POLICY FOR THE DECONTAMINATION OF MEDICAL AND NON MEDICAL DEVICES.

Transcription

1 POLICY FOR THE DECONTAMINATION OF MEDICAL AND NON MEDICAL DEVICES. Version Number 6 Post Holder responsible for Policy: Directorate responsible for Policy: SERVICES Sterile Services Manager and Lead on Decontamination CLINICAL SUPPORT AND FAMILY Contact details: Peter Wells, Lead on Decontamination, Salisbury District Hospital Date written: November 2004 Date revised: September 2011 Approved by: Ratified by: Decontamination Group, Infection Prevention, Control Working Group and Infection and Prevention Control Committee CMB Date approved: September 2011 Next due for revision: September 2014

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3 Table of Contents 1. INTRODUCTION DEFINITIONS DECONTAMINATION RESPONSIBILITIES Chief Executive Executive Manager General Manager Estates Technical Services Decontamination and Sterile Services Manager (Decontamination Lead Manager) User Operator Directorate Management Teams (Directorate Managers and Senior s) Director of Infection Prevention and Control (DIPC) Infection Control Doctor (ICD) Microbiologist (Decontamination) Specialist Technical Roles Authorising Engineer (Decontamination) (AE(D)) Authorised Person (Decontamination) (AP(D)) Competent Person (Decontamination) (CP(D)) Competent Person (Pressure Systems) RISK CATEGORIES FOR DECONTAMINATION Training DETERGENTS AND DISINFECTANTS Detergents General Cleaning with Detergent (See Appendix J) Chemical Disinfectants Chlorine-Releasing Preparations (Hypochlorite) (e.g. Chlor-Clean, Titan Sanitizer, Actichlor) Alcohols General Guidance on the Use of Detergents and Disinfectants PURCHASE OF EQUIPMENT MEDICAL DEVICES/SURGICAL INSTRUMENTS Re-Usable Medical Device Life Cycle Handling, collection, decontamination and transportation of used instrumentation (HSC 2000/032) Reprocessing of Medical Devices Loan of Equipment to, and from, external sources Centralised Service WHO TO ASK FOR ADVICE Patient equipment: General decontamination advice: Medical Devices/Surgical instruments: Medical Devices/Electronic: Decontamination processing equipment: REFERENCES Key Legislation Department of Health Policy / Advice / Guidance / Reports Other Appendices - Index i P a g e

4 10.1 APPENDIX A - Decontamination Group membership and terms of reference APPENDIX B - Functional responsibilities and Decontamination Organisational Chart APPENDIX C - Colour Coding for Cloths APPENDIX D - Disinfectant and Cleaning Agents APPENDIX E - Colour Coding Chart for Mops APPENDIX F - Colour Coding for linen bags APPENDIX G - Hand Decontamination Technique APPENDIX H - NHS Estates Local Instrument Washing Protocol APPENDIX I - Graphic labelling of Medical Devices EN APPENDIX J - Decontamination A Z APPENDIX K - The Decontamination, storage and use of flexible and rigid endoscopes APPENDIX L - Decontamination of Healthcare Equipment for Serving or Repair APPENDIX M - NICE Guidance Patient safety and reduction of risk Transmission of Creutzfeldt-Jakob disease (CJD)...23 ii P a g e

5 Other relevant policies: INFECTION CONTROL POLICY HAND HYGIENE POLICY THE USE OF MEDICAL DEVICES DESIGNATED SINGLE OR LIMITED USE MEDICAL DEVICE MANAGEMENT POLICY WASTE MANAGEMENT POLICY CREUTZFELDT- JAKOB DISEASE (CJD) POLICY iii P a g e

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7 1. INTRODUCTION Healthcare associated infections (HCAIs) affect approximately one in ten patients in acute healthcare facilities. To maintain the safety of patients and staff, compliance with the Health Act (2006) (Health and Social Care Act revised 2010) standards and those laid out within the NHS Litigation Agency (NHSLA) standards, are essential in managing the risks posed by HCAIs. This policy and appendices relate to the decontamination of patient equipment, medical devices/surgical instruments, patient areas and endoscopes. The responsibility lies with the User for ensuring correct decontamination of all equipment takes place between patients. Decontamination is the combination of processes (including cleaning, disinfection and sterilisation) used to make a usable item safe for further use on patients and handling by staff. The effective decontamination of reusable items is essential in reducing the risk of transmission of infectious agents. The transmission of infection in association with equipment has long been recognised as a problem. Outbreaks of infection in hospital have been traced back to inadequate decontamination of equipment and the environment. Methods used to remove micro-organisms from hospital equipment and the environment are cleaning, disinfection and sterilisation. Staff have a duty of care to all patients, colleagues and themselves wherever possible to prevent and minimise the risks of infection/cross infection. This requires the physical environment surrounding the patient, the equipment used on the patient and procedures involving the patient, to be rendered as safe as possible. Bacteria, viruses, fungi and spores can all contaminate the hospital environment. The level of decontamination/disinfection depends on the situation involved. For instance, instrumentation of 'sterile areas' of the body, i.e. internal organs require sterile equipment. Cleaning of rooms may require disinfection and, intact skin cleansing, antisepsis, only. Definitions of these terms are given on the next page. 1 P a g e

