Policy & Procedure Authors Name & Title: Nicola Best- Infection Prevention Nurse Scope: Trust Wide Classification: Clinical Replaces: v2.0 To be read in conjunction with the following documents: Medical equipment policy Infection prevention & control standard arrangements Hand hygiene policy Endoscope decontamination policy Other protocols pertinent to specific areas or procedures Document for public display? Yes Unique Identifier: TC43(08) Review Date: 1 st June 2015 Issue Status: Approved Version No: 2.1 Issue Date: 11 th Authorised by: Infection Prevention Committee Authorisation Date: 1 st June 2013 After this document is withdrawn from use it must be kept in an archive for 10 years Archive: Document Control Date added to Archive: Officer responsible for archive: Document Control Administrator Has the document undergone Equality Analysis? Has Endorsement been completed? Yes/No Yes Page 1 of 10
POLICY STATEMENT In order to protect patients and staff from the transmission of infection from medical devices or other equipment, all equipment must be decontaminated appropriately. 1. Roles and Responsibilities Trust board Has a duty to ensure that appropriate arrangements and management systems are in place for infection prevention and control (The Health Act 2006). Director of Infection Prevention and Control Is responsible for implementation of this policy. The Infection Prevention Committee Is responsible for development and approval of this policy and for its review. Ward/departmental managers Have responsibility for decontamination of equipment in their area and also a responsibility to ensure that staff working in their area e.g. nursing staff and housekeepers are aware of this policy and that staff involved with decontamination have adequate and suitable training. All staff Have a responsibility to ensure that they comply with this policy, that they use equipment provided appropriately and that they report any concerns or seek further advice as necessary from their manager or the Infection prevention team. Temporary or agency staff, contractors, students or others will be expected to comply with the requirements of this policy, applicable to their area of operation. 2. Standards Staff will be expected to adhere to the standard precautions policy for infection prevention & control and to the Control of Substances Hazardous to Health regulations. 3. Protocol 3.1 Cleaning, disinfection and sterilisation -definitions Decontamination is the process of rendering an article safe to handle by cleaning with or without disinfection or sterilisation. Cleaning is the physical removal of dust, grease or organic matter that will reduce the number of micro-organisms present and remove medium supporting the growth of microorganisms. Cleaning is necessary prior to disinfection and sterilisation. Page 2 of 10
is the process of reducing the number of micro-organisms to a level at which they are not harmful, with the exception of bacterial spores and prions. Sterilisation is the process of removing or destroying all micro-organisms, including spores. 3.2 Choice of decontamination method All reusable equipment will require cleaning. Some equipment will also require disinfection or sterilisation. The choice of method will depend on the purpose of the equipment and other risk factors as follows: Risk Application Method of decontamination High Items that penetrate the Sterilisation or use of skin/mucous membranes or sterile single use items enter sterile body cavities Medium Items that have contact with mucous membranes or are contaminated with pathogenic readily transmissible microorganisms Low Items in contact with intact skin Cleaning Sterilisation or disinfection or use of sterile single use item 3.3 General principles for decontamination of equipment 3.3.1 Cleaning the general environment and any equipment classified as low risk will not usually require disinfection. Water and a neutral detergent can be used or suitable disposable impregnated cloths. Equipment should be dismantled if necessary in line with manufacturer s guidelines prior to cleaning. See appendix 1 for procedure for cleaning equipment and also for blood and body fluid spillages. 3.3.2 - chemical disinfectants must always be used at the correct strength and for the correct length of time as specified by the manufacturer. Disinfectants should always be stored in the appropriate, labelled container. Staff in the theatre department will undergo local training prior to using automated washer disinfectors for flexible endoscopes and records of each disinfection cycle will be kept in the theatre department. Endoscope reprocessing is addressed in more detail in the Endoscope Decontamination policy. See appendix 2 for disinfectant list. Page 3 of 10
