Instrument Reprocessing in Podiatry – An Overview
Instrument reprocessing is no side issue in podiatry and medical foot care. It is an operator obligation, it is checked during inspections – and it determines how long your instruments last.
This article gives an orientation on how the subject is structured. It replaces neither the relevant sets of rules nor professional hygiene advice.
The legal basis in two sentences
The decisive text is the German Medical Devices Operator Ordinance (Medizinprodukte-Betreiberverordnung, MPBetreibV). It requires cleaning, disinfection and sterilisation to be carried out with suitable validated procedures – taking the manufacturer’s specifications into account.
Added to this is the joint recommendation of KRINKO (RKI) and BfArM, “Hygiene requirements for the reprocessing of medical devices”. Its weight comes from what is known as the presumption effect: anyone who follows it is presumed to reprocess correctly. That is why every authority looks exactly there during an inspection.
Autoclavable practice instruments
Designed for the reprocessing cycle described in this article:
- Ruck trapeze nail/corner nipper – fully autoclavable
- Ruck nail nipper – for daily use in the practice
- Scalpel with metal handle – with replaceable blades, hygienic
The most important step comes before everything else: the classification
Before any equipment is purchased, it must be clear which risk class an instrument falls into. The entire effort depends on that:
- Non-critical – contact only with intact skin. Lowest requirements; no validation under § 8 MPBetreibV is required here.
- Semi-critical – contact with mucous membrane or pathologically altered skin. Cleaning and disinfection in a validated procedure.
- Critical – instruments that penetrate skin or mucous membrane or may come into contact with blood. Additionally sterilisation in a validated procedure.
In a foot care practice this is not a theoretical exercise: as soon as blood can flow during a treatment – and with scalpels, corner nippers and nail nippers that is realistic – you end up in the top category.
As the operator you carry out the classification yourself and document it. It is the basis of your entire hygiene plan.
The reprocessing sequence
The process is a chain. Every link counts – a skipped step devalues all those that follow:
- Pre-treatment and collection immediately after use, so that nothing dries on
- Dismantling, where provided for – hinged instruments are reprocessed in the open position
- Cleaning – the truly decisive step; what is not clean will not become sterile either
- Disinfection
- Rinsing and drying
- Checking the technical and functional safety – sharpness, action, damage, corrosion
- Packaging
- Sterilisation, where required
- Labelling and documented release
- Proper storage
Manual or machine?
Machine processing in a washer-disinfector (WD) is the more reproducible route – the process runs to a fixed programme and largely documents itself.
A frequent misunderstanding: manual reprocessing also has to be validated. “We do it by hand” does not exempt anyone from that. For the validation of manual procedures there is a joint guideline from DGKH, DGSV and AKI, which authorities also refer to.
Two details where it often goes wrong
Water quality. It is consistently underestimated. The final rinse with appropriately treated water in particular determines whether instruments stay free of spots. Entire instrument sets are ruined by tap water in the final rinse.
Residual moisture before sterilisation. Damp instruments in the autoclave are one of the most frequent causes of spotting and rust on complete sets.
What that means for the instruments themselves
Reprocessing is stress. With every cycle, temperature, chemistry and moisture act on the steel. This is where the difference between instruments shows very clearly:
- Only autoclavable instruments made of hardened stainless steel survive that in the long run.
- Nickel-plated goods are as a rule unsuitable for machine reprocessing – the coating does not stand up to it.
- The manufacturer’s reprocessing instructions are binding. Anyone who departs from them takes on the responsibility themselves.
That is why a cheap instrument often turns out to be the more expensive one in practice: if it shows pitting on the cutting edge after thirty cycles, it was no saving.
Documentation
What is not documented counts as not having happened during an inspection. This usually includes the hygiene plan, the risk classification of the instruments, work instructions, batch documentation of the sterilisation, release decisions as well as proof 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 public health office and the competent state authority are the right contacts – as is a qualified hygiene consultancy.
Practice account: conditions for ongoing needs
Instruments are wearing parts – anyone who reprocesses also reorders regularly. With our practice account you buy permanently at special conditions, with all the Solingen brands in one place. In addition there is 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. What counts are the currently applicable sets of rules and the specifications of the instrument manufacturers.
Reprocessable instruments at nagelzange.de:
Read also: The most important instruments for podiatrists and Rust spots on instruments.
