Medical Devices Decontamination and Single Use Policy. Safety and Risk: Infection Control

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1 Title: Purpose: Applicable to: Document Author: Ratified by and Date: Medical Devices Decontamination and Single Use Policy To provide general principles and recommendations to ensure as far as reasonably practicable, that all reusable medical devices are properly decontaminated and outline the legal implications and safety issues in relation to single use equipment. Staff, Patients, Carers or Relatives, Maintenance staff Leslie Lawson-Kinross, Infection Control/Medical Devices Lead In collaboration with RCHT Trust wide Decontamination Lead Sharon Linter Director of Quality and Governance / Executive Nurse 4 June 2014 Review Date: December months prior to the expiry date Expiry Date: Document library location: Related legislation and national guidance: See version control table 3 years after ratification unless there are any changes in legislation or changes in clinical practice Safety and Risk: Infection Control MHRA (2014) Managing Medical Devices: Guidance for healthcare and social services organisations. MHRA (2013) Single-use Medical Devices: implications and Consequences of Reuse MHRA (2008) Devices in practice: a guide for professionals in health and social care Medical Devices Regulations 2002 (Amended 2003) MHRA (2013) Medical Device Alert MDA/2013/019 Detergent and disinfectant wipes used on reusable medical devices with plastic surfaces. All manufacturers. MHRA (2011) Medical Device Alert MDA/2011/096 Reusable laryngoscope handles - all models and manufacturers MHRA (2010) Medical Device Alert MDA/2010/060 Sigmoidoscope and anoscope systems and accessories manufactured by Welch Allyn Limited. MHRA (2010) Medical Device Alert MDA/2010/002 All types of bed mattresses Medical Devices Directive (MDD) Council Directive 93/42/EEC (1992) BS EN 980:2008 Symbols for medical device labelling BS EN ISO 13485:2012 Medical devices. Quality Management Systems. Requirements for regulatory purposes Page 1 of 39

2 BS EN ISO 9001:2008 Quality management systems. Requirements BS EN ISO 14971:2012, Medical devices. Application of risk management to medical devices BS EN ISO 17664:2004, Sterilization of medical devices. Information to be provided by the manufacturer for the processing of resterilizable medical devices BS EN ISO :2009 Sterilization of medical devices. Microbiological methods. Tests of sterility performed in the definition, validation and maintenance of a sterilization process BS EN ISO :2006 Sterilization of medical devices. Microbiological methods. Determination of a population of microorganisms on products BS EN 285:2006+Amendment Sterilization. Steam sterilizers. Large sterilizers BS EN ISO :2006 Washer-disinfectors. General requirements, terms and definitions and tests BS EN ISO :2006 Washer-disinfectors. Requirements and tests for washerdisinfectors employing thermal disinfection for surgical instruments, anaesthetic equipment, bowls, dishes, receivers, utensils, glassware, etc. BS EN ISO :2008 Washer-disinfectors. Requirements and tests for washerdisinfectors employing chemical disinfection for thermolabile endoscopes BS EN 15424:2007 Sterilization of medical devices. Low temperature steam and formaldehyde. Requirements for development, validation and routine control of a sterilization process for medical devices BS EN ISO :2007 Sterilization of health care products. Ethylene oxide, Requirements for development, validation and routine control of a sterilization process for medical devices BS EN 14885:2006 Chemical disinfectants and antiseptics. Application of European Standards for chemical disinfectants and antiseptics BS EN ISO : 2007 Sterilization of health care products. Radiation. Establishing the sterilization dose Care Quality Commission (2010) Essential standards of quality and safety. The Health and Social Care Act 2008 (Regulated Activities) Regulations 2010 NHS England and MHRA (2014) Improving medical device incident reporting and learning. Department of Health (2013) Management and decontamination of surgical instruments used in acute care. Page 2 of 39

3 Associated Trust Policies and Documents: Equality Impact Assessment: Training Requirements: Carriage of Dangerous Goods by Road Regulations 1996 Health and Safety at Work etc. Act 1974 The Control of Substances Hazardous to Health Regulations 2002 Consumer Protection Act 1987 (Consumer Safety and Product Liability) Advisory Committee on Dangerous Pathogens Transmissible Spongiform Encephalopathy (ACDP TSE) Risk Management Subgroup (2013) Minimise transmission risk of CJD and vcjd in healthcare settings NICE (2006) Patient safety and reduction of risk of transmission of Creutzfeldt Jakob disease (CJD) via interventional procedures. Interventional procedure guidance 196 Infection Control Policies Health and Safety Policy The Management of Medical Devices and Equipment Control of Substances Hazardous to Health Policy Generic Waste Management Policy The Equality Impact Assessment Form was completed on 20 th May 2014 Staff will be trained and monitored as part of the compulsory training programme, and the physical healthcare monitoring training which includes medical devices. Training compliance is reported to the service line clinical cabinet and Quality, Improvement, Safety, Experience & Effectiveness Committee. The organisation trains staff in line with the requirements set out in its training needs analysis and published in its Corporate Curriculum. Training which is categorised as statutory or essential must be completed in line with the training needs analysis and Corporate Curriculum. Compliance with statutory and essential training is monitored through the Learning and Development team with monthly manager s reports and staff individual training records twice yearly. Training reports are also submitted quarterly through the Trust Quality and Governance Committee Meeting. Staff failing to complete this training will be accountable and could be subject to disciplinary action. Monitoring Arrangements: A rolling program of audit utilising the Infection Prevention Society Quality Improvement Tools will be carried out by the Infection Control/Medical Devices Lead and nominated ward/department representatives. An audit report will be submitted to the relevant clinical cabinet, Infection Prevention and Control Committee and Medical Devices Safety Group. Page 3 of 39

