Decontamination in primary care dental practices - Gov.uk

Decontamination: Health Technical Memorandum 01-05 – Decontamination in primary care dental practices (2013 edition)Benchtop sterilizers4.9 Benchtop sterilizers should be operated to ensurethat:• they are compliant with the safety requirementsstated in this guidance and in the manufacturer’snotes;• they are installed, commissioned, validated andmaintained appropriately in compliance withthe manufacturer’s instructions (see Section 3);• they are operated in accordance with theequipment manufacturer’s instructions.Pre-wrap instruments only where this isrecommended by the manufacturer and wherethe sterilizer is vacuum-assisted. The sterilizershould be validated for the intended load and islikely to be of type B or S. The use of a type Nsterilizer is not appropriate for wrappedinstruments.4.10 All steam sterilizers are subject to the PressureSystems Safety Regulations 2000 and must beexamined periodically by a Competent Person(Pressure Vessels).Use and testing of benchtop sterilizers4.11 To ensure the safety of this device, the followingpoints should be adhered to:1. Each sterilizer will have a reservoir chamberfrom which the water is delivered for steamgeneration. This should be filled, at least daily,using distilled or RO water. However, morefrequent draining and refilling offers qualityadvantages in terms of the appearance andsuitability of the finished instruments. At theend of the working day, the device should thenbe cleaned, dried, and left empty with the doorkept open. For single-shot types, which do notstore water between cycles of use, these rules stillapply in terms of the water quality to be used.2. Validation is necessary to demonstrate that thephysical conditions required for sterilization(temperature, pressure, time) are achieved.Consultation with appropriately qualifiedengineers will be necessary. A Competent Person(Decontamination) or service engineer will beable to ensure that validation is achieved andthat the instrumentation used for parametricrelease is functioning and calibratedappropriately. The Competent Person(Decontamination) or service engineer will beneeded to validate or revalidate the equipment(see Section 3).Parametric release is defined as the release of a batchof sterilized items based on data from the sterilizationprocess. All parameters within the process have to bemet before the batch can be released for use.3. Testing is an integral part of ensuring thata benchtop sterilizer consistently performs tooperating parameters set during the machine’scommissioning. Failure to carry out routineperiodic tests and maintenance tasks couldcompromise safety and have legal andinsurance-related implications for the RegisteredManager (see paragraph 9.3).4. A schedule for periodic testing should thereforebe planned and performed in accordance withSection 3. The schedule should provide detailsof daily, quarterly and yearly testing or be inaccordance with manufacturers’ guidelines.Each sterilizer should have a logbook (file) inwhich details of the following are recorded:• maintenance;• validation;• faults;• modifications;• routine tests (see Appendix 2).4.12 Health Service Circular (HSC) 1999/053 and thesubsequent ‘Records management: code of practiceparts 1 and 2’ (April 2006) provide guidance onthe length of time for which records should beretained. Reference should be made to the timeperiod of legal rights of patients, and all relevantdocumentation should be retained for the practiceto meet any request within these rights. The coderequires that these records be maintained for notless than two years, although longer periods may beapplicable subject to local policy-making.4.13 The logbook should contain all informationpertaining to the lifecycle of the equipment (frompurchasing through to disposal).4.14 If the sterilizer has an automatic printer, the printoutshould be retained or copied to a permanentrecord. If the sterilizer does not have a printer, theuser will have to manually record the followinginformation in the process log:• date;• satisfactory completion of the cycle (absence offailure light);24