Sterilization traceability is not just record-keeping — it's a legal obligation with precise requirements. SecuSteri is designed to meet them.
In Italy, sterilization obligations apply to every profession that uses reusable instruments. Dental practices must comply with D.Lgs 81/2008 Title X (Art. 274), the ISPESL Linee Guida of May 2010, and UNI/TR 11408:2011 — the full reprocessing chain, from decontamination to traceability. Tattoo, piercing, and permanent makeup studios are not governed by any national law: they are regulated by the laws of the 20 Regioni (Lombardia L.R. 13/2021, Toscana L.R. 28/2004, Lazio L.R. 2/2021, and others). Podiatrists, recognized as a healthcare profession under D.M. 666/1994 and registered with the Albo FNO TSRM e PSTRP, are subject to the same D.Lgs 81/2008 obligations. UNI EN 13060 defines the technical requirements for the small autoclaves used in these professions (Class B mandatory for hollow instruments). SecuSteri is built to cover the compliance needs of every regulated profession in Italy.
Italian rules require a record of every sterilization cycle proving that parameters were validated. The ASL (in Lombardia: ATS) evaluates the quality of records during inspections — both planned and unannounced. SecuSteri generates a traceability record for every cycle, digitally released by the operator with their personal PIN. Once released, the record is locked — no modifications are possible. It is the digital equivalent of a dedicated logbook, without the risks of fading thermal printouts or illegible handwriting.
The ISPESL Linee Guida and UNI/TR 11408:2011 require complete traceability from the sterilization cycle to the patient. SecuSteri goes further: every sterilized instrument is linked to its cycle, operator, container, and use-by date. The traceability chain is complete and verifiable — from autoclave cycle to patient record.
Every significant action in SecuSteri is recorded in a tamper-proof audit log: who did what, when, and on which record. This log is append-only — technically impossible to modify or delete, even by an administrator. In the event of an ASL inspection or a disciplinary proceeding before the professional Order, the complete history of operations is available.
Each operator releases cycles with their personal 4-digit PIN. This signature individually identifies the person responsible for releasing the cycle — essential for professional accountability. The PIN is stored as a cryptographic hash (bcrypt) — even the SecuSteri administrator cannot read it.
The ISPESL Linee Guida and UNI/TR 11408:2011 require three levels of control: physical (cycle parameters), chemical (Class 1 process indicators per UNI EN ISO 11140-1), and biological (Geobacillus stearothermophilus spores). SecuSteri logs autoclave checks — vacuum leak test, Bowie-Dick, Helix, biological indicators — linked to each device, with date and result. During an inspection, the complete check history for each autoclave is available instantly.
Law 24/2017 (Gelli-Bianco) turned sterilization documentation into an element of legal defense. Article 5 requires healthcare professionals to follow published guidelines (ISPESL, UNI). Art. 590-sexies of the Criminal Code introduces criminal liability for injury or death from professional negligence — with a critical exception: non-punishability applies ONLY when the published guidelines were followed and documented. Art. 7 establishes dual liability: contractual for the struttura sanitaria (10-year prescription) and extracontractual for the individual practitioner (5-year prescription). Without documentation, non-punishability does not apply. With SecuSteri, the documentation is automatic, time-stamped, and immutable.
Article 4 of the Legge Gelli requires the healthcare facility to make clinical documentation available within 7 days of patient request. A local PC that fails, is stolen, or is inaccessible (owner on vacation, disk full) cannot reliably meet this requirement. Cloud does — SecuSteri is accessible from any device, at any time, from anywhere.
The ISPESL Linee Guida and UNI/TR 11408 require reprocessing records to be retained for 5–10 years, depending on regional directive. SecuSteri automatically retains your data according to your plan duration: 5 years (Standard), 10 years (Pro), unlimited (Clinic+). No risk of loss, fire, or water damage. Your sterilization history is always accessible — for an ASL inspection, a professional Order proceeding, or your own quality assurance.
Your data is hosted in the European Union on the Scaleway Paris infrastructure. Italy, as an EU member state, is fully covered by the GDPR — EU hosting meets all data residency requirements. The transfer between your browser and our servers is encrypted (TLS). Data at rest is encrypted. SecuSteri is GDPR compliant: right of access, right to data portability, right to erasure. Your data never leaves the EU. We never sell your data and never use it for advertising.
You can request a complete export of all your data (cycles, instruments, autoclaves, audit log) as a zipped CSV archive, delivered by email. The export covers your plan's retention window. Your data belongs to you — you can retrieve it at any time.
The paper register remains the standard in many Italian practices. But paper records present documented risks: missing pages, illegible handwriting, forgotten entries after a rushed cycle, inability to search quickly, and no backup in case of disaster. Thermal printouts from autoclaves fade over time. With 20 Regioni able to inspect independently, administrative penalties under D.Lgs 81/2008, criminal liability under Art. 590-sexies of the Criminal Code (Legge Gelli), and regional examples such as Lombardia (€3,000–€15,000 + immediate closure under L.R. 13/2021), having digital records instantly accessible from any device is a decisive advantage. SecuSteri eliminates these risks by digitizing the entire process while meeting the same professional obligations.
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