Easi-Sterilise Standard Operating Procedures Section 3 Sterilizing

Easi-Sterilise Easi-Sterilise Standard Operating ProceduresStandard Operating Procedures

Section 3Section 3SterilizingSterilizing

Section 3Section 3

Sterilising

3.1 Batching & Recording of a load prior 3.1 Batching & Recording of a load prior to sterilisationto sterilisation

Purpose

MUST HAVE DOCUMENTED EVIDENCE OF ALL ITEMS

of a sterilising process = tracking/tracing proof

Assists in the recall of an item/load

Recording of load contents assists in compiling of

statistical data on production volume

Warning: Warning: Do Not Store Unprocessed Do Not Store Unprocessed Items In The SterilizerItems In The Sterilizer

The sterilization cycle shall be commenced immediately after loading.

Warm, moist atmosphere of the chamber can lead to— (a) release of unprocessed items for use; (b) contamination of packaging by condensate; (c) an increase in bioburden on unprocessed items; and (d) the deterioration of:

(i) chemical indicators, packaging and labelling; and (ii) adhesive of self seal pouches, labelling and sterilizing tape.

3.2 LOADING AND RECORDING OF ITEMS 3.2 LOADING AND RECORDING OF ITEMS FOR STEAM STERILISATIONFOR STEAM STERILISATION

Purpose Sterilant needs to have contact and/or penetrate all surfaces

of the all itemsDo not: crush items together allow items to touch the floor, top, door or walls of the

chamber Allow enough space between each item for:

air removal, steam penetration, draining of condensate drying to occur

Loading the steriliser Light items on top shelves Heavy items on lower shelves Porous/wrapped items on upper shelf, unwrapped lower Wrapped perforated sets/kits/cassettes may be laid flat or

vertically Hollow ware must be tilted on edge in a draining position

1.to facilitate the removal of air, 2.allow steam penetration to all surfaces3.condensation will drain from the hollow.

Vertical loading of Laminated Packaged Instruments

Horizontal loading of laminated pouches

Shall be placed with the paper side facing downward

Not overlapping – to allow air removal, steam penetration and condensate drainage

Reference AS/NZS 4815:2006 - 3.4.3.3 Flexible packaging pg 26

Loading hollow ware & pouches

Place hollow ware on a 45 degree angle

Loading the steriliser

All loads/cycles must have a chemical indicator to distinguish between processed and unprocessed loads

A “control” pouch containing a class 5 or 6 chemical indicator and batch label attached is included in all loads as per direction from the Chief Dental Officer, Jan 2010

Loading of control pouch

The “control” pouch may be placed at the back of the sterilizer load on the lowest shelf (as per direction from the Chief Dental Officer, Jan 2010) or if unwrapped items are in the load, to prevent condensation dripping onto the control pouch, place the control pouch on the same shelf or above the unwrapped items

Cleaning Brushes Reusable cleaning brushes that are unable to be

disinfected in a washer disinfector are to be sterilized separately. If agreed to by the engineering department it may be possible to run this sterilizing cycle overnight.

If time does not permit, as a minimum requirement, instruments are to be cleaned and dried and left unwrapped in a dry, closed, lidded, labelled container that clearly identifies that the items are unsterile, to prevent contamination until processing can occur.

Note:

No instruments are to be sterilized overnight.

Sterilizing of any instrument (other than brushes) is not to occur in accordance with the requirements AS/NZS 4815: Sections 5 and 6.

The Sterilisation CycleThe Sterilisation Cycle

Air removal stage & steam generation & temperature pre vacuum x 1 or x 3 or x 6 vacuums downward displacement Holding/sterilisation - time at temperature Drying – exhaust steam May have a post –vacuum drying stage

. bench top class N downward displacement autoclave capable of processing both wrapped and unwrapped loads

Downward Displacement Validator Plus Steriliser

Small Pre vacuum

Lisa MB17Lisa MB17

Lisa 500 series

Examples of sterilisation cyclesRecognised International

Temperature, Pressure, Time RelationshipInternational Units of Pressure

Temp C kPa psi mb bar Holding time (minutes)

121 103 15 1030 1.03 15

126 138 20 1380 1.38 10

132 186 27 1860 1.86 4

134 203 30 2030 2.03 3

Physical checks

Cycle completed check printout for evidence:

Temperature has reached 134°C

Time at 134°C > 3 mins + penetration time

Pressure 203 kPa or 2.03 bar

stand alone printer

In built printer

Other types?

