence of the pre-acceptance audit should be suppliedto the healthcare waste disposal contractor used by thepractice. If the audits are not undertaken the wastecontractor may refuse to accept the waste, as withoutevidence of the audit they will be in breach of theirEnvironment Agency permit conditions. For furtheradvice, consult with your waste contractor, also, in-depthguidance on waste auditing is available in HTM 07-01:Safe Management of Healthcare Waste.

Waste carriersThe waste contractor who collects the waste must be aregistered waste carrier.

This should be checked by, for example, comparing thecarrier registration number on Part C of theconsignment note to the information held on theEnvironment Agency’s electronic public register.

Waste disposalWaste from small practices is frequently taken to a wastetransfer station where it is combined with other wastesand sent for final disposal.

Check if the waste is being taken to a waste transferstation and, if this is the case, ask for copies of thedocumentation used for onward movement of the wasteto its final destination.

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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.

• Bar soap must not be used or made available in thepractice.

• Do not use scrub or nail brushes because these cancause abrasion of the skin where microorganisms canreside.

• 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/gels formulated for usewithout water can be used on visibly clean hands inconjunction with a good hand-washing technique forinvasive dental procedures.

• Antibacterial-based hand-rubs/gels can also be usedinstead of hand-washing between patients duringsurgery sessions.

• Follow local infection control guidance ormanufacturers’ instructions on the maximum numberof applications of antibacterial-based hand-rubs/gelsthat 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/gels, as theyare not effective in hand decontamination.

• Use a foot-operated or sensor-operated waste bin.

81

Appendix 2 – Hand-hygiene policy

82


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.

83

Appendix 2 – Hand-hygiene policy

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HANDCLEANING

TECHNIQUES

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)

Infection control nurse

Competent Person (Pressure vessels)*

Authorised Person

(Decontamination)

Competent Person

(Decontamination)*

Service engineer

Microbiologist

Review of records by PCT/Authorised Person (Decontamination)

Date Comments on review Name/signature

*These personnel should have qualifications/training/registration defined in HTM 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

84

85


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 HTM 01-05

Faults – new or existing (also enter in plant history record)

86

Decontamination: Health Technical Memorandum 01-05 – Decontamination in primary care dental practices - Welsh edition 2011 Update One

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 HTM 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)

87


Type

of

auto

clav

e

Den

tal p

ract

ice

Star

t da

te f

or t

his

shee

t

Dep

artm

ent/

loca

tion

Ref

. No

Seri

al N

o.

FAU

LTS

RE

CO

RD

MA

INT

EN

AN

CE

RE

CO

RD

Faul

tD

ate

Cyc

leD

etai

ls o

f fa

ult

Not

ed a

ndD

ate

Faul

tM

aint

enan

ce r

ecor

d –

incl

ude

serv

icin

g C

arri

ed o

ut b

ynu

mbe

rnu

mbe

rre

port

ed b

ynu

mbe

ras

wel

l as

faul

t-fin

ding

det

ails

Tabl

e A

5:

Aut

ocla

ve h

isto

ry r

ecor

d sh

eet

88


Den

tal p

ract

ice

Star

t da

te f

or t

his

shee

t

Dep

artm

ent/

loca

tion

Ref

. No

Seri

al N

o.

Dat

eC

ycle

Cyc

leC

ycle

Cyc

le p

ass

Prin

tout

Com

men

tsnu

mbe

rst

art

sele

cted

Des

crip

tion

of

load

chec

ked

OK

and

oper

ator

tim

e(i

f ap

plic

able

)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

89

Appendix 4 – Periodic test: small steam sterilizers

Key

Table 2: Types of sterilization cycle (taken from reference documents)

Daily Tests

Cycle type Air removal Load type Advantages Disadvantages

N Passive (gravity Non-wrapped solid Simplest type. Least expensive to Not to be used for:displacement). items. purchase, operate and maintain. • Hollow devices or those with

lumens;• Wrapped loads (e.g. items in

pouches).

B Active (forced) Wrapped or non- Widest range of applications. Expensive to purchase andair removal. wrapped solid items maintain.

(e.g. cannulae withindimensions specified Additional periodic testing required.by sterilizermanufacturer). Post-sterilization drying stage

Porous loads (e.g. essential for wrapped items increases

fabrics, swabs,total cycle times.

dressings).

S Active (forced) Only suitable for Wider range of applications than Expensive to purchase and maintain.air removal types of loads Type N

specified by the Additional periodic testing required.sterlizer manufacturer.

Post-sterilization drying stage essential for wrapped items increases total cycle times.

