Decontamination in primary care dental practices - Gov.uk

Decontamination: Health Technical Memorandum 01-05 – Decontamination in primary care dental practices (2013 edition)© Crown copyright 2009, 2013This document/publication is not covered by the HMSOClick-Use Licences for core or added-value material.If you wish to re-use this material, please send your applicationto:Copyright applicationsThe Copyright UnitOffice of Public Sector InformationInformation Policy TeamKewRichmondSurreyTW9 4DUe-mail: licensing@opsi.gov.ukFirst published 2009; second edition 2013iv

Decontamination: Health Technical Memorandum 01-05 – Decontamination in primary care dental practices (2013 edition)Health Technical Memorandum 03Heating and ventilation systemsHealth Technical Memorandum 04Water systemsHealth Technical Memorandum 05Fire safetyHealth Technical Memorandum 06Electrical servicesHealth Technical Memorandum 07Environment and sustainabilityHealth Technical Memorandum 08Specialist servicesSome subject areas may be further developed into topicsshown as -01, -02 etc and further referenced into Parts A,B etc.Example: Health Technical Memorandum 06-02 Part Awill represent:Electrical Services – Electrical safety guidance for lowvoltage systemsIn a similar way Health Technical Memorandum 07-02will simply represent:Environment and Sustainability – EnCO 2de.All Health Technical Memoranda are supported by theinitial document Health Technical Memorandum 00which embraces the management and operational policiesfrom previous documents and explores risk managementissues.Some variation in style and structure is reflected by thetopic and approach of the different review workinggroups.DH Estates and Facilities Division wishes to acknowledgethe contribution made by professional bodies,engineering consultants, healthcare specialists andNHS staff who have contributed to the production ofthis guidance.Figure 2 Engineering guidanceHE ALTHHTM 08SpecialistServicesSPECIFICINDUSTRYDOCUMENTSHTM 01DecontaminationSTANDARDSH E A LT HS P E C IFHTM 07Environment &SustainabilityI CHTM 06ElectricalServicesD O C U M E N T SHTM 05FireSafetyINTERNATIONAL & EUROPEAN STANDARDSINTERNATIONAL & EUROPEAN STANDARDSHTM 00Policies andPrinciplesIN D USTRYSTA N DA R D SHTM 04WaterSystemsHTM 02MedicalGasesHTM 03Heating &VentilationSystemsH E A LT HD O C U M E N T SS P E C I FI Cvi

Executive summaryPreambleThis document forms part of the Health TechnicalMemorandum 01 Decontamination series. Other partsinclude:• Choice Framework for local Policy and Procedures01-01:Management and decontamination of surgicalinstruments (medical devices) used in acute care• Health Technical Memorandum 01-02:Decontamination in laboratories• Health Technical Memorandum 01-03:Decontamination in pharmacies• Choice Framework for local Policy and Procedures01-04: Decontamination of linen for health and socialcare• Choice Framework for local Policy and Procedures01-06: 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 (localdecontamination)• Section 3: Engineering, technology and standards.Aim of the guidanceHealth Technical Memorandum 01-05 is intendedto progressively raise the quality of decontaminationwork in primary care dental services by covering thedecontamination of reusable instruments within dentalfacilities.Who should use this guidance?Health Technical Memorandum 01-05 will be of interestto all staff involved in decontamination in primary caredental services.It is intended to be used, or referred to, by all members ofa dental team providing primary care dental services (thatis, dentists and support staff as well as engineering staffproviding services in key areas).Reference to other parts of the Choice Framework forlocal Policy and Procedures 01 series may be necessary(on a limited basis only).2013 edition of Health TechnicalMemorandum 01-05This section does not give an exhaustive list of theamendments made to the 2009 edition but rathersummarises the rationale behind this new edition, inparticular the main policy changes.This 2013 edition of Health Technical Memorandum01-05 reflects the consensus on patient safety in the areaof storage of dental instruments. Consequently, thisreview of the guidance on storage times (in particular, seeparagraphs 2.4k, 4.22 and 4.26–4.27) has been carriedout in advance of the planned revision of HealthTechnical Memorandum 01-05.It is recognised that potentially infectiousrecontamination of sterilized dental instruments is eventrelatedrather than time-dependent. Within dentalpractices, there is a rapid turnaround of the mostregularly used dental instruments. The 2009 edition wasnot helpful in the management of these frequently usedinstruments.The rationale for this change is that these dentalinstruments are used in contaminated body areas. Anyenvironmental contamination that takes place wouldhave a minimal impact on patient safety compared withcontamination with another patient’s blood or bodyfluid, which would be a significant hazard to patients.Thus, the emphasis is on ensuring effectivedecontamination and preventing contamination withanother patient’s blood and body fluid rather than onpreventing environmental contamination of sterilizedinstruments.The guidance document has also been updated to reflectthe changes to the NHS infrastructure following theHealth and Social Care Act 2012.vii

Decontamination: Health Technical Memorandum 01-05 – Decontamination in primary care dental practices (2013 edition)AcknowledgementsAllan Hidderley Medicines & Healthcare products Regulatory AgencyChristine Arnold British Dental AssociationDaniel McAlonan British Dental AssociationEsther Dias Infection Prevention Officer and Decontamination Lead, NHS BromleyGeoff Ridgway Clinical microbiologistHugh Bennett Deputy Chief Dental Officer for WalesJimmy Walker Health Protection AgencyKen Toal Health Estates, Northern IrelandLesley Derry British Dental AssociationLester Ellman General Dental PractitionerMargie Taylor Chief Dental Officer for ScotlandMartin Jones Infection Prevention SocietyMurray Devine Safety Strategy Lead, Healthcare CommissionPaul Gray NHS Business Services Authority, Dental Services DivisionPaul Langmaid Chief Dental Officer for WalesStuart Johnston British Dental AssociationDH Working Group on Water Quality in Use and Decontamination of Surgical Instruments.Chairman Nigel TomlinsonEngineering and Science Advisory Committee on the decontamination of surgical instruments.Chairman Mike PainterInternal consulting groupBarry Cockcroft Chief Dental Officer for EnglandJerry Read Section Head, Dental and Eye Care DivisionSerbjit Kaur Head of Quality and Standards, Dental and Eye Care ServicesRuth Gasser Department of HealthIan Rowlan Senior Engineer, Department of HealthPhilip Ashcroft Principal Buildings and Facilities Management Services Engineer, Department of HealthNigel Tomlinson Principal Scientific Adviser, Department of Health2013 edition working groupDaniel McAlonan British Dental AssociationJimmy Walker Health Protection AgencySerbjit Kaur Head of Quality and Standards, Dental and Eye Care ServicesPeter Hoffman Health Protection AgencyPaul Gray NHS Business Services Authority, Dental Services DivisionPhilip Ashcroft Principal Buildings and Facilities Management Services Engineer, Department of HealthExcept where stated, all photographs are published by kind permission of Bromley Primary Care Trustviii

ContentsContentsPrefaceExecutive summaryPreambleStructureAim of the guidanceWho should use this guidance?2013 edition of Health Technical Memorandum 01-05AcknowledgementsInternal consulting group2013 edition working groupSECTION 1: DECONTAMINATION POLICY AND FOREWORD 1Chapter 1Policy and foreword(Barry Cockcroft, Chief Dental Officer) 2Registration“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 guidanceSECTION 2: ADVICE TO DENTISTS AND PRACTICE STAFF 9Chapter 2 Essential quality requirements and best practice 10Decontamination of instruments –an overviewComplianceEssential quality requirementsChapter 3 Cleaning instruments 16IntroductionGeneral requirements for cleaning methodsAutomated cleaning: washer-disinfectorsUsing a washer-disinfectorRecordsConsiderations for cleaning handpiecesAutomated cleaning: ultrasonic cleaningUltrasonic cleaning procedureManual cleaningAvoiding instrument damageCleaning procedure summaryRinsing of instruments after cleaning and or disinfectionvii

Decontamination: Health Technical Memorandum 01-05 – Decontamination in primary care dental practices (2013 edition)Inspection and care of instruments before sterilizingHandpiece careChapter 4 Sterilization 22Types of sterilizerDental handpiecesBenchtop sterilizersUse and testing of benchtop sterilizersDaily testing and housekeeping tasksPackaging and related decontamination strategyStorage of sterilized instruments/devicesChapter 5 Setting up a decontamination area 29Physical segregationChapter 6 General hygiene principles 33Hand hygieneDrying of handsSkin careFacilities and procedures for hand-washingPersonal protective equipment for decontamination processesGlovesDisposable plastic apronsFace and eye protection for decontamination proceduresClothing, uniforms and laundryRemoval of PPESurface and equipment decontaminationGeneralEnvironmental conditionsSurfaces and equipment – key design issuesDecontamination equipmentCleaning protocols and techniquesDecontamination of treatment areasDental unit water lines (DUWLs)GeneralDUWLsChapter 7 Impressions, prostheses and orthodontic appliances 42SECTION 3: ENGINEERING, TECHNOLOGY AND STANDARDS 43Chapter 8 Regulatory framework and compliance 44BS/EN/ISO StandardsDH guidelinesChapter 9 Staff roles and responsibilities in decontamination 46Chapter 10 Procurement of decontamination equipment and instruments 48Determining the load to be processedDecontamination equipment: washer-disinfectors and sterilizersDecontamination equipment: ultrasonic cleanersSpecificationsSelecting instrumentsPolicy on new reusable instrumentsChapter 11 Decontamination equipment: general guidance on maintenance and testing 53Maintenance and servicingValidation and testingDocumentationChapter 12 Installation, validation, maintenance and testing of sterilizers 55Maintenance and servicingviii

ContentsValidation and testingPeriodic testsChapter 13 Installation, validation, maintenance and testing of washer-disinfectors 57Maintenance and servicingValidationChapter 14 Installation, validation, maintenance and testing of ultrasonic cleaners 59Maintenance and servicingValidationPeriodic testsChapter 15Additional information on test procedures (in addition to those provided in the Standards)61Automatic control testMethodUltrasonic activity testMethodSafety checksWeekly checksYearly checksChapter 16 Approach and protocol for manual cleaning 63Cleaning procedure for dental instrumentsChapter 17 Steam and water quality 65SteamQuality of input waterConditions of storage and frequency of changeWaterCleaningFinal rinsingDetergentsChapter 18 The use of lubricants 66Chapter 19 Hot and cold water systems and dental unit water lines 67Safe 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 storageCold water distribution systemDrinking waterInstantaneous water heaters for single or multi-point outletsSafe hot water delivery devicesMaterials of constructionTemperature control regimenPoint-of-use filtrationSummary checklistix

Decontamination: Health Technical Memorandum 01-05 – Decontamination in primary care dental practices (2013 edition)Microbiological monitoringAppendix 1 – Hand hygiene policy 76Appendix 2 – Examples of logbook pages 78References83Northern Ireland references, equivalents and variations 86x

1 Policy and foreword (Barry Cockcroft, Chief Dental Officer)Section 1: Decontaminationpolicy and foreword1

1 Policy and foreword (Barry Cockcroft, Chief Dental Officer)of a dental service is capable of operating in asafe 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 ‘Health and Social CareAct 2008: Code of Practice on the prevention andcontrol of healthcare associated infections andrelated guidance’ (the Code of Practice). Thisrequires that effective prevention and control ofhealthcare-associated infection be embedded ineveryday practice. For this reason, the guidance iswritten with emphasis on practical and readilyimplemented measures. Appendix B of the Code ofPractice refers specifically to the requirements fordental practices.1.5 The 2010 revision to the Code of Practiceestablishes a duty to provide and maintain aclean and appropriate environment for healthcarewithin which a specific requirement for effectivearrangements for the appropriate decontaminationof instruments and other equipment is given.This guidance is designed to assist all primary caredental providers (including salaried dental services)in meeting these requirements.1.6 ‘Clean, safe care – reducing infections andsaving lives’ refers to the need for high-qualityenvironmental cleaning and decontamination asvital components in reducing rates of infection.“Essential quality requirements” and“best practice”1.7 Every practice should be capable of meeting theessential quality requirements, that is:• Regardless of the technology used, the cleanedinstruments, prior to sterilization, should befree of 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 every six months using an audit tool(the use of the Infection Prevention Society/DHaudit tool is strongly recommended). This canbe downloaded from www.ips.uk.net at the“resources/dental audit tool” section of thewebsite.• 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 2.4.1.8 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 donot conflict with the requirement for a cleanenvironment.• The storage of reprocessed dental instrumentsin a simple but carefully designed facility clearlyseparate from the clinical treatment area is animportant best practice improvement. Thefacility should take account of the need toreduce recontamination of sterilized instrumentsand also make the identification/selection of3

Decontamination: Health Technical Memorandum 01-05 – Decontamination in primary care dental practices (2013 edition)For best practice, the clinical treatment area should be clearly separate from the decontamination facilitiesinstruments easy. This storage facility willordinarily be part of the clean area within thedecontamination room(s).1.9 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.1.10 Following the guidance in this document willhelp to achieve a satisfactory level of risk controltogether with equivalent compliance with the“essential requirements” of the regulations.Progression towards best practice1.11 Not all practices will, at present, be in a position toadopt best practice recommendations. However,every practice will need to assess the improvementsthey need to undertake to move towards these andprepare a plan to implement the changes.1.12 No schedule for attainment ofbest practice is provided in this guidance for thepresent. It is recognised that not only areimprovements in premises and equipment requiredto achieve higher standards, but also changes inpractice management and the culture in whichpatients are treated by the dental team arenecessary.4

1 Policy and foreword (Barry Cockcroft, Chief Dental Officer)“Sterile” and “sterilized”As the environment in which dental instruments areused is not sterile, it follows that dental instrumentswill not be sterile at the point of use. (They should,however, be in a sterile state at the end of thedecontamination process when the sterilizer dooris opened.)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.Noteand reamers (see paragraph 2.18). Otherinstrument or device types for which a reliablecleaning regime is not available should also beconsidered for replacement by single-use typesor by the single use of reprocessible instruments.Information regarding risk in this important area iscontained in ‘Potential vCJD transmission risks viadentistry: an interim review’ (December 2007).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 (http://www.dh.gov.uk/health/2012/11/acdp-guidance). The guidancesuggests that special precautions beyond fullinstrument decontamination will not be necessary.1.13 This guidance is based upon a principle ofcontinuous improvement in the quality ofdecontamination practices and the environmentused. Where dental practices use the same room forpatient treatment and decontamination (essentialquality requirements), they should have a plan inplace that facilitates a separate and controlleddecontamination room. This plan will normallyalso contain statements on staff training anddevelopment to suit work in a dedicateddecontamination room or suite.1.14 In addition, the plan should realistically outlinethe way forward in relation to best practicerequirements, for example:• measures to purchase and incorporate a washerdisinfector;• the separation of decontamination processesfrom the patient treatment area.Prion decontamination1.15 Recent research has indicated that a low level ofprion 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 Englandhas published requirements for endodontic files1.16 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 a usefullevel of deactivation of prion infectivity. While thiswould not be significant in high-risk tissue surgery,the effect is large enough to be of significance indentistry (excluding, that is, endodontic proceduresas mentioned in paragraph 1.15). In addition,there is a risk of prion transmission through proteincontamination of instruments, hence the measuresoutlined in this guidance to improve washing anddisinfection of dental instruments.1.17 Currently there is no recognised process thatcan fully deactivate prion protein in the sense ofremoving any foreseeable level of contamination. Inthis Health Technical Memorandum, the cleaningprocess and its ability to remove protein in tandemwith a validated steam sterilization procedure isemphasised, as this is known to at least reducethe risk of prion transmission through dentalinstruments.5

