Prion tests

13/07/2015

Prion tests for autoclaves: legal requirements

Legal requirements

All medical establishments are required to carry out regular sterilization procedures to protect staff from the pathogenic agents responsible for communicable diseases. These activities must be conducted in accordance with the guidelines , which lays down the specific measures that must be taken by the persons in charge of medical establishments in order to ensure that they implement all of the procedures necessary for the sterilization and decontamination of surgical instruments, equipment and workplaces.

This health and hygiene legislation applies not only to hospitals, surgeries, private clinics and veterinary centres, but also to dental practices, where the same health, hygiene and safety regimes must be upheld both for the patients and for the staff.
To this end, special sterilizing machines called autoclaves have been created. They use the physical action of heat to decontaminate the micro-organisms on dentists’ instruments. Autoclaves reach temperatures of over 150°C, thus ensuring that instruments are sterilized correctly.

Good instrument decontamination results are dependent on proper maintenance of autoclaves, so every machine must undergo specific monitoring cycles on a regular basis in order to assess its working capacity.

Pursuant to Italian Legislative Decree 81/2008 (as amended), dental autoclaves must undergo Prion tests. This involves a specific Type B cycle for special sterilization of the chamber and instruments, as they may be infected with the prion responsible for Creutzfeldt-Jakob disease, which is often called a human form of mad cow disease.

This is extremely important, so every dental autoclave must have a preset Prion test cycle, during which the sterilization chamber and materials are heated to 134°C. It is essential to reach this temperature so that the prion responsible for Creutzfeldt-Jakob disease is completely inactivated and destroyed.
Prion tests allow users to ensure that the instruments, materials and surfaces in a dental autoclave have been exposed to the specific sterilization cycle, thus preventing infection and complying with the legal guidelines for sterilization activities.

In general, a Prion test will last 20-30 minutes. When it is over, it is possible to conduct a further check using specific testers placed inside the chamber that has undergone the cycle, which provide proof that the sterilization is complete.
The rules are indispensable and of crucial importance in all dental practices, because correct maintenance of dental autoclaves and regular sterilization of them are an essential way of monitoring their working order and above all their efficacy, which has a direct impact on the quality of the service provided.
In addition, carrying out Prion tests is a legal requirement which protects the health and safety of all members of medical staff who handle working instruments. The figures in question could come into contact with pathogenic micro-organisms, contract serious diseases and then pass on serious infectious and contagious diseases to the public.

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