PPE and Personnel Hygiene

During the various phases of the sterilization process, designated operators must wear the provided PPE (headgear, visor/protective glasses, cut-resistant gloves, latex gloves, and face mask). Operators must wash their hands each time they enter and exit the work area, between procedures, or if their hands are visibly dirty. Users are prohibited from entering the sterilization rooms.

Separate and Controlled Routes

The sterilization room is divided into functionally and physically separate areas to prevent contamination of clean areas. Zone A is dedicated to the decontamination, washing, drying, and lubrication of medical devices. Zone B is dedicated to the packaging process. Zone C is dedicated to the sterilization, traceability, and sorting processes. Dirty and clean medical devices are transferred through dedicated routes and pass-through windows.

Decontamination and Washing Process:

The soiled material is transferred to dedicated trays.

A *chemical decontamination* is performed (immersion in an enzymatic liquid for at least 5 minutes, changed every 5 hours or when visibly soiled). The solution must be checked for organic residues after each wash.

Alternatively, or in addition, a *thermodisinfector* (Miele G7881) is used, which adds a 10-minute decontamination process at 93°C to the wash. Both the chemical and thermal decontamination procedures are necessary to protect the operator from contact with viruses.

The chemical decontamination is followed by a *thorough manual washing* in running water, dismantling complex instruments and using interdental brushes or cavity brushes.

The instruments are then *thoroughly dried* with a medical air gun or disposable cloths to avoid residual moisture that could compromise the sterilization process.

Each medical device requiring lubrication is lubricated according to the manufacturer’s instructions (e.g., surgical handpieces with KAVO SPRAY).

Packaging and Traceability:

This phase takes place in Zone B. The heat sealer is checked weekly with an ink test.

Each step is traceable: the operator fills out a table that allows tracing the person who performed the decontamination, packaging, and autoclave placement of the medical device.

Each medical device is labeled with the packaging date, batch/sterilization cycle, expiration date, and operator number.

The bag is signed by the operator who packaged it, adding further information to the traceability process.

Advanced Sterilization (Class B Autoclaves):

We have two *Melag 40B+ EVO Class B* autoclaves.

The products are subjected to a *134°C* cycle (5-7 minutes at 2 atmospheres).

Each label has an adhesive die that is placed on a dedicated table when the medical device is unpacked and used on a patient, making the process completely traceable up to the point of use on a single patient.

The sterilization protocols for each cycle are saved on flash cards and stored on a server, ensuring the methods, times, and temperatures are saved.

Bagged instruments are considered sterile for 30 days.

Daily and Periodic Effectiveness Checks:

The control systems are complementary and must all be performed regularly.

*Vacuum Test (chamber leak test):* Performed every morning before using the autoclave.

*Bowie & Dick Test (steam penetration test for porous materials):* Performed once a week (if requested, not essential for Class B and no textiles).

*Helix Test (steam penetration test for hollow objects):* Performed daily in the morning before using the autoclave.

*Incubator and Spore Test (biological test):* Evaluates the autoclave’s ability to destroy microorganisms and spores, performed once a month.

*Sterility Supplement (chemical tests):* Test strips are inserted into each cycle to verify exposure to heat and pressure.

All test results are carefully recorded and retained for 10 years.

Rigorous Maintenance

Autoclaves require a cleaning cycle at least once every 15 days. Chairs follow daily and monthly maintenance protocols.

Specific Cleaning Protocols

We have detailed procedures for cleaning the dental unit between patients and for cleaning the operating field after surgeries, with particular attention to waste disposal.

Correct Use of Gloves

There are specific rules regarding the use and replacement of gloves (disposable gloves for nursing, sterile gloves for surgery, cut-resistant gloves for sterilization) to avoid any risk of cross-contamination.