HDL(2006)40 - Scottish Government Health Directorates
Contents
1. INVESTOR IN PEOPLE SCOTTISH EXECUTIVE NHS HDL 2006 40 Health Department Directorate of Finance Dear Colleague DECONTAMINATION UPDATED GUIDANCE ON COMPLIANCE IN PRIMARY CARE Purpose 1 The purpose of this HDL is to provide revised deadlines for achieving compliance with the Glennie Technical Requirements for decontamination in Primary Care settings and provide an update on developments on issues relevant to decontamination namely o P CAT o Education o SHPN 13 o Audit of SPS and o Anew Glennie Sub Group for Decontamination Requirements Revised Deadlines for Achieving Compliance 2 HDL 2005 1 issued in January 2005 provided deadlines for achieving compliance with the Glennie Technical Requirements for decontamination in Primary Care settings Due to the unforeseen time required to develop the audit tool and identification of the significant time required to carry out an audit of all General Medical and Dental Practitioners podiatrists optometrists and other healthcare professionals treating NHS patients and engaged in the local decontamination of re useable instruments the Sterile Service Provision Review Group the Glennie Group has revised the compliance deadlines 3 In revising the deadlines the Group is clear that the deadline of 31st December 2009 by which time the physical environment and equipment at all local decontamination sites is to be upgraded is immovable2. PPE amp Ea Dirty Decon Clean Decon Treatment a zone eg Treat room dental chair Sterilizer ia Ultrasonic we EEA sm 13 Two room local decontamination vacuum sterilizer 7 Sterile devices invasive procedures possible hers U ps pete A ht peer re cataaer eat aaa aa acer aa a poe eee hhh hth htk nE EON moe EEE be be l chottt htt et bbb tt EEE 3 t ki 3 a ete CLEAN ZONE ea DIRTY ZONE o Ultrasonic EE Dirty Decon Clean Decon WD Treatment kag Sink SS zone eg Treat room dental chair
3. ABO Syess Efe ve g N DISAB ae July 2006 Addresses For action Chief Executives NHS Boards NHS National Services Scotland Scottish Ambulance Service and State Hospitals Board for Scotland For information Chief Executive NHS Quality Improvement Scotland Chief Executive NHS Education for Scotland Directors of Finance NHS Boards Medical and Nursing Directors NHS Boards Chief Administrative Dental Officer Dental Hospitals NHS Boards Medical Director HPS General Managers Independent Hospitals Chief Executive Scottish Prison Service Enquiries to Ross Scott Directorate of Finance Health Department Basement Rear St Andrew s House EDINBURGH EH1 3DG Tel 0131 244 2363 Fax 0131 244 2371 Email ross scott scotland gsi gov uk 4 The revised deadlines differentiating between Directly Managed Units and Independent Contractors and the three phases of Action Plan are as follows DIRECTLY MANAGED UNITS By 31 July 2006 Submission of Action Plan Phase 1 The SQL Script supporting this action plan comprises approximately 20 of the overall non compliances By 30 September 2006 Submission of Action Plan Phase 2 The SQL Script supporting this action plan comprises approximately 50 60 of the overall non compliances By 31 December 2006 Submission of Action Plan Phase 3 The SQL Script supporting this action plan will comprise the remaining non compliances
4. Clinical Governance Committees Directors Primary Care Estates and Any other relevant staff O oOo 00000000 Yours sincerely Pa ra Zod Uff fa HE ae F if ee ne ALEX SMITH Interim Director of Finance ANNEX A Advice on the decontamination of re usable surgical instruments and other re usable medical devices in General Medical Practice Glennie Group Primary Care Strategy Subgroup CONTENTS A Strategic approach B Local decontamination of re usable surgical instruments and other re usable medical devices l Upgrading premises to provide suitable decontamination facilities Decontamination equipment including installation and commissioning 3 Clarification of other related issues Annex 1 Priorities for immediate action CMO CDO letter CMO 2004 21 Annex 2 Further sources of information on local decontamination Annex 3 Detergents for manual cleaning of instruments Annex 4 Model layouts for local decontamination facilities SCOTTISH EXECUTIVE Advice on the decontamination of re usable surgical instruments and other re usable medical devices in General Medical Practice A STRATEGIC APPROACH General Medical Practitioners GMPs require sterile instruments and accessories in order to undertake a number of procedures These include treatment room procedures such as dressings and wound care removal of sutures and family planning procedures e g use of vaginal specula In addition many G
