MePV Art. 72 requires recording of sterilization process and validation data — without prescribing the format. Paper logbooks remain common; their limitations show when the Kantonsarztamt arrives for an announced or unannounced inspection and expects to verify cycle-by-cycle parameters, biological control results, and load verification across months of activity. A digital register removes that friction — instant search, tamper-evident audit trail, and a hosting location compatible with both the GDPR and the revised Federal Act on Data Protection (Scaleway Paris, EU-resident infrastructure).
In Switzerland, documenting every sterilization cycle is a legal requirement. For dental practices and podiatry, MePV / ODim (SR 812.213) Art. 72 requires recording of sterilization process and validation data for every cycle. The format is not prescribed — the GPA 2022 (Swiss Good Practice for Medical Device Reprocessing), KIGAP 2010 (status 2017), and the SSO Quality Guidelines on Practice Hygiene (2018) define state-of-the-art compliance. The Kantonsarztamt / Service du médecin cantonal has inspected practice-level reprocessing since 1 July 2011 — 15 years of continuous inspection. For tattoo, body piercing, and permanent makeup studios, Art. 62 LGV (SR 817.02) requires cantonal notification (since 1 May 2017, fully binding since 1 May 2018), and the EDI Ordinance on objects in human contact (SR 817.023.41) Art. 4 to 7 sets the hygiene and documentation obligations. The cantonal enforcement authority (Kantonales Labor / ALV / SCAV / SAAV depending on the canton) may conduct announced or unannounced inspections.
Switzerland operates a federal model: federal law (MePV, LGV, EDI Ordinance) with cantonal enforcement by 26 Kantonsarztämter and 26 cantonal enforcement authorities. Additional cantonal authorization (Bewilligungspflicht) for tattoo, piercing, and permanent makeup is required only in Genève and Neuchâtel; all other cantons apply only the federal notification baseline. For a complete overview of regulations per profession, see our sterilization regulations guide.
Paper documentation — a binder where cycle data is entered by hand — remains legally acceptable, but has significant weaknesses. Handwritten entries are error-prone and often illegible. Thermal printouts from the autoclave fade within months, losing their evidentiary value — a serious problem given the long-term archival expected for civil-liability purposes. A binder can be lost, damaged by water, or simply become unreadable. Targeted search is impossible: finding a specific cycle from last year in a binder with hundreds of pages is impractical.
Furthermore, paper does not allow linking a sterilization cycle to the specific instruments in the load — traceability is limited to date and cycle number, with no connection to the patient or client. During reprocessing inspection by the Kantonsarztamt / Service du médecin cantonal or an inspection by the cantonal enforcement authority, inspectors expect complete and immediately accessible documentation that allows full reconstructability of every cycle, every instrument batch, and every patient contact.
A digital sterilization register automatically stores the parameters of every cycle (temperature, pressure, hold time, result), generates a unique batch number, links the instruments in each load to the corresponding cycle, and preserves data with automatic backups. Search is instant: finding a specific cycle takes seconds, not hours.
SecuSteri imports autoclave reports directly (PDF or HTM depending on the manufacturer), extracts parameters automatically, and generates labels with QR codes linking each pouch to its sterilization cycle. The complete register is accessible from any device — during a cantonal inspection, the entire documentation can be presented on screen immediately, even if the local PC has failed or the practice owner is on vacation. EU-resident hosting (Scaleway Paris) meets both the GDPR and the revised Swiss Federal Act on Data Protection (revFADP).
Switzerland operates a federal model: MePV and LGV apply uniformly under federal law, but enforcement is carried out by 26 Kantonsarztämter and 26 cantonal enforcement authorities (Kantonales Labor / ALV / SCAV / SAAV depending on the canton). For professionals operating across multiple cantons — tattoo artists at conventions, practices with multiple cantonal locations — a cloud-based digital register offers a decisive advantage: data is accessible regardless of location.
This is especially relevant for tattoo artists, whose industry is characterized by high mobility between conventions and guest spots. A cantonal enforcement authority in Ticino can request the sterilization documentation of a tattoo artist from Zürich — with a digital register, the response is immediate, including ink batch numbers and the corresponding REACH compliance records under Annex XVII Entry 75 (binding in Switzerland since 1 February 2025).
Since 1 July 2011, the Kantonsarztamt / Service du médecin cantonal has inspected practice-level reprocessing — 15 years of continuous inspection with growing depth. The GPA 2022 (Swiss Good Practice for Medical Device Reprocessing) consolidates state-of-the-art expectations; the SSO Quality Guidelines on Practice Hygiene (2018) detail the expectations for dental practices. For prion-relevant procedures, CJKV / OMCJ (SR 818.101.21) requires the 134°C / 18-minute cycle. During reprocessing inspection, the Kantonsarztamt expects cycle-by-cycle verification of parameters, biological control results, and batch traceability across multiple months — a requirement that is difficult to meet with paper records in practice.
Documentation failures may be pursued under SSO disciplinary procedures; the cantonal practice license may be suspended or revoked by the Cantonal Health Directorate. For tattoo, piercing, and permanent makeup studios, warnings, fines, and — in Genève and Neuchâtel only — suspension of the cantonal Bewilligungspflicht apply. For a complete overview of the regulations, see our sterilization regulations guide.
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