BTEC Level 3 Certificate in the Decontamination of Reusable Medical Devices: Unit Five

LINKS TO A PRINTABLE TEXT DOCUMENT, IMAGES OF THE ORIGINAL WORK, AND PROOF OF CERTIFICATION:

Original text document can be opened in a print-friendly format here
An image of the Assessment Plan pertaining to Unit Five can be seen here
Images of the Assessment Checklist pertaining to Unit Five can be seen here: page one; page two; page three.
Images of the Assessment Report pertaining to Unit Five: page one; page two.
Images of the Witness Statement pertaining to Unit Five: page one; page two.
Images of the original work submitted for BTEC Unit Five: page one; page two; page three; page four; page five; page six; page seven; page eight; page nine; page ten; page eleven; page twelve.
Images of Evidence 5A submitted as part of BTEC Unit Five: page one; page two.
Image certifying Chris Larham’s attainment of the BTEC Level 3 Certificate in the Decontamination of Reusable Medical Devices can be seen here
Image certifying Chris Larham’s competence in all six modules of the BTEC Level 3 Certificate in the Decontamination of Reusable Medical Devices can be seen here

LEVEL 3 CERTIFICATE IN DECONTAMINATION OF REUSABLE MEDICAL DEVICES: UNIT FIVE

UNIT FIVE CONTENTS:

Transportation via the conveyor belt.
Demonstrate how to store sterilised devices in accordance with organisational policies.
Summarise the checks that are carried out on the sterilizing equipment in line with relevant legislation and guidance requirements.
Clarify what personal protective clothing is worn in the area and why this is important.
Demonstrate the sterilizer load configuration is in accordance with working instruction.
Examine printout to ensure the parameters of the cycle have been met. Explain the circumstances which may result in a sterilised pack being rejected.
Explain what records and logs are used in this area. Explain why it is important to use these records and logs.
Clarify the daily process of sterilizer tests and the importance of this taking place.
Explain how to ensure that tracking and traceability is achieved.
Demonstrate the organisational procedure for removing items from the sterilizer.
Demonstrate the checks that are needed prior to product release.
Explain in what situations a decontamination certificate is required.
Handling & Storage – Stock Rotation
Handling & Storage – Batch Release
Processing Equipment – Gas Plasma

Transportation via the conveyor belt.

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When items have been inspected, assembled, and wrapped in the IAP Area they are placed on the conveyor belt to be transported into the Autoclave Area. The conveyor belt should only be activated when the Autoclave Attendant is present – otherwise, sets will congregate at the end of the conveyor belt’s ‘runners’, increasing the likelihood of damaged wraps (per ‘SOP-11’). The member of staff in the IAP Area should also check that there is enough room for the items to pass beyond the second set of flaps prior to activating the conveyor belt. ‘SOP-11’ states that items requiring sterilisation should not be taken past the yellow tape on the floor on the Sterile Store side of Autoclave Number 4 under any circumstances, since this tape serves as the pre-sterilisation boundary demarcation line.

Demonstrate the sterilizer load configuration is in accordance with working instruction.

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The Autoclave Attendant will remove items from the conveyor as soon as possible, minimising the risk of wrap degradation, and proceed to load the items onto an Autoclave Trolley. ‘D-3’ outlines the process for loading items onto a Trolley: the Trolleys are labelled A(1)/B(2)/C(3)/D(4)/E(5)/F(6)/G(7), and the correct Trolley is selected on the HESSDA traceability system by clicking the relevant Trolley and scanning your name badge; all the barcoded items are then scanned into HESSDA and placed on the Trolley; and the ‘CLOSE’ button is clicked once the Trolley is full.

Further relevant information is included in this SSD policy document: any labels or marks on the Trolleys should be removed as soon as possible using Sani-Cloth 70s; any Trolley faults should be reported to a Supervisor, who will in turn report the fault to an Engineer; ‘procedures’ should be kept separate from Theatre items, using baskets to separate them – this makes it easier to sort these items in the Despatch Area, and reduces the risk of items being despatched to the wrong location; a check should be made that all sets have a strip of Autoclave Indicator Tape attached to them – this provides a post-Autoclave visual confirmation that a set has been sterilised; to avoid condensate dripping onto the sets it is advisable to keep sets clear of the ends of the trolley on the lower shelves; spare items for different Theatres should not be mixed up on the Trolley – these items should be spread across the shelves but not stacked on top of each other; and in the event that an “URGENT” set is sent down the conveyor, it is necessary to ask the Supervisor whether a partial load should be placed in an Autoclave.

‘D-7’ advises members of staff to load Viewpacked items onto the bottom shelf of the Trolley when possible, and states that all forms that arrive with ‘procedures’ via the conveyor belt should be kept with the Trolley until it is loaded into an Autoclave – the forms are then kept on the relevant Autoclave folder until the cycle is complete, whereupon they will be ‘married up’ with the relevant ‘procedures’ and taken to the Procedure Despatch Area after an appropriate cooling time. “Disinfect Only” items skip the Autoclave process, are passed into the Autoclave Area via the Transfer Hatch rather than the conveyor belt, and are taken to the Despatch Area straightaway (‘D-9’).

