Steriliser Cycle Record Book User Guide Version 2
Contents
1. ELEVATORKTS Pre Sterilization MOTOR IMPRESSION TRAYS EXTRACTION FO ENEPERIOKIT SLOWSPEEDHANDPIECE KETAC GICGUN BORCER ORALSURGERY KIT STRAIGHT HANDPIECE HAND SCALERS PROPHY KIT __ SURGICAL HANDPIECE mru PRE STERILIZATION TRIPLEX BODY LUXATOR LABELHERE simuaeKit EX BODY amp TIP m AUB pue SINOLNIYd SPATULA 8 SIGNATURE OF PERSON LOADING PRINTED NAME CONTROL POUCH CYCLE PARAMETERS BATCH LABEL STERILIZATION STERILZATIONPRESSURE PRINTOUT 8 coma Post Sterilization TEMPERATURE LARGE STEAM STERILIZERS LOAD RELEASE RESULTS PARAMETERS CHECKED IME RELEASE NUMBER ITEMS ITEMS VISUALLY CHECKED When items removed CONTROL POUCH CHEMICAL INDICATORS EASON FOR FAILED ITEMS CLASS 5 6 INDICATORS CHECKED PLACED IN COOLING AREA _ AFTER STERILIZATION CHECKED BY 10 QUALITY ASSURANCE CHECK REVIEWED BY PRINT NAME PRINT NAME SIGNATURE DATE DATE V2 1 October 2013 Page 15 of 31 Vacuum leak rate test cycle USE THE NEXT CYCLE RECORD If the sterilizer is a pre vacuum sterilizer a vacu2. PROCESS BIOLOGICAL SERVICE OR Where Applicable LEAK RATE TEST TYPE TEST INDICATOR Step 5 Determine what the next cycle number should be based on the type of cycle selected and enter this number Generally the number is determined by noting the previous sterilization printout record number and add one number Note Some sterilizer manufacturer s test cycles such as the Bowie Dick type test BD and vacuum leak rate tests may not use a new cycle number only the sterilization cycles have dedicated cycle numbers So if this is the case you will continue to use the previous cycle number for these test cycles For example if the last recorded cycle number was 761 and the next cycle you will be performing is a vacuum test the vacuum test will be recorded as 761 Then if the Bowie Dick type test cycle is to be performed that test cycle will also be recorded as 761 Remember there has only been one sterilizing cycle with a cycle number of 761 Step 6 Place an unprocessed batch label showing the allocated sterilizer ID allocated sterilization batch cycle number and date of sterilization in to the sterilizer cycle record book Step 7 Place a line through the item content field This indicates that the chamber did not contain any instruments Step 8 On completion of this type of cycle examine the sterilizer cycle record printout to ascertain if the parameters have been met passed or not Tick th
3. Count and document all the items wrapped packed pouched and unwrapped that are to be loaded in to the sterilization chamber for the identified cycle In the example following EXAM KITS 4 TRIPLEX BODIES 4 X RAY HOLDERS 3 HAND SCALER 1 Total number of items 12 Apply one unprocessed batch label to an Oral Health Control Pouch that contains a Class 5 or 6 chemical indicator The Oral Health control indicator pouch is included in every sterilization instrument cycle that contains wrapped and or unwrapped items If using the sterilizer to sterilize cleaning brushes these items must not be placed in the sterilizer chamber with instruments Step 11 Enter the total number of items loaded In the example following the total items loaded is 12 Step 12 Enter your signature Step 13 Print your name QUEENSLAND HEALTH STERILIZER CYCLE RECORD FOLIO DISTRICT FACILITY STERILIZER No SERIAL No AA 4 HAL I DATE 08 CODE QUALIFICATION ALL ITEMS THAT ARE STERILIZED 1 0 CYCLE NUMBER ENDO EQUIPMENT BURS PACKISTAND COMPOSITE GUN 5 RUBBER DAM FRAME ENDO FILE PACK HIGH SPEED COUPLING CURING LIGHT TIP RUBBER DAM CLAMPS carci tages ENDO KIT HIGH SPEED HANDPIECE EVACUATION ADAPTORS ELEVATOR KITS RUBBER DAM PUNCH Pre Sterilization EXAM KIT MOTOR IMPRESSION TRAYS EXTRACTION FORCEPS HYGIENE PERIO SLOW SPEED HANDPIECE KET
4. If the parameters have not been met document up to section 9 step 23 of the instructions for documenting the results of the cycle Step 1 Notify the supervisor immediately and write Failed Cycle Document in the comments section the supervisors recommendations and or actions taken All items and packs must be removed the batch labels removed and discarded and new packaging new labels pertaining to the next cycle must be applied Step 2 Print your name sign and date SIGNATURE OF PERSON LO LENGTH OF STERILIZATION STERILIZATION TIME HOLDING TIME TEMPERATURE LARGE STEAM 5 PARAMETERS CHECKED TIME OF RELEASE TEMS VISUALLY CHECKED CHEMICAL INDICATORS CHECKED STERILIZATION PRESSURE STERILIZERS mss 5 BY PRINT NAME FALL SIGNATURE fr NUMBER ITEMS RELEASED when lams removed NUM FALED PLACED IN coouna AREA REASON FOR FAILED ITEMS QUALITY ASSURANCE CHECK REVIEWED BY PRINT NAME DATE 12 Auditing the sterilizer cycle record Step 1 At a period of time defined by the individual sites district the sterilizer cycle records are audited to ensure all signatures are present Step 2 Tick to confirm all information is complete The sterilizer cycle record books should not be culled or archived without the information being complete Remember this sterilizing
5. Remember if you take this number from the sterilizer cycle counter this should be a sequential number following on from the previous cycle Enter the date the sterilizer cycle record log book commenced Print your name Sign that you have opened this book and completed the information required for successful use of the sterilizer cycle record book OPTIONAL to include the performance qualification information see next step V2 1 October 2013 Page 8 of 31 innovators Traceability M Meditrax QUEENSLAND HEALTH ORAL HEALTH STERILIZER CYCLE RECORD BOOK EIPISTRICT STERILIZER 3 THIS IS LOAN LOAN MACHINE FROM 4 STERILIZER MAKE STERILIZER MODEL STERILIZER SERIAL No S STERILIZER ASSET No CYCLE FROM cYcLeTo LOG OPENED __ DATE LOG CLOSED __ signature 1800 074 085 07 5597 5244 16 JADE DRIVE NERANG QUEENSLAND 4211 07 Copyright Uata Corte Sock torres pert 7 PRINT CODE MHERODCH VERSON 2 V2 1 October 2013 Page 9 of 31 inside front cover The fastener on the inside front cover may be used to store sterilizer cycle information test results or any other useful information The first page Per