Decontamination: Health Technical Memorandum 01-05 – Decontamination in primary care dental practices (2013 edition)Infection control policy1.18 All dental practices should have an infectioncontrol policy in place and available for externalinspection.1.19 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 outlinedon page 15).NoteThis statement is subject to staged implementationand to local constraints (for example, the physicalinability to provide a separate room).1.20 Infection control needs to include all aspects ofthe running of a dental practice: from attention topersonal hygiene – hand-washing, masks, protectiveclothing – to the cleaning and sterilization ofinstruments and the maintenance of theequipment.1.21 Practices need to have a process in place to clearlyidentify the date of reprocessing of wrappedinstruments (paragraph 2.4k(i)). The record shouldshow the date of decontamination or the expirydate.Training and education1.22 Training and education in the processes ofpathogen 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 01-051.23 Health Technical Memorandum 01-05 relates tolocally conducted decontamination procedures,which are the most common method ofdecontamination in primary dental care. As such,this includes all work where the end-user and thepersons conducting decontamination are employeesof the same organisation working in the same orrelated premises. Ordinarily this will be a generaldental practice or salaried primary care dentalservices.1.24 Where practices choose to make use of anexternal service – such as a central sterile servicesdepartment – which is fully compliant with theMedical Devices Regulations 2002 and is registeredwith the Medicines and Healthcare productsRegulatory Agency (MHRA), the guidancecontained in Choice Framework for local Policyand Procedures 01-01 will be appropriate to thatservice.1.25 The policy clarification from DH(‘Decontamination of reusable medical devices inthe primary, secondary and tertiary care sectors(NHS and Independent providers) – 2007clarification and policy summary’) states that localdecontamination should meet with the appropriate“essential requirements” of the Medical DevicesRegulations 2002. This implies that dentalpractices ensure that their local policies give rise tothe production and use of sterilized instruments foruse with patients.1.26 This document is divided into three sections:• Section 1: Decontamination policy andforeword.This 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 staff.This 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 andstandards.This section gives technical advice toengineering and technical staff, including6

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2 Essential quality requirements and best practiceSection 2: Advice to dentists and practice staff9

Decontamination: Health Technical Memorandum 01-05 – Decontamination in primary care dental practices (2013 edition)2 Essential quality requirements and bestpracticeDecontamination of instruments –an overview2.1 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 of instrumentdecontamination.ComplianceEssential quality requirements2.3 Instruments should be reprocessed using a validateddecontamination process including a validatedsteam sterilizer, and at the end of the reprocessingcycle they should be sterilized.2.4 In maintaining and developing dentaldecontamination practices, all the following shouldbe included:a. A local infection control policy subject toupdate as required by the Code of Practice, or attwo-yearly intervals, whichever is the shorter.AcquireClean:• with a washer-disinfector (WD);• with or without an ultrasonic cleaner;• manuallyTransportNon-clinical area(max. 1 week)UseClinical area(max. 1 day)Store(max. 1 year)• Location• Facilities• Equipment• Management• Policies and proceduresInspectRepeat cleaningif necessaryUnwrappedand dryWrappedand dryStore(max. 1 year)Steam-sterilize(Type N)WrapSteam-sterilizein vacuum sterilizer(Type B or S)10

2 Essential quality requirements and best practiceCompliance definitionsCompliance – Essential quality requirementsThis 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 developingtowards higher levels of achievement in this area overtime. The use of an audit tool will assist dentalpractices in reaching the necessary standards (seeparagraph 2.21).In order to demonstrate compliance with essentialquality requirements, practices will beexpected to provide a statement on plans for futureimprovement. Details on registration requirements aregiven in Chapter 8.Compliance – Best practiceBest practice refers to the full level of compliance thatmay be achieved immediately or via a documentedimprovement from essential quality requirements.b. The above policy should have detailedrequirements/procedures for thedecontamination of instruments.c. The practice should have a nominated leadmember of staff responsible for infection controland 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 shouldbe consulted for further information.Guidance on COSHH is available from theHealth & Safety Executive (http://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 and disposal.)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 an ultrasonicbath, but this should be covered during use torestrict the release of aerosols. Manual cleaningmay also be used. Practices should plan for theintroduction of washer-disinfectors. Inspectionprocesses should ensure that the standards ofcleaning achieved are visually satisfactory – thatis, that instruments are free from particulatecontamination, salt deposits or markeddiscoloration. The use of a simple magnifyingdevice with task lighting is required.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 instruments sterilizedin a specific controlled clean area. In the firstinstance, where practices are meeting theessential 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 useof a designated room or rooms will becomeappropriate (see Figures 1–3 in Chapter 5).k. Instrument storage and wrappingrecommendations:(i) Wrapped instruments may be stored up to1 year (see paragraphs 4.25–4.29):• pre-sterilization wrapped if type B or S;• post-sterilization wrapped if type N.(ii) Unwrapped instruments in the clinicalarea: maximum storage 1 day. Instrumentsshould be:• dry; and• protected from contamination, forexample in mini-racks placed in cupboardsor in covered drawer inserts. Instrumentsshould not be stored on open worksurfaces, particularly in clinical areas. It isimportant that practices have well11

Decontamination: Health Technical Memorandum 01-05 – Decontamination in primary care dental practices (2013 edition)developed protocols and procedures inplace to prevent contamination of theseinstruments by ensuring that thoserequired for a particular patient areremoved from their protected environmentbefore treatment commences. Thiseliminates the need to open cupboarddoors or drawers during patient treatment.If an instrument does need to be retrievedfrom a cupboard or drawer duringtreatment, the practice should haveprotocols in place to preventcontamination and to ensure that staffhands are clean and that new gloves aredonned before handling unwrappedsterilized instruments. Regard allinstruments set out for each patient ascontaminated after the treatment whetheror not they have been used.Instruments that are kept unwrapped should bereprocessed at the end of the working day,regardless of whether they have been used.Alternatively, instruments can be reprocessed atthe beginning of the next working day.(iii) Unwrapped instruments in a non-clinicalarea: maximum storage 1 week.Non-clinical area in this context isdesignated as a clinical area not in currentuse or in a clean area of a separatedecontamination room. Instruments shouldstill be stored as follows:• dry; and• protected from contamination, forexample in mini-racks placed incupboards, or in covered drawer inserts.Instruments should not be placed on openwork surfaces.m. Develop a quality system approach so that thestorage of wrapped instruments does not exceedone year.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 and thatcorrect functioning should be monitored andrecorded (see Section 3).Notep. 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 for allstaff engaged in decontamination (see Section 3for details).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 exampleprotection against serious illness, protectionagainst spreading illness) and drawbacks (forexample reactions to the vaccine) of vaccination.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 availableand may be of value. However, validationin this area is difficult, and the advice ofmanufacturers/suppliers should be sought.u. Separate wash-hand basins for use by staffconducting decontamination should beprovided.v. Washing and rinsing of instruments can beachieved by:• Two dedicated sinks with a separate orshared water supply.• One sink with a removable bowl, whichcan be contained within the sink that canaccommodate the instruments for rinsing.This is the least preferred option as itrequires lifting and moving bowls ofcontaminated water with associatedspillage risks. The practice should haveclear processes and protocols in place toensure that the removable bowl is not usedfor the washing of instruments.These sinks should not be used for hand-washing.12

2 Essential quality requirements and best practiceEssential infection control policies and procedures2.5 This guidance is primarily focused on medicaldevices and instruments used in dentistry. However,local policies must be broad-based and considera comprehensive view of hygiene and cleanlinessacross all aspects of dental practice and associatedfacilities.2.6 All dental practices should have an infectioncontrol policy together with guidelines andprocedures that contain the following information:• a written policy with regard to minimising therisk of blood-borne virus transmission, withparticular attention to the possibility ofsharps injuries. The policy should includearrangements for an occupational healthexamination of all staff thought to be at risk ofhepatitis B. (This is related to risk reduction inblood-borne virus transmission and generalinfection.) Confidential records of all suchexaminations should be maintained. Inaddition, a record of all sharps injuries must bemaintained in accordance with current healthand safety legislation. Further detail can befound in the Green Book (http://immunisation.dh.gov.uk/category/the-green-book);• 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) (for furtherdetails see Health Technical Memorandum 07-01);• a policy for hand hygiene (see Appendix 1);• 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 should include,at a minimum, the methods used, the frequencyof each procedure and appropriate recordkeepingpractices.2.7 Dental practices may consult with local infectioncontrol specialist advisers in order to obtain supportin the writing of local policies, within theframework provided here, and the design of localprocedures together with guidance implementationplanning (see also Chapter 6, which gives generalguidance on cleaning and disinfection protocolswithin the practice).Movement of instruments to and from adjacentdecontamination areas2.8 The object of the measures outlined below is toreduce the risk of cross-contamination betweeninstruments.2.9 The practice should have safe procedures for thetransfer of contaminated items from the treatmentto the decontamination area.2.10 Sterilized instruments and single-use instrumentsshould be clearly separated from those that havebeen used and are awaiting decontamination.2.11 A separate sterilized instrument tray should be usedfor each patient. These trays should be of a suitablesize to enable them to be placed in the sterilizer.Alternatively, single-use instrument trays may beused, provided these have been stored in a cleanand dry environment.2.12 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.Potable water immersion or the use of commercialgels/sprays may be considered if a delay inreprocessing is unavoidable.Segregating instruments2.13 Prior to cleaning, reusable instruments to becleaned should be segregated from items fordisposal.2.14 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.13

Decontamination: Health Technical Memorandum 01-05 – Decontamination in primary care dental practices (2013 edition)2.15 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.2.16 Shown below is the symbol that identifies singleuseitems. This will appear on packaging but mightnot be present on individual items. If in doubt,further advice should be sought from themanufacturer.22.17 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.2.18 Where endodontic reamers and files are designatedreusable, they should be treated as single patientuse or single use – regardless of the manufacturer’sdesignation – to reduce the risk of priontransmission. Practices must have effectiveprocedures in place to exclude errors in identifyingthe instrument(s) and associating them with thecorrect patient.2.19 Care needs to be exercised in the cleaning of reusableendodontic reamers and files. Whereautomated washer–disinfectors are used, the risk ofcross-contamination to other instruments would bevery low, in view of the dilution factors. Theseinstruments do not need to be processed on aseparate cycle. However, owing to the variability indilution during manual washing, the files/reamersshould be washed separately from otherinstruments.Quality assurance system and audit2.20 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.2.21 Compliance with this Health TechnicalMemorandum will be seen as indicative of thepresence of valid quality assurance systems. At aminimum, practices should audit theirdecontamination processes every six months, withan appropriate review dependent on auditoutcomes.NoteThe Infection Prevention Society/DH audit toolparallels the guidance provided in this document. Inaddition, a number of other safety-related topics areincluded in the tool. See paragraph 1.7.2.22 It is important that the audits are made available toregulatory bodies for inspection when required.2.23 Audit documents should be stored for at least twoyears. They should not be removed from thepremises or destroyed.Taking instruments to other locations2.24 The practice should have safe procedures for thetransfer of contaminated items from the treatmentarea to the decontamination facility.2.25 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 against accidentaldamage;• capable of being closed securely;• robust enough to prevent instruments beingdamaged in transit.14

2 Essential quality requirements and best practice2.26 Containers for transport of instruments fordecontamination and of sterilized instrumentsshould be clearly marked as for each function andshould not be used interchangeably2.27 Containers for transporting instruments fordecontamination should be kept visibly clean.When transporting sterilized instruments, to avoidrecontamination it is preferable that they arewrapped or separated from direct contact with theircontainer on a tray that itself has been sterilized. Ifthis is not feasible, sterilized instruments may betransported in a container that has been disinfectedwith a single-use disinfectant wipe and allowed todry, but chemical disinfection is a lower qualityassurance process than sterilization2.28 Where contaminated instruments are to betransported outside of the healthcare premiseson a public highway, those responsible for suchtransportation should refer to the requirements ofthe Carriage of Dangerous Goods and Use ofTransportable Pressure Equipment Regulations2007 and the Health and Safety at Work etc Act1974.2.29 A protocol for transportation that ensures thesegregation of contaminated product from clean/sterilized instruments should be followed.2.30 Contaminated instruments will be regarded as lowbiohazard materials and must be part of a notedconsignment. This means recording details ofthe group of items transported (that is, dentalinstruments), the time of dispatch and the intendedrecipient. Records should be such as to allow eachmovement to be traced and audited if necessary.The note should be positioned prominently withinany vehicle used for transportation and shouldcarry a contact telephone number.2.31 Where instruments travel in a vehicle with a dentistor other expert person, record-keeping may besimplified to cover the date and vehicle used only.This rule is applicable to, for example, school anddomiciliary visits.Best practiceProgress towards achieving best practice shouldinclude the following:• Install a validated washer-disinfector of adequatecapacity to remove the need for manual washing.• Improve separation of decontamination processesfrom other activities and enhance the distinctionbetween clean and dirty workflows.• Provide suitable storage for instruments, whichreduces exposure to contamination. Best practicewill include the development of a local qualitysystem focused on safe and storage of instruments.This will ensure that instrument storage is wellprotected in the appropriate clean room against thepossibility of exposure of stored instruments tocontaminated aerosols. In addition themanagement approach will ensure that commonlyusedinstruments are dealt with on a first-in firstoutprinciple and less frequently used instrumentsare stored with clear identification and reprocessedif not used within the designated storage periods.15

Decontamination: Health Technical Memorandum 01-05 – Decontamination in primary care dental practices (2013 edition)3 Cleaning instrumentsGuidance on the installation, validation, maintenanceand testing of ultrasonic cleaners and washerdisinfectorscan be found in Section 3.Introduction3.1 The principal methods of cleaning reusable dentalinstruments currently available are: cleaning using awasher-disinfector; manual combined withultrasonic 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 washerdisinfectorincludes a disinfection stage that rendersinstruments safe for handling and inspection.3.3 Manual cleaning, governed by an appropriateprotocol, is acceptable within the essential-qualityrequirementsframework. 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 that pre-washingmay be helpful (for example in the removal oftenacious dental materials), such action may beappropriate 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 or gel intended to maintain a moist orhumid environment are thought useful in aidingsubsequent decontamination. Long periods of wetstorage should, however, be avoided.3.6 When working with substances that can harden oninstruments (for example cements), the instrumentsshould be cleaned immediately. Instruments thatcannot be cleaned should be discarded.3.7 Where recommended by the manufacturer,instruments and equipment that consist of morethan one component should be dismantled to alloweach part to be adequately cleaned. Members of thedental team should be appropriately trained toensure 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’ instructionsrelating to instruments, dental equipment, cleaningdevices and cleaning solutions.3.9 Whenever possible, cleaning should be undertakenusing an automated and validated process inpreference to manual cleaning. Manual cleaningshould be considered where manufacturers’instructions 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.This is 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 ensurethat equipment and procedures remain valid inengineering terms.16

3 Cleaning instrumentsAutomated cleaning: washerdisinfectors3.13 The fitting and plumbing of washer-disinfectorsmust comply with the requirements of the WaterSupply (Water Fittings) Regulations 1999. Furtherdetails can be found on the WRAS website (http://www.wras.co.uk). Each stage of thedecontamination process should contribute to thereduction of bioburden on the device beingreprocessed. Using a washer-disinfector is thepreferred method for cleaning dental instrumentsbecause it offers the best option for the control andreproducibility of cleaning; in addition, thecleaning process can be validated under EuropeanNorms (ENs).3.14 Washer-disinfectors are used to carry out theprocesses of cleaning and disinfection consecutivelyin an automated cycle. A typical washer-disinfectorcycle for instruments includes the following fivestages:• 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 to preventprotein coagulation and fixing of soil to theinstrument.• Wash – removes any remaining soil. Mechanicaland chemical processes loosen and break upcontamination adhering to the instrumentsurface. Detergents used in this process mustbe specified by the manufacturer as suitablefor use in a washer-disinfector and compatiblewith the quality of water used. Detergentsshould also be compatible with the instrumentsbeing processed to avoid instrumentdegradation including discoloration, staining,corrosion and pitting.• Rinse – removes detergent used during thecleaning process. This stage can contain severalsub-stages. The quality of water to be used forthis stage is an important consideration in termsof ensuring a clean unmarked product aftersterilization. Advice should be taken frommanufacturers with respect to the compatibilityof the hardness or quality of the water supplywith the equipment and detergents used.NoteSome systems with a water capacity anddelivery rate specially suited to use in thisand other dental applications are available.The supply arrangements will frequentlyinclude a comprehensive package such thatwater is supplied as a service.• Thermal disinfection – the temperature of theload is raised and held at the pre-set disinfectiontemperature for the required disinfectionholding time: for example, 80oC for10 minutes; or 90oC for 1 minute.• Drying – Purges the load and chamber withheated air to remove residual moisture.Using a washer-disinfector3.15 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 on thedetergents and/or disinfectants recommended foruse with the device. These instructions form partof 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 correct operationof a washer-disinfector, including how to performdaily tests and housekeeping tasks. Records oftraining and the achievements of staff should bemaintained (see Section 3).3.17 It is crucial to load a washer-disinfector correctly, asincorrectly loaded instruments will not be cleanedeffectively. Therefore, follow an instrument-loadingprocedure that has been shown to achieve effectivecleaning in the washer-disinfector used in thepractice. To do this:• do not overload instrument carriers or overlapinstruments;• open instrument hinges and joints fully;• attach instruments that require irrigation to theirrigation system correctly, ensuring filters are inplace if required (for example for handpieces, ifspecified 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 value17