5. INDEPENDENT CONTRACTORS By 31 December 2006 All NHS boards will have completed the P CAT audit exercise for all independent contractors General Medical and Dental Practitioners podiatrists optometrists and other healthcare professionals treating NHS patients and engaged in the local decontamination of re useable instruments By 31 March 2007 Submission of Action Plan Phase The SQL Script supporting this action plan comprises approximately 20 of the overall non compliances By 30 June 2007 Submission of Action Plan Phase 2 The SQL Script supporting this action plan comprises approximately 50 60 of the overall non compliances By 30 September 2007 Submission of Action Plan Phase 3 The SQL Script supporting this action plan will comprise the remaining non compliances 5 Action Plans for the compliance with Glennie Technical Requirements for both Directly Managed Units and Independent Contractors should be submitted to Ross Scott at SEHD for approval for all local decontamination units SQL Scripts Action Plans 6 In order to facilitate standardisation of action plans and a staged approach to corrective action HPS has developed a series of three software applications SQL Scripts and corresponding standardised action plans for each of the three phases Each SQL Script is programmed to search global data for specific non compliances and identify the sites to which the non compliances apply This informati
6. audit the decontamination processes within your practice Priorities for immediate action 1 Don t re use single use items Single use items should be labelled as such the symbol used on packaging is Specifying a medical device as single use is the responsibility the manufacturer of the device Once removed from the packaging there may be no labelling on the device itself ensure that it is clearly segregated from re usable devices of similar appearance 2 Ensure that decontamination equipment washer disinfectors ultrasonic cleaners heat sealers sterilizers water treatment units is used in accordance with the manufacturers instructions If you don t have the instruction manual for your ultrasonic cleaner steriliser or other equipment make sure you get a copy please read it and follow the written instructions Your NHS Board Authorised Person Sterilisers or Scottish Healthcare Supplies may have a copy of the appropriate steriliser instructions if the manufacturer can t supply one contact details are in Annex 2 3 Ensure that decontamination equipment is properly maintained day to day Change the water in the reservoir of bench top steam sterilizers regularly at least daily using purified bacteria free water this can be freshly prepared distilled or reverse osmosis RO water or sterile water for irrigation there may be local bulk purchasing arrangements for the latter Change the solution in the
7. is drawn from the source of contamination directly out of the processing area Maximum working temperatures are not legally specified but an HSE leaflet Thermal comfort in the workplace guidance for employers says than an acceptable zone of comfort for most people in the UK is between 13 C 56 F and 30 C 86 F A shared dedicated decontamination facility is likely to be a better and more cost effective solution for a multiple surgery practice further options for this are suggested in Annex 4 1 2 Where space is limited In all cases the above dirty to clean workflow must be maintained Lack of space may dictate that a setting down space has to be used for both dirty and clean instruments at various points in the decontamination process if so the surface must be thoroughly cleaned between steps with a detergent and water solution with or without alcohol LDUG 3 6 to prevent cross contamination If there is space for only one sink rinsing may be carried out using a clean plastic bowl These constraints will inevitably make processes more difficult for the member of staff carrying them out and will increase the risks of cross contamination This degree of compromise indicates that the physical premises may not be fit for purpose in the longer term Lack of space may also dictate that decontamination has to be carried out in a patient treatment room Decontamination should be deferred until the room is unoccupied LDUG 2 2 and Anne
8. trained P CAT auditors and this has tremendously helped a number of boards to make progress with their P CAT audit requirements The potential need for additional staff to be trained as auditors has been identified due both to higher than anticipated workload for auditors and the attrition of trained staff Accordingly the Glennie Group has agreed that a further 3 week training course should be presented by HPS if required and is planned to commence on Monday 4 September 2006 13 Meantime NHS boards should be assessing their training needs and identifying individuals of A amp C grade 5 6 or above ideally with a science engineering or other technical background and basic IT skills to be trained A specific trawl for delegates will be carried out before the end of June Education 14 After a problematic start NES and HPS are now working at full speed on the delivery of a Primary Care Decontamination Training Programme The Programme will be based on the Department of Health s successful Decontamination Programme delivered by Intuition but heavily customised to suit Primary Care settings in Scotland The DH Programme is based on 15 modules and at this stage it is considered that only one of the modules is not appropriate for a Primary Care Programme Work has commenced on reviewing the modules and it is anticipated that the first few modules will be complete by early autumn and the remainder of the modules will be incrementally released s