4 Monthly Specifications for cleanliness in the NHS audits reported to the Patient Environment Action Group (PEAG), the Infection Control Committee and Medical Devices Safety Group. Implementation: The policy will be uploaded onto the Trust s Document Library and will replace any previous versions. Staff will be made aware of this policy at induction. Version Control Version Date Reviewed Changes By Whom February 2014 Expiry date extended to 31 March 2014 due to currently working on the joint policy Leslie Lawson- Kinross with RCHT and PCH colleagues March 2014 Expiry date extended to 30 June 2014 as EMG agreed by Executive Management Group V3 May 2014 New trust format and inclusion of Single Use Policy June 2017 Extended 6 months LG Leslie Lawson- Kinross This document Replaces: HS.IC/022/11 Medical Devices Decontamination Policy HS.IC/023/11 Single Use Policy This document can be released under the Freedom of Information Act. Page 4 of 39

5 Contents 1. Introduction Aims Definitions/Glossary Responsibilities General principles of decontamination Choosing the most appropriate method of decontamination Procurement Personal Protective Equipment (PPE) Environment Storage Transportation Record Keeping Tracking and Traceability Decontamination prior to service, repair, transfer, disposal, investigation, or return Creutzfeldt Jakob Disease (CJD) and other Transmissible Spongiform Encephalopathies (TSEs) Appendix 1 Procedure for Decontamination by Manual Cleaning Appendix 2 A Z Guide of Methods of Decontamination for Equipment (and Environment) Appendix 3 Decontamination Certificate - Declaration of contamination status Appendix 4 Surgical Instruments / Sundries example Single Use Policy Introduction Indications against reuse Technical implications Actions by healthcare professionals Single Patient Use Equality Impact Assessment Proforma Initial Screening Page 5 of 39

6 1. Introduction Decontamination of re-usable medical devices is the combination of processes, which if not correctly undertaken, individually or collectively, may increase the likelihood of microorganisms being transferred to patients or staff. Decontamination is a process, which removes or destroys contamination and thereby prevents microorganisms or other contaminants reaching a susceptible site in sufficient quantities to initiate infection or any other harmful response. All medical devices and equipment used in either a hospital or community environment may become contaminated with biological, chemical or radioactive material and thus present a risk to those subsequently handling or using them. The term reusable medical devices, applies to all such devices whether owned by the Trust, rented, on loan or acquired by other means. All medical devices and equipment loaned, rented or leased to a patient for use in either the hospital or community environment must be treated with the same level of caution and preparation. This also applies to items that have been used for demonstration purposes. 2. Aims 2.1 To provide general principles and recommendations to ensure as far as reasonably practicable that all reusable medical devices are properly decontaminated (adequately cleaned, disinfected or sterilised) according to its function prior to use or transfer and that all risks associated with decontamination facilities are adequately managed. So as to protect as far as reasonably practical the health, safety and welfare of its staff, patients and those recipients who are involved in inspection, service, repair or transportation of medical devices or equipment. 2.2 To enable all staff involved in the decontamination process to understand the associated hazards, the potential for contamination and the risks of harming themselves and others by their acts or omissions. 2.3 To provide a standard for the purchasing of equipment through to delivering and use, cleaning and disinfecting, sterilizing, repairing and disposing to enable effective decontamination to take place. 2.4 This policy will also take into account furniture (including overbed tables and patient lockers) and seating (including patient, visitors, and outpatients). 3. Definitions/Glossary Definitions used within the policy are: 3.1 Employees are: Direct employees of the Trust Employees of other organisations but directly managed by the Trust Page 6 of 39

7 3.2 Microbial agent any micro-organism, cell culture, or human endoparasite, including any which have been genetically modified, which may cause infection, allergy, toxicity or otherwise create a hazard to human health. 3.3 Decontamination- the decontamination of re-usable medical devices is the combination of processes, which if not correctly undertaken, individually or collectively, may increase the likelihood of micro-organisms being transferred to patients or staff. Decontamination is a process which removes or destroys contamination and thereby prevents micro-organisms or other contaminants reaching a susceptible site in sufficient quantities to initiate infection or any other harmful response. The decontamination process is required to make medical devices: Safe for staff members to handle Safe for use on the patient Three processes of decontamination are commonly used: Cleaning- a process which physically removes contamination but does not necessarily destroy micro-organisms. The reduction of microbial contamination is not routinely measured and will depend upon many factors, including the efficiency of the cleaning process and the initial bioburden. Cleaning removes micro-organisms and the material on which they thrive. Disinfection- a process used to reduce the number of viable micro-organisms but which may not necessarily inactivate some microbial agents such as certain viruses and bacterial spores. Disinfection does not achieve the same reduction in microbial contamination levels as sterilisation. Sterilisation a process used to render an object free from micro-organisms including viruses and bacterial spores. Normal sterilisation methods will not destroy prions. 3.4 Single- use device - (see appendix 5, Single Use Policy). Any device deemed unsuitable by the manufacturer for reprocessing. Such products will be labelled with the words single use or other synonymous reference, and may have the following symbol: 4. Responsibilities 4.1 The Director of Quality & Governance / Executive Nurse is the Director responsible for all aspects of decontamination. Page 7 of 39

