Instrument Reprocessing in Podiatry – An Overview
The reprocessing of instruments is not a minor matter in podiatric and medical foot care. It is an operator's duty, it is checked during inspections – and it determines how long your instruments will last.
This article provides an orientation on the structure of the topic. It does not replace the relevant regulations or professional hygiene advice.
The legal basis in two sentences
The decisive factor is the Medical Devices Operator Ordinance (MPBetreibV). It requires that cleaning, disinfection and sterilization be carried out with suitable validated procedures – taking into account the manufacturer's instructions.
In addition, there is the joint recommendation from KRINKO (RKI) and BfArM "Requirements for hygiene in the reprocessing of medical devices". Its weight results from the so-called presumption effect: those who observe it are presumed to reprocess properly. This is why every authority looks closely at exactly this point during an inspection.
Autoclavable practice instruments
Designed for the reprocessing cycle described in this article:
- Ruck Trapezoid Cutter/Corner Nippers – fully autoclavable
- Ruck Nail Clippers – for daily use in the practice
- Scalpel with metal handle – with replaceable blades, hygienic
The most important step comes before everything else: classification
Before any device is purchased, it must be clear into which risk class an instrument falls. The entire effort depends on this:
- Non-critical – contact only with intact skin. Lowest requirements; no validation according to § 8 MPBetreibV is required here.
- Semi-critical – contact with mucous membranes or pathologically altered skin. Cleaning and disinfection by a validated procedure.
- Critical – instruments that penetrate skin or mucous membranes or may come into contact with blood. Additionally sterilization by a validated procedure.
In foot care practice, this is not a theoretical exercise: as soon as blood can flow during a treatment – and this is realistic with scalpels, corner nippers and nail nippers – you land in the highest category.
You, as the operator, carry out the classification yourself and document it. It forms the basis of your entire hygiene plan.
The reprocessing process
The process is a chain. Every link counts – a skipped step invalidates all subsequent ones:
- Pre-treatment and collection immediately after use, so nothing dries on
- Disassembly, if provided for – hinged instruments are reprocessed in the open position
- Cleaning – the actually decisive step; what is not clean will not be sterile either
- Disinfection
- Rinsing and drying
- Testing of technical and functional safety – sharpness, movement, damage, corrosion
- Packaging
- Sterilization, if necessary
- Labeling and documented release
- Proper storage
Manual or machine?
Machine processing in a washer-disinfector (WD) is the more reproducible way – the process runs according to a fixed program and largely documents itself.
A common misconception: Manual reprocessing must also be validated. "We do it by hand" does not exempt you from this. For the validation of manual procedures there is a joint guideline from DGKH, DGSV and AKI, which is also used by the authorities.
Two details where it often fails
Water quality. It is consistently underestimated. Especially the final rinse with appropriately treated water determines whether instruments remain stain-free. Entire sets of instruments are ruined by tap water in the final rinse.
Residual moisture before sterilization. Moist instruments in the autoclave are one of the most frequent causes of staining and rust formation on complete sets.
What this means for the instruments themselves
Reprocessing is a strain. With each cycle, temperature, chemicals and moisture act on the steel. Here the difference between instruments becomes very clear:
- Only autoclavable instruments made of hardened stainless steel can withstand this permanently.
- Nickel-plated goods are generally unsuitable for machine reprocessing – the coating cannot withstand it.
- The manufacturer's instructions for reprocessing are binding. Anyone who deviates from them assumes responsibility for it themselves.
Therefore a cheap instrument is often the more expensive one in practice: if it shows pitting corrosion at the cutting edge after thirty cycles, it was not a saving.
Documentation
What is not documented is considered not to have happened during an inspection. This usually includes the hygiene plan, risk classification of the instruments, work instructions, batch documentation of sterilization, release decisions and evidence of validation and requalification.
Where to get binding information
The current versions of the KRINKO-BfArM recommendation are published by the Robert Koch Institute. For your specific practice, the responsible health department and the responsible state authority are the right contact points – as is qualified hygiene advice.
Practice account: conditions for ongoing needs
Instruments are wear parts – anyone who reprocesses reorders regularly. With our practice account you buy permanently at special conditions, with all Solingen brands in one place. Plus our sharpening service, which makes blunt instruments usable again instead of replacing them.
This article is a general orientation and not legal or hygiene advice. The regulations in force at the time and the instrument manufacturers' specifications are decisive.
Reprocessable instruments at nagelzange.de:
Also read: The most important instruments for podiatrists and Rust stains on instruments.