9. ultrasonic bath regularly at least each morning afternoon session or more frequently if there is a high throughput of contaminated instruments Remember that RO and distillation equipment need regular maintenance too check the manufacturer s instructions 4 Ensure that decontamination equipment is tested regularly to ensure that it is working Is your steriliser working properly If not all your work counts for nothing Get your sterilizer tested now and get it serviced quarterly by a qualified person Do you know if your ultrasonic cleaner is actually working You can carry out a test for your ultrasonic bath now and add this to your maintenance contract 5 Ensure that the load to be sterilized is appropriate for the type of sterilizer being used Don t wrap instruments or place them inside a solid bowl before sterilising in a bowl amp instrument type sterilizer also known as an unwrapped instruments and utensils sterilizer they won t sterilise reliably Only wrap before sterilising if you have a vacuum or forced air removal type steriliser if in doubt consult the instructions If you are wrapping after sterilization remember to visually check instruments for dryness first 6 Ensure you have pressure vessel insurance for pressure vessels in your practice If you have a steam sterilizer of any type you are legally required to have specific pressure vessel insurance NB standard generic insurance policies do no
10. 4 21 B LOCAL DECONTAMINATION OF RE USABLE SURGICAL INSTRUMENTS AND OTHER RE USABLE MEDICAL DEVICES A number of guidance documents have been issued from various sources in the past few years This is also an evolving field and new guidance will of necessity be required as the underpinning science develops The main source of advice for NHS Scotland is the Glennie Group and its Primary Care Strategy Subgroup The current document aims to pull the relevant sources together and to outline in straightforward pragmatic terms the critical issues to address in upgrading premises equipment and ways of working The main practical guidance document for local decontamination is Local Decontamination Units Guidance on the Requirements for Equipment Facilities and Management LDUG produced by Health Protection Scotland for the Glennie Group it runs to 57 pages and should be downloaded as a reference resource It is available at http www show scot nhs uk scieh infectious hai decontamination documents LDU_Guidance 190105_Local 20Decontamination 20Units 20Guidance pdf or can be obtained in hard copy from HPS see Annex 2 for addresses and HPS decontamination website Specific numbered sections of this guidance are referred to below as e g LDUG 2 2 The LDU guidance in turn refers on to the appropriate Scottish Health Technical Memorandum SHTM documents which are more detailed still and outline the various regulatory requirements 1 Up
11. MPs undertake a variety of surgical and investigative procedures as well as suture of wounds all of which require sterile equipment Other visiting practitioners e g podiatrists may also undertake such procedures on the premises To meet national standards relating to safe working practices for practitioners and patients GMPs are advised to assess their procedures and to carry out an appraisal of the best option for their practice In order of preference these options are 1 Employ only single use instruments and other medical devices sterile supplies and dressings 2 Reprocess instruments and medical devices via a Central Decontamination Unit CDU if this is available locally 3 If neither of these options is operationally or financially viable establish a local decontamination unit LDU which is compliant with current regulations and guidance The key message is that GMPs should only undertake local decontamination as an option of last resort It may be that a combination of options represents the best solution for some practices An option appraisal framework is available within the document Local Decontamination Units Guidance on the Requirements for Equipment Facilities and Management produced by Health Protection Scotland for the Glennie Group http www show scot nhs uk scieh infectious hai decontamination documents LDU_Guidance 251005LDUGuidance pdf Single use instruments are now available in wide variety and
12. and does not aid cleaning abrasive cleaners can cause scratches which can trap contamination 9 Staff involved in decontamination should wear suitable personal protective equipment eye and mouth protection gloves waterproof apron Remember that good hand hygiene and basic infection control precautions are essential for staff and patient safety 10 When buying new instruments always check with the supplier that they are compatible with your own decontamination processes Some instruments have very specific requirements for decontamination If you can t meet these requirements given the facilities and procedures you use locally decontamination may be ineffective and the manufacturer s warranty may be invalid Scottish Executive Health Department November 2004 ANNEX 2 Further sources of information on local decontamination 1 Sources of Support and Advice e Authorised Person s Sterilizers name dependent upon NHS Board area Health Protection Scotland 1 Cadogan Square Cadogan Street Glasgow G2 7HF Tel 0141 300 1945 e mail decon_team hps scot nhs uk e Local Responsible Person Decontamination Equipment e g Principal Engineer Primary Care Community Health Divisions or other designated person s responsible for Decontamination equipment e Sterile Service Managers via NHS Board Head Offices e Public Health Infection Control Nurse or Infection Control Nurse as appropriate via NHS Board Head Office
