Decontamination in primary care dental practices - Gov.uk

Decontamination: Health Technical Memorandum 01-05 – Decontamination in primary care dental practices (2013 edition)2.15 The re-use of a single-use device has implicationsunder the Medical Devices Regulations. Anyonewho reprocesses or re-uses a device CE-marked foruse on a single occasion bears the responsibilitiesnormally carried by the manufacturer for the safetyand effectiveness of the instrument.2.16 Shown below is the symbol that identifies singleuseitems. This will appear on packaging but mightnot be present on individual items. If in doubt,further advice should be sought from themanufacturer.22.17 Where instruments are difficult to clean,consideration should be given to replacing themwith single-use instruments where possible. Indentistry this will include, but is not limited to,instruments such as matrix bands, saliva ejectors,aspirator tips and three-in-one tips.2.18 Where endodontic reamers and files are designatedreusable, they should be treated as single patientuse or single use – regardless of the manufacturer’sdesignation – to reduce the risk of priontransmission. Practices must have effectiveprocedures in place to exclude errors in identifyingthe instrument(s) and associating them with thecorrect patient.2.19 Care needs to be exercised in the cleaning of reusableendodontic reamers and files. Whereautomated washer–disinfectors are used, the risk ofcross-contamination to other instruments would bevery low, in view of the dilution factors. Theseinstruments do not need to be processed on aseparate cycle. However, owing to the variability indilution during manual washing, the files/reamersshould be washed separately from otherinstruments.Quality assurance system and audit2.20 Dental practices are required to establish andoperate a quality assurance system that covers theuse of effective measures of decontamination andinfection control. This may best be demonstratedby undertaking audits and assessments of theirinfection control and decontamination practices.These audits should be filed for inspection as partof their risk management system.2.21 Compliance with this Health TechnicalMemorandum will be seen as indicative of thepresence of valid quality assurance systems. At aminimum, practices should audit theirdecontamination processes every six months, withan appropriate review dependent on auditoutcomes.NoteThe Infection Prevention Society/DH audit toolparallels the guidance provided in this document. Inaddition, a number of other safety-related topics areincluded in the tool. See paragraph 1.7.2.22 It is important that the audits are made available toregulatory bodies for inspection when required.2.23 Audit documents should be stored for at least twoyears. They should not be removed from thepremises or destroyed.Taking instruments to other locations2.24 The practice should have safe procedures for thetransfer of contaminated items from the treatmentarea to the decontamination facility.2.25 Transport containers should be such as to protectboth the product during transit and the handlerfrom inadvertent contamination, and thereforeshould be:• leak-proof;• easy to clean;• rigid, to contain instruments, preventing thembecoming a sharps hazard to anyone handlingthe goods and to protect them against accidentaldamage;• capable of being closed securely;• robust enough to prevent instruments beingdamaged in transit.14