Once a Trolley is laden with items, the next available Autoclave in sequence (coloured blue on the screen) should be chosen, and the appropriate file printout checked to ensure that the previous cycle finished within the last four hours – if the last cycle finished over four hours ago it is necessary to perform a Pre-Heat Cycle (Program 11) before use. Assuming that the last cycle finished less than four hours ago, the cycle number on the last printout should be checked to ensure that it is one number behind the cycle number on the Autoclave control panel (obtained by pressing the left arrow key [<-] on the control panel and reading the batch counter number) and the HESSDA Autoclave number – any discrepancy should be reported to a Supervisor. The correct program for sterilising Trolley loads is P03.

‘SOP-15’ states that a check must be made at the beginning and end of each cycle to ensure that the chamber pressure is at zero, while ‘SOP-13’ stresses that important daily checks in the Autoclave Area include: ensuring the ‘Steam Pressure’ gauges read 2-2.3bar g; removing any debris- including labels- from the Autoclaves (wearing heat-resistant gloves); and damp-dusting fascia panels and gauges with a clean cloth and detergent solution or appropriate agent.

Document ‘D-5’ details the procedure for loading Trolleys into an Autoclave: click on the appropriate Autoclave in the HESSDA traceability software, scan your name, click ‘Add From Trolley’, and select the appropriate Trolley from the drop-down box; open the Autoclave door by pressing the button with the U-shaped open-door ‘[_]’ symbol, ensuring that the door opens fully and correctly, flush with the Autoclave side wall; use the Trolley handle to transport the Trolley to the open Autoclave, aligning the Trolley with the two triangular locking devices in the Autoclave; using only the Trolley handle, push the Trolley forward so that it locks into the locking devices, moving the locking handle as required to lock it into place; apply the Trolley brakes, push down the release lever, and gently push the Carriage into the Autoclave – if force is required to move the Carriage then the Trolley is not correctly positioned in relation to the Autoclave ‘runners’, and the Trolley should be re-positioned ‘flush’ to the Autoclave ‘runners’; in order to ensure airflow around the Carriage (thus decreasing the chance of wrap condensation), the front of the Carriage should be aligned with the front of the Autoclave ‘runners’; the Trolley brakes are released, and the Trolley itself is released from the triangular locking devices by manipulating its locking lever; the Trolley is left in front of the Autoclave door, which is then closed by pressing the control panel button with the square symbol on it; return to the computer and click ‘OK’, then click on ‘Finish Loading’; press ‘Start’ on the Autoclave, thus ensuring that the cycle will begin successfully, before returning to the computer and clicking ‘YES’ to confirm the Autoclave loading process on the HESSDA traceability software – in the event that “URGENT” items have been loaded into the Autoclave, a sign indicating this fact should be hung up on the Autoclave display panel (“URGENT ITEMS IN THIS AUTOCLAVE”).

It is possible to estimate the finish time of a given Autoclave with a fair degree of accuracy, following the guidelines in ‘D-10’. By clicking on the ‘Active Autoclave’ function of the HESSDA traceability system it is possible to obtain the start time of the Autoclave cycle – it is simply a case of adding 26 minutes (Pre-Heat Cycle P11)/30 minutes (Bowie Dick Cycle P07)/50 minutes (P02 Porous Load Cycle)/60 minutes (P03 Porous Load with Extra Drying Cycle)/1 hour 25 minutes (P04 only on Autoclave 4 has an extra 25 minutes drying time) to the start time specified on HESSDA to arrive at an accurate finish time estimate. The items will then need to be cooled for a minimum of thirty minutes prior to despatch, so an item loaded into an Autoclave set on P03 at 10am will be ready for unloading at 11am (10am + 1 hour cycle), and able to be despatched at 11:30am (post-cooling and stamping).

Demonstrate the organisational procedure for removing items from the sterilizer.

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Approximately an hour after loading an Autoclave, the process outlined in ‘D-6’ should be followed in order to unload the Autoclave. The Autoclave control panel will display “Cycle Complete”, and a printout will be generated specifying whether a cycle has passed/failed. Once the Autoclave is opened and the Trolley secured, the Carriage can be removed…

Clarify what personal protective clothing is worn in the area and why this is important.

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…It is vital to wear heat-resistant gloves when removing the Carriage from the Autoclave, since a heat-conducting metal Autoclave Carriage that has undergone a sixty-minute sterilisation cycle (reaching a temperature in excess of 134 degrees Celsius and maintaining that temperature for at least three minutes) constitutes a serious burn risk

Demonstrate the checks that are needed prior to product release.

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…When the Trolley is clear of the Autoclave, a visual check of the load should be performed, checking for wet sets, ensuring that the Indicator Tape stripes and Viewpack panels have changed colour, checking all seals are intact, and making sure that there is no apparent damage to the packaging (‘SOP-15’); any loose items in the Autoclave should be retrieved using the grasper provided prior to shutting the door.

