Requirements for medical foot care instruments

Healthy and well-groomed feet

Healthy and well-groomed feet are the field of activity of two very different professional groups: chiropodists on the one hand and podiatrists on the other.

The distinction is easy to understand even for laypeople:
Chiropodists carry out care and decorative treatments on healthy feet.
These include, for example, nail trimming and foot massages.
Preventive, therapeutic and rehabilitative measures on the threatened or already damaged foot, however, are reserved for podiatrists.

Increased hygiene requirements for podiatry instruments

Why is this distinction important? Both fields of activity require, in some cases, very different tools.
During podiatric treatments, the skin and nails of the feet are treated, and aids are applied.
Examples include the removal of thickened calluses, the removal of corns or the application of orthoses, nail correction braces and systems.
Special scalpels, forceps, cutters and grinders are used, as well as ointments, tinctures and disinfectants.
Since this often occurs on the vulnerable or diseased foot, podiatrists must meet increased requirements for handling and hygiene when using the instruments.
These requirements are laid down, among other things, in the Medical Devices Act (MPG) and the Medical Device Operator Ordinance (MPBetreibV).
Chiropodists, however, are not subject to this regulation.

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

Medical devices in podiatric practice

According to Section 3 MPG within the meaning of Directive 93/42/EEC, medical devices
"instruments, apparatus, devices, aids, materials or other articles (including associated software) used alone or in combination",
intended for use in humans for the following purposes:

• Detection, prevention, monitoring, treatment, alleviation of disease, injury or disability
• Investigation, replacement or modification of the anatomical structure or a physiological process

In podiatric practice, active and non-active medical devices are used for this purpose.
Active medical devices include, for example, motors for driving milling cutters, ultrasound devices, film sealing devices, sterilizers or motor-driven treatment couches.
Non-active medical devices include instruments such as head cutters and forceps.

The Medical Device Operator Ordinance (MPBetreibV) requires that medical devices may only be operated and used by persons who have the necessary training or knowledge and experience.

Risk classification of typical podiatry instruments

The correct risk classification of medical devices used in podiatry is important,
to ensure safety for patients and users.