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1 Policy No: RM30 Version: 6.0 Name of Policy: Policy for the Procurement Management and Use of Medical Devices Effective From: 07/09/2015 Date Ratified 11/08/2015 Ratified Medical Devices Management Group Review Date 01/09/2017 Sponsor Director of Estates and Facilities Expiry Date 11/08/2018 Withdrawn Date Unless this copy has been taken directly from the Trust intranet site (Pandora) there is no assurance that this is the most up to date version This policy supersedes all previous issues Policy for the Procurement Management and Use of Medical Devices v5

2 Version Control Version Release Author/Reviewer Ratified by/authorised by Date 1.0 February Trust Policy 13/02/ Forum 2.0 February Trust Policy 13/02/ Forum 3.0 October 2006 Trust Policy Forum October /08/2009 J Edwards PQRS 17/07/2009 Changes (Please identify page no.) /10/2012 J Edwards MDMG 26/09/ /09/2015 J Edwards MDMG 11/08/2015 Policy for the Procurement Management and Use of Medical Devices v5 2

3 Contents Page No 1. Introduction Policy Scope Aim of policy Roles and Responsibilities Definition of terms Inventory for Re-usable Medical Devices Process for ensuring Decontamination of re-usable Medical Devices Process for ensuring that all medical devices are properly maintained and repaired Disposal/ Decommissioning of Equipment Selection and procurement of equipment Equipment on loan to or from the organisation Ensuring devices are used safely and correctly used Single use medical devices Adverse Incident Reporting Training Equality & Diversity Process for monitoring compliance with the policy Consultation and review of this policy Implementation of policy strategy References Associated documentation APPENDICES Appendix 1 Different types of device Appendix 2 Comparison of in-house maintenance with an external provider Appendix 3 Decontamination Certificate Appendix 4 Decontamination Guidelines Appendix 5 Decontamination pathway Appendix 6 Decontamination of devices subject to investigation Appendix 7 Maintenance licence scheme Policy for the Procurement Management and Use of Medical Devices v5 3

4 1. Introduction Policy for the Procurement Management and Use of Medical Devices A medical device is NOT necessarily complex, high tech equipment used in acute hospital care. It does in fact cover a broad range of products used in everyday health care settings (see Appendix 1). A medical device can be defined as any product used in:- Diagnosis, prevention, monitoring, treatment or alleviation of disease/ injury / disability. Investigation, replacement or modification of the anatomy or of a physiological process. Control of contraception Categories of Medical devices:- Equipment used in diagnosis or treatment of disease. Equipment used in life support. In vitro diagnostic medical devices. Equipment used by people with disabilities Used in general care Devices supplied by pharmacists The development of this policy is based on the criterion specified within the CQC Essential Standards of Safety and Quality and is based on essential elements of former NHSLA Risk Management Standards still relevant today.. It also takes into account the principles cited within: MDA DB 9801 Medical Device and Equipment Management for Hospital and Community Bases Organisations. Checking & Tests Of Newly Delivered Medical Devices MDA DB2000 Medical Devices and Equipment Management: Repair and Maintenance Provision MDA DB2000 Single use Medical Devices: Implications and Consequences of reuse National Audit Office HC475 The Management of Medical Equipment in the NHS Acute Trusts in England MHRA, The CE Mark Bulletin 2 Dec 2005 MDA 2001 Devices in practice: a guide for health and social care professionals MDA 2000 Equipped to Care; the safe use of medical devices in the 21 st century MHRA 2006 (05) Managing Medical Devices April 2015 MDA DB2002(02) March 2002 Management of In Vitro Diagnostic Medical Devices MDA DB2002(03) March 2002 Management and use of IVD Point of Care Test Devices Department of Health Decontamination guidance MHRA MAC guidelines (2006) Epic 2 Guidelines (2007) WHO medical devices technical series MHRA Devices in practice checklists for using medical devices June 2014 The main principles are shaped to meet the needs of the Trust and ensure practices are such, to effectively reduce identified risks and promptly mitigate adverse consequences associated with the management of medical devices to subsequently protect patients staff and others. Recent advances in healthcare technology have led to the provision of more complex devices being used in clinical care; this in consequence has portrayed a rise in the number of device related incidents. Policy for the Procurement Management and Use of Medical Devices v5 4