8 4.2 Nominated Decontamination Lead will: Provide specialist advice on aspects of equipment decontamination. Be responsible for over-seeing the operation and implementation of the policy throughout the Trust and will respond to all decontamination issues. 4.3 Managers will ensure that: There is adequate provision of disinfectants, cleaning agents and equipment necessary to achieve the required standard of decontamination. Ensure that this policy and its associated procedures are fully adhered to within their area of responsibility. Ensure that each medical device that is to be reused has written instructions to render it safely decontaminated. Ensure staff are aware of and implement correct procedures. Action all Hazard and Safety Notices issued to them as appropriate. All actions must be recorded. Ensure devices designed as Single Use Only are never reused. Ensure that staff performing decontamination duties; receive training appropriate to the equipment and practices within individual departments. Inadequately trained staff may fail to decontaminate instruments or equipment properly, thus putting patients or other staff at risk. They may also risk their own health and safety it they are unaware of safe practice standards. Ensure that all staff involved in the use, maintenance and decontamination of medical devices should be properly supervised and their performance monitored. Be responsible for identifying and replacing where practicable instruments/equipment that are difficult to clean and/or in poor condition with versions that are easier to clean. Consider the decontamination process when procuring devices, obtaining specialist advice from the Infection Control Team and the Decontamination Lead, to ensure that the equipment can be decontaminated adequately. Ensure that appropriate risk assessments are carried out and are recorded in accordance with Trust protocols prior to the decontamination of equipment and the use of chemicals. Report all incidents involving a decontamination procedure, where any persons have been placed at risk, in accordance with the Trusts policy on incident reporting. Ensure all new disinfectants/cleaning products are referred to the Infection Control team and Decontamination Lead for approval prior to use. Ensure that no reusable devices are purchased or trialled unless cleaning/decontamination instructions are available and have been reviewed and approved by the Infection Control Team/Decontamination Lead. 4.4 Employees will: Prior to using any item of equipment the user must ensure that the equipment has been decontaminated adequately. Co-operate and assist with the implementation of this policy, and its associated procedures. Page 8 of 39

9 Bring to the notice of management, any problems or failings associated with the decontamination process. Undertake appropriate training courses / programmes as required including induction and mandatory training. Make themselves aware of, and follow safe systems of work and control methods (including the use of personal protective equipment) provided for their safety and the safety of others. Promptly report all incidents concerning the decontamination process in accordance with the Trusts Policy and Procedure on reporting incidents. Report any adverse ill health effects arising from the decontamination process to both the Health & Safety Department and the Occupational Health department. Seek specialist advice as necessary. Never re-use single use devices. 4.5 Procurement Department will: At the request of the Manager responsible for the procurement obtain details of the decontamination requirements of the equipment to enable the Manager responsible for the purchase to liaise with Infection Prevention and Control, Health and Safety, Medical Physics and the Decontamination Lead. Consult with Health and Safety and Infection Prevention and Control before the introduction of new chemicals for use (or trial) within the decontamination process. 4.6 Infection Control Team will: Provide specialist advice for the decontamination of equipment prior to purchase and during use. Provide information and advice to enable managers and users to undertake risk assessments on levels of decontamination required. Conduct investigations into areas of special risk advising on safe practice. Audit practice and monitor standards in line with current legislation and guidance. Identify areas for improvement and report to Managers, Infection Prevention & Control Committee, Health & Safety Committee and others as appropriate. Report on incidents to the Infection Prevention & Control Committee the Medical Devices Safety Group and the Decontamination lead as necessary. Consult with Supplies before the introduction of new chemicals/equipment for use (or trial) within the decontamination process. 4.7 Sterile Services Department will: Provide decontamination services which will comply with current legislation and guidelines. Provide specialist advice on decontamination and sterilisation as appropriate. Report any significant or major decontamination incidents to the Decontamination Lead, who will liaise with Infection Control, Health and Safety, and the MHRA/NHS England. Page 9 of 39

10 4.8 Health, Safety and Improvement Manager will: Support the risk assessment process for the use of chemicals associated with the Decontamination process. Advise on the environmental suitability of activity areas used or intended to be used for decontamination activities. Support the completion of Health and Safety risk assessments relating to all activities related to decontamination, including the movement of equipment and devices are undertaken as required and that the results of these are communicated to the appropriate Manager and to the Decontamination Lead. 5. General principles of decontamination Ensure that appropriate decontamination facilities and compatible agents are available before purchasing new devices. Staff handling used medical devices and equipment must assume that they are contaminated, unless clearly indicated otherwise and take precautions to reduce the risk to themselves and others. All decontamination activities and agents must be carried out in accordance with the equipment manufacturer s instructions by appropriately trained personnel who are provided with suitable equipment. The Medicines and Healthcare products Regulatory Agency (MHRA) should be notified if the manufacturer is unable to provide this information or if it is inadequate. Consult the medical device and reprocessing equipment manufacturer/supplier before changing any decontamination process and obtain their written approval for the change in decontamination process. The cleaning process must take place in a designated cleaning facility Mains operated equipment must be disconnected from the supply before commencing the decontamination process. The person carrying out the task must wear appropriate protective clothing. The choice of decontamination method must be related to the infection risk associated with the intended use of the equipment (Table 1). Where this information is not given, thoroughly clean the device using one of the recommended wipes (details available on the supplies website) paying particular attention to parts in contact with the patient, handles, controls and crevices especially around pump mechanisms. Use no other type of wipe without first checking with the Infection Control Team that it is suitable for the purpose. Dispose of the wipe and any protective clothing safely as per Generic Waste Management Policy. Page 10 of 39

