REPROCESSING PROCEDURE FOR DENTAL INSTRUMENTS AND IMPLANTABLE RADICULAR DEVICES

 

Full sterilisation guidelines can also be found on the Maillefer website or on pages 46 and 47 of the Endodontic Product Catalogue  

FOREWORD
For hygiene and sanitary safety purposes, all instruments not marked «sterile» must be cleaned, disinfected and sterilized before each usage to prevent any contamination according to EN ISO 17664. This concerns the first use as well as the subsequent ones.

GENERAL RECOMMANDATION

• Single use marked instruments are not approved for re-use.
• The user is responsible for the sterility of the product for the first cycle and each further usage as well as for the usage of damaged or dirty instruments.
• For your own safety, please wear personal protective equipments (gloves, glasses).
• Use only disinfecting solution which is approved for their efficacy (DGHM-listing, CE marking, FDA approval)
• Tungsten Carbide burs, Plastic Support, Hand instruments and NiTi instruments are degraded by Peroxide hydrogen (H2O2) solution.
• NiTi Instruments are degraded if immerged more than 5 minutes in a solution of NaOCl at more than 5%.
• Instruments made of aluminium are degraded in presence of caustic soda solutions with mercury salt. Do not use acid (pH < 6) or alkaline (pH > 8) solutions.
• After 5 cycles, degradation of marking may appear.

AREA OF APPLICATION

A1. Instruments:
Cutting instruments, (hand and engine driven) such as:
• Endodontics instruments (files, broaches, reamers, enlargers, endodontic burs);
• Rotative cutting instruments (Diamond burs, tungsten carbide burs, stainless steel drills, carbon steel burs, reamers).
• Root canal filling instruments (Plugger, spreader, compactor);
• Supports, kits and systems of instrumental organization;
• Hand instruments.

A2. Implantable devices:
Dentinal and radicular posts made of steel, titanium and fiber posts.
Supports, kits and organization systems for the posts.

B. Filling material:
Gutta percha, Thermafil obturation devices.

EXCLUSION

Paper points: Sterile paper points are recommended
Equipments as Motor, Contra-angle, Apex locator, where reprocessing procedures are included in the individual Direction for Use.
MTA, Glyde, Topseal.

A. Devices

Operation  
1. Pre-Disinfection or Decontamination

Operating mode

Soak immediately just after usage all instruments in a disinfectant solution combined with proteolytic enzyme if possible.

Warning

- Follow instructions and observe concentrations and immersion time given by the manufacturer (an excessive concentration may cause corrosion or others defects on instruments).
- The disinfectant solution should be aldehyde free (to avoid blood impurities fixation).
- Do not use disinfectant solution containing Phenol or any products which are not compatible with the instruments (See general recommendation).
- For visible impurities are observed on instruments a pre-cleaning is recommended by brushing them manually with soft material.

Operation

2a. Automated Cleaning Disinfection

Operating Mode

- Disassemble the devices (silicone stops to be removed)
- them in a kit, support or container
- Put them in the thermodisinfector (for at least 10 min at 93°C or Ao value > 3000).

 

Warning
- Discard any instruments with large obvious defects (broken, bent).
- Avoid any contact between instruments or posts when placing in the thermodisinfector.
- Follow instructions and observe concentrations given by the manufacturer (see also general recommendation).
- The thermodisinfector is not recommended for instruments made of aluminium, tungsten carbide or carbon steel. In case of chemical disinfection, there is a danger of remnants of the disinfectant on the instruments.
- Sufficient rinsing step should be available in the program. Use purified water for rinsing (max 10 germs/ml and max 0.25 endotoxin units/ml) like Aqua Purificata.
- Use filtered air for drying the instruments or posts.
- Use only approved thermodisinfector according to EN ISO 15883, maintain and calibrate it regularly.
- If possible, an automated procedure is preferred.

Operation
2b. Manual Cleaning Disinfection

 

Operating Mode
- Disassemble the devices silicone stops to be removed)
- Immerse them in the disinfectant solution assisted with ultrasonic device if suitable.
- Rinse the devices thoroughly with clean, demineralised or distilled water and then dry them with filtered compressed air.

 

Warning 
- No visible impurities should be observed on the instruments.
- Discard any instruments with large obvious defects (broken, bent, and twisted).
- Avoid any contact between instruments or posts when placing in the solution, use kits, supports or container.
- Follow instructions and observe concentrations and time given by the manufacturer (see also general recommendation).
- Use purified water for rinsing (max 10 germs/ml and max 0.25 endotoxin units/ml) like Aqua Purificata.
- If a disinfectant solution contains a corrosion inhibitor, it is recommended to rinse the instruments just before autoclaving.

Operation

3. Inspection

 

Operating Mode 
- Inspect devices and sort out those with defects.
- Assemble the devices (stops).

 

Warning
- Dirty instruments must be cleaned and disinfected again.
- Discard instruments which show any deformations (bent, twisted), damages (broken, corroded) or defects (loss of colour coding or marking) affecting the resistance, the safety or the performance of the instrument or posts.
- Protect carbon steel bur with corrosion inhibitor before packaging.

Operation
4. Packaging

 

Operating Mode

 - Pack the devices in “Sterilisation pouches”.

Warning

- Check the validity period of the pouch given by the manufacturer to determine the shelf life.
- Use packaging which are resistant up to a temperature of 141°C (286°F) and in accordance with EN ISO 11607.

Operation

5. Sterilization
- Steam sterilisation at: 134°C (273°F) during 18 min for endodontics instruments and root canal filling instruments 134°C (273°F) during at least 5 min for all other devices.

Warning

- The instruments, posts and the plastic supports must be sterilized according to the packaging labelling.
- Use fractionated vacuum or gravity (less preferred) autoclaves (according to EN 13060, EN 285).
- Use validated sterilisation procedure according to EN ISO 17665-1.
- Respect maintenance procedure of the autoclave device given by the manufacturer.
- Use only the listed sterilization procedures.

Operation

6. Storage

 

Operating Mode

- Keep devices in sterilization packaging in a dry and clean environment.

Warning

- Sterility cannot be guaranteed if packaging is open, damaged or wet (check the packaging before using the instruments).



B. Filling Material

Operation  
1. Desinfection

 

Operating mode

 - Immerse the obturation devices in alcohol during 30 sec at ambient temperature.

Warning

- Sterility cannot be guaranteed if packaging is open, damaged or wet (check the packaging before using the instruments).