DECONTAMINATION POLICY FOR RE-USABLE MEDICAL DEVICES

Transcription

1 This document is uncontrolled once printed. Please refer to the Trusts Intranet site for the most up to date version. DECONTAMINATION FOR RE-USABLE MEDICAL DEVICES NGH-PO-418 To be read in conjunction with NGH-PC-870 of patient equipment and the patient environment Ratified By: Procedural Documents Group Date Ratified: August 2014 Date(s) Reviewed: August 2014 Next Review Date: August 2015 Version No: 3 Superseded Document No: 2 Responsibility for Review: Head of Sterile Services Trust Lead Infection Prevention and Control Team Contributors: Head of Sterile Services Trust Lead Infection Prevention and Control Team NGH-PO-418 Page 1 of 29

2 Version Control Summary Version Date Author Status Comment V.1 Reviewed Dec 2009 and Archived V.2 Reviewed March 2010 and to be archived once V3.3 uploaded. V 3 August 2014 G Hunt Issued Reviewed May 2014 and updated NGH-PO-418 Page 2 of 29

3 CONTENTS Version Control Summary... 2 CONTENTS... 3 SUMMARY INTRODUCTION PURPOSE SCOPE COMPLIANCE STATEMENTS DEFINITIONS ROLES & RESPONSIBILITIES SUBSTANTIVE CONTENT Principles Purchase of New Equipment Loan Equipment Detergent Chemical Disinfectants Medical Devices supplied for Single-Use only Suspected Contamination with Prions Managing used Equipment prior to further use or collection Further advice and Guidance and Risk Management IMPLEMENTATION & TRAINING MONITORING & REVIEW REFERENCES & ASSOCIATED DOCUMENTATION APPENDICES APPENDIX 1: DISINFECTION PROCESS (STERILE SERVICES) APPENDIX 2: METHODS OF STERILIZATION APPENDIX 3: LOCAL DECONTAMINATION APPENDIX 4: CLEANING AND DECONTAMINATION OF PATIENT EQUIPMENT: FLOWCHART FOR WARD STAFF APPENDIX 5 DECLARATION OF CONTAMINATION STATUS LABEL (TWO-SIDED) 26 APPENDIX 6: FLOWCHART FOR HANDLING OF EQUIPMENT PRIOR TO INSPECTION, SERVICE, REPAIR, RETURN TO LENDING ORGANISATION OR FOR RE-CIRCULATION NGH-PO-418 Page 3 of 29

4 SUMMARY This policy outlines guidance to staff that have a responsibility for the cleaning and disinfection of medical devices. As part of the overall risk management strategy for the Trust, it is essential that healthcare workers understand and follow the guidance set out in the Health and Social Care act The aim of this policy is to provide staff with the necessary information to decontaminate medical devices safely in order to protect patients, public, and members of staff from infection, injury or other harm without compromising the integrity and purpose for which each item of equipment was originally intended. This is an overarching policy. Specific protocols for various items or types of equipment that come into patient contact will be held locally where decontamination takes place at a central point (e.g. Endoscopy). 1. INTRODUCTION The Trust must comply with the guidelines and standards that relate to the decontamination of medical equipment and medical devices. This includes standards such as the European Medical Devices Directive 93/42/EEC, ISO13485:2012, Choice Framework documents, European and International Standards, and also incorporates the guidance set out within the Health and Social Care Act Failure to comply with legislative requirements leaves the Trust liable to prosecution. For this reason, decontamination is a risk listed on the Trust risk register and it needs to have assurance that current controls are in place and are effective. High standards in cleaning, disinfection and sterilisation are essential for the prevention of cross infection in the hospital. The cleanliness of the equipment used in patient care is the responsibility of all staff. Over recent years there have been many technological advances made in the methods employed to decontaminate medical equipment. Medical equipment is more specialised, and the equipment used to decontaminate it has become technically more complex. Additionally, 'cold' chemical sterilants have been developed for use where 'high temperature' processes cannot be used resulting a safer more efficacious process. Consequently it is essential that the Trust has trained competent staff to complete the decontamination process in a safe and controlled way and to ensure that the equipment used for decontamination activities is effectively maintained. The key objective of this policy is to minimise the risk of:- infection to patients exposed to medical devices and, ill health to staff carrying out the decontamination processes NGH-PO-418 Page 4 of 29

5 Where reasonably practicable all medical devices or equipment is processed by the Trust s Central Facility in the Sterile Services Department (SSD) or the Medical Equipment Library (MEL). It is recognised, however, that this may not always be practicable therefore whenever deviation from using the SSD or MEL is deemed appropriate there will be agreed procedures, authorised by the Head of Sterile Services & Trust Lead and the Senior Infection Prevention Nurse or nominated Deputy. Where reasonably practicable, the Trust s SSD should be utilised for all decontamination activities of reusable medical and surgical equipment by all Departments and/or other stakeholders. 2. PURPOSE In the hospital setting effective decontamination is essential to remove micro-organisms from medical devices to prevent cross-infection or the transmission of micro-organisms from patient to patient. The purpose of this policy is therefore: To protect staff and patients and explain when decontamination should be carried out. To ensure that staff and patients are not put at risk by the use of equipment or procedures that are not approved by the Head of Sterile Services & Trust Lead, Senior Infection Control Nurse or nominated Deputy. To define, control and monitor the local standards and procedures employed when central processing is not 'practicable due to a shortage of equipment that may also be sensitive to the high temperature sterilising process e.g. - flexible endoscopes. To standardise Cleaning & Disinfection Procedures and the Detergents/Chemicals used throughout the Trust. 3. SCOPE This policy applies to all items of medical equipment such as syringe drivers/pressure redistribution aids / mattresses, also including surgical instruments in all areas of the Trust and all individuals employed by the Trust who undertake decontamination or any form of manual cleaning on these devices, including contractors, voluntary workers, students, locum, bank, agency staff and all sites managed by Northampton General Hospital Trust. This policy does not cover the decontamination of the patient environment and patient associated equipment such as drip stands/commodes etc. NGH-PO-418 Page 5 of 29

