Decontamination in primary care dental practices - Gov.uk

Decontamination: Health Technical Memorandum 01-05 – Decontamination in primary care dental practices (2013 edition)8 Regulatory framework and complianceBS/EN/ISO Standards8.1 BS EN Standards for sterilization were firstpublished in 1994. They included:• BS EN 285 on larger steam sterilizers;• BS EN ISO 17665 on the monitoring of steamsterilization; and• BS EN 556 on the definition of sterilization.8.2 Subsequent standards covered benchtop sterilizers(BS EN 13060).8.3 Reviews and rewrites of the above Standardscoupled with the production of new Standards hasled to a revision of the content of Health TechnicalMemoranda – including this document – in orderto bring their content in line with that of theBS/EN/ISO Standard portfolio.8.4 A list of these Standards is provided in theReferences. It is in the light of these changes thatthis Health Technical Memorandum is published.Reference to the content of a relevant Standard ismade where necessary but the content of thatStandard is not included in this document.DH guidelines8.5 Guidance produced by DH for decontaminationhas evolved in recent years.8.6 Advice on decontamination of medical devices wasissued in HSC 2000/032 and in ‘Decontaminationof reusable medical devices in primary, secondaryand tertiary care sectors (NHS and Independentproviders)’ 2007.8.7 The Chief Dental Officer’s letter (April 2007)advised the single-use of all endodontic files andreamers, as well as any other instruments for whicheffective decontamination was difficult. Thiswas reinforced by the release of ‘Potential vCJDtransmission risks via dentistry. An interim review’(December 2007).8.8 Health Technical Memorandum 01-05 has drawnupon all guidance issued previously, includingHSG (93)40 ‘Protecting health care workers andpatients from hepatitis B’.8.9 It is issued specifically to improve standards indecontamination for primary care dental practices,where decontamination is carried out locally withinthe practice.8.10 Advice to the secondary sector was provided bypolicy document ‘Decontamination of reusablemedical devices in the primary, secondary andtertiary care sectors (NHS and Independentproviders)’. This document required demonstrationof compliance with the “essential requirements”of the Medical Devices Regulations and gave thefollowing four options for the decontamination ofreusable medical devices:• ensure all sites of decontamination comply tothese essential requirements;• use single-use devices;• outsource decontamination to an accreditedSSD;• a combination of the above.8.11 Health Technical Memorandum 01-05 sets out therequirements for the first of the above options.44