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9 2. DEFINITIONS Further Definitions are shown in Section 3 and Appendix B Antiseptic A substance which will inhibit the growth and development of micro-organisms, but not including bacterial spores. Suitable for use on living tissue e.g. skin cleansing. Antiseptics are not suitable for environmental disinfection. Cleaning Removal of micro-organisms by cleaning with an approved detergent and hot water/disposable detergent wipe will sufficiently decontaminate most items of equipment. NB: Once items have been cleaned, they should be rinsed, dried and stored dry to prevent recontamination. Damp dusting is carried out above floor level using a disposable cloth/wipe that is moistened with clean water (and detergent). Dust will cling to it and thus avoid dispersal of micro-organisms. Contamination Contamination the soiling of inanimate objects or living material with harmful, potential infectious material. In the clinical situation this is most likely to be organic matter and micro-organisms but may also include inorganic substances such as dust. Such contamination may affect the function of the inanimate object and may also be transmitted to a susceptible host. Decontamination Decontamination is the combination of processes, including cleaning, disinfection and/or sterilisation used to render a re-useable medical device safe for further episodes of use. The level of decontamination depends on the situation involved. For instance, instrumentation used for sterile areas of the body (e.g. internal organs) require sterilisation whereas rooms may only require cleaning/disinfection and procedures on intact skin, antisepsis. Detergent An agent whose action in combination with cleaning removes dirt and the majority of microorganisms and in some cases may have antiseptic qualities. It may contain a deodorant. Disinfectant An agent that destroys micro-organisms including bacteria, viruses and parasites but not necessarily bacterial spores. Generally applied to inanimate objects. Heat is the most effective form of disinfection (e.g. water at 80 C). Chemical disinfectants should not be used when sterilisation is required unless the article is heat sensitive. NOTE: Organic material may inactivate disinfectants e.g. urine, faeces, blood, pus and vomit. Articles must be clean before being disinfected. Sterilisation The removal or destruction of all living microbes, bacteria, viruses, fungi and parasites including bacterial spores. Heat (autoclaving) is the method of choice. Chemical disinfection may only be used when autoclaving is not possible. Medical Device A medical device is any instrument, apparatus, appliance, material or other article whether used alone or in combination, intended by the manufacturer to be used for human beings for the purpose of: control of conception; diagnosis; prevention; monitoring; treatment or alleviation of or compensation for an injury or handicap; investigation replacement or modification of the anatomy or physiological process. Surgical instruments are medical devices (HSC 2000/032). Operator An Operator is defined as any person with the authority of the Trust [appointed by the User] to operate a washer-disinfector or a sterilizer, including the noting of instrument readings and simple housekeeping duties. (See 3.6) User The User is defined as the person designated by the Trust to be responsible for the management of the process. The User is also responsible for Operators. (See 3.5) 3 P a g e

10 Single Use/Single Patient Use/limited use Refer to Trust policy for this. See Appendix A for symbols. Patient Equipment For the purpose of this document the term patient equipment relates to items other than medical devices which are reusable and are used in the process of patient care, e.g., commodes, beds, blood pressure cuffs, trolleys. According to the MHRA these are medical devices Endoscopes Flexible and rigid endoscopes that are used in diagnostic and treatment procedures. Validation Equipment used for decontamination within the Trust, i.e. autoclaves, bedpan washers, AER s disinfector washers will be validated, serviced and maintained as described in HTM 01. Note Wearing of personal protective clothing/equipment as required is essential to undertaking these procedures. Personnel undertaking all decontamination/disinfection/sterilisation/cleaning procedures must have received training in the process. Where decontamination instructions are not available from a manufacturer / supplier, a risk assessment is required. 4 P a g e

11 3. DECONTAMINATION RESPONSIBILITIES (See Appendix A & Appendix B for further details) 3.1 Chief Executive Decontamination Policy September 2011 The Chief Executive has ultimate management responsibility, including allocation of resources and the appointment of personnel, for the Trust and ensuring legislation, current Department of Health policy / mandates and guidance is met and that where appropriate is implemented across the Trust. 3.2 Executive Manager In SFT this role is fulfilled by the Director of Nursing / Director of Infection Prevention & Control, who takes the lead and holds professional responsibility at Executive Board level for all aspects of decontamination within the Trust They works closely with the General Manager Estates Technical Services to ensure that provision is made to adequately support the Trust s decontamination service. Provides the essential senior management link between the organisation and the AE(D). 3.3 General Manager Estates Technical Services The General Manager Estates Technical Services fulfils the HTM role of Senior Operational Manager and is technically, professionally and managerially responsible for the engineering aspects of the decontamination service for the Trust 3.4 Decontamination and Sterile Services Manager (Decontamination Lead Manager) The Decontamination Lead is responsible for the implementation of an operational policy for decontamination. He/she should ensure that the operational policy clearly defines the roles and responsibilities of all personnel who may be involved in the use, installation and maintenance of decontamination equipment. The Decontamination Lead is also responsible for monitoring the implementation of the policy. The Decontamination Lead may delegate specific responsibilities to key personnel; the extent of such delegation should be clearly set out in the operational policy together with the arrangements for liaison and monitoring. 3.5 User The User is defined as the person designated by the Trust to be responsible for the management of the process. The User is also responsible for Operators. The principal responsibilities of the User are as follows: To certify that the decontamination equipment is fit for use To hold all documentation relating to the decontamination equipment, including the names of other key personnel To ensure that decontamination equipment is subject to periodic testing and maintenance To appoint operators where required and ensure that they are adequately trained To maintain production records To establish procedures for product release in line with the quality management system To ensure that procedures for production, quality control and safe working are documented and adhered to in the light of statutory requirements and accepted best practice. The User may seek the advice of infection control teams, which may consist of a Director of Infection Prevention and Control, Control of Infection Officer or Microbiologist (Decontamination). 3.6 Operator An Operator is defined as any person with the authority of the Trust [appointed by the User] to operate a washer-disinfector or a sterilizer, including the noting of instrument readings and simple housekeeping duties. 3.7 Directorate Management Teams (Directorate Managers and Senior s) Actively work towards compliance with this policy. 5 P a g e