6 4. COMPLIANCE STATEMENTS Equality & Diversity This document has been designed to support the Trust s effort to promote Equality and Human Rights in the work place and has been assessed for any adverse impact using the Trust s Equality Impact Assessment tool as required by the Trust s Equality and Human Rights Strategy. It is considered to be compliant with current equality legislation and to uphold the implementation of Equality and Human Rights in practice. NHS Constitution The contents of this document incorporates the NHS Constitution and sets out the rights, to which, where applicable, patients, public and staff are entitled, and pledges which the NHS is committed to achieve, together with the responsibilities which, where applicable, public, patients and staff owe to one another. The foundation of this document is based on the Principles and Values of the NHS along with the Vision and Values of Northampton General Hospital NHS Trust. 5. DEFINITIONS The following definitions apply to this policy: CE Mark The Trust is obliged to purchase and use medical devices that bear the CE mark as an indication of accredited manufacturing procedures and processes. The CE Mark is shown below: Cleaning COSHH Disinfection The cleaning process removes gross soil, large numbers of microorganisms and organic matter. The cleaning process is a prerequisite to disinfection and sterilisation. Control of Substances Hazardous to Health. The combination of processes used to make a reusable medical device safe to be used on subsequent patients by reducing the risk of cross infection. Disinfection is a general term used to describe the destruction or removal of microbial contamination or bio-burden to render an item environmentally safe. This includes the destruction of non-spore forming or "vegetative" microorganisms (e.g. staphylococci, salmonellae and most viruses). NGH-PO-418 Page 6 of 29

7 Re-Usable Devices Single Use Devices Most medical devices are capable of repeated reuse and therefore require decontamination between uses. Manufacturers/providers of such devices are obliged to provide decontamination instructions and, where relevant, define a number of successive uses allowed. These instructions should be followed implicitly. Pre-Purchase questionnaires should be used to ensure devices can be reprocessed within the Trusts current facilities. If the manufacturer s decontamination instructions are at odds with the conventional decontamination procedures in use, clarification should be sought in writing from the manufacturer/provider and, where necessary, alternative instrumentation purchased that is compatible with current processes. Single Use devices are designed to be used once only. They are not designed to be reprocessed and thus decontamination instructions are not provided. Such devices are required to be identified by the single-use-symbol on the instrument or its packaging as shown below. Such devices must be disposed of safely after patient use and not returned to SSD. Single-use devices presented for surgery but not used are not capable of reprocessing and will be disposed of safely. Some devices are Single-Patient Use. These devices can be decontaminated; however they must be re-used upon the same patient, and not put into general circulation with other instrumentation. Sterilisation Sterilisation is the complete destruction or removal of all living material. There are several different methods of sterilisation, however for the purpose of this document Sterilisation by Steam is the most appropriate. For decontamination purposes, a more specific definition is required. BS-EN defines a process after which the load can be considered to be sterile. The Standard defines the process as one after which there is a probability of a viable micro-organism remaining in, or on the device, to be equal to, or less than, 1 in 1 million. NGH-PO-418 Page 7 of 29

8 6. ROLES & RESPONSIBILITIES The roles and responsibilities applicable to this policy are listed as follows: Chief Executive and Trust Board Consultant Microbiologist Trust wide Lead / Designated Person Departmental Link Head of Sterile Services Has ultimate responsibility for safe use and management of Trust property and items on hire or loan to the Trust, including the allocation of resources. Responsible for the implementation of policies and the monitoring of progress, reviews and reports. Monitoring assurance provided against the implementation of this policy in line with national standards in relation to infection prevention and control. Provides advice on hospital policies for infection control, risk assessments and management of accidental exposures to infection. Cooperation with infection control teams and DIPC, including liaison with the relevant health protection staff in the investigation and prevention of communicable diseases in the community. Every Healthcare organisation must have a designated Lead that has board level responsibility for the effective, technically compliant provision of decontamination Services. The lead will provide advice on all aspects of re-processing Medical Devices; the lead will also arrange the external annual documentation audits for Sterile Services and participate with departmental audits including Endoscopy and Theatres. The Lead will also provide a monthly decontamination report to the Infection Prevention & Control Committee. The Lead is responsible for advising on purchase of equipment to ensure it can be decontaminated appropriately on site. Local nominated link with responsibility for decontamination in specific departments are responsible for the day to day reprocessing of medical devices in their department, reporting any concerns to the Trust wide Lead and attending the monthly User Group meetings. The Head of Sterile Services is responsible for the daily management of the Sterile Services Department, ensuring relevant quality standards are maintained with regards to the effective decontamination of reusable medical devices and transport to relevant departments e.g. theatres. NGH-PO-418 Page 8 of 29

9 Director of Infection Prevention and Control DIPC (in full no abbreviation) Lead Infection Prevention Nurse Modern Matron Authorised Engineer () Authorised Person () Competent Person () The Director of Infection Prevention and Control (Director of Nursing, Midwifery & Patient Services) is a strategic role with responsibility to the chief Executive for overseeing the Trust s performance relating to infection preventative and control issues. Provides a direct route for clinical areas to access Infection Prevention and Control Services and ensure Infection Prevention and Control training and key messages are cascaded to their clinical areas. Ensure all staff under their control are aware of Infection Prevention and Control measures. Undertaken monthly IPC audit and feedback given during the Modern Matron s report at the Infection Preventative Control Committee. The person designated by the Director of Facilities/ Lead to act as an independent and impartial adviser on all decontamination / sterilization matters and to present reports of annual audits. Management is safeguarded if the personal profile of the Authorised Engineer (Sterilisers & Washer Disinfectors) matches that defined in HTM 01 Will possess adequate technical knowledge and relevant training and is responsible for the implementation and operation of procedures relating to the technical and engineering aspects of decontamination. The Authorised Person () is responsible for signing off quarterly test reports for decontamination equipment. Is responsible for the maintenance, validation and periodic testing of washer-disinfectors, automated endoscope reprocessors and sterilizers. Test Person () Ward and Departmental Managers Domestic Supervisor and Domestics and those who are responsible for carrying The test person is responsible for the testing only of decontamination equipment. It is the responsibility of all managers to make staff aware of the existence of this policy and ensure that access to the policy is readily available. It is the responsibility of individuals to ensure that they have read and understood the content of this policy and follow it at all times. Ward and departmental managers are responsible for monitoring compliance of all staff with infection prevention and control policies and guidelines. They are responsible for ensuring that all IP&C policies and guidelines are circulated and implemented. The Domestic Supervisors, Domestics and those responsible for carrying out deep cleaning have a responsibility to do so in accordance with infection prevention and control policies and Appendices 4-6 of the Policy to ensure a NGH-PO-418 Page 9 of 29