11 Once the decontamination process has been completed, prior to transportation the items must be labelled with a declaration to identify their status. Labels can be purchased through EROS or from the RCHT Medical Physics website Care should be taken not to remove the asset Identification number when cleaning. It is essential that following decontamination equipment/devices etc. are correctly reassembled according to manufacturer s guidance. Staff must be adequately trained to be able to disassemble and reassemble equipment and check that it is operating normally before re-use. 6. Choosing the most appropriate method of decontamination The Sterile Services Department (SSD) should always be used for the decontamination of equipment if appropriate. Note: Where sterilisation will damage equipment, cleaning followed by high level disinfection may be used as an alternative. If in doubt contact the SSD for advice All equipment designed for patient use should be decontaminated before and after use. Any item of equipment that has direct contact with the patient, be it diagnostic, therapeutic, or for direct care of the patient must be decontaminated following use. The choice of decontamination method may be related to the infection risk associated with the intended use of the equipment. Factors that must be considered include: The nature and extent of the contamination. The time required for processing. The heat, pressure, moisture and chemical tolerance of the object. The availability of the processing equipment. The quality and risks associated with the decontamination method. The manufacturer s guidance. The susceptibility of the host The nature of the investigative or therapeutic procedure The method of decontamination will depends on the infection risk associated with the equipment/medical device. These risks can be classified as high, intermediate, low and minimal (Ayliffe et al 2000). Table 1: Classification of infection risk associated with the decontamination of medical devices and equipment. Adapted from Sterilization, disinfection and cleaning of medical equipment: Guidance on decontamination from Microbiology Advisory Committee to the Department of Health Medical Devices Agency (MAC manual) [2]. Risk Application of Item Minimum Standard Low In contact with healthy skin Not in contact with patient Cleaning only Page 11 of 39

12 Intermediate High In contact with mucous membranes Contaminated with virulent or readily transmissible organisms For use on immuno-compromised patients In close contact with broken skin or mucous membrane For introduction into sterile body areas. Cleaning followed by sterilization or disinfection, or single use Cleaning followed by Sterilization, or single use Adapted from DB2003 (05) June 2003 The three processes of decontamination that are commonly used: Cleaning - A process, which physically removes micro organisms and the organic matter on which they thrive, but does not necessarily destroy micro-organisms. A further reduction in numbers occurs as the surface dries. In order to decontaminate medical devices effectively, all organic debris (e.g. blood, tissue and other body fluids) must be removed from the item prior to disinfection and/or sterilisation. Effective cleaning of medical devices prior to disinfection or sterilisation is of the utmost importance in reducing the risk of transmission of infectious agents. Automated washing methods are preferred to manual cleaning, due to the provision of efficient reproducible processes, which can be controlled and validated. All items, which can be, should be processed within the sterile services department. When manual cleaning is the only option the procedure outlined in appendix 1 must be followed. Disinfection - A process using either heat or chemicals to reduce the number of viable microorganisms but which may not necessarily inactivate some microbial agents, such as certain viruses and bacterial spores. Disinfection is required for items in contact with intact skin or mucous membranes e.g. respiratory and non-intentionally invasive equipment or items not associated with a patient with particularly transmissible/virulent infections. Chemicals disinfection should only be used if heat treatment is impractical or undesirable, e.g. for skin, flexible endoscopes, etc. Choice and use of disinfectant - Factors which affect the disinfectant activity: 1. The concentration of disinfectant ensure that the dilution follows the manufacturer's instructions and is appropriate to the task. 2. The number and type of microbial contamination the greater the number of microbes present the more difficult the surface to disinfect. Choosing the right disinfectant to kill the microbe, some microbes being more resistant than others. 3. The cleanliness of the surface the presence of organic matter e.g. pus blood. Page 12 of 39

13 Sterilisation means the complete destruction or removal of all micro-organisms, including spores. Normal sterilisation methods will not destroy prions. Items involved with a break in the skin or mucous membranes should be sterilized, e.g. surgical instruments, wound care products, and products intended for parenteral use or for instillation into body cavities. Autoclaving with steam above atmospheric pressure (121ºC - 134ºC), is an acceptable method for hospital use, however the use of sterilizers within the Trust is restricted. All items requiring steam sterilization must be sent to the SSD at RCHT. Chemicals with sporicidal activity (e.g. glutaraldehyde, peracetic acid etc.) may sterilize but are less reliable, requiring lengthy exposure times (those specified by the supplier of the chemicals must be applied), rinsing to remove toxic residues, and should be avoided if possible. Control of substances hazardous to health (COSHH) regulations must be followed when using any toxic or irritant substance. 7. Procurement. Due to the design and use of equipment purchased being diverse it is essential that risk assessments are undertaken by the requesting/authorising Manager prior to use to include the following:- How the item of equipment is decontaminated? Is the item intended for reuse? I.e. establish that it is not described as single use For what purpose is the device used? I.e. is it invasive? Is it used in contact with skin, body fluids or potentially infectious materials? How do manufacturers recommend it is cleaned, disinfected and sterilized? Can it be disassembled to facilitate cleaning? Is decontamination required at the point of use? Will it withstand an automated process? How soon will it be needed? Can it be wrapped to protect it from recontamination? How many times can it be reprocessed? Does processing constitute a hazard to patients and/or staff? If so, is COSHH hazard data and monitoring equipment available? Can it withstand cleaning with detergent and water? Can it withstand the high temperatures used for disinfection and sterilization? Can it withstand disinfectants e.g. chlorine releasing agents? If the manufacturers guidelines recommend the use of chemical disinfectants the following needs to be considered; Is the disinfectant recommended by infection control? Does the use and storage comply with COSHH? Will the product adequately decontaminate equipment? How cost effective is the disinfectant? Can it be adequately and safely stored? What is the availability of the disinfectant and is there an alternative? Page 13 of 39

