Peninsula Dental Social Enterprise Decontamination and Storage of Dental Instruments Version 3.0 Date approved: October 2016 Approved by: The Board Review due: October 2019 Policy will be updated as required in response to a change in national policy or evidence-based guideline. Page 1 of 13
Contents Section Topic Page No 1 Introduction 3 2 Purpose 3 3 Training 4 4 Responsibilities 4 5 Hand Decontamination 4 6 Single Use Instrumentation 4 7 Personal Protective Equipment Required 5 8 Protocol 5 9 Decontamination - Wash 5 10 Decontamination Clean Room 7 11 Decontamination Autoclave 8 Appendix A 10 Appendix B 11 Appendix C 12 Appendix D 13 The Dental Education Facility Protocol on the Decontamination and Storage of Dental Instrumentation. Page 2 of 13
1. Introduction 1.1 Decontamination describes a range of processes, including cleaning, disinfection and sterilisation, which remove or destroy contamination and thereby prevent infectious agents or other contaminants reaching a susceptible site in sufficient quantities to cause infection or any other harmful response. 1.2 Thermal Sterilisation in SDU is the preferred method for processing all invasive instruments that are not degraded by heat. Heat sensitive equipment can be disinfected using other agents (Alkazyme). 1.3 The appropriate Material Safety Data Sheets and Control of Substances Hazardous to Health (COSHH) assessments should be performed before employing cleaning and disinfection chemicals. 1.4 Appropriate Personal Protective Equipment should be used according to the risk of transmission of infection and the method of cleaning or decontamination selected. 1.5 Items marketed for single use should not be re-used. 2. Purpose 2.1 The purpose of this document is to provide direction regarding the decontamination of medical/dental devices, in accordance with relevant national standards and guidance. 2.2 Decontamination is a term used to describe a range of processes, including cleaning, disinfection and sterilisation, which remove or destroy contamination: Cleaning.Physically removing soil along with most pathogens using detergents (enzymatic and soap), water and friction. This is a pre-requisite to successful disinfection and sterilisation, which will generally be ineffective on surfaces that have not already been physically cleaned. Disinfection. A chemical or physical process that kills pathogens and reduces them to a level that does not pose a risk to human health. This process does not guarantee the removal of all bacterial spores or Mycobacteria. Sterilisation. A chemical or physical process that removes or kills all pathogens (with the exception of prions). This usually involves steam, oxygen super radicals or irradiation. 2.3 Reusable medical devices should be decontaminated in accordance with Manufactures instructions and current national or local best practise guidance ( HTM 01-05 ).This must ensure that the device should be clean and, where appropriate,sterilised at the end of the decontamination process and maintained in a clinically satisfactory condition up to the point of use. Page 3 of 13
3. Training 3.1 Education in infection Control is offered to all staff including those in support services. This includes a corporate induction for all staff. Decontamination must be considered part of the professional development for all staff and must be included in Appraisal to highlight the delivery of further decontamination training and effectiveness via monitoring. 4. Responsibilities 4.1 All decontamination equipment should be subject to validation, testing, maintenance and servicing as recommended by the manufacturer/supplier. All records of these procedures should be retained for audit/inspection. 4.2 These are as outlined in Health Technical Memorandum (HTM 01:05).Decontamination of reusable medical instruments (Section 11/12/13). 5. Hand Decontamination 5.1 Effective cleaning to remove all organic material is essential for high level disinfection or sterilisation. Although automated cleaning is the preferred method, some instruments cannot be processed in a washer disinfector or may need manual cleaning prior to processing in a washer disinfector (Appendix D). 6. Single use Instrumentation 6.1 The expression single use on the packaging of medical devices means that the manufacturer: Intends the device to be used once and then discarded Considers the device is not suitable for use on more than one occasion Has evidence to confirm that reuse would be unsafe The symbol to indicate single use on medical device packaging can be found in the form of a circle with a 2 inside, with a line going through it. Single use devices should be discarded after use in a safe manner. 7. Personal Protective Equipment Required Page 4 of 13