10 out deep cleaning All employees Infection Prevention and Control Team. Designated User of Equipment Contractors Portering Services Estates Personnel Infection Control Committee Committee high standard of cleaning is maintained and the risk of crossinfection prevented. They also responsible for attending annual infection prevention training. All employees have a responsibility to follow infection prevention and control policies and guidelines and to attend relevant mandatory IPC training sessions. The basic principle that protecting patients, staff and visitors from infection is everyone s responsibility should be embedded in the culture of all wards and departments throughout the Trust. Responsibility of the infection Prevention and Control Team (IPCT) to provide input into policy formulation, projects and schemes within the Trust that this policy may apply to (e.g. Expansion of services, relocation of services etc.) to identify appropriate solutions. The IPCT liaise with the Lead and Medical Equipment Library Team on matters relating to decontamination of equipment. The persons designated by the Departmental Management, to be responsible for the operation of the Equipment (Autoclaves, Washer Disinfectors, Automatic Endoscope Re-processors, Storage Cabinets) The Designated User takes responsibility for the safety of the products of disinfection, for product liability and, also, is responsible for certifying that Equipment is fit for purpose. Contractors and sub-contractors should have their own individual policies and procedures. However, those individuals with responsibility for contractors are responsible for ensuring compliance with this policy. The Portering service is responsible for cleaning wheelchairs between patient uses. The Estates team are responsible for cleaning beds and maintenance work to ward/department macerators. The infection control committee is responsible for monitoring compliance and feeding in to the Governance process at Board level. The decontamination committee is responsible for ensuring compliance with this document and reporting to the infection control committee on any breaches of the policy. NGH-PO-418 Page 10 of 29

11 7. SUBSTANTIVE CONTENT 7.1. Principles Thorough cleaning using approved detergent wipes or hot water and detergent followed by effective drying removes most bacteria from devices. The method of cleaning needed is dictated by the risk of cross infection to patients. This can be classified as: HIGH RISK INTERMEDIATE RISK LOW RISK MINIMAL RISK Invasive items in close contact with a break in the skin or mucous membrane or introduced into a sterile body area (e.g. surgical instruments, dressings, catheters and prosthetic devices). If these items of equipment are not designated as single use, they require sterilization and should be re-processed centrally in the Sterile Services Department. Items in contact with intact mucous membranes, body fluids or contaminated with particularly virulent or readily transmissible organisms, or items to be used on highly susceptible patients or treatment sites (e.g. gastrointestinal endoscopes, respiratory equipment). These items require high level disinfection by specifically trained staff in designated areas equipped with validated machines. These areas include the Endoscopy or Sterile Services Department. Items in contact with normal and intact skin (e.g. patient equipment, toilets, bedding). Cleaning and drying followed by chemical disinfection is usually adequate. All commodes must be cleaned using a chlorine-releasing agent such as Chlorclean. Additionally Chlorclean is used if there is a known infection risk (e.g. commode/toilet after use by patient with Clostridium difficile associated diarrhoea (CDAD) and for daily isolation cleans. Items not in close contact with the patient or his/her immediate surrounds (e.g. drip stands, floors, walls, sinks etc.). Cleaning using detergent (or detergent wipes) followed by drying is usually adequate. The Disinfection process adopted by the Sterile Services is detailed in Appendix 1. The Methods of Sterilization available from or via the Sterile Services Department is listed in Appendix 2. Disinfection using a Chlorine Releasing Agent (e.g. Chlorclean ) is required for daily isolation cleaning and for terminal isolation cleaning. It is especially important during outbreak situations. The Daily Isolation Clean and Deep Isolation procedures are detailed in the Trusts of Patient Equipment and Environment Policy. NGH-PO-418 Page 11 of 29

12 PRINCIPLES OF GOOD PRACTICE 1 Organic matter (e.g. blood smears, pus) may inactivate disinfectants. Surfaces must be cleaned with hot water and detergent or detergent wipes before disinfection takes place. 2 Read all decontamination instructions carefully and dilute to the appropriate ratio. Some chemicals can be dangerous if incorrectly used and quickly becomes inactive when diluted or challenged with a high bacterial/microbial load. 4 Some staff may be sensitive to Chlorine Dioxide. Advice should be sought from the Occupational Health Department. Following guidance from Occupational Health, Trigene may be used as an alternative on specialist equipment where manufacturers recommendations stipulate this disinfectant can be used instead. 5 Wear disposable aprons and gloves when using disinfectants. 6 Secure disinfectants in approved cupboards following COSHH guidelines. 7 Mops, brushes etc. must not be stored in disinfectants and must always be stored dry and inverted. 8 To help prevent cross-infection, the following national colour coding is adopted in this Trust: - Yellow mops/cloths Isolation areas Red mops/cloths Blue mops/cloths Green mops/cloths Bathrooms, washrooms, showers, toilets, basins and bathroom floors. General areas including departments, offices and basins in public areas. Catering departments, ward kitchen areas and patient food service at ward level. 9 Disposable aprons are effective barriers and when used correctly help to prevent cross infection: Discard after each patient contact following a "dirty task" Always discard after cleaning spillage, etc. Apply fresh apron before undertaking "clean task" i.e. feeding patients. Apply fresh aprons before undertaking aseptic procedures (aprons should be readily available in all ward areas - preferably in designated dispensers). NGH-PO-418 Page 12 of 29

