Explain what environmental checks are routinely carried out in the clean room and the relevant legislation.

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Prior to entering the IAP Area, staff members pass through the IAP viewing area. This area is maintained at a positive pressure differential above 10 Pascal, forming one of the checks of environmental cleanliness associated with the IAP Area (per ‘SOP-10’) that ensure compliance with Class 9 standards as defined in BS EN ISO 14644. Shift Supervisors check the magna-helix to ensure that the pressure is maintained above 10 Pascal, and the readings are recorded every 8 hours.

Other controls that are in place include: the control and monitoring of the particulate air content; replacing contaminated air with clean filtered air; disinfecting all material before entry to the IAP Area; removing outer wraps and cardboard from items prior to IAP Area entry; periodic room surface cleaning; and the use of specific clothing.

Independent monitoring of the environment is conducted by the Pharmacy Department on a six-monthly basis, with reports detailing: sample time; airborne particles present at 0.5 micron per cubic foot (maximum permitted is 1,005,714) and 5 micron per cubic foot (maximum permitted is 8,371); pressure differential; monitoring points; time and date of test; and summary findings, conclusions, and recommendations.

In line with recognised infection prevention techniques, all staff members wash their hands using hand soap and water before entering the IAP Area (following the procedure outlined in Unit One) in order to remove transient skin flora and reduce the chance of infection outbreak. Hospital-approved moisturising cream is then applied to the hands, preventing skin cracking and deterioration that can arise from the use of concentrated hand soaps – cracked skin, and the possible minor bleeding resulting from this, is another source of potential contamination that must be guarded against.

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

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In order to maintain the cleanliness of the IAP Area, staff put on a surgical cap and a blue over-gown in the gowning room. This PPE helps to minimise the risk of hair follicles and any particles present on the staff member’s uniform contaminating any sets processed in the IAP Area.

The SSD Policy Document ‘C-26’ states that every Monday morning the Supervisor in charge will organise the laundry of all gowns, removing gowns from the coat hooks, ensuring they are correctly zipped up and fastened, and placing them in a clear bag along with the top sheet of the duplicate book with quantity, date, and location details recorded. The bag is then labelled with a marker pen- “Mini Laundry from SSD”– and placed under the Drivers’ notice board adjacent to the Sterile Store. The Driver takes them over to Mini Laundry, picks up any clean ones, and returns to Mini Laundry later in the week to collect the gowns. The Supervisor will count the gowns to ensure the correct quantity has been returned, and then sort the gowns into different size categories and place them on the appropriate gowning room shelf.

Explain the process of inspecting and assembling equipment [including unloading the Washers].

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Once the cycle log from the Belimed computer has been printed out, checked against the independent cycle data, and signed off by the Supervisor or Production Controller (‘SOP-7’), and the HESSDA traceability system has been confirmed as having the correct cycle number, carriages can be unloaded from the Washers. ‘HESSDA-5’ provides details on the correct manner in which to unload the Washers: once the HESSDA program has been opened and the ‘Wash Area’ module selected, it is necessary to click on the relevant Washer icon, scan your name badge, check the HESSDA cycle number corresponds with the Belimed machine number and the Neqis independent monitoring software number, and click on the Unload Washer icon.

If there is a problem relating to the cycle numbers, it is advisable to click the Leave Load icon while the problem is investigated – the Washer will simply stay loaded. If there is a problem with an individual item/set on the wash carriage (for example, an instrument in a set has obviously not been disassembled), the Fail Item icon should be clicked and the action confirmed by entering the reason for failure in the textbox. If the entire carriage should be non-conformed back to the Wash Room (for example, the carriage has been loaded in an incorrect sequence, thus voiding traceability), then the Fail All icon should be clicked and the action confirmed once again.

Further technical details relating to unloading the Washers are detailed in ‘C-18’, including: ensuring that red dye has been removed from the carriage’s load check; checking that the machine cycle pass/fail lights are green; ensuring the parameters for the cycle have been met by checking the Neqis printout; unloading Theatre sets onto the appropriate shelves; placing Theatre spares on the designated spares rack; and taking sets and spares from clinics and outside surgeries to the correct area at the back of the IAP Area.

