Digital sterilization register in Belgium

What the regulations require

In Belgium, traceability requirements vary by profession. For tattoo artists and piercers, the Royal Decree of 25 November 2005 mandates ministerial agrément, a 20-hour hygiene training certificate, and documented sterilisation protocols. For dentists, the CSS/HGR (opinion 8363) recommends a complete sterilisation register linking cycles to patient records. For podiatrists, CSS/HGR 9682 recommends traceability of reusable medical devices.

The format is not prescribed: paper or digital, both are accepted. But the register must be complete, legible, and accessible during an inspection. For full details on regulatory requirements, see the sterilisation regulations guide.

The limitations of a paper register

Missing or torn pages. Illegible handwriting. Forgotten entries after a rushed cycle. Inability to search quickly (finding a cycle from 3 years ago). No backup in case of fire, flood, or theft. Bulky physical storage. No automatic link between the autoclave report and the traceability record.

The advantages of a digital register

Automatic import of the autoclave report (PDF or machine file). Traceability records generated in seconds. Instant search by date, cycle number, or instrument. Digital archives accessible on tablet, phone, or computer. Automatic backup — no risk of loss. Printable traceability labels with QR codes linking the pouch to the cycle.

During an FPS Public Health inspection or INAMI audit, present your tablet to the inspector: all records, all reports, all biological controls are accessible in seconds. No more flipping through binders.

The autoclave ticket is not enough

Many practitioners believe that the ticket or USB key from their autoclave constitutes sufficient traceability. It does not. Complete traceability requires the link between the patient, the instruments used, and the autoclave cycle — a link that only a structured register (detailed paper or dedicated software) can establish. The autoclave ticket contains only the cycle parameters, not the load contents or the operator's identity.