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

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

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At the beginning of each shift, the driver changes into a recognisable uniform of black trousers, a green jumper, and crush-resistant shoes, as well as ensuring that the staff ID badge is clearly visible. This uniform is recognisable to staff members on the various wards and theatres, enabling the driver to collect used items without causing alarm. The footwear is a vital piece of Personal Protective Equipment (PPE), reducing the risk of foot-crushing tail-lift accidents and helping to prevent damage if the driver had to stop suddenly while manoeuvring a fully-laden trolley whose momentum carried it into the driver’s foot. A high-visibility jacket is worn when the driver needs to traverse busy loading bay areas, in order to alert other vehicle operators to his presence and reduce the chance of serious accidents. When moving used equipment- for example, from the trolleys outside the individual theatres in Tower Theatres into one buggy that will be transported back to the Sterile Services Department- appropriate hand PPE is used: ‘Blue Nitrile Powder-Free Examination Gloves’. Nitrile gloves form an effective barrier between the skin and used equipment.

State the responsibilities when collecting used equipment and the potential consequences of not meeting these responsibilities.

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A major responsibility when collecting used equipment is firstly to check the roadworthiness of the transport vehicle. ‘FORM-4 (Rev.3)’ contains a detailed vehicle checklist section that all drivers are duty bound to complete (see Evidence 1A); any defects must be recorded on this form. This document also requires the driver to record the times and details of all their journeys, the mileage readings at the beginning and end of each shift, how many dirty trolleys were collected from the ward/theatre and the trolley numbers, and how many clean buggies were delivered to the ward/theatre. In line with the department’s policy document ‘Transport (SOP-1)’, drivers must ensure that all buggies are securely fastened using the straps in the van.

Failing to complete ‘FORM-4 (Rev.3)’ could have severe consequences in the sense that if daily vehicle checks are not carried out and the police stop the van and deem it unfit for purpose, there will be major disruption to the theatre-agreed timetable that the drivers must stick to. With a van out of action, there is a high chance that theatre operations would have to be cancelled if they needed specific sets that SSD are now unable to transport. In turn, this could lead to hospital targets not being met, as patients are forced to wait longer for operations. ‘FORM-4 (Rev.3)’ also provides proof for the SSD Production Controller that the theatre-agreed timetable has been followed; if left uncompleted there is no defence against complaints of negligence from wards and theatres.

Explain the importance of ensuring that containers and bags are sealed and labelled correctly.

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As stated in the Institute of Decontamination Sciences’ ‘Standards and Practice Guidance Document 2011’ it is important that containers and bags are sealed correctly, since all used items are considered to be potentially contaminated. The van is used for the transportation of clean buggies as well as dirty buggies, and any spillages from incorrectly sealed containers and bags would compromise the van as a suitable means of transporting decontaminated items. The containers and bags must also be labelled correctly, since certain items have a higher priority level and require faster processing through the department. Failing to label a bag or container correctly could lead to SSD staff in the washroom being unaware that high priority items are sealed within.

Identify where used items are received and unload them in the correct place for sorting.

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Used items are taken from the theatres/wards to the washroom in the SSD. Buggies and containers of used items are left in the washroom by the driver in a manner which doesn’t endanger staff safety – passageways and doorways remain free. These buggies and containers are then emptied by SSD staff wearing a full complement of PPE: blue nitrile ‘inner’ gloves; a surgical hat; a water-repellent apron; suitable protection for the eyes (either glasses or a full-face visor); and blue PVC ‘outer’ gloves. This assembly of PPE offers protection for the hands, hair, body, and eyes against the risk of direct contact with bodily-fluid-contaminated equipment. After removing and discarding the wraps and any unused disposable stock from the sets, washroom staff members load the sets on to the racking for processing; ‘fast-track’ items are placed on a trolley for priority processing. Wraps and unused disposable stock are placed in orange refuse sacks. Once these are full, the SSD staff member signs, dates, and writes “RCHT SSD” on the sack before sealing it appropriately and putting it in the yellow collection bin exterior to the department, ready for collection and subsequent incineration.

Explain how and why the decontamination area/washroom is segregated and the importance of this.

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With potentially-contaminated medical devices being continuously received into the washroom, there is a need to segregate the washroom from the rest of the department in order to prevent the spread of contamination. Sticking to the washroom housekeeping schedule helps to reduce the spread of contamination – in line with the Institute of Decontamination Sciences ‘Teaching and Training Manual’, the following housekeeping routine applies to the washroom: all work surfaces are thoroughly cleaned and disinfected at the end of each shift; spillages are dealt with immediately; floors are cleaned and disinfected daily; waste is removed at frequent intervals; suitable provision is made for the storage of equipment and cleaning materials; and equipment used to clean the washroom is not used in other departments.

