Requirements for medical foot care instruments

Healthy and well-groomed feet

Healthy and well-groomed feet are the domain of two very different professional groups: foot care specialists on the one hand and podiatrists on the other.

The distinction is easily understandable even for laypersons:
Foot care specialists perform care and decorative procedures on healthy feet.
This includes, 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 areas of activity require, in some cases, very different tools.
Podiatric treatments include, among other things, the treatment of the skin and nails of the feet or the application of assistive devices.
Examples include the removal of thickened calluses, the removal of corns, or the application of orthoses, nail correction braces and systems.
This involves the use of special scalpels, pliers, milling cutters and grinders, 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 Devices Operator Ordinance (MPBetreibV).
However, foot care specialists 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 of the German Medical Devices Act (MPG) within the meaning of Directive 93/42/EEC, medical devices are
"instruments, apparatus, devices, aids, materials or other articles (including associated software), whether used individually or in combination"
which are intended for use on humans for the following purposes:

• Detection, prevention, monitoring, treatment, and alleviation of diseases, injuries, or disabilities
• Investigation, replacement or modification of the anatomical structure or a physiological process

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

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

Risk classification of typical podiatry instruments

Correct risk classification of medical devices used in podiatry is important to ensure the safety of patients and users.