Decontamination: Health Technical Memorandum 01-05 – Decontamination in primary care dental practices (2013 edition)Recordsof this part of the process.) The satisfactorycompletion of this step means that theseinstruments may be clearly designated as readyfor sterilization.3.19 Washer-disinfector logbooks and records shouldbe kept 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 handpieces3.20 Check with the handpiece manufacturer that awasher-disinfector can be used to clean thehandpieces.3.21 Certain types of washer-disinfector can be adaptedto clean handpieces, and these can be validatedindependently 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 a pressurisedsystem to clean and lubricate handpieces. However,unlike a washer-disinfector, it does not disinfect.3.23 Always consult the washer-disinfector manufacturerfor operating details (for example whether filters arerequired) and running costs before 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).Using a washer-disinfector is the preferred method for cleaning dental instruments because it offers the best option for the control andreproducibility of cleaning18

3 Cleaning instrumentsNote1. 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 machines that both clean and sterilizedental handpieces. At present it is not possible tovalidate the cleaning cycle of these devices usingaccepted criteria. However, due to the use of avacuum sterilization cycle (Type S) there is anadvantage of this process over using a Type Nsterilizer.Automated cleaning: ultrasoniccleaning3.25 Evidence on the effectiveness of ultrasonic cleaninggives support to its use in dentistry. However,it is important to ensure that the water/fluid ismaintained, cleaned and changed at suitableintervals (see paragraph 3.30k). The bath shouldalso be kept free of dirt released in the cleaningprocess. Good maintenance is also essential. Theappearance of instruments following ultrasoniccleaning should be checked to ensure that theprocess 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 accordingto the manufacturer’s instructions or, in the absenceof these, quarterly (see Section 3, Chapter 14).Ultrasonic cleaning procedure3.30 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 recommendations forthe safe operating procedure of the ultrasoniccleaner and follow the points outlined belowregarding loading and unloading the cleaner.c. Ensure that joints or hinges are opened fullyand instruments that need taking apart arefully disassembled before they are immersedin the solution.d. Place instruments in a suspended basket andfully immerse in the cleaning solution, ensuringthat all surfaces are in contact with the solution.The solution should be made up in accordancewith the manufacturer’s instructions.e. Do not overload the basket or overlapinstruments, because this results in poorcleaning and can cause wear to the instruments.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,a modified basket or tray system might alsobe necessary 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. Ensure19

Decontamination: Health Technical Memorandum 01-05 – Decontamination in primary care dental practices (2013 edition)that 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 where possiblecheck for any wear or damage beforesterilization.3.31 Instruments cleaned in an ultrasonic cleaner (orby hand) 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 distilled water. Washhandbasins should not be used. (This step may beomitted if the local policy and procedure involvesthe use of a washer-disinfector as the next stage inthe decontamination process.)NoteHard-water contamination of wet instruments, whichthen go on to sterilization, can compromise the properfunction of a small steam sterilizer. Advice should besought from the manufacturers. When potable water isused, a water softener device may be needed (seeparagraphs 17.8–17.10).3.32 Instruments should be sterilized as soon as possibleafter cleaning to avoid air-drying (which canresult in corrosion and/or microbial growth). Forinstruments processed in a vacuum sterilizer, beforebeing wrapped, instruments should be dried usinga disposable non-linting cloth.Manual cleaning3.33 In principle, manual cleaning is the simplestmethod to set up, but it is hard to validate becauseit 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. A visualinspection for cleanliness, wear and damage shouldbe 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 washerdisinfector.Avoiding instrument damage3.39 Most dental instruments are made of high-qualitymaterials designed to minimise corrosion ifreprocessed correctly. The corrosion resistance isbased on their alloy composition and structure,which forms a protective passivation layer on thesurface. The ability of the instruments to resistcorrosion depends on the quality and thickness ofthis layer.3.40 It is important to avoid damage to the passivationlayer during cleaning. Accordingly, methods suchas the use of wire brushes, which may give rise tosurface abrasion, should be avoided.3.41 Any instruments that have rust spots should beremoved.Cleaning procedure summary3.42 Effective cleaning of dental instruments beforesterilization is of the utmost importance to reducethe risk of transmission of infectious agents.3.43 Research suggests that instruments cleaned as soonas possible after use are more easily cleaned thanthose left for a number of hours beforereprocessing.3.44 Instruments should be transferred from the pointof use to the decontamination areas as soon as ispractical to ensure that processing takes place assoon as possible after use. Evidence indicates thatkeeping instruments moist after use and prior todecontamination improves protein removal andoverall decontamination outcomes.3.45 It should be noted that certain solutions arecorrosive to stainless steel instruments and willcause pitting and then rusting if allowed to remainon instruments for any length of time. Dental20

3 Cleaning instrumentsprofessionals should consult with the suppliers/manufacturers of decontamination agents to ensurethat the products used are appropriate and unlikelyto cause significant long-term corrosion (refer toCOSHH for further advice).3.46 Always check packaging for the single-use symbolbefore use, and note that it might be difficult to see(see also paragraphs 2.13–2.19).Rinsing of instruments after cleaningand or disinfection3.47 Instruments cleaned in an ultrasonic cleaner (or inaddition by hand) should be rinsed thoroughly in adedicated sink or bowl (separate from the one usedfor the original wash) using satisfactory potablewater, or freshly prepared RO water or distilledwater in order to remove residual soil anddetergents with minimum risk of salt deposition.NoteThis step may be omitted if the local policy andprocedure involves the use of a washer-disinfectoras the next stage in the decontamination process.3.48 Instruments should be sterilized as soon as possibleafter cleaning to avoid air-drying (which can resultin corrosion and/or microbial growth). However,where instruments are to be wrapped prior tovacuum sterilization, the instruments should bedried.Inspection and care of instrumentsbefore sterilizing3.49 All instruments that have been through anycleaning 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 freemovement of all parts and that joints do not stick;the edges of clamping instruments meet with nooverlap and that teeth mesh together; scissor edgesmeet to the tip and move freely across each otherwith no overlap or burrs (rough edges); all screwson jointed instruments are tight and have notbecome 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.A non-oil-based lubricant should be used to avoidit interfering (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 theirlifespan. If devices are found to be faulty ordamaged during inspection and function-testing, orif users identify that they are faulty, they should betaken out of use and either repaired or replaced.Instruments for repair should be decontaminated,labelled to identify they have been through thedecontamination process, and then returned toeither the manufacturer or a reputable repaircompany.Handpiece care3.55 Handpieces should be lubricated according to themanufacturer’s instructions. Those that have beenprocessed in a washer-disinfector might have hadthe lubricant removed and require lubrication againbefore going into the sterilizer.3.56 A separate canister of lubricant should be usedfor cleaned instruments. The canisters should belabelled so that it is clear which canister is usedfor unclean instruments and which is used forinstruments that have been cleaned in a washerdisinfector.Another canister for use withhandpieces after sterilization might be requiredif the manufacturer recommends it.3.57 Inadequate lubrication can lead to unnecessarydamage to the internal mechanism.21

Decontamination: Health Technical Memorandum 01-05 – Decontamination in primary care dental practices (2013 edition)4 SterilizationGuidance 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 thehighest temperature compatible with the product isthe preferred method for the sterilization of mostinstruments used in the clinical setting.4.3 To facilitate sterilization, load items should firstbe thoroughly cleaned and disinfected (where awasher-disinfector has been used). In the case ofnewer machines, the parameters monitored for eachcycle will be stored and/or available as a print-outto provide a short-term record. The use ofautomated data-loggers or interfaced smallcomputer-based recording systems is acceptableprovided the records are kept securely and backedup.These records should be copied, as the qualityof the print-out fades over time. Manual recordingusing a logbook is also acceptable, and in any casewill be a necessity if a machine does not have anyautomatic print-out function (see paragraph 4.14for further details on manual recording). Therecord should, at minimum, document the absenceof a failure warning or the temperature/pressureachieved as appropriate to the indications provided.Records are required for every sterilization cycle. Itis recommended that records be maintained for notless than two years.4.4 It is likely that steam sterilizers used in dentalpractices will have a chamber volume of less than60 L and thus be considered to be small deviceswithin the standards applied by national andinternational bodies.4.5 Standards describe three types of benchtop sterilizerused within the healthcare setting:• Type N: air removal in type N sterilizers isachieved by passive displacement with steam.They are non-vacuum sterilizers designed 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).Sterilization process data can be recorded by an automatic printer• Type S: these sterilizers are specially designed toreprocess specific load types. The manufacturerof the sterilizer will define exactly which load,or instrument, types are compatible. These22

4 SterilizationSterilizer with automatic printersterilizers should be used strictly in accordancewith these instructions.Types B and N are most frequently used in dentalpractices.4.6 In each case, practice staff should consult withthe manufacturer/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 Practices can seek the advice on thedecontamination of handpieces from the handpiecemanufacturer. Dental handpieces are constructedwith a number of features that are difficult to cleanand steriliize. The use of a validated washerdisinfectormay be successful provided that thehandpiece and washer-disinfector are compatible.Where this is established, sterilization using a typeB or type S sterilizer is likely to be useful, althoughit should be accepted that it is unlikely that sterilitywill be achieved – whatever sterilizer is used – dueto the presence of lubricating materials. Theinformation above should be used by practices tomake an informed decision on the choice ofsterilizer (Type B, S or N).4.8 If no validated and compatible washer-disinfector isavailable, steam sterilization will generate areduction in contamination. Accordingly, progresstowards best practice may be seen as a further riskreduction measure in this context.23

Decontamination: Health Technical Memorandum 01-05 – Decontamination in primary care dental practices (2013 edition)Benchtop sterilizers4.9 Benchtop sterilizers should be operated to ensurethat:• they are compliant with the safety requirementsstated in this guidance and in the manufacturer’snotes;• 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.Pre-wrap instruments only where this isrecommended by the manufacturer and wherethe sterilizer is vacuum-assisted. The sterilizershould be validated for the intended load and islikely to be of type B or S. The use of a type Nsterilizer is not appropriate for wrappedinstruments.4.10 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 benchtop sterilizers4.11 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, at least daily,using distilled or RO water. However, morefrequent draining and refilling offers qualityadvantages in terms of the appearance andsuitability of the finished instruments. At theend of the working day, the device should thenbe cleaned, dried, and left empty with the doorkept open. For single-shot types, which do notstore water between cycles of use, these rules stillapply in terms of the water quality to be used.2. Validation is necessary to demonstrate that thephysical conditions required for sterilization(temperature, pressure, time) are achieved.Consultation with appropriately qualifiedengineers will be necessary. A Competent Person(Decontamination) or service engineer will beable to ensure that validation is achieved andthat the instrumentation used for parametricrelease is functioning and calibratedappropriately. The Competent Person(Decontamination) or service engineer will beneeded to validate or revalidate the equipment(see Section 3).Parametric release is defined as the release of a batchof sterilized items based on data from the sterilizationprocess. All parameters within the process have to bemet before the batch can be released for use.3. Testing is an integral part of ensuring thata benchtop sterilizer consistently performs tooperating parameters set during the machine’scommissioning. Failure to carry out routineperiodic tests and maintenance tasks couldcompromise safety and have legal andinsurance-related implications for the RegisteredManager (see paragraph 9.3).4. A schedule for periodic testing should thereforebe planned and performed in accordance withSection 3. The schedule should provide detailsof daily, quarterly and yearly testing or be inaccordance with manufacturers’ guidelines.Each sterilizer should have a logbook (file) inwhich details of the following are recorded:• maintenance;• validation;• faults;• modifications;• routine tests (see Appendix 2).4.12 Health Service Circular (HSC) 1999/053 and thesubsequent ‘Records management: code of practiceparts 1 and 2’ (April 2006) provide guidance onthe length of time for which records should beretained. Reference should be made to the timeperiod of legal rights of patients, and all relevantdocumentation should be retained for the practiceto meet any request within these rights. The coderequires that these records be maintained for notless than two years, although longer periods may beapplicable subject to local policy-making.4.13 The logbook should contain all informationpertaining to the lifecycle of the equipment (frompurchasing through to disposal).4.14 If the sterilizer has an automatic printer, the printoutshould 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);24

4 Sterilization• temperature/pressure achieved;• signature of the operator.Daily testing and housekeeping tasks4.15 Some benchtop sterilizers require a warm-up cyclebefore instruments can be processed. Themanufacturer’s instruction manual should beconsulted to find out whether this is the case.4.16 The daily tests should be performed by theoperator or user and will normally consist of:• a steam penetration test – Helix or Bowie-Dicktests (vacuum sterilizers only);• an automatic control test (all benchtopsterilizers) in line with manufacturers’instructions;• a record of the temperature and pressureachieved at the daily test, to ensure this issatisfactory before the autoclave is used forsterilizing instruments.4.17 These outcomes should be recorded in the logbooktogether with the date and signature of theoperator.4.18 The tests may be carried out at the same time.4.19 The manufacturer’s advice should be sought onwhether the daily tests can be carried out whileinstruments are being reprocessed.4.20 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 distilled water or ROwater;• turn the power source on.4.21 If the sterilizer fails to meet any of the testrequirements, it should be withdrawn from serviceand advice should be sought from the manufacturerand/or maintenance contractor. Any instrumentsprocessed in an unsuccessful cycle should not beused.Packaging and related decontaminationstrategy4.22 There are three combinations of steam-sterilizationand instrument-wrapping strategies that can beused within dental practices:a. Instruments should be cleaned and dried beforebeing wrapped with purpose-designed materialsThe outcomes of daily tests should be recorded in the logbook25

Decontamination: Health Technical Memorandum 01-05 – Decontamination in primary care dental practices (2013 edition)compatible with the sterilization process. Thesepackaging materials should either conform toBS EN ISO 11607-1 or, for Type S sterilizers,be validated as suitable by the sterilizermanufacturer. These instruments are suitable forstorage for up to 12 months in their originalpackaging as long as their packaging is intact.Practices will need to have systems in place to beable to demonstrate that the 12-month storagetime is not being exceeded.b. With a displacement steam sterilizer (type N),the instruments will not be wrapped prior tosterilization. Immediately after removal fromthe sterilizer, instruments should be asepticallywrapped using suitable sealed view packs. Thiscould be achieved by the use of forceps, cleangloves or any other appropriate process. Inaddition, the entire tray may be placed within asealed pack for storage purposes. In both ofthese instances, storage for up to 12 months isrecommended. Practices will need to be able todemonstrate that this storage time is not beingexceeded.c. Unwrapped following processing in adisplacement steam sterilizer (type N) (seeparagraph 2.4k(ii) and (iii)).4.23 In all three cases, the instruments should bedried using disposable non-linting cloths and beappropriately handled. It is essential to ensurethat the cloth is adequately dry and free fromcontamination. Accordingly, the cloth should bedisposed of after each sterilizer load.4.24 Regardless of the packaging used, whereinstruments are to be stored, the date by whichthey should be used or by which they are subject toa further decontamination cycle should be clearlyindicated on the packaging.Storage of sterilized instruments/devices4.25 Regardless of the approach described above, it isessential 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 be achievedby ensuring that instruments are stored in anenvironment where they are protected againstexcessive heat and where conditions remain dry.NoteBS 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 lidmay be 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 usewith vacuum sterilizers.d. Header bag. This is manufactured as a sealed bagwith a heat-sealed permeable closure, which can bepeeled off. This type is suitable for storage of largeritems.e. In larger-scale operations, automated systems suchas form/fill/seal (FFS) or four-side-sealing productsmay 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.4.26 There should be control of storage of wrappedinstruments, including the maintenance of records,clear identification of content of instrument packs,if not visible, and storage times. For commonlyusedinstruments, a first-in first-out principle willbe helpful.Where packs are non-transparent, it may be useful touse a label to indicate the contents.26