12 Ensure that prior to purchasing all new medical equipment advice is sought regarding manufacturers' decontamination guidance, consulting appropriately with the Decontamination Lead and AP(D). Ensure the Trust has the facilities to achieve compliance with this advice. Ensure that equipment is compliant with the Medical Devices Directive, bear the CE marking or suitable alternative and comply with British/ European Standards. Ensure that equipment is adequately maintained by internal or external sources according to manufacturer s guidance and a maintenance log is held. This will include ensuring documented procedures are followed in line with HTM 2030, HTM 2010 and HTM 01 in areas where washer disinfectors and/or sterilisers are used. Comply with Trust guidelines re Single / Limited Use Devices. (Please refer to the Trust Policy for the use of medical devices designed as single use, single patient use or limited use.) Have the responsibility to ensure that relevant risk assessments are undertaken in all clinical areas; these should incorporate identifying all equipment decontaminated within the clinical area and ensuring that proper processes have been identified to minimise risks of transmission of infection to patients and staff. 3.8 Director of Infection Prevention and Control (DIPC) The Director of Infection Prevention and Control reports to the chief executive and the board. He/she is responsible for infection control aspects of decontamination. 3.9 Infection Control Doctor (ICD) The Infection Control Doctor (ICD) is defined as a person designated by Management to be responsible for advising the User on all infection control aspects Microbiologist (Decontamination) The Microbiologist (Decontamination) is defined as a person designated by the Trust to be responsible for advising the User on microbiological aspects of disinfecting and sterilizing nonmedicinal products. He/she should also be defined as the person responsible for advising the User on the microbiological aspects of handling, washing, disinfecting and sterilizing used medical devices. The principal responsibilities of the Microbiologist (Decontamination) are as follows: to advise the User on the microbiological aspects of decontamination procedures for non-medicinal products to audit the documentation from all decontamination equipment that has been tested by microbiological methods Specialist Technical Roles Authorising Engineer (Decontamination) (AE(D)) The AE(D) is a suitably qualified independent professional advisor 1 retained by the Trust to provide independent auditing and advice on washer-disinfectors, sterilizers and sterilization and to review and witness documentation on validation. The AE(D) is required to liaise closely with other professionals in various disciplines across the Trust Authorised Person (Decontamination) (AP(D)) The AP(D) is an individual possessing adequate technical knowledge and having received appropriate training, appointed in writing by the Executive Manager (in conjunction with the advice provided by the AE(D)), who is responsible for the practical implementation and operation of the Trusts Health & Safety Policy and procedures relating to the engineering aspects of decontamination equipment as described in HTM 01-01, HTM 2010, 2030 and other documentation,. 1 The Institution of Healthcare Engineering and Estates Management (IHEEM) sets professional standards for AE(D) voluntary registration and for the accreditation of training courses, as was the case for the former Health Technical Memorandum 2010-defined AP(S) role. The Department of Health set the technical standards as relevant. 6 P a g e

13 Competent Person (Decontamination) (CP(D)) Decontamination Policy September 2011 The CP(D) is defined as a person designated by the Trust via the AP(D) to carry out maintenance, validation and periodic testing of washer-disinfectors and sterilizers. To ensure that appropriate cover is provided more than one CP(D) will be appointed. CPs(D) will be appointed from the pool of multi skilled engineering technicians in ETS Competent Person (Pressure Systems) The Competent Person (Pressure Systems) is an external advisor retained by the Trust to provide an independent in-service inspection of pressure equipment as required by the Pressure Systems Safety Regulations The CP (PS) also advises on the scope written scheme of examination; draws up the written scheme and certifies it. The service will be provided by a body with UKAS accreditation to BS EN 5004: 1995, for the scope of in-service inspection of pressure equipment. This person must not be the User. The decontamination structure for the Trust is shown overleaf 7 P a g e

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15 Chief Executive Trust Executive Board Director of Infection Prevention and Control Joint Board of Directors Facilities Director General Manager ETS / SDU Infection Prevention & Control Committee Medical Devices Committee Authorising Engineer (Decontamination) Estate Operations Manager Decon Lead / SDU Manager Decontamination Working Group Technology Working Groups Authorised Person (Decontamination) SDU Production Manager Competent Persons (Decontamination) SDU Decon. Eqpt. Operators Ward / Dept Decon. Eqpt. Operators ETS and SDU Line Management Responsibility 08/07/2011 Decontamination Structure Rev 1 9 P a g e

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17 4. RISK CATEGORIES FOR DECONTAMINATION The following risk categories may be helpful, to aid staff in the choice of decontamination method to be used: Category Indication Level of Decontamination Items that penetrate Sterilise High Risk skin/mucous membranes or enter sterile body areas. e.g. surgical instruments and instruments that are single-use sterile disposable, e.g. needles, staple guns etc Methods Autoclave and use sterile, Dispose of single use Medium Risk Low Risk Items that have contact with mucous membranes or are contaminated by microbes that are easily transmitted. e.g. vaginal speculum. Endoscopes. Bedpans, crockery. Items used on intact skin. e.g. washbowls, mattresses. Disinfect or sterilise Chemically disinfect Pasteurise Clean Autoclave (not in packs) Preferably by Automated Endoscope Reprocessor Automatic washers Wash with detergent and hot water and dry 4.1 Training Staff training for decontamination will be given through various routes including the Trust Managed Learning Environment (MLE), Infection Prevention & Control Module or the on line National Decontamination Training Programme. 11 P a g e

