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)(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
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Executive summaryPreambleThis docum
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ContentsContentsPrefaceExecutive su
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ContentsValidation and testingPerio
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1 Policy and foreword (Barry Cockcr
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Decontamination in primary care dental practices - Gov.uk

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