Click on the appropriate Autoclave in the HESSDA Autoclave module, scan your name badge, and- assuming that the load has been sterilised correctly- click on “Unload Autoclave” and confirm the action. The printout should be signed and stamped using the relevant stamp gun (a check should be performed to ensure that the Autoclave Number, Autoclave Cycle, Sterilisation Date, and Expiry Date details are correct), before being hole-punched and placed in the correct folder on the worktop. The stamp gun should then be placed on top of the Trolley, and the Trolley wheeled past the yellow demarcation tape into the Cooling Area at the Sterile Store end of the Autoclaves; only Trolleys that have passed the sterilisation cycle should be pushed past the yellow tape on the floor.

The Trolley should be left to cool for ten minutes prior to stamping up all items thereon – this is to avoid touching any of the wraps before they have sealed completely. Every item should be securely stamped in the designated stamping area; in the case of items with two labels (for example, a Bipolar Lead and a Bipolar Forceps that have been Viewpacked together), both labels should be stamped. Items are left to cool in the Cooling Area for a minimum of thirty minutes, and items that have not cooled completely after this time will be left for longer before being processed in the Despatch Area. Theatre despatch duties are performed by the Autoclave Attendant or the member of staff working in the Procedure Despatch Area. Any ‘procedures’ should be taken to the Procedure Despatch Area for processing by the member of staff working in that area.

Explain in what situations a decontamination certificate is required.

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There are two situations in which a Decontamination Certificate is required: when a set (almost always an On Loan item) is to be returned and not used; and when items are being sent away for repair. In both instances, the Decontamination Certificate should be placed next to the folder of the Autoclave that the on-loan/repair items have been scanned into, and upon successful cycle completion it should be stamped to show that the equipment has been sterilised.

Instruments for repair are scanned into the Autoclave on the HESSDA traceability software using the “Instrument for Repair” barcode situated on the wall next to the computer. On Loan sets are treated in the same way as other Theatre sets, with a check being made to ensure that the set name has been written on the generic On Loan label – if no name is present, the set must be returned to the IAP Area. In the case of On Loan items, both the equipment and the Decontamination Certificate should be returned to the Theatre or kept for collection in the Despatch Area (‘D-4’); items that need to be sent away for repair are taken to the Raw Materials Store along with the Decontamination Certificate – Jane Ham is in charge of Telescopes and other Laparoscopic equipment, whilst Julie Tregunna-Kessell deals with all other instruments (thus, it is necessary to leave a note [“FAO Jane Ham”/”FAO Julie”] with these items in the Raw Materials Store) (‘D-13’).

Clarify the daily process of sterilizer tests and the importance of this taking place.

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Each Autoclave must pass a Bowie Dick steam penetration test every morning prior to operation. As stated in ‘SOP-13’, all Autoclave records must be filed tidily and kept for a minimum period of twenty-one years. At the beginning of each week, the previous week’s printouts should be filed away in the appropriate filing cabinet by a Supervisor or other authorised person, and each Autoclave should be shut down and restarted once a week in order to ensure that the internal memory does not become overloaded (‘D-1’).

If more than four hours have elapsed since the previous Autoclave cycle finished, a Pre-Heat P11 cycle must be run prior to performing the Bowie Dick test – only Supervisors and senior authorised individuals are permitted to perform a Pre-Heat cycle. The SSD policy document ‘D-12’ provides details on performing a Pre-Heat cycle: once the cycle numbers on the printout, the Autoclave display panel, and the HESSDA traceability system have been checked for accuracy, the cycle on the Autoclave panel is changed to P11 Pre-Heat and the ‘Extra Process’ HESSDA icon is clicked. The Supervisor’s name is scanned, the appropriate Autoclave will be selected from the drop-down box, and the ‘OK’ button clicked to confirm the action. ‘Pre Heat’ will be chosen from the available options after clicking on the ‘Extra Process’ drop-down box, then ‘Save’ will be clicked, and the action confirmed. The ‘Start’ button on the relevant Autoclave is then pressed, and approximately twenty-six minutes later a printout will be obtained after the cycle ends.

Assuming that the cycle passes, the Supervisor will sign the printout and affix a batch label, prior to completing the ‘Extra Process’ on HESSDA: the Supervisor clicks on ‘Extra Process’ -> scans name badge -> selects the relevant Autoclave from the drop-down box -> clicks on the ‘Pass/Fail’ drop-down box and chooses appropriately -> clicks ‘Save’ -> confirms the action -> opens the Autoclave door and then closes it, allowing changes to be made to the Autoclave display panel -> changes the cycle on the Autoclave panel to P03 X D.

After ensuring that the Autoclave has been used within the last four hours, a Bowie Dick test can take place, following the procedure outlined in ‘D-1’. A Bowie Dick test pack is removed from the storage cupboard and placed on one of the small racks provided. Wearing heat-resistant gloves, the Supervisor will then place the rack in the centre of the Autoclave, thus ensuring that the test pack is situated 100-200mm above the Autoclave grill (‘SOP-14’), change the Autoclave cycle to P07 Bowie Dick test, and ensure that the cycle number matches the HESSDA number (one higher than that displayed on the last printout).