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19 5. DETERGENTS AND DISINFECTANTS 5.1 Detergents The use of neutral or enzymatic detergents is recommended in accordance with manufacturer s instructions. Alternative detergents and disinfectants should not be purchased without the prior agreement of the Infection Prevention & Control Team (IPCT). The Control of Substances Hazardous to Health (COSHH) Regulations 2002 and amendment 2003 require an assessment to be made of the hazards involved in the use of any disinfectant. Material data safety sheets should be available from the manufacturer for all products used. COSHH Sheets are also available from the Occupational Health and Safety Department and must be kept in a COSHH folder which is easily accessible to all staff, and reviewed once a year Further advice concerning disinfectants and their use in the work area is available from the IPCT. (See References) General Cleaning with Detergent (See Appendix J) Supplies of neutral or enzymatic detergents (as appropriate) must be available in all areas. These are available from Hotel Services or the Supplies Department. Cleaning of articles with warm water and neutral detergent will increase the efficiency of any disinfectant used. Hot water and neutral detergent or disposable detergent wipes are acceptable for routine cleaning of patient equipment and the environment in wards and departments. If a surface is contaminated by blood or bloodstained body fluids, disinfection is required (see Appendix J). Warm water and either neutral or enzymatic detergents are used for the decontamination of endoscopes prior to disinfection. The manufacturer s instructions regarding the appropriate product must be followed. 5.2 Chemical Disinfectants Chlorine-Releasing Preparations (Hypochlorite) (e.g. Chlor-Clean, Titan Sanitizer, Actichlor) Solutions, once mixed, must be used within 24 hours. Solutions MUST be made up with warm/tepid water NOT hot to prevent the release of chlorine fumes. They may damage certain materials (e.g., some metals and fabrics). Avoid use on metallic equipment wherever possible. A dilution chart should be displayed in each clinical area. Preparations available include: hypochlorite tablets hypochlorite powder hypochlorite granules Guidance on Preparation of Hypochlorite Solutions Alcohols Freshly-prepared solutions should be made, as required, with effervescent hypochlorite tablets (Chlor-Clean). (See Appendix C) Manufacturers recommendations must be followed when preparing solutions. Alcohols are disinfectants that kill micro-organisms on drying. They should be used only on clean items as they penetrate poorly. (See Appendix C) Preparations available include: 70% alcohol-impregnated wipes 70% alcohol with glycerine hand rub 13 P a g e

20 Chemical Disinfectants for Endoscope Decontamination There are several disinfectants available for use. All disinfectants intended for use with medical devices, including endoscopes, must be CE marked. The disinfectant used must be agreed with the Infection Prevention & Control Committee and Decontamination Group. Prior to use staff must ensure that the disinfectant is compatible with the endoscopes and autowasher-disinfector machine to be used (MDA SN2001/28). Guidance for the use of the chemical disinfectants must be developed locally in accordance with manufacturer s instructions and Infection Control advice. These guidelines must be clearly displayed within the users department. (See Appendix J & Appendix K for further information). 5.3 General Guidance on the Use of Detergents and Disinfectants Relevant health and safety policies should be followed when handling disinfectants which may be caustic (COSHH 2003). If staff experience problems when using cleansing or disinfectant products (e.g. skin or respiratory) they must consult the Occupational Health and Safety Department. A risk assessment must be carried out when chemical disinfectants are in use. All areas must hold a COSHH file, which is easily accessible to all staff. COSHH documentation is available from Occupational Health and Safety Department. When cleaning contaminated equipment protective clothing must be worn. Disposable gloves must be worn when using disinfectants. Eye protection is necessary and should conform to BS 2092(C). (Nitrile gloves must be used when in contact with glutaraldehyde.) Any spillage or splashes of disinfectants should be dealt with promptly. After applying a surface disinfectant the area should be wiped with a cloth dampened with water to remove disinfectant residues. This is unnecessary after the use of alcohol sprays or wipes. (See Appendix C) Do not, under any circumstances, decant disinfectants/detergents/cleaning agents from one container to another because there is risk of: Mis-identification of substances Microbiological contamination ALWAYS wash or clean any pump dispensers prior to transfer between bottles. Pump dispensers are readily available from your Pharmacy Department or Procurement Department. 14 P a g e

21 6. PURCHASE OF EQUIPMENT Advice from the Medical Devices Committee and the Infection Prevention & Control Committee must be sought prior to the purchase of medical devices, patient equipment and other associated items. This can either be by seeking advice directly from IPCT or through the Trust Working Groups. Any decontamination equipment must only be procured in consultation with the Decontamination Lead and AP(D) 15 P a g e

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23 7. MEDICAL DEVICES/SURGICAL INSTRUMENTS The decontamination process is required to make medical devices safer for use on the patient and safe for staff members to handle. If manufacturers have not provided relevant instructions, the purchase / loan process must be stopped and a risk assessment must be performed to identify the method of decontamination of these devices, e.g., surgical instruments must be sterilised. 7.1 Re-Usable Medical Device Life Cycle ACQUISITION 1. Purchase 2. Loan TRANSPORT CLEANING DISINFECTION USE STORAGE At all stages: Location Facilities Equipment Management Policies/Procedures INSPECTION TRANSPORT STERILIZATION PACKAGING DISPOSAL 1. Scrap 2. Return to lender 7.2 Handling, collection, decontamination and transportation of used instrumentation (HSC 2000/032) Personnel must receive relevant training through CBT national training package and on the job practical training. Personal protective equipment (PPE) should be worn in accordance with the relevant Infection Control Precautions / Health & Safety Instructions which have been developed following Risk Assessment. Reusable devices must be separated from clinical waste at the point of use. Sharps should be removed and placed into approved containers conforming to BS7320 at the point of use. Reusable textiles should be placed in soiled linen bag and returned to laundry. (See Appendix F) Body fluids/contaminated liquids should be disposed of in the dirty utility room. Used medical devices awaiting collection by Sterilisation and Disinfection Unit, (SDU), should be confined and contained in labelled, closed, leak proof plastic bags/containers to avoid spills, generation of aerosols or contact with staff and environmental surfaces. Used medical devices should be transported as soon as possible to the appropriate decontamination area. Contaminated medical devices/equipment must be kept separate from clean medical devices/equipment during transportation. This can be achieved by using separate containers to provide physical barriers between clean and dirty items. Contaminated medical devices/equipment must only enter the SDU department through the decontamination area. There should be a tracking system in place to enable the identification of patients on whom instrument sets/endoscopes have been used. In the event of exposure to a potential risk patients can then be identified and appropriate action taken (DOH HSC 2000/032). 7.3 Reprocessing of Medical Devices Medical devices must be reprocessed using equipment (washer disinfectors, sterilisers etc.) that are subject to: planned preventative maintenance programme, periodic calibration and testing. In accordance with HTM2010, HTM2030, HTM2031 and HTM 01. Quality Control Systems should 17 P a g e