Note: Ideally, only the highest specification cycle should be available to the operator. Other cycles should be disabled, untilspecifically needed

Test Type Sterilizer Cycle Type Applicable

Automatic Control Test B, N, S

Steam Penetration Test B, S

Weekly Test




Air Leakage Test B, S

Air Detector Function Test B, S

Quarterly Test



Air Leakage Test (Sensors inserted) B, S


Verification of Control

Small Load Thermometric Test B, N, S

Air Leakage Test (Sensors removed) B, S



90


Yearly/Revalidation Test

Test Type Sterilizer Type Applicable


Air Leakage Test (Sensors inserted) B, S


Verification of Control B, N, S

Chamber Wall Temperature test B, N, S

Steam Generator overheat cut-out test B, N, S

Air Detector Performance Test – Small load B, S

Air Detector Performance Test – Full load B, S

Full Load Thermometric Test B, N, S

Porous Load Dryness Test B, S

Small Load Thermometric Test B, N, S

Solid Load Thermometric Test B, N, S

Solid Load Dryness Test

Tests for Performance Re-qualification B, N, S(as required by User)

Air Leakage Test (Sensors removed) B, S



Please consult documents listed for further clarification.

MDA DB 9804 (1998): This Device Bulletin has been withdrawn fromcirculation. However, for the purposes of the above tests this document isstill considered to be ‘best practice’ until the proposed HTM 01-07Decontamination in primary care document is published.

MDA DB 2002 (06) – 2002

BS EN 13060

HTM 2010

Manufacturers’ guidance

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 regulationsCarriage of Dangerous Goods and Use ofTransportable Pressure Equipment Regulations 2007.SI 2007 No 1573. HMSO, 2007.http://www.legislation.gov.uk/uksi/2007/1573/contents/made

Consumer Protection Act 1987. HMSO, 1987.http://www.legislation.gov.uk/ukpga/1987/43/contents

Control of Substances Hazardous to HealthRegulations (COSHH) 2002. SI 2002 No 2677.HMSO, 2002.http://www.legislation.gov.uk/uksi/2002/2677/contents/made

Hazardous Waste (England and Wales) Regulations2005. SI 2005 No 894.http://www.legislation.gov.uk/uksi/2005/894/contents/made

Health Act 2006. HMSO, 2006.http://www.legislation.gov.uk/ukpga/2006/28/contents

Health and Safety at Work etc Act 1974. HMSO, 1974.http://www.legislation.gov.uk/ukpga/1974/37/contents

Health and Social Care Act 2008. HMSO, 2008.http://www.legislation.gov.uk/ukpga/2008/14/contents

Medical Devices Regulations 2002. SI 2002 No. 618.HMSO, 2002.http://www.legislation.gov.uk/uksi/2002/618/contents/made

Pressure Systems Safety Regulations 2000. SI 2000No 128. HMSO, 2000.http://www.legislation.gov.uk/uksi/2000/128/contents/made

Waste Electrical and Electronic Equipment Regulations2006. SI 2006 No. 3289. HMSO, 2006.http://www.legislation.gov.uk/uksi/2006/3289/contents/made

Water Supply (Water Fittings) Regulations 1999. SI1999 No 1148. HMSO, 1999.http://www.legislation.gov.uk/uksi/1999/1148/contents/made

Water Supply (Water Quality) Regulations 2000. SI2000 No 3184. HMSO, 2000.http://www.legislation.gov.uk/uksi/2000/3184/contents/made

Codes of PracticeThe Health and Social Care Act 2008: Code ofPractice on the prevention and control of infectionsand related guidance (2010).http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_122604

British, European and InternationalStandardsBS 5925:1991. Code of practice for ventilationprinciples and designing for natural ventilation. BritishStandards Institution, 1991.

BS 6700:2006. Design, installation, testing andmaintenance of services supplying water for domestic usewithin buildings and their curtilages. Specification.British Standards Institution, 2006.

BS 6920-1:2000. Suitability of non-metallic productsfor use in contact with water intended for humanconsumption with regard to their effect on the quality ofthe water. Specification. British Standards Institution,2000.

BS EN 285:2006+A1:2008. Sterilization. Steamsterilizers. Large sterilizers. British Standards Institution,2008.

BS EN 556-1:2001. Sterilization of medical devices.Requirements for medical devices to be designated“STERILE”. Requirements for terminally sterilizedmedical devices. British Standards Institution, 2001.

BS EN 556-2:2003. Sterilization of medical devices.Requirements for medical devices to be designated“STERILE”. Requirements for aseptically processedmedical devices. British Standards Institution, 2003.

91

References

http://www.legislation.gov.uk/uksi/2007/1573/contents/made
















http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_122604


BS EN 806-2:2005. Specifications for installations insidebuildings conveying water for human consumption.Design. British Standards Institution, 2005.