5 Human Factors have been identified as a key feature associated with device related incidents. It is believed this is largely due to the wide range of complex devices now available; if training (including that in relation to maintenance) cannot correspond to the rate of technological advancements there is scope for a significant risk gap to develop. This policy shall focus on systems to limit such incidents with resultant safer practice. Gateshead Health NHS Foundation Trust attaches the greatest importance to the safety and care of its patients and considers it essential to provide effective safe medical equipment: the use of for good quality patient care. With the implementation of these guidelines the Trust can confidently show all clinical staff has an increasing awareness of safety and lessening of risk when using medical devices. 2. Policy Scope The policy contains recommendations relevant to all hospital settings where diagnostic, monitoring and therapeutic devices are used; including dental, pathology and post-mortem equipment. It covers all staff required to use clinical equipment, either directly or indirectly for diagnostic, therapeutic or treatment purposes of patient's illnesses, injuries, disease, or disability. The recommendations made in this policy are approved by the Chief Executive, although the implementation of the recommendations will be carried by qualified clinical staff that are responsible for the delivery of day to day care. Support will be offered by other managers, technical staff and trainers etc. who have shared responsibility to ensure appropriate action is taken in response to the recommendations. 3. Aim of the policy The overall aim is to ensure, whenever a medical device is used:- It is suitable for its intended purpose, complying with recommended standards relating to safety. The user s will be clinical staff identified as authorised users with adequate training and evidence of achieving competency, or working under direct supervision of a trainer/competent user (see Medical Devices Training Policy RM45,). Safeguards are in place, which are monitored to protect patients, carers and users from, possible adverse incidents. It is properly understood by the professional user, who has undertaken appropriate training. Training will increase confidence and efficiency of staff and reduce the risk of delay in treatment or occurrence of untoward adverse incidents. It is used as intended by the manufacturer It is maintained in a safe and reliable manner with associated records kept. It has been appropriately assessed, procured and the benefits of standardisation considered. Disposed of correctly at the end of its useful life Traceable wherever possible Suitable for intended purpose The Trust s Medical Devices Management Group will review this policy as new guidance becomes available or by the pre-set expiry and ensure that the policy addresses: Responsibilities in relation to medical device management Decontamination The equipment life cycle (including: selection, acquisition, acceptance, maintenance, repair, monitoring, traceability and disposal/replacement) of all medical devices Risk management including adverse incident reporting and actions required within safety alerts (also see RM 63 policy for the dissemination of safety alerts) Policy for the Procurement Management and Use of Medical Devices v5 5

