Every dental practice in Malta must have a written infection prevention and control policy and Standard Operating Procedures — the implicit expectation of the Standards for Dental Clinics (March 2024). HCSD inspectors verify both the documentation and its implementation. The protocol must cover the sterilisation chain, the validation regime, the cycle and load verification steps (Standards 5.1, 5.4, 6), staff training records, and Hepatitis B vaccination records (anti-HBs ≥10 mIU/mL titre) for those performing Exposure Prone Procedures. This guide details what your protocol must contain and what inspectors look for.
Every dental practice in Malta must have a written infection prevention and control policy and Standard Operating Procedures (SOPs) — the implicit expectation of the Standards for Dental Clinics (March 2024). These must be accessible to all staff and available for presentation during HCSD inspections. The documents describe the procedure to follow at each step of the sterilisation chain and assign responsibilities. The absence of written SOPs is grounds for non-compliance during an HCSD inspection.
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) per EN ISO 17665-1. The frequency of biological and physico-chemical controls (daily Bowie-Dick/Helix, weekly tests, regular spore indicators). The traceability method used (paper or digital register). Hepatitis B vaccination records (anti-HBs ≥10 mIU/mL titre) for staff performing Exposure Prone Procedures — verbatim from the Standards. 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 (or evidence-based equivalent per the Standards for Dental Clinics) to sterilise hollow instruments (turbines, contra-angles) and wrapped loads.
Before the first load of each working day, the Standards for Dental Clinics expects a Bowie-Dick test (pre-vacuum autoclaves) or Helix test (hollow instruments) to validate proper autoclave function. Validation of the sterilisation process is documented per Standard 5.1; cycle parameter checks once each load is completed per Standard 5.4; completed load verification per Standard 6. 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.
The Standards for Dental Clinics (March 2024) published by the Healthcare Standards Directorate (HCSD) is the primary benchmark for dental sterilisation in Malta. It covers the entire process: premises (separate decontamination area, pre-sterilisation items kept in a dedicated area per Standard 1.1f/g, forward flow principle respected), equipment (Class B steam steriliser or evidence-based equivalent, validated autoclave, functional cleaning equipment), procedures (written SOPs, traceability, biological controls), and documentation (sterilisation register, autoclave maintenance log, training certificates, Hepatitis B vaccination records).
The Standards reference HTM 01-05, CDC Guidelines, and Scottish Dental Clinical Guidance internally as source documents — the legal framework is Maltese (Health Care Professions Act Chapter 464 + Public Health Act Chapter 465 + EU MDR). Self-evaluating against the Standards before an inspection is the best preparation. HCSD inspections are routine and unannounced.
The protocol must define the traceability method used. The Standards for Dental Clinics does not prescribe a format — paper registers remain accepted. But their limitations are well documented: missing pages, illegible handwriting, forgotten entries, no instrument-to-cycle link, risk of loss.
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 — or in the event of a fitness to practise proceeding before the Medical Council of Malta under the Health Care Professions Act (Chapter 464).
For a detailed comparison, see our digital vs paper register guide.
Verify every compliance point before the inspector arrives. Download the PDF instantly — no email required.