What is the sterility assurance level in surgical power tool systems? How is it ensured?

sterility assurance

In order to ensure sterility, knowledge of the levels and types of contamination in used surgical instruments is a primary requirement. Sterility is determined by the density of bacteria, in other words, the microbial load. This means that the number of bacteria contaminating surgical power tool systems determines how long it takes for a cleaning agent or disinfectant to destroy bacteria.

All used surgical instruments cannot be cleaned and sterilised with the same method. This is because all surgical instruments are contaminated to a certain extent after each intervention. This bacterial load varies according to the region where the surgery is performed, in other words, genetically heterogeneous bacterial populations.

bacteria on used surgical instruments

Bacteria living and reproducing on the earth and in the body of living organisms, adapted to different physical, chemical, biological and natural conditions, show a kind of adaptation that can easily live under quite different hydrostatic pressure.

They can develop and reproduce within the temperature limits specific to their species. They are divided into 3 types as cold loving (psychrophile), warm loving (mesophile) and hot loving (thermophile) microbes. Generally, most of the microorganisms that have the ability to develop and reproduce between 20-45 °C and cause diseases in humans and animals are included in the mesophile group.

What to look for when creating methods?

The main purpose of cleaning and sterilisation methods of surgical power tool systems prepared according to the density and possible type of bacterial population is to ensure sterility.

While creating the methods; the microbial loads that may occur on the product are calculated on average in line with scientific studies, the measures taken in line with the identified risks are carried out experimentally in the laboratory environment and the presence of bacteria on surgical power tool systems is investigated. The safety of the result, i.e. all details of the method applied, are declared in the user manuals of the surgical power tool systems.

The best example of a change in time according to the method is the following; humid temperature is more effective than dry temperature. Spores that die in 15 minutes at 115 °C in autoclave (humid temperature) die in one hour at 150 °C in Pasteur oven (dry temperature). (Excerpted from PDF) With this information, the user can ensure the level of sterility by saving time according to the technology at hand.

Biocontamination is a powerful factor that destroys the labour of the healthcare worker and the patient’s cells in surgical intervention. However, the methods to destroy this power have been calculated and presented to the users by the ACF team like all other manufacturers. The only thing users need to do to ensure sterility is to read the user manuals before use and apply the specified method.

The sterility assurance level of Acf Surgical Power Tool Systems is ensured by cleaning in the first 30 minutes after use and sterilised in autoclave under the conditions given in the table below. 

power tool sterilization parameters

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