6 Training and access to manufacturer s instructions (also see RM 45 policy for medical devices training and OP 31 Operational policy for medical engineering and equipment library Records, including device inventory. Equipment financing. 4. Trust-wide Roles and Responsibilities for the safer use, management and procurement of Medical devices The Chief Executive The Trust Board Director of Estates and Facilities Management/ Deputy Chief Executive Is responsible for ensuring that the Trust complies with all safety and quality regulations and approved guidance. In practice the tasks and responsibilities for ensuring compliance with stipulated regulations and guidance relating to medical equipment are delegated to senior managers but overall responsibility will remain with the Chief Executive. Is overall responsible for formally reviewing the systems and processes for ensuring safe acquisition, decontamination storage, deployment and use of medical devices; and all governance issues surrounding equipment use and maintenance, including risk management, CQC requirements, safety, incident investigation, associated learning and sharing, procurement, service contingency planning, policy development and monitoring, developing and dissemination of safety alerts and its associated monitoring. Advises the Trust Board as to the level of funding required for equipment replacement as part of prioritising capital funds. The Director has the delegated responsibility for maintaining medical equipment and liaising with the Medical Devices Management Group. In practice this responsibility is delegated to the Head of Medical Devices.. Responsible for regular monitoring and review of decontamination procedures and advising the Trust Board accordingly. Clinical Directors In liaison with divisional managers will be responsible for ensuring systems and arrangements in place cover all staff groups including medical staff. Head of Medical The Head of Medical Devices has the delegated responsibility from the Devices and Director of Estates & Facilities Management / Deputy CEO for overseeing the Designated management of medical equipment across the Trust. These duties include:- Medical Devices Liaises with and offering a point of contact to the Director t/ Deputy Safety Officer for CEO and other senior members of staff on matters concerning medical the Trust devices. Provides a point of contact for advice on matters concerning medical equipment. To provide a complete management service for Medical Equipment and to its users. This will include planning workload for others and developing appropriate departmental policies and maintenance regimes for highly sophisticated equipment across the Trust. Involving all aspects of equipment management including procurement, acceptance testing, performance monitoring the ability to diagnose faults and advise others as to the repair of highly complex equipment and systems. Benchmarking shall be used together with evidence based techniques to ensure that risk is balanced against resources. Manage staff within Medical Engineering and the Medical Devices Department. This will include designation of duties and personal development. This will be monitored by regular staff appraisals. Ensure that equipment records, both manual and computerised are accurately kept up to date. This will include the interrogation of records to produce reports and identify trends. Policy for the Procurement Management and Use of Medical Devices v5 6

7 Departmental Budget Holder and Signatory for Medical Engineering Department. Procure equipment in line with the needs and requirements of the Trust. This will include interpretation of user requirements; detailed specification preparation, pre and post tender negotiations with suppliers and order placement. Also advise users as to the most appropriate and technically suitable equipment. Ensure that delegated areas of responsibility within the Trusts Capital Programme are delivered on time and within budget. Also provide information with regard to medical devices and assist in formulating the Trusts Capital Programme for approval by the Trust Board. Liaise with equipment suppliers and external bodies regarding all aspects of equipment operation and safety. This will include the MHRA in implementing recommendations set out in Safety Alerts and co-operating with the MHRA in investigations regarding defects and failures. Investigation of equipment failures cited in the Trust Incident Reporting procedure and liaison with clinical and senior nursing staff as to the cause and outcome of such investigations. Implement controls to reduce the likelihood of repeat occurrences. Acts as the Trust s Central Alerting System (CAS) Officer for the dissemination of Medical Device Alerts Divisional Managers Matrons or equivalent responsibilities Act as the medical devices safety liaison officer for the Trust Therefore hold responsibilities for:- Working to improve incident reporting this will include:- 1. Supporting wards and departments to report medical device incidents and ensure lessons are learnt and shared. 2. Delivering / coordinating training on incident reporting. 3. Deliver training identified as a result of an incident. Managing or reviewing incidents in the Trust for data quality where necessary investigate and collect additional info from reporters, including liaising with Datix systems administrator to ensure incidents meet the required quality prior to NRLS upload. In addition will receive and respond to requests for more info from patient safety domains. Implementation of Medical Device Initiatives and support daily operations to improve safety through training. Ensuring a medical devices management group deliver set responsibilities. Acting as a main contact for NHS England, MHRA and manufacturers, represent the Trust at the National Medical Devices Safety Network. Will receive feedback data on the quality of MD incident reports every 6 months. Are responsible for ensuring adequate resources are available for Medical Device links and clinical staff to manage processes within their own area. Each Matron or equivalent manager will ensure all clinical areas within the division have access to training programmes. Documentation is kept up to date relating to training. All policies are implemented. Local policies are completed for ward /dept. equipment including specialist equipment and training requirements. Matrons / equivalent will be responsible for agreeing and supporting Policy for the Procurement Management and Use of Medical Devices v5 7