6. Standard If more than two different types of cycles have been validated ensure both cycles are documented and clearly differentiated Step 3 Enter the minimum temperature that must be reached during the sterilization time holding time sterilization phase e g 134 C Enter the minimum length of time that the sterilization temperature as shown in 15 must be held Enter the sterilization pressure to be reached and provided on the sterilization record printout Pressures can be measured in different ways e g bar millibar mb Kilopascal kPa Step 4 Enter the details of the contents of the PQ validated load the description how many of a specific item and what rack were they placed in the sterilizer Step 5 If available attach photographs or photocopies of photographs showing the contents and where and how these items were loaded into the sterilizer Note Sufficient numbers of these photographs photocopies or a system to transfer the photographs to the next sterilizer cycler record book may need to be in place V2 1 October 2013 Page 11 of 31 6 The sterilizer cycle record Each page of the sterilizer cycle record book contains two 2 cycle records M QUEENSLAND HEALTH STERILIZER CYCLE RECORD Meditrax DISTRICT FACILITY STERILIZER No SERIAL No AA mnow _ feat rma jien pf fe 1 FIRS
7. NUMBER ITEMS RELEASED NUMBER ITEMS FAILED CONTROL POUCH CHEMICAL INDICATORS CLASS 5 6 INDICATORS CHECKED pracen in COOLING AREA go EEREN FOR FAILED ITEMS AFTER STERILIZATION CHECKED BY PRINT SIGNATURE ASSURANCE CHECK REVIEWED BY PRINT NAME PASS V2 1 October 2013 Page 17 of 31 Bowie Dick type test USE THE NEXT CYCLE RECORD If the sterilizer is a pre vacuum sterilizer a daily Bowie Dick type test is required Step 1 When more than one sterilizer is present in the facility insert the allocated sterilizer number for which this book should be used This will assist staff to identify and use the correct sterilizing cycle record book Step 2 Circle the letter that represents the day M Monday T Tuesday W Wednesday T Thursday F Friday S Saturday S Sunday Step 3 Entering the wrong date is a common error Tip If unsure check your mobile phone or computer calendar for the correct date Step 4 Place tick in the box that indicates Bowie Dick Type test section modeled HEALTH STERILIZER CYCLE RECORD FOLIO 1 DISTRICT FACILITY STERILIZER No SERIAL CYCLE PERFORMANCE QUALPEATON P ALL ITEMS THAT ARE TO BE STERILIZED NOTE THE WORD 15 T W F S s CYCLE 4 circle day WARM UP CYCLE VACUUM BOWE
8. PASS or FAIL a cycle based on other visual indicators This box is very important for instrument cycles Remove the items from the chamber Do not place on a solid surface Place in a dedicated cooling area zone Visually check and document the results of the control pouch class 5 6 chemical indicator by ticking Pass or Fail Visually check the items to ensure packaging is dry intact not split or punctured Tick to confirm items have been checked Visually check the class 1 chemical indicators have changed colour Tick to confirm the chemical indicators on the packs pouches have been checked Empty the chamber as soon as possible after the end of the cycle Document the time of release of the items from the chamber This time may differ from the time the cycle ended Ensure the number and type of items removed from the chamber correspond to the number and type documented prior to loading the chamber Enter the number of items released and or number of items failed If none of the items failed in the cycle then enter zero 0 in the box relating to the number of failed items Enter a reason for the failed items If required the Comments section may also be used Do not leave failed items to cool with items able to be released remove and clearly label failed item s as such V2 1 October 2013 Page 23 of 31 Step 24 When the control pouch has cooled check the colour change of the batch label has changed correct
9. applied use the next available space To show that all failed packs are accounted for sign or initial before the first batch label and after the last and count tally The purpose of the signature is twofold Firstly it will be easier to pick out the range of failed items Secondly it forms part of the accountability element in that by signing you are vouching for the correctness of your action Tick supervisor notified box as applicable Enter the date of notification Print the name of person notified Print your name Document recommendations and or actions as advised by the supervisor SUPERVISOR NOTIFIED OF NON CONFORMANCE ves NO SUPERVISORS RECOMMENDED ACTION S i 1 MIFIED NOTIFIED THE SUPERVISOR RECORD OF FAILED ITEMS DATE OF NOTIFICATION 4 el Adidasi use HERE gt SURETRAX LABEL HERE ee LABEL HERE LABEL F SURETRAX ae V2 1 October 2013 Page 26 of 31 11 Documenting a failed cycle When the whole cycle fails we do not need to remove and apply the batch labels to the record of failed items The purpose of the record on the reverse of each sheet is to account for failed items in a successful cycle will be discarded If the cycle has failed then the batch