BS EN 806-3:2006. Specifications for installationsinside buildings conveying water for humanconsumption. Pipe sizing. Simplified method. BritishStandards Institution, 2006.

BS EN 13060:2004. Small steam sterilizers. BritishStandards Institution, 2004.BS EN 61010-1:2001, IEC 61010-1:2001. Safetyrequirements for electrical equipment for measurement,control and laboratory use. General requirements. BritishStandards Institution, 2001.

BS EN ISO 11607-1:2006. Packaging for terminallysterilized medical devices. Requirements for materials,sterile barrier systems and packaging systems. BritishStandards Institution, 2006.

BS EN ISO 15883-1:2006. Washer-disinfectors.General requirements, terms and definitions and tests.British Standards Institution, 2006.

BS EN ISO 15883-2:2006. Washer-disinfectors.Requirements and tests for washer-disinfectorsemploying thermal disinfection for surgical instruments,anaesthetic equipment, bowls, dishes, receivers, utensils,glassware, etc. British Standards Institution, 2006.

BS EN ISO 17665-1:2006. Sterilization of health careproducts. Moist heat. Requirements for thedevelopment, validation and routine control of asterilization process for medical devices. BritishStandards Institution, 2006.

Department of Health publicationsAdvice for dentists on reuse of endodontic instrumentsand variant Creutzfeldt-Jakob Disease (vCJD). “DearColleague” letter, April 2007.www.dh.gov.uk/en/Publicationsandstatistics/Lettersandcirculars/Dearcolleagueletters/DH_074001

Clean, safe care: reducing infections and saving lives.2008.www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_081650

Decontamination of reusable medical devices in theprimary, secondary and tertiary care sectors – 2007.Clarification and policy summary. 2007.www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_074722

Getting ahead of the curve: a strategy for combatinginfectious diseases (including other aspects of healthprotection). Department of Health, 2002.www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_4007697

Health Building Note 13 – Sterile services department.The Stationery Office, 2004.

Health Facilities Note 30 – Infection control in thebuilt environment. The Stationery Office, 2002.

Health Service Circular (HSC) 1999/178 – VariantCreutzfeldt-Jakob Disease (vCJD): minimising the riskof transmission.http://www.dh.gov.uk/en/Publicationsandstatistics/Lettersandcirculars/Healthservicecirculars/DH_4004969

Health Service Circular (HSC) 1999/179 – Controlsassurance in infection control: decontamination ofmedical devices.http://www.dh.gov.uk/prod_consum_dh/groups/dh_digitalassets/@dh/@en/documents/digitalasset/dh_4077786.pdf

Health Service Circular (HSC) 2000/032:Decontamination of medical devices.www.dh.gov.uk/en/Publicationsandstatistics/Lettersandcirculars/Healthservicecirculars/DH_4002990

Health Service Guideline (HSG) (93)40: Protectinghealth care workers and patients from hepatitis B.http://webarchive.nationalarchives.gov.uk/+/www.dh.gov.uk/en/Publicationsandstatistics/Lettersandcirculars/Healthserviceguidelines/DH_4084234

Health Technical Memorandum 00 – Policies andprinciples: best practice guidance for healthcareengineering. The Stationery Office, 2006.

Health Technical Memorandum 01-01 –Decontamination of reusable medical devices. Part A:Management and environment. The Stationery Office,2007.

Health Technical Memorandum 01-01 –Decontamination of reusable medical devices. Part B:Additional management guidance and commonelements. The Stationery Office (forthcoming).

Health Technical Memorandum 01-01 –Decontamination of reusable medical devices. Part C:Sterilizers. The Stationery Office (forthcoming).

Health Technical Memorandum 01-01 –Decontamination of reusable medical devices. Part D:Washer-disinfectors and ultrasonic cleaners. TheStationery Office (forthcoming).

Health Technical Memorandum 01-02 –Decontamination in laboratories. The Stationery Office(forthcoming).

Health Technical Memorandum 01-03 –Decontamination in pharmacies. The Stationery Office(forthcoming).

Health Technical Memorandum 01-04 –Decontamination of laundry and infected linen. TheStationery Office (forthcoming).

92


http://www.dh.gov.uk/en/Publicationsandstatistics/Lettersandcirculars/Dearcolleagueletters/DH_074001




http://www.dh.gov.uk/en/Publicationsandstatistics/Lettersandcirculars/Healthservicecirculars/DH_4004969

http://www.dh.gov.uk/prod_consum_dh/groups/dh_digitalassets/@dh/@en/documents/digitalasset/dh_4077786.pdf

http://www.dh.gov.uk/en/Publicationsandstatistics/Lettersandcirculars/Healthservicecirculars/DH_4002990

http://webarchive.nationalarchives.gov.uk/+/www.dh.gov.uk/en/Publicationsandstatistics/Lettersandcirculars/Healthserviceguidelines/DH_4084234

Health Technical Memorandum 01-06 –Decontamination of flexible endoscopes. The StationeryOffice (forthcoming).

