Sterilization traceability is not just record-keeping — it's a legal obligation with precise requirements. SecuSteri is designed to meet them.
In Switzerland, sterilization requirements vary by profession and supervising authority. Dental practices fall under MePV / ODim (SR 812.213) Art. 71 and 72, with the Kantonsarztamt / Service du médecin cantonal performing practice-level reprocessing inspection since 1 July 2011. The Swiss Good Practice for Medical Device Reprocessing (GPA 2022), KIGAP 2010 (status 2017), and the SSO Quality Guidelines on Practice Hygiene (2018) define state-of-the-art compliance. Tattoo, body piercing, and permanent makeup studios must notify the cantonal enforcement authority of their activity under Art. 62 LGV (SR 817.02) — federal cantonal notification since 1 May 2017, fully binding since 1 May 2018 — and comply with the EDI Ordinance on objects in human contact (SR 817.023.41) Art. 4 to 7. Additional cantonal authorization (Bewilligungspflicht) is required only in Genève and Neuchâtel; all other cantons apply only the federal notification baseline. Podiatry in Switzerland is regulated under the EFZ Ordinance (SR 412.101.220) and the SBFI Framework Curriculum Podologie HF of 7 February 2022 — sterilization is codified as a core HF competency; KIGAP explicitly names podologists among its user groups. SecuSteri addresses the documentation obligations of every regulated profession and cantonal authority in Switzerland.
MePV Art. 72 requires recording of sterilization process and validation data for every cycle, demonstrating that parameters have been met. During reprocessing inspection by the Kantonsarztamt / Service du médecin cantonal, the quality of this documentation is reviewed. SecuSteri generates a traceability record for each batch, digitally released by the operator with their personal PIN code. Once released, the record is locked — no modifications are possible. It is the digital equivalent of a dedicated sterilization register, without the risks of fading thermal printouts or illegible handwriting.
The GPA 2022, KIGAP 2010 (status 2017), and the SSO Quality Guidelines on Practice Hygiene (2018) expect seamless traceability from the autoclave to the patient — particularly for prion-relevant procedures under CJKV / OMCJ (SR 818.101.21), which require a 134°C / 18-minute cycle. SecuSteri goes further: every sterilized instrument is linked to its batch, operator, container, and use-by date. The traceability chain is complete and verifiable — from the sterilization cycle to the patient record.
Every significant action in SecuSteri is recorded in a tamper-proof audit trail: who did what, when, and on which record. This trail is append-only — technically impossible to modify or delete, even by an administrator. In the event of a cantonal inspection or a disciplinary proceeding before the Swiss Dental Society (SSO), the complete history of operations is available.
Each operator releases batches with their personal 4-digit PIN code. This release individually identifies the person responsible for validating the batch — essential for the personal-liability framework under MedBG. The PIN is stored as a cryptographic hash (bcrypt) — even the SecuSteri administrator cannot read it.
The GPA 2022, KIGAP, and SSO Quality Guidelines on Practice Hygiene (2018) require triple validation — physical (pressure, temperature, hold time), chemical (Class 1 to Class 6 indicators per SN EN ISO 11140-1), and biological (Geobacillus stearothermophilus spore indicators per SN EN ISO 11138). SecuSteri tracks all autoclave checks — vacuum test, Bowie-Dick, Helix, biological controls — linked to each device, with date and result. During a cantonal inspection, the complete check history for each autoclave is available instantly.
Switzerland has no codified retention period in MePV; the GPA 2022 and KIGAP recommend alignment with SN EN 868 (packaging) and SN EN ISO 11607 (packaging validation) plus long-term archival for civil-liability purposes. SecuSteri archives indefinitely by default; you can selectively export or delete at any time. Your sterilization documentation is always accessible — whether for a Kantonsarztamt / Service du médecin cantonal reprocessing inspection, a cantonal enforcement check for tattoo / piercing / permanent makeup studios, or your own quality assurance.
Your data is hosted in the European Union on the Scaleway infrastructure in Paris — a hosting location compatible with both the GDPR and the revised Swiss Federal Act on Data Protection (revFADP). The transfer between your browser and our servers is encrypted (TLS). Data at rest is encrypted. SecuSteri is GDPR and revFADP 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 (batches, instruments, autoclaves, audit trail) 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 Swiss practices. But paper records present documented risks: missing pages, illegible handwriting, forgotten entries after a rushed cycle, inability to search quickly across months of activity, and no backup in case of disaster. Thermal printouts from autoclaves fade over time — a serious problem given the long-term archival expected under GPA 2022 and KIGAP. Switzerland is NOT within the direct scope of the EU Medical Devices Regulation — MePV / ODim is the governing law, harmonized with EU law via SN EN ISO standards under the Schweiz-EU MRA. For dental practices, SSO disciplinary proceedings apply, and the Cantonal Health Directorate may suspend or revoke the cantonal practice license; for tattoo, piercing, and permanent makeup studios, warnings, fines, and — in Genève and Neuchâtel only — suspension of the cantonal Bewilligungspflicht. Practices that maintain their reprocessing documentation per GPA 2022 and the SSO Quality Guidelines on Practice Hygiene (2018) are ready for the next Kantonsarztamt / Service du médecin cantonal inspection. SecuSteri eliminates the risks of paper records while meeting the same professional obligations.
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