7.1 Full PPE is to be worn for these procedures Clinical clothing Scrubs Long sleeved gown Eye protection Gloves Thermal gloves/long sleeve shirt Autoclave PPE Mask Theatre hat Specific Shoes 7.2 All long heavy duty gloves should be washed with detergent, hot water and dried after use to remove visible soil. They should be replaced weekly or sooner if there are signs of wear or tear. 8. Protocol 8.1 At the start of each day switch on and carry out daily performance checks Washer Disinfector Machines HTM2030 Assistina 301 Plus lubricating and maintenance machines Sterilisers HTM2010 (Bowie Dick test) 8.2 The instructions for these procedures can be found adjacent to all machines in question, in department SOP S and Appendix s within this protocol. 9. Decontamination Wash 9.1 At the end of each Clinical session, really useful boxes are brought up in a Red Trolley by the Clinical Support Staff. Within each really useful box in the Red Trolley, the Dental nurse on Bay must ensure a contents list accompanies each box and is signed. 9.2 Devonport Def,Clinical Support staff are to leave all Red trolleys in the Wash Link lobby and ring the bell to alert SDU staff to a delivery. Delivery times are 11.00am/12.00/16.00 onwards. Any specific Urgent deliveries requiring urgent turnaround are to be brought up in the same manner with the urgent request written on the contents list. A red tag should to be placed in with Urgent items to indicate its priority on starting the W/D. 9.3 Derriford Def contaminated deliveries arrive at 1pm approx via courier transport provided by PCH. All contaminated instrumentation will arrive in really useful boxes Page 5 of 13
contained securely in a cable tied clear plastic bag. This will all be held within a contaminated blue transport box. A consignment form must be with each contaminated delivery. 9.4 The wash process is the same for Devonport Def except all baskets/fine lidded baskets are identified with Purple tags. 9.5 Exeter Def contaminated deliveries should arrive between 2.30-3.30pm daily as per schedule via Private Courier. All contaminated instrumentation will arrive in really useful boxes contained securely in a cable tied clear plastic bag. This all held within a secure contaminated blue transport box. A consignment form must accompany each contaminated delivery. 9.6 The wash process for all Exeter Def instrumentation is treated the same as per Devonport/Derriford Def s, however origin of use/def is identified by means of a Blue tag throughout the whole process. 9.7 Any disposable or sharp items should be disposed of on Bay but any remaining should be reported to the SATO/Bay then disposed of following relevant protocols on waste disposal. Matrix bands should be removed using artery forceps or tweezers and disposed of in the Sharps bin. 9.8 All contents should be checked against the contents list and then placed in the appropriate baskets. Any reusable High speed burs and other small delicate/sharp items should be placed in small fine lidded baskets or strainers. Light cure Tips to be placed on Blue silastic matting in a fine lidded basket to prevent damage. Any missing items are to be reported to SATO/Bay. Any faulty items reported to SATO and a repair tag should accompany the item. 9.9 Removing the clasps, reassemble the instruments in each tray to ensure no instruments are overlapping or sticking out. All sharp points should be seated in a down wards position. Forceps should be unlocked and open. 9.10 Ensure all fine lidded/baskets clearly have the relevant coloured ID tag to ensure each DEF (Derriford Purple Tag/Devonport White tag) remains separate and identifiable. Single surgery instrumentation must also have its own relevant coloured tag with it. 9.11 All handpieces should not be oiled prior to the wash process, but placed in to a medium basket. 9.12 Place instrument trays on the washer docking trolley. All baskets/fine lidded baskets can be place directly on the W/D racks. Six trays or two Medium baskets per shelf. 9.13 The docking trolley is now ready to load in to the washer, observing all manual handling procedures. Once loaded the W/D is now ready to use, the protocol for use can be found adjacent to the machine and in the unit policy (SOP 10). The wash process takes approx. 60 minutes. 9.14 Change gloves. Page 6 of 13
9.15 Wipe down the instrument trolley with disinfectant wipes and secure. 9.16 Using the clean side of the wash room, wipe out the really useful boxes using fresh disinfectant wipes. All the inside and the outside should be wiped plus the lid and paying particular attention to the clasp area as well. Place the boxes on top of the trolley and wheel the trolley to the link lobby area. They are now ready to be returned to the relevant bay by the CSW. 9.17 Wipe down all the work surfaces and the WD machines. 10. Decontamination Clean Room 10.1 The W/D are double sided, after the wash process has finished the instrumentation will be ready to unload into the clean room. Wearing Heat Protective gloves press the door release button and observing safe manual handling (brakes are in the locked position) pull out the wash rack on to the clean room docking trolley. 10.2 Place an empty wash rack into the empty wash chamber and close the door in the same manner as opening it. 10.3 Place the clean instrumentation onto the relevant Def rack in the clean room to cool, still wearing thermal gloves. 10.4 When the W/D cycle has finished, check and sign the validation print out plus the independent monitoring system (Cerberus).The first printout of the day should be recorded in compliance with HTM2030 and stapled to the record sheets held in the clean room. All subsequent wash cycles are still to be checked and signed. These are placed in the grey printout basket and archived at the end of the week. 10.5 All instruments are be visually inspected for dirt/faults/damage etc. using where necessary the illuminated magnifiers. Points, hinges, serrations are to be inspected for damage/cleanliness. All cannulated items should be air gunned before inspection to ensure all instrumentation is dry. Use the fume cabinet insitu to maintain health and safety and best practise for this task. 10.6 Any faults found should be reported to SATO and a replacement found. The fault is to be recorded in the faults books in lieu of a tracking system. 