Requirements for medical foot care instruments

Healthy, well-cared-for feet

Healthy, well-cared-for feet are the field 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 care and cosmetic treatments on the healthy foot.
This includes trimming nails and foot massages, for example.
Preventive, therapeutic and rehabilitative measures on an at-risk or already damaged foot, on the other hand, are reserved for podiatrists.

Higher hygiene requirements for podiatry instruments

Why does this distinction matter? The two fields partly call for quite different tools.
Podiatric treatments involve working on the skin and nails of the foot or fitting aids.
Examples are removing thickened callus, removing corns or fitting orthoses, nail braces and nail correction systems.
Special scalpels, nippers, burs and grinders are used for this, as well as ointments, tinctures and disinfectants.
Because this often takes place on an at-risk or diseased foot, podiatrists have to meet higher requirements for handling and hygiene when using the instruments.
These requirements are set out in the German Medical Devices Act (MPG) and the Medical Devices Operator Ordinance (MPBetreibV), among others.
Foot care specialists are not subject to this ordinance.

The correct procedure for instrument disinfection can be found in this catalogue on pages 38 and 39.

Medical devices in podiatry practice

Under Section 3 MPG within the meaning of Directive 93/42/EEC, medical devices are
“instruments, apparatus, appliances, aids, substances or other articles (including the associated software), used alone or in combination”,
which are intended for use on humans for the following purposes:

• Detection, 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 podiatry practice.
Active medical devices include motors for driving burs, ultrasound units, film sealers, sterilisers and motorised treatment couches.
Non-active medical devices include instruments such as head nippers 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 necessary knowledge and experience.

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.