Revision 1 - February 2014 - Wales

1 WHTM 01-05 Welsh Health technical memorandum Decontamination in primary caredental practices andcommunity dental servicesRevision 1 - February 2014 The amendments made in this Revision are:AcknowledgementsParagraph amendedDiagram on page 20 amendedParagraph amendedNote following paragraph addedNote following paragraph amendedParagraph amendedParagraph amendedParagraph amendedParagraph amendedAppendix 1: First line of the first note amendedAppendix 2: Three bullet points added2 Welsh Health technical memorandum 01-05 - Decontamination in primary care dental practices and community dental services Revision 1 - February 2014 DisclaimerThe contents of this document are provided by way of general guidance only at the time of its publication. Any partymaking any use thereof or placing any reliance thereon shall do so only upon exercise of that party s own judgementas to the adequacy of the contents in the particular circumstances of its use and application.

2 No warranty is given asto the accuracy, relevance or completeness of the contents of this document and NHS Wales Shared ServicesPartnership Facilities Services shall have no responsibility for any errors in or omissions there from, or any use madeof, or reliance placed upon, any of the contents of this :Heath Building Notes (HBNs) and Health technical Memoranda (HTMs) issued by the Department ofHealth in England are being superseded by specific Welsh editions which will be titled Welsh Heath Building Notes(WHBNs) and Welsh Health technical Memoranda (WHTMs). Until this process is complete, where a WHBN orWHTM is referred to in the text but has not yet been published, refer to the relevant publications page on the NHSW ales Shared Services Partnership Facilities Services website for the latest approved document. Intranet: : by NHS Wales Shared Services Partnership Facilities ServicesThis guidance is based on the HTM 01-05 Decontamination in primary care dental practicesWelsh edition 2011guidance published by Welsh Health Estates which, in turn, was based on the 2009 edition produced by theDepartment of HealthThis publication can be accessed from the NHS Wales Shared Services Partnership Facilities Services ISBN: 978-1-909899-19-3 Copyright NHS Wales Shared Services Partnership Facilities Services 2014 Supersedes Welsh Health technical memorandum 01-05 Decontamination in primary care dental practices andcommunity dental services January 2014 Cover image of Neath Port Talbot Primary Care Resource Centre by courtesy of Abertawe Bro by Stewart Brooks, NWSSP-FSCover designed by Keith James 3 Patients deserve consistent standards of care every timethey receive treatment.

3 It is essential that they are treatedin a safe and clean environment with minimal risk ofperson-to-person transmission of document has been produced after wideconsultation and reflects our commitment to improvingstandards in dental believe that, by building on existing good practice,this guidance can help us to deliver the standard ofdecontamination that our patients have a right to policy and guidance provided in this WHTM areaimed at establishing a programme of continuousimprovement in decontamination performance. Theguidance suggests options to dental practices withinwhich choices may be made and a simple progressiveimprovement programme established. It is expected thatat publication of this guidance all primary care dentalpractices will be working at or above the requirementsdescribed in my letter of May 2012 CDO(2012)2. ( ).This revised guidance is intended to support andadvance good practice throughout primary care dentistryincluding that delivered by general dental practices,community dental services and where primary care isdelivered in acute settings.

4 4 Foreword by David Thomas, Chief Dental Officer5 Scope, status and structure ofWHTM 01-05 Welsh Health technical memorandum (WHTM) 01-05is intended to progressively raise the quality ofdecontamination work in primary care dental services bycovering the decontamination of reusable instrumentswithin dental guidance relates to locally conducteddecontamination procedures, which are the mostcommon method of decontamination in primary dentalcare. As such, this includes all work where the end-userand the persons conducting decontamination areemployees of the same organisation working in the sameor related premises. Ordinarily this will be a generaldental practice or community dental services functioningas part of the local health practices choose to make use of an externalservice, such as a central sterile services department,which is fully compliant with the Medical DevicesRegulations 2002 and is registered with the Medicinesand Healthcare products Regulatory Agency (MHRA),the guidance contained in WHTM 01-01 Decontamination of medical devices within acuteservices will be CDO ( Wales ) letter (2006)1- Decontamination/Sterilisation of Re-usable Instruments in General DentalPractice states The Medical Device Regulations 2002require the manufacturer of medical devices to supplyinformation on the appropriate processes to allow reuse,including cleaning, disinfection, packaging and, whereappropriate, the method of sterilization.