13. d testing as specified in SHTM 2010 is followed Most practices use non vacuum sterilizers Recommended equipment is available through national contracts Scottish Healthcare Supplies can advise 031 275 6000 sterap shs csa scot nhs uk In order to quality assure the process the sterilizer must be able to record pressure and temperature achieved during the sterilising cycle via an independent process verification recorder These data should act as a permanent record whether as paper or as a dated computer record This should be specified in the contract when buying as should installation and validation to SHTM 2010 Sterilization similar to section 2 1 above Recorders can also be retrofitted to some existing sterilizers Whichever machine you use it is essential that daily weekly quarterly and annual testing is performed and recorded in a sterilizer logbook A sterilizer equipped with an independent process verification recorder makes the process of record keeping easier Further detailed guidance relating to local decontamination equipment available on central contract MEK 005 CONTRACT Benchtop Sterilizers Ultrasonic Cleaners amp Benchtop Washer Disinfectors will be available in the very near future NB Remember that separate specific Pressure Vessel Insurance is a legal requirement Pressure Vessel Indemnity must be in place and the sterilizer inspected by a Competent Person Pressure Vessels at least once in every 14 months I
14. e pAr reac e mie Rapizyme Ltd a Ltd Enzymatic Cleaner PO Box 432 Richmond TW9 2YR Date 03 May 2005 11 Model layouts for local decontamination facilities Health Protection Scotland ANNEX 4 The options considered are Typical existing unsatisfactory layout all decontamination activity in treatment room compare option 5 for workflow space oJ e e All decontamination activity in treatment room e Separate facility for dirty process for single treatment room 2 options e Separate facility for dirty process for multiple treatment rooms e Separate facility for all decontamination activity single room B amp I Treatment kia zone eg sterilizer dental chair e Separate facility for all decontamination activity single room Vacuum sterilizer Ultrasonic Sink e Separate two room decontamination facility with pass through WD Seii erilizer Ene Note PPE Personal Protective Equipment We Segregation of dirty decontamination activity from patient area Segregation of dirty decontamination activity from patient area 2 Single treatment room decontamination room Option A Single treatment room Decontamination area Option B Product flow Product flow Hatch ee tt rh pita Hatch tates Treat room amp eee eae ee ee Cleandecon eee Treat room amp ee Pere poner Clean decon es ae Dirty Decon J ae l 4 ad Dirty Decon e A T
15. e taken by practices in advance of being fully compliant to the TRs and investigate the real issues preventing practices from being compliant Membership of this group will include a number of GDPs as well as representatives from Health Protection Scotland Health Facilities Scotland NHS Education Scotland and P CAT auditors Advice on the decontamination of re usable surgical instruments and other re usable medical devices in General Medical Practice 19 Annex A contains a paper prepared by the Primary Care Sub Group to provide advice on the decontamination of re usable surgical instruments and other re usable medical devices in General Medical Practice Please ensure that copies of this Annex are made available top General Medical Practitioners and Practice Managers Action 20 NHS Board Chief Executives should comply with the revised compliance dates and bring the contents of this HDL to the attention of o All General Medical and Dental Practitioners podiatrists optometrists and other healthcare professionals engaged in the local decontamination of re useable instruments o Practice Managers Infection Control Managers for onward dissemination to infection control teams and those involved in local decontamination Sterile Services Managers Directors of Public Health Consultants in Public Health Medicine CD amp EH Consultants in Dental Public Health Clinical Directors of Dental Services Risk Management Committees
16. for cleaning and manual cleaning alone is acceptable as a third if least good option Manual cleaning is variable in quality and cannot be quality controlled It also poses potential health amp safety risks to staff e g through injuries to hands and generation of aerosols LDUG 2 17 4 3 3 Cleaning brushes should be single use or thoroughly cleaned and stored dry after use 3 2 Detergents for cleaning instruments Detergents specifically formulated for manual or ultrasonic cleaning of instruments should always be used Note that chlorhexidine e g Hibitane handscrub washing up liquid cleaning creams or soap should not be used chlorhexidine in particular makes proteins stick to steel Examples of suitable products are available on the FAQs page of the HPS decontamination website the current version and the web address are attached at Annex 3 3 3 Buying new instruments LDUG 2 1 Before purchasing new instruments you should check with the manufacturer or supplier whether they are compatible with the decontamination processes available to you If not another brand or type of instrument should be chosen 3 4 Single use instruments designated by Dina Practitioners must agree practice policies protocols with staff so that every member of the practice team is aware of which instruments are single use and which are designed for reuse after decontamination Items designated as single use must never be re processed and should be disp