8 Head of Procurement General Ward or Department Managers The Medical Devices Clinical Risk & Equipment Library Manager The Medical Devices Management Group decisions locally for who authorised users are of the equipment used in the clinical areas, this will be available to the Medical Devices Clinical Risk Manager. Is to ensure compliance with Trust standing orders, legal obligations and European Legislation in respect of tendering and contract procedure, to ensure compliance with guidance, codes of conduct and good practice in respect of procurement and supply of medical equipment. Responsible for designating staff from within their ward or department to act as Medical Device Lead, who with support of the manager will have responsibility for representing all aspects of the use of medical equipment within their particular field of responsibility. The manager will also ensure staff are aware and adhere to Trust policies in relation to medical devices, and required training & updates. Is responsible for:- Ensuring there are appropriate systems in place to manage medical devices within the trust. The implementation of improvements, efficiency and quality of care in relation to medical devices. Directly managing the Medical Equipment Library. The provision of technical and clinical expertise and advice to clinical staff within the trust. Participate in audit, monitoring, evaluation and practice developments. Advising and supporting risk assessment processes. Providing and supporting application of policies and protocols. Discover Training requirements for the use of key medical devices and assist in the development of appropriate training packages. Minute and disseminate outcomes of Medical Devices Management Group Meetings. Assisting in the investigation of clinical incidents involving the use of a medical device. Ensure decontamination procedures are performed on equipment leaving the Medical Equipment Library. Ensure Medical Equipment Library staff are aware of decontamination procedures and have adequate supplies to perform such procedures. Provide advice and offer support to clinical areas in relation to decontamination of medical devices prior to routing inspection, servicing or investigation. Developing reports following the monitoring of processes outlaid within this policy and therefore presenting findings and consequential action plans to MDMG and Health & safety Provides feedback in the form of an annual report to the Health and safety committee relating to monitoring and assurance Chairs Medical Devices Management Group Meetings The Medical Devices Management Group, formulated to coordinate Trust wide management of medical devices, to advise, approve and assist in the review of policies and procedures appertaining to the procurement and use of medical equipment. This includes the selection and assessment of medical devices suitable for standardisation across the Trust. The group will:- Ensure all plans and actions are in line with local and national requirements. Support the training and education with the development of competency based assessments for all those using medical devices. Policy for the Procurement Management and Use of Medical Devices v5 8

9 The Point of Care Management Team Infection Control Team All users of medical devices Review the composition of group members to include end users from each directorate, to provide feedback from clinical areas. Group members are to relay information, guidelines etc discussed, back to their own areas. All divisions are to report back to the Medical Devices Management Group with reference to the implementation, compliance and achievements toward this policy. National Alerts, hazards and reports should also be brought to the attention of this group for appropriate action that may be required. This group is responsible for reporting to Safe care on an annual basis Are responsible for:- Ensuring there are appropriate systems in place to manage PoCT devices within the trust. The implementation of improvements, efficiency and quality of care in relation to PoCT device equipment. To provide a supportive role in the purchase of PoCT devices at all stages of procurement and implementation. The provision of technical and clinical expertise and advice to clinical staff within the trust. Advising and supporting risk assessment processes. Providing and supporting applications of policies, procedures and protocols in strict accordance with the manufacturer s guidelines. Set up a framework of training and competency based assessment for all PoCT devices and assist in the development and delivery of appropriate training packages. Participate in audit, quality assurance assessments, evaluations and practice developments. Ensure PoCT support in respect of maintenance and equipment supplies as appropriate. Providing Health and Safety advice and guidance for all PoCT devices in accordance with trust policies and legislation. Assisting in the investigation of clinical incidents involving the use of PoCT devices. Responsible for providing advice and feedback on the cleaning, disinfection, decontamination and if required the sterilization of medical devices. Participate in audit, monitoring and evaluation relating to decontamination, cleaning and disinfection issues. Promote practice developments in relation to decontamination, cleaning and disinfection issues. Are responsible for ensuring the following:- Theoretical and Practical Training of all medical devices used within the clinical area has been achieved, or declared if not achieved. Competency has been assessed and approved in the use of medical devices (evidence must be available). If training or assessment has not taken place the user will not attempt to use the device, unless under direct supervision of a competent trainer/user. Equipment selected is suitable for the purpose required, awareness of other models and the differences. Correct supplies/ disposables/ attachments are selected for use with the device (expiry dates checked). Single use devices are not re-used e.g. syringes, needles. Ref MDA DB2000(04) (V2) 2011 discusses implications and consequences. Policy for the Procurement Management and Use of Medical Devices v5 9