Explain why it is important to follow the housekeeping schedule and the potential consequences of non-compliance.

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The SSD policy document ‘VALIDATION OF WASHER/DISINFECTORS (SOP-5)’ also outlines some daily checks related to washroom equipment that will help ensure correct cleaning. Staff must check the spray arms of washer carriages to ensure they move freely; staff must check the spray nozzles of washer carriages to ensure there are no blockages; and staff must remove and clean the industrial washers’ strainers and filters. Failure to do this could lead to inadequate cleaning, resulting in fully-laden washer carriages being non-conformed back to the washroom for a rewash, leading to a backlog of work and the potential inability to meet target turnaround times. Similarly, it is vital to ensure that the washer cycle number of the HESSDA traceability system is correct (ie 1 higher) in respect to the cycle number of the Belimed washer and the Neqis System, since an incongruence in these numbers will lead to washer carriages being non-conformed to the washroom and the above-mentioned consequences.

Identify non-conforming items and follow the relevant procedures.

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Since the washroom is the place where items are initially received and processed in the department, it is also the first place where non-conforming items are dealt with. SSD employs the Q-Pulse system for the logging of non-conformances. Q-Pulse provides the scope for distinguishing between different categories of non-conformance: ‘External non-conformances’ (for example, a member of Theatre staff stating that a particular instrument is no longer fit for purpose); ‘Internal non-conformances’ (for example, a member of the SSD staff noting that an instrument is missing from a set upon its return from Theatre); and ‘Tray List Amendments’ (when a member of staff either internal or external to the SSD feels that the checklist associated with a particular set should be revised to better reflect its contents). The member of staff in the washroom will log the non-conformance under the appropriate category, obtaining a reference number in the form of ‘IN-[record number]’/’EX-[record number]’/’TLA-[record number]’ depending on the type of non-conformance; this reference number is then written on the relevant checklist and scanned through to the Inspection and Packing (IAP) Area to alert packing room staff to the non-conformance. A red non-conformance tag is affixed to the set in order to highlight its problematic nature when it is unloaded in the IAP area. Q-Pulse sends email notification of the non-conformance to relevant members of the management staff who can address the problem – namely, the Production Controller (Internal and External non-conformances) and the Systems Administrator (Tray List Amendments). As sets are often required to be processed when neither the Production Controller nor Systems Administrator are present, SSD Supervisors are frequently entrusted to deal with non-conformances that arise during the shift, using the reference number on the scanned checklist to access the record and close it out once the problem has been dealt with.

As outlined in RCHT’s ‘Incident Reporting & Management Policy and Procedure’ document, all incidents (for example, a member of the SSD staff actually suffering personal injury owing to a knife handle blade not being discarded in Theatre) and near miss incidents (for example, a member of the SSD staff- without actually suffering personal injury- noticing that a full vial of anaesthetic in a cartridge syringe has not been discarded in Theatre) must be reported as soon as possible following the event. Such incidents are reported by completing the DATIXWeb form on the Trust’s electronic risk management system in a factual and accurate manner. Red asterisks signify mandatory fields depending on the type of incident, and each incident is graded for its severity, with ‘No apparent injury or minor injury not requiring first aid’ at one end of the five-category-spectrum and ‘Death or major permanent incapacity’ at the other end. Once the form is completed, email notification is sent to appropriate members of the management team and an investigation is carried out under the supervision of the Divisional Manager. The expected timeframe for such investigations is fourteen days, during which time the DATIXWeb record is continually updated; the record for any investigation exceeding the fourteen-day target must be updated every seven working days. Results from each investigation- including findings, corrective actions, system/procedural changes, lessons learned, and identified risks and the grading of these risks- must be recorded in the Investigation section of the DATIXWeb record. Emailed feedback will be sent to the individual who completed the DATIXWeb record if feedback was requested at the time of logging.

Summarise relevant legislation and organisational procedures in relation to infection prevention and health and safety measures.

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Washroom staff members deal with contaminated items throughout the shift and have to pay attention to the cleanliness of their hands in order to prevent the spread of micro-organisms. The SSD implements a six-step hand washing method in line with the World Health Organisation’s 2012 hand washing guidelines to remove transient skin flora and reduce the chance of infection outbreak: firstly, hot water is applied to the hands; enough soap to thoroughly wash the hands is applied; hands are thoroughly washed up to the elbows, making sure that areas between fingers and under nails are attended to; soap is then thoroughly washed off using hot water; paper towel is used to turn the tap off before being discarded; and fresh paper towel is used to thoroughly dry the hands up to the elbows. This hand washing technique is used every time washroom staff members leave the work area, as well as after using the toilet. Any cuts or breaks in the skin must be protected with a waterproof dressing, since damaged skin is susceptible to blood-borne viruses and may become infected; first aid kits with suitable dressings are present in the washroom.