As well as following the Trust’s guidelines on manual handling (detailed in Evidence 2A of Unit 2), staff should be aware of the SSD Manual Handling tips detailed in ‘SOP-38’ when unloading the Washers, assessing the weight of objects prior to moving them, asking for help with heavy objects rather than struggling alone, and using available trolleys to transport heavy and/or awkward sets to the relevant section of the IAP Area. Any manual handling issues should be discussed with the Production Controller or the Training Manager.

All staff must clean the work bench surfaces with Sani-Cloth 70s at the beginning and end of every shift (‘SOP-7’), as well as ensuring that the surfaces are clutter-free. Once these checks have been completed, staff members are able to begin the process of inspecting and assembling sets. The first step is to scan a set or spare to be processed, a procedure outlined in ‘C-25’: in order to produce a packing label and checklist for a barcoded pack, it is necessary to scan the item’s barcode and then scan your name; to produce a packing label for a dot-matrixed item, the item’s etching must be focused correctly in the VDU of the dot matrix scanner – once the beep sounds to signify successful scanning, your name badge must be scanned; to produce a packing label (and checklist as appropriate) for a KeyDotted item, the handheld scanner is used to scan the item’s KeyDot and your name badge is then scanned.

A Supervisor is responsible for replacing labels and toner/ink in the printers.

Complete and use check sheets/packing slips correctly. Place the instruments into the tray/din in the correct position to meet service requirements.

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An example of a barcoded set that could be scanned in this way is a Laparoscopic Set. The resulting label will be placed on the appropriate colour-coded carrier card (‘C-1’) – in this example, a Laparoscopic Set’s label will need to be placed on a white (Penzance Theatre)/green (Tower Theatres)/orange (Trelawny Theatres) carrier card. The set, checklist, and labelled carrier card will be taken back to the workbench, and the instruments checked and ticked off on the checklist.

It is important to place the instruments back in the DIN tray/container in a manner that facilitates efficient checking by Theatre staff; laying out the instruments in the fashion that Theatre staff expect helps them to identify any missing instruments that are necessary for the procedure, giving them the chance to obtain the relevant instruments prior to commencing surgery. In the vast majority of sets this means that instruments are placed in the DIN tray/container according to the position of the instrument on the checklist – the first instrument is placed on the furthest left side, followed by the second instrument, then the third, and so on in a progressively left-to-right fashion. With regards to the Laparoscopic Set chosen as an example, certain instruments are placed on the silicone pin matting at the bottom of the container (the Light Lead, the Diathermy Lead, the Black Handles, the Cholangeogram Forceps, the Pyramidal-tipped Trocars and Cannulae, and the Suction & Irrigation Cannula), others are placed in the middle tray (the 6mm and 11mm Multi-Function Valves with Wire Inserts and the Reducer), and the remaining instruments are placed on the top racking in the container.

Visually check that all devices are clean and dry; inspect delicate devices in a way that will avoid damage. Confirm devices are suitable for function and serviceability.

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A visual inspection is made of instruments to check that all contamination has been removed during the wash cycle, ensuring that the instruments are legitimately disinfected prior to packing and later sterilization. Any excess water that has not been fully dried by the final drying stage of the wash cycle is removed using Kleenex roll. An example of this in a Laparoscopic Set takes the form of holding the black Outer Sheaths over some Kleenex roll placed on the workstation and gently tapping out the excess water, ensuring that the water is clear and not contaminated. It is important to remove excess water in order to minimise the risk of sets having to be non-conformed following the autoclave process owing to condense-compromised wraps. Once the black Outer Sheaths have been confirmed as clean and serviceable they are used in the assembly of the various Forceps in a Laparoscopic Set, whereby the relevant Forceps are inserted into the Outer Sheaths, which in turn are attached to the appropriate Handles.

The Telescope in a Laparoscopic Set requires a delicate inspection and assessment of function and serviceability, as outlined in the SSD policy document ‘C-12’. The Telescope must be carefully removed from the container and placed on the workstation, before the outer light connector and inner sleeve are disconnected, cleaned with Sani-Cloth 70s, and replaced finger tight. A careful visual check for damage on both ends is undertaken, and it is necessary to look down the Telescope in order to determine that at least 60% light transmission is present and that a clear, unblemished image is afforded by the lens. The Light Lead should be temporarily attached to the Telescope to make sure that there is an effective connection between these two items. Other items processed in the IAP Area that require delicate handling during the inspection and assessment phases include Laryngeal Mask Airways (LMAs, ‘C-6’), Dental Drills (‘C-13’), and ophthalmic equipment (‘C-10’).