4 SterilizationImmediately after removal from a type N sterilizer, instruments maybe wrapped using suitable sealed view-packs4.27 As a general rule:• The storage of reprocessed surgical instrumentsshould ensure restraint of recontamination. 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 disinfectantwipes at sessional intervals.• Instruments should be decontaminated in anarea and in manner that enforces the flow fromdirty to clean through the successive processesthat comprise decontamination, such that, at nostage is an instrument recontaminated via asurface that has been contaminated at a previousdecontamination stage. Dental practices mustensure that the correct processes and flows arerigorously maintained.• Unwrapped instruments should be transportedand stored in a way that minimisescontamination. Appropriate personal protectiveequipment is required for the aseptic transfer ofinstruments from a type N steam sterilizer forstorage (see paragraph 6.13). The worktop onwhich the tray or shelf of instruments is to beplaced must be cleaned with a pre-prepared orSterilized instruments should be stored in purpose-designed storage cabinets that can be easily cleaned27

5 Setting up a decontamination area5 Setting up a decontamination area5.1 There is a clear need to maximise the separation ofdecontamination work from clinical activity withinthe constraints of space and room availability.Where instruments are reprocessed in the sameroom as the patient treatment area, the reprocessingarea should be as far from the dental chair aspracticality allows. As dental practices progresstowards 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 ofinstruments, 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 instrumentsare at a lower risk of coming into contact withdecontaminated instruments. This requires awell-developed routine for surface cleaning/decontamination within the facilities:VentilationinputVentilationextraction oroutputWash-handbasin(optional)OUT(optional,dependentupon spaceand layout)Inspectionand storageCLEANZONEInspectand,whereapplicable,packSterilizerDIRTYZONEDeliverWash-handbasinOUTINKeyRinsingsinkUltrasoniccleaner(optional)WashingsinkInstrument flowAirflowNotes1. The use of an ultrasonic cleaner is optional. Where such a cleaner is not provided,handling difficulties will be reduced by siting the washing sink near to the rinsing sink orby combining both sinks through the installation of a double-bowl sink assembly.2. Practices may increase the number of sterilizers if capacity and service continuitydictates.Figure 1 Example layout for essential quality requirements29

Decontamination: Health Technical Memorandum 01-05 – Decontamination in primary care dental practicesVentilationinputVentilationextraction oroutputWash-handbasin(optional)CLEANZONEDIRTYZONEWash-handbasinOUT(optional,dependentupon spaceand layout)OUTINInspectionand storageInspectand,whereapplicable,packSterilizerDeliverKeySingle-endedwasherdisinfectorRinsingsinkUltrasoniccleaner(optional)WashingsinkInstrument flowAirflowNotes1. The use of an ultrasonic cleaner is optional. Where such a cleaner is not provided,handling difficulties will be reduced by siting the washing sink near to the rinsing sink orby combining both sinks through the installation of a double-bowl sink assembly.2. Practices may increase the number of washer-disinfectors and sterilizers if capacity andservice continuity dictates.Figure 2 Example layout for single decontamination room• the decontamination area should be wipeddown carefully after each decontamination cycleis completed;• for clinical areas, a similar wipe-clean is requiredafter each patient procedure and before the nextpatient is admitted. Procedures for the wipedownprocesses are described in Chapter 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 of twoseparate rooms is the preferred option as it providesfor a higher degree of separation between dirtyinstruments 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 dirtyto-cleanworkflow 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).Physical segregation5.7 Physical segregation within essential qualityrequirements means using different areas fordifferent activities. A decontamination area should30

5 Setting up a decontamination areaVentilationextraction oroutputDouble-endedwasher-disinfectorVentilationinputWash-handbasinWash-handbasinOUTCLEANInspectand,whereapplicable,packDIRTYINVentilationinputInspectionand storageDeliverVentilationextraction oroutputSterilizerRinsingsinkUltrasoniccleaner(optional)WashingsinkKeyInstrument flowAirflowNotes1. An alternative is to have a single-ended washer-disinfector in the dirty area. Theprovision of a transfer hatch between the two rooms would be beneficial in reducing therisks of manual handling.(While double-ended washer-disinfectors offer advantages in reducing the risks of manualhandling, the use of a single-ended washer-disinfector will fulfil the objectives of thisguidance provided it is validated.)2. The use of an ultrasonic cleaner is optional. Where such a cleaner is not provided,handling difficulties will be reduced by siting the washing sink near to the rinsing sink orby combining both sinks through the installation of a double-bowl sink assembly.3. Practices may increase the number of washer-disinfectors and sterilizers if capacity andservice continuity dictates.Figure 3 Example layout for two decontamination roomsbe set up which preferably comprises a single run ofsealed, easily cleaned worktops. The following keydesign points should be observed:• The dirty zone will be used to receivecontaminated instruments. An area of benchingshould be clearly designated for this purposeand 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,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 require31

Decontamination: Health Technical Memorandum 01-05 – Decontamination in primary care dental practices (2013 edition)inspection. A dedicated clean area of benchingwith good task lighting should be provided.• The sterilizer should be situated well away fromthe other activities/facilities in order to promotestaff safety and good decontamination practice.• After sterilization, the sterilizer will need tobe unloaded 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, itis acceptable for a single wash-hand basin tobe used for this and clinical hand-washing.However, this basin should be distinctly separatefrom the sinks used in decontamination.• 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, the washerdisinfectorshould be built directly into theseparating 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. Inareas where building alterations to existing premisesare restricted and/or purpose-built premises may bedifficult or impossible to acquire, best practicemay not be achievable.32

6 General hygiene principles6 General hygiene principlesHand hygiene6.1 The term hand hygiene covers not only handwashing,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.6.4 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 and after the removal of PPE;• following the washing of dental instruments;• before contact with instruments that havebeen steam-sterilized (whether or not theseinstruments are wrapped);• after cleaning or maintaining decontaminationdevices used on dental instruments;• at the completion of decontamination work.6.5 Mild soap should be used when washing hands. Barsoap should not be used. Apply the liquid soap towet 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 hands6.6 Effective drying of hands after washing isimportant because wet surfaces transferSkin caremicroorganisms more easily than when they aredry, and inadequately dried hands are prone to skindamage. To prevent recontamination of washedhands, disposable paper towels should be used.6.7 Hand cream, preferably water-based, should beused to avoid chapped or cracking skin. Communaljars of hand cream are not desirable as the contentsmay become contaminated and subsequentlybecome an infection risk. Ideally, wall-mountedhand-cream dispensers with disposable cartridgesshould be used. Any staff that develop eczema,dermatitis or any other skin condition should seekadvice from their occupational health departmentor general practitioner (GP) as soon as possible.6.8 Fingernails should be kept clean, short and smooth.When viewed from the palm side, no nail shouldbe visible beyond the fingertip. Staff undertakingdental procedures should not wear nail varnish andfalse fingernails.6.9 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-washing6.10 In accordance with the advice above, a separatewash-hand basin should be provided:• The basin should not have a plug or an overflowand be fitted with a remote running trap (thatis, the U-bend is not directly under theplughole).• It should have a sensor-operated or leveroperatedmixer tap.• Taps should not discharge directly into thedrain aperture as this might generate aerosols.33

Decontamination: Health Technical Memorandum 01-05 – Decontamination in primary care dental practices (2013 edition)6.11 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 sourceof contamination.6.12 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 processes6.13 The local infection control policy should specifywhen personal protective equipment (PPE) is tobe worn and changed. PPE training should beincorporated into staff induction programmes.6.14 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.6.15 When used appropriately, and in conjunction withother infection control measures, PPE forms aneffective barrier against transmission of infection.Gloves6.16 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.6.17 Used gloves should be replaced before performingactivities that require strict aseptic precautions orwhen touching equipment that is difficult to clean.A separate wash-hand basin should be provided for use by staffconducting decontamination. This basin should be distinctly separatefrom the sinks used in decontaminationPPE includes disposable clinical gloves, plastic disposable aprons,face masks and eye protection34

6 General hygiene principles6.18 It is important that gloves fit properly if they are toproduce the level of protection against the expectedcontaminants. The use of latex gloves is subject to aHealth & Safety Executive recommendation, whichcalls for local risk assessment. This is partlyattributable to reports of long-term allergydevelopment in some users. The use of vinyl ornitrile gloves may be a satisfactory substitute andshould be made available to staff within thepractice.6.19 Powdered gloves should not be used. Individualswho are sensitised to natural rubber latex proteinsand/or other chemicals in gloves should take advicefrom their GP or occupational health departmentfor an alternative to latex gloves.6.20 All disposable clinical gloves used in the practiceshould be CE-marked and should be:• low in extractable proteins (

Decontamination: Health Technical Memorandum 01-05 – Decontamination in primary care dental practices (2013 edition)wear long-cuffed gloves or disposable long-sleevedgowns to protect their arms.6.34 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.6.35 Uniforms and workwear should be washed at thehottest temperature suitable for the fabric to reduceany potential microbial contamination (see theDepartment of Health’s (2010) ‘Uniforms andworkwear: guidance on uniform and workwearpolicies for NHS employers’).Removal of PPE6.36 Depending on the type of PPE worn, items of PPEshould 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 of intoa clinical waste receptacle (see HTM 07-01).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 equipmentdecontaminationGeneral6.37 Surfaces and equipment used in thedecontamination of dental instruments shouldbe cleaned carefully before and after eachdecontamination process cycle. The procedure usedshould comply with written local policies.6.38 All surfaces should be such as to aid successfulcleaning and hygiene. Wherever possible, surfaces(including walls) should be continuous and freefrom damage and abrasion. They should be freefrom dust and visible dirt.Environmental conditions6.39 The environmental conditions in decontaminationfacilities should be controlled to minimise thelikelihood of recontamination of sterilizedinstruments. Key considerations include thecleanability of surfaces, fittings and equipment.6.40 Ventilation and air quality are importantconsiderations. In non-purpose-built facilities,the control 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 fanbasedventilation 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 freestandingor ceiling-mounted fan units, however,is not recommended.6.41 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 key aim.Detailed guidance can be found in BS 5925:1991.6.42 The ventilation system in the decontamination areaor room(s) should be designed to supply reasonablequantities of fresh air to the positions wherepersons work and to remove excess heat fromequipment and processes.6.43 Where used, mechanical extract units should beceiling- or wall-mounted. Care should be taken toensure that airflow is from clean to dirty.6.44 Where full mechanical ventilation solutions areused, the extract system should be located and sized36

6 General hygiene principlesto draw about one-third of the air across thedecontamination benches in the clean-to-dirtydirection.6.45 Mechanical ventilation equipment should includecoarse air filtration on the input side. This willrequire periodic maintenance. Practices are advisedto consult a heating and ventilation engineer ifchoosing to install a mechanical ventilation system.Surfaces and equipment – key design issues6.46 All work surfaces where clinical care ordecontamination is carried out should beimpervious and easily cleanable. They should bejointless as far as is reasonable; where they arejointed, such joints should be welded or sealed.6.47 Flooring in clinical care and decontamination areasshould be impervious and easily cleanable.Carpets, even if washable, should not be used. Anyjoins should be welded or sealed. Flooring shouldbe coved to the wall to prevent accumulation ofdirt where the floor meets the wall6.48 It should be ensured that surfaces:• can be easily accessed;• will dry quickly.6.49 Manufacturers’ advice should be sought in terms ofthe compatibility of detergents and disinfectantswith the surface materials used.Decontamination equipment6.50 Specialist items of equipment (for example,ultrasonic baths, washer-disinfectors, sterilizersand RO machines) may require cleaning anddecontamination processes that are purposedesigned.6.51 Although information will be provided bymanufacturers, it is recommended that, whenwriting local protocols, assistance is sought froma qualified 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) viathe Institute of Healthcare Engineering and EstateManagement (IHEEM).6.52 Planned cleaning programmes will have links topreventive maintenance and the validation process.Local policies should reflect these requirements andclearly state the intervals at which actions are to betaken and a procedure for the keeping of records.6.53 It is often during cleaning work that minor defects,wear or damage to equipment will be detected.Local policies should ensure that such defects arereported to the responsible person.For floor and general surface cleaning, the nationalcolour coding scheme for cleaning materials andequipment in primary care medical and dentalpremises may be useful:• red – for wash-rooms;• blue – for offices;• green – for kitchens;• yellow – for clinical and decontamination areas.Cleaning protocols and techniques6.54 The dental practice should have a local protocolclearly outlining surface- and room-cleaningschedules. The cleaning process will be mosteffective if the more contaminated areas are cleanedfirst. Materials and equipment used to clean clinicalareas and other higher-risk areas should be storedseparately from those used for general and nonclinicalareas. Simple records should be maintainedin accordance with the Code of Practice.6.55 Cleaning staff should be briefed on the specialmeasures to be observed in cleaning of patient careareas or room(s) used for decontamination. In someinstances, full training of personnel will be needed.6.56 If instruments become contaminated (through, forexample, being dropped or being placed in a dirtyarea), they should be sent for further reprocessing.6.57 The use of disinfectant or detergent will reducecontamination on surfaces. If there is obviousblood contamination, the presence of protein willcompromise the efficacy of alcohol-based wipes.NoteAlcohol has been shown to bind blood and proteinto stainless steel. The use of alcohol with dentalinstruments should therefore be avoided.6.58 It is not good practice to refill spray bottles used toapply cleaning or disinfecting solutions. Bacteriacan contaminate the bottles and become adapted tothese solutions and grow in the spray mechanisms37

Decontamination: Health Technical Memorandum 01-05 – Decontamination in primary care dental practices (2013 edition)(Ehrenkranz et al., 1980; Sautter et al., 1984). Suchbottles, whether supplied pre-filled or empty,should be single use.6.59 Local provision of steam cleaning from practiceresources is unlikely to be economical. 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 cleanedafter 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.NoteDental chairs should be free from visible damage (forexample rips and tears).6.63 Areas and items of equipment that need to becleaned after each session include:• taps;• drainage points;• splashbacks;• sinks.In addition, cupboard doors, other exposed surfaces(such as dental inspection light fittings) and floorsurfaces, including those distant from the dentalchair, should be cleaned daily.NoteSpittoons 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 at weeklyintervals 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 For infection control reasons, in clinical areas:• covers should be provided over computerkeyboards; or• conventional keyboards should be replacedwith “easy-clean” waterproof keyboards asrecommended in the Department of Health’s(2008) ‘Clean, safe care: reducing infections andsaving lives’.Where covers or 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 Dry cleaning should be avoided wherever possibleas this may result in dust suspension.6.69 Care should be taken to keep water well away fromelectrical 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.38