10.7 If still visibly contaminated a rewash form (SOP 11a) must be completed and the item returned to the wash via the transfer hatch. In the Wash they are to be cleaned in accordance to SOP 11/18. The said item can also be hand washed in accordance to the Protocol on the Hand Decontamination of Dental Instruments prior to a wash cycle in the W/D. 10.8 All instruments are to be checked against the relevant master tray list (Tray contents list/photos can be found in folders in the clean room) and any deficiencies rectified. All faults are to be recorded and Decontamination Certificates completed (SOP 19) for Handpieces found to be faulty and requiring repair at MEMS. Page 7 of 13
10.9 Handpieces are to be cleaned, lubricated (Assistina Machines) and sterilised in accordance with the Protocol on the care and Sterilisation of Dental Handpieces. 10.10 Worn Burs should be disposed of in the sharps bin and replaced as required. 10.11 Rubber Dam clamps and other small instruments are to be removed from the small mesh baskets and packed accordingly once inspected. 10.12 Once inspected and packed in the relevant sterilisation pouches in Accordance to HTM01-05 using an autoclave compatible marker pen the date of packaging and expiry date of 12 months later must be written on the pouch. To maintain identification all packed Derriford Def instruments will have written on the pouches DF PDSE plus dates. Exeter Def packed instruments will have EX PDSE written on the pouches as well as the date of packing plus 12 month sterility date in accordance with HTM 01-05. 10.13 After packing, all instrumentation is to be transferred to the Autoclave hatch being mindful to not mix either DEFS equipment. Segregation is achieved by means of laminated labels and only one Def instruments placed in the hatch at any one time. 11. Decontamination Autoclave 11.1 The Autoclave ATO of each day is responsible for carrying out the daily performance check (Bowie Dick Test) and subsequent recording in log books of both Autoclaves DH14487/ 88. They must also ensure the independent monitoring is observed and cycle numbers are matching. 11.2 Load all instrumentation on to the docking trolley (there are 2 docking trolleys in the autoclave room) in an appropriate manner. Singles should be in baskets, trays placed paper side up etc. Ensure the instrumentation is not mixed between sites. 11.3 Place a Steriliser Process sheet (SOP 17) with each Porous load detailing, time /date/cycle number and specifics of each load. The docking trolley is now ready to be loaded into the Autoclave chamber.operating Instructions can be found adjacent to the machine and also in local policy (SOP 14). PPE and safe Manual Handling must also be observed. 11.4 The Autoclave cycle takes approx. 33minutes reaching the critical point of Sterilisation of 134 degrees for 3 minutes during the cycle time. 11.5 On unloading ensure the correct PPE is worn due to the heat of the docking trolley/instruments. Ensure all paper work is present. 11.6 On completion of the cycle all process sheets/independent recording are to be observed/ recorded and signed. Each autoclave cycle is downloaded to the independent recording upon ending of each cycle. The operator is also to inspect all the packaging to ensure the colour indicators situated on the end of all the sterilisation pouches have changed colour, this also indicates sterilisation has taken place. The autoclave tape placed on each process sheet should also have changed Page 8 of 13
colour from clear to black to indicate sterilisation. All process sheets are held until the end of each week and then archived. The archiving also applies to all log sheets of daily performance for each area of the unit. 11.7 Once instruments have cooled, all packaging must be inspected for tears/rips. If any packaging is found be compromised the instrument/s must be sent back to the clean room via the transfer hatch. Remaining intact sterile instrumentation is to be packed accordingly, dependant on relevant Def. Devonport Def instrumentation is to be packed into a green Trolley and taken via CSW to the ground floor store room. (SOP18). 11.8 Derriford Def sterile instrumentation, is to be packed in clear plastic bags then placed in a CLEAN blue transport box, observing manual handling/risk assessments in place for lifting of loads. The bag and both ends of the blue box lid must be made secure with Green cable ties. 11.9 A consignment form is to accompany each clean load back to Derriford Def just as a consignment form must arrive with all contaminated deliveries from Derriford Def. The sterile delivery back to Derriford Def will be picked up at the same time as a contaminated delivery arrives. All Derriford Def sterile instrumentation/empty boxes should be held in the corridor outside of the ground floor Consumables room, awaiting daily collection. 11.10 Exeter Def sterile instrumentation, is to be packed in the same manner as Derriford Def, maintaining segregation at all times. An Exeter Def consignment form must accompany all sterile packed instrumentation. All Exeter Def Sterile instrumentation/empty boxes should be be held in the ground floor stairwell awaiting collection each morning as per schedule. Page 9 of 13