The following process is in place for checking LMAs: ensuring the mask cuff and the tube are clean; checking that no damage has occurred to the aperture bars, connector, or the reinforcing wire; inflating the LMA using an appropriately air-filled syringe according to its size, making sure that no bulges or splits are present; placing the LMA cuff face down into the correct-sized LMA Shaper, fastening it in place with the Shaper’s toggles; deflating the LMA and withdrawing it from the Shaper so that it is in the optimum shape for autoclaving; and finally, scanning the LMA, heat sealing it in single Viewpack, and sticking the label onto the Viewpack.

Intubating LMAs are used for difficult airways and must be packed together with the relevant pink E.T. Tube (or “Pusher”). Proseal LMAs have a double tube and a hole at the top of the cuff, and it is vital to ensure that the red tap is left open for the autoclave process. Reinforced Flexi E.T. Tubes must be packed individually, in single Viewpack, once the appropriate check of the reinforced wire has taken place.

Dental Drills are flushed through with Kavo lubricating spray in the Wash Room prior to being passed through the hatch into the IAP Area. It is necessary to check that they are dry, clean, and undamaged. Once they have been scanned in order to produce a label, they should be wiped over with Sani-Cloth 70s and heat sealed in Viewpack (double Viewpack for Theatres, single Viewpack for Oral Surgery/Orthodontics/Oral PDS), with the individual labels attached in such a manner that the handle end of the Dental Drill is not obscured.

Ophthalmic equipment is very delicate, necessitating careful handling when inspecting these items. As with normal Theatre sets, the instruments present should be checked against those listed on the checklist, and placed in the silicone matting in the set according to the checklist. Examples of checks carried out on ophthalmic equipment include: ensuring Scissors are closing correctly; making sure that the tips of Forceps are aligned correctly; and visually inspecting the items for cleanliness.

The number on the Hand Piece of Phaco Hand Piece Sets is scanned in order to produce an appropriate checklist, and Hand Pieces must be cleaned with Sani-Cloth 70s prior to placement in the container with the other instruments. White carrier card is used for ophthalmic sets, and they are wrapped in either 100 x 100cm OneStep paper (Probus Surgical Centre) or 100 x 100cm interleaved paper (Ophthalmic [Newlyn Unit] and West Theatres). Latex gloves should be used when handling EIBOS Lenses; any excess water on these Lenses should be dried with Kleenex roll, and the Lenses subsequently wiped with Sani-Cloth 70s.

Clarify when rigid containers must be used.

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The majority of ophthalmic spares are processed in small, separate, rigid containers in order to ensure that no damage occurs to them at any stage of the decontamination cycle or during transportation. Rigid containers are also used to transport Laparoscopic Sets owing to the fragile and expensive nature of certain instruments therein (for example, £3000+ Telescopes). DIN trays are used for sets with a large number of instruments (for example, Ortho Basic/General Basic/Cardio Vascular Sets), since the number and weight of the instruments would damage the blue plastic containers that are used for sets with fewer and lighter instruments (for example, Dermatology Standard Sets/Dermatology Lead and Forceps Sets).

Explain the process to follow if reusable medical devices are missing.

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If an item is noted to be missing from a set by a member of staff in the IAP Area, the first action is to request the checklist from a member of the Wash Room staff. The Wash Room staff member will search for the checklist and scan it through to the IAP Area. The member of staff that processed the set in the Wash Room will be identifiable by the checklist, since all staff must write their staff number on the checklists for all the sets that they process.

As stated in ‘HESSDA-7’, an internal non-conformance should be logged on Q-Pulse, and the matter must be investigated by a Supervisor. This investigation will include a check of the scanned traylist to make certain that no comments have been written by Theatre staff to the effect that they have removed the item intentionally, and will also involve a conversation with the member of Wash Room staff that processed the set in order to ascertain whether or not the item was present initially. If the Supervisor is satisfied that the item is missing as a result of Theatre staff’s actions (and not, for example, left on the side in the Wash Room, or floating around in the sonic tank), s/he will phone the relevant Theatre to check if the set should be sent with the instrument marked as missing. If so, the process for placing items as missing outlined in ‘HESSDA-7’ will be followed by a Supervisor: the ‘Item Action’ icon of the IAP Area section of the HESSDA traceability system will be clicked; the set’s ID number will be entered and the ‘Search’ button clicked; the correct set is highlighted and the ‘OK’ button is clicked, followed by a scan of the Supervisor’s name badge; the item is highlighted on the ‘Contents’ section, the ‘Remove’ button is clicked, the ‘Action’ is specified as ‘Missing’, the reason for the item’s removal is entered, and the ‘OK’ button is clicked.

