Standard Operating Proceedures Sterilising

1 Standard Operating ProceeduresSterilising BATCHING & RECORDING OF A LOAD PRIOR TO STERILISATION PURPOSE All items being reprocessed in a steriliser shall have batch and load information on each pack/tray/bundle To have documented evidence of all items that have been through a Sterilising process Allows for tracking/tracing proof of the Sterilising process Assists in the recall of an item/load if required, and Recording of load contents assists in compiling of statistical data on production volume Operating PROCEDURE Information on the Batch Piggyback Label includes date/steriliser number/load number/ and or contents (this label will be filed in the patients Operating notes by OT) Piggy-back label is placed on each item and that item is then identified on the steriliser-recording log Pre- sterilisation labelling should be done after steriliser and cycle assignment is determined Reference: AS/NZ4187 Sections 3 & 8 BATCHING & RECORDING OF A LOAD PRIOR TO STERILISATION COMPETENT ADVANCED BEGINNER NOVICE Meets current best practice requirements.

2 Requires re-assessment within 1 month. Requires immediate action by manager to manage risk. Review annually. Requires re-assessment in 1 week. LOADING & RECORDING OF ITEMS FOR STEAM STERILISATION PURPOSE To ensure that the sterilant has contact with, and/or penetrates all surfaces of the items. To allow for conditions of sterility attainment to be met. Operating PROCEDURE Place light items on top shelves and heavy items on lower shelves Place linen bundles vertically in a steam steriliser. Place a hand between each bundle to ensure the bundles are not packed too tightly Place wrapped perforated trays flat on the trolley Place hollowware on a 45 degree angle (to allow air removal, steam penetration and drainage of condensate) Place jugs upside down Laminates are placed either vertically with laminate to paper or horizontally with paper facing downward All items loaded into the steriliser chamber are to be spaced (to allow air removal, steam penetration and drainage of condensate)

3 All items loaded in the boundaries of the steriliser trolleys are not to come in contact with chamber walls Load types are ONLY to be the same as those validated for during yearly performance requalification Documentation of the specific load contents is recorded in the steriliser-recording log Select the appropriate cycle (short or long) Commence the cycle as soon as the steriliser is loaded and recorded DO NOT OPEN the door to the steriliser prior to the completion of the cycle Reference: AS/NZ4187 Sections 5 & 8 LOADING & RECORDING OF ITEMS FOR STEAM STERILISATION COMPETENT ADVANCED BEGINNER NOVICE Meets current best practice requirements. Review annually. Requires re-assessment within 1 month.

4 Requires immediate action by manager to manage risk. Requires re-assessment in 1 week. HYDROGEN PEROXIDE PLASMA STERILISATION PURPOSE To ensure correct sterilisation of heat sensitive items. Operating PROCEDURE Check unit is switched on and working Document all items for sterilisation load in logbook Use of special adaptors boosters for some lumen items as per manufactures instructions (check the booster expiry date) Selection of appropriate packaging or wrap : o Porous non-cellulose based flexible packing system o Non-cellulose, non-woven wrap o Rigid reusable sterilisation containers Attach cycle batch piggyback label giving steriliser number, load number, date or scan record using an electronic tracking/management system Load items into unit, a single layer per shelf only Do not overload or allow items to touch electrode & check the balance of metal and plastic is correct Flexible packaging pouches may be leaned vertically against packs with non visible (tyvek)

5 Side to wrap At the end of the cycle, place items on cooling rack Check that Sterilising tape has changed according to the tape manufacturer s guidelines Check printout and external chemical indicators to verify load has passed Attach printout to log book and sign When changing cassettes, check expiry date and colour change on package Check and clean vapour plate weekly ensuring PPE is worn Always dispose of used cassettes according to manufactures instruction and facilities waste management plan Reference: AS/NZ4187 Sections 4, 7 & 8 HYDROGEN PEROXIDE PLASMA STERILISATION COMPETENT ADVANCED BEGINNER NOVICE Meets current best practice requirements. Review annually.

6 Requires re-assessment within 1 month. Requires immediate action by manager to manage risk. Requires re-assessment in 1 week. RELEASING & UNLOADING A STERILISED LOAD PURPOSE To ensure the integrity of the load through a validation process. Operating PROCEDURE When using manually operated trolleys, use operator hand protection for removing trolley cassettes from steriliser Check printout / graph when trolley removed from the steriliser to ensure parameters have been met Attach batch label to cycle printout and to steriliser record/log Make sure the batch/item information corresponds with the load documents and that the batch label and/or ID label has/have not dislodged during sterilisation Check external chemical indicator for a clear even colour change Place the trolley in cool down area (no fans or air conditioning vents)

7 Prior to transferring load to cooling shelf After 15 to 30 minutes transfer items to cooling shelf or leave to cool on trolley cassette and check for wetness and integrity of wrapping material. Any items that are wet or packaging damaged are not considered sterile and must be reprocessed Leave items on cooling shelf/trolley until completely cool (up to 2 hours and even longer for large sets of orthopaedic loan instruments) Check integrity of wrapping. Check flexible packaging materials are intact and seal is secure Check packaging for staining, ink marks, water marks or oil stains When releasing the load ensure the items correspond with load documentation; time of release and signature or identification of person releasing the load is recorded.

8 Check and record results of process challenge devices (if used) on control chart Check and record results of biological indicator (if used) on control chart If items are to be dust covered they must cooled before being placed into a plastic dust cover and sealed If the following occurs the shift supervisor is to be notified as this will result in a failed load and can cause delays, as the items are NOT considered sterile and require reprocessing: Wet loads Parameter measurements in doubt Failure to print complete cycle record Loading integrity identified Fault indication during cycle When results of external indicators are in doubt Hot items stored or transported may sweat causing condensation build up.

9 If this occurs, isolate and dismantle the load, place an Out of Order sign on the steriliser and notify shift supervisor and maintenance immediately. Reference: AS/NZ4187 Section 6 & 8 RELEASING & UNLOADING A STERILISED LOAD COMPETENT ADVANCED BEGINNER NOVICE Meets current best practice requirements. Review annually. Requires re-assessment within 1 month. Requires immediate action by manager to manage risk. Requires re-assessment in 1 week. EMERGENCY SHUT DOWN OF STEAM STERILISER PURPOSE To ensure safe shut down of steam supply and power to the steriliser Operating PROCEDURE Guidelines must be sought from steriliser manufacturer and instructions available at point of use for each steriliser, and may include: o Turning isolation valve off completely (steam supply valve can be at the front or rear of the machine) o Switching power off Record time and information for shut down on the control document Notify shift supervisor Reference: AS/NZ4187 Section 4 EMERGENCY SHUT DOWN OF STEAM STERILISER COMPETENT ADVANCED BEGINNER NOVICE Meets current best practice requirements.

10 Review annually. Requires re-assessment within 1 month. Requires immediate action by manager to manage risk. Requires re-assessment in 1 week.