6 General hygiene principles6.71 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 in digitalradiology imaging are potential sources of crossinfection.Accordingly, where reusable devices areused, they should be decontaminated in accordancewith the manufacturer’s instructions. For intra-oralholders, this will require the use of steamsterilization following washing and disinfection.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 hypochlorite at 1000 ppmavailable chlorine is recommended. Hypochloriteshould be made up either freshly usinghypochlorite-generating tablets or at least weekly inclean containers. Contact times should bereasonably prolonged (not less than five minutes).A higher available chlorine concentration of 10,000ppm is useful, particularly for bloodcontamination. The process should be initiatedquickly and care should be taken to avoid corrosivedamage to metal fittings etc. The use of alcoholwithin the same decontamination process is notadvised.Dental unit water lines (DUWLs)NoteIn view of the expertise required in this specialisedfield, practices (through the Registered Manager)should engage with an external specialist to assist inmeeting the recommendations given in Section 3 ofthis guidance. This may be a locally-based engineeringconsultant with specialist knowledge of Legionella andother water-borne organisms.General6.75 Best practice guidelines on the control of Legionellaare provided in the Health & Safety Commission’s‘Legionnaires’ disease – the control of Legionellabacteria in water systems. Approved Code ofPractice & guidance’ (also known as L8) andHealth Technical Memorandum 04-01 – ‘Thecontrol of Legionella, hygiene, “safe” hot water,cold water and drinking water systems’.NoteThe 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 organisationwould need to demonstrate that it had complied withthe law in some other way, or a court would find it atfault.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) shouldensure that arrangements are made such that thepractice can continuously achieve compliance withthe requirements of these regulations. Registrationwith the Legionella Control Association or otherrecognised body is recommended.Microbiological monitoring6.78 Apart from situations where there are indicationsfrom taste or odour, microbiological monitoringusing dip slides for total viable counts (TVCs) isnot considered essential. However, some companiesand other institutions offer comprehensive waterpurificationservices that include periodicmicrobiological sample monitoring. Such services,provided they are quality-controlled, maycontribute usefully to risk reduction in this area.6.79 Where monitoring is undertaken, the TVC shouldbe expected to lie in the range 100 to 200 colonyforming units per millilitre (cfu/ml). In general,incubation should be at 22oC. These measurementscan be carried out by commercial microbiologicalservices or by Public Health England. (Somecommercial water-purification services offermicrobiological control such that TVC values maybe maintained below 10 cfu/ml.)NoteThis is a complex procedure and the use of in-housetest kits is not recommended.39

Decontamination: Health Technical Memorandum 01-05 – Decontamination in primary care dental practices (2013 edition)DUWLs6.80 No currently available single method or device willcompletely eliminate biocontamination of DUWLsor exclude the risk of cross-infection. To reducecontamination risk, a combination of methods isapplicable.6.81 With regard to Legionella and other water-bornepathogenic agents, the HCAI Code of Practice(2009) states:“Premises should be regularly reviewed for potentialsources of infection and a programme should beprepared to minimise any risks. Priority should begiven to patient areas although the exact priority willdepend 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.NoteThe self-contained water supplies used with dental caresystems should be distilled or RO water (see Section3). Certain systems recycle water back to a storagefacility. Where this is done, repurification will benecessary 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.Note6.85 DUWLs should be flushed for at least two minutesat the beginning and end of the day and after anysignificant period when they have not been used(for example, after lunch breaks). In addition, theyshould also be flushed for at least 20–30 secondsbetween patients. Whilst these actions have beenshown to have only a small effect on biofilm buildupwithin the DUWL system, they do usefullyreduce microbiological counts in the water deliverytube during the period when patients are likely tobe exposed. Some water-purification systems arecapable of supplying DUWLs and may be able toreduce microbiological risks.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 inthe removal of biofilm as well as the reduction ofmicrobacterial contamination. However, theseagents should only be used where recommendedby manufacturers. If they are used, care shouldbe taken to ensure that DUWLs are thoroughlyflushed after disinfection and before being returnedto clinical use.Notes(1) There is disagreement within the scientificliterature concerning the effectiveness of waterbasedflushing of DUWLs, particularly in respectof biofilm control. For systems making use ofpotable water (that is, where the water supply isdrawn from a mains water system), the nature ofNotesthe building’s water-supply arrangements may bean important consideration. This is particularlyso where storage tanks are used. Where deliveredwater quality is in doubt, dental practices shouldconsider adopting continuous dosing systemsif permitted by the DUWL manufacturer’srecommendations. If dosing is used, it is importantto ensure that the dose rates delivered are withinthe recommended safe limits for the product used.Dental practices that use a potable water option –through air-gap supply or the use of bottles –should consult with their appointed CompetentPerson in respect of local water quality andsuitability.(2) For those using purified water, such as distilled orRO, possibly with UV treatment, the rate ofbiofilm build-up is likely to be low, provided thatwater lines are regularly disinfected andmaintained.40

6 General hygiene principles(3) Particular caution should be taken with regardto dental handpieces where dosing is applied, as anumber of instances of damage have been reported.6.87 Dental equipment requiring protection againstbackflow should have anti-retraction valvesincorporated on all handpieces, ultrasonic scalersand/or water lines (see Section 3). Responsiblepersons should ensure these are fitted whererequired. They must be regularly monitored andmaintained.6.88 Examples of dental equipment requiring backflowprotection are:• dental spittoons;• three-in-one syringes;• wet-line suction apparatus; and• self-filling automatic radiographic 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 flapsor other access into body cavities involvingirrigation, the use of sterile water or sterileisotonic saline provided from a separate singleusesource is recommended.41

Decontamination: Health Technical Memorandum 01-05 – Decontamination in primary care dental practices (2013 edition)7 Impressions, prostheses and orthodonticappliances7.1 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 clean runningwater. This process should continue until thedevice is visibly clean.b. All devices should receive disinfection accordingto the manufacturer’s instructions. This willinvolve the use of specific cleaning materialsnoted in the CE-marking instructions. Afterdisinfection, the device should again bethoroughly washed. This process should occurbefore and after any device is placed in apatient’s mouth.c. If the device is to be returned to a supplier/laboratory or in some other fashion sentout of the practice, a label to indicate that adecontamination process has been used shouldbe affixed to the package.42

8 Regulatory framework and complianceSection 3: Engineering, technology andstandards43

Decontamination: Health Technical Memorandum 01-05 – Decontamination in primary care dental practices (2013 edition)8 Regulatory framework and complianceBS/EN/ISO Standards8.1 BS EN Standards for sterilization were firstpublished 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 benchtop sterilizers(BS EN 13060).8.3 Reviews and rewrites of the above Standardscoupled with the production of new Standards hasled to a revision of the content of Health TechnicalMemoranda – including this document – in 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 DH for decontaminationhas evolved in recent years.8.6 Advice on decontamination of medical devices wasissued in HSC 2000/032 and in ‘Decontaminationof reusable medical devices in primary, secondaryand tertiary care sectors (NHS and Independentproviders)’ 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 for whicheffective decontamination was difficult. Thiswas reinforced by the release of ‘Potential vCJDtransmission risks via dentistry. An interim review’(December 2007).8.8 Health Technical Memorandum 01-05 has drawnupon all guidance issued previously, includingHSG (93)40 ‘Protecting health care workers andpatients from hepatitis B’.8.9 It is issued specifically to improve standards indecontamination for primary care dental practices,where decontamination is carried out locally withinthe practice.8.10 Advice to the secondary sector was provided bypolicy document ‘Decontamination of reusablemedical devices in the primary, secondary andtertiary care sectors (NHS and Independentproviders)’. This document required demonstrationof compliance with the “essential requirements”of the Medical Devices Regulations and gave thefollowing four options for the decontamination ofreusable medical devices:• ensure all sites of decontamination comply tothese essential requirements;• use single-use devices;• outsource decontamination to an accreditedSSD;• a combination of the above.8.11 Health Technical Memorandum 01-05 sets out therequirements for the first of the above options.44

8 Regulatory framework and complianceHealthcare regulation by theCare Quality CommissionThe regulation of the provision of health and adultsocial care became the responsibility of the CareQuality Commission (CQC) on 1 April 2009.Cleanliness and infection control, includingdecontamination, is a requirement for registrationand has applied to all primary care dental providerssince 1 April 2010.Appendix B of the December 2010 version of theCode of Practice is specifically related to dentalpractices. It takes due note of the guidance in thisHealth Technical Memorandum and does not imposeany additional burdens on decontamination.45

Decontamination: Health Technical Memorandum 01-05 – Decontamination in primary care dental practices (2013 edition)9 Staff roles and responsibilities indecontamination9.1 It is essential that all staff involved indecontamination are suitably trained and have theirroles and responsibilities defined and that everyoneis aware of each other’s responsibilities.9.2 Choice Framework for local Policy and Procedures01-01 Part A provides general advice – for the acutesector – on these responsibilities along with theexperience, qualifications and training required.However, that advice is based on a universalapplication to decontamination in complex systemswhich are probably inappropriate to primary caredental practices.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 Choice Framework for local Policy andProcedures 01-01 Part A. The following may beused as a guide to these roles. The terminology ofPart A is used for clarity but it is likely that localpersonnel may have differing titles. Small practicesmay be unable to appoint all these responsible postsand a local decision regarding them will need to bemade. Essentially, a practice should be able todemonstrate the following responsibilities:• an understanding of legal liabilities and currentbest 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 the PressureSystems Safety Regulations 2000.It should be borne in mind that it is likely that oneindividual may carry out two, or possibly more, ofthe following 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 contractor, practice owner or a personof similar authority.Decontamination Lead: the Code of Practicemakes 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.Designated Person: this role acts as the interfacebetween the practice and support services suppliedexternally, including service, maintenance andtesting. This could be the general manager of thepractice. The Decontamination Lead could also actas 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) (http://www.iheem.org.uk/Technical-Platforms).Authorised Person (Decontamination): theAuthorised Person provides technical support to theCompetent Person and liaises with the AuthorisingEngineer. The Authorised Person may be directlyemployed by the practice or provided by a thirdparty.Competent Person (Decontamination): theCompetent Person is responsible for the servicing,testing and maintaining of the decontaminationequipment within the practice. The CompetentPerson may be directly employed by the practice orprovided by a third party.Competent Person (Pressure Systems): eachpractice will have a legal responsibility for the safetyof its decontamination equipment, particularly thesterilizers that are pressure vessels. The need forinsurance and a Written Scheme of Examinationis a legal liability and can be provided by the46

9 Staff roles and responsibilities in decontaminationCompetent Person (Pressure Vessels). This is likelyto be provided by an insurance company.Service engineer: a person provided under aservice level agreement or contract who is certifiedby the service agent or equipment 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 thisdocument. 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 responsibilityfor the management of the decontaminationequipment and processes. A likely overlapmay mean that this role is duplicated, but theresponsibility must be demonstrated. An importantfunction of the User is to ensure that anyoneoperating and testing decontamination equipment(that is, an Operator) is suitably trained andcompetent.The User should seek advice from manufacturers orthe service engineer on how to carry out the testingof equipment and daily tasks.With regard to infection control, the User shouldseek advice from infection control teams, whichmay consist of a microbiologist or control ofinfection officer.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 equipmentPurchaser: 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): whilemost decontamination 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 institutions that employ such professionals. Thiswould include acute trusts, pathology departmentsand Public Health England laboratories.9.5 The Registered Manager should ensure thatall personnel fulfilling the roles defined aboveshould receive appropriate training, that they candemonstrate competency in their duties and thatindividual training records for all staff are retained.Training should always be supported by definedlearning outcomes and competencies and mayinclude, where appropriate, the following:• an understanding of the whole decontaminationprocess;• 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 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 experience issufficient for their full implementation.9.7 It is likely in a dental facility that the rolesabove will 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).47

Decontamination: Health Technical Memorandum 01-05 – Decontamination in primary care dental practices (2013 edition)10 Procurement of decontamination equipmentand instrumentsNoteIn 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.Determining the load to be processed10.1 In order to ensure full compatibility of theequipment with the decontamination process,the need for packaging and storage should beconsidered, as this will affect the type of airremovalprocess and therefore the type of sterilizerchosen (vacuum or displacement).10.2 For the cleaning process, instrument designwill also 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 loading carriageswith lumen connections may be required.10.4 In addition to the types of load items:• their quantities should also be assessed. This willenable the number of equipment items to bedetermined;• 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.NotePeriodic testing for washer-disinfectors, sterilizersand ultrasonic cleaners can take up to a full session.Accordingly Registered Managers should planschedules to allow for this, particularly if theequipment is located close to clinical areas. (Theprocess effectively takes a machine out of use for thatsession.) Times will be different for sterilizer types N,B and S. Removal, or disablement, of unwanted cycleson multi-cycle machines can help to reduce this.Decontamination equipment: washerdisinfectorsand sterilizers10.5 Decontamination equipment should be procuredagainst the relevant Health Technical Specification(formerly, Model Engineering Specification). Theseare currently available for washer-disinfectors andsterilizers.10.6 Advice on completing the specifications forsterilizers and washer-disinfectors and on theproduction of a specification for ultrasoniccleaners/irrigators is available from the AuthorisingEngineer (Decontamination).NoteAll Model Engineering Specifications are beingprogressively revised and retitled as Health TechnicalSpecifications (HTS).10.7 New decontamination equipment should display aCE mark (see below) to demonstrate compliancewith the Medical Devices Regulations 2002.48

10 Procurement of decontamination equipment and instruments10.8 When selecting new equipment, the size, modeland type should be considered against workloadand throughput requirements, together with theavailability of space and the service infrastructureavailable.10.9 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, and willthey be achievable in practice?• Does it have an automated cleaning process?• What cleaning agents are recommended andwill they comply with COSHH and health andsafety requirements?• What commissioning and validation is requiredfor the equipment? What are the ongoing costs?10.10 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;NoteIn general terms, as primary-care dentists maynot have in-house engineering staff, robustcontractual arrangements to ensure breakdowncover, routine maintenance and continuity ofvalidation will be needed.• process data capture (that is, chart recorder/datarecorder/printer): this information is needed toclarify the audit process on product release –manual recording of displayed parameters atthe end of a cycle should be recorded to anappropriate log.10.11 The equipment should come with an easilyreadableoperating, maintenance and technicalmanual that includes:• make, model, serial number and installationand warranty requirements;• an explanation of the purpose of the equipmentand 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 copied sothat it can be displayed and undertaken by anoperator) including frequencies etc;• monthly maintenance requirements;• yearly testing and validation requirements/procedures;• consumable parts list and spares componentslist incorporating identification numbers.10.12 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: ultrasoniccleaners10.13 The following are more specific considerationswhen procuring ultrasonic cleaners.10.14 Ultrasonic cleaners can be freestanding or integralto the washer-disinfector.10.15 They should comply with the electrical safetyspecifications given in BS EN 61010-1.49

Decontamination: Health Technical Memorandum 01-05 – Decontamination in primary care dental practices (2013 edition)10.16 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).10.17 Ultrasonic cleaners may be designed to operate at asingle frequency, across a frequency range, and/orwith a controlling system to adjust the frequencyin response to the loading conditions.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.10.20 An ultrasonic cleaner needs to be maintainedby a Competent Person (Decontamination) or asuitably qualified person.Specifications10.21 When procuring ultrasonic cleaners, the followingspecification points should be 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 so thatmicro-dental instruments or instruments withfine 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 easilyreadableoperating, 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;50

10 Procurement of decontamination equipment and instruments• 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 followingshould 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?• 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?Note• 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 ongoing costs?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 instrumentsshould be fully decontaminated.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 thanone component 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-linting51

Decontamination: Health Technical Memorandum 01-05 – Decontamination in primary care dental practices (2013 edition)cloth 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.52

11 Decontamination equipment: general guidance on maintenance and testing11 Decontamination equipment: generalguidance on maintenance and testingMaintenance and servicing11.1 All decontamination equipment should besubjected to validation, testing, maintenance andservicing as recommended by the manufacturer/supplier. All records of these procedures should beretained for audit/inspection.11.2 All equipment should also be periodically testedas advised in Chapters 12–14. An unsatisfactorytest result indicates that the decontaminationequipment should not be used until the fault hasbeen rectified.11.3 Failure to perform these tasks or retain evidence oftheir performance may indicate non-compliance ofthe decontamination process. Alternative protocolsof maintenance should be equal to, or exceed, themanufacturer’s specification and must be justified.Validation and testing11.4 All pieces of decontamination equipment will needa 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)or service engineer should then submit thevalidation/service report to the RegisteredManager in order to bring the equipment intoservice.c. The Registered Manager should copy andforward the report to an Authorising Engineer(Decontamination).d. If the Authorising Engineer (Decontamination)confirms the report, he/she will return it tothe Registered Manager for record-keepingpurposes.NoteIf the report is rejected by the Authorising Engineer(Decontamination), the Authorising Engineer shouldnotify the Registered Manager as soon as practicable.11.6 The second option (option B) for steam sterilizers– and the standard approach for washer-disinfectorsand ultrasonic cleaners – is as follows:a. The service engineer produces a service reportcontaining a validation statement declaring thatthe equipment manufacturer can demonstratethat the product complies with the CE-markingprocess under the terms of the Medical DevicesRegulations.b. By this process, the contract betweenthe Registered 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 consultedon the contents of the logbook (see alsoAppendix 2).11.10 If local or in-house documentation is used, itssuitability should be discussed and agreed with thedecontamination equipment manufacturer. Inaddition, where available, an Authorising Engineer(Decontamination) will also be able to advise.11.11 Periodic inspections/testing logs will needto be signed by the Competent Person53

