The Standards for Dental Clinics (March 2024) and the Standards for Tattoo and Body Piercing (January 2025) require sterilisation records — date, time, cycle number, parameters (temperature, pressure, hold time), result, and link to the patient or client record. The format is not prescribed; the expectation is full reconstructability of every cycle, every instrument batch, and every load when HCSD inspects. For tattoo and semi-permanent makeup studios, the Standards add ink batch numbers, single-use device batch numbers, signed informed consent with health-status declaration, and incident reporting.
The Standards for Dental Clinics (March 2024) and the Standards for Tattoo and Body Piercing (January 2025) — both published by the Healthcare Standards Directorate (HCSD) — require sterilisation records to be maintained and accessible during inspections. Neither document prescribes a specific record form — the obligation is to demonstrate that every cycle was properly run, validated, and linked to the instruments processed (Standard 5.1 — validation of the sterilisation process; Standard 5.4 — cycle parameters checked once each load is completed; Standard 6 — completed load verification). For tattoo, piercing, and semi-permanent makeup studios, the Standards add ink batch numbers, single-use device batch numbers, signed informed client consent with health-status declaration, and incident reporting. For podiatry, the CPCM Podiatry Benchmark Document (18 January 2024) sets clinical-practice expectations including surgical scope, making sterilisation documentation central.
For full details on regulatory requirements, see the sterilisation regulations guide.
Based on the Standards for Dental Clinics (March 2024) and general healthcare best practice, a sterilisation traceability record should include: the date and time of the cycle, autoclave identification, cycle number or batch number, cycle type and programme used, recorded parameters (temperature, pressure, duration), cycle result (pass or fail), the identity of the operator who loaded and validated the cycle, and the instruments or pouches included in the load.
For dental practices, the Standards also expects documentation of daily Bowie-Dick or Helix test results (before the first load), weekly vacuum leak and safety device checks, regular biological control results, and Hepatitis B vaccination records (anti-HBs ≥10 mIU/mL titre) for staff performing Exposure Prone Procedures. For details on use-by dates, see the sterilisation use-by date guide.
Dental practices have the most detailed expectations: the Standards for Dental Clinics (March 2024) requires written infection prevention and control policy, Standard Operating Procedures, and accessible sterilisation records. HCSD inspections are unannounced and scrutinise record completeness. For podiatrists, the CPCM Podiatry Benchmark Document (18 January 2024) sets a 1650-hour supervised clinical practice benchmark across six areas including surgery — sterilisation records are core for the surgical scope. For tattoo, body piercing, and semi-permanent makeup studios, the Standards for Tattoo and Body Piercing (January 2025) is binding and explicitly cites EN 17169:2020 (Tattooing — Safe and Hygienic Practice) — full sterilisation records are part of the regulatory expectation, not voluntary best practice.
Neither the Standards for Dental Clinics (March 2024) nor the Standards for Tattoo and Body Piercing (January 2025) prescribes a specific retention period for sterilisation records. General healthcare best practice suggests retaining records for at least the period during which a patient complaint or fitness to practise proceeding could be brought before the Medical Council of Malta. Most dental practices retain sterilisation records for a minimum of 8 years (aligning with patient record retention guidance). For other professions, a minimum of 5 years is prudent.
Paper records are the traditional approach, but they are vulnerable to loss, damage, and illegibility. HCSD inspections of dental clinics increasingly scrutinise record completeness. A digital system generates the traceability record automatically from the autoclave report, links instruments to patients, and makes every record searchable and instantly accessible — exactly what an inspector expects to see.
For a detailed comparison between paper and digital registers, see our digital register guide.
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