14 8. Personal Protective Equipment (PPE) Appropriate PPE e.g. gloves, aprons, respiratory and eye protection, etc. will be available for use whenever necessary. It is the responsibility of employers to monitor the correct and safe working of protective measures and to produce procedures that explain what is to be worn and when. It is the employee s responsibility to follow such procedures. 9. Environment The cleaning / disinfection process should be carried out in the place designated by the ward/unit managers for that purpose; this must be away from the clinical area. Dedicated equipment must be used. The hand wash basin must not be used for manual cleaning. It is not necessary to separate clean and dirty equipment by a wall, but the two areas must be clearly identifiable. Clean and dirty equipment must be stored separately, preferably at opposite ends of the workflow e.g. dirty equipment in at one end of the building, clean equipment stored / out at the opposite end. For further information see Infection control in the Built Environment: NHS Estates. 10. Storage The environmental conditions of the areas designated for storage and distribution should ensure the integrity of all materials and products i.e. clean, well ventilated and secure. The accommodation should afford adequate protection to prevent contamination or deterioration of the product. Stock rotation should be used for storage i.e. FIFO (First in, First out). Checks of expiry dates of decontaminated items must also be undertaken at regular intervals in order that those items that require to be decontaminated again can be identified, removed from stock and be sent for subsequent decontamination. Equipment should not be stored on floor. 11. Transportation Equipment and other medical devices including instruments must be transported so as to prevent microbial contamination or damage and protect the individual transporting them. Containers used for transportation must be suitable for purpose, rigid, enclosed and easily decontaminated for re-use. Containers used for transporting soiled items for decontamination should be labelled with the word BIOHAZARD. Containers used for transporting decontaminated items after decontamination should be labelled DECONTAMINATED MEDICAL DEVICES. Records of which items of equipment are transported, on what date, by whom, and between which locations must, be made and retained for audit. Page 14 of 39

15 12. Record Keeping Tracking and Traceability The Consumer Protection Act (1987) (6), and in particular Product Liability has implications for the processing of devices used for patient care. It is essential to maintain adequate records that demonstrate how a particular device was processed; this includes a description of the method/s employed together with details of available trained personnel with copies of training records. The organisation should have the ability to demonstrate how instruments/equipment have been processed through the decontamination cycle. For surgical instruments and endoscopes, records must be maintained and retained, to enable instruments to be traced to individual patients. It is important to be able to trace surgical instruments through the decontamination process to which they have been subjected to ensure that processes have been carried out correctly. In the event of a sterilization cycle failure products can then be recalled. Records should be maintained for all sets identifying: The decontamination method used The name of the person undertaking decontamination Details of the item/set being processed. Records should be kept by the organisation for a minimum of 11 years. A computerised system is used for this purpose within the Sterile Services department. Systems exist which allow traceability between set and patient. This identifies which set was used for the patient and the decontamination process it has undergone. Such a system is required in the event of a look back exercise. Tracking systems are also available for endoscopes processed through automated endoscope reprocessors. 13. Decontamination prior to service, repair, transfer, disposal, investigation, or return. The Trust has a legal requirement under The Health and Safety at Work etc. Act 1974, The Management of Health and Safety at Work Regulations 1992, COSHH Regulations 2002, and the Health Act 2008 to ensure that people, (staff, patients, visitors, contractors) are not exposed to unnecessary risks through contaminated items. Anyone who inspects, services, repairs or transports medical, dental or laboratory equipment either on hospital premises or elsewhere has a right to expect that the medical devices have been appropriately treated so as to remove or minimise the risk of infection or other hazards e.g. chemical, radioactive. Page 15 of 39

16 Medical devices and equipment which may be contaminated with body fluids, chemicals, radioactive toxic or other harmful substances, intended for inspection, service, repair or off site transportation, must be provided with a declaration of contamination status. All decontamination procedures must be undertaken by suitably qualified, trained and supervised staff, using suitable methods of decontamination. In situations where decontamination of the item is not possible the details of type of contamination must be clearly stated on the decontamination certificate. Items that are visibly contaminated must not be presented or sent for inspection, service or repair. All outward signs of contamination must be removed. Equipment presented with visible signs of contamination will NOT be accepted for repair Sending medical devices for service or repair. All medical devices must be decontaminated prior to service or repair. Prior warning must be given to the intended recipient. The agreed method and Decontamination process must be followed. The decontamination status of the item must be clearly labelled (appendix 3) so that it can be determined prior to opening of the inner packaging. This may be achieved by enclosing the documentation in an envelope marked Examine enclosed documents before unpacking. The packaging should be sufficiently robust to withstand transport and ensure that the contents of the inner pack cannot contaminate the outer one. Porters transporting medical devices must for their own safety first check that the device is visually clean, that it has been wrapped and a completed decontamination label is attached. If they are not satisfied that the device is clean the porter must refuse to transport the device and advise the ward/department manager Service or repair of Medical Devices on the ward or department On occasions it may be appropriate for a medical device to be worked on whilst in the ward or department. The same decontamination process and labelling is required. Technicians must for their own safety first check that the device is visually clean and has a completed decontamination label attached. If they are not satisfied that the device is clean the technician must refuse to work on the device and advise the ward/department manager. Page 16 of 39

17 13.3 Equipment on Loan Instrumentation or equipment may be loaned so that a particular procedure can be performed. The instruments may be loaned both from manufacturers and other hospitals and are returned after use. This practice increases the risks associated with the decontamination and reprocessing of such devices because the organisation may not be familiar with them. All loan instrumentation must be decontaminated both before and after use in accordance with the manufacturer s instructions. Where appropriate, equipment should be decontaminated in a Sterile Services Department. Ensure that loaned instrumentation is accompanied by relevant reprocessing instructions and a comprehensive list of contents. If these are missing or if you do not have the facilities to follow them (e.g. inappropriate sterilisation time/temperature relationships are quoted) the instruments should not be used. Equipment that needs to be processed via the SSD must be delivered to the SSD for decontamination at least 48 hours prior to use. Ensure that adequate time is allowed to carry out effective decontamination both prior to and after use. Ensure that systems are in place to allow instrumentation to be tracked through the decontamination processes and to the patient upon which it is used. Check that indemnity forms have been completed and that responsibilities for the instrumentation have been identified and documented Condemned equipment Equipment must be decontaminated wherever practicable before following the Trust s procedure for disposal of equipment. In certain cases it may be necessary to dispose of equipment which cannot be decontaminated. In such cases the equipment should be condemned and the most appropriate method of disposal should be used. Refer to the Generic Waste Policy or seek the advice of the operational waste manager. It is the responsibility of the user department to ensure compliance with this policy and its procedures Transfer of Ownership and Disposal of Used Medical Devices. Prior to the transfer/disposal of medical devices they must be adequately decontaminated and a decontamination certificate provided Items subject of complaint or investigation Decontamination may alter or influence the investigation; therefore, the advice of the investigating body must be sought prior to decontamination Page 17 of 39