17. grading premises and equipment to provide suitable decontamination facilities GMPs work in a variety of premises with varying available space and room shapes that can compromise the adoption of ideal solutions Whilst some practices have invested heavily in refurbishment or have moved to new premises they may continue to have fundamentally unsuitable decontamination facilities through simply not being aware of basic principles Any practice looking to develop a new facility should ensure that this meets all the requirements and regulations and have all plans appropriately scrutinised See Section 1 3 Many if not most General Practices undertake manual cleaning of instruments prior to sterilizing in a bench top sterilizer While this may suffice and in a few instances is the only method of cleaning for some equipment where this is the manufacturer s instruction it is not sustainable in the long term for the reasons stated in Section 3 1 Facilities and equipment should be upgraded to move away from manual cleaning to use of automated washer disinfectors See Section 2 1 1 1 The ideal facility The ideal set up is a dedicated room or rooms for decontamination which is separate from patient treatment rooms that is designed to establish a dirty to clean workflow LDUG 2 2 The best arrangement would comprise a single run of sealed easily cleaned worktop with in order e a setting down area for dirty instruments e ultra
18. high quality These are increasingly available through national contracts which seek to minimise costs for NHSScotland Disposal of single use instruments should be in accordance with Scottish Hospital Technical Note 3 SHTN3 Management and Disposal of Clinical Waste see Annex 2 for links NHS Board Decontamination Advisers and or Infection Control Teams will be able to advise practices on assessing the safest and most cost effective ways of ensuring the necessary supply of appropriate instruments whether as disposable or from a CDU The remainder of the current document is aimed at those practices who for various reasons wish to or have to undertake local decontamination within their own premises This is a complex and costly process and it is regulated by numerous technical standards and regulations that have to be met by those undertaking decontamination It is very important to note that the GMS Contract requires all practitioners to undertake decontamination in line with current guidelines and regulations running a compliant Local Decontamination Unit is neither a cheap nor an easy option This document aims to give a simple overview and broad principles with direction towards specific technical resources and sources of advice for tackling any specific issues It also meshes with the ten priority areas for action attached for information at the end of this advice note as Annex 1 which were circulated with the CMO CDO Letter CMO 200
19. ice on this in the near future http www show scot nhs uk scieh infectious hai decontamination haidecon htm WDs all require to be commissioned on site prior to use by a suitably qualified person they are not plug in and use machines and believing that they are is a common and expensive mistake It has to be the correct machine for your needs correctly installed in the right location with the right plumbing connections and formally commissioned When purchasing WDs make sure you specify that installation and commissioning to SHTM 2030 Washer Disinfectors is part of the contract You should also insist on a validation certificate signed by the qualified Test Person Sterilizers which should then be signed off by an Authorised Person Sterilizers for your records LDUG 3 5 Staff will require training in proper and safe use of WDs as they do for all decontamination equipment Additional staff time required for daily testing and maintenance of WDs will be offset at least in part by the savings on time spent manually cleaning instruments The cycle time will depend on the type of machine purchased and particularly on whether a there is a drying stage 2 2 Steam sterilizers LDUG 2 10 2 16 22 2 16 29 Vacuum wrapped instrument sterilizers and non vacuum unwrapped instrument amp utensil sterilizers are suitable for instrument decontamination provided that national guidance on validation maintenance an
20. in line with dates for submission of action plans It is highly advised that the SQL Scripts are installed and executed by IT professionals In order to run the SQL Scripts NHS Boards require Microsoft SQL Server software 10 Action plans for directly managed units after the data has been processed by the SQL Scripts any test sites and independent contractor sites will have to be identified and removed from the results Please refer to user manual Action plans for independent contractor sites after the data has been processed by the SQL Scripts any test sites and directly managed units will have to be identified and removed from the results Again please refer to user manual Further support is available from HPS Robert Heaney Systems Developer Decon_Team hps scot nhs uk or Tel 0141 300 1945 11 It is anticipated that through the combined processes of risk management and corrective action both the standard and safety of decontamination practices will be significantly improved NHS boards which feel that they cannot comply with any of the deadlines within this revised timescale should notify Ross Scott see contact details on the front page by Friday 21 July 2006 explaining why the deadline s cannot be met and seek agreement to an alternative deadline s The P CAT Audit Tool Training 12 HPS ran a very successful 3 week course last October to train staff to carry out P CAT audits Since then HPS has provided support to the
