Every dental practice in Germany must have written reprocessing work instructions. The Gesundheitsamt checks these during announced and unannounced inspections. The KRINKO/BfArM Recommendation 2012 and DAHZ Hygieneleitfaden 2024 are the reference documents. This guide details what your protocol must contain and how compliance triggers the Vermutungswirkung under MPBetreibV §8(2).
In Germany, every dental practice must have a written hygiene plan (Hygieneplan) that describes the reprocessing of medical devices in detail. This plan must be accessible to all staff and available for presentation during health authority inspections (Praxisbegehung). The KRINKO/BfArM Recommendation 2012 ("Requirements for hygiene in the reprocessing of medical devices") provides the technical foundation, and the Medical Device Operator Ordinance (MPBetreibV) Section 8 establishes the legal obligation. The hygiene plan is not a simple poster on the wall -- it is an operational document that describes how, when, and who performs each step.
Its absence or insufficiency is one of the most common findings during inspections. By following recognized standards (DIN EN 13060, DIN EN ISO 15883), the practice achieves the presumption of conformity (Vermutungswirkung) under MPBetreibV Section 8(2) -- the practice can assume that reprocessing is carried out properly.
The designation of the person responsible for reprocessing under MPBetreibV Section 5, including their qualification (expertise per DGSV continuing education recommendation). A detailed description of each step in the reprocessing chain (pre-cleaning, machine cleaning and disinfection in a washer-disinfector per DIN EN ISO 15883, rinsing, drying, inspection, packaging, sterilization, release, storage). The products used at each step (trade name, concentration, contact time). The sterilization parameters of the autoclave (program, temperature, pressure, duration). The frequency and type of controls (daily Bowie-Dick/Helix test, chemical indicators per load, weekly biological indicators). The procedure in case of a failed cycle or non-compliant test. The autoclave maintenance schedule (servicing, calibrations, gasket replacement). Instrument-specific reprocessing instructions for medical devices with special requirements.
The hygiene plan must be updated when a product, device, or procedure changes. Each update must be dated and signed by the responsible person. The DAHZ Hygiene Guide 2024 provides current guidance for creating the plan.
For a step-by-step breakdown of the reprocessing chain, see our dental sterilization chain guide.
A cycle is valid when the recorded parameters match the selected program and all indicators are compliant. In German dental practice, the reference cycle is 134°C for 18 minutes (prion cycle). The autoclave must be Class B per DIN EN 13060 to sterilize hollow instruments (turbines, contra-angles) and wrapped loads.
Before the first load of each working day, a Bowie-Dick test or Helix test validates proper autoclave function. The KRINKO risk classification determines the required controls: Critical B instruments (hollow instruments such as turbines and contra-angles) require the Helix test to validate steam penetration. A failed cycle or a non-compliant indicator requires repackaging and resterilization of the entire load.
For details on biological controls, see our autoclave biological controls guide.
The local health authority (Gesundheitsamt) conducts inspections (Praxisbegehungen) of dental practices. Inspections can be scheduled (as part of the regular inspection calendar) or unannounced (following complaints or hygiene incidents). The inspector checks: the existence of the hygiene plan, its compliance with current regulations, that staff know and follow it, that reprocessing documentation is complete and up to date, and that periodic controls (Bowie-Dick, biological controls) are performed as documented.
The state dental chamber (Landeszahnaerztekammer) can also conduct quality reviews and handles complaints regarding practice hygiene. The qualification of the responsible person under MPBetreibV Section 5 is particularly scrutinized -- the DGSV continuing education recommendation defines the required expertise for reprocessing medical devices in dental practice. The most frequently flagged issues during inspections: missing instrument-to-patient traceability, absent or incomplete hygiene plan, undocumented biological controls, and insufficient qualification of the person responsible for reprocessing.
The hygiene plan must define the traceability method used. German regulations do not prescribe a format -- paper registers remain legally accepted. But their limitations are well documented: missing pages, illegible handwriting, forgotten entries, no instrument-to-patient link, risk of loss in case of disaster. Under MPBetreibV, all records must be retained for a minimum of 5 years.
A digital register eliminates these risks. SecuSteri automatically imports the autoclave report, links each instrument to its cycle, and generates a signed, tamper-proof record. Each cycle is archived according to the plan's retention period, accessible at any time during an inspection.
For a detailed comparison, see our digital vs paper register guide.
Verify every compliance point before the inspector arrives. Enter your email and receive the checklist immediately.