Guideline: Sterilization of Band Assemblies
Basic Concepts
Progressive Orthodontics does not require bands and their attachments to be sterilized before use; the decision to sterilize is made solely by the user of this product.
Procedures for cleaning, disinfection, and sterilization must adhere to any local, regional, national, and international standards or regulations pertaining to these activities.
Cleaning
Instructions for two different cleaning methods are provided in this guideline:
- Ultrasonic Cleaning
- Automatic Cleaning using Automated Washer Unit
The user is responsible for selecting one of the two cleaning methods to perform according to this guideline. Selection should be guided by relevant local, regional, national, and international standards or regulations pertaining to these activities.
- Ultrasonic Cleaning
- Soak band assemblies in the cleaning solution for 5 minutes. Ensure that all band assemblies are sufficiently immersed with no contact between them.
- Sonicate for 15 minutes.
- Remove the band assemblies from the cleaning solution and rinse them intensively.
- Inspect the band assemblies. If visible debris remains, repeat steps 1 through 3.
- Automatic Cleaning using Automated Washer Unit
- Place band assemblies into cassettes or other suitable tray systems compatible with the washer unit.
- Start the cycle. Program should include the following sequence at a minimum: pre-wash, wash 1, wash 2, rinse, dry.
- Remove the band assemblies from the automated washer unit after end of the cycle.
Packaging for Sterilization
Use of sterilization pouches or other suitable sterilization containers is recommended. Such containers should be:
- FDA approved
- suitable for steam sterilization (temperature resistance up to at least 141 °C (286 °F), sufficient steam permeability)
- sufficiently protective of the devices and the sterilization packaging against mechanical damage
- maintained regularly according to the manufacturers’ instructions
Devices must be completely dry prior to sterilization.
Sterilization
Use only the recommended sterilization procedure listed below. Any deviations from this procedure are the responsibility of the user.
It is the responsibility of the user to ensure that the sterilization process, as it is actually performed, achieves the desired results.
Steam Sterilization
- Use a steam sterilizer according to ANSI/AAMI ST55 or ANSI/AAMI ST8.
- Ensure equipment/process is validated according to ANSI/AAMI ST79 (valid IQ/OQ and product specific performance qualification (PQ)).
- Follow sterilizer manufacturers’ instructions with respect to routine inspection and regular maintenance.
- Abide by any special instructions provided by the sterilizer equipment manufacturer.
- Sterilizers with an automatic drying program are recommended, as the sterilized items must be completely dried after sterilization and before handling.
Minimum cycle times for gravity-displacement steam sterilization cycles Item Exposure time at 121°C (250°F) Drying times Band assemblies 30 minutes Minimum 30 minutes Minimum cycle times for dynamic-air-removal steam sterilization cycles Item Exposure time at 132°C (270°F) Drying times Band assemblies 4 minutes Minimum 30 minutes
Restrictions
- Flash sterilization procedures must not be used.
- Do not use radiation sterilization, formaldehyde sterilization, ethylene oxide sterilization, dry heat sterilization, or plasma sterilization.