3.3.3 Sterilisation - most equipment requiring sterilisation will be packaged and sent offsite to an approved sterile services department. Records of surgical trays and equipment re-processed in this way will be recorded in the theatre records to ensure traceability. Some equipment will be purchased pre-sterilised. 3.4 Standard infection control precautions 3.4.1 Hand hygiene is the single most important measure in preventing infection and hand hygiene should be performed after all exposure to potentially contaminated equipment (see hand hygiene policy for further details). 3.4.2 Protective clothing should be worn when decontaminating equipment on the basis of a risk of transmission of the healthcare practitioners clothing and skin by blood, secretions or other fluids. A disposable apron and gloves should be worn and also face protection if a risk of splash to the eyes and mouth. 3.5 Decontamination Certificates prior to service, inspection or repair 3.5.1 If equipment is to be returned to the medical engineering department or to the supplier because of a fault or for routine service/inspection then a decontamination certificate label must then be completed correctly, signed and attached to the equipment. 3.5.2 Supplies of these labels are available on each ward/department and further supplies can be obtained from the medical engineering department. If the equipment is visibly unclean or the label has not been completed satisfactorily the medical engineering department will not accept the equipment and ensure that it is returned to the relevant ward/department for cleaning and correct completion of the label. 3.5.3 If the exterior of the equipment cannot be decontaminated for any reason this should be noted on the decontamination form and the equipment should be packaged in a clear plastic bag and prior warning given to the intended recipient. 3.5.4 If the internal mechanism has been contaminated with blood or body fluids it may not be possible to safely clean the equipment on the ward. This should be noted on a decontamination form and prior warning given to medical engineering before it is returned. 3.6 Single use devices. 3.6.1 Devices designated for single-use must not be reused under any circumstances. The reuse of single-use devices can affect their safety, performance and effectiveness, thereby exposing patients and staff to unnecessary risk. The reuse of single-use devices has legal implications. 3.6.2 Anyone who reprocesses or reuses a device intended by the manufacturer for use on a single occasion, bears full responsibility for its safety and effectiveness. Page 4 of 10
3.6.3 For further guidance, reference should be made to MDA (Medical Devices Agency) Device Bulletin DB2000 (04), which deals with the implications and consequences of reuse of single-use medical devices. 3.7 COSHH (Control of Substances Hazardous to Health) Regulations 3.7.1 COSHH regulations require that an assessment is made of any health risks that may arise from exposure to hazardous substances and that appropriate control measures must be provided to minimise the risks. 3.7.2 Most disinfectants are hazardous to some degree and are therefore subject to COSHH regulations. Information should therefore be available in all places of use. Managers are required to ensure that staff are properly trained and aware of the proper use of cleaning agents and disinfectants. 4 Policy Implementation Plan 4.1 The infection prevention committee is responsible for implementing this policy. 4.2 This policy will be available on the intranet and the contents will be made known to link staff during link staff meetings and also staff will be made aware of the policy during annual mandatory updates. 4.3 Domestic staff will be made aware of the requirements in this policy during their induction process and during annual updates. 4.4 Relevant theatre staff will undergo training in disinfection and sterilisation processes and will also use a self-assessment competency programme. 5. Monitoring of Compliance 5.1 General decontamination of equipment will be monitored as part of the infection control audit tool (performed at least 6 monthly)and results will be feedback to each individual area, with an action plan to be completed by that ward/department. 5.2 Decontamination of equipment will also be monitored by the matrons as part of the weekly cleaning schedules. 5.3 Theatre staff will monitor the washer disinfection and sterilisation processes by using protein residue testing system weekly on instruments selected at random. An audit of endoscope decontamination processes will be performed at least annually. Results will be fed back to the theatre manager and the decontamination group and any action plans will be monitored by this group. 5.4 Decontamination of equipment prior to service, repair and inspection will be monitored by the medical engineering department and they will do an audit at least annually to monitor compliance with this policy, results of which will be fedback to the infection prevention committee References Page 5 of 10