10. batch label showing the allocated sterilizer ID allocated sterilization batch cycle number and date of sterilization in to the sterilizer cycle record book LOADING CYCLE NUMBER BATCH LABEL Pre Sterilization PRE STERILIZATION LABEL HERE AFFIX Step 7 Step 8 Step 9 Place a line through the item content field This indicates that the chamber did not contain any instruments On completion of the warm up cycle examine the record printout to ascertain if the parameters have been met passed or not Tick the appropriate box for PASS or FAIL In the CYCLE box tick the appropriate box for PASS or FAIL The cycle box allows the operator to PASS or FAIL a cycle based on other visual indicators This box is very important for Bowie Dick test cycles and instrument cycles Step 10 The person who is checking the results of the warm up cycle prints their name signs and dates the cycle record V2 1 October 2013 Page 14 of 31 Example of a warm up cycle record QUEENSLAND HEALTH STERILIZER CYCLE RECORD FOLD 1 DISTRICT FACILITY STERILIZER No SERIAL AA freeones E Eor crae AEN eh ENE OR CODE PO ALL ITEMS THAT ARE BE STERILIZED NOTE THE WORD KIT IS INTERCHANGEABLE WITH CASSETTE TRAY RUBBER DAM FRAME CYCLE BURS PACKISTAND COMPOSITE GUN CURETTES ELEVATORS
11. checking the results of the vacuum leak rate cycle prints their name signs and dates the cycle record Example of a vacuum leak rate test cycle record HEALTH STERILIZER CYCLE RECORD FOLIO FACILITY STERILIZER SERIAL No AA MTWTFSS day weer voc a BOWE DICK BD Nstauvenrcycue L_ process LEAK RATETEST type test INDICATOR PERFORMANCE 08 CODE QUALIFICATION PO 27 TTEMISE ALL ITEMS THAT ARE STERILIZED NOTE THE WORD KIT IS INTERCHANGEABLE WITH CASSETTE TRAY CYCLE NUMBER BURS PACK STAND COMPOSITE GUN ENDO FILE PACK HIGH SPEED COUPLING CURING LIGHT TIP __ HIGH SPEED HANDPIECE EVACUATION ADAPTORS lt SOWSPEEDRMORESE __ suncica HaNopece _ EX BODY amp TIP SIGNATURE OF PERSON LOADING BATCH LABEL Pre Sterilization AFFIX PRE STERILIZATION LABEL HERE RESTORATIVE KIT SUTURE KIT TOTALITEMSLOADED CONTROL POUCH BATCH LABEL Post Sterilization STERILIZATION TEMPERATURE Jayo AUB pue SLNOLNIYd HOWLLY STERLIZATION PRESSURE PRINTOUT printout 8 cycue 9 eass FAIL LABEL HERE PARAMETERS CHECKED ITEMS VISUALLY CHECKED TIME OF RELEASE E when items removed
12. cycle record book is documentary evidence that may be needed to defend your actions Step 3 Sign and print your name if you are undertaking the documentation audit T 1800 074 085 07 5597 5244 Medtrax Dental Sionilizar Oyon Book forms Austen DO NOT REPRODUCE Copyright 1 AUDIT Relevant Present ves _ Sign Modifrux Trnoeabtity System RE ORDER CODE V2 1 October 2013 Page 27 of 31 13 Service or performance qualification Step 1 Tick the service or performance qualification in conjunction with the steps found in Section 8 Documenting an instrument cycle Steps 1 to Steps 7 Use the comments box as needed WARM UP CYCLE VACUUM BOWED EST Oe Where LEAK RATE TEST 14 Storage When packs have been sterilized and cooled they may enter sterile circulation Usually this will mean being stored for a period of time as opposed to being used immediately This section is concerned with good housekeeping Ensure a process is in place to help with good stock rotation for example pick items from the front in the storage area for use and restock to the back For every out of date item that needs to be re processed there is a cost With good stock rotation that cost can be reduced To minimise the type and number of items being repro
13. AC GIC GUN FORCEPS ORAL SURGERY KiT STRAIGHT HANDPIECE MATRIX RETAINER HAND SCALERS AFFIX PROPHY KIT SURGICAL HANDPIECE MIRROR LASYRINGE PRE STERILIZATION RESTORATIVE TRIPLEX BODY PROBE LUXATOR LABEL HERE SUTURE KIT TRIPLEX TIP SCISSORS NEEDLE HOLDERS TRIPLEX BODY amp TP SPATULA PLIERS XRAYHOLDERS ULTRASONIC SHANK CLEANING BRUSHES ULTRASONIC TIP amp GUARD ITEMS LOADED SIGNATURE OF PERSON LOADING PRINTED NAME COMMENTS a lt gt LOADING Aue pue 1 HOVLLY V2 1 October 2013 Page 21 of 31 Documenting the results of a sterilization cycle QUEENSLAND HEALTH STERILIZER CYCLE RECORD FOLIO DISTRICT FACILITY STERILIZER No SERIAL No AA m CYCLE NUMBER BATCH LABEL Pre Sterilization E AFFIX PRE STERILIZATION LABEL HERE XRAYHOLDERS ULTRASONIC SHANK as SIGNATURE OF PERSON LOADING 121 PRINTED NAME 0 a CONTROL POUCH Post Sterilization renee POST STERILIZATIO 2 CONTROL POUCH CHEMICAL INDICATORS REASON FOR FAILED IT
14. EMS ion sere 21 ms E AFTER STERILIZATION CHECKED BY QUALITY ASSURANCE CHECK REVIEWED BY PRINT NAME 30 PRINT NAME 7 one Aue SLNOLNI Yd V2 1 October 2013 Page 22 of 31 9 Documenting the results of a sterilization cycle Step 14 Step 15 Step 16 Step 17 Step 18 Step 19 Step 20 Step 21 Step 22 Step 23 On completion of the cycle examine the results printout to ensure the critical parameters time temperature and pressure have been met See the first page Performance Qualification information Go to the UNLOADING section and the CYCLE PARAMETERS section Enter the length of the sterilization time holding time Enter the sterilization temperature Ensure the minimum sterilization temperature has been reached and held at that temperature for the required time Report to your supervisor s temperatures that are below the minimum sterilization temperature or exceed the 136 C and note in the comments section AS NZS 4187 2003 requires the pressure of large steam sterilizers to be recorded For large steam sterilizers record the pressure Read the sterilizer printout result In the PRINTOUT box tick the appropriate box for PASS or FAIL In the CYCLE box tick the appropriate box for PASS or FAIL The cycle box allows the operator to
