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Key:
|
D
|
Quality system task performed and documented
|
ND
|
Quality system related task performed. Not documented
|
|
Precleaning
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Use PPE: chemically resistant long-cuffed gloves, gown/apron, and full-face protection.
|
|
Wipe down device, removing gross debris.
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|
Spray with enzyme foam or keep moist with wet cloth. Do not use saline solution.
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|
Enclose in a covered container and transport to reprocessing area.
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|
Cleaning and documentation
|
Sort items for automated cleaning.
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|
Dispose of waste including single use items.
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|
Manual cleaning (Pre-treatment only)
Only used to remove visible soil before placing in washer-disinfector
|
Manually clean devices with detergents that meet the current relevant standard.
|
ND
|
|
Use appropriate cleaning agents and tools (eg brushes that meet relevant standards).
|
|
Rinse thoroughly until all debris is removed.
|
|
Dry using lint-free cloth.
|
|
Automated cleaning
|
Open all devices and containers and load automated washer-disinfection equipment racks.
|
|
Monitor automated washer-disinfection with verification test weekly (preferably daily) and record result.
|
D
|
|
Monitor physical parameters of automated washer-disinfection for each cycle. Initial results on printout and retain.
|
D
|
|
Ultrasonic cleaning (optional step)
|
Place instruments recommended for ultrasonic bath for time specified in instructions for use. Follow the specified cycle time and solution requirements.
|
|
Rinse and dry items with lint-free cloth.
|
|
Transport items to "clean side" for preparation and packaging.
|
|
Preparation and packaging
|
Sort instruments into appropriate sets.
|
|
Inspect all devices for cleanliness and functionality. Test as indicated by device design and instructions for use.
|
|
Segregate and tag all devices that need repair.
|
D
|
|
Assemble sets referring to list of how packs are put together / pack guideline and assembly instructions.
|
ND
|
|
Use packaging with chemical indicators or tape.
|
ND
|
|
Place process indicator on outside of each package. Label with date, load number and operator.
|
D
|
|
Select appropriate sized peel pouch for single items. Pouches need to have indicators.
|
|
Sterilisation
|
Place packaged items appropriately on steriliser loading rack.
|
|
Identify and record date, load number and operator.
|
D
|
|
Document descriptions of all items in load in electronic or paper system.
|
D
|
|
Routinely test steriliser efficacy with biological indicator (B1) in process challenge device, at least weekly (preferably daily) and for all implant loads. Quarantine implant loads until results of biological indicator are known.
|
D
|
|
Warm up steriliser and load and start cycle. (Generally part of cycle)
|
|
Cool items for at least 30 minutes after cycle before handling.
|
|
Recordkeeping and load release
|
At conclusion of cycle:
- review printout or data logged information to ensure the successful completion of process
- inspect packaging to ensure is intact and there has been colour change in chemical indicator
- document in recordkeeping system and initial.
|
D
|
|
Determine final load status.
Confirm that all monitoring parameters meet Acceptable Quality System results.
|
Successful results:
|
D
|
|
Failed or suspect monitoring result:
- Quarantine load for reprocessing
- Begin investigation process according to procedure to resolve.
|
D
|
|
Store / inventory / issue
|
Store sterilised items in sterile storage area with defined and documented environmental conditions.
|
D
|
|
Place items in sterility maintenance (dust) covers as appropriate.
|
ND
|
|
If not otherwise specified, the shelf life of packaged sterile item is 12 months. Before release, inspect item packaging and do not issue if labelling or sterility integrity is suspected to be compromised.
|
ND
|
|
Rotate stock according to first in, first out process.
|
|
Transport of all clean or sterile items should be in a covered container when in uncontrolled environments. To maintain integrity of sterilisation, items need to be returned in a clean container.
|
|
Aseptic presentation and use
|
Before packaged item is opened, inspect the integrity of the packaging and the chemical indicator change.
|
ND
|
|
Open package aseptically.
|
|
Ready for use.
|
|
Quality controls
|
Not routinely done with each load
|
|
Leak test for vacuum-assisted steriliser – once per week, determined by manufacturer (instructions for use).
|
|
If required, test dynamic air removal sterilisers daily prior to placing in service with Bowie-Dick type test. Document results and retain test sheet. If failed result occurs, do not use steriliser and follow policy and procedures.
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