24 be in place in SDU facilities to ensure the required standards for decontamination are achieved. Bench top sterilisers are not recommended for use within local departments. 7.4 Loan of Equipment to, and from, external sources Managers must ensure that indemnity forms have been completed for any loaned or trialled equipment and that responsibilities for the equipment have been identified and documented. These forms are available from the Medical Devices Management Centre. Acceptance checking of equipment must be undertaken in accordance with manufacturer s instructions to include: instructions for use; list of contents; clear definition of responsibilities and maintenance/safety checks. Loan kit coming into the Trust must have a decontamination certificate provided by the previous User and clear instructions on decontamination requirements. After use, a Decontamination Certificate must be issued by this Trust for any loan or trial kit leaving Salisbury NHS Foundation Trust. Instruction regarding all aspects of decontamination of reusable equipment must accompany the equipment. Staff undertaking decontaminating, (disassembling etc,) or using the equipment for the first time, must receive relevant training. Decontamination of loan or trial equipment must be undertaken prior to and after use. Contaminated items must not be returned to originating departments or companies. 7.5 Centralised Service The Sterilisation and Disinfection Unit, (SDU), based on level 2 of the Salisbury District Hospital, provides the centralised decontamination service for instrumentation in Salisbury NHS Foundation Trust. This unit has accreditation for ISO EN 13485:2003, MDD 2007/43/EEC and ISO EN 9001:2008 which allows us to place goods on the market. (The department is audited biyearly by external auditors Notified Body on behalf of the MHRA.) Items requiring decontamination must be purchased in adequate quantities to allow the decontamination process described in section 8 to be undertaken in the SDU. The SDU will and record tracking of instrumentation during the decontamination process. The Trust will track trays and endoscopes to patients Sterilisers and washer disinfectors receive regular maintenance, servicing and calibration, by in house and external parties. The Trust will process flexible endoscopes in a centralised endoscopy decontamination facility. These areas will be audited by members of the Decontamination Committee. (See Appendix A). 18 P a g e

25 8. WHO TO ASK FOR ADVICE The following departments are able to give advice on decontamination procedures. 8.1 Patient equipment: Medical Devices Management Centre Ext or Infection Prevention & Control Team Ext General decontamination advice: Infection Prevention & Control Team Ext Decontamination and Sterile Services Manager Ext Medical Devices/Surgical instruments: Sterilisation and Disinfection Unit, Decontamination and Sterile Services Manager Ext Medical Devices/Electronic: Medical Electronics. Ext Decontamination processing equipment: Estates Technical Services Authorised Person (D). Ext Decontamination and Sterile Services Manager Ext P a g e

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27 9. REFERENCES 9.1 Key Legislation Health Act (2006) Consumer Protection Act (1987) Medical Devices Regulations (2002), amended 2003 The Health and Safety at Work etc. Act (1974) Control of Substances Hazardous to Health Regulations. (2003) Personal Protective Equipment Regulations (2002) Provision and Use of Workplace Equipment Regulations (1998) 9.2 Department of Health Policy / Advice / Guidance / Reports 9.3 Other 1. Department of Health. The Health and Social Care Act 2008 Code of Practice on the prevention and control of infections and related guidance. (revised 2010). 2. Department of Health. Health Technical Memorandum Decontamination of Reusable Medical Devices Part A: Management and environment, (2007) TSO, London 3. Department of Health Letter from CMO : 21ST February Department of Health. Health Technical Memorandum 00 - Best Practice Guidance for 5. Healthcare Engineering, (2006) TSO, London 6. Department of Health. The decontamination of surgical instruments in the 7. NHS in England update report: A Step Change, June Department of Health. Assessing the risk of vcjd via surgery: an interim review. Skipton House, London. March Medical Devices Agency. (2000). Handling of Surgical Instruments on Loan from another Organisation. MDA SN 2000(18). London, Department of Health. 10. Medical Devices Agency. (2000). Single Use Medical Devices: Implications and Consequences of Reuse. MDA DB 2000(04). London, Department of Health. 11. Department of Health. (2000). Decontamination Programme: Technical Manual. Leeds, NHS Engineering and Science Group/NHS Estates. 12. Health Service Circular. 1999/179 Controls Assurance in Infection Control: Decontamination of Medical Devices London, NHS Executive. 13. Health Service Circular. 1999/178. Variant Creutzfeldt-Jakob Disease (vcjd) Minimising the Risk of Transmission. London, NHS Executive. 14. Health Service Guidance. (1993). Reporting Adverse Incidents and Reactions and Defective Products Relating to Medical and Non-Medical Equipment and Supplies, Food, Buildings, Plants and Medicinal Products. HSG(93) Health Service Guidance. (1993). Decontamination of Equipment Prior to Inspection, Service or Repair. HSG(93) Health Circular. (1991). Decontamination of Equipment, Linen or Other Surfaces contaminated with Hepatitis B and/or Human Immunodeficiency Virus. HC(91) Medical Devices Agency. (2002). Compatibility of Medical Devices and Reprocessing Equipment with Decontamination Agents. MDA SN 2001(28). London, Department of Health. 18. Medical Devices Agency. (2002). Decontamination of Endoscopes. MDA DB 2002(05). London, Department of Health. 19. Medical Devices Agency. (2002). Management of loaned medical devices, equipment or accessories from manufacturers or other hospitals. MDA SN 2002(17). London, Department of Health. 20. Health Service Circular HSC 2001/005 Governance in the new NHS Controls 21. Assurance Statements 2000/2001 and Establishment of the Controls Assurance Support Unit 22. Health Service Circular HSC 2000/032 Decontamination of Medical Devices NHS Estates (1997) HTM2010 Sterilization:. Leeds, NHS Estates. 24. NHS Estates. (1997). HTM 2030 Washer Disinfectors:. Leeds, NHS Estates. 1. NICE guidance Patient Safety and reduction of risk of transmission of Creutzfeldt-Jakob Disease (CJD) via interventional procedures. Nov P a g e