15. Easi Sterilise STEPS FOR A SAFER HEALTH CARE SYSTEM QUEENSLAND HEALTH ORAL HEALTH SIs CMC Il ORD 6 USER GUIDE v2 Queensland Government Meditrax This document has been completed to requirements policy and procedures of Queensland Oral Health as supplied by Centre for Healthcare Related Infection Surveillance and Prevention This work is protected by copyright No part of this design may be reproduced stored in a retrieval system or transmitted in any form or by any means electronic mechanical photocopying recording or otherwise without the prior permission of the copyright owner Manual issue 2 1 Second printing June 2011 Trademarks Suretrax is a trademark Meditrax is a division of the Altrax Group V2 1 October 2013 Page 2 of 31 Contents ce 10 11 12 13 14 15 16 17 PAT e E E 5 5 What is accomplished using system 6 How to use the lt 7 Opening a sterilizer cycle record 8 Theon lA 8 The inside front cover 10 The first page Pe
16. ICATION RUBBER DAM FRAME HIGH SPEED COUPLING ELEVATORS BATCH LABEL Pre Sterilization e AFFIX PRE STERILIZATION LABEL HERE V2 1 October 2013 HIGH SPEED HANDPIECE ELEVATOR KITS RUBBER DAM PUNCH MOTOR EXTRACTION FORCEPS FORCEPS STRAIGHT HANDPIECE SURGICAL HANDPIECE HAND SCALERS LASYRINGE TRIPLEX BODY LUXATOR TRIPLEX TIP NEEDLE HOLDERS TRIPLEX BODY amp TIP PLIERS X RAY HOLDERS ULTRASONIC SHANK CLEANING BRUSHES UTRASONCTP amp GUARO TOTALITEMS LOADED SIGNATURE OF PERSON LOADING PRINTED Page 20 of 31 Aue SLNOLNI Yd HOWLLY Step 10 Enter the specific details of the contents and the number of items the sterilizer cycle record The most common items included in this sterilizer cycle record were indicated for inclusion by the QH Dental Assistants Network to minimise the writing time required The columns were grouped by packs kits sets of instruments then hand pieces motors and triplex followed by common instruments For those items not mentioned use the blank row s to write the name of the item and number Every wrapped packed pouched item must be checked for non conformity such as damage or not sealed correctly and have a batch label applied with the sterilization cycle details Only the packs to be included in the current cycle should be labeled
17. M oy LEAK CYCLE TYPE TOR eal 1 _ XRAY HOLDERS ULTRASONIC SHANK eth SIGNATURE OF PERSON LOADING 121 PRINTED NAME LENGTH OF STERILIZATION STERILIZATION STERILIZATIONPRESSURE PRINTOUT 17 tear TIME HOLDING TIME LARGE STEAM STERILIZERS 17 16 38 raw PARAMETERS CHECKED PARAMETERS CHECKED 25 veep rene 23 when items removed __ NUMBER TTENS CHENICAL INDICATORS Evel FOR TEMS Aue SLNOLNIHd HOVLLY 18 V2 1 October 2013 Page 25 of 31 10 Documenting failed items In the case where one or more items but not all have failed in a successful cycle an additional action is required in the sterilizer cycle record book Remembering any pack which fails in a cycle should not be left to cool with items that have not failed or be allowed to enter product circulation The next step is to account for the batch labels on the failed packs Step 1 Step 2 Step 3 Remove the batch label from each failed item and adhere them on to the reverse side of the sterilizer cycle record sheet When applying labels to the failed items record start placing them from the top left If labels from earlier failed cycles are already
18. T CYCLE RECORD ON THE PAGE HE TIME OF RELEASE CE items fees Once nor STERILIZATION CHECKED QUALITY ASSURANCE CHECK REVEWED p 9 DE DATE SECOND CYCLE RECORD ON THE PAGE aema I oe 2220 nea BY TA ei 1800 074 085 we F 07 5597 5244 7 Copyright of Cental Sterfizer Record Sock forms part of Traceaniity System RE ORDER CODE V2 1 October 2013 Page 12 of 31 7 Documenting preparation of the sterilizer One of the main principles of the sterilizing cycle record book is that everything should be complete and accounted for It is important to account for each and every cycle that is run in a sterilizer and if this is not completed it could be possible for critical activities to be overlooked There are different types of cycles for different purposes To account for each cycle means that the e warm up tests e vacuum leak rate tests e Bowie Dick type tests e service technician operational and performance qualification cycles must be recorded using a separate cy
19. YRINGE PRE STERILIZATION RESTORATIVE KIT TRIPLEX BODY PROBE LUXATOR LABEL HERE SUTURE KIT TRIPLEX TIP SCISSORS NEEDLE HOLDERS FRIPLEX BODY amp TIP SPATULA PLIERS X RAY HOLDERS ULTRASONIC SHANK ULTRASONIC TIPaGUARO SIGNATURE OF PERSON LOADING CYCLE PARAMETERS LENGTH OF STERILIZATION TIME HOLDING TIME CONTROL POUCH BATCH LABEL Post Sterilization STERILIZATION TEMPERATURE PRINTED NAME STERILIZATION PRESSURE LARGE STEAM STERILIZERS PRINTOUT 8 CYCLE 4ayjo AUB 51 HOVLLY ITEMS VISUALLY CHECKED when items removed pass re NUMBER ITEMS RELEASED NUMBER ITEMS FAILED CHEMICAL INDICATORS CHECKED AFTER STERILIZATION CHECKED BY PRINT NAME CONTROL POUC CLASS 5 6 INDICATORS pracen In COOLING AREA go Pal QUALITY ASSURANCE CHECK REVIEWED BY PRINT NAME SIGNATURE V2 1 October 2013 Page 19 of 31 8 Documenting an instrument cycle Use the next cycle record Step 1 identify and use the correct sterilizing cycle record book Step 2 When more than one sterilizer is present in the facility insert the allocated sterilizer number for which this book should be used This will assist staff to Circle the letter that represents the day M Monday T Tuesday W Wednesday T Thursday F Frida
