Every dental practice in the UK must have a written infection prevention and control policy. CQC inspectors in England assess practices under the Single Assessment Framework (2024) against Quality Statements including safe care and treatment. HTM 01-05 is the reference standard. This guide details what your protocol must contain and what inspectors look for.
Every dental practice in the UK must have a written infection prevention and control policy. CQC-registered practices in England are assessed under the Single Assessment Framework (2024) against 34 Quality Statements under 5 key questions (Safe, Effective, Caring, Responsive, Well-led). HTM 01-05 is the reference standard for decontamination protocols. The documents describe the procedure to follow at each step of the sterilisation chain and assign responsibilities. The absence of written protocols is grounds for non-compliance — and Regulation 12 (Safe Care and Treatment) is the most commonly prosecuted CQC regulation.
The designation of the person responsible for sterilisation within the practice. A detailed description of each step in the sterilisation chain (pre-disinfection, cleaning, rinsing, drying, packaging, autoclaving, storage). The maintenance and validation schedule for the autoclave (initial qualification, annual requalification, preventive maintenance). The frequency of biological and physico-chemical controls (daily Helix/Bowie-Dick for vacuum sterilisers, periodic tests per manufacturer instructions, regular spore indicators). The traceability method used (paper or digital register). The clinical waste management procedures. The continuing professional development plan for staff.
For a step-by-step breakdown of the sterilisation chain, see our dental sterilisation chain guide.
A cycle is valid when the recorded parameters match the selected programme and all indicators are compliant. In dental practice, the reference cycle is 134°C for 18 minutes (prion cycle), mandatory for instruments in contact with nervous or lymphoid tissue. The autoclave must be Class B (Type B vacuum steriliser, as recommended by HTM 01-05) to sterilise hollow instruments (turbines, contra-angles) and wrapped loads.
Before the first load of each working day, HTM 01-05 requires a steam penetration test (Helix or Bowie-Dick) for Type S and Type B vacuum sterilisers. A failed cycle or a non-compliant indicator requires repackaging and resterilisation of the entire load.
For details on biological controls, see our autoclave biological controls guide.
HTM 01-05 (Health Technical Memorandum 01-05: Decontamination in primary care dental practices, 2013 edition) is the primary decontamination standard for dental practices in England. Wales references WHTM 01-05; Scotland and Northern Ireland also reference the same standard. It covers the entire process: premises layout (forward flow principle), equipment (validated autoclave, functional cleaning equipment), procedures (written protocols, traceability, biological controls), and documentation (dedicated logbook per machine, autoclave maintenance log, training records).
CQC assesses compliance under Regulation 12 (Safe Care and Treatment) of the Health and Social Care Act 2008. CQC fines are unlimited on indictment. Operating without CQC registration carries up to 12 months imprisonment. The GDC can also investigate fitness to practise for individual dental professionals, with sanctions up to erasure from the register.
The protocol must define the traceability method used. HTM 01-05 explicitly accepts "automated data-loggers or interfaced computer-based recording systems" but warns that autoclave thermal printouts may fade over time and recommends photocopying them. Paper registers remain accepted, but their limitations are well documented: missing pages, illegible handwriting, forgotten entries, no instrument-to-cycle link, fading printouts.
A digital register eliminates these risks. SecuSteri automatically imports the autoclave report, links each instrument to its cycle, and generates a signed, tamper-proof record. Each cycle is archived according to the plan's retention period, accessible at any time during an inspection.
For a detailed comparison, see our digital vs paper register guide.
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