The process for logging a Bowie Dick test on the HESSDA traceability system can be summarised as followed: click the ‘Extra Process’ icon -> select the appropriate Autoclave from the drop-down box -> scan name badge -> select ‘Bowie Dick Test’ from the drop-down box, entering the batch number from the Bowie Dick pack into the log/batch number box -> click ‘Save’ and confirm the action. The Supervisor will then start the Autoclave, and approximately thirty minutes later the cycle will complete – the Autoclave is then opened and the Bowie Dick test pack removed. The test pack is opened and checked that the test has changed correctly, in line with the manufacturer’s instructions; assuming that the test has passed successfully, the appropriate details will be filled in on the test and both the test and the printout will be stamped with the apposite stamp gun – these are then filed in the pertinent folder.

To finish the Bowie Dick process on HESSDA the Supervisor will: click ‘Extra Process’ -> select the Autoclave from the drop-down box -> scan their name badge -> select pass or fail, then confirm the action.

The display panel of the Autoclave is then manipulated to the effect that P03 Porous Load X D is the chosen program for use in future cycles throughout the day. Prior to using an Autoclave the designated Autoclave Attendant will perform a series of cycle checks, listed in ‘D-2’: ensure that all Autoclaves in service have had a Bowie Dick test within the last twenty-four hours and that the test and the computer printout have been signed off by a Supervisor or authorised person; check that all the Autoclaves are set on the right program; and make certain that the cycle numbers on the Autoclaves and the HESSDA computer correspond.

Examine printout to ensure the parameters of the cycle have been met. Explain the circumstances which may result in a sterilised pack being rejected.

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Occasionally, an error will be detected by an Autoclave during a cycle – for example, the parameters for successful sterilisation (in the Treliske Hospital SSD this means between 3-3.5 minutes at a temperature of 134-137 degrees Celsius, although sterilisation can also be achieved if a heat between 121-124 degrees Celsius has been maintained for 12.3-12.5 minutes, ‘SOP-14’) not being reached, the water cooling temperature being too low, or an inadequate drying time post-sterilisation. It is vital to check the steam graph printout associated with the failed cycle in order to determine the error (if a printout has not been issued it is necessary to inform a Supervisor, who will try to retrieve it from the computer before failing the load): in the latter example, a Supervisor or other authorised person might inspect the load and decide that, since sterilisation has been achieved and the sets are not wet, the load will be fit for despatch following an extended period in the Cooling Area; if a load fails owing to incorrect cooling temperature prior to sterilisation- failing after about fifteen minutes of the cycle, prior to the Autoclave Indicator Tape changing colour- a Supervisor might decide that this load can be failed back to the Autoclave Area, ready to be processed in the next available Autoclave; in the case where sterilisation has begun but has not satisfied the aforementioned sterilisation criteria, the process for failed loads outlined in ‘D-8’ should be followed.

‘HESSDA-12’ describes the process that a Supervisor will follow in order to obtain a non-conformance report from the HESSDA traceability system in the event that a printout has not issued following an Autoclave failure: click on ‘Switch User’ -> type the word ‘SUPERVISOR’ into the username text field -> type in the relevant password -> click on the ‘Reporting’ module -> scan name badge -> click on the ‘Module Area Reports’ tab -> select the Autoclave module and click on ‘Item History’ -> specify the appropriate details in the ‘From date’ and ‘To date’ fields -> click on ‘Select Autoclaves’ -> place a tick next to the required Autoclave number and type in the relevant cycle number next to the ‘Select Autoclaves’ button -> click ‘Apply Filter’ -> click the printer icon on the report thus generated, ensuring the correct printer is shown -> click ‘Print’ -> click ‘Close’ when you are finished with the Reporting Module, then ‘Switch User’, and enter the Username and Password details on the white label affixed to the monitor in order to return to the Autoclave Module of the HESSDA traceability system.

‘D-8’ offers the following information for dealing with failed loads: an Autoclave will halt the program if an error is encountered, and the key on the control panel will have to be activated at the end of the cycle; the computer printout will state “Cycle Failed” and give a reason for the failure – this printout should be stamped with the “FAILED LOAD” stamp found in the drawer opposite the Autoclaves; the Autoclave should be unloaded following the normal procedure, Autoclave Indicator Tape should be placed in a cross over the top of the Trolley, and the Trolley left in front of the Autoclave to cool; a “Do Not Use” sign should be obtained from the labelled Engineers’ Drawer and hung on the appropriate Autoclave; the HESSDA traceability system should be updated with details of the failure – select the Autoclave -> scan name -> click “Fail All” -> specify the return location as “IAP Area (before packing)” -> enter the reason for the cycle failure -> click “Next”, “Yes”, and confirm the action.

As much detail as possible should be filled in on ‘FORM-25’, before passing this Form to a Supervisor who will report the fault to the Estates Department and get a job number to go on the Form -> ‘FORM-25’ must be kept with the printouts for the relevant Autoclave, and the Autoclave is not to be used again until the Form has been signed to say that it is fit for purpose. ‘FORM-26’ must be stamped, filled in, and kept with the unsterile load; the load and ‘FORM-26’ must be passed back to the IAP Area once the load has cooled sufficiently.

