Sterilization traceability is not just record-keeping — it's a legal obligation with precise requirements. SecuSteri is designed to meet them.
In Germany, strict regulations govern the reprocessing of medical devices across all professions that use reusable instruments. Dental practices fall under the MPBetreibV (Medizinprodukte-Betreiberverordnung, 2025) §8, which mandates reprocessing with validated procedures. §8 Abs. 2 grants a Vermutungswirkung (presumption of compliance) — following the KRINKO/BfArM recommendation of 2012 is deemed compliant. Tattoo, piercing, and PMU studios as well as foot care businesses are subject to the IfSG (Infektionsschutzgesetz — Infection Protection Act) §36(2) and the respective Landes-Hygieneverordnungen (state hygiene regulations), enforced by the local Gesundheitsamt (public health authority). Podiatrists are additionally regulated as a health profession under the PodG (Podologengesetz, 2001) and must comply with the MPBetreibV. DIN EN 13060 defines the technical requirements for small steam sterilizers (Class B, S, and N). SecuSteri covers the documentation obligations of every regulated profession in Germany.
The MPBetreibV requires complete Chargendokumentation (batch documentation) for each sterilization cycle, demonstrating that parameters have been met. During a Praxisbegehung (practice inspection) by the Gesundheitsamt, 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 KRINKO/BfArM recommendation of 2012 requires seamless traceability from the autoclave to the patient. 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 Praxisbegehung by the Gesundheitsamt, or a disciplinary proceeding by the Landeszahnaerztekammer (state dental chamber), 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 personal liability. The PIN is stored as a cryptographic hash (bcrypt) — even the SecuSteri administrator cannot read it.
The KRINKO/BfArM recommendation and DIN EN 13060 require three levels of control: physical (cycle parameters), chemical (indicators), and biological (spore tests). SecuSteri tracks all autoclave checks — vacuum test, Bowie-Dick, Helix, biological controls — linked to each device, with date and result. During a Praxisbegehung, the complete check history for each autoclave is available instantly.
The MPBetreibV requires retention of reprocessing documentation for a minimum of 5 years. 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 documentation is always accessible — whether for a Gesundheitsamt inspection, a professional disciplinary proceeding, or your own quality assurance.
Your data is hosted in the European Union on the Scaleway infrastructure in Paris. Germany, as an EU member state, is fully covered by the DSGVO (Datenschutz-Grundverordnung — General Data Protection Regulation). 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 (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 German 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 16 Bundeslaender (federal states) that inspect independently, and fines up to 25,000 euros under IfSG §73 — plus criminal liability under §§74–76 — having digital records instantly accessible from any device is a decisive advantage. Those who follow the KRINKO/BfArM recommendation benefit from the Vermutungswirkung (presumption of compliance) under MPBetreibV §8(2) — SecuSteri makes exactly that provable. SecuSteri eliminates the risks of paper records while meeting the same professional obligations.
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