28 2. Ayliffe, G. et al. (2000). Decontamination of minimally invasive surgical endoscopes and accessories. Report for the Minimal Access Therapy Decontamination Working Group. Journal of Hospital Infection. 45, The Report of an Independent Review of Endoscope Decontamination in Northern Ireland (March 2005) 22 P a g e

29 10. Appendices - Index 10.1 APPENDIX A - Decontamination Group membership and terms of reference 10.2 APPENDIX B - Functional responsibilities and Decontamination Organisational Chart 10.3 APPENDIX C - Colour Coding for Cloths 10.4 APPENDIX D - Disinfectant and Cleaning Agents 10.5 APPENDIX E - Colour Coding Chart for Mops 10.6 APPENDIX F - Colour Coding for linen bags 10.7 APPENDIX G - Hand Decontamination Technique 10.8 APPENDIX H - NHS Estates Local Instrument Washing Protocol 10.9 APPENDIX I - Graphic labelling of Medical Devices EN APPENDIX J - Decontamination A Z APPENDIX K - The Decontamination, storage and use of flexible and rigid endoscopes APPENDIX L - Decontamination of Healthcare Equipment for Serving or Repair APPENDIX M - NICE Guidance Patient safety and reduction of risk Transmission of Creutzfeldt-Jakob disease (CJD) 23 P a g e

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31 APPENDIX A Decontamination Group membership and Terms of Reference Membership Tracey Nutter Executive Lead Bernie Dunn DSU Peter Wells (Chair person) Decontamination Lead Nicki House MDMC Dr Julian Hemming ICD Vanessa John Procurement Dr Stephen Cotterill Deputy ICD Wendy Oliver Finance Fiona McCarthy Senior ICN Mandy Biddle Maternity Services Andy Gillespie ETS Neal Clever Respiratory Care Janet Hope Theatres Sally Smith Midwife All the named attendees above should send a deputy to the meeting if they are unable to attend. Accountability Quoracy To the Infection Prevention & Control Committee and with close liaison with the Infection Prevention & Control Working Group and the Medical Devices Committee. A minimum of four group members must be present including either the chair or Executive lead. Frequency of meetings Functions Quarterly To project manage decontamination business investment plan relating to the successful April 2002 bid, and any subsequent investment plans. Advise the Infection Prevention & Control Working Group, Infection Control Committee and Medical Devices Committee and Technology Working Groups regarding decontamination issues. To monitor and drive the Trust compliance with national guidance and Care Quality Commission Standards for decontamination of re-usable medical devices and the single use of medical device items. Ensuring compliance with NHSLA Standards and monitoring specific decontamination risk assessments. To develop an annual decontamination programme and monitor its implementation Ensure an awareness and understanding of the decontamination issues relating to medical device management. Lead and oversee decontamination training in collaboration with the Infection Prevention & Control Team. Develop and recommend trust-wide policies involving decontamination Distribution of minutes Infection Prevention & Control Committee Update to the Infection, Prevention & Control Working Group and Consumables Technology Working Group/Medical Devices Committee GM ETS and Estates Operations Manager Reviewed April 2010 Planned Review Date April P a g e

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33 APPENDIX B Functional Responsibilities From HTM 00 and HTM Key personnel In this Policy, the following are key personnel have specific responsibilities within the Trusts decontamination service: Chief Executive Decontamination Lead (this person may also act as the Designated Person if locally agreed) Designated Person General Manager Estates Technical Services User (normally the sterile services manager) Authorising Engineer (Decontamination) Authorised Person (Decontamination) Competent Person (Decontamination) Director of Infection Prevention and Control Infection Control Doctor Microbiologist (Decontamination) Operator Competent Person (Pressure Systems). Chief Executive The Chief Executive has ultimate management responsibility, including allocation of resources and the appointment of personnel, for the Trust and ensuring legislation, current Dept of Health policy / mandates and guidance is met and that where appropriate is implemented across the Trust. Trust Decontamination Lead The nominated Trust Decontamination Lead has responsibility for decontamination, either at board level or who has line management responsibility to a senior responsible person at that level (see The Health Act 2006: Code of practice for the prevention and control of healthcare associated infections (Department of Health, 2006)). The Decontamination Lead should report directly to the Executive Manager. The Decontamination Lead is organisationally responsible for the effective, and technically compliant, provision of decontamination services. The Decontamination Lead is responsible for the implementation of an operational policy for decontamination. He/she should ensure that the operational policy clearly defines the roles and responsibilities of all personnel who may be involved in the use, installation and maintenance of decontamination equipment. The Decontamination Lead is also responsible for monitoring the implementation of the policy. The Decontamination Lead may delegate specific responsibilities to key personnel; the extent of such delegation should be clearly set out in the operational policy together with the arrangements for liaison and monitoring. The Decontamination Lead may also act as the Designated Person. Designated Person This person provides the essential senior management link between the organisation and the independent professional support. The Designated Person should also provide an informed position at board level. The Designated Person should work closely with the General Manager Estates Technical Services to ensure that provision is made to adequately support the decontamination service. User 27 P a g e

