Decontamination in primary care dental practices - Gov.uk

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