Decontamination: Health Technical Memorandum 01-05 – Decontamination in primary care dental practices (2013 edition)(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 foruse” based on information and advice from themanufacturer (often represented by the CompetentPerson (Decontamination) or service engineer).Lack of a User signature may well indicate noncompliance.NoteThe User is defined as the person designated bythe Registered 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 outlinedin paragraph 11.5 and Chapter 12 are part of theessential quality requirements. However, interms of testing schedules for washer-disinfectorsand ultrasonic cleaners, manufacturers’ guidanceshould be sought. Note that the schedules outlinedin Chapters 13 and 14 should be followed in theabsence of manufacturers’ instructions.• 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 schemeof examination and examination reports;• list of all named designated responsible persons;• other relevant documentation.Documentation11.14 Documentation provides the only evidence ofcompleted 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;54

12 Installation, validation, maintenance and testing of sterilizers12 Installation, validation, maintenance andtesting of sterilizersMaintenance and servicing12.1 The sterilizer should be maintained and serviced inaccordance with the manufacturer’s instructions.Validation and testing12.2 Validation is needed for new equipment atinstallation and annually thereafter. It will also benecessary to validate equipment after any majorrepairs have been carried out. Manufacturers’guidance on validation should be followed.12.3 The following type-tests or works tests will berequired.EuropeanNorm(EN)referenceB S N Manufacturer EN 13060Test Type Performed byDynamic chamberpressureAir leakage B S Manufacturer EN 13060Empty chamber B S N Manufacturer EN 13060Solid loadNon-wrappedSingle-wrappedDouble-wrappedN SSB SManufacturer EN 13060Small porous itemsSingle-wrappedDouble-wrappedSmall porous loadSingle-wrappedDouble-wrappedFull porous loadSingle-wrappedDouble-wrappedSSSB SSB SManufacturer EN 13060Manufacturer EN 13060Manufacturer EN 13060Hollow load B S Manufacturer EN 13060Solid load drynessNon-wrappedSingle-wrappedDouble-wrappedSSB SManufacturer EN 13060Small porousitems: drynessSingle-wrappedDouble-wrappedSSManufacturer EN 13060Test Type Performed bySmall porous load:drynessSingle-wrappedDouble-wrappedFull porous load:drynessSingle-wrappedDouble-wrappedSSSB SEuropeanNorm(EN)referenceManufacturer EN 13060Manufacturer EN 13060Residual air S N Manufacturer EN 13060Microbiological test B S N Manufacturer EN 13060(optional)Note: Immediately after installation, the air leakage andempty chamber tests should be undertaken by theCompetent Person (Decontamination) or serviceengineer.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.NoteUsers and operators (when delegated) should receivethe appropriate training before carrying out any ofthese tests. This training should be documented onpersonal training records.The Registered Manager should liaise with theequipment manufacturer with regard to training.55

Decontamination: Health Technical Memorandum 01-05 – Decontamination in primary care dental practices (2013 edition)Test Type Performed by ReferenceDAILYSteam penetration B S User or, by delegation, Operator MDA DB 2002(06)Automatic control test B N S User or, by delegation, operator Paragraphs 15.3–15.5WEEKLYincluding daily tests plus:Air leakage B S User or, by delegation, Operator MDA DB 2002(06)Residual air test S N 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 9804ANNUALLYincluding quarterly tests plus:Steam generator overheat cut-out test B N S CP(D)/service engineer MDA DB 9804Thermometric testsB N S CP(D)/service engineer EN 13060Small loadLarge loadDryness testsSmall loadLarge loadB S CP(D)/service engineer EN 1306056

13 Installation, validation, maintenance and testing of washer-disinfectors13 Installation, validation, maintenance andtesting of washer-disinfectorsMaintenance and servicing13.1 The washer-disinfector should be maintained andserviced in accordance with the manufacturer’sinstructions.Validation13.2 Validation is needed for new equipment atinstallation and annually thereafter. It will also benecessary to validate equipment after any majorrepairs have been carried out. Manufacturers’guidance on validation should be followed;alternatively, the following protocol is suggested.(Tests not defined in the referred Standards aredefined in Chapter 15.)Test Description Performed by ReferenceVerification of calibration The accuracy of indicatingand recording instruments ischecked against certificatedsource instrumentsCP(D)/service engineer BS EN ISO 15883:1 andBS EN ISO 15883:2Automatic control testRinse-water quality testThe values of cycle time andtemperature are noted atrelevant stages of the cycleso that a fingerprint of theautomatic cycle can be made.Indicates acceptable valuesfor all critical chemical purityparametersCP(D)/service engineerCP(D)/service engineerBS EN ISO 15883:1 andBS EN ISO 15883:2BS EN ISO 15883:1 andBS EN ISO 15883:2Pipework Ensures free-flowing drainage CP(D)/service engineer BS EN ISO 15883:1 andBS EN ISO 15883:2Doors and door interlocksFluid emissionDetergent dosing testCleaning efficacy testThermometric testLoad carriersConfirms safety to operatorand exposure to completecycle onlyConfirms door-sealprevents contamination tosurroundingsConfirms repeatable detergentadditionUsing an artificial soil to cleana worst-case load, chamberwalls and load carriersto confirm the exposureto cleaning parameters issufficient to remove soilThermocouples are attachedto worst-case load, chamberwalls and load carriers toconfirm that disinfectionparameters are acceptableConfirms mechanicalalignment of all load carriersCP(D)/service engineerCP(D)/service engineerCP(D)/service engineerCP(D)/service engineerCP(D)/service engineerCP(D)/service engineerBS EN ISO 15883:1 andBS EN ISO 15883:2BS EN ISO 15883:1 andBS EN ISO 15883:2BS EN ISO 15883:1 andBS EN ISO 15883:2BS EN ISO 15883:1 andBS EN ISO 15883:2BS EN ISO 15883:1 andBS EN ISO 15883:2BS EN ISO 15883:1 andBS EN ISO 15883:257

Decontamination: Health Technical Memorandum 01-05 – Decontamination in primary care dental practices (2013 edition)Periodic tests13.3 The following testing protocol is recommended.Additionally any additional tests defined by themanufacturer should also be performed.Test Description Performed by ReferenceDAILYRemove and clean strainersand filtersCleaning efficacyProtein residue testEnsures filters and strainersare cleanVisual examination of all loaditemsConfirms that cleaningprocess retains the capabilityof removing proteinUser or, by delegation,OperatorUser or, by delegation,OperatorWEEKLYincluding daily tests plus:User or, by delegation,OperatorBS EN ISO 15883:1 andBS EN ISO 15883:2BS EN ISO 15883:1 andBS EN ISO 15883:2BS EN ISO 15883:1 andBS EN ISO 15883:2Safety checks Check condition of door seal User or, by delegation, ManufacturerOperatorQUARTERLY (or to manufacturers’ recommendations)including weekly tests plus:Safety checksCheck safe operation of doors CP(D)/service engineer Paragraphs 15.14–15.18and door interlocksAutomatic control test CP(D)/service engineer BS EN ISO 15883:1 andBS EN ISO 15883:2Cleaning efficacy test CP(D)/service engineer BS EN ISO 15883:1 andBS EN ISO 15883:2Chemical dosingThermometric disinfectiontestCompletion of all validationtests aboveConfirm delivery of detergent CP(D)/service engineer(and any other additives) isrepeatable and the machinereacts correctly to low levels ofany additiveUse of thermocouples on CP(D)/service engineerworst-case load to confirmdisinfection parameters areacceptableANNUALLYincluding quarterly tests plus:CP(D)/service engineerBS EN ISO 15883:1 andBS EN ISO 15883:2BS EN ISO 15883:1 andBS EN ISO 15883:2BS EN ISO 15883:1 andBS EN ISO 15883:258

14 Installation, validation, maintenance and testing of ultrasonic cleaners14 Installation, validation, maintenance andtesting of ultrasonic cleanersMaintenance and servicing14.1 The ultrasonic cleaner/irrigator should bemaintained and serviced in accordance with themanufacturer’s instructions. However, in theabsence of these instructions, the schedulesoutlined in this chapter should be followed.Validation14.2 Validation is needed for new equipment atinstallation and annually thereafter. It will also benecessary to validate equipment after any majorrepairs have been carried out. Manufacturers’guidance on validation should be followed;alternatively, the following protocol is suggested.(Tests not defined in the referred Standards aredefined in Chapter 15.)Test Description Performed by ReferenceVerification of calibration The accuracy of indicatingand recording instruments isCP(D)/service engineer BS EN ISO 15883:1 andBS EN ISO 15883:2checked against certificatedsource instrumentsAutomatic control test The values of cycle time andtemperature are noted atrelevant stages of the cycleso that a fingerprint of theautomatic cycle can be made.CP(D)/service engineer Paragraphs 15.3–15.5Drainage test (whereapplicable)Lid (ie door) interlockFluid emissionChemical dosing test (whereautomated)Cleaning efficacy testThermometric test (wheremachine also disinfects)Ultrasonic activity testEnsures free-flowing drainage CP(D)/service engineer BS EN ISO 15883:1 andBS EN ISO 15883:2Confirms safety to operatorand exposure to completecycle onlyConfirms door-sealprevents contamination tosurroundingsConfirms repeatable detergentadditionUsing an artificial soil toclean a worst-case load, theexposure to ultrasonic activityfor a sufficient time period isconfirmedThermocouples are attachedto worst-case load to confirmthat disinfection parametersare acceptableThe use of aluminiumfoil within the cleanertank indicates a uniformdistribution of ultrasonicactivityA wand meter may be used aslong as points of measurementare compatible with the foiltest and are fully recordedCP(D)/service engineerCP(D)/service engineerCP(D)/service engineerCP(D)/service engineerCP(D)/service engineerBS EN ISO 15883:1 andBS EN ISO 15883:2BS EN ISO 15883:1 andBS EN ISO 15883:2BS EN ISO 15883:1 andBS EN ISO 15883:2BS EN ISO 15883:1 andBS EN ISO 15883:2BS EN ISO 15883:1 andBS EN ISO 15883:2CP(D)/service engineer Paragraphs 15.6–15.1359

Decontamination: Health Technical Memorandum 01-05 – Decontamination in primary care dental practices (2013 edition)Periodic tests14.3 The following testing protocol is recommended.Additionally any additional tests defined by themanufacturer should also be performed.Test Description Performed by ReferenceDAILYRemove and clean strainersand filtersEnsures filters and strainersare cleanUser or, by delegation,OperatorManufacturerDrain machine at end of day/sessionCleaning efficacyEnsures contaminated water isnot stored in tankVisual examination of all loaditemsUser or, by delegation,OperatorUser or, by delegation,OperatorWEEKLYincluding daily tests plus:Safety checks Check condition of door-seal User or, by delegation,OperatorProtein residue testConfirms that cleaningprocess retains the capabilityof removing proteinUser or, by delegation,OperatorManufacturerManufacturerManufacturerParagraphs 15.14–15.18BS EN ISO 15883:1QUARTERLY (or to manufacturers’ recommendations)including weekly tests plus:Automatic control test CP(D)/service engineer BS EN ISO 15883:1Verification of calibration CP(D)/service engineer BS EN ISO 15883:1Cleaning efficacy test CP(D)/service engineer BS EN ISO 15883:1Ultrasonic activity test CP(D)/service engineer BS EN ISO 15883:1ANNUALLYincluding quarterly tests plus:Completion of all validationCP(D)/service engineer As abovetests aboveNoteFor cleaning efficacy tests and protein residue tests, where the cycle does not have a rinse stage, items should be rinsed as a normalprocedure before these tests are carried out, otherwise the tests could return false positives.60

15 Additional information on test procedures (in addition to those provided in the Standards)15 Additional information on test procedures(in addition to those provided in theStandards)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 Choice Framework for localPolicy and Procedures 01-01 Part A for furtherguidance on training and certification), it will notbe necessary for the practice to possess copies ofthese Standards. It will, however, be necessary thatany contracted test performance include referenceto the 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 relevant tothe type of decontamination equipment beingused.Automatic control test15.3 This test (see list of tests in Chapters 12–14) isdesigned to show that the operating cycle functionscorrectly as shown by the values of the cyclevariables indicated and/or recorded by theinstruments fitted to the decontaminationequipment.Method15.4 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 start thecycle to be tested. If a process-data recording is notmade by the machine, the elapsed time, chambertemperatures and pressures – at all significant stagesof the cycle – should be observed and noted.15.5 At the approximate mid-point of the hold time(disinfection, cleaning, sterilizing), note the elapsedtime and indicated critical parameters. The test willbe considered satisfactory if the followingrequirements are met:• a visual display of “cycle complete” occurs;• during the whole of the cycle the values ofthe cycle parameters as indicated or shown onthe process-data record are within the limitsestablished as giving satisfactory results either bythe 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 cycleis complete (it is not advisable to attempt toopen the 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 not observeany mechanical or other anomaly.Ultrasonic activity test15.6 The ultrasonic activity can be investigated by theerosion pattern created on aluminium foil exposedin the tank for a short period. This activity may notbe uniform throughout the tank. Validation testswill determine the pattern variation at definedpositions and the time required to produce thispattern.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;Method• adhesive tape (for example autoclave indicatortape or masking tape);• a watch or clock with a second hand;• a rule or tape measure.15.9 The following method should be used:• Cut strips of aluminium foil in lengths 120 mmlonger than the bath is deep. Roll up one end ofthe foil so that the foil is now as long as the bathis deep.• Ensure that:– the water in the tank is at the required level;61

Decontamination: Health Technical Memorandum 01-05 – Decontamination in primary care dental practices (2013 edition)62– 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 include aperiod of operation to eliminate dissolved gasesfrom the solution in the bath (the degassingprocedure).• Using strips of adhesive tape across the top ofthe bath, suspend nine strips of the preparedfoil in the bath in a 3 × 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 conveniently bysticking them to a sheet of plain paper using atransparent adhesive tape.• Drain the bath and clean to remove debris oferoded aluminium foil.Reproduced by kind permission of the Scottish DentalClinical Effectiveness ProgrammeResults and interpretation15.10 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,it indicates 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 meters15.13 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 of thewand will need to be noted in order to make thetest repeatable.Safety checksWeekly checks15.14 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 checks15.16 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)/serviceengineer should ensure verification of the adequacyand safe connection of engineering services.