34 The User is defined as the person designated by the Trust to be responsible for the management of the process. The User is also responsible for the Operators. The principal responsibilities of the User are as follows: To certify that the decontamination equipment is fit for use To hold all documentation relating to the decontamination equipment, including the names of other key personnel To ensure that decontamination equipment is subject to periodic testing and maintenance To appoint operators where required and ensure that they are adequately trained To maintain production records To establish procedures for product release in line with the quality management system To ensure that procedures for production, quality control and safe working are documented and adhered to in the light of statutory requirements and accepted best practice. The User may seek the advice of infection control teams, which may consist of a Director of Infection Prevention and Control, Control of Infection Officer or Microbiologist (Decontamination). General Manager Estates Technical Services The General Manager Estates Technical Services fulfils the HTM role of Senior Operational Manager and is technically, professionally and managerially responsible for the engineering aspects of the decontamination service for the Trust. Authorising Engineer (Decontamination) (AE(D) The AE(D) is a suitably qualified independent professional advisor 2 retained by the Trust to provide independent auditing and advice on washer-disinfectors, sterilizers and sterilization and to review and witness documentation on validation. The AE(D) is required to liaise closely with other professionals in various disciplines across the Trust. Role of the AE(D) 3 The AE(D) has a reporting route to the Decontamination Lead and provides professional and technical advice to AP(D)s, CP(D)s, Users and other key personnel involved in the control of decontamination processes. Responsibilities The principal responsibilities of the AE(D) are as follows: to provide the Trust with general and impartial advice on all matters concerned with decontamination to advise the Trust on programmes of validation to audit reports on validation, revalidation and yearly tests submitted by the AP(D) to advise the Trust on programmes of periodic tests and periodic maintenance to advise the Trust on operational procedures for routine production to advise Management on the appointment of the AP(D). Authorised Person (Decontamination) (AP(D) 2 The Institution of Healthcare Engineering and Estates Management (IHEEM) sets professional standards for AE(D) voluntary registration and for the accreditation of training courses, as was the case for the former Health Technical Memorandum 2010-defined AP(S) role. The Department of Health set the technical standards as relevant. 3 This role has been developed from the prior Authorised Person (Sterilizers) arrangements. 28 P a g e

35 Authorised Person (Decontamination) (AP(D) Continued The AP(D) is an individual possessing adequate technical knowledge and having received appropriate training, appointed in writing by the Designated Person (in conjunction with the advice provided by the AE(D)), who is responsible for the practical implementation and operation of the Trusts Health & Safety Policy and procedures relating to the engineering aspects of decontamination equipment. Role of the AP(D) The AP(D) is required to provide the safe and effective management of the engineering and safety aspects of the decontamination service for the Trust. Additional responsibilities should not reduce the importance of the role nor impair the ability of the AP(D) to carry out his/her duties effectively. To ensure that appropriate cover is provided more than one AP(D) will be appointed one of whom will be appointed as Senior AP(D). It is recommended that the AP(D) reports professionally to the Designated Person. Responsibilities The AP(D) will is responsible for: The engineering management of decontamination equipment Line management and/or appointment of the CP(D) The safe and effective systems of work for all installed decontamination equipment within their area of responsibility The acceptance criteria for operational and performance testing of all installed decontamination equipment Liaison with the AE(D), Decontamination Lead, User and other interested professionals Authorising the use of decontamination equipment after major repair or refurbishment and after quarterly or annual tests Operation of the permit system, working closely with the User. Ensuring the continued registration of the CP(D)s, as appropriate Liaising with the User, and other technical support personnel, to enable them to discharge their responsibilities for management of decontamination effectively. Competent Person (Decontamination) (CP(D) The CP(D) is defined as a person designated by the Trust via the AP(D) to carry out maintenance, validation and periodic testing of washer-disinfectors and sterilizers. To ensure that appropriate cover is provided more than one CP(D) will be appointed. CPs(D) will be appointed from the multi skilled engineering technicians in ETS. Role of the CP(D) Healthcare organisations may wish to maintain the separate functional roles of testing and maintenance. In this case, the acronyms CP(D)(T) (for the test person) and CP(D)(M) (for the maintenance person) could be used as alternatives. The content of this role will relate to the HTM Part A skills matrix, which will be developed over time by the Department of Health. Responsibilities The principal responsibilities of the CP(D) are as follows: to carry out the maintenance tasks outlined in Health Technical Memorandum 2010 & 2030 (until replaced by HTM Part B when those procedures are to be followed) to carry out additional maintenance and repair work at the request of the User to conduct the validation tests specified in Health Technical Memorandum 2010 & 2030 (until replaced by HTM Part B when those procedures are to be followed) and to prepare the validation report 29 P a g e