20. cessed document the items requiring reprocessing and in order to reduce the costs associated with reprocessing unused items a blank table is contained in section 17 to assist with monitoring and determining what stock may be superfluous 15 Patient record One of the benefits of the Suretrax batch label is that it can be re applied The significance of this is in the recording of items used in an operation In general this means the application of the Suretrax label from each item used onto the patient s record A Suretrax batch label is an accountable document It provides a direct link to the sterilizer cycle which sterilized an item Without the label there is no way to prove that e The sterilizer cycle responsible for the sterilization of the pack was successful and hence that the pack is sterile e The pack was actually in that cycle t Application of Batch code label proves packs into the autoclave V2 1 October 2013 Page 28 of 31 16 Closing off sterilizer cycle record book When a sterilizer cycle record book is filled and before starting a new sterilizer cycle record book complete the details on the front cover of the old sterilizer cycle record book Step 1 Fill in the cycle to box as appropriate Step 2 Date the close of the sterilizer cycle record book log Step 3 Print your name Step 4 Sign for the closure CYCLE FROM CYCLE DATE LOG OPENED By Name Signatur
21. cle record V2 1 October 2013 Page 13 of 31 Warm up cycle If applicable Step 1 Step 2 Step 3 Step 4 When more than one sterilizer is present in the facility insert the allocated sterilizer number for which this book should be used This will assist staff to identify and use the correct sterilizing cycle record book Circle the letter that represents the day M Monday T Tuesday W Wednesday T Thursday F Friday S Saturday S Sunday Enter the date Entering the wrong date is a common error Tip unsure check your mobile phone or computer calendar for the correct date Tick the warm up cycle box Note each type of preparation cycle test requires a separate sterilizing cycle record to be completed circle day WARM UPCYCLE KY VACUUM QUEENSLAND HEALTH STERILIZER CYCLE RECORD FOLIO 1 DISTRICT FACILITY STERILIZER No SERIAL MTWTES TICK APPROPRIATE TYPE OF CYCLE BOWIE DICK BD E INSTRUMENT CYCLE PROCESS TYPE TEST CYCLE TYPE CHALLENGE DEVICE BIOLOGICAL INDICATOR BI SERVICE OR QUALIFICATION E Applicable LEAK RATE TEST Determine what the next cycle number should be based on the type of cycle selected and enter this number Generally the number is determined by noting the previous sterilization printout record number and add one number Place an unprocessed
22. ding pattern how these contents were loaded V2 1 October 2013 Page 10 of 31 On first page of the book enter the performance qualification information Enter details of current PQ validated load and type of cycle for the sterilizer that this book relates A written description of the challenge load and a photograph or diagram is very useful This assists all staff including casual staff to identify the date of the last validation of the sterilizer or when it is due ldentify the sterilizer cycle was validated e g wrapped cycle that sterilizes at 134 C Identify the Challenge Load that was validated and should not be exceeded overloading 01 Description of items used include position of items on rack 4 Space to attach a photographs 5 1 Showing the contents 2 The loading pattern how these contents were loaded Step 1 Enter the date of performance qualification by the technician At minimum performance qualification must be undertaken annually Step 2 Enter the type of cycle that was validated on that date The cycle should be a sterilization cycle that will be routinely used by the facility suitable for sterilization of instruments that incorporates a drying stage To avoid confusion use the terminology used by the sterilizer manufacturer and found on the record printout e g Wrapped
23. e DATE LOG CLOSED Signature The fastener on the bottom edge of the book should be used to fasten the log book the front cover and the back cover together The book has been designed to expand to take the additional paper thickness when the book is complete The information that you have gathered gives a detailed history of your sterilizers That information is like an insurance policy providing evidence that the batches you have processed have been accounted for whether sterilization has been successful or not Under Australia product liability laws you are required to keep records of processes for a minimum period of time Check with you your medical records department before destroying any records If you are required to produce evidence regarding the success of a batch during that period then it makes sense to introduce an archival system to enable easy finding For your guidance in setting up an archiving system please note the following An archival system should be designed to allow you and those that follow you to find records quickly and efficiently Set up an archival register to include some or all of the following information Sterilizer number Date of opening closure Location Where you store your records today may not be where they end up tomorrow record all movements If you remove files make sure they go back in the right place Finally remember the