5 If correctlyfollowed, these instructions will ensure that the devicewill be safe for another episode of use . This implies thatdental practices ensure their local policies give rise to theproduction and use of sterilized instruments for use document is divided into three Sections: Section A: Decontamination policyThis section outlines the policy and principles ofdecontamination in dental practices, and explains therequirements for decontamination. Section B: Advice to dentists and practice staffThis section gives plain advice to dentists andpractice staff on how to achieve improved goodpractice; how to clean and sterilize instruments; andhow to set up a decontamination area within thepractice. Section C: Engineering, technology and standardsThis section gives technical advice to engineering andtechnical staff, including the roles and responsibilitiesof staff in the decontamination process. Such as theUser Authorising Engineer (Decontamination)(AE(D)), Authorised Persons (Decontamination)(AP(D)), Competent Persons (Decontamination)(CP(D)) and to guidance and standards provided by theWelsh Government and MHRA is provided andexplained throughout this engineering and technical information is provided(Section C), references to source standards and evidenceare given.

6 However, such references are omitted inSection Bto aid clarity of presentation and is important to remember that this is a workingdocument; changes to it may be necessary as newevidence around the methodology ofdecontamination becomes available. The user shouldalways seek advice on policies, technical issues andguidance to ensure improvements are should use WHTM 01-05 WHTM 01-05 will be of interest to all staff involved indecontamination in primary care dental services is intended to be used, or referred to, by all membersof a dental team providing primary care dental servicesthat is, dentists and support staff as well as engineeringstaff providing services in key areas. In addition, HealthBoards will find the contents of to other parts of the WHTM 01 series may benecessary on a limited basis below are the contributors to the originalDepartment of Health Publication on which thisWelsh Edition is HidderleyMedicines & Healthcare productsRegulatory AgencyChristine ArnoldBritish Dental AssociationDaniel McAlonanBritish Dental AssociationEsther DiasInfection Prevention Officer andDecontamination Lead, NHS BromleyGeoff RidgwayClinical microbiologistHugh Bennett Deputy Chief Dental Officer for WalesJimmy WalkerHealth Protection AgencyKen ToalHealth Estates, Northern IrelandLesley DerryBritish Dental AssociationLester EllmanGeneral Dental PractitionerMargie TaylorChief Dental Officer for ScotlandMartin JonesInfection Prevention SocietyMurray DevineSafety Strategy Lead, HealthcareCommissionPaul GrayNHS Business Services Authority.

7 DentalServices DivisionPaul LangmaidChief Dental Officer for WalesStuart JohnstonBritish Dental Association DHWorking Group on Water Quality in Use andDecontamination of Surgical Instruments. ChairmanNigel TomlinsonEngineering and Science Advisory Committee on thedecontamination of surgical instruments. ChairmanMike PainterInternal consulting groupBarry Cockcroft Chief Dental Officer for EnglandJerry ReadSection Head, Dental and Eye Care DivisionSerbjit KaurHead of Quality and Standards, Dentaland Eye Care ServicesRuth GasserDepartment of HealthIan RowlanSenior Engineer, Department of HealthPhilip AshcroftPrincipal Buildings and FacilitiesManagement Services Engineer, Department of HealthNigel TomlinsonPrincipal Scientific Adviser,Department of HealthListed below are the contributors to this Welshedition publication who sit on the WHTM GuidancePeer Group as directed by the Welsh AssemblyGovernment s All Wales Decontamination ThomasChief Dental Officer, WelshGovernmentLisa HowellsSenior Dental Officer, Welsh GovernmentTracey GauciNursing Officer, Welsh GovernmentMike SimmonsConsultant in Public HealthMicrobiology and Service Lead.