18 Items that are designated single use only will not be provided with reprocessing instructions. Users must follow the advice of the investigating body or contact the manufacturer in order to determine the most appropriate method of decontaminating a single-use device if it is required Surgical Instruments/Sundries All reusable instruments and sundries used at ward/departmental level need to be returned to the Sterile Services Department (SSD) at RCH for decontamination prior to being used on the next patient. The SSD provide a collection and delivery service in order to facilitate this and users must ensure that there are enough instruments/sundries to cover a 24- hour turnaround. Please adhere to the following instructions: 1. Blue boxes with the details return to SSD are available for each area. 2. Each item will have either or both of the labels detailed in appendix 4. Remove the bottom blue and/or yellow label and place in the patient s paper notes as traceable proof that the set has been subjected to the decontamination processes. 3. Place your used instrument or set into the original outer packaging.( No need to wash first) 4. Place into the blue box. 5. Only return the re-useable items of the procedure to SSD. Discard the non-re-useable items. E.g. Swabs, needles, syringes in the appropriate receptacles. 6. Do not send inappropriate items e.g. patient s property. All re-useable items processed by SSD will be delivered as per your top up requirements 14. Creutzfeldt Jakob Disease (CJD) and other Transmissible Spongiform Encephalopathies (TSEs) To minimise the risk of CJD transmission via contaminated devices, clinical teams must have systems in place to ensure patients at greatest risk of developing CJD/vCJD are identified prior to any invasive procedure (including surgery or endoscopic investigation). This procedure should conform to Annex J of the latest guidance on the prevention of CJD/vCJD issued by the TSE risk management group. Where risk factors for asymptomatic CJD / vcjd have been identified this should be communicated to any department which will be sent (or has received) contaminated medical devices or pathological samples from this patient. This may include sterile services, endoscope reprocessing, cell pathology and microbiology. Special consideration must be given to the use and decontamination of any devices which are likely to become contaminated with high risk tissues (as defined in Annex A1 of guidance on the prevention of CJD/vCJD issued by the TSE risk management group). Infection Prevention and Control and Sterile Services can provide support but departments likely to encounter tissue or medical devices which may become contaminated with CJD/vCJD prion proteins must have a written procedure for quarantine and safe disposal of contaminated vices, in accordance Page 18 of 39

19 with relevant Annex E of the devices, in accordance with the relevant Annex E of the TSE guidance on risk management. Page 19 of 39

20 Appendix 1 Procedure for Decontamination by Manual Cleaning PROCEDURE FOR DECONTAMINATION BY MANUAL CLEANING Document Reference Code: IC/013/14 Manual cleaning would normally be undertaken either by employing immersion or non-immersion techniques depending on the construction of the device and according to the manufacturer guidelines. IMMERSION METHOD PROCEDURE FOR MANUAL CLEANING To minimise the risk to personnel undertaking manual cleaning, splashing and the creation of aerosols must be avoided at all times. a) Fill the clean sink (not hand wash basin) with water and detergent (detergent dilution and water temperature should be in accordance with manufacturers instructions and/or local documented policy/procedures). b) Wearing protective clothing, dismantle or open the instrument/equipment to be cleaned and fully immerse in the solution in order to displace trapped air and to ensure penetration of the lumen if hollow instruments/equipment are being cleaned. Consideration should be given to the use of a protein-enzyme dissolving solution when cleaning medical devices with lumens or complex parts. c) Brush, wipe, agitate, irrigate, jet wash or hand spray the item to dislodge and remove all visible soil, taking care to ensure the item remains under the surface of the water at all times to prevent the creation of aerosols. d) Remove the item from the sink and drain any excess detergent prior to rinsing the item thoroughly with clean water or water jet gun under the surface of the water. e) Remove and drain the item before drying using the preferred method. f) Complete any necessary documentation to record the item being processed and the method and solutions employed. If either the cleaning solution or the rinse water becomes obviously soiled or contaminated, it should be changed and the process repeated. NB: Cleaning materials should be safely disposed of in accordance with local policy in the appropriate waste containers following use. Jet guns should only be connected to the cold water supply. NON-IMMERSION HAND WASHING METHODS Are appropriate for certain equipment where items will become compromised by soaking in aqueous solutions, e.g. electrical and electronic equipment. These items should be cleaned in accordance with manufacturer s instructions. Page 20 of 39

21 FACTORS AFFECTING MANUAL CLEANING Due to the lack of acknowledged methods of control available to the user to test the efficacy of manual cleaning processes, the user should be aware of the factors which may affect the efficiency of this method of cleaning. These include: a) staff training and competence b) water temperature (it is important to be aware that protein coagulates at 35ºC and must not be used for initial immersion of devices prior to cleaning) c) detergent concentration d) nature and method of soil removal e) accessibility of fluid to the item. Page 21 of 39