Explain the importance of being able to recognise instruments processed by the department.

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It is vital to be able to recognise instruments and sets processed by the SSD, since unlabelled items would inevitably be sent back to the wrong location (as in the Laparoscopic Set example above, which, if unlabelled, could be sent to Tower Theatres/Trelawny Theatres/Penzance Theatre, as all three Theatres use this set), impacting negatively upon planned operations and leaving the SSD open to accusations of negligence.

Certain measures are in place to ensure that all items arrive at the correct destination, as outlined in ‘SOP-27’: the drivers transport contaminated items back to the SSD in labelled buggies; any spare instruments left in bags in the buggies are immediately transferred to the relevant spares DIN container, which will be identifiable through the attachment of a colour-coded Theatre tag to its side (one labelled DIN container for Trelawny Theatres, another labelled DIN container for Penzance Theatre, and so on); staff working in the various wards of Treliske Hospital- as well as staff working in the outside surgeries- will use either labelled, lidded containers or clear bags with the location written on the side in permanent pen in order to transport soiled items; every set is barcoded and all spares are either dot-matrixed or KeyDotted prior to processing through the decontamination cycle, ensuring the creation of a record on the HESSDA traceability software with location details amongst other data, thus making it possible to track the progress of all items (as detailed in Unit One, ‘The Traceability Cycle’ diagram); sets for outside surgeries are scanned onto a separate carriage in the Wash Room, minimising the risk of these packs being mixed up with Theatre sets when undergoing the wash process; care is taken in the IAP Area to make sure that equipment for different destinations is not mixed up; Viewpack packaging is employed to enable the instruments to be identified by the User without necessarily having to refer to the item’s label, increasing the efficiency of item sorting at the User’s end; and the HESSDA traceability software makes an audible beep if an item is scanned to a location that differs from the location that has been specified as the item’s default location, halting the scanning of all other items in the Despatch Area, and requiring confirmation that the item should be scanned to this unusual destination (for example, if a Dental Basic Set that is owned by Newlyn Unit has been loaned to Penzance Theatre).

Explain the importance of rejecting damaged or dirty devices.

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When inspecting and assembling sets in the IAP Area it is vital to reject all dirty devices, since the ensuing autoclave process will simply bake the contamination into the instruments. If a surgeon uses contaminated equipment during an operation, the patient is at a high risk of infection – with obvious health-related and legal issues as the logical conclusions.

‘HESSDA-6’ outlines the procedure to follow when soiled items are identified in a set: the Non-Conformance icon on the HESSDA traceability software is clicked; the Select Reason button is clicked and the reason for the non-conformance is selected; a comment may be optionally entered in the Comment box; the return location (in this case, the Wash Area) is selected from the drop-down box; and Show Contents is clicked and the relevant contaminated instrument is selected by ticking the box next to the instrument; once all the details have been filled in, the OK button is clicked to complete the non-conformance process. The entire set (not just the contaminated instruments) is then placed on an unloaded Washer Carriage and sent back to the Wash Room for re-processing.

Similarly, damaged items that are no longer fit for purpose must be rejected, since a surgeon will not be able to perform an operation correctly with faulty equipment. ‘C-20’ details the process for items that Theatre staff members have identified as being in need of repair: Theatre staff will write relevant comments on the checklist, which must be logged on the Q-Pulse System as an External Non-Conformance – the traylist is then scanned through to the IAP Area with the log number written in the top right corner; Theatre staff will have marked the instrument in need of repair by attaching a red tag or red twine to the relevant item; the Supervisor in the IAP Area will remove the instrument from the set and amend the checklist following the procedure outlined above, stating when and by whom the instrument was removed, and giving the specific reason for its removal (for example, in need of sharpening); the instrument in need of repair is then placed in single Viewpack and placed in the IAP Area office for the attention of Julie Tregunna-Kessell (the Supervisor in charge of repairs), with a brief note summarising the item’s fault.

