Risk classification of instruments
When performing beauty or medical podiatry on healthy feet with undisturbed skin, a full instrument reprocessing procedure—including sterilisation and packaging—is not strictly necessary. Although the instruments must be cleaned and disinfected as part of standard practice hygiene after treatment, they do not require any further reprocessing. However, as soon as the instruments come into contact with mucous membranes, pathologically altered skin or even wounds and blood, the procedures are classified as medical treatments. Following the performance of such procedures, the instruments that have been used should undergo more specific reprocessing. The basis for this classification and categorisation within the reprocessing process is the risk classification of the instruments. This has a significant influence on the instrument reprocessing procedure and the technique employed. According to the law, the risk classification of the instruments and the resulting reprocessing procedure are located in the responsibility of the practice owner. They can perfectly assess the risk of use, as they work with the instruments themselves and know their intended purpose. The three risk groups are explained in more detail below, accompanied by questions that can serve as a guide or aid in risk classification:
Classification as non-critical
Instruments that come into contact exclusively with undisturbed, i.e. healthy, skin can be classified as ‘non-critical’. Penetration of the skin is not intended in this case, so cleaning and subsequent disinfection can generally be considered adequate. To this end, it is recommended that instruments be correctly sorted after treatment, that single-use items such as scalpel blades be disposed of, and that instruments capable of being dismantled be taken apart. This allows the instruments to be completely saturated with the cleaning and disinfection products. Cleaning and disinfection can be performed manually, for example in an ultrasonic bath, or mechanically using a cleaning and disinfection machine (CDM).
Contact with mucous membranes or damaged skin?
Classification as semi-critical
The ‘semi-critical’ risk category provides instruments with the ability to come into contact with mucous membranes or pathologically altered skin. The risk of infection during the next procedure increases thanks to improper cleaning and disinfection of the instrument. For this reason, this category is further divided into two groups, which describe the effort required and the requirements for reprocessing. Group A comprises all standard instruments with no special reprocessing requirements. They are treated in the same way as instruments classified as non-critical with regard to cleaning and disinfection. Group B includes instruments with increased reprocessing requirements, for example due to non-visible cavities or rough surfaces. It is helpful here to sort the instruments correctly, dismantle instruments that can be taken apart, and clean them in a machine.
Classification as critical
Any instruments intended to penetrate the skin and which come into contact with blood, internal tissues or organs, including wounds, can be classified as critical. Here too, there is a more detailed classification. Groups A and B correspond to those of instruments classified as semi-critical and can be reprocessed accordingly. Group C has especially high reprocessing requirements, for example for instruments that deform or are not heat-resistant. However, as intentional penetration of the skin is not intended in podiatry, podiatrists usually work in the semi-critical or non-critical categories.
Is penetration of the mucous membrane and skin intended?
Risk classification of instruments in practice
In this video, Elisabeth Prinz demonstrates how she incorporates risk classification in her practice. Elisabeth Prinz is a podiatrist and alternative practitioner specialising in podiatry, and runs a thriving practice in Neustadt an der Weinstraße. She is passionate about her work as a podiatrist and gives her extensive expertise to anyone interested through her videos.
Everything you need to know at a glance
Useful companions for instrument reprocessing
Ultrasonic bath
The ultrasonic bath can be used for manual reprocessing and is filled either with a cleaning solution or with an instrument disinfectant solution that contains a cleaning agent. The ultrasonic waves loosen dirt and reduce the contact time required for the disinfectant. The instruments can then be dried using disposable wipes.
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Cleaning and disinfection unit (CDU)
Machine reprocessing using an RDG provides the possibility of performing cleaning, disinfection and drying in a single machine, similar to the principle of a dishwasher. Once the programme has been successfully completed, instruments classified as non-critical and semi-critical are immediately ready for use.
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Autoklave
In the autoclave, a steam steriliser, the instruments are sterilised using steam (moist heat) at 134 degrees and then dried. Depending on the type of machine and the load, the instruments can be safely sterilised in just 20 minutes.
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Hot-air steriliser
In hot-air sterilisation, germs and microorganisms are killed by dry, hot air. To do this, the instruments are placed in the steriliser after cleaning and drying. Thanks to the mechanical air circulation, the cycle time can be reduced to just 60 minutes with a standard load of unpackaged items.
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Please note: Regulations vary from state to state. You can find an overview of the framework hygiene plans here.