Disposable materials used in the sterilisation process

Purpose and requirements

Sterile barrier systems are designed to:

• protect contents from contamination during storage
• allow aseptic removal of the contents at the point of use.

Sterile barrier systems need to:

• allow air removal, steam penetration, and drying of contents
• ensure devices are effectively sterilised and remain sterile
• be standardised for quality.

Types of sterile barrier systems

• Paper bags requiring tape for sealing
• Self-sealing pouches made of paper backed with clear plastic (laminate)
• Rolls of paper with laminate, cut to size and sealed at both ends using tape or heat sealing
• Sheets of low-lint single-use nonwoven material (spunbond-meltblown-spunbond [SMS] polypropylene and/or cellulose)
• Rigid reusable sterilisation containers and cassettes.

Do not use reusable linen wraps, as they do not meet contemporary infection prevention and control standards.

Choosing the correct barrier system

• Size and contents: Laminate pouches are suitable for small-to-medium items; nonwoven fabrics or rigid containers are suitable for larger packs or instrument trays.
• Type of device/equipment: The material needs to be compatible with the instruments and sterilisation process.

Most practices use pre-made bags or pouches for convenience and suitability for small-to-medium items. Larger items, such as surgical instrument trays, require specialist wrapping techniques, which require training. The Sterilizing Research Advisory Council of Australia provides a list of sterilising courses available in all states and territories.

Chemical indicators

• All packs need to include an external Class 1 chemical indicator.
• Pouches and bags often incorporate the indicator in the material.
• For rolls or sheets, the wrapped package needs to be secured and sealed with adhesive tape containing a Class 1 indicator.

Sealing:

• Pouches and bags need to be correctly sealed to prevent contamination.
• Laminate rolls require a heat sealer (spare elements should be kept on hand) or adhesive tape.

Validation and Storage:

• Annual validation confirms the suitability of the barrier system.
• Packs of pouches or rolls of material need to be stored in clean cupboards or drawers, not on open benches or shelves, to prevent contamination.

All items placed in a sterile barrier system need to incorporate a Class 1 chemical indicator on the bag or pouch, or on the tape used to seal the item.

Class 1 chemical indicators are designed to demonstrate that the sterile barrier system has been exposed to the physical conditions of the sterilisation process, but do not guarantee sterility. They are designed to react to one or more of the critical variables, such as changing colour when the correct temperature is reached.

Water quality is critical at all stages of reprocessing. Poor-quality water can:

• reduce cleaning effectiveness
• damage reusable medical devices.

The water used for reprocessing needs to meet the requirements of the current relevant standard.

Requirements for sterilisers

• Modern Class S or B sterilisers typically require demineralised water (distilled or deionised).
• Water can be supplied by:
  • purchasing 5–20 litre containers from a commercial supplier
  • producing on-site using a demineraliser.

Water supply and filtration

• Sterilisers draw water through a tube connected to the water supply.
• Small reverse osmosis filtration systems can be installed to supply water to sterilisers and washer-disinfectors, reducing the inefficiency and cost of bottled water.
• Filters need to be regularly maintained to ensure effective operation.

Water use in sterilisers

• Most modern sterilisers recycle water internally.
• Older sterilisers may require manual addition of water and topping up the reservoir.
• Water that is discharged from any steriliser is not suitable for reuse.

Filtration systems reduce plastic waste, lower the carbon footprint associated with bottled water production and transportation, and are generally more sustainable in the long term. When bottled water is necessary, facilities could:

• minimise reliance on bottled water by investing in high-quality filtration systems
• adopt responsible disposal or recycling of plastic bottles to reduce environmental impact.