Decontamination in primary care dental practices - Gov.uk

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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
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Executive summaryPreambleThis docum
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Page 11 and 12: ContentsValidation and testingPerio
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