Sterilisation, disinfection & cleaning of medical equipment: Guidance on decontamination from the microbiology advisory committee to the Department of Health, medicines and healthcare products regulatory agency.2005 MDA DB 2000 (04) Single use medical devices: implications and consequences of reuse. Medical Devices Agency 2000 MHRA DB 2003 (03) Management of medical devices prior to repair, service or investigation. Pratt RJ et al and the epic guideline development team (2007). National Evidence Based Guidelines for preventing healthcare associated infections in NHS hospitals. Journal of Hospital Infection. 65S (supplement) S1-S64 APPENDIX 1 1. General protocol for decontamination of medical equipment All reusable equipment should be cleaned following every episode of care. Page 6 of 10
If the manufacturer s instructions for decontamination of the equipment are available then these must be followed. If no instructions are available the general guidelines below should be followed for external cleaning of the equipment: If the equipment is electrical then disconnect/unplug from the electrical power source Clean with a disposable cloth lightly dampened with water and a general purpose detergent e.g. Hospec or alternatively use a disposable multi-surface wipe and clean until all visible traces of soiling has been removed Care must be taken to ensure water does not get inside any electrical equipment so the cloth must be only lightly dampened Wipe with dry cloth Alcohol/alcohol wipes should not be used generally unless it has been confirmed by the manufacturer that the alcohol will not damage the surfaces of the equipment. If the equipment is contaminated with blood/body fluids: Standard/universal precautions must be adhered to when handling and cleaning the equipment. Gloves and aprons should be worn and eye protection if there is a risk of splashing. The equipment should be disinfected following the manufacturer s instructions or if no instructions are available by cleaning and then using a cloth lightly dampened with a 1000ppm chlorine solution (e.g. antichlor solution). 2. Procedure for Blood Spillages - Wear plastic apron and gloves - Cover the blood spill with actichlor granules (or suitable alternative) - Leave for 2 minutes, to allow granules to absorb spillage - Clear up granules with a disposable cloth and discard into a yellow clinical waste bag - Clean area with detergent and water DO NOT USE ABOVE METHOD ON URINE SPILLAGES AS THE HYPOCHLORITE MAY REACT WITH THE URINE 3. 3. Procedure for Body Fluid eg Urine/Faeces Spillages - Wear plastic apron and gloves - Soak up the spillage with disposable paper towels - Discard into a yellow waste disposal bag - Clean area with detergent and water - Wipe area with actichlor solution and disposable cloth APPENDIX 2 Disinfectant Reason for Use Examples Page 7 of 10
Products Chlorine Disinfectant tablets e.g. Actichlor 1 tablet in 1 litre of water = 1000pm chlorine for surfaces Disinfectant granules e.g. actichlor Peracetic acid e.g. Aperlan Chlorine Dioxide e.g.tristel wipes Isopropyl Alcohol solution Isopropyl impregnated wipes with chlorhexidine For disinfection of surfaces and equipment For environmental cleaning when patients are in isolation or during outbreaks or deep cleaning For disinfection of surfaces following spillages of body fluids For disinfection in automated washer/disinfector For disinfection of probes For disinfection of suitable hard surfaces if visibly clean For disinfection of suitable equipment if visibly clean Mattresses, commodes, fixtures and fittings in isolation rooms Blood spillage Bronchoscopes TOE probes Metal trolleys Needleless connectors on intravenous lines Chlorhexidine acetate 0.015% and cetrimide 0.15% solution Denatured ethanol 70% + hydrogen peroxide 0.125% Sterile denatured ethanol 70% 1% hypochlorite solution Proceine Qceine in aseptic suite in pharmacy in aseptic suite in pharmacy in pharmacy in aseptic suite Impregnated mopping system for cleaning in aseptic suite Work surfaces in aseptic suite Equipment in aseptic suite Equipment in isolator room and isolator Equipment and surfaces in aseptic suite Floors,walls, ceilings in aseptic suite Page 8 of 10
Endorsed by: Name of Lead Clinician/Manager or Committee Chair Position of Endorser or Name of Endorsing Committee Date Director of Infection prevention and Control Infection Prevention Committee June 2013 Page 9 of 10
Record of Changes to Document - Issue number: Changes approved in this document: Date: Section Amendment Deletion Addition Reason Number (shown in bold italics) Appendix Actichlor replaces Haz tab Appendix 2 2 Appendix Tristel wipes Appendix 2 2 Appendix Examples column Appendix 2 2 3.3.3 Some fine instruments will be sterilised in a dedicated area within the theatre complex. Only staff trained and competent to do so will process this equipment and all records of sterilisation cycles and instrument swill be kept in the theatre department. 3.3.3 Page 10 of 10