10 Medical Engineering Dept Single patient devices are not shared between patients e.g. oxygen masks. Devices held by clinical areas shall be appropriately stored in accordance with manufacturer instructions. Incidents are reported via completion of a Datix incident form in accordance with Incident Reporting Policy RM 04. Malfunctioning devices are returned to the Medical Engineering Department for Repair Assessment of patient s abilities e.g. physical/ sensory abilities, likelihood to tamper, and ability to remember or understand are to be carried out prior to the device being left with the patient. Monitoring patient and device for adverse effects, reactions etc. Checking devices for signs of wear and tear. Ensuring device alarms are used in compliance with recommendations of Allitt Report. Be aware of local policies and procedures appertaining to medical devices. They have full awareness of their responsibilities in the use of medical devices. Interpretation or analysis of data produced by the medical device must only be carried out by those members of staff with underpinning clinical skill; this must be done within a locally agreed specified time frame. Ensure appropriate methods of decontamination are considered and carried out on any ward or department held medical devices prior to routine inspection, servicing, repair, investigation or loaned devices used in the clinical area. Ensure training is attended including annual mandatory infection control sessions Ensure knowledge is obtainable for decontamination processes of certain medical devices used in the clinical area and that personal protective clothing is considered during these processes Deputy Chief Executive has the delegated responsibility for maintaining medical equipment. In practice this responsibility lies with the Head of Medical Devices. Each technician working within Medical Engineering must be aware of their own responsibilities to ensure they work to the most up to date guidance and policy, and be aware that the publication of new national, local or manufacturer guidance supersedes previous versions, Each technician has a duty to ensure they remain up to date with guidance and professional responsibilities; this involves being proactive in seeking out new guidance and sharing with colleagues as well as accepting that disseminated by other sources in the Trust. The Medical Engineering Department will: Carry out maintenance duties as appropriate Including a 24-hour on-call for emergency breakdowns. In addition they will: Maintain an equipment register of electronic medical devices. Maintain records of device calibration, planned maintenance, inspection activities and expected replacement dates. Advise users on the technical nature and operation of equipment. Advise users of common faults and assists with defect and failure reports. Identify equipment beyond economic repair, following damage, wear & tear. Policy for the Procurement Management and Use of Medical Devices v5 10

