Decontamination in primary care dental practices - Gov.uk

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