21. n DB2000 04 Single use Medical Devices Implications and Consequences of Reuse http www mhra gov uk home idcplg IdcService SS_GET_PAGE amp useSecondary tr ue amp ssDocName CON007348 amp ssTargetNodeld 572 e MDA Bulletin DB2002 06 Benchtop Steam Sterilizers Guidance on Purchase Operation and Maintenance http www mhra gov uk home idcplg IdcService SS_GET_PAGE amp useSecondary tr ue amp ssDocName CON007326 amp ssTargetNodeld 572 10 ANNEX 3 Detergents for manual cleaning of instruments advice from Health Protection Scotland May 2005 check FAQs page of the HPS decontamination website for updates at http www show scot nhs uk scieh infectious hai decontamination faq htm decontamination REQUENTLY ASKED QUESTION FAQ ID FQ_008 00 Topic Annex 2 point 5 of the CMO CDP letter SEHD CMO 2004 21 Detergents and manual washing Where can suitable suppliers be sourced to purchase the appropriate detergent to undertake manual cleaning of instrument if required Question Annex 2 point 5 of the CMO CDP letter SEHD CMO 2004 21 Detergents and manual washing Where can suitable suppliers be sourced to purchase the appropriate detergent to undertake manual cleaning of instrument if required Answer Suitable detergents are available from most of the major detergent suppliers Examples include Detergent Supplier Haemarinz contact www westons com Neutracon www decon co uk Haemosol w
22. on allows Boards to complete the corresponding action plans for the required phase The action plan is populated with the corresponding non compliances for each phase ve Boards are required to enter the following data into each of the action plans for each applicable non compliance o Number of sites per non compliance by 31 July this will be the number of Directly Managed Units per non compliance Risk level high medium low Has a risk assessment been carried out Corrective action required Timescale for resolution e g 0 3 months 3 6 months or 6 12 months Action by Estimated completion date Estimated cost Priority high 1 medium 2 or low 3 O0O000000 0 When submitting Action Plans Boards will be required to explain instances where for example a high risk non compliance has an estimated completion date of more than 3 months or is not assigned a high priority 8 Each of the three SQL Scripts covers each of the sections in the Primary Care Audit Tool and identifies a range of non compliances some of which will require planning and investment as well as other non compliances requiring more simple action 9 These scripts associated user documentation and standardised action plans are available on request from HPS Decontamination Team Administration Decon Team hps scot nhs uk or Tel 0141 300 1945 The release dates of this software and supporting documents will be staggered
23. oon thereafter Further details about publicity and roll out will be provided in due course Scottish Health Planning Note 13 15 Health Facilities Scotland has been commissioned to prepare guidance for NHSScotland on the provision management and operation of decontamination facilities in both acute and primary care settings The guidance which will be badged as SHPN 13 Decontamination Facilities and will cover two main areas o Planning and design of decontamination facilities including those in primary care settings and o Management and operation of decontamination facilities including those in primary care settings 16 HFS aim to issue a draft of the note on primary care by the end of July Audit of SPS 17 There has been some confusion over where responsibility lies for the P CAT audit of facilities within prisons This is a very high risk population in terms of HIV amp hepatitis therefore it is extremely important that infection control decontamination processes are robust This matter is currently under discussion with SPS 4 18 A New Glennie Sub Group for Decontamination Requirements 19 Following recent discussions with Dental Practitioner decontamination representatives it has been agreed that a new short life group meet to review the current position with regards Glennie Technical Requirements TRs for GDPs This group will also address advice available to Dental Practitioners on the interim steps required to b