11 Point of Care Team Safely decommission or dispose of unusable devices in accordance with guidance. Medical Devices Engineering department shall ensure maintenance and service requirements are considered prior to purchase. The following actions are to be taken into account and addressed within the Trust s Medical Engineering Dept by each Technician:- The repair and maintenance of a device is considered and reviewed at the purchase stage, a decision relating to In-house, manufacturer other maintenance service provider needs to be agreed and evaluated on a yearly basis. All information necessary to undertake a repair or to maintain a device safely is made available. Systems are in place to bring any changes to repair and maintenance methods to the attention of the repairer. The repairers are appropriately trained, competent and up-dated with their knowledge of repair and maintenance methods. The repairer can demonstrate efforts towards compiling evidence portfolios of training and competency in relation to maintenance. The instruction used should be specified by the manufacturer. Replacement parts should be equivalent to those specified by the manufacturer. The use of alternative instructions, methods and parts should be demonstrated to be equivalent and take into account all risks to patients and users, this process must be fully documented. Traceability of all critical components used in a repair or maintenance is required. All associated repair and test equipment is suitable for its purpose and is appropriately maintained and calibrated. Repairer is made aware of any changes in circumstances which may affect the repair and maintenance and assess the impact of those changes to ensure that agreed specifications continue to be met. Repairers have a system in place to manage device repair and maintenance activities. The device itself remains identifiable throughout its life. Records are accurate, detailed and accessible regarding the service and maintenance of medical devices. Audits are undertaken regularly to review maintenance processes, action is then taken as necessary. The manufacturer reports conditions of potential device failure or other factors likely to compromise the clinical outcome. Reportable device failures are reported to the MHRA. A contract is drawn up to define responsibilities of the Manufacturer and the Trust in relation to service and maintenance. Legal responsibilities and liabilities are acknowledged. Devices intended for service or maintenance are not handled unless it is clear they are safe to touch i.e. contamination status is addressed. Roles and responsibilities of medical device engineers is further expanded within OP 31 (Operational policy for medical engineering). Is responsible for:- Carry out maintenance duties as appropriate Maintain an equipment asset register of all PoCT devices Maintain records of device calibration, planned maintenance, inspection activities and expected replacement dates. Policy for the Procurement Management and Use of Medical Devices v5 11

12 Medical devices library/ assistant At the users request they will contribute to user training in the use of PoCT equipment. Advise users on the technical nature and operation of equipment. Advise users of common faults interference and assists with defect and failure reports. Identify equipment beyond economic repair, following damage, ware & tear. Safely decommission or dispose of unusable devices. The medical equipment library employs assistants to ensure equipment is delivered to requesting wards within a timely manner, in a clean workable condition. To ensure an efficient service is provided the library assistants will:- Receive adequate training to fulfil the role of Library assistant (decontamination, infection control issues, etc). Deliver and collect devices from departments. Provide basic advice to departments on the use of medical devices. Decontaminate devices once they are returned to the library. Ensure accurate record keeping of the device loans. Carry out basic checks on equipment and report any damages to the Medical Devices Clinical Risk Manager/ electronic department. Assist in the collection of audit data relevant to the medical devices. 5 Definition of terms Assets Inventory Decontamination Procurement In-house Backtraq the property that is owned by the organisation a record of the organisation's current assets, including ownership, assets to hand, and the value etc. Decontamination is a series of processes to remove or destroy contamination so that infectious agents or other contaminants cannot reach a susceptible site in sufficient quantities to start infection or any other harmful response. Differing levels of decontamination are used depending on the device and the procedure involved. to obtain something working, carried out, or existing within the organisation The Trusts Asset management data base that monitors location and maintenance histories for medical devices. 6. Inventory for Reusable Medical Devices Used Within the Organisation Within the organisation details of specific reusable diagnostic, monitoring and therapeutic medical devices/equipment require entry onto the inventory (Backtraq) to log details of purchase date, supplier, maintenance logs and device ownership/ location of use etc. Acceptance checks for new devices will ensure the correct product has been delivered, with complete accessories and manuals. It will ensure devices are in good condition and working order. Any initial safety checks, calibrations or technical training is to be carried out by specially trained staff only. This could be medical engineering technicians or the manufacturer. Whoever performs Policy for the Procurement Management and Use of Medical Devices v5 12