Top of the printout

W&H Lisa™ Manual

New Lisa 500 series manual

3.3 Releasing & Unloading a Sterilised Load3.3 Releasing & Unloading a Sterilised Load

To ensure that the staff unloading the steriliser check that sterilisation has occurred in accordance with the validated process and authorises the release of the load

3.3 Releasing & Unloading a Sterilised Load3.3 Releasing & Unloading a Sterilised Load Immediately cycle has completed Printout confirms sterilisation parameters are met - signRemove load - Visually check Chemical indicators have changed colour correctly No visible wet packs & packs intact Check items unloaded correspond with load documentation Check and record results of process challenge devices

(if used) on sterilizing log chart Check and record results of biological indicator (if used) on

sterilizing log chart

3.3 Releasing & Unloading a Sterilised Load3.3 Releasing & Unloading a Sterilised Load

Only in exceptional circumstances (such as involved in providing direct patient care) would a delay to removing a completed sterilization load, be considered acceptable and no more than 30 minutes from when the cycle has finished.

3.3 Releasing & Unloading a Sterilised Load3.3 Releasing & Unloading a Sterilised Load

Document in steriliser record/log Sign the sterilizer cycle printout and attach Document time of release Signature or identification of person releasing the load Ensure the items unloaded correspond with load

documentation Attach the “control” pouch batch label Attach the control class 5 chemical indicator Immediately notify the supervisor if not met.

Each Sterilizer’s information is written

once on the front page

Found on

CHRISP Oral

Healthwebsite

Documenting a sterilization cycle

In the case where one or more items (but not all) have failed, in a successful cycle

3.3 Releasing & Unloading a Sterilised Load3.3 Releasing & Unloading a Sterilised Load

Considerations for unwrapped items/load – written procedures for appropriate handling to minimise cross contamination

Handling Transfer or transportation Storage

Cooling itemsCooling items

Away from high activity areas Do not use forced cooling by fans or air con. Do not place on solid surfaces, as condensation

from vapour (still within the pack) can result. Items dropped on the floor, placed on a dirty

surface, compressed, torn, have broken seals, or are wet, are considered non-sterile and shall be reprocessed.

Following cooling

Where plastic dust covers are used, the item shall be cooled before being placed in the dust cover

Plastic dust covers – new, clean, intact, sealed. If dust covers are used for the purpose of storage,

they shall be labelled ‘Dust cover only’.

The key pieces of legislation relating to recordkeeping are

Public Records Act 2002 Public Services Act 1996 Electronic Transactions (Qld) Act 2001 Evidence Act 1977

See also QH clinical records retention and disposal schedule

http://paweb.sth.health.qld.gov.au/sqrm/hims/records/documents/disposal_retention_sched.pdf

3.4 Managing a failed sterilizer cycle and load

Common Reasons for failed cycles Wet items Packaging not in tack Chemical indicator colour change Sterilising parameters Steriliser printout (illegible, run out of paper) Power outages

3.4 Managing a failed sterilizer cycle and load

Items must be: Unwrap Re-wash if the item has become wet, was dropped on

the floor or in contact with other contaminants Rewrapped Reloaded Resterilised manufacturer’s instructions provide troubleshooting

(rectification) procedures, undertake a sterilisation cycle with an empty chamber with a class 5 or 6 chemical indicator

3.4 Managing a failed sterilizer cycle and load

Documenting the failed load: The sterilizer print out must be fixed to the log sheet with

‘FAILED LOAD” written clearly across the print out in permanent ink in a blank area

The steriliser log/record must indicate that the load was identified as failed

If the steriliser requires maintenance, place an out of order sign on the steriliser and inform management and maintenance immediately