Once the load has been re-packed, it will be sent down the conveyor belt to the Autoclave Area along with the Form (bearing the name of the person who re-packed it); when the load has been autoclaved, the Form will be stamped with the new Batch number (in the unlikely event that the load has to be split between two Autoclaves, both stamps should be used on the Form). ‘FORM-26’ must be passed to the Production Controller once it is complete; if an Autoclave fails its daily Bowie Dick test only ‘FORM-25’ will be filled out – this Autoclave remains out of action until it is checked by an Engineer and passes a subsequent Bowie Dick test.

Individual items can be non-conformed back to the ‘IAP Area (Before Packing)’ if condense has compromised the wrap, the wrap has blown open, or the wrap has been damaged during the Autoclave loading process. ‘D-11’ explains how to perform the non-conformance process: click on ‘Non-Conformance’ -> scan your name -> scan the barcode of the set/instrument -> select the reason for the non-conformance from the drop-down box -> click ‘OK’ -> specify the return location as “IAP Area (Before Packing)” from the drop-down box -> click ‘Save’ and confirm the action. All Non-Conformance records are retained and considered during the periodic Audit meetings (‘SOP-29’).

Explain what records and logs are used in this area. Explain why it is important to use these records and logs.

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All Steam Generator failures must be recorded in the Steam Generator Logbook on ‘FORM-24’. Technicians are permitted to sort out the “Malfunction of Feeder” issue by following the procedure detailed in ‘DN-41’: open the Steam Generator door; silence the alarm; turn off the Steam Generator for ten seconds, then turn it back on; and, in the case of a persistent Feeder fault, report the issue to a Supervisor, who will in turn report the matter to the Estates Team and obtain a Job Number, recording the Estates Call Reference on ‘FORM-24’.

For all other faults, the white button is pushed to silence the alarm, ‘FORM-24’ is filled out, and the issue is reported to a Supervisor, who will in turn notify the Estates Helpdesk and record the Estates Call Reference on ‘FORM-24’.

The SSD policy document ‘QP-7’ explains how to raise a machine/asset fault non-conformance: firstly, report the fault on the Estates system -> copy the Job Number thus obtained -> log into Q-Pulse -> click on the ‘Create a Non-Conformance’ icon, selecting the ‘Machine/Asset Fault Non-Conformance’ template -> choose the faulty Asset using the drop-down arrow -> click on ‘Add Item’ -> enter the details of the faulty machine/asset, including the Job Number that was given when reported on ‘CHESS’ (the Estates system) -> the ‘Source’ and ‘Status’ fields are to remain as displayed, while the ‘Raised by Person’ field should be filled in appropriately -> click ‘OK’, leaving the ‘Owner’ field set as Darren May -> and finally, click on ‘Finish’. A MAF-reference number will be generated, and Darren May/Jane Ham/Angela Baigent should be informed so that they can print out a copy of the fault and hand it to an Engineer. Upon fault resolution, the Engineer will give details of the corrective and preventative action taken; this information is then added to the Q-Pulse MAF-log so that the Non-Conformance can be closed out correctly. When urgent Autoclave repairs are required during ‘unsociable hours’, the duty Engineer is to be reported via the Hospital Switchboard (‘SOP-31’).

Explain how to ensure that tracking and traceability is achieved.

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‘SOP-26’ provides information relating to traceability and product recall: the manufacturer’s Lot/Batch codes of all raw materials are recorded onto ‘FORM-14’ upon issue to the IAP Area; items are scanned into the HESSDA traceability software at each stage of the decontamination cycle, ensuring they can be located as required; in the unlikely event that the HESSDA system ceases to work, the load details of all production cycles are recorded on ‘FORM-23’; and Lot Labels indicating the Autoclave number (1-4), Autoclave cycle number, and date of processing are affixed to the outside of all sterilised products.

If a recall is instituted in relation to a particular cycle (for example, a load has been released when the Autoclave was not set on the correct cycle), the staff working in the Despatch Area will be instructed to collect all products with the identified cycle number. The Users’ locations will then be targeted using the HESSDA system to identify the items’ locations.

When a supplier of raw materials informs the SSD Management of a problem with a certain item, all products containing that raw material will be recalled; all such recalled items will be clearly labelled and quarantined awaiting advice from the Service Leads. Where a Customer agrees that it is more convenient to discard the faulty component rather than the entire pack, suitable replacements will be provided and the manufacturer’s justification for recall will be given to the Customer. The Theatre and Anaesthetics Divisional Manager will be immediately advised of any need to institute this procedure.

Demonstrate how to store sterilised devices in accordance with organisational policies.

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Items that have been correctly sterilised and left to cool for at least thirty minutes are then despatched to the appropriate Theatre/Ward/Outside Customer. ‘E-1’ outlines the procedure for loading and issuing Theatre sets and spares. Each Theatre set is checked to ensure that the wrap is intact and condense has not pooled thereon; providing the set passes these checks, it is necessary to initial the set’s main label as confirmation that the set left the SSD in an appropriate condition. In the interest of efficient working, it is best to perform this check-and-initial process on all sets while they are still on the Autoclave Trolley, rather than doing each set individually as it is scanned into the HESSDA traceability system. The sets are then recorded on HESSDA by scanning the barcode of the appropriate Despatch Trolley -> scanning your name badge… -> … and proceeding to scan all sets and spares into the Trolley.