16 Approach and protocol for manual cleaning16 Approach and protocol for manual cleaningNoteThe use of manual cleaning presents particularproblems. Because the process is not automatic, itis not possible to fully validate the process. Manualcleaning is thus not the preferred method of cleaning.Where possible, manual cleaning should be replacedwith automated cleaning. However, where manualcleaning is necessary (for example, as advised by themanufacturer) and where the practice is operatingunder the essential quality requirements, the criticalparameters should be controlled as much as possible toreduce the variability in cleaning performance. Thefollowing advice aims to enable this control as muchas possible.16.1 A dirty-to-clean workflow should be maintainedthroughout the cleaning procedure. Two sinksor bowls 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 decontamination process,the surface should be thoroughly cleaned betweenstages using a water–detergent solution to minimisethe risks of cross-contamination.16.3 Always use detergents specifically formulated formanual cleaning of instruments.ImportantDo not use chlorhexidine handscrub (for exampleHibiscrub), washing-up liquid, cleaning creams orsoap. Chlorhexidine in particular makes proteins stickto steel.Cleaning procedure for dentalinstrumentsa. Measure the volume of water and detergent toachieve the concentration specified by thedetergent manufacturer. A line painted on thesink is useful to indicate the required volume ofwater. The detergent should be designed for themanual 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, fullysubmerge items to be cleaned in the detergentsolution.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.Or dispose of brushes if they are single-use.Reusable brushes should be replaced at themanufacturer’s recommended interval or morefrequently if the brush is seen to havesignificantly deteriorated.g. Carry out a final rinse in the clean sink usingsatisfactory potable water (see paragraphs 3.14,and 17.8–17.10), or RO water or distilled wateronly.h. After rinsing, drain and dry if instruments are tobe wrapped.63

Decontamination: Health Technical Memorandum 01-05 – Decontamination in primary care dental practices (2013 edition)Protocol for the manual cleaning of dental instrumentsImmersion methodAll personnel involved in the decontamination of dental instruments should be trained in the content andapplication of this protocol and associated guidance.To minimise the risk to personnel undertaking manual cleaning, the splashing and creation of aerosols shouldbe 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 satisfactory potable, distilled or RO water.• After rinsing, drain and dry if instruments are to be wrapped.• Visually inspect all items under an illuminated magnifier ensuring they are clean, functional and ingood 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.64

17 Steam and water quality17 Steam and water quality17.1 For the purposes of this document, either one ofthe following types of water is considered suitable:sterile water for irrigation; distilled water; reverseosmosis water or suitable potable water (seeparagraph 3.14).Steam17.2 Decontamination within a dental decontaminationfacility should ensure that the quality and safety ofthe instruments are not affected by thedecontamination process itself.17.3 Factors affecting the quality of the steam, and thusthe safety of the instruments, include the following:material of chamber construction; quality of feedwater;conditions of storage of feed-water; periodbetween changes of feed-water.Quality of input water17.4 The quality of input water for benchtop sterilizers isdefined in Annex C of BS EN 13060. Care shouldbe taken to observe use-by dates. Any water unusedor left in opened containers at the end of the dayshould be discarded.Conditions of storage and frequency of change17.5 Feed-water may be stored in a reservoir in 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.17.6 However, even high-quality water is subjectto microbial contamination. For this reason –irrespective of whether the water is used onceonly – the reservoir should be emptied at such afrequency as to eliminate microbiological build-up.17.7 Current recommendations are for the reservoir tobe drained down and cleaned at the end of eachworking day or daily shift. Water should not be leftin the machine overnight.WaterThe configuration of water supply networks nowmeans the water sources from which supplies aredrawn may vary considerably in many parts ofEngland, such that hard water can appear in normallysoft water areas. The local water supplier (undertaker)will be able to advise on local supply quality andpotential changes.Cleaning17.8 Cleaning and rinsing (either manual or automated)can be performed with potable water as long as thewater hardness is low enough and other aspectsof water quality are satisfactory. This should beconfirmed with the manufacturer of the washerdisinfectorand detergent.17.9 Practices should check with the detergentmanufacturer that level of hardness is compatiblewith the detergent used and for its use in a washerdisinfector.If the input water has a hardness that isnot compatible, water softening is expresslyadvised. An ongoing knowledge of the hardness ofthe incoming water feed is therefore necessaryFinal rinsing17.10 The final rinsing of instruments – for example,those washed manually, in an ultrasonic bath or ina washer-disinfector – should be carried out usingsatisfactory potable water, or RO water or distilledwater.Detergents17.11 The efficacy of cleaning will depend on therelationship between potable water quality anddetergent performance. The detergent should bechosen for its cleaning efficacy and itscompatibility with the water quality.65

Decontamination: Health Technical Memorandum 01-05 – Decontamination in primary care dental practices (2013 edition)18 The use of lubricants18.1 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.If lubrication is practised in accordance withmanufacturers’ instructions, the consequence ofthis recontamination should be assessed. Thisassessment will require consultation with theequipment manufacturer or service agent whomshould be asked to approve the choice of lubricantused.66

19 Hot and cold water systems and dental unit water lines19 Hot and cold water systems and dental unitwater lines19.1 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 the Healthand Safety Commission’s (2000) Approved Code ofPractice L8:• 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.• These schemes should be written by experiencedand competent people.• 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 fromthird parties such as architects.– step-by-step instructions to operate,maintain, control and shut down the watersupply, storage and distribution systemswithin those premises;– a schedule of possible emergency incidentscausing loss of the water supply fromthe water undertaker. Each item in theemergency incident schedule should includeguidance on operational procedures to reestablisha stable wholesome water supply.19.3 The Registered Manager should implement aprogramme of staff training to ensure that thoseappointed to devise strategies and carry out controlmeasures are appropriately informed, instructedand trained, and should be assessed as to theircompetency. It is also essential that they have anoverall appreciation of the practices affecting waterhygiene and safety, and that they can interpret theavailable guidance and perform their tasks in a safeand technically competent manner.Safe hot water temperature19.4 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.Utilisation19.6 One of the critical factors affecting the qualityof water within hot and cold water distributionsystems is the extent of utilisation. The RegisteredManager needs to ensure that there is good liaisonbetween staff members in the dental practice toensure that the water services are sufficiently used.67

Decontamination: Health Technical Memorandum 01-05 – Decontamination in primary care dental practices (2013 edition)19.7 L8 recommends that, for sporadically used taps,flushing is carried out once a week. The procedurefor such practice should be fully documented andcovered by written instructions.Flushing dental unit water lines (DUWLs)19.8 For procedures on flushing DUWLs betweentreatment sessions and at the beginning/end of eachworking day, see paragraphs 6.84–6.86.Decommissioning of DUWLs19.9 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 water systems)should be removed, flushed with distilled or ROwater and left open to the air for drying. Theyshould then be stored inverted to preventcontamination during the temporary closure.Recommissioning of DUWLs19.12 In the absence of manufacturers’ guidance, flushthe DUWL for at least three minutes, disinfectthe DUWL 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.NoteCare 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 ROwater. Where visual contamination is present,flushing with a suitable disinfectant followed bythorough washing is necessary. The manufacturer’sNoteinstructions 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.The self-contained water supplies used for dental caresystems should be distilled or RO water (see Chapter17).19.16 As part of the recommissioning, dental equipmentrequiring protection against backflow shouldhave the anti-retraction valves (incorporatedon handpieces or waterlines) checked by theresponsible person. They should ensure they aresuitably decontaminated, refitted correctly andare operating 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 policy19.18 The Registered Manager is ultimately responsiblefor the provision of a wholesome water supply inthe premises under his/her authority.Contract maintenance19.19 When selecting subcontractors, particularlyin relation to the control of Legionella, theircompetence should be established beforehand (forexample, companies/individuals who are membersof the Legionella Control Association).Emergency action19.20 Contingency plans should be available in the eventof the following:68

19 Hot and cold water systems and dental unit water linesa. 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. This:– may result in the temporary cessation of theproduction of RO water;– may require the temporary cessation ofsterile supply activities;– may result in hygiene issues for patient andstaff WCs/washrooms.The emergency action to be taken during anoutbreak of healthcare-associated legionellosisis covered in Health Technical Memorandum04-01 Part B Appendix 1.Documentation19.21 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 drawings19.23 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-fitteddrawings can be obtained from third parties suchas architects.19.24 In addition to drawings, there should becomprehensive schedules of outlets, lists of sentinelNotetaps (outlets), other outlets to be tested annuallyand other components in the system.The information required above could be compiledby the Competent Person employed to produce thewritten scheme, since much of the information is anintegral part of the written scheme itself.Record-keeping19.25 The User should ensure that an accurate recordof all assets relating to the hot and cold waterdistribution systems is set up and regularlymaintained.19.26 The User should also ensure that records of allmaintenance, inspection and testing activities arekept up-to-date and properly stored. Recordsshould be kept for at least five years. As aminimum, the following items should be recorded:• 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 the maintenanceof 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;69

Decontamination: Health Technical Memorandum 01-05 – Decontamination in primary care dental practices (2013 edition)• 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 hygiene19.32 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 EN806-3:2006 and BS 8558:2011 (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 or birds(for example, ensure covers are in place onstorage tanks/cisterns);• backflow (back-siphonage) of contaminatedwater into systems conveying potable water(mains and storage structures).Water treatment19.34 In a properly installed and commissioned hotwater system, it should be possible to maintain atemperature of at least 55oC at the furthest drawoffpoint 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 itis not 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.NoteIn addition to residual biocidal techniques, thereare other 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 cold waterservice systems to control the growth of Legionellais not generally recommended. Advice on the useof biocides should be sought from the personadvising the practice on Legionella.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 systems19.40 Where chemical treatment is introduced, it isessential to ensure that all parts of the systemare purged so that adequate concentrations areachieved.19.41 As temperature monitoring is performed onsentinel and representative outlets on a rollingbasis only, additional draw-off will be required atall points on a regular basis.Ozone and ultraviolet treatment19.42 Whereas treatments such as chlorine dioxide 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).70

19 Hot and cold water systems and dental unit water linesMetal contamination19.43 See Health Technical Memorandum 04-01 Part AChapter 6.Filtration19.44 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 isalso disinfected appropriately during filter ormembrane maintenance.Water storage19.46 For general information on water storage, seeHealth Technical Memorandum 04-01 Part A(paragraphs 7.1–7.2) and Health TechnicalMemorandum 04-01 Part B (paragraphs7.54–7.61).Cold water distribution system19.47 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, BS EN 806-3:2006 and BS 8558:2011. (See Chapter 8 ofHealth Technical Memorandum 04-01 Part A forfurther information.)19.48 The control of water temperature in the cold waterservice will essentially rely on good insulation andwater turnover. Cold water services should be sizedto provide sufficient flow and should be insulatedand kept away from areas where they are prone tothermal gains (this also applies to water suppliesfor spittoons). Stagnation must be avoided. Specialattention should be given to the maintenance andmonitoring of these systems.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 of leakageor 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 water19.51 If separate drinking water supplies are provided,reference should be made to Health TechnicalMemorandum 04-01 Part A (paragraphs 8.13 and8.14).Hot water storage and distribution19.52 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 8558:2011. 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, itis essential 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 at thesupply to the furthermost draw-off point in thecirculating system.NotesA minimum of 55oC may be required for theoperation of suitable mixing devices to provide “safe”hot water at the upper limit of the recommendedrange.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.71

Decontamination: Health Technical Memorandum 01-05 – Decontamination in primary care dental practices (2013 edition)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 60oC forat least an hour.See also Health Technical Memorandum 04-01Part B paragraphs 7.74–7.76 for further advice oncalorifiers.Instantaneous water heaters for single or multipointoutlets19.56 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 8558:2011. 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 devices19.57 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 construction19.61 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 regimen19.62 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 below in Table 1.Point-of-use filtration19.63 Point-of-use filters must be changed in accordancewith manufacturers’ recommendations, typicallyat least 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 waterservices 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.72

19 Hot and cold water systems and dental unit water linesTable 1 Tests for temperature performanceFrequency Check Cold water Hot water NotesMonthly † Sentinel outlets The water temperatureshould equilibrate below20oC after draw-off for2 minutes 1,2 The water temperatureshould equilibrate to atleast 50oC after draw-offfor 1 minute 3These measurements areapplicable to non-mixedoutlets onlyMonthly Inlets to sentinel TMVs Temperatures as above Temperatures as above Measurements can bemade by means of surfacetemperature probesMonthly Water leaving andreturning to calorifierAlso to be monitoredcontinuously by BMS6-monthlyIn-coming cold water atinlet to building – in thewinter and in the summerThe water should bebelow 20°C 2The water temperatureAnnually ‡ Representative outlets The water temperature2 minutes 1,2 for 1 minute 3should equilibrate below20oC after draw-off forshould equilibrate to atleast 50oC after draw-offNotes:Also to be continuouslymonitored by BMS† Sentinel outlets are normally those that – on a hot water service – are the first and last outlets on a recirculating system. Oncold water systems (or non-recirculating hot water systems), they are the closest and furthermost from the storage tank (orwater heater). The choice of sentinel taps should also include other outlets that are considered to represent a particular risk, forexample those installed in accommodation in which particularly susceptible patients are treated, or others identified in the riskassessment and temperature mapping exercise as having the least satisfactory temperature performance.‡ Representative outlets include conventional and mixed-temperature taps; 20% of the total number installed throughout thepremises 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 to achievean equilibrium temperature below 20°C. Achieving this minimum requirement would be indicative of an exceptionallyunderutilised water system. (At a typical flow to a wash-hand basin of 4.5 L/m, 2 minutes to achieve temperature wouldindicate 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 at temperaturesup to 25oC. In practice, the water temperature is likely to be below this maximum value, typically below 10oC in winter and20oC in summer. If, during prolonged periods of high environmental temperature, the water temperature starts to exceed20oC, the water undertaker should be asked to see whether remedial action could be undertaken. Within the curtilage of thepremises, the aim should be to ensure that the temperature difference between the in-coming supply and most distal parts ofthe distribution system is below 2oC.3. The Health & Safety Commission’s (2000) Approved Code of Practice L8 permits a period of 1 minute to achieve anequilibrium temperature of 50oC. A minimum of 55oC may be required for the operation of suitable mixing devices requiredto provide “safe” hot water at the upper limit of the recommended range. Hot water at 55oC is required in many cases forreasons of food hygiene or decontamination requirements, for example in kitchens and sluice rooms etc. In a properly balancedhot water circulating system, with the circulation taken close to the draw-off point, achieving temperature should be virtuallyinstantaneous. (At a typical flow to a wash-hand basin of 4.5 L/m, 1 minute to achieve temperature would indicate a 25 mdead-leg of 15 mm pipe.)73

Decontamination: Health Technical Memorandum 01-05 – Decontamination in primary care dental practices (2013 edition)Table 2 Summary checklist for hot and cold water servicesService Task* FrequencyHot water servicesArrange for samples to be taken from hot water calorifiers/ Annuallywater heaters in order to note condition of drain waterCheck temperatures in flow and return at calorifiers/water Monthly 4heatersCheck water temperature after draw-off from outlets for Monthly 4outlets 1,2,51 minute to ensure that 50oC has been achieved in sentinelVisually check internal surfaces of calorifiers/water heaters Annuallyfor scale and sludge. 5Check representative taps for temperature as above on arotational basisManual check to confirm secondary hot water recirculation Monthlypumps are operating effectivelyCold water services Check tank water temperature remote from in-coming ball 6-monthly 4valve and mains temperatures. Note maximum temperaturesrecorded by fixed max/min thermometers, where fittedCheck temperature in sentinel outlets after draw-off for Monthly2 minutes to establish that it is below 20oC 2,3Visually inspect cold water storage tanks and carry out Annuallyremedial work where necessary.Check representative taps for temperature, as above, on arotational basisDental equipment Drain down and clean At the end of each working dayEmergency eye wash sprays Flush through and purge to drain 6-monthly or more frequently ifrecommended by manufacturersMixed-temperature outlets Check delivery temperature in accordance with D08 6-monthlyShowerheads Dismantle, clean and descale showerheads and hoses Quarterly, or as necessarySporadically-used outlets Flush through and purge to drain, or purge to drain At least twice weekly 6immediately before use without release of aerosolsNotes:* See paragraph 182 in the Health & Safety Commission’s Approved Code of Practice L8 for further guidance on tasks thatshould be undertaken.1. For effective operation of hot water services, the minimum equilibrium temperature should be 55oC and be achieved withinseconds.2. For thermostatic mixing devices, temperatures should be measured at the inlet.3. For satisfactory operation of cold water services, temperature equilibrium to below 20oC should be achieved well within oneminute.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 distal points.6. Risk assessment may indicate the need for more frequent flushing of outlets. It is preferable that this form part of the dailycleaning routine where appropriate. Alternatively, self-purging showers that discharge water to a drain prior to use and withoutthe release of aerosols can be considered.74

19 Hot and cold water systems and dental unit water linesMicrobiological monitoring19.66 Apart from situations where there are taste orodour problems, microbiological monitoring fortotal viable counts (TVCs) is not considered to benecessary.19.67 If performed for these purposes, the detection oflow TVCs is not necessarily an indication of theabsence of Legionella, but is an indication of theoverall water quality and signifies a generallyunfavourable environment for bacteria.19.68 All microbiological measurements should be byapproved methods and/or be carried out by UnitedKingdom Accreditation Service (UKAS)-accreditedlaboratories. Dip slides are not acceptable.75