24. osed of after use Policies should detail the procedures for safe disposal See links in Annex 2 SHTN3 and DB 2000 04 3 5 Education and training in local decontamination LDUG 2 17 1 All personnel carrying out decontamination processes should have a formally documented training needs assessment and a record of training received in accordance with the Glennie requirements LDUG 1 2 17 2 NHS Education for Scotland NES in collaboration with Health Protection Scotland HPS are developing a new practice based training package the first modules of which should be available later this financial year 3 6 Priorities for action relating to current practice Following the national survey of dental decontamination reported in 2004 all general dental and medical practitioners were asked to ensure that ten basic points of good everyday practice in local decontamination were addressed as outlined by the letter from the Chief Medical and Dental Officers CMO 2004 21 dated 25 November 2004 Many of the points in the current document were raised in that circular The text of the priorities for immediate action also developed by the Primary Care Strategy Subgroup is reproduced below as Annex 1 Scottish Executive Health Department July 2006 CMO CDO letter CMO 2004 21 ANNEX 1 Local Decontamination of Instruments in Primary Care and Related Settings Please share and discuss these priorities with all members of your team and regularly review and
25. reatment el Ren zone eg ee POX aid i a Treatment e EER dental chair trta t zone eg fe e dental chair B WD Ultrasonic Ji C Sterilizer amp WD Ultrasonic p EEA Sink B amp l orVac WHB EA Sterilizer 12 Sink B amp I or Vac WEE Segregation of dirty decontamination activity from patient area Decontamination area serving one or more surgeries Treat room amp fered fete a Clean decon Dirty Decon Treatment B amp I zone eg dental chair Ultrasonic WD Sterilizer 4 B amp I or Vac WHB gt Used devices Transfer in EES sm amp gt Clean non sterile devices Lidded containers Single room for local decontamination bowl and instrument sterilizer 5 Sterilized devices only BEEBE BES SSE DIRTY ZONE CLEAN ZONE Put down Clean Rinse Inspect Sterilize Pack store Ea fq m Be Bal PRODUCT FLOW Air flow PERSONNEL PE Sterilizer Ultrasonic ee Dirty Decon Clean Decon fa Treatment D WHB knd Sink B zone eg Treat room dental chair Single room for local decontamination vacuum sterilizer Sterile devices invasive procedures possible BEEBE EEE G DIRTY ZONE i i CLEAN ZONE nspect Put down Clean Rinse iva pack Sterilize Store I gs Ee vac PRODUCT FLOW Air flow PERSONNEL
26. s e Decontamination technical enquiry service at Health Protection Scotland previously SCIEH 1 Cadogan Square Cadogan Street Glasgow G2 7HF Tel 0141 300 1945 email decon_team hps scot nhs uk e Primary Care Community Health Division Decontamination Groups where Medical and Dental practitioners along with other service providers are represented via NHS Board Head Offices 2 Useful Websites e Health Protection Scotland decontamination pages http www show scot nhs uk scieh infectious hai decontamination haidecon htm e The Glennie Report 2001 Appendix DIA Decontamination technical requirements section on low risk category http www show scot nhs uk sehd publications sspr sspr 11 htm e The Glennie Report 2001 Appendix D3 Protocol for local decontamination of surgical instruments http www show scot nhs uk sehd publications sspr sspr 14 htm e Standard Infection Control Precautions http www show scot nhs uk scieh infectious hai infection_control SICP StandardPrecautions htm e CMO CDO Letter CMO 2004 21 full text http www show scot nhs uk sehd cmo CMO 2004 21 pdf e SHTM 2010 and 2030 http www show scot nhs uk pef guest decontamination CD Ver2 Contents1 pdf e Scottish Hospital Technical Note 3 SHTN3 Management and Disposal of Clinical Waste http www pef scot nhs uk guest or NHSnet users only http www pef scot nhs uk secure clinicalwaste SHTN3 V4 index htm e Medical Devices Agency Bulleti
27. sonic cleaner e a washing sink with detergent dispenser e a setting down area for manually cleaned instruments e arinsing sink e a setting down area for rinsed instruments e an automated washer disinfector e a setting down area for machine processed and or manually cleaned rinsed instruments with task lighting for inspection for visible contamination and functionality damage LDUG 2 8 e an area for wrapping instruments prior to sterilization in a vacuum sterilizer e asteam sterilizer e an area for setting down and wrapping sterilised instruments LDUG 2 9 2 11 e clean dry orderly storage for instruments prior to use LDUG 2 12 e arrangements for safe transport of instruments to the clinical area in a clean rigid box with lid LDUG 2 13 1 NB the few practices using a vacuum Sterilizer would wrap instruments before sterilizing Some suggested layouts are given in Annex 4 the above basic system within a single room is represented there by option 5 The provision of an additional dedicated wash hand basin and personal protective equipment storage is important for infection control and staff safety There are currently no national standards or formal guidance on air quality ventilation for local decontamination units although further information will be contained within the forthcoming Scottish Health Planning Note on local decontamination SHPN 13 Where ventilation is used it should be installed to ensure that air