The first set scanned in becomes the default location for the entire Trolley; if the screen turns red during this scanning process, a fault has occurred – either the set’s location does not match the Trolley’s location (and a prompt screen will question whether the set should be despatched to this unusual location, or if the attempted despatch should be cancelled), or the set has not been scanned into an Autoclave (“No Record of Autoclaving”, in which case the set should be returned [along with an explanatory note] to the IAP Area via the Transfer Hatch for re-wrapping, then sent back down the conveyor into the Autoclave Area for sterilisation; this item’s track position on the HESSDA traceability system will already read ‘PACKED’, so there is no need to perform a Non-Conformance in the Despatch Area prior to passing it back to the IAP Area).

In order to issue a Despatch Trolley, the following process should be followed: click on “Default Transfer Point” -> scan your name -> click “Add from Trolley” -> scan the Trolley barcode -> and finally, click on ‘Issue Items’, a procedure that generates two printouts – both checklists should be taken over to Theatre by the Driver. A small pool of sets- with a default location of ‘SSD Sterile Store’– is kept in the Sterile Store on the racking designated for the storage of sterilised items; these items are despatched to Theatre as and when they are required.

Handling & Storage – Stock Rotation

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The member of staff working in the Sterile Store must ensure that a number of duties are fulfilled on a daily basis, detailed in ‘E-3’. It is necessary to: check that items for Probus have been despatched in time for morning collection by the courier drivers; make up Theatre orders before 10am, ensuring that all items that are issued are recorded on the HESSDA traceability system; put away all stock items that have been delivered from the Raw Materials Store, ensuring stock items are rotated (older stock items placed at the front to be used first) and kept off the floor (stock items on the floor constitute a Health and Safety hazard); inform the IAP Area Supervisor of any stock items- for example, Linen Packs and Dental Burrs– that need to be replenished; bag up and issue any ‘procedures’ that are waiting to be despatched in the Procedure Despatch Area; answer the telephone when it rings, taking stock orders from Theatres/Wards/Outside Customers; and, if the workload allows, the duty of loading and despatching Theatre Trolleys for the Drivers can be shared with the Autoclave Attendant.

‘SOP-16’ stresses the importance of keeping the doors to the Sterile Store closed unless equipment is being passed through, ensuring that the fire exits are not obstructed by transport containers and trolleys. Additionally, heavy items must not be stored above shoulder height; the steps provided are to be used when stock stored above shoulder height is required.

Handling & Storage – Batch Release

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Orders for stock items are generally received by telephone, but can also be received via fax or directly delivered by the Driver. Pink stock forms are used for Theatre requests and green stock forms are used for all other Wards/Outside Customers. The Despatch Operator will gather these items from the shelves in the Sterile Store and proceed to issue them, following the process detailed in ‘E-5’: the Theatre location, date of issue, and the Operator’s packing number must be written on a white sticky label in the case of Theatre/Ward issue, and location details, surgery name, name of town, shelf letter, date, and packing number should be written on a tie-tag for Outside Customer issue; order items are placed in a clear plastic bag, ticking off the order form as you go; to record the stock issue on HESSDA, it is necessary to click on “Select Transfer Point” -> scan your name badge -> select the appropriate location from the drop-down box and click “OK” -> enter the 7-digit stock number from the requisition form into the code box and press Enter on the keyboard -> confirm the issue by pressing ‘I’ on the keyboard -> highlight the item and click on the “Edit Quantity” icon, specifying the number of stock items to be issued -> repeat this process until all items on the requisition form have been logged -> click on “Issue Items” -> place the delivery note thus obtained in the clear plastic bag along with the items, and tie up the bag, affixing the white sticky label/brown tie-tag -> put the bag in the relevant place for the Theatre Driver/Couriers -> file the form in the appropriate section of the filing cabinet, ensuring it has been completed correctly (with your packing number, date of issue, and number of items issued).

The process for despatching ‘procedure’ sets and spares (‘E-7’) is almost identical to the issuing of stock items, except that the barcodes on the items to be despatched (including “Disinfected Only” items, ‘E-10’) are scanned into the selected transfer point (rather than entering the 7-digit stock numbers on the requisition form). Similar to the issuing of Theatre sets and spares, attention should be paid to the screen while scanning in ‘procedure’ items, and any problems encountered (incorrect location/“No Record of Autoclaving”) should be dealt with in the manner described above. Where stock items have been requested on a requisition form but are out of stock, this will be indicated on the order form using the abbreviation ‘O/S’, and a ‘FORM-72’ (incomplete order form) will be included with the bagged stock issue.

