Sterilization

The sterilization protocol in the dental surgery

The sterilization process aims to eliminate all living microbial forms (pathogenic and non-pathogenic, including spores and fungi) from the instruments used. The sterilization of surgical instruments in medical and dental practices is carried out using steam autoclaves that must comply with EN 13060.

Standards EN 29000 and UNI EN 556-1 define sterilization as a special process whose effectiveness cannot be verified by inspecting the finished product. The process must therefore be validated prior to its execution, as a whole protocol, starting with decontamination and ending with the return of the reconditioned instrument back into service.

This definition emphasises the crucial importance of every single aspect of the sterilization process. Therefore, just like the correct choice of autoclave cycle, it is important that the autoclave is loaded correctly.

Autoclaves

Steam sterilizers, commonly called autoclaves, are devices that are used in medical practices and dental clinics to sterilize instruments and materials used in the course of professional practice. In autoclaves, sterilization of instruments, textiles and medical devices is ensured by a combination of pressure, saturated steam temperature and exposure time.

There are currently three different types of autoclaves for sterilization on the market:

• Class N autoclaves that can only sterilize solid, non-bagged products and therefore do not permit the sterilization of textiles, porous loads or hollow instruments;
• Class B autoclaves that permit the sterilization of porous materials, solid instruments and hollow instruments, such as handpieces, turbines and tips, even if they are bagged;
• Class S autoclaves that guarantee the sterilization of porous products and solid instruments, but not that of hollow instruments, such as handpieces and turbines, making them unsuitable for use in dental practices.

What distinguishes class B autoclaves is the ability of the vacuum pump to create “fractionated vacuums” that can extract air from even the smallest instrument cavities, allowing steam to contact the entire inner surface of the instrument and sterilize it perfectl

Useful tips for autoclave sterilization of surgical instruments

• Do not place pouches over the trays;
• Pouch paper should be facing upwards to facilitate steam penetration and drying;
• Only store dry pouches at the end of the sterilization cycle; instruments in wet or open pouches should be reprocessed.

Euronda Pro System autoclaves

Euronda Pro System autoclaves offer maximum efficiency and ease of use, innovative technology and a comprehensive traceability system with the ultimate goal of ensuring maximum protection for dentists, assistants and patients.

Water treatment systems

The water used to supply the Euronda autoclaves within the dental practice must be demineralised, deionised or osmosis-treated in order to avoid expensive restoration and maintenance costs due to the presence of limescale and deposits.

Useful tips for choosing the right water treatment system:

• Measure the conductivity level of the water;
• Define the number of autoclaves installed;
• Calculate the number of average cycles performed in a month.

Water treatment devices

Euronda Pro System offers a range of different water treatment devices depending on the conductivity value of the water and the number of autoclaves in the medical or dental practice.

Control tests

An object is considered sterile if the SAL (sterility assurance level) is less than 10⁻⁶, i.e. the probability of finding a microorganism is less than 1 in 1 million. Since it is not possible to verify sterility by means of tests on the processed product, certain control and function tests are carried out.

The purpose of the tests is to ensure that the sterilization process is capable of ensuring perfect sterility of the dental instruments. The tests must be performed systematically according to the practice’s internal protocol.

They are divided into:

• Function test: performed before using the autoclave to ascertain that it is working correctly. To this category belong: the Vacuum Test, the Bowie & Dick Test and the Helix Test.

• Sterilization control test: instruments are placed in the autoclave with the load to check that the cycle meets the required parameters. Examples are migrating bar sterilization indicators, process self-assessments and biological tests (bacillus stearothermophilus).

Useful tips*

We recommend testing at the following intervals:

• Every day: Vacuum Test;
• Every day: Steam penetration test for hollow (Helix Test) and/or porous load simulation test (Bowie & Dick Test);
• At each cycle: Cycle parameter verification test;
• Every month: sealing strip test (Euroseal Check Test)

* These are general guidelines, the Practice Manager must always refer to the relevant local and national regulations.

Tests for autoclaves

The Euronda Pro System product range includes 3 function tests, designed as a perfect complement to the daily use of autoclaves. The objective of these tests is to verify the operational effectiveness of the autoclave in performing B or S cycles.

Traceability and connectivity

Traceability within the sterilization process consists of including all the information on the pathway of the instruments used during the procedure in the patient’s clinical history, so as to certify that the entire sterilization process of the instruments has taken place correctly. The most commonly tracked parameters are: the day the process took place, the device used, the type of cycle performed, the sequence number, the outcome, the operators involved and the established expiry date.

Traceability can be implemented by computer or manually. Although simple and cost-effective, the latter option is slower and more difficult to manage in the archiving and traceability phase, i.e. the reconstruction of the sterilization process performed by the instrument. Computerised traceability is the ideal procedure because it considerably reduces the time and physical space required for archiving records and it simplifies traceability.

Traceability guarantees safety for both operators and patients. On the one hand, traceability provides an “element of evidence” for the professional in the event of a legal dispute. On the other, it is intended to act as a “seal of guarantee” for patients who, given the increased awareness of its importance, need to be reassured that the steps in the sterilization process have been carried out correctly.

Useful tips for correct sterilization protocol in dentistry

• Create a register containing information on the equipment used in the sterilization process, preparing the practice’s internal protocol and indicating the procedures that will be adopted;
• Store the results of the instrument sterilization process on the patient record;
• Store on the storage medium (USB, PC) the data relating to the sterilization cycle of the instruments used on the patient.

Traceability systems

The Euronda Pro System offers a range of accessories and a software program that allow the recording, control and sharing of work cycle data from each stage of the sterilization process, either through paper or digital media.

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