Requirements for medical foot care instruments
Healthy, well-cared-for feet
Healthy, well-cared-for feet are the field of work of two very different professions: foot care specialists on the one hand and podiatrists on the other.
The distinction is easy to follow, even for laypeople:
Foot care specialists carry out caring and cosmetic treatments on the healthy foot.
This includes shortening nails and foot massages, for example.
Preventive, therapeutic and rehabilitative measures on the endangered or already damaged foot, by contrast, are reserved for podiatrists.
Instruments that meet these requirements
Made of surgical steel and fully autoclavable:
- Ruck Trapez Nagel-/Eckenzange – a combination of head cutter and corner nipper
- Ruck Nagelzange – for everyday use in the practice
- Skalpell mit Metallheft – for callus and the nail fold
Higher hygiene requirements for podiatry instruments
Why does this distinction matter? The two fields of activity call for partly very different tools.
Podiatric treatments involve working on the skin and nails of the foot or fitting aids.
Examples are removing thickened callus, taking off corns or fitting orthoses, nail bracing systems and correction devices.
Special scalpels, nippers, burrs and grinders are used for this, but also ointments, tinctures and disinfectants.
Because this often happens on an endangered or diseased foot, podiatrists have to meet higher requirements for handling and hygiene when using the instruments.
These requirements arise, among other things, from the EU Medical Device Regulation (MDR, Regulation (EU) 2017/745), the German Medical Devices Law Implementation Act (MPDG) and the German Medical Devices Operator Ordinance (MPBetreibV).
Foot care specialists, by contrast, are not subject to this regulation.
How reprocessing works step by step is explained in our article Instrument reprocessing in podiatry.
Medical devices in podiatric practice
Under Article 2 of Regulation (EU) 2017/745 (MDR), medical devices are
“instruments, apparatus, appliances, aids, substances or other articles (including the associated software) used alone or in combination”,
intended to be used on human beings for the following purposes:
- diagnosis, prevention, monitoring, treatment or alleviation of disease, injury or disability
- investigation, replacement or modification of the anatomy or of a physiological process
Both active and non-active medical devices are used for this in podiatric practice.
Active medical devices include motors driving burrs, ultrasound units, foil sealing devices, sterilisers and motor-driven treatment couches.
Non-active medical devices include instruments such as head cutters and tweezers.
The Medical Devices Operator Ordinance (MPBetreibV) requires that medical devices may only be operated and used by people who have the necessary training or the knowledge and experience required for the purpose.
Risk classification of typical podiatry instruments
Correct risk classification of the medical devices used in podiatry is important in order to ensure safety for patients and users alike.