13 7.2. Purchase of New Equipment Advice on currently approved decontamination and sterilising equipment is available from the Head of Sterile Services & Trust Lead, Senior Infection Prevention and Control Nurse; the Trust s contracted Authorised Engineer for (AED) and the Head of Procurement When purchasing new medical devices including surgical instruments advice must be sought by the Medical Devices Group or Trust Lead to ensure that decontamination instructions are obtained that follow UK accepted decontamination processes. See also the Trusts Purchasing Policy for further information Loan Equipment The Trust policy for 'on-loan' medical equipment is in accordance with the MHRA Safety Notices 2000(18) and 2002(17). Any equipment, which is loaned to this Trust, excluding sterile equipment, must be accompanied by the following::- A decontamination status certificate. A comprehensive list of items for each tray. The manufacturer s instructions for cleaning, disinfection and sterilisation. Adequate training on dismantling, reprocessing Loan of the Trust s medical equipment to other Trusts or organisations must be authorised by a Senior Manager. Any item of medical equipment loaned out from Northampton General Hospital NHS Trust to another Trust or organisation must be referred to the Medical electronic Department, as appropriate, prior to the loan. This will enable the loan to be recorded and the equipment verified as not being overdue for planned maintenance. A Certificate will be sent with the equipment. When the equipment is returned, it will have a contamination status or decontamination document from the returning organisation attached. Devices will be checked for their function upon return and breakages will be recharged accordingly Detergent The specific detergent to be used in any automatic washer/disinfector or ultrasonic unit will be determined by the Head of Sterile Services & Trust Lead in consultation with the Consultant Microbiologist, Occupational Health Dept., Health & Safety Dept. and the Senior Infection Prevention and Control Nurse. NGH-PO-418 Page 13 of 29

14 7.5. Chemical Disinfectants Peracetic Acid either 5% or 15% high level disinfectant single shot is the only chemical specified for use in the current automatic endoscope re-processors as advised by the washer manufacturer and ratified by the Group Peracetic Acid, e.g. 'Perasafe', is the only cold sterilant chemical approved for use in open trays on heat sensitive equipment which cannot be reprocessed in the central facility of SSD or Endoscopy Department. Approval for their use must be obtained from the Head of Sterile Services & Trust Lead in consultation with the Health and Safety Advisor. The Occupational Health Department are to be informed wherever any chemical sterilant is in use and a full COSHH assessment is to be carried out by a 'competent person' before it is used for the first time. Note: When handling chemicals always ensure correct personal protective equipment is worn. Always refer to the department/wards COSHH file for further guidance regarding chemical use or spillages Medical Devices supplied for Single-Use only Devices designated for single use should be discarded after use as per MDA guidance DB 2000(04) and in line with the Trusts Waste Management Policy. There are a number of potential hazards associated with re-processing and re-using medical devices intended for single-use; such re-processed devices should not be re-processed or re-used on patients Users, who disregard this information and prepare single-use products for further use, may be transferring legal liability for the safe performance of the product from the manufacturer to themselves, or to the organisation that employs them Labelling and meaning of Single-Use. Single use on packaging of medical devices indicates that the manufacturer intends the items to be used once then discarded; considers the items are not suitable for use on more than one occasion or has insufficient evidence to confirm that re-use would be safe. Single Use symbol Potential hazards with Re-use. Materials becoming adversely affected, leading to device failure, infection arises due to inadequate cleaning, disinfection or sterilisation or the status of the re-processed device being unclear as a result of inadequate labelling Single patient use. Equipment marked with single patient use may be used for more than one episode of use on one patient only provided that the equipment is marked NGH-PO-418 Page 14 of 29

15 with the patients name to aid identification. The device may undergo some manual washing between each use. E.g. breast pumps 7.7. Suspected Contamination with Prions (e.g. CJD or vcjd) If equipment is believed to be contaminated with prions then the equipment should be quarantined immediately and not be decontaminated without seeking advice from the Consultant Microbiologist (Ext 5043), Lead (Ext 5792) or DIPC (Ext 5785). Prions are an abnormal protein thought to be the causative agent of Transmissible Spongiform Encephalopathies (TSE) e.g. Creutzfeldt-Jakob disease. The protein is remarkably resistant to conventional methods of disinfection and sterilisation. Further information can be found in the Creutzfeldt-Jakob disease (CJD) policy (NGH-PO-20-03) and the Department of Health dangerous pathogens website Managing used Equipment prior to further use or collection of ward equipment for Investigation, Inspection, Service or Repair or onward use The Health and Safety at work act (1974) requires safe systems of work should be implemented to protect all staff including persons who are not employed by Northampton General Hospital Trust. The Medicines and Healthcare Products Regulatory Agency (MHRA 2003) outlines the need to prevent the transmission of infection from medical equipment whether laboratory, consumables or material used in the treatment, diagnosis or care of patients, and other equipment which comes into contact with body fluids. The process to follow when sending equipment for investigation, inspection, service or repair is outlined as follows: (see flow charts in appendix 6). a) Medical Equipment should be cleaned with detergent wipes or detergent and water prior to repair, service or inspection following the general principles for cleaning. Disinfection with Chlorclean will be required for equipment contaminated with blood or body fluids. b) All Medical Devices being returned to either Medical Electronics or the Medical Equipment Library will have attached a YELLOW Declaration of Contamination Status Label. The label can also be used to report defects for service/repair or arrange for collection. The Declaration of Contamination Status label is only completed when equipment is transported from clinical areas to Medical Electronics or the Medical Equipment Library. Supplies of the Yellow Declaration of Contamination Status Labels are retained in each clinical area and are available from Medical Equipment Library. c) All used equipment must be thoroughly cleaned prior to further patient use and a dated and signed green sticker attached to the equipment (see Appendix 4). d) Equipment which can be autoclaved should be dismantled and sent to the Sterile Service Department. Consult either the SSD Manager or the Medical Electronics Department before sending. It may be necessary to use plastic bag for transporting. e) For equipment which cannot be decontaminated without dismantling by an engineer, advice should be sought from the Medical Electronics Department and the equipment should be cleaned and then sealed in plastic bag to contain. f) If equipment is subject of a complaint, incident or other investigation, decontamination may prevent a full investigation from being conducted. In these NGH-PO-418 Page 15 of 29

