KRINKO/BfArM-compliant documentation creates Vermutungswirkung under MPBetreibV §8(2) — your reprocessing is legally presumed proper. SecuSteri replaces paper batch records with a tamper-proof digital archive.
The Medizinprodukte-Betreiberverordnung (MPBetreibV, revised February 2025) mandates documented reprocessing procedures for all medical devices. §8(2) creates a Vermutungswirkung — a legal presumption that your reprocessing is proper when you follow the KRINKO/BfArM Recommendation 2012. This recommendation requires batch documentation (Chargendokumentation), daily Bowie-Dick/Helix tests, regular biological controls, and instrument risk classification (Unkritisch through Kritisch B). Records must be retained for 5 years. The Gesundheitsamt conducts announced and unannounced inspections.
MPBetreibV (2025), §§5, 8, 12-13 · KRINKO/BfArM Empfehlung 2012 · DIN EN 13060 · DIN EN ISO 15883 · DAHZ Hygieneleitfaden 2024
Regulatory guides to help you understand your obligations.
Instrument-level traceability
Go beyond simple cycle logging. Track which specific instruments were in each autoclave load and link them to patient records via QR-coded labels.
Automatic report import
Upload your autoclave's PDF report — SecuSteri extracts the cycle data automatically. Currently supports W&H Lisa, Castellini, and Anthos with more brands added regularly.
Multi-user for group practices
Invite your dental assistants as team members. Each person signs cycles with their own PIN — individual accountability in a shared practice.
Always ready for inspection
Every signed cycle is tamper-proof and instantly accessible. Present your complete sterilization history on a tablet during any inspection.
These instruments come pre-loaded when you create your account. You can add, edit, or remove instruments at any time.
W&H, Castellini, and Anthos reports are imported automatically via AutoReport or manual upload. Other brands? Upload the report or enter cycle data manually — we add automatic support progressively.
Verify every compliance point before the inspector arrives. Enter your email and receive the checklist immediately.
30 days free. No credit card required. Set up in under 5 minutes.