36 Competent Person (Decontamination) (CP(D) Continued to conduct the periodic tests specified in Health Technical Memorandum 2010 & 2030 (until replaced by HTM Part B when those procedures are to be followed) and to prepare reports as required by the User to conduct any additional tests at the request of the User. For those CP(D)s who carry out maintenance duties, they should be a engineering craftsman with evidence to demonstrate competence in the maintenance of one or more types of decontamination equipment. The CP(D) should be in a position to deal with breakdowns, and have the ability to diagnose faults and carry out repairs, or to arrange for repairs to be carried out by others. Competent Person (Pressure Systems) The Competent Person (Pressure Systems) is retained by the Trust to provide an independent inservice inspection of pressure equipment as required by the Pressure Systems Safety Regulations The CP (PS) also advises on the scope written scheme of examination; draws up the written scheme and certifies it. The service will be provided by a body with UKAS accreditation to BS EN 45004: 1995, for the scope of in-service inspection of pressure equipment. This person must not be the User. Director of Infection Prevention and Control (DIPC) The Director of Infection Prevention and Control reports to the chief executive and the board. He/she is responsible for infection control aspects of decontamination. Infection Control Doctor (ICD) The Infection Control Doctor is defined as a person designated by Management to be responsible for advising the User on all infection control aspects. Microbiologist (Decontamination) The Microbiologist (Decontamination) is defined as a person designated by the Trust to be responsible for advising the User on microbiological aspects of disinfecting and sterilizing non-medicinal products. He/she should also be defined as the person responsible for advising the User on the microbiological aspects of handling, washing, disinfecting and sterilizing used medical devices. Responsibilities The principal responsibilities of the Microbiologist (Decontamination) are as follows: to advise the User on the microbiological aspects of decontamination procedures for nonmedicinal products to audit the documentation from all decontamination equipment that has been tested by microbiological methods. Operator An Operator is defined as any person with the authority of the Trust [appointed by the User] to operate a washer-disinfector or a sterilizer, including the noting of instrument readings and simple housekeeping duties. 30 P a g e

37 Colour Coding for Use of Cloths APPENDIX C Cloth Colour Use For Disposal Details GREEN KITCHEN AREAS DISPOSE OF WHEN VISIBLY CONTAMINATED RED TOILETS, BATHROOMS, AND SHOWERS SINGLE USE ONLY BLUE WARD, OFFICE, AND GENERAL DEPT AREAS DISPOSE OF WHEN VISIBLY CONTAMINATED WHITE DISPOSABLE CLOTHS ISOLATION AREAS SINGLE USE ONLY These items are always available from the Housekeeping Department Extension 2111/Bleeps: 1636/1288 Housekeeping Decontamination Certificate The Housekeeping Department will issue a Housekeeping Decontamination Certificate after Terminal Cleaning for Post Infection Clean, Sewerage related incidents, Environmental Clean or Post Builders Clean. This is to prove that the room / area has been decontaminated and when handed over is accepted by the in Charge. 31 P a g e

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39 Disinfectants and Cleaning Agents APPENDIX D DISINFECTANT PACK COMMENTS 1. NaDCC (Actichlor) (Sodium Dichloroisocyanurate) 7 x 2.5g tablets in 1 litre of cold water. 10,000ppm For blood / body spillages from all patients. Accidental environmental spillages or soiling by blood or body fluids (i.e. blood and body fluid spillage) 1 x 2.5g tablet in 1,500mls of cold water. 1,000ppm 2. Alcohol 70% 200ml spray bottle (Methylated Spirit) Specific disinfection of known hazards (Usual dilution for routine disinfection purposes i.e. room and equipment decontamination) Refer to Actichlor dilution chart for further information located within each department/area. Supplied by pharmacy 3. Gigasept Solution Gigasept Solution and activator. (Hydrogen Peroxide.) Used for contingency disinfection or sterilisation of clean cytoscopes and endoscopes. Solution must be changed as per manufacturers instructions. 4. General Purpose Detergent 750mls General purpose detergent used for most ward environment cleaning. (Supplied by Housekeeping Department). 5. Toilet Cleaner e.g. Swirlfresh 1 litre A detergent of ph value 7 to 10 (See manufacturer s instructions). To be used for cleaning all sanitary fittings, (supplied by Housekeeping Department). COSHH Sheets are available from the Occupational Health and Safety Services (OHSS) Department and must be kept in a COSHH folder which is easily accessible to all staff, and reviewed once a year by the area COSHH representative. 33 P a g e

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41 Colour Coding for Mops and Buckets APPENDIX E COLOUR USE FOR CLEANING COMMENTS Blue Mop Blue Bucket Blue Round Mops Rubber Gloves Green Buckets Green Round Mops Green Clothes Gloves General Areas including wards and Departments Kitchen Areas and the Catering Department The Trust uses the National Colour Coding for cleaning materials and equipment as described in the NPSA Guidelines Red Mop Red Bucket Red Round Mops Red Disposable Cloths Disposable Gloves Bathroom Areas Yellow Mop Yellow Bucket White Disposable Wipes Yellow Round Mop Barrier nursed patients and reverse barrier nursed patients i.e. oncology patients Infected Cases or Areas The Housekeeping Department supplies all above equipment. Extension: P a g e

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43 Linen Bags APPENDIX F LINEN TYPE Used linen BAG TYPE White Linen bag All linen that is not soiled with body fluids Patients linen Small Green patients linen bag See special instructions on the ward or ring patients clothing department ext 2204 Foul and/or infected linen Must be bagged in a soluble clear bag secured with a tie or a knotted top Place inside a red linen bag Fouled linen is that soiled with urine, faeces, blood or any other body fluid Theatre linen Large green linen bag Theatre use only. Heavily soiled theatre linen must be bagged using a soluble clear bag Dirty mop and deceased patients clothing Transparent large plastic bag Staff Uniforms Brown Linen Bags Ensure any item of equipment, particularly sharps, are removed from the linen. Bags are only two thirds full. Do not over fill bags. Secure ALL bags Do not send patients personal clothing items to the main laundry Please refer to the Trust Waste Management Policy and Linen Segregation Chart. 37 P a g e

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45 APPENDIX G Hand Decontamination Technique Effective hand decontamination technique Remove all jewellery Remove wrist watch Keep nails short No nail polish Wet hands 1. Palm to palm. 2. Back of each hand. Apply soap.. 3. Palm to palm with fingers interlaced. 4. Backs of fingers to opposing palms. Infection Prevention & Control Team Ext Rubbing finger tips 6. Rotational rubbing on palm of hand. of thumbs and inclusion of the wrists. Rinse and dry hands thoroughly 39 P a g e