16 circumstances the equipment must be quarantined and the investigation body must be notified. g) Medical Equipment which is being forwarded to a third party repairer will be subjected to a disinfection or sterilisation process either carried out via the Medical Equipment Library, Medical Electronics or the Sterile Service Department. A certificate must be attached to the equipment prior to sending externally (A copy of the decontamination certificate must be retained for 5years) Further advice and Guidance The decontamination of medical equipment can be very complicated and advice should be sought if the user is in any doubt on what action to take. Advice is always available from the following:- Lead Infection Prevention Nurse Extension 5785 Health & Safety Adviser Extension 5087 Occupational Health Manager Extension 5358 Head of Sterile Services & Trust Lead Extension 5718 Medical Devices Manager Extension 5050 Risk Management Team Extension and Risk Management Where an incident has been identified which relates to decontamination, all staff are responsible for ensuring that the incident is reported using the Trusts Datix e-reporting system on the Trust intranet. All incidents will be overseen by Directorate Teams - Directorates will seek advice as and when required from the Lead for. Directorates must ensure that robust assurances are received that appropriate actions have been identified and implemented to prevent reoccurrence. Learning the lessons is a fundamental and part of risk management and all appropriate action must be taken following a decontamination related incident to ensure that the appropriate Infection Prevention & Control measures are complied with. This section should be read in conjunction with the Policy for the Management of Incident (Including Serious Incidents). NGH-PO-418 Page 16 of 29

17 8. IMPLEMENTATION & TRAINING All staff will undertake annual infection prevention training and the importance of effective hand hygiene in the prevention of infection to patients as defined in the Trust Mandatory Training Policy. Specialised training will be provided within individual departments where specialised decontamination is undertaken. This training includes effective decontamination processes for reusable medical devices and is arranged through the Lead and provided by the relevant manufactures. These speciality departments are listed in Appendix 3. NGH-PO-418 Page 17 of 29

18 9. MONITORING & REVIEW Minimum policy requirement to be monitored Process for monitoring Responsible individual/ group/ committee Frequency of monitoring Responsible individual/ group/ committee for review of results Responsible individual/ group/ committee for development of action plan Responsible individual/ group/ committee for monitoring of action plan Acceptable adoption of the policy used Trust- Wide. Audit Feedback from staff. Lead Infection Control Committee Committee Monthly review of incidents, concerns, comments, or complaints that result in a breach of this policy Lead Infection Prevention Committee Committee Lead Infection Prevention Committee Committee Lead Infection Prevention Committee Committee Microbiologist Microbiologist Department of Health (2010). Saving Lives High Impact Intervention 8: care Bundle to improve the Cleaning and of Clinical Equipment. Matrons Dashboard Monthly cleaning audit scores are reported to the Infection Prevention Committee and episodes of poor compliance are monitored and actioned through the IPC Monthly compliance rates are reported to the Infection Prevention Committee and episodes of poor compliance are monitored and actioned through the Infection Prevention Committee Infection Prevention Committee Infection Prevention Committee Infection Prevention Committee NGH-PO-418 Page 18 of 29

19 Health and Social Care Act 2008 Regulation 12 /Outcome 8 Cleanliness and Infection Control Health and Social Care Act 2008 Regulation 10 /Outcome 16 Assessing and Monitoring the Quality of Service Provision Directive 93/42/EEC Article 12 Annex V ISO 13485:2012 ISO 9001:2000 External JAG Audit (Joint accreditation for gastroenterologists) Internal / external audits. Copy of external audit report forwarded to CQEG via the Facilities Governance Group Internal / External audit specific for decontamination. Audit reports forwarded to CQEG via General Surgery Quarterly Governance group. Any adverse incidents are thoroughly investigated and outcomes/lessons learnt are shared Risk management Reports and lessons learnt from Serious Incidents are shared at Patient Safety Learning Forum. Patient safety reports to CQEG Lead Infection prevention committee Lead Infection prevention committee Lead Infection prevention committee Lead Infection prevention committee Lead NGH-PO-418 Page 19 of 29

20 An annual environmental audit of all areas is undertaken by the Infection Prevention Team and these detailed reports are fed back to Ward and Departmental Mangers with any recommendations made. If an area falls short of the required standards then a follow up audit will be agreed with the manager. Areas where specialised decontamination is undertaken such as the Endoscopy Department or the Sterile Service Department then various external audits apply in accordance with UK Legislation. These audits include CE Accreditation and JAG Audits. The Trust Lead reports external audits to the Medical Device Committee, Infection Control Committee and the Facilities Governance Group. NGH-PO-418 Page 20 of 29

21 10. REFERENCES & ASSOCIATED DOCUMENTATION Advisory Committee on Dangerous Pathogens (2003) Guidance from the ACDP TSE Risk Management Subgroup [online] DH. Available from: [Accessed 16th December 2011] British Standards Institute (2012) BS EN ISO 13485:2012 Medical devices: Quality management systems: requirements for regulatory purposes. Milton Keynes: BSI British Standards Institute (2001) BS EN 556-1:2001 Sterilization of medical devices. Requirements for medical devices to be designated "STERILE": Requirements for terminally sterilized medical devices. Milton Keynes: BSI Consumer Protection Act 1987 (c.43) [Online]. London. HMSO. Available from: [Accessed 16th December 2011] Council Directive 93/42/EEC of 14 June 1993 concerning medical devices [Online]. EurLex. Publications Office. Available from: [Accessed 16th December 2011] Department of Health (2013). NHS Constitution: the NHS belongs to us all. [online]. London. Department of Health. Available from _Constitution.pdf [Accessed 1 st May 2014] Department of Health (2010) Saving lives: reducing infection, delivering clean and safe care. High impact intervention no. 8. Care bundle to improve the cleaning and decontamination of clinical equipment. [Online]. London. Department of Health. Available from: [Accessed 16th December 2011] Department of Health (2010) The Health Act 2008: Code of practice on the prevention and control of infections and related guidance [online] London. DH. Available from: nce/dh_ [Accessed 16th December 2011] NGH-PO-418 Page 21 of 29