13 the initial check, in-house technicians or external technicians must ensure a record is kept within Backtraq. All electronic medical devices require allocation of a unique ID number which allows the equipment to be traced during use and enables recall for maintenance or servicing; the unique ID number or Asset number as they are known will be generated by Backtraq and assigned during the acceptance testing stage. The main equipment asset inventory register- Backtraq is managed within medical engineering, however other departments across the Trust that hold local asset registers include Radiology, Endoscopy, Medical Devices Library, Pathology and CSSD but on the whole this information is replicated centrally in Backtraq, despite it being fully managed locally. Because newly purchased or loaned electronic equipment requires entry in to the inventory system with suitable acceptance checks carried out; in conjunction with equipment being deployed or accepted into the Trust via different means or delivery points the Trust acceptance process must be followed to ensure Medical Engineering are made aware of new reusable medical devices, so an asset record can be created and managed appropriately throughout the equipment s life cycle. 6.1 Process for Ensuring Decontamination of Re-Usable Medical Devices Decontamination requirements are to be considered before reusable medical devices are acquired to ensure they are compatible with the decontamination procedures and equipment available locally. Decontamination pre-purchase questionnaires are to be used to collect data in relation to decontamination, prior to purchase. It is then the manufacturer s duty to provide details of such processes. Medical devices must be decontaminated and stored in accordance with guidelines issued by the manufacturer, legislation and best practice requirements, advice and support can also be accessed via infection control or medical devices dept. Items subject to inspection, maintenance, repair or disposal, either in-house or at the manufacturer's premises, should be decontaminated beforehand. Any loaned items being returned to a manufacturer or supplier should also be decontaminated. Devices intended for single-use only do not require decontamination, except where they are implicated in an adverse incident and may need to be sent to the manufacturer for investigation. In this situation, contact the manufacturer to find out the most appropriate method of decontamination. Once decontamination has been completed, the items should be labelled accordingly and declarations of contamination status form/label or completed or completion of the electronic decontamination declaration within the electronic repair request section of backtraq. This requirement applies to all devices being returned to Medical Engineering inhouse or the Medical Equipment Library i.e. a contamination notification (clinell sticker) should be affixed to the device to indicate it is clean and safe to handle if returned to library. Electronic confirmation of decontamination is sought within Backtraq when an electronic maintenance request is made, ward staff have a responsibility to ensure if they tick this declaration that they do carry out appropriate decontamination process always in accordance with manufacturer instructions. Staff must be aware it is their responsibility to ensure they seek training in relation to relevant decontamination processes; this can be via infection control, medical devices team, colleagues or manufacturer. Policy for the Procurement Management and Use of Medical Devices v5 13

14 Staff must be aware It is illegal to send contaminated items through the normal post Ensure that single use items are disposed of and not reused even if decontamination has been attempted. Locally each department must ensure that:- There are systems developed and maintained to ensure staff, patients and others are not unnecessarily exposed to contaminated medical devices Staff are aware of their responsibilities in decontamination processes. Risks associated with decontamination processes are minimised. Staff receive training and guidance in decontamination procedures relevant to their area of work. Adequate and appropriate actions are taken by staff following the use of medical devices or those requiring maintenance or investigation to limit exposure to cross contamination. Selected methods of decontamination take into account the degree of infection risk associated with the use of the equipment and is in accordance with the manufacturer's instruction. See appendix 3-6. Required levels of decontamination depend upon how the device is used i.e. its function, the risk of the equipment transmitting infection or acting as an infection source. The vast majority of equipment or loan equipment will not require much cleaning and occasional disinfection. See appendix 3-6 for examples of equipment stored in clinical areas. Effective decontamination of reusable devices /loan devices is essential in reducing the risk of transmission of infectious agents and Allows the safe handling of devices for:- Medical device Library staff. Subsequent users, patients, carers or the patient's family. Maintenance staff. Staff handling devices that have been on loan - unless labelled as decontaminated must assume equipment to be contaminated and take precautions to reduce the risk of transmission of infectious agents through contact with blood and other body fluids. Appropriately trained personnel who are provided with suitable equipment and personal protective equipment should carry out decontamination activities in accordance with the equipment manufacturer s instructions. Personal protective equipment should be considered, in accordance with Infection control and decontamination policies IC3, IC14, IC15. The Medical Equipment Library Responsibility for the decontamination of medical devices held in the equipment library lies with trained library staff. Refer to the Operational Policy for Medical Device Engineering and Library OP 31. Surface decontamination is required for all equipment prior to its return to the Library; this decontamination procedure remains the responsibility of the clinical area prior to return to the Medical Devices Library, see Decontamination certificate Appendix 3 add clinell sticker. CSSD Responsibility for the decontamination of re-usable surgical instruments lies with specially trained CSSD staff. Refer to CSSD Process Manuals. Policy for the Procurement Management and Use of Medical Devices v5 14