24. e appropriate box for PASS or FAIL Step 9 Examine the processed Bowie Dick Test Indicator and determine the result In the CYCLE box tick the appropriate box for PASS or FAIL Please note that even though the sterilizer cycle parameters have been met on the printout a failure of the Bowie Dick Test indicator is a failed cycle Step 10 The person who is checking the results of the Bowie Dick cycle prints their name signs and dates the cycle record V2 1 October 2013 Page 18 of 31 Example of a Bowie Dick test cycle record pistRicT FACILITY STERILIZER No circle day DATE ih ne BEALS RECORD FOLIO SERIAL No AA BIOLOGICAL SERVICE OR 8 L_ o PERFORMANCE QUALIFICATION PQ ALL ITEMS THAT ARE BE STERILIZED NOTE THE WORD KIT IS INTERCHANGEABLE WITH TRAY CYCLE NUMBER ENDO EQUIPMENT BURS PACK STAND COMPOSITE GUN CURETTES RUBBER DAM FRAME ENDO FILE PACK HIGH SPEED COUPLING CURING LIGHT TIP ELEVATORS ENDO HIGH SPEED HANDPIECE BATCH LABEL EVACUATION ADAPTOAS ELEVATOR KITS Pre Sterilization EXAM KIT MOTOR IMPRESSION TRAYS EXTRACTION HYGIENE PERIO KIT SLOW SPEED HANDPIECE KETAC GIC GUN ORAL SURGERY KIT STRAIGHT HANDPIECE MATRIX RETAINER HAND SCALERS PROPHY KIT SURGICAL HANDPIECE u LAS
25. ery cycle of a sterilizer and any equipment used a patient which has passed through this process 2 Reason For consumer protection we must be able to identify any specific item or equipment which has been used on a patient and PROVE that it has successfully been through a decontamination and sterilization process and that it has been checked according to Queensland Health policy and procedures Remember our defense in litigation is to provide documentary evidence that equipment has passed through a decontamination and sterilization process which has been carried out and checked From that evidence there is a high probability that the equipment used was sterile The Queensland Health QH Oral Health Sterilizer Cycle Record Book SCRB assists in providing traceability and accountability The need to trace an object applies not only to finding the object but to determining retrospectively where it has been and what has happened to it during it s journey Accountability is the process of accepting responsibility for the processes that an object is subject to An account of manufacturing processes is required in order to demonstrate that the necessary care has been taken in the manufacture or re manufacture of items in order to protect life and finance provides an account or record of processes to be maintained plus a record of the person or persons responsible for those processes able to identify those person s
26. formance Qualification PQ information Note that this is optional to complete You may choose to put a line through it and note to refer to technicians report which should be kept near the sterilizer Note This page is Optional to complete You may choose to put a though it and a note to refer to the technician s Performance Qualification tepon and where this can be found Instructions Enter details of current validated load and cycle for the sterilizer that this book relates A written description of the challenge load and a photograph diagram is very useful This assists all staff including casual staff to 1 identify the date of the last validation of the sterilizer or when it is due 2 identify what sterilizer cycle was validated e g wrapped cycle that sterilizeS at 134 C 3 identify the Challenge Load that was validated should not be exceed DATE OF PERFORMANCE QUALIFICATION BY TECHNICIAN _____ OF CYCLE VALIDATED e g WRAPPED STANDARD Sterilization Minimum Temp Sterilization Minimum Time Sterilization Pressure E Immediately report failure to attain these sterilization parameters DESCRIPTION OF CONTENTS VALIDATED Description of items used Include position of items on rack Please refer to the current Performance Qualification Report cat lt lt to attach a photographs 1 Showing the contents 2 The loa
27. irns Smithfield CHS Innovators in Traceability M Meditrax QUEENSLAND HEALTH ORAL HEALTH STERILIZER CYCLE RECORD BOOK FACILITY V2 1 October 2013 Page 7 of 31 5 Opening sterilizer cycle record book The front cover Read the front cover of the log and enter the following information with a black biro pen The numbers shown in the step by step instructions correspond to the following image Step 1 Step 2 Step 3 Step 4 Step 5 Step 6 Step 7 Step 8 Enter your district name e g Cairns Enter the name of the facility This is the actual site where the sterilizer is installed District Facility sterilizer no This is number that has been allocated by the facility and or district Only one number is to be allocated and used for a sterilizer to avoid confusion If this sterilizer cycle record book is to be used for a loan sterilizer place a tick in the box Enter from where the loan sterilizer came from Enter the sterilizer make Fill in the sterilizer model number As sterilizer manufacturer s improve their sterilizers the model number changes for their reference parts may be quite different from one model to another Fill in the sterilizer serial number This number is a unique number only for that particular machine Enter the QH Asset number allocated to this sterilizer Fill in the first cycle number that is to be entered in the sterilizer cycle record book
