French law requires a sterilization register but does not specify the format. The paper logbook is the traditional choice, but its limitations are significant against growing traceability requirements and intensifying ARS inspections.
In France, the Public Health Code mandates the keeping of a sterilization register. For tattoo artists and piercers, the Order of 11 March 2009 (Arrêté du 11 mars 2009) requires a traceability record for each cycle. For dentists, Art. L.5212-1 of the Public Health Code requires a register linking cycles to patient records. For podiatrists, the ONPP (Ordre National des Pédicures-Podologues -- podiatry regulatory body) requires the patient-instrument-cycle link.
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 sterilization regulations guide.
Missing or torn pages. Illegible handwriting. Forgetting to fill it in after a rushed cycle. Inability to search quickly (finding a cycle from 3 years ago). No backup in case of fire, flooding, or theft. Bulky physical storage over 5 years. No automatic link between the autoclave printout and the traceability record.
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 each pouch to its cycle.
During an inspection, hand your tablet to the inspector: every record, every report, every biological control is accessible in seconds. No more binders to leaf through.
The ONPP (Ordre National des Pédicures-Podologues -- podiatry regulatory body) states that most podiatrists mistakenly believe the USB stick or SD card from their autoclave constitutes adequate 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.
Automatic autoclave report import, instrument-patient traceability, QR labels, digital archives accessible on any device. 30-day free trial.