In order to explain the importance of Helix tests for autoclaves, it is necessary to make a few preliminary legal remarks. Article 1176, paragraph 2 of the Italian Civil Code requires professional figures to take all necessary measures to ensure that their work causes no harm to third parties, including employees. This requirement is reinforced by Italian Legislative Decree 81 of 2008, which establishes guidelines for occupational safety and for sterilization as a form of collective protection for staff in the health industry. The law establishes that the employer in small medical practices (such as dental practices) is responsible for selecting appropriate techniques for the sterilization procedure. This means that the employer is also legally responsible for any harm caused during the performance of professional duties. In the event of court proceedings, employers must be able to prove that suitable sterilization procedures have been adopted in their practices.

This requirement is particularly relevant in the field of dentistry because staff come into contact with the blood and mucous membranes of patients and it is also necessary to protect subsequent patients. Therefore, effective sterilization procedures must be put in place for the various instruments, including hollow items. They can be divided into two types:
- Type A, consisting of small devices such as wands and turbines.
- Type B, consisting of tips and tubes.

These instruments can be sterilized with an autoclave, which uses the power of steam to eliminate potentially harmful micro-organisms and pathogenic agents. However, it is also necessary to establish whether the sterilization instruments are in perfect working order. This can be done with a Helix test: a method for assessing whether a steam autoclave is functioning properly and therefore for measuring its capacity for sterilization and steam penetration in a hollow item.

A Helix test shows the strength of steam penetration in a chamber. It is an essential test because dental practices use a number of instruments with reasonably long hollow sections, which can pass on bacteria and viruses to patients and staff if they are not impeccably sterilized.

The test must be carried out when starting an approved autoclave model with an air expulsion system.

Procedure

It involves placing a chemical indicator inside a container connected to a 1.5 metre tube. All of the air must be removed from the tube to create a vacuum and steam must then be introduced to measure the sterilization capacity. When the sterilizing agent or steam comes into contact with the indicator, the latter will change colour to show the level of efficiency of the sterilization process. The manufacturer of the Helix test will state in the instructions how to read the results. At present, Helix tests are considered the most efficient and cheapest testing method that complies with the legal requirements.
If a Helix test has negative results, it means that there has not been optimum steam penetration, so the sterilization process has not been successful. Consequently, it will be necessary to repeat the sterilization process for all of the items that have been sterilized with the autoclave that produced unsatisfactory Helix test results.
Helix test results can be saved and used as evidence in any future court proceedings.

Source: http://dentalbistro.euronda.com/en/helix-tests-for-autoclaves-legal-requirements