28. ll packs instruments were checked after the sterilization process Records all maintenance and testing showing you operate a maintained sterilizer Convenient storage of all sterilizer printouts within the sterilizer cycle record book All records pertaining to cycles print outs etc shall be stored with the book to give a complete record of the sterilizer history e The paper used in the sterilizer cycle record book is manufactured from Sterisyn waterproof synthetic paper for essential record protection in harsh wet environments The batch labels used in the process and placed in patient records allow tracking from the patient record back to the sterilizer cycle record book You can confirm the sterilizer cycle s in which your patients instruments were sterilized The advantage of this is that you may now trace to a unique sterilization event that may also be backed up by sterilizer print outs This provides added security for you and your patients V2 1 October 2013 Page 6 of 31 4 How to use user guide Each instruction is numbered Each section has an image of the part of the sterilizer cycle record book to which the instruction relates The number relates directly to the image of the sterilizer cycle record book For example the following numbered instructions relate to the image where number 1 is in red Step 1 Enter your district name and the facility the actual site where the sterilizer is installed e g Ca
29. ly and remove the batch label and adhere to the sterilizer cycle record Step 25 Tick the parameters checked box when all the above steps have occurred Step 26 Items must be cooled prior to storage Tick to confirm items have been placed into the cooling area Cooling must occur prior to storage Step 27 Use the comments section to document notes that would assist another person to understand what has occurred during the cycle Step 28 The person authorising the release of the load is accountable and must print their name sign and date Step 29 Attach printout and any other evidence of the cycle Please ensure that Process Challenge Device and or Biological Indicator results are recorded in the area provided Please note that even though the sterilizer cycle parameters have been met on the printout a failure of Process Challenge Device and or Biological Indicators is a failed cycle Step 30 Optional A simple double check by another healthcare team member can be a system factor which helps to prevent errors It is an action to prevent or minimise harm from health care errors Ideally this is undertaken at the end of each day or the beginning of the next day As a quality assurance check ask a co worker to check the documented details such as e Correct day is circled e Correct date is on the batch labels in the cycle record and written in the cycle record The written cycle number is the same cycle number a
30. r s test cycles such as the Bowie Dick type test BD and vacuum leak rate tests not use a new cycle number only the sterilization cycles have dedicated cycle numbers So if this is the case you will continue to use the previous cycle number for these test cycles For example if the last recorded cycle number was 761 and the next cycle you will be performing is a vacuum test the vacuum test will be recorded as 761 Then if the Bowie Dick type test cycle is to be performed that test cycle will also be recorded as 761 Remember there has only been one sterilizing cycle with a cycle number of 761 Step 6 Place an unprocessed batch label showing the allocated sterilizer ID allocated sterilization batch cycle number and date of sterilization in to the sterilizer cycle record book This helps to keep the batch label gun number in sequence Step 7 Place a line through the item content field This indicates that the chamber did not contain any instruments Step 8 completion examine the vacuum leak rate test cycle record printout to ascertain if the parameters have been met passed or not Tick the appropriate box for PASS or FAIL Step 9 In the CYCLE box tick the appropriate box for PASS or FAIL The cycle box allows the operator to PASS or FAIL a cycle based on other visual indicators This box is very important for Bowie Dick test cycles and instrument cycles V2 1 October 2013 Page 16 of 31 Step 10 The person who is
31. rformance Qualification PQ information 10 The sterilizer cycle 12 Documenting the preparation of the sterilizer 13 Warm up cycle TiappliG able 22 2 14 rate test cycle 16 Bowie Dick type LOS acces ax nsaaasoraaneeterncacus sa 18 Documenting an instrument 000400 20 Documenting the results of a sterilization cycle 23 Documenting the results of a sterilization cycle 25 Documenting failed 26 Documenting a failed 27 Auditing the sterilizer Cycle 27 Service or performance qualification 28 Storage tua sca lent cantare sane 28 Ot alae ean 28 Closing off a sterilizer cycle record DOOK 29 Recording expired or compromised sterile 30 V2 1 October 2013 Page 3 of 31 V2 1 October 2013 Page 4 of 31 1 Aim To identify and record ev
32. s on both labels and the printout The control batch label class 1 chemical indicator has changed colour from to grey black minimum sterilization time temperature and pressure has been reached refer to the Performance Qualification information in the front cover or technicians report this may be confirmed on the printout f cleaning brushes are noted as being a cycle these items must be sterilized separately from instruments and not be placed in the sterilizer chamber with instruments e Total number of items loaded and unloaded including failed items is the same e Signature and name of person loading and unloading releasing is present Print name or if the person doesn t wish to be named place a tick or initials to show a double check has been done V2 1 October 2013 Page 24 of 31 Documenting results of a sterilization cycle 5 SS CYCLE NUMBER BATCH LABEL Pre Sterilization AFFIX PRE STERILIZATION LABEL HERE CONTROL POUCH BATCH LABEL Post Sterilization POST STERILIZATIO CLASS 5 6 INDICATOR AFTER STERILIZATION CHECKED BY 28 QUALITY ASSURANCE CHECK REVIEWED BY PRINT NAME PRINT NAME sicnarure CONTROL POUCH 19 QUEENSLAND HEALTH STERILIZER CYCLE RECORD FOLIO DISTRICT FACILITY STERILIZER No SERIAL No AA weu wo C VACUU