28. t cover this Your insurance broker or Primary Care Estates advisor can help There may be local discounts for bulk policy purchase available 7 Ensure the layout of your decontamination facility is fit for purpose Decontamination should be segregated from other activities so that cross contamination cannot occur The flow of work should be a one way trip from dirty at one end of the bench to sterile at the other Don t splash or drip dirty water onto sterilised instruments or onto the surfaces they will be laid out on If space is short clean up between parts of the process Don t use the same sink for cleaning instruments prior to sterilisation and other activities e g general cleaning food drink preparation hand washing and especially keep cups and plates well away from where they could be splashed while cleaning dirty instruments If you have only one all purpose sink use dedicated bowls to clean and rinse instruments as an interim measure and decontaminate the bowls regularly When cleaning instruments by hand keep brush and instruments under the water while scrubbing to prevent splashes and aerosols 8 Use the correct detergent solution for manual cleaning Use a neutral detergent intended for use with medical devices at the correct amount in the right volume of water at a hand hot temperature Plain water won t do the job Don t use inappropriate cleaning agents chlorhexidine hand scrub makes proteins stick to metal
29. t is a mandatory requirement by law that a written scheme of examination is available with each sterilizer pressure vessel in line with the Pressure Systems Safety Regulations 2000 Your insurance company who provides 3 party liability for the pressure vessel should be able to provide this service 2 3 Water for use in steam sterilizers and washer disinfectors Steam sterilizers The requirement SHTM 2031 Clean steam for sterilization and SHTM 2010 is for water that is free of chemicals and pyrogens Tap water is not suitable on either count this must be Sterile Water for Irrigation BP or freshly produced reverse osmosis RO water or freshly produced distilled water Seek guidance before purchasing RO or distilled water units Washer disinfectors To avoid recontamination of instruments following a thermal disinfection cycle in a WD water that meets the requirements of the current LDU guidance should be used The preferred option is RO water from a properly maintained system Cleaned washed instruments should ideally be rinsed in this same quality of water prior to sterilization but mains tap water is acceptable for this purpose if instruments are dried before sterilization LDUG 2 7 3 Clarification of other related issues 3 1 Manual cleaning of instruments LDUG 2 5 2 16 1 The best option to ensure quality and consistency of cleaning is to use an automated washer disinfector WD the next best is to use an ultrasonic bath
30. ww barberofsheffield co uk Alconox www alconox com UK dealer PC International Ltd 01223 893402 Please note that a this is not a comprehensive list and b listing a manufacturer or product here is NOT an endorsement of the product c other suppliers should be able to provide suitable products also you may wish to ask your usual supplier to suggest products that meet the specification given in the letter NB 1 A neutral detergent is regarded as one that has a pH within the approximate range of PH 5 to pH 9 when diluted in accordance with the manufacturer s in use specification High pH detergents 9i e greater than pH 10 at the in use dilution are unsuitable for use on devices made of aluminium NB 2 If you know of other detergent products from other suppliers that meet the criteria please email us with details at Decon _Team hps scot nhs uk e Decon 90 was previously cited in error Although Decon 90 is suitable for cleaning typical instruments it is a high pH detergent A recent survey of detergent manufacturers undertaken by the Glasgow Dental Hospital has identified further products that the manufacturer claims are suitable for ultrasonic and por manual cleaning of instruments see below The material Safety Data sheet should be consulted and appropriate measures for the safety of staff put in place COSHH before a ces Cleaning Biosonic UC30 Coltene Whaledent http wwww coltenewhaledent Yes E imali a i a paint osonic e mi
31. x 4 option 5 provides a suitable approach to layout 1 3 Getting it right It is important that basic requirements are taken into consideration at the design stage dedicated space two sinks with an additional separate wash hand basin adequate work surface layout which facilitates dirty to clean workflow ventilation suitable storage for sterilised instruments detergents disinfectants cleaning brushes personal protective equipment storage for water or space for RO still units suitable plumbing and bench space for ultrasonic washers washer disinfector and sterilizers If you are contemplating refurbishment upgrading work please contact your NHS Board Decontamination Advisor and Infection Control Team The Health Protection Scotland Decontamination Team can advise on technical and design issues 0141 300 1945 Decon_team hps scot nhs uk Scottish Healthcare Supplies can advise on procurement of decontamination equipment 031 275 6000 sterap shs csa scot nhs uk 2 Decontamination equipment including installation and commissioning 2 1 Washer disinfectors WDs LDUG 2 16 8 It is intended that as many sites as possible move to using automated washer disinfectors WDs within the next three years There are now some suitable benchtop models on the market but seek advice on recommended best options from Scottish Healthcare Supplies or Health Protection Scotland see Annex 2 The HPS decontamination website will include adv
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