22 APPENDICES APPENDIX 1: DISINFECTION PROCESS (STERILE SERVICES) TO ACHIEVE STERILISATION ALL ITEMS MUST FIRST BE CLEANED AND DISINFECTED 1 METHODS OF DISINFECTION All items must be clean and visibly free from debris, blood and other organic matter, or disinfection will not be achieved. All items for sterilisation should first be disinfected by an automated process. This should be undertaken in an appropriately designated area. Manual washing is discouraged at all times unless the equipment manufacturer states this is the only acceptable method. 2 MACHINERY FOR THE DISINFECTION OF EQUIPMENT All items and pieces of equipment must always be disinfected in the machinery designed and purchased for that purpose i.e. automatic washer/disinfector Manual washing of equipment is not permitted in normal circumstances as this creates an unacceptable risk to the operator and may spread infection to one or more patients. There can be no validation of a manual process. However, the manufacturers of some delicate equipment advise washing by hand e.g. flexible endoscopes which must undergo a process of manual cleaning before being disinfected in the automatic endoscope re-processor. For this the member of staff must wear appropriate personal protective clothing. i.e. gloves, disposable plastic apron and eye protection. Items for disinfection may be processed by: Automated ultrasonic washer with heat assisted disinfection cycle and attachments for cannulated instruments. Automatic Washer/Disinfector for surgical instruments High grade chemical disinfection in tank/automatic washer/disinfector using approved chemical disinfectant. NGH-PO-418 Page 22 of 29

23 APPENDIX 2: METHODS OF STERILISATION (STERILE SERVICES) Before the sterilisation process all items must first be cleaned then disinfected by one of the methods outlined in the Disinfection Section. (APPENDIX 1) ALL STERILISATION IS UNDERTAKEN CENTRALLY IN THIS TRUST. 1. MACHINERY FOR THE STERILISATION OF EQUIPMENT - High Temperature/Pressure Porous Load Sterilizers (134 C-137 C for 3.5 minutes) 2. TYPES OF STERILISATION - Steam under pressure 134 C 137 C for 3.5 minutes is the method adopted by the Trust. 3. OTHER TYPES OF STERILISATION USED FOR HEAT SENSITIVE PRODUCTS The following are used in industry and some large centres, but due to the excessive time taken for the process are not suitable for this Trust. a) Low Temperature Steam/Formalin b) Ethylene Oxide Gas c) Gamma Irradiation d) Gas Plasma Sterilisation available at Coventry please contact Sterile Service Manger for more information TYPES OF MEDICAL EQUIPMENT THAT UNDERGO THE DISINFECTION/STERILISATION PROCESS ALL EQUIPMENT MUST BE CLEANED AND DISINFECTED BEFORE IT IS STERILISED EQUIPMENT General surgical instruments/trays Heat tolerant endoscopes (Rigid Telescopes) Poly-ware and jugs Stainless steel utensils/bowls Heat sensitive anaesthetic items Heat sensitive endoscopes PROCESS TO BE USED Automated cleaning/disinfection followed by steam sterilisation in central facility. As above. Automated cleaning/disinfection and where required sterilisation, in the central facility. As above. Automated cleaning/disinfection in central facility. Automated cleaning/disinfection using approved chemical disinfectant in Endoscopy clinic or approved point of use. STAFF CARRYING OUT THESE PROCEDURES MUST BE TRAINED AND DEEMED COMPETENT BY THEIR SUPERVISOR/MANAGER. NGH-PO-418 Page 23 of 29

24 APPENDIX 3: LOCAL DECONTAMINATION High Level Disinfection is carried out in the following places within the Trust due to the fact there is heat sensitive equipment or insufficient high cost equipment. When using high level disinfectants or wipes please follow the manufacturers instructions, ensure sensitive equipment is compatible with disinfectants. SUB-SPECIALITY REASON ITEMS STAFF RESPOSIBLE ENDOSCOPY HEAT SENSITIVE FLEXIBLE ENDOSCOPES (Accredited unit) Endoscopy reprocess heat liable devices from ITU, Day Surgery T&O and Main Theatre Endoscopy Manager / Trust Lead ENT OPD HEAT SENSITIVE ENT Naso-Endoscopes ENT Ward Manger (Tristel 3 wipe system) X2 MAIN THEATRE HEAT SENSITIVE / TOO LONG (Peri-safe paracetic acid using open Trough) EXTRA LONG RECTAL PROBE Theatre Manager HEART CENTRE UNABLE TO SUBMERGE OPERATING END TOE PROBES TEE PROBES Unit Manager (Tristel 3 wipe system) HEAD & NECK WARD HEAT SENSITIVE (Tristel 3 wipe system) ENT Naso-Endoscopes X1 Ward Manager MAXILLO FACIAL UNIT HEAT SENSITIVE (Tristel 3 wipe system) ENT Naso-Endoscopes X1 Unit Manager ONCOLOGY OPD HEAT SENSISTIVE (Gas Plasma via Walsgrave Hospital) NASOENDOSCOPE Oesophageal Dilators Oncology Outpatient Manager GYNAECOLOGY OPD (3 areas) HEAT SENSITIVE (Tristel 3 wipe system) TRANS VAGINAL PROBES Unit Manager NGH-PO-418 Page 24 of 29

25 APPENDIX 4: CLEANING AND DECONTAMINATION OF PATIENT EQUIPMENT BEING RETURNED TO THE EQUIPMENT LIBRARY: FLOWCHART FOR WARD STAFF Is the equipment leaving the ward? NO Thoroughly clean the item in accordance with Saving Lives High Impact Intervention 8 and attach a yellow Declaration of Contamination Status label Thoroughly clean the item in accordance with Saving Lives High Impact Intervention 8 and attach signed and dated green indicator tape The item can then leave the ward or be collected by the Medical Equipment Library or Medical Electronics If you use a piece of equipment that does not have signed and dated green indicator tape YOU must thoroughly clean it before using it for a patient References Department of Health (2010). Saving Lives High Impact Intervention 8: Care Bundle to Improve the Cleaning and of Clinical Equipment. Department of Health, London NGH-PO-418 Page 25 of 29