Decontamination: Health Technical Memorandum 01-05 – Decontamination in primary care dental practices (2013 edition)Appendix 1 – Hand-hygiene policyA hand-hygiene policy must be available within thepractice and should contain, at least, the following:• Carry out hand hygiene between each patienttreatment, and before donning and after removal ofgloves.• 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 and as required.• Hand-washing should take place at least at thebeginning and end of every session, and if hands arevisibly soiled.• Antimicrobial handrubs conforming to BS EN 1500can be used on visibly clean hands as an alternative towashing.• If hands become sticky with the build of handrubresidue, they must be washed as normal using aproper hand-hygiene technique.• Alcohol-impregnated wipes used for cleaning surfacesshould not be used in place of handrubs/gels, as theyare not effective in hand decontamination.• Use a foot-operated or sensor-operated waste bin.76

HAND CLEANING TECHNIQUES2 31a1bApply a small amount (about 3ml) of the productin a cupped hand, covering all surfacesRub hands palm to palm4Rub back of each hand withthe palm of other hand withfingers interlaced5920-30 secRub palm to palm withfingers interlaced6 7Rub with backs of fingersto opposing palms withfingers interlockedOnce dry, your hands are safe9 1011770 1Wet hands with waterApply enough soap tocover all hand surfacesAdapted from WHO World Alliance for Patient Safety 2006Rub each thumb claspedin opposite hand usingrotational movement8Rub tips of fingersin opposite palm ina circular motionRub each wrist with opposite handRinse hands with water12Use elbow toturn off tapYour hands are now safeDry thoroughly witha single-use towel40-60 secAppendix 1 – Hand-hygiene policy

Decontamination: Health Technical Memorandum 01-05 – Decontamination in primary care dental practices (2013 edition)Appendix 2 – Examples of logbook pagesTable A1 Summary detailsSteam sterilizer detailsDental practice address Room MakeModel Ref. No Serial No.Contents – the following forms:Name of form Code No. Copy Purpose TableDaily test sheet Yes A record of all daily testing A3Weekly test sheet plant historyNo A record of faults/maintenance A4recordQuarterly and yearly test sheets Yes Competent Person’s–(Decontamination) quarterly andyearly test sheetsTest history record Yes History of the weekly, quarterly and –yearly testsAutoclave history record sheet Yes Record of all faults, maintenance A5and repairs to the autoclaveProcess log sheet No Provides a record of every sterilizerload processedA6Personnel Name/organisation Tel. No.Registered managerUserOperator(s)Infection control nurseCompetent Person (Pressure vessels)*Authorised Person(Decontamination)Competent Person(Decontamination)*Service engineerMicrobiologist*These personnel should have qualifications/training/registration defined in CFPP 01-01 Part APressure Systems Safety Regulations 2000This section to be filled in by the Competent Person (Pressure vessels)Written scheme of inspection exists/is suitableInspection carried out on Date: Inspected by:Result of examination/commentsReview of records by Registered Manager or external regulatory bodyDate Comments on review Name/signature78

Decontamination: Health Technical Memorandum 01-05 – Decontamination in primary care dental practices (2013 edition)Table A3 Weekly test sheetTests to be carried out in accordance with HTM 01-05Sterilizer location Serial No. DepartmentMake/modelRef. No.WeekbeginningCyclenumberAutomatic airleakage testresult*Pass/FailResidual airtestPass/FailAutomaticcontrol testresultPass/FailSteampenetrationtestPass/Fail/NotapplicableP/F P/F P/F P/F/NA S/UP/F P/F P/F P/F S/UP/F P/F P/F P/F S/UP/F P/F P/F P/F S/UP/F P/F P/F P/F S/UP/F P/F P/F P/F S/UP/F P/F P/F P/F S/UP/F P/F P/F P/F S/UWeekly safetychecksSatisfactory/UnsatisfactoryCertified fitfor use byuser* Only where the sterilizer has an in-built self-test programme. Otherwise the test should be carried out by a CP(D) and copiesof the CP(D)’s test sheets should be inserted.Weekly safety checks (tick if satisfactory)WeekbeginningCyclenumberDoor sealDoor pressureinterlockDoor closedinterlockSatisfactory/UnsatisfactoryTested byS/US/US/US/US/US/UFaults – new or existing (also enter in plant history record)80

Table A4 Autoclave history record sheetType of autoclaveDental practiceStart date for this sheetDepartment/location Ref. No Serial No.FAULTS RECORDMAINTENANCE RECORDFaultnumberDateCyclenumberDetails of faultNoted andreported byDateFaultnumberMaintenance record – include servicing as well asfault-finding detailsCarriedout byAppendix 2 – Examples of logbook pages81

82Table A5 Processed log sheet – benchtop autoclaveDental practiceStart date for this sheetDepartment/location Ref. No. Serial No.DateCyclenumberCyclestarttimeCycleselectedDescription of loadCycle passYes/NoYes/NoYes/NoYes/NoYes/NoYes/NoYes/NoYes/NoYes/NoYes/NoYes/NoYes/NoYes/NoYes/NoYes/NoYes/NoYes/NoYes/NoYes/NoYes/NoYes/NoYes/NoYes/NoYes/NoYes/NoPrintoutchecked OK(ifapplicable)Yes/NoYes/NoYes/NoYes/NoYes/NoYes/NoYes/NoYes/NoYes/NoYes/NoYes/NoYes/NoYes/NoYes/NoYes/NoYes/NoYes/NoYes/NoYes/NoYes/NoYes/NoYes/NoYes/NoYes/NoYes/NoCommentsandoperatorinitialsDecontamination: Health Technical Memorandum 01-05 – Decontamination in primary care dental practices (2013 edition)

ReferencesReferencesIt 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.For Northern Ireland variations, see page 95.Acts and regulationsCarriage of Dangerous Goods and Use ofTransportable Pressure Equipment Regulations 2009.SI 2009 No 1348. HMSO, 2009.http://www.legislation.gov.uk/uksi/2009/1348/contents/madeControl of Substances Hazardous to HealthRegulations (COSHH) 2002. SI 2002 No 2677.HMSO, 2002.http://www.legislation.gov.uk/uksi/2002/2677/contents/madeHealth and Safety at Work etc Act 1974. HMSO,1974.Health and Social Care Act 2008. HMSO, 2008.http://www.legislation.gov.uk/ukpga/2008/14/contentsHealth and Social Care Act 2012. HMSO, 2012.http://www.legislation.gov.uk/ukpga/2012/7/contents/enactedMedical Devices Regulations 2002. SI 2002 No. 618.HMSO, 2002.http://www.legislation.gov.uk/uksi/2002/618/contents/madePressure Systems Safety Regulations 2000. SI 2000No 128. HMSO, 2000.http://www.legislation.gov.uk/uksi/2000/128/contents/madeWater Supply (Water Fittings) Regulations 1999.SI 1999 No 1148. HMSO, 1999.http://www.legislation.gov.uk/uksi/1999/1148/contents/madeWater Supply (Water Quality) Regulations 2010.SI 2010 No 994. HMSO, 2000.http://www.legislation.gov.uk/wsi/2010/994/contents/madeCodes 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_122604British, European and InternationalStandardsBS 5925:1991. Code of practice for ventilationprinciples and designing for natural ventilation. BritishStandards Institution, 1991.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 8558:2011. Design, installation, testing andmaintenance of services supplying water for domesticuse within buildings and their curtilages. Complementaryguidance to BS EN 806. British Standards Institution,2011.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.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 installations insidebuildings conveying water for human consumption. Pipesizing. Simplified method. British Standards Institution,2006.83

Decontamination: Health Technical Memorandum 01-05 – Decontamination in primary care dental practices (2013 edition)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. Generalrequirements, terms and definitions and tests. BritishStandards Institution, 2006.BS EN ISO 15883-2:2006. Washer-disinfectors.Requirements and tests for washer-disinfectors employingthermal disinfection for surgical instruments, anaestheticequipment, bowls, dishes, receivers, utensils, glassware,etc. British Standards Institution, 2006.BS EN ISO 17665-1:2006. Sterilization of health careproducts. Moist heat. Requirements for the development,validation and routine control of a sterilization processfor medical devices. British Standards Institution, 2006.Department of Health publicationsAdvice for dentists on reuse of endodonticinstruments and variant Creutzfeldt-Jakob Disease(vCJD). “Dear Colleague” letter, April 2007.http://www.dh.gov.uk/en/Publicationsandstatistics/Lettersandcirculars/Dearcolleagueletters/DH_074001Clean, safe care: reducing infections and saving lives.2008.http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_081650Note:The Space for Health website has closed. From April2013, all DH estates guidance and other materialsnormally accessed via Space for Health will be availablefrom the individual websites of England, Wales, Scotlandand Northern Ireland.As the details of these individual websites are notcurrently available, any queries about the status of, andaccess to, the following DH estates guidance documentsshould be addressed to help@spaceforhealth.netThis reference list will be updated once the full accessdetails of the migrated guidance documents areestablished.Decontamination of reusable medical devices in theprimary, secondary and tertiary care sectors – 2007.Clarification and policy summary. 2007.http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_074722Health Building Note 13 – Sterile servicesdepartment. 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 therisk of transmission.http://webarchive.nationalarchives.gov.uk/+/www.dh.gov.uk/en/Publicationsandstatistics/Lettersandcirculars/Healthservicecirculars/DH_4004969Health Service Circular (HSC) 1999/179 – Controlsassurance in infection control: decontamination ofmedical devices.http://webarchive.nationalarchives.gov.uk/+/www.dh.gov.uk/en/Publicationsandstatistics/Lettersandcirculars/Healthservicecirculars/DH_4004321Health Service Circular (HSC) 2000/032:Decontamination of medical devices.http://webarchive.nationalarchives.gov.uk/+/www.dh.gov.uk/en/Publicationsandstatistics/Lettersandcirculars/Healthservicecirculars/DH_4002990Health 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_4084234Health Technical Memorandum 00 – Policies andprinciples: best practice guidance for healthcareengineering, 2006.Choice Framework for local Policy and Procedures01-01 – Management and decontamination of surgicalinstruments (medical devices) used in acute care. PartA: The formulation of local policy and choices, 2012.Choice Framework for local Policy and Procedures01-01 – Management and decontamination of surgicalinstruments (medical devices) used in acute care. PartB: Common elements, 2012Choice Framework for local Policy and Procedures01-01 – Management and decontamination of surgicalinstruments (medical devices) used in acute care. PartC: Steam sterilization, 2012.84

ReferencesChoice Framework for local Policy and Procedures01-01 – Management and decontamination of surgicalinstruments (medical devices) used in acute care. PartD: Washer-disinfectors, 2012.Choice Framework for local Policy and Procedures01-04 – Decontamination of linen for health andsocial care. 2012.Health Technical Memorandum 04-01 – The controlof Legionella, hygiene, “safe” hot water, cold waterand drinking water systems, 2006.Health Technical Memorandum 07-01 – Safemanagement of healthcare waste. Second edition. 2011.Potential vCJD transmission risks via dentistry: aninterim review.http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_081170Records management: NHS code of practice. 2006.http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_4131747Uniforms and workwear: guidance on uniform andworkwear policies for NHS employers.http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_114751Other publicationsBuildCert (2009). TMV approval scheme. BuildCert,Gwent.http://www.buildcert.com/tmv3.htmEhrenkranz, N.J., Bolyard, E.A., Wiener, M. and Cleary,T.J. (1980). Antibiotic-sensitive Serratia marcescensinfections complicating cardiopulmonaryoperations: contaminated disinfectant as areservoir. Lancet. Vol. 2 No. 8207, pp. 1289–92.Health and Safety Commission (2000). Approved Codeof Practice, Legionnaires’ disease: the control oflegionella bacteria in water systems (L8). Health andSafety Executive, 2000.http://www.hse.gov.uk/pubns/priced/l8.pdfMedicines and Healthcare products Regulatory Agency.DB 9804 (including update sheet, November 2003)– The validation and periodic testing of benchtopvacuum steam sterilizers. MHRA, 1998.http://www.mhra.gov.uk/home/groups/dts-bi/documents/publication/con2015680.pdfMedicines and Healthcare products Regulatory Agency.MDA DB 2002 (06) (including update sheet, October2004) – Benchtop steam sterilizers: guidance onpurchase, operation and maintenance. MHRA, 2002.http://www.mhra.gov.uk/home/groups/dts-bi/documents/publication/con007327.pdfMeiller, TF et al (1999), ‘Dental unit waterlines:biofilms, disinfection and recurrence’. The Journal of theAmerican Dental Association, Vol 130 No 3, January,pp 65–72.NHSScotland. Survey of decontamination in generaldental practice. Sterile Services Provision Review Group,2004.http://www.scotland.gov.uk/Publications/2004/11/20093/45208Pankhurst CL, Johnson NW and Woods RG, Microbialcontamination of dental unit waterlines: the scientificargument. International Dental Journal, Vol 48, 1998,pp 359–368.Pankhurst CL, Woods RG and Johnson NW, Causes andprevention of microbial contamination of dental unitwater. FDI World, Vol 8 No 1, 1999, pp 6–13.Sautter, R.L., Mattman, L.H. and Legaspi, R.C. (1984).Serratia marcescens meningitis associated with acontaminated benzalkonium chloride solution.Infection Control. Vol. 5 No. 5, pp. 223–225.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.WHO (World Health Organization) (2011). Watersafety in buildings. WHO, Geneva.http://www.who.int/water_sanitation_health/publications/2011/9789241548106/en/85

Decontamination: Health Technical Memorandum 01-05 – Decontamination in primary care dental practices (2013 edition)Northern Ireland references, equivalents andvariations• The Care Quality Commission and the HCC do nothave authority in Northern Ireland. The Departmentof Health, Social Services and Public Safety(DHSSPS) proposes to register and regulate theprivate dental sector through the Regional Qualityand Improvement Authority (RQIA). Officials fromboth organisations are progressing this work atpresent. RQIA have no plans to register the dentalsector at present, although this is subject to ongoingreview.• In November 2007, the DHSSPS issued “qualityimprovement scheme” (QIS) letters outliningpriorities for improvements at general dental practices,expecting practices to work towards these within athree-to-five-year time period.• ‘Decontamination in general dental practices -supplementary guidance’ (issued in November 2007),which includes decontamination room layouts andsterilizer and washer-disinfector model specifications,is available at www.dhsspsni.gov.uk/index/hea/decontamination-general-dental-practices.htm• Chief Dental Officer’s letters etc can be found atwww.dhsspsni.gov.uk/index/dental/dental-whatsnew.htm• The Northern Ireland equivalent of DB 2000(04)‘Single use medical devices: implications andconsequences of reuse’ is DB 2000/04(NI) availableon the NIAIC web site: www.dhsspsni.gov.uk/index/hea/niaic/niaic_device_bulletins.htm• The Northern Ireland equivalent of DB 2002(06) isDB(NI)2002/06 ‘Benchtop steam sterilizers –guidance on purchase, operation and maintenance’available at www.dhsspsni.gov.uk/hea-db(ni)2002-06.pdf• The Northern Ireland equivalent of HSC 1999(178)is HSS(MD)15/99 (www.dhsspsni.gov.uk/healthprotection-cjd), and of HSC 1999(179) isHSS(MD)16/99 (www.dhsspsni.gov.uk/hssmd15-99.pdf)• • Northern Ireland legislation, policy circulars, codes ofpractice, device bulletins etc equivalent to those listedthroughout this document can be obtained from thefollowing web sites:• Ministry of Justice – the UK Statute Law Databaseprovides details of equivalent legislation across the UK(www.statutelaw.gov.uk).• The DHSSPS provides policy information includingChief Medical Officer (CMO) circulars (www.dhsspsni.gov.uk).• The Northern Ireland Adverse Incident Centreprovides access to device bulletins (DB), warningnotices etc (equivalent to MHRA publications)(www.dhsspsni.gov.uk/niaic).• The Health and Safety Executive for Northern Ireland(HSENI) provides information on Northern Irelandhealth and safety legislation and codes of practice(www.hseni.gov.uk).• On behalf of the DHSSPS, the Estates PolicyDirectorate of Health Estates issues ProfessionalEstates Letters (PELs). These set out departmentalpolicy in relation to estates issues, including medicaldevices, non-medical equipment, buildings and plant(www.dhsspsni.gov.uk/index/hea/niaic/niaic_pels.htm).86