33. se records prove that your policy and procedures are correct Treat them with the respect and care they deserve V2 1 October 2013 Page 29 of 31 17 Recording expired or compromised sterile items This is an optional activity Some facilities have found it a useful quality improvement activity to monitor the number of items being returned for reprocessing within a three month period and to account for all batch labels including those that have been compromised prior to use The following tables have been developed and provided by the Bundaberg Oral Health Dental Service RECORD OF EXPIRED ITEMS DATE STICKER STICKER STICKER STICKER DESCRIPTION OF INSTRUMENTS DATE STICKER STICKER STICKER STICKER DESCRIPTION OF INSTRUMENTS DATE STICKER STICKER STICKER STICKER DESCRIPTION OF INSTRUMENTS DATE STICKER STICKER STICKER STICKER DESCRIPTION OF INSTRUMENTS DATE STICKER STICKER STICKER STICKER DESCRIPTION OF INSTRUMENTS DATE STICKER STICKER STICKER STICKER DESCRIPTION OF INSTRUMENTS DATE STICKER STICKER STICKER STICKER DESCRIPTION OF INSTRUMENTS V2 1 October 2013 Page 30 of 31 RECORD OF COMPROMISED ITEMS BATCH LABEL V2 1 October 2013 Page 31 of 31
34. um leak rate test will be required Depending on whether or not the sterilizer has an air detector fitted will depend on the frequency of the vacuum leak rate test Step 1 When more than one sterilizer is present in the facility insert the allocated sterilizer number for which this book should be used This will assist staff to identify and use the correct sterilizing cycle record book Step 2 Circle the letter that represents the day M Monday T Tuesday W Wednesday T Thursday F Friday S Saturday S Sunday Step 3 Entering the wrong date is a common error Tip If unsure check your mobile phone or computer calendar for the correct date Step 4 Place a tick in the box that indicates a Vacuum Leak Rate test _ QUEENSLAND HEALTH STERILIZER CYCLE RECORD 1 DISTRICT FACILITY STERILIZER No SERIAL No AA WARM UP CYCLE VACUUM BOME DICK 60 I oe PROCESS BIOLOGICAL SERVICEOR Where Applicable LEAK RATE CHALLENGE INDICATOR PERFORMANCE DEVICE QUALIFICATION ALL ITEMS THAT ARE TO BE STERILIZI STERILIZED Note THE WORD KIT IS INTERCHANGEABLE WITH CASSETTE TRAY Step 5 Determine what the next cycle number should be based on the type of cycle selected and enter this number Generally the number is determined by noting the previous sterilization printout record number and add one number Note Some sterilizer manufacture
35. who are able to explain the process A process is accounted for by the acceptance of responsibility by a person or persons Documentation is designed around requirements of QH and AS NZS 4187 2003 Cleaning disinfecting and sterilizing reusable medical and surgical instruments and equipment and maintenance of associated environments in health care facilities AND AS NZS 4815 2006 Office based health care facilities Reprocessing of reusable medical and surgical instruments and equipment and maintenance of the associated environment The majority of sterilization carried out in office based practice is carried out in benchtop small steam sterilizers V2 1 October 2013 Page 5 of 31 3 What is accomplished using the system e Each sterilizer has an individual record e Shows total control of the sterilization activities Consecutively numbered pages of the book mean that information cannot be added deleted providing record integrity Meets AS NZS 4187 2003 and AS NZS 4815 2006 documentation requirements for sterilization e Shows what you are sterilizing Proof you are not overloading or sterilizing incorrect items e Proof of who loaded the sterilizer e Proof of the success or failure of the cycle and details of individual items which have failed the process e Each page in the log is double sided allowing for cycle information to be recorded on the front and item failures on the back e Proof that a
36. y S Saturday S Sunday Step 3 Enter the date Entering the wrong date is a common error Tip unsure check your mobile phone or computer calendar for the correct date Step 4 Step 5 Step 6 process challenged device box Step 7 biological indicator box Step 8 Place a tick in the box that indicates an instrument cycle Enter the cycle type or code e g B S B standard If incorporating a process challenge device in the instrument cycle tick the If incorporating a biological indicator in the instrument cycle tick the Determine what the next sterilization cycle number should be and enter this number Generally the number is determined by noting the previous printout record number and add one number This number should be the next sterilization cycle number to be recorded on the printout record Step 9 Place an unprocessed batch label showing the allocated sterilizer ID allocated sterilization batch cycle number and date of sterilization in to the sterilizer cycle record book QUEENSLAND HEALTH STERILIZER CYCLE RECORD DISTRICT FACILITY STERILIZER No W T F TICKAPPROPRIATE OF CYCLE 4 circle day VACUUM BOME DICK 80 INSTRUMENT CYCLE Where Applicable TEST N DATE gt S CYCLE NUMBER FOLIO SERIAL AA LEAK RATE TEST BURS PACK STAND 6 BIOLOGICAL SERVICE OA QUALIF
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