22 Appendix 2 A Z Guide of Methods of Decontamination for Equipment (and Environment) Frequency of decontamination should take into account guidance from The National Specifications of Cleanliness within the NHS. Method statements can be found within the Cleaning Strategy, Policy and Manual Item Method of Decontamination Frequency Alcohol hand rub holders Detergent wipe, dry thoroughly Daily and on end of bed discharge/transfer Airways Single Use Single Use Anaesthetic equipment Disposable or return to SSD Arm rests After each patient Audiometer headphone Detergent wipe, dry thoroughly After each patient Bath Wash with warm water & detergent, rinse After each patient thoroughly Baby changing mat After each patient Bed frames Daily and on discharge/transfer Bed, under bed Weekly and on discharge/transfer Bed cradles Daily and on discharge/transfer Bed pan holder After each patient detergent wipe, dry thoroughly. Bed pan holder Wash with solution of combined detergent After each patient (diarrhoea) & Sodium hypochlorite (1000ppm) Bed pan Disposable, macerate Bowls (patient wash Disposable, macerate or Single Patient Single Use bowls) Use Brushes, hair Single Patient Use Single Use Brushes, nail Single Patient Use Single Use Brushes, surgical nail Single Use Single Use Breast pumps Single Patient Use. Accessories washed After every use with warm water & detergent, rinsed thoroughly and disinfected in dishwasher or steam sterilizer. Pump wiped with detergent wipe. Clip boards, note holders Detergent wipe, dry thoroughly. Daily and on Page 22 of 39

23 at end of bed Cloths (for cleaning) Disposable: Yellow Kitchen; Red Bathroom & Toilets; Blue Ward & General Areas; Green Isolation rooms & Theatre Commodes Wash with solution of combined detergent & Sodium hypochlorite (1000ppm) discharge/transfer Single Use for each bed space or side room After each use Daily Cots and Incubators Crockery & cutlery Dishwasher (cycle should heat disinfect, 80 0 C for 1 minute) Discharge/transfer & prior to admission After use Drip stands Detergent wipe Daily Drugs trolley Detergent wipe Weekly Duvets Ear pieces (Auroscope) Ear Syringe Machine (Propulse) ECG & Cardiac machines Monitor Leads Electrodes detergent wipe, dry thoroughly Preferably disposable If reusable: send to SSD for disinfection Flush system with fresh tap water. Drain water from system and flush with Sodium hypochlorite solution (10,000ppm). Dry reservoir tank with paper towel Clean tips with warm water and detergent or detergent wipe ensure all debris removed. Immerse in Sodium hypochlorite solution (10,000ppm) for 10 minutes, then rinse under running water. Damp dust with detergent wipe Detergent wipe Disposable After each patient Single Use After each patient Before each use After each use Daily Daily Single Patient Use Page 23 of 39

24 Item Method of Decontamination Frequency Electric razor Single Patient Use (patient s own razor) Single Patient Use Endoscope (flexible) Endoscope (rigid) Examination couch Examination couch frame Enteral tube feeding syringes Eye protection (goggles, visors) Floor cleaning equipment Mop heads Follow instructions in Endoscopy policy Return to SSD Single Use Disposable or launder (cycle should heat disinfect, 65 0 C for 10 minutes or 71 0 C for 3 minutes) After each use After each use After each patient Daily Single Use After each use Daily and after use in isolation room and cohort bay. Bucket Wash with warm water & detergent, rinse and dry thoroughly. Daily and after use in isolation room and cohort bay Daily Hoist (frame) Hoist sling Single Patient Use. Launder if visibly soiled Single Patient Use Laryngoscope Disposable blades Single Use Handle (Reusable). Wash with warm water After each use & detergent or detergent wipe, dry thoroughly Mattress When visibly dirty and on detergent wipe, dry thoroughly discharge/transfer Mattress When visibly dirty and on (alternating/specialised) detergent wipe, dry thoroughly discharge/transfer Medicine pots, spoons Single Use Single Use Nebulizer equipment Disposable Single Use Oxygen masks/ nasal cannulae Pillow Disposable detergent wipe, dry thoroughly. Single Patient Use When visibly dirty and on discharge/transfer Page 24 of 39

25 Item Method of Decontamination Frequency Raised Toilet Seat After each patient Razor (disposable) Single Patient Use (patient s own razor) Single Patient Use Resuscitation equipment Airways Self-inflating bag, e.g. Ambu-bag Suction tubing & liner Swivel connector Sharps Trays Sigmoidoscopes Spacer (for teaching patients inhalation technique) Specula (vaginal) Disposable Disposable or use with disposable filter (change after each use) Disposable Disposable Disposable. Protect insufflator bulb with a filter Single Patient Use Preferably disposable Reusable: return to SSD. Wipe gel from speculum immediately after use Single Use Single Use Single Use Single Use After each use Single Use After each use Single Use After each use Stethoscope Detergent wipe, dry thoroughly Before & after each use Sphygmometer Detergent wipe, dry thoroughly Daily Disposable cuff Disposable Single Patient Use Vinyl cuff Detergent wipe, dry thoroughly After each patient Sputum pots Disposable Single Use Syringe drivers Switch off and disconnect from electricity supply. Detergent wipe, dry thoroughly After each patient or weekly Page 25 of 39

26 Item Method of Decontamination Frequency Suction apparatus Rigid outer container Tubing Catheters/Yankeur Use rigid container with a disposable liner Detergent wipe, dry thoroughly Disposable Disposable Weekly and on discharge/transfer Single Patient Use After every use Filters Disposable Change every 3 month in high use area and every 12 months in low use areas Telephone Detergent wipe, dry thoroughly Daily Thermometers Tempadot Electronic Tympanic Display window Probe covers Probe tip & mount Tourniquets Fabric tourniquets Disposable tourniquets Toys Made from non-absorbent materials Made from absorbent materials Trolleys Dressing trolley Disposable, dry thoroughly Use with single-use cover/sheath Detergent wipe Disposable Detergent wipe, dry thoroughly Avoid use Disposable Avoid for communal use Single Use Single Use Daily Single Use Daily Single Patient Use Single Use Weekly & when visible soiled. After each use Page 26 of 39