Extra Information – Receipting/Transferring Items

Occasionally, unused stock items with uncompromised packaging will be returned from Theatres/Wards/Outside Customers. These items are receipted in the Sterile Store, using the method outlined in ‘E-6’: click on “Credit Items Previously Issued Offsite” -> scan your name badge -> enter the 7-digit number of the item on the requisition form and press Enter on the keyboard -> highlight the item, click on “Edit Quantity” and enter the number of stock items to be received -> focus the text cursor in the ‘Original Invoice Reference’ box and enter the 5-digit number from the original delivery note -> click the “Credit and Return” icon, and place the printout thus obtained in the appropriate place to be returned to the customer.

A related function concerns the transfer of items between locations, necessary for instances where a set has been issued to its default location (for example, a ‘Dental Basic Set’ for Newlyn Unit) and has been loaned to another location (for example, Penzance Theatre) – the Local Driver will collect this set from Newlyn Unit and place it on the Penzance Theatre Trolley, ready for the West Driver to take with the next load. Updating its location on HESSDA is necessary in order to maintain the traceability of the item, and is achieved by following the procedure outlined in ‘E-9’: click on “Transfer Between Locations” -> scan your name badge -> select the set’s new location from the drop-down box -> click ‘OK’, and proceed to scan the barcodes of all sets/spares that must be transferred -> click on “Transfer Item” icon and click ‘OK’. The process for non-conformances encountered in the Despatch Area (‘E-8’) is identical to that described in paragraph twenty-eight of this Unit, in relation to Autoclave Area non-conformances.

Extra Information: Sub Store

A further job associated with the Sterile Store is that of ‘Sub Store’ duty, the name given to the Treliske Top-Up Service that ensures sufficient stocks of SSD products are available at the various Treliske Hospital Wards. Excepting Christmas Day, two members of the SSD staff are employed Monday-Saturday for Sub Store collection and distribution duties; the employees assigned this duty changes regularly.

‘SOP-18’ provides an overview of a typical working day for employees fulfilling the Sub Store role: firstly, the designated Sub Store operatives will visit Wards and Clinics, completing order forms for stock required and collecting any used instruments/linen -> laden with bagged, dirty items and green order forms, operatives are picked up from the Loading Bay on the main site, returning to the SSD in order to begin packing orders for Wards and Clinics in clear plastic bags -> following a break, they will finish packing Ward/Clinic orders and return to the main site with completed orders -> they will then deliver stock to all Wards and Clinics, also returning decontaminated items that had been collected from Tower Block on the previous day -> finally, operatives return to the SSD to have a lunch break, finishing off the working day in an area of the department decided by the Supervisor on duty.

Completed stock forms are stored for at least one month prior to disposal. The following locations (and days of the week that the Top-Up Service is provided) are served by the SSD: Acute Renal Unit, Ante Natal Clinic, Carnkie, CIU, Fracture Clinic, Geevor, Grenville, Lowen, Neonatal, Phoenix, Polgooth, Polkerris, Roskear, Sennen, Short Stay Unit, South Crofty, Surgical Recovery Unit, Wellington, Wheal Fortune, Wheal Jane, and Wheal Rose (Monday, Wednesday, Friday); Accident and Emergency; Admissions, Aural Care, Cardiac Cath. Lab., CCU, Diabetic Foot Clinic, Early Pregnancy Unit, Gerrans, Godolphin, Histopathology, ITU, Kernow, MAU 1, MAU 2, Medical Day Care/CDU, Mount Stephens, OPD, Oncology, Poldark, Tincroft, Tolgus, Wheal Agar, Wheal Coates, and X-Ray (daily); Cardiac Dept., Clinical Oncology, Colposcopy, Cystoscopy, DVT Clinic, Endoscopy, Pain Clinic, Pharmacy, Plaster Room, Renal DCU, Respiratory Physiology, Rheumatology DCU, Therapy Department and Thoracic Department (as required); ENT-OPD, Fistral, Orthopaedic Assessment Unit and Paediatric Day Case (Monday); Gwithian (Tuesday); and Harlyn and Urology (Thursday).

Extra Information – Radio Use

It is possible to contact a variety of staff members via radio using the Radio Base Station situated in the Despatch Area. The following numbers are used to facilitate radio communication: 701Bulk Store handheld radio; 702Supervisor handheld radio; 703West Driver handheld radio; 704Local Driver handheld radio; 705West Driver van radio (WK09 XCZ); 706Local Driver van radio (WK09 XEH); and 707Supervisor Base Station.

The process for radio communication is detailed in ‘E-11’: dial the relevant number and press the Push to Talk (PTT) button to call the desired member of staff; push the PTT button and speak in to the radio when you wish to begin communication; use the word “OVER” when you have finished talking, releasing the PTT button to allow the other person to acknowledge and respond to the communication; and use the words “OVER AND OUT” to end the communication, making sure to press the ‘C’ button on the handheld part of the radio in order to end the call.

Summarise the checks that are carried out on the sterilizing equipment in line with relevant legislation and guidance requirements.

