Romanian law requires a sterilization register but does not specify the format. The paper logbook is the traditional choice, but its limitations are significant — especially as DSP inspections become more frequent and traceability requirements under Ordinul MS 1761/2021 grow more detailed.
Ordinul MS nr. 1761/2021 requires maintaining a sterilization register. The register must contain: the batch number, the contents of the packages, the start and end date and time, the temperature, the results of physicochemical and biological indicators, and the name and signature of the responsible person. For dental practices, traceability also requires linking the tray code to the patient's medical record.
The format is not specified: paper or digital, both are accepted. But the register must be complete, legible, and accessible during a DSP (Directia de Sanatate Publica — Public Health Directorate) 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. Impossible to search quickly (finding a cycle from 3 years ago). No backup in case of fire, flood, or theft. Bulky physical storage over the years. No automatic link between the autoclave report and the traceability record.
Automatic autoclave report import (PDF or HTM file). Traceability records generated in seconds. Instant search by date, cycle number, or instrument. Digital archives accessible on tablet, phone, or computer. Automatic backup — zero risk of loss. Printable traceability labels with QR code linking the pouch to the cycle.
During a DSP inspection, show your tablet to the inspector: all records, all reports, all biological controls accessible in seconds. No more flipping through binders.
Many practitioners mistakenly believe that the USB stick or SD card from their autoclave constitutes sufficient traceability. It does not. Complete traceability under Ordinul 1761/2021 requires linking the patient, the instruments used, and the autoclave cycle — a link that only a structured register (detailed paper logbook or dedicated software) can establish.
Important context: dental procedures are the leading documented route of Hepatitis B transmission in Romania (8.7% of cases). Proper traceability is not just a legal obligation — it is an essential safeguard against liability claims.
Automatic autoclave report import, instrument-patient traceability, QR labels, digital archives accessible on any device. 30-day free trial.