26 APPENDIX 5 DECLARATION OF CONTAMINATION STATUS LABEL (TWO-SIDED) Northampton General Hospital NHS Trust DECLARATION OF CONTAMINATION STATUS Please tick box A if applicable. Otherwise complete all parts of part B, or part C providing further information. A B This equipment/item has not been used in any invasive procedure or been in contact with blood, other body fluids, respired gases, or pathological samples. It has been cleaned in preparation for Inspection, servicing, repair or transportation. Has this equipment/item been exposed internally or externally to hazardous materials as indicated below? Provide further details here Blood, body fluids, respired gases. Pathological samples: Other biohazards: Chemicals or substances hazardous to health: Other hazards: /NO /NO /NO /NO Has this equipment/item been cleaned and decontaminated? /NO Indicate the methods and materials used: C This equipment could not be decontaminated. Standard precautions are necessary. I declare that I have taken all reasonable steps to ensure the accuracy of the above information, in accordance with Trust decontamination policy. Print Name... Date... 1) MEDICAL DEVICES JOB REQUEST - Please ring extension 5440 Device Description... Asset Number... Location... Job Number... Contact Name... (Person Operating Device at time of failure) Date... Details of Fault or Service Required ) MEDICAL DEVICES RETURN REQUEST - Please ring extension 4300 NGH-PO-418 Page 26 of 29

27 APPENDIX 6: FLOWCHART FOR HANDLING OF EQUIPMENT PRIOR TO INSPECTION, SERVICE, REPAIR, RETURN TO LENDING ORGANISATION OR FOR RE-CIRCULATION. On Ward or Department Is the equipment leaving the ward or broken / faulty? On Ward or Department Thoroughly clean item and attach Declaration of Contamination Status Label. Complete both sides of label. Arrange collection from Medical Electronics or Medical Equipment Library In Medical Electronics or Medical Equipment Library Does the equipment require additional servicing from a third party repairer? Yes Yes In Medical Electronics or Medical Equipment Library Prior to despatch complete decontamination certificate and attach to equipment. No Notes No Notes Thoroughly clean item after use and attach a signed and dated green clean indicator sticker If you need to use a piece of equipment and it does not have a signed and dated green clean indicator sticker attached then you must thoroughly clean the item. Cleaning where possible, should take place in a dedicated area away from patient care. Always follow the manufacturers instructions and if necessary refer to the infection Control Policy. Porters or staff from MEL and ME will not collect equipment without a Declaration of Contamination Status Label attached. Complete the necessary service or repair and attach a new: Declaration of Contamination Status Label and return to Ward /Department or place back into the Medical Equipment Library Stock. Ensure that the decontamination processes follows the manufacturers instructions. The decontamination process should be carried out in a defined area. Ensure PPE and COSHH guidance is adhered to. Retain copy of Certificate for 5 years. Copies retained in Medical Electronics NOTE Please ensure the: Cleaning & decontamination of patient equipment flowchart for ward staff Appendix 4 is displayed in the appropriate areas. NGH-PO-418 Page 27 of 29

28 Flowchart for Handling of Equipment prior to investigation of adverse incident. Can the equipment be decontaminated without removing evidence important to a repair or an investigation? (If unsure, check with the Trust No Lead) Yes Decontaminate Item Prior to despatch complete decontamination certificate and attach to equipment. Retain copy of decontamination certificate for audit purposes for five years Inform repair organisation or investigating body Repair organisation or investigating body agrees despatch? No Yes Contain Item inside plastic bag Complete decontamination certificate. Note fault/ defect. Pack and despatch for service/repair or investigation Arrange visit by service / repair organisation or investigating body. Contain Item inside plastic bag Complete decontamination certificate. Note fault/ defect. Quarantine in preparation for service / repair or investigation NGH-PO-418 Page 28 of 29

29 Flowchart for Handling of Equipment in Theatres prior to inspection, service, repair, return to lending organisation or for re-circulation. In theatres Is the equipment leaving theatres or broken / faulty? NO PAR Thoroughly clean item after use and attach signed and dated green clean indicator tape. Theatre suites Thoroughly clean all equipment between each case in accordance with Theatre Practice Guidelines. In theatres Thoroughly clean item and attach Declaration of Contamination Status Label. Complete both sides of label. Arrange collection from Medical Electronics or Sterile Service Department. Note Always follow the manufacturers instructions and if necessary refer to the infection Control Policy. Porters or staff from Medical Electronics will not collect equipment without a Declaration of Contamination Status Label attached. In Medical Electronics or Sterile Service Department Does the equipment require additional servicing from a third party repairer? NO Complete the necessary service or repair and attach a new: Declaration of Contamination Status Label and return to Theatres. In Medical Electronics or Sterile Services Department Prior to despatch complete decontamination certificate and attach to equipment. Note Ensure that the decontamination processes follows the manufacturers instructions. The decontamination process should be carried out in a defined area. Ensure PPE and COSHH guidance is adhered to. Retain copy of Certificate for 5 years (retained in Medical Electronics). NGH-PO-418 Page 29 of 29

30 Policy for Re-usable Medical Devices #NGH-PO-418 Business Area Facilities Person Responsible Clare Topping Created Last Review 14th April, th April, 2014 Status Next Review Complete 14th April, 2015 Screening Data Name, job title, department and telephone number of the person completing this Equality Impact Assessment Clare Topping Energy and Sustainability Manager, Facilities ex 5754 What is the title and number of this policy/procedure/guideline? Policy for Re-usable Medical Devices NGH-PO-418 What are the main aims, objectives or purpose of this policy/procedure/guideline? Ensure that staff have sufficient information to decontaminate reusable medical devices effectively to ensure that they are safe to use and free from viable organisms to the correct sterility assurance level. Who is intended to benefit from this policy/procedure/guideline? All staff and patients as it will ensure that devices are safe to use Is this a Trustwide, Directorate only or Department only policy/procedure/guideline? Trustwide Who is responsible for the implementation of the policy/procedure/guideline? Sterile Services Manager / Trust Lead Recommend this EA for Full Impact Analysis? No Comments No groups with protected characteristics will be discriminated against by this policy