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As stated in ‘SOP-15’, the SSD is equipped with Porous Load Sterilisers that are validated and maintained in accordance with the requirements of the Department of Health’s Choice Framework for local Policy and Procedures 01-01 Management and decontamination of surgical instruments (medical devices) used in acute care Part C: Steam sterilization. The SSD policy document dedicated to the maintenance of plant and equipment, ‘SOP-25’, contains useful information relating to the Autoclave Area: all critical equipment in SSD is maintained according to a programme of Planned Preventive Maintenance (PPM); all tests, breakdowns, and maintenance must be correctly documented and signed off in the appropriate SSD Logbooks, with the Estates Directorate having free access to these records; significant Autoclave malfunctions that lead either to persistent, unsatisfactory sterilisation performance or endanger the safety of those working in the Autoclave Area must be brought to the attention of the SSD Manager immediately; weekly tests [relating to the Air Removal Stage, Sterilising Stage, Drying Stage, Venting Stage, plus a ‘Leak Rate Test’ and an ‘Air-Detector Function Test’] are performed on the Autoclaves by the Engineers and recorded on ‘FORM-43’ (see Evidence 5A); Quarterly and Annual testing is undertaken on the Autoclaves by external contractors, who must produce copies of relevant Competence and Calibration Certificates; statutory two-yearly Pressure Vessel tests are performed; and when it is not operationally feasible to release an Autoclave for routine maintenance, an explanatory note will be made in the Logbook to this effect, together with the agreed alternative date – any given Autoclave cannot be used when the interval since the last maintenance exceeds two weeks.

‘SOP-24’ stresses the manner in which all devices used to test Autoclave performance- as well as other important equipment in the SSD– must be checked themselves for correct functioning: Thermograph Recorders must undergo an on-site calibration check against a certified Temperature Reference Unit prior to carrying out any thermocouple testing on the Autoclaves; test devices are serviced, tested and certified annually by the manufacturer, with all equipment marked to ensure verification within Calibration Certificates; Pressure Recorders are calibrated on at least a quarterly basis against certified test equipment; the SSD will hold copies of Calibration certificates, with Master Copies kept in the Estates Office’s file; if any item of inspection, measuring, or test equipment is found to be out of calibration during the three-monthly check, previous inspection and test results must be reviewed; and whenever an Autoclave’s installed gauges or recording devices are being repaired or replaced, a record of the calibration status must be appended in the Autoclave Logbook.

The quality of steam used to feed the Autoclaves is compliant with the guidelines outlined in CFPP 01-01 Part C, which states that typical feedwater for a steam generator should follow this process: Mains water -> Base exchange softener -> Reverse osmosis purifier -> Hot well -> Steam generator -> Steriliser. Interesting information is given in the CFPP 01-01 Part C about the five-stage operating cycle of a Porous Load steriliser: the first stage is termed Air Removal, whereby sufficient air is removed from the chamber and the load so that sterilisation conditions can be attained -> the second stage is concerned with Steam Admission, during which steam is admitted to the chamber until the specified sterilisation temperature is attained throughout the chamber and the load -> stage three is concerned with the Holding Time, whereby the temperature throughout the chamber and load is maintained within the sterilisation temperature band for the appropriate length of time -> the penultimate stage is that of Drying, during which steam is removed from the chamber and the chamber pressure is reduced to allow the evaporation of condensate from the load either by prolonged evacuation (the SSD Autoclave panel reads “Drying Evac” at this point) or by the injection and extraction of hot air or other gases -> and the final stage is termed Air Admission, whereby air is admitted to the chamber until the chamber pressure approaches atmospheric pressure. The CFPP 01-01 Part C’s advice that two separate records are maintained for each Autoclave- a plant history file, plus a steriliser process log– is followed in the SSD, as shown with reference to various SSD policy documents throughout this Unit.

Processing Equipment – Gas Plasma

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An alternative to steam sterilisation is that of gas plasma sterilisation, whereby hydrogen peroxide vapour and low-temperature gas plasma is used to sterilise devices efficiently and with no toxic residues. A deep vacuum is created in the chamber, with approximately sixty per cent aqueous hydrogen peroxide being vaporised into the chamber – devices are then enveloped in this hydrogen peroxide vapour. Once the gaseous hydrogen peroxide has diffused throughout the load, chamber pressure is reduced, allowing for the generation of low-temperature gas plasma. Radio Frequency (RF) energy is applied to the chamber via an RF amplifier, inducing the plasma state. Reactive species are generated from the hydrogen peroxide in this state, reacting with materials and each other. Once the high-energy species have reacted, they re-combine to form water vapour, oxygen, and other non-toxic by-products. Upon completion of sterilisation, items are ready for sterile storage or immediate use. (This overview of gas plasma sterilisation has been paraphrased from the information found at: http://www.infectioncontroltoday.com/articles/2000/06/sterilization-gas-plasma-steam-and-washer-deconta.aspx.)

Copyright 2016-present day sharedsapience.info. Permission to use quotations from this BTEC Unit is granted subject to appropriate credit being given to Chris Larham and sharedsapience.info as authorial and website sources, respectively.

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34-year-old father of three wonderful children [William, Seth, and Alyssa]. Works as an Assistant Technical Officer in the Sterile Services Department of Treliske Hospital, Cornwall. Enjoys jogging, web design, being a bit of a geek, and supporting Arsenal FC. Obtained a BA degree in English from the University of Bolton in 2008, and has continued to gain qualifications in a diverse range of subjects thereafter.

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