Health Technical Memorandum 04-01 – The controlof Legionella, hygiene, “safe” hot water, cold water anddrinking water systems. The Stationery Office, 2006.

Health Technical Memorandum 07-01 – Safemanagement of healthcare waste. The Stationery Office,2006.

National standards, local delivery: main principles to beconsidered when setting up a decontamination servicefor PCTs. National Decontamination Programme, 2005.www.dh.gov.uk/prod_consum_dh/idcplg?IdcService=GET_FILE&dID=29244&Rendition=Web

Potential vCJD transmission risks via dentistry: aninterim review.www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_081170

Records management: NHS code of practice. 2006.www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_4131747

Uniforms and workwear: Guidance on uniform andworkwear policies for NHS employershttp://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_114751

Winning ways: working together to reduce healthcare-associated infection in England. 2003.http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_4064682

Other publicationsHealth and Safety Commission (2000). Approved Codeof Practice, Legionnaires’ disease: the control oflegionella bacteria in water systems (L8). Health andSafety Executive, 2000.

Medicines and Healthcare products Regulatory Agency.DB 9804 (including update sheet, November 2003) –The validation and periodic testing of benchtopvacuum steam sterilizers. MHRA, 1998.www.mhra.gov.uk/Publications/Safetyguidance/DeviceBulletins/CON007359

Medicines and Healthcare products Regulatory Agency.MDA DB 2002 (06) (including update sheet, October2004) – Benchtop steam sterilizers: guidance onpurchase, operation and maintenance. MHRA, 2002.www.mhra.gov.uk/Publications/Safetyguidance/DeviceBulletins/CON007326

Meiller, 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.

NHSScotland. Survey of decontamination in generaldental practice. Sterile Services Provision Review Group,2004.www.sehd.scot.nhs.uk/publications/DC20041202Dental.pdf

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, Causesand prevention 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.

Water Regulations Advisory Scheme (WRAS). WaterFittings and Materials Directory. WRAS, Gwent, 2005.

World Health Organization (WHO). Guidelines fordrinking-water quality. Third Edition. WHO Press,Geneva, 2008.www.who.int/water_sanitation_health/dwq/secondaddendum20081119.pdf

Healthcare associated infections – a communitystrategy for Waleshttp://wales.gov.uk/topics/health/protection/communicabledisease/publications/community/?lang=en

Advice for dentists on re-use of endodontic instrumentsand variant Creutzfeldt-Jakob disease (vCJD)http://wales.gov.uk/topics/health/ocmo/professionals/dental/publication/cdo-letters/cjd/?lang=en

National Infection Control Policies for Waleshttp://www.wales.nhs.uk/sites3/page.cfm?orgid=379&pid=38960

WHC(2000)71 - For the record - Managing Records inNHS Trusts and Health Authoritieshttp://www.wales.nhs.uk/documents/WHC(00)71.htm

The Private Dentistry (Wales) Regulations 2008http://www.legislation.gov.uk/wsi/2008/1976/contents/made

93

References

www.dh.gov.uk/prod_consum_dh/idcplg?IdcService=GET_FILE&dID=29244&Rendition=Web







http://www.mhra.gov.uk/Publications/Safetyguidance/DeviceBulletins/CON007359

http://www.mhra.gov.uk/Publications/Safetyguidance/DeviceBulletins/CON007326

http://www.sehd.scot.nhs.uk/publications/DC20041202Dental.pdf

http://www.sehd.scot.nhs.uk/publications/DC20041202Dental.pdf

http://www.who.int/water_sanitation_health/dwq/secondaddendum20081119.pdf

http://wales.gov.uk/topics/health/protection/communicabledisease/publications/community/?lang=en

http://wales.gov.uk/topics/health/ocmo/professionals/dental/publication/cdo-letters/cjd/?lang=en

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

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

http://www.wales.nhs.uk/documents/WHC(00)71.htm

http://www.legislation.gov.uk/wsi/2008/1976/contents/made

http://www.legislation.gov.uk/wsi/2008/1976/contents/made

94


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STATUS IN WALES 01 05 Wales ed... · 2015-10-27 · For queries on the status of this document contact [email protected] or telephone 029 2031 5512 2014 HEALTH TECHNICAL MEMORANDUM