As outlined in the Institute of Decontamination Sciences’ ‘Standards and Practice Guidance Document 2011’ the Health and Safety at Work Act (1974) states that employers must protect staff from hazards, and stresses the importance of training and equipment that is fit for purpose in establishing a safe working environment. The Act also emphasises the fact that each employee has a duty toward himself and his colleagues in terms of working in a safe manner, not endangering himself or others by his working practices. SSD staff members must familiarise themselves with the Department Health & Safety Policy (SOP-38, Rev.3, available on the Q-Pulse system), which includes several relevant guidelines for working in the washroom, including: the importance of PPE; the need to keep work areas tidy and to deal with any spillages in the correct manner; how to handle detergents properly, ensuring any splashes to the skin are rinsed with water immediately; ensuring waste is disposed of correctly (for example, used aerosol cans and glass should be placed in the fire resistant cabinet in the bulk store, in the dedicated disposal bin); making sure that hands are not immersed in the tank of ultrasonic washing machines whilst in operation; and the requirement to take special care when handling sharp instruments, glassware and blades (scalpel handle blades should only be removed with a blade remover or artery forceps to minimise the risk of personal injury).

Explain the process for the removal of personal protective clothing.

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PPE is removed whenever a washroom staff member leaves the washroom – to use the toilet, to go for a break, or at shift completion. The method for PPE removal is as follows: PVC outer gloves are removed first since they are often wet and laden with micro-organisms; next, the apron is removed, with eyes and hair still protected as it is lifted over the head; then eye protection is removed, followed by the surgical cap; lastly, the inner gloves are disposed of. At the end of the shift, all PPE is disposed of in the orange waste disposal bags. Hands are washed using the technique outlined above before leaving the washroom.

Explain what recording systems are used in relation to used items. Explain why it is important to use these systems.

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When a set is ready for processing through the industrial washers it is scanned onto a washer carriage using the HESSDA traceability software that is employed by the SSD. A full washer carriage is then scanned into the washer, and is unloaded in the IAP area. The set is scanned for processing in the IAP area, producing a checklist and a label unique to that set. It is then sent down the conveyor belt into the autoclave area and scanned onto an autoclave trolley. A full autoclave trolley is then loaded into an autoclave, and unloaded when the cycle is complete. Once the set has cooled for thirty minutes and had the appropriate lot label affixed (indicating the cycle and sterilizer number and date of processing), it is scanned into a despatch buggy, ready to be issued to the relevant Theatre. The contents of the buggy are then issued to the appropriate destination in line with the Theatre-agreed timetable. Scanning the item at each stage of the decontamination cycle means that it is possible to pinpoint the whereabouts of a set whenever a member of Theatre/ward/outside customer staff rings the SSD to enquire about its status simply by typing the set’s name or its unique identification number into the ‘LOCATE’ function of the HESSDA traceability system.

The Traceability Cycle (HESSDA Track Positions):

…”OFFSITE” –> “ON A WASHER CARRIAGE” –> “WASHING” –> “WASHER COMPLETE” –> “PACKED” –> “ON AN AUTOCLAVE TROLLEY” –> “AUTOCLAVING” –> “AUTOCLAVE COMPLETE” –> “ON A DESPATCH TROLLEY” –> “OFFSITE“…

Describe any procedures relating to the use of these systems.

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It is possible to non-conform items to an earlier stage in the decontamination cycle using the HESSDA system. Examples of this include: dirty sets in the IAP area that need to be non-conformed back to the washroom for a rewash; sets whose wraps have blown open during the autoclaving process that need to be non-conformed back to the IAP area for rewrapping; and sets which have become laden with cooled water vapour during the autoclaving process and need to be non-conformed back to the IAP area. The HESSDA traceability system also logs the name of the staff member who processes the set at each stage of the decontamination cycle. This makes it easy for the management team to help correct poor work performance – for example, if a member of staff is continually having sets non-conformed owing to incorrect cleaning in the washroom/incorrect wrapping in the IAP area, a member of the management team can speak to the individual concerned and correct the faulty work processes.

Explain the consequences of non-compliance.

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As well as the above-mentioned benefits to using the HESSDA traceability system, it is vital to maintain records in order to prove compliance with industry standards when external bodies perform an audit of the SSD. Failure to prove compliance could result in failing the audit, leading to the SSD being considered unfit for purpose and a cessation of service. In the unlikely event that items issued by the SSD need to be recalled (for example, owing to an issue with raw materials supplied with the sets), the records kept on the HESSDA traceability system can be checked and all affected items can be recalled and quarantined awaiting advice from the Service Leads, as outlined in the SSD policy document ‘SOP-26, Rev.3, Traceability and Product Recall’.