Where faulty equipment is found in the IAP Area, a request will be made of Wash Room staff to scan the original checklist through (‘C-14’); if no mention of the fault has been made by Theatre staff, an Internal Non-Conformance should be logged, and the Supervisor on duty informed. The Supervisor will call Theatre to discuss what should be done with the set (for example, whether they deem the fault to be sufficient to remove the item from the set, and whether the set should be sent with the item missing, or if an attempt should be made to replace the item from the Theatre’s spares), and then close out the Non-Conformance on the Q-Pulse System in the appropriate manner.

Explain the organisational procedures for transferring raw materials into the working areas.

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The stock items required in some sets (for example, Receivers, Quivers, Instrument Bags), as well as all the materials used to wrap sets, are kept in the Raw Materials Store of the SSD. ‘SOP-19’ states that there are the following main areas of this Store: a Quarantine area for all incoming goods and clearly-labelled non-conforming items; a Storage area for raw materials and historical documentation and data; an Issue/Transfer area and hatch, used to transfer items into the IAP Area; Instrument cupboards, used primarily for the storage of instruments that are used as replacements for set items that are missing or damaged beyond repair- these instruments must not be directly transferred into the IAP Area, they require processing through the Washer first- and to store instruments that have been made up into sets, decontaminated via the Wash Room, but are not yet ready for issue, so are stored along with a decontamination certificate; an area used to store chemicals and cleaning materials, with all flammable chemicals being stored in the fire-retardant cabinet; and fridges used to store raw materials that require cool storage (for example, Load Checks).

Raw materials that will be used in the IAP Area must not be unwrapped prior to storage, ensuring that they are not exposed to dust, damp, or heat. In order to prevent excess materials being stored in the IAP Area, requests are given to a Supervisor, with all transfers and associated Batch/Lot numbers being recorded on ‘FORM-14’, a process that is also followed in the case of external customers’ requests for raw materials; these forms are periodically filed by the Production Controller, who is in charge of the day-to-day running of the Raw Materials Store.

The outer packaging of the raw materials must be removed before products are passed through the transfer hatch into the IAP Area. Any empty boxes must be flat-packed and placed either immediately in the outside Cardboard Recycling Bin or on the trolley used to collect and transport cardboard to this Recycling Bin.

Demonstrate how to store raw materials.

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Further information pertaining to the Raw Materials Store is provided in ‘SOP-20’, ‘SOP-21’, and ‘SOP-22’. Relevant information includes: the Production Controller or other senior member of staff must check the type and quantity of goods received against the supplier’s delivery note, affixing a signed and dated SSD receipt label to the delivery note, which will subsequently be filed; raw materials should only be received in unopened containers – where the packaging of a product is compromised, it will only be accepted if the actual product is undamaged and its subsequent storage will not lead to deterioration; it is the responsibility of the Production Controller to place sensible orders with the NHS Purchasing and Supply Agency, in order that some stock items are replenished on a weekly basis – the EROS computer requisitioning system is used for all other stock and non-stock items; any discrepancies between the delivery note and the physical goods delivered must be recorded on the delivery note, and the supplier- as well as the NHS Purchasing and Supply Agency- should be notified immediately; sufficient raw materials for at least one week’s production should be kept in the Raw Materials Store, with requisitions continually maintaining this standard – there should be no overstocking of raw materials; the raw materials should be stored in such a way that the product labels are clearly visible – this helps individuals working in the Raw Materials Store to meet requests in an efficient manner; raw materials are issued in a ‘first in, first out’ rotation, ensuring that the manufacturer-specified shelf life (or three years, whichever comes first) is not exceeded; and at least two members of staff will check all stock levels at the end of each financial year, with any unsuitable stock items being recorded for write-off on the authority of the Decontamination Lead.

Secure packing seals, apply the correct indicators and labels. Identify the types of packaging materials used for wrapping items to be sterilised. Explain the different methods of wrapping and securing packaging.

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Three main types of packaging materials are used to wrap items in the IAP Area: blue/green interleaved paper (used, for example, to wrap Penzance Theatre’s ophthalmic sets); OneStep wrap (used, for example, to wrap Probus Surgical Centre’s ophthalmic sets); and Viewpack (used, for example, to wrap spare ophthalmic instruments for all destinations). Different sizes of each type of packaging are available, with the checklist associated with each set specifying the kind of packaging material to use.