31 Rate this EA Low Organisation Sign-off Data If the policy is implemented what is the potential risk of it having an adverse effect on equality? Low Risk - probably will not have an adverse effect on equality If the policy is implemented what is the potential of it having a positive effect on equality and relations? High Potential - highly likely to promote equality of opportunity and good relations If the potential for risk or positive effect occurred what would be the potential number of people it effected? A moderate amount of people would be affected Based on the answers to questions 1-3 will this policy promote equality and diversity? Yes It will ensure that all patients and staff are protected from contaminated equipment Do you have any additional comments or observations about the policy? How will the results of the Equality Impact Assessment will be published? N/A Have you completed any Action Boxes with recommended actions or changes for completion? No If 'Yes' please print off an action plan report along with a copy of the Equality Impact Assessment report to the policy/procedure/guidelines owner, and record below who it has been sent to If 'No' please print off a copy of the Equality Impact Assessment report to the policy/procedure/guidelines owner, and record below who it has been sent to Sent to Garry Hunt, Sterile Services Manager and Governance Department Please give details of the monitoring arrangements Will be reviewed whenever the policy is reviewed Next Review Date Outstanding Actions No outstanding actions

32 FORM 1 & 2 - To be completed by document lead FORM 1a- RATIFICATION FORM - FOR COMPLETION BY DOCUMENT LEAD Note: Delegated ratification groups may use alternative ratification documents approved by the procedural document groups. DOCUMENT DETAILS Document Name: Policy for Re-usable Medical Devices Is the document new? Yes / No If yes a new number will be allocated by Governance If No - quote old Document Reference Number NGH-PO-418 This Version Number: Version: 3 Date originally ratified: December 2009 Date reviewed: August 2014 Date of next review: a 3 year date will be given unless you August 2015 (1 Year) specify different If a Policy has the document been Yes / No Equality & Diversity Impact Assessed? (please attach the electronic copy) DETAILS OF NOMINATED LEAD Full Name: Garry J. D. Hunt Job Title: Lead Directorate: Facilities Address: [email protected] Ext No: 5792 DOCUMENT IDENTIFICATION Keywords: please give up to 10 to assist a search on intranet ; Medical Devices; Cleaning; Disinfection; Sterilization; Repair; Health and Social Care Act. GROUPS WHO THIS DOCUMENT WILL AFFECT? ( please highlight the Directorates below who will need to take note of this updated / new policy ) Anaesthetics & Critical Care Gynaecology Medicine Child Health Haematology Nursing & Patient Services Corporate Affairs Head & Neck - inc Ophthalmology Obstetrics Diagnostics Human Resources Oncology Facilities Infection Control Planning & Development Finance Information Governance Trauma & Orthopaedics General Surgery Trust wide TO BE DISSEMINATED TO: NB if Trust wide document it should be electronically disseminated to Head Nurses/ Dm s and CD s.list below all additional ways you as document lead intend to implement this policy such as; as presentations at groups, forums, meetings, workshops, The Point, Insight, newsletters, training etc below: Where When Who Committee 27 th January 2014 Committee NGH-PO-001 Version 7.2 Appendix 4.1 Page 1 of 2

33 FORM 1 & 2 - To be completed by document lead FORM 2 - RATIFICATION FORM to be completed by the document lead Please Note: Document will not be uploaded onto the intranet without completion of this form CONSULTATION PROCESS NB: You MUST request and record a response from those you consult, even if their response requires no changes. Consider Relevant staff groups that the document affects/ will be used by, Directorate Managers, Head of Department,CDs, Head Name, Committee or Group Consulted Committee Nurses, NGH library regarding References made, Staff Side (Unions), HR Others please specify Date Policy Sent Amendments requested? Amendments Made - for Consultation Comments 27 th January 2014 Change Appendix 11 to Appendix 4 Existing document only - FOR COMPLETION BY DOCUMENT LEAD Completed Have there been any significant changes to this document? / NO if no you do not need to complete a consultation process Sections Amended: / NO Specific area amended within this section Re-formatted into current Trust format / NO Summary/ Introduction/Purpose / NO Scope / NO Definitions / NO Roles and responsibilities / NO Substantive content / NO Monitoring / NO Refs & Assoc Docs / NO Appendices / NO Some appendices removed and placed into the new of Equipment and Patient Environment Policy currently out for consultation. NGH-PO-001 Version 7.2 Appendix 4.1 Page 2 of 2

34 FORM 3- RATIFICATION FORM (FOR PROCEDURAL DOCUMENTS GROUP USE ONLY) Read in conjunction with FORM 2 Document Name: Overall Comments from PDG re the Policy Consultation Do you feel that a reasonable attempt has been made to ensure relevant expertise has been used? Title -Is the title clear and unambiguous? Is it clear whether the document is a strategy, policy, protocol, guideline or standard? Summary Is it brief and to the point? Introduction Is it brief and to the point? Purpose Is the purpose for the development of the document clearly stated? Scope -Is the target audience clear and unambiguous? Compliance statements is it the latest version Definitions is it clear what definitions have been used in the Roles & Responsibilities Do the individuals listed understand about their role in managing and implementing the policy? Substantive Content is the Information presented clear/concise and sufficient? Implementation & Training is it clear how this will procedural document will be implemented and what training is required? Monitoring & Review (policy only) -Are you satisfied that the information given will in fact monitor compliance with the policy? References & Associated Documentation / Appendicesare these up to date and in Harvard Does the information provided provide a clear evidence base? Are the reference provided using Harvard Referencing format? Are the keywords relevant See track changes Document No: NGH-PO-418 / NO / NA Recommendations Recommendations completed Complete table last three columns Completed Check library references inserted in document (changes in red) Completed Name of Ratification Group PDG Name of Ratification Group Ratified Yes: Ratified No: Ratified subject to amendments and chair approval Ratified Yes: Ratified No: Date of Meeting: 17/07/2014 Date of Meeting: August 2014 Taken from NGH-PO-001 Version 7.2 Appendix (last updated June 2012) Page 1 of 1