27 Transfer trolley Linen trolley Ultrasound scanner Probe Empty and wash with warm water & detergent or detergent wipe, dry thoroughly* Detergent wipe, dry thoroughly Dependent on type of procedure After each use Daily Daily After each use Urinary Drainage Systems Catheters (indwelling) and drainage bag Overnight drainage bags Stand/hanger Urine jugs (plastic) Urine jugs (pulp) Vase (flower) Volumetric Infusion Pump Disposable Disposable Disposable Disposable Disposable Wash with warm water & detergent in a designated sink, dry thoroughly. Do not use hand wash basins. Switch off and disconnect from electricity supply Detergent wipe, dry thoroughly Single Use Single Use Single Use Single Use Single Use After discarding flowers or weekly, whichever is sooner After each patient or weekly Vomit bowls Disposable Single Use Weighing scales Contact points Wheelchair, contact points Weekly or when visibly soiled. After each use After each use Page 27 of 39

28 Wheelchair X-Ray machine X-Ray wedges detergent wipe, dry thoroughly Weekly Daily or when visibly soiled. After each use * Wash with warm water and neutral detergent or Detergent wipe and dry with paper towel. If contaminated with body fluid, first wash with warm water and neutral detergent or wipe with detergent wipe and then disinfect with Sodium hypochlorite solution (1000ppm). Page 28 of 39

29 Appendix 3 Decontamination Certificate - Declaration of contamination status Before equipment is re-used or sent for repair or storage both within and outside the Trust, equipment must be decontaminated (cleaned) and a certificate completed declaring the contamination status of equipment, failure to comply will result in return of the equipment. Internal movement of a device, such as transfer between wards label to declare status (purchase through EROS) Return to Medical Physics or Estates - the RCH Declaration of Contamination Status label (EROS code CHA2517) From: Fault and Contamination Status Attach To Medical Equipment When Returning For Inspection, Servicing, Repair or Disposal Please ensure that the item has been suitably prepared to enable safe handling/transportation Hospital: Ward or Unit: Phone No: Return to: (if different from sender s address) Hospital: Ward or Unit: Phone No: Make, Model & Description of Item to include Asset number (in-house label) or other specific identification DETAILED description of fault or other instructions and information: (continue overleaf if required) If this item has been involved with an incident/near miss please mark here: Decontamination: and provide details overleaf This item has / has not been in contact with blood, other body fluids, respired gasses or pathological samples* (Delete as appropriate) HAS THE ITEM BEEN DECONTAMINATED IN ACCORDANCE WITH TRUST POLICY? * Yes / No *Please note: Equipment that has not been decontaminated, or is believed to be internally contaminated, must not be transported without the prior agreement of the recipient. Any reference or contact name for this agreement must be given here: Date: Print Name: Signature: Job title: Phone No: Page 29 of 39

30 For a device being returned directly to manufacturer or their supplier - the MHRA Declaration of Contamination Status [appendix 2 of DB2003 (05)]. This is available as Operational Form 29 in the CEMS Quality Manual and may be obtained upon request from Medical Physics. If it has not been practicable to clean and decontaminate a medical device, or if you believe it may have been internally contaminated, it must be appropriately labelled, quarantined and kept in a secure place until you have discussed the situation with the intended recipient. If possible it should be placed in a clear plastic bag also labelled "Contaminated Medical Device". Contaminated items should not be returned without prior agreement of the recipient Page 30 of 39

31 Appendix 4 Surgical Instruments / Sundries example Page 31 of 39

32 Single Use Policy 1. Introduction Single use refers to the medical device that is intended for use on an individual patient during a single procedure and then discarded. Single use devices are not intended to be reprocessed and used on another patient. If a device is reprocessed and it is not fit for its intended purpose, both the reprocessor and the professional user may be committing an offence. The reuse of single use devices has legal implications. It is the policy of the Cornwall Partnership NHS Foundation Trust (CFT) that medical devices designated for a single episode of use are not to be reused under any circumstances. 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. 2. Indications against reuse Devices designated for single use must not be reused under any circumstances. Key points are: The reuse of single-use devices can affect their safety, performance and effectiveness exposing patients and staff to unnecessary risk The reuse of single-use devices has legal implications: - - Anyone who reprocesses or reuses devices intended by the manufacturer for use on a single occasion bears full responsibility for its safety and effectiveness. - Anyone who reprocesses a single-use device and passes it to a separate legal entity has the same legal obligations under the Medical Devices Regulations as the original manufacturer of the device. If a device is reprocessed and it is not fit for its intended purpose, both the reprocessor and the professional user may be committing an offence under one or more of the following Acts/Regulations; Health and Safety at Work Act 1974 Part 1 of the Consumer Protection Act 1987 (3) General Product Safety Regulations 2005 Medical Devices Regulations 2002 (1) 3. Technical implications The most important factor open to influence is instrument decontamination. A single use device may be manufactured in such a way that decontamination may damage or alter the device to such an extent that further use is unsafe. The following problems have been identified: Potential for cross-infection Inadequate cleaning and disinfection Page 32 of 39

33 Residues from chemical decontamination agents Material alteration Mechanical failure Reactions to endotoxins Physical damage to sterilisers and other equipment If a device is reprocessed and it is not fit for its intended purpose, both the re-processor and the professional user may be committing an offence under one or more of the following Acts: Health and Safety at Work Act 1974 Consumer Protection Act Part 1 General Product Safety Regulations 1994 Medical Devices Regulations Actions by healthcare professionals Look for the DO NOT REUSE symbol on device packaging After use, dispose of device safely as per Generic Waste Management Policy Symbols used on Medical devices on their Packaging Page 33 of 39