Certain packs for outside surgeries are to be wrapped using blue/green interleaved paper and a combination of ‘parcel’ and ‘envelope’ folds, whilst the majority of Theatre sets are wrapped using OneStep Wraps. ‘C-27’ provides a visual guide as to how to achieve the correct parcel/envelope/OneStep technique for the interleaved paper and OneStep Wraps (see Evidence 4A). As outlined in ‘SOP-8’, Steam Indicator Tape conforming to BS EN ISO 11140-1:2005 (or indicator panels on Viewpack pouches) will serve to indicate that devices have undergone a steam sterilisation process.

Viewpack pouches are sealed using a Heat Sealer. All Heat Sealers are sent away to a company (‘Henderson Medical Limited’) for annual calibration. To ensure the effective performance of the Heat Sealers, the Supervisor on duty for the early shift each Monday will perform an efficacy test on all Heat Sealers (‘C-17’). This test takes the following form: each Heat Sealer is turned on and a piece of Viewpack with a seal check inserted is passed through the Heat Sealer once it has reached the correct temperature of 180 degrees – the test Viewpack’s seal is then checked and the results transferred onto ‘FORM-57’. Staff members in both the IAP Area and the Autoclave Area are responsible for checking that heat-sealed items are firmly sealed prior to sterilisation.

‘SOP-9’ outlines further relevant details pertaining to Heat Sealer use, including: items should be inserted as far as possible into the Viewpack before sealing; the ‘mouth’ of the Viewpack should be held closed while it is being passed into the Heat Sealer; the temperature of a given Heat Sealer might drop if too many Viewpack pouches are passed through the Heat Sealer at too high a speed, compromising the sealing process; a Supervisor, and subsequently the Production Controller, should be notified immediately if a Heat Sealer consistently fails to form an effective seal; only Engineers are permitted to adjust the thermostat settings; and, at the end of Saturday, Sunday, and Bank Holiday shifts, the Heat Sealers should be switched off and the plugs removed from the power supply.

Summarise the possible consequences of not following the correct processes on packaging and labelling.

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It is vital to follow the correct processes on packaging and labelling. The major problem regarding labelling occurs when an SSD staff member scans and processes multiple sets at once – although the instruments will be placed in the correct fashion in the correct DIN tray/container, having multiple labelled carrier cards on one desk increases the chance of an incorrect card being tied with ribbon to a wrapped set. Clearly, if one set is sent for sterilisation with an incorrect label, at least one other set will be similarly incorrectly-labelled.

The best-case result of this is that two incorrectly-labelled sets are sent to the same Theatre, whereby Theatre staff opening up the first set can at least identify the other set in the store room that will require re-processing (since an erroneously-labelled item that is opened but not used, owing to its contents not matching its description, will have to be sent back to the SSD as it is no longer sterile). The other potential outcome involves incorrectly-labelled sets being sent to entirely the wrong Theatre, again impacting negatively upon the efficiency of operations as Theatre staff members have to return to the store room and select a correctly-labelled set so that the surgeon has the right equipment with which to work. Thus, incorrect labelling renders all the processes involved in the entire preceding decontamination cycle of the set (Wash Room processing -> Wash -> Washer Unload -> IAP Area processing -> Autoclaving -> Cooling -> Despatch -> Transport) a complete waste of time.

A second labelling issue concerns the failure of staff members to affix a “FRAGILE ITEM” sticker to the front of delicate sets (for example, a Laparoscopic Set [containing a relatively fragile but very expensive Telescope]); this issue is not as major as the first-mentioned labelling problem, since staff members at all stages of the decontamination cycle are aware of the care and attention that must be taken when handling items processed through the SSD – nevertheless, “FRAGILE ITEM” stickers serve to draw attention to the most delicate sets, further decreasing the likelihood of them being damaged as a result of careless handling.

The main problem surrounding incorrect packaging of items concerns the tightness of the ribbon that is used to attach the carrier cards to the wraps. When this ribbon is pulled too tight it creates recessed areas in the wrap that are prone to condense-pooling post-autoclaving. Excessive condense on a wrap results in that set being non-conformed back to the IAP Area for re-wrapping, following which it will have to undergo another autoclave cycle; as with the muddled labelling issue, this results in inefficient processing since the previous IAP Area wrapping -> Autoclave cycle will have been a waste of time.