Appendix A Daily Performance Checks BHT Thermal Washer/Disinfector x3in compliance with HTM 2030 Wash room Clean Drain Outlet Filter Remove any debris from meshed drain filter (situated at the bottom right of the chamber). There is no requirement to remove the filter, but it can be removed if debris is trapped in the mesh. Remove and Clean Spray Arms Ensure drain filter is in place before carrying out this procedure. There are 3 spray arms to check- top, middle and bottom. Check water inlet valve (RHS in Chamber) On the RHS of the chamber is black self sealing water feed valve. When pressed with the hand this should move back and forward with a spring action. If no movement is obvious, report as a fault. Check Detergent level Only to be carried out by staff trained to do so Ensure that there is enough detergent available for use during the day. Top up if required. (COSHH/Risk assessment in place) The machine will not work if there is insufficient detergent. All daily checks, in compliance with HTM2030, are to be recorded in the daily log book. Clean Room The validation printout/cerberus (IMS) details from the first wash cycle of the day are to be recorded on the Log sheets found in the clean room.all subsequent wash cycles are recorded and signed in compliance to HTM2030. Page 10 of 13
Appendix B Daily Performance Checks : Assistina Plus 301 Lubricating and Maintenance Unit. At the beginning of the day Check the oil and cleaning fluid levels. Top these up if required. The white chamber is for oil and the green chamber, cleaning fluid. Do not mix these fluids. Place a clean liner into the filter tray and return to the machine. O rings /filters to the back of the machines should be checked regularly and replaced every 6 months. At the End of the day Remove the filter tray and discard the liner in to the clinical waste bin. The tray should be cleaned and disinfected by putting it through a cycle in the Washer/Disinfector. Page 11 of 13
Daily Performance Checks BMM Weston Autoclaves x 2 (DH14487 /DH14488 Appendix C Carry out as first task a 134 degrees Porous load cycle (empty chamber) as a warm up cycle. A Bowie Dick Test cycle is to be carried out after the warm up cycle is completed on both autoclaves. A Bowie Dick Test pack is to be placed in the centre of each empty chamber. Each pack to be marked indicating which Autoclave it has been placed into. At the end of the cycle un wrap the Test pack and check that the Bowie Dick indicator card has changed colour and has no variation through it. If not, the test should be considered suspect and a new Bowie Dick test pack carried out. If there is still a suspect colour change, Estates are to be informed. This could indicate the Autoclave has a fault. The indicator card and machine validation printouts should be placed into the relevant Daily Check log folder after recording/signing all results. The independent recording also requires recording on this and every subsequent cycle for verification. This is in compliance to HTM2010. All trays must have their clasps in place before autoclaving. Loose instruments should be placed evenly on the Autoclave shelves.do not overlap or overload the shelves. Handpieces should be cleaned and oiled using the Assistina Plus 301 Lubricating and Maintenance Unit and then placed in a sterilisation pouch before Autoclaving. Any pouched trays should be placed onto the autoclave shelf paper side up. Single items are placed in baskets. All manual instructions for operating the autoclaves can be found adjacent to the autoclaves and in local policy. PPE/ Gloves must be worn at all time Page 12 of 13
Appendix D Def Protocol on the Hand Decontamination of Dental Instruments Personal Protective Equipment Required Full PPE is to be worn for these procedures Clinical Clothing Long Sleeve Gown Eye Protection Gloves Protocol Alkazyme Enzymatic Cleaner/Disinfector solution (Alkazyme soluble 5g sachets) is to be used per litre of water, when manually cleaning instruments. The DIRTY sink is to be filled with warm water and the cleaner/disinfector as specified by the manufacturer s instruction. Chlorhexidine hand scrub (hibiscrub), washing up liquid, cleaning creams and soaps are not to be used as they allow proteins to stick to steel. The items are to be fully submerged in the solution for 5 minutes, thus preventing aerosols during the cleaning process. The instruments will then be scrubbed using long handled brushes with soft plastic bristles in an away from the person action to agitate the surface contamination. Drain off any excess cleaning solution/ residue in the CLEAN sink prior to drying. All handwashed instrumentation is to be placed in a clean basket /or small fine lidded basket clearly indicating place of origin using the colour coded tags insitu and placed in the transfer hatch. If the said instrument is a rewash item, visually inspect the item after handwashing prior to its second wash via the W/D. All rewash forms are to be kept in the wash. Dispose of cleaning materials in accordance with policies All brushes should be changed at regular intervals or at signs of wear. Wire brushes or wire pot scourers are not to be used to clean instruments as they can irreversible damage. Page 13 of 13