Sterilising Podiatry Instruments: Autoclave 134 °C — Complete Guide

The reprocessing of podiatric instruments is not merely a matter of hygiene — it is a statutory requirement and directly affects the service life of high-quality instruments. Incorrect cleaning, incorrect packaging, or use of the wrong autoclave programme risks both patient safety and premature equipment failure. This guide describes the complete RKI-compliant reprocessing workflow for a podiatric practice.

Legal Framework: What Applies in Germany?

For approved podiatric practices (therapeutic service providers under § 124 SGB V):

• RKI Recommendation “Requirements for Hygiene in the Reprocessing of Medical Devices” (current edition): Instruments with patient contact are medical devices in a risk class — they must be sterilized, not merely disinfected.
• MPBetreibV (Medical Devices Operator Ordinance): requires validation of the reprocessing process and documentation.
• TRBA 250: Biological agents ordinance — protects practice staff during reprocessing.

In practice, this means: wiping disinfection alone is insufficient. Instruments that come into direct contact with skin or nails (nail nippers, burrs, podiatry probes, onychoorthosis pliers) must go through the autoclave.

Step 1: Pre-Cleaning Immediately After Treatment

Immediately after each treatment: blood, callus material, and biofilm must be removed before disinfection, because disinfectants cannot fully penetrate organic matter.

Procedure:

1. Place instruments immediately in an enzymatic solution (soaking solution containing proteases) — do not allow to dry, as dried contaminants are very difficult to remove.
2. Soaking time 15–30 minutes (follow manufacturer’s instructions).
3. Brushing or ultrasonic cleaner: joints, cutting edges, and cavities are worked with an instrument brush or in an ultrasonic bath (minimum 3 minutes, 40–50 kHz).
4. Rinse with distilled water.

Ultrasound removes residue from joints and grooves considerably more thoroughly than manual brush cleaning — particularly important for nippers with precision joints such as the ND Onychoorthosis series and CP nail nippers.

Step 2: Disinfection

After cleaning, instrument disinfection follows as a chemical-physical precursor to sterilization:

• Immersion disinfection solution (e.g., aldehyde- or alcohol/quaternary ammonium salt-based, listed in the VAH compendium)
• Follow concentration and contact time exactly as per manufacturer’s instructions
• Instruments must be fully submerged — no air pockets in joints

After disinfection: rinse with sterile or distilled water, allow to dry — no tap water (lime and mineral residue promote corrosion in the joint).

Step 3: Packaging Before Autoclaving

Instruments must not be placed loosely in the autoclave — the sterile barrier must be maintained:

• Sterilization pouches with paper/film combination (Type II per EN ISO 11607)
• Seal the pouch, write the batch number and date on the outside
• No overloading: steam circulation must be ensured

For hinged instruments: package with the instrument open — otherwise steam cannot reach all surfaces.

Step 4: Autoclaving — Parameters and Programmes

For podiatric instruments in Germany:

Parameter	Value
Temperature	134 °C
Holding phase	≥ 3 minutes (pre-vacuum autoclave)
Pressure	~3 bar
Autoclave type	Pre-vacuum autoclave (Class B) — not gravity autoclave

Why not a gravity autoclave (Class N)? Instruments with joints, cavities, and complex surface geometries (all nippers, burrs) are not reliably steam-penetrated by the gravity method. The pre-vacuum method actively evacuates air and ensures uniform steam penetration.

Carbide burrs — such as the FW 670 — are designed for 134 °C pre-vacuum autoclaving. The same applies to all surgical steel instruments in the CP nail nipper series, the Callus Nipper CS 00-10, and the Onychoorthosis Nippers ND 05-15 and ND 02-12.

Not autoclavable: Instruments with rubber handles, plastic components, adhesive-bonded assemblies, or gold-plated surfaces — always check manufacturer specifications.

Step 5: Storage and Documentation

After autoclaving:

• Allow pouches to dry completely (damp pouches = sterile barrier compromised)
• Store in a clean, dust-protected drawer, away from direct light
• Storage period: Per DIN EN 868 and manufacturer’s instructions — typically 6 months for sealed pouches under proper storage conditions
• Maintain batch records: date, autoclave unit number, batch number, parameter check (integrator strip). This documentation is mandatory and may be requested during a practice inspection.

Instrument Maintenance: Extending Service Life

Correctly maintained surgical steel instruments last 5–10 years or more in clinical use. Key measures:

After autoclaving:

• Oil the joints with instrument oil (specifically formulated for autoclave instruments, not regular oils) — one drop into the joint, then open and close once.
• Check for corrosion spots: small brown dots or pitting indicate crevice corrosion — replace the instrument, do not continue using it.

General:

• Never store surgical steel and carbon steel together (galvanic corrosion)
• No abrasive cleaning agents (steel wool, coarse abrasives)
• Do not stack instruments on top of each other (cutting edges damage each other)

Sharpness check:

• Nail nippers: paper cutting test — clean cut without burr formation
• Burrs: visual inspection of the cutting flutes, no broken or bent edges
• Onychoorthosis nippers: check joint play — no lateral play, consistent spring action

Documentation Requirements at a Glance

Document	Content	Retention
Batch record	Date, time, programme, parameters, integrator result	≥ 5 years
Autoclave logbook	Maintenance, calibrations, faults	Ongoing
Technical documentation for instruments	Manufacturer information, autoclavability	While in use
Validation record	Initial validation + annual repeat	Ongoing

Further Reading

• Nail Nipper & Corner Nipper: Choosing the Right Instrument
• Nail Bracing: Wire vs. Adhesive Brace — Which Method and When?
• Setting Up a Podiatry Practice: Which Instrument Set for Beginners?