Preparing the load for sterilising
Reusable medical devices required to be sterile at the time of use must be protected by a sterile barrier system (bags, pouches or wrap; see Sterile barrier systems (packaging).
Packaging of cleaned, dried reusable medical devices for sterilisation into sterile barrier systems takes place in the ‘clean’ zone of the reprocessing area, protected from splash and movement in the ‘dirty’ area.
Reusable items may be dried and placed in packs directly while wearing clean nonsterile latex-free, puncture resistant, chemical-resistant utility gloves (preferably longer cuffed). However, gloves are not necessary if dried items are being placed in packs – hands must be clean.
General principles for packing devices into sterile barrier systems
Packaging must be large enough to contain the items in accordance with the manufacturer's instructions for use and allow for adequate air removal, steam penetration and drying.
Before sealing a pack, as much air as possible must be expelled from the inside.
Individual packs must not include combinations of types of devices that would require different sterilisation parameters, such as combinations of hollow items, instruments, gauze dressings, drapes and tubing.
All hinged or ratcheted items must be open and unlocked to allow for expansion of the metal and steam contact with all surfaces. Scissors must only be loosely opened, not to the maximum extent. Multi-part instruments must be disassembled or loosened.
Validated tip protectors can be used to prevent sharp reusable medical devices from perforating the sterile barrier system and protect the tip, following the device manufacturer’s instructions.
Reusable medical devices with handles should be placed with the handle towards the end of the pack/pouch that will be opened. This allows aseptic removal and decreases the possibility of injury from the instrument tip when the bag is opened.
Kidney dishes, gallipots or bowls that require sterilisation should be placed with the open side against the non-laminate surface (for example, the paper surface) to avoid condensation on the inside of the item if being sterilised in paper/laminate rolls or pouches. They should be tilted on their edges (ie in a draining position) to allow steam to displace the air and adequate drainage of condensate.
If placing several of these type of items together in a sterile barrier system, ensure that all openings are facing the same way and that each item can move freely. This allows adequate steam penetration and drying. Use spacers between tightly fitting identical items (eg when sterilising two or more identical and stackable kidney dishes).
If instruments trays are used, they must be metal and perforated to allow air removal and steam penetration during sterilisation.
Sterilising of textiles (eg gauze, towels or drapes) is not recommended. It is preferable to use single-use disposables.
Each package must be checked to ensure it does not exceed the contents of the validated ‘challenge pack’ (the test pack representing the hardest to sterilise; see Validation). Photographs of the validated contents and their arrangement within the sterile barrier system are useful as a valuable ready reference.
If reprocessing items from a failed sterilisation cycle, they must be repacked in a new sterile barrier system, but do not require recleaning unless they have been contaminated (eg dropped on the floor) after opening.
Rubber bands must not be used when transporting or storing packs.
Packaging items for sterilisation in pack/bag/pouch-type barrier systems
(For information on the use of rolls and sheets, see Packaging items for sterilisation using wrapping-type barrier systems.)
Remove the number of packs anticipated and close the container before returning to its storage cupboard/drawer.
Check each pack for damage and check the expiry date.
Choosing the correct size
Choose correct-sized pouch for contents:
- Fill only three-quarters of the volume of each pack.
- Leave approximately 2 cm space around each item.
- Allow an empty space of at least 5 cm from the seal area for aseptic opening.
Sealing the pouch or bag
The pouch or bag must be sealed with no gaps that could allow contaminants to enter after removal from the steriliser. Follow the instructions provided by the manufacturer of the sterile barrier system.
Pouches and bags are self-sealed, heat-sealed or sealed with sterilising indicator tape, depending on the type.
If using a self-sealing pouch, precisely fold seals along the ‘dotted’ line, from the middle to the edges with both thumbs to facilitate an effective seal.
Sterilising indicator tape must not be used on self-sealing or heat-sealed pouches.
If using sterilising indicator tape to seal a non-self-sealing bag or pouch, the open end of the bag/pouch should be sequentially folded over 2–3 times, then taped across the folded edge with one continuous piece of tape extending across at least 25 mm around the back of the pouch on both sides.
String, non-adhesive tape, staples or elastic bands must not be used to seal bags and pouches because these items can compromise the integrity and sterility of these barrier systems.
Packaging items for sterilisation using wrapping-type barrier systems
Preparing packages for sterilisation using barrier systems supplied as sheets or rolls (including wrapping and the use of class 1 chemical indicators) requires specific, validated (envelope-fold or square-fold) techniques that are outside the scope of this document.
The Sterilizing Research Advisory Council of Australia provides a list of sterilising courses available in all states and territories.
The wrapping material must be checked before use to ensure that it is not damaged or past the expiry date.
Instrument trays used to contain instruments must be metal and perforated to allow air removal and steam penetration.
All packages for sterilisation must be labelled with the date of sterilisation and the batch number (which includes the cycle or load number if more than one load processed on the same day), as a minimum. This enables appropriate stock rotation and the identification of other affected items if a problem with a processed item is identified.
If appropriate, additional labelling may include:
- steriliser identification number (in practices using more than one steriliser)
- identification of the contents, if items are not clearly visible (eg when using paper bags or wraps or if reusable medical devices within a kidney dish are sterilised in laminate pouches, as the hollow side faces the paper)
- identification of the person responsible for cleaning and placing items in the sterile barrier system (if more than one staff member prepares items for sterilisation)
- location of storage post-sterilisation (this may be applicable in larger practices to enable storage of different packs near their locations of use).
This information can be recorded using various codes, which varies in complexity.
Packages for sterilisation can be labelled with barcode adhesive labels (using barcode generator and scanner), prepared sterilisation labelling systems, or manually using a felt-tipped marking pen with non-toxic, water-resistant ink (preferably a validated purpose-designed sterilisation marker) or rubber stamp.
Sharp-tipped, water based or ball-type pens must not be used as they may compromise pack integrity.
When writing on laminate pouches and reels, the writing must be on the laminate side outside the sterile window area. Typically, flat wrappers are labelled by writing on the chemical indicator (steriliser) tape.