15 Endoscopy Responsibility for the decontamination of scopes used in the department lies with specially trained staff working within the Endoscopy Unit. Please refer to IC Policy No. 16 Use of, Cleaning, Disinfection and Maintenance of Endoscopy Equipment. Decontamination of medical devices Stored in a clinical area Remains the responsibility of clinical staff. All reusable devices must be cleaned between each patient use. Staff using a medical device are responsible for decontamination following its use, and this must be in accordance with manufacturer instructions. See appendix 3-6 Decontamination of medical devices taken from clinical areas for Maintenance or loan to another area Any device taken out of a clinical area must show contamination status for the recipients protection. Examples of situations requiring documented contamination status are as follows. Equipment returned to the equipment library (see Operational policy for Medical Equipment Library OP31). Equipment sent for repair. Equipment returned to manufacturer. Equipment being investigated following an incident. Equipment loaned form one area to another. In occasional circumstances decontamination may not be feasible e.g. following an incident where decontamination may interfere with the investigation evidence, in such cases the user MUST ensure they alert the recipient or person performing the investigation. If the devices cannot be decontaminated prior to it being taken to another area it is the responsibility of the department in possession of the device to ensure the next recipient is fully aware of the contamination status, this should be communicated via a decontamination certificate (appendix 3). Vehicles/transporting trolleys used in the delivery and collection of equipment should be ideally adapted to allow the segregation of clean decontaminated equipment to that of dirty contaminated equipment. The transporting trolley needs to be impermeable, capable of being cleaned with compatible cleaning and disinfection agents. The transport apparatus or vehicle should be cleaned following collection and delivery rounds or sooner if visibly soiled. Also see CSSD Process manuals, Use of, Cleaning, Disinfection and Maintenance of Endoscopy Equipment, Operational policy for medical device engineering and Library OP 31 and appendix Process for ensuring that all medical devices are properly maintained and repaired This section should be read in conjunction with OP 31 Operational policy for medical engineering department and medical equipment library. Policy for the Procurement Management and Use of Medical Devices v5 15

16 The frequency and type of planned preventive maintenance will be specified by the Head of Medical devices and Medical Engineering, in line with the manufacturer s instructions, taking into account the expected usage and the environment in which it is to be used. The Trust is responsible for ensuring its medical devices are maintained appropriately. This includes consideration (prior to procurement and throughout the life cycle of the device), for how each device should be maintained and repaired, by whom, accessibility and/or purchase of any additional arrangements or resources including training and test equipment. Comparisons must be made against the benefits of internal maintenance verses external maintenance, bearing in mind which service level is the most appropriate to meet requirements. Consideration must be made against risk, performance and cost criteria and also potential savings opportunities that may be available through innovative approaches such as moving to multi-year contracts. In addition reflection must be given to how planned maintenance schedules fit with the capabilities of in-house service options. These comparisons and considerations support decisions made by the Head of Medical Devises as to the method of maintenance chosen. Where other regulations apply, Ionising Radiations Regulations 1999] and The Lifting Operations and Lifting Equipment Regulations 1998 for example, the tests therein should be carried out in addition to the maintenance and testing recommended in the manufacturer in the instructions for use (IFU) supplied with the device, not instead of. Within the Trust we do not differentiate between the term 'maintenance' and 'repair' we have pre-planned maintenance for device servicing and reactive maintenance for device failures and faults therefore the term maintenance is used. The workload is prioritised by the Head of Medical Devices or Chief Technician according to the associated risk of the device being out of action regardless of the task being a repair or pre planned servicing. The Medical Engineering Dept will within the course of