8 Public Health WalesPhillip FlearSterile Services Manager (Hywel DdaHealth Board)Eric ThomasAssistant Director, EnvironmentalManagement and Engineering, NHS Wales SharedServices Partnership Facilities ServicesGraham StantonSenior Decontamination Engineer,NHS Wales Shared Services Partnership FacilitiesServicesJohn PrendergastDecontamination Engineer, NHSW ales Shared Services Partnership Facilities ServicesChristopher LewisEnvironmental ManagementAdvisor, NHS Wales Shared Services Partnership Facilities ServicesPeter WilesDeputy Director, NHS Wales SharedServices Partnership Facilities ServicesAcknowledgements67 ACDP-TSE: Advisory Committee on DangerousPathogens Transmissible Spongiform EncephalopathyRisk Management SubgroupAE(D):Authorising Engineer (Decontamination)AP(D):Authorised Person (Decontamination)BS:British StandardsCAPR:Clinical Audit and Peer ReviewCDO:Chief Dental OfficerCE:Conformit Europ enneCPD:Continuing Professional DevelopmentCP(D):Competent Person (Decontamination)COSHH:Control of Substances Hazardous to HealthDUWL:Dental unit water lineEN:European NormEU:European UnionEWC:European Waste CatalogueHCAI:Healthcare associated infectionsIHEEM:Institute of Healthcare Engineering and EstateManagementISO:International Standards OrganisationMDD:Medical Devices DirectiveMHRA:Medicines and Healthcare products RegulatoryAgencyNWSSP-FS:NHS Wales Shared Services Partnership Facilities ServicesPGMDE:Postgraduate Medical & Dental EducationPPE:Personal Protective EquipmentRO:Reverse osmosisSSD:Sterile Services DepartmentTVC:Total viable countsWHTM:Welsh Health technical memorandum AbbreviationsContentsForeword by David Thomas, Chief Dental Officer4 Overview5 Scope, status and structure of WHTM 01-05 Who should use WHTM 01-05 Acknowledgements6 Abbreviations 7 Section A.

9 Decontamination policyChapter 1 Policy 13 RegistrationIntroductionThe need for guidanceImprovements and enhancements in practice with the latest guidance,policy and standardsImprovements and enhancements in practicePrion decontaminationInfection prevention and control policyTraining and educationExclusionsRelationship to other sources of information and guidanceFurther guidanceSection B: Advice to dentists and practice staffChapter 2 Improvements and enhancements of the decontamination process20 Decontamination of instruments an overviewComplianceMeeting the standards requiredChapter 3 Cleaning instruments27 IntroductionGeneral 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 disinfection8 Inspection and care of instruments before sterilizingHandpiece careChapter 4 Sterilization33 Types of sterilizerDental handpiecesSmall sterilizersUse and testing of small sterilizersDaily testing and housekeeping tasksPackaging and related decontamination strategyStorage of sterilized instruments/devicesChapter 5 Setting up a decontamination area39 Physical segregationChapter 6 General hygiene principles43 Hand hygieneDrying of handsSkin careFacilities and procedures for hand-washingPersonal protective equipment for decontamination processesGlovesDisposable plastic apronsFace and eye protection for decontamination proceduresFootwareClothing.

10 Uniforms and laundryRemoval of PPES urface 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 appliances51 Section C: Engineering, technology and standardsChapter 8 Regulatory framework and compliance53BS/EN/ISO StandardsNHS Wales guidelinesChapter 9 Staff roles and responsibilities in decontamination54 Chapter 10 Procurement of decontamination equipment and instruments57 Determining the load to be processedDecontamination equipment: washer-disinfectors and sterilizersDecontamination equipment: ultrasonic cleanersSpecificationsSelecting instrumentsPolicy on new reusable instruments9 ContentsChapter 11 Decontamination equipment: general guidance on maintenance and testing61 Maintenance and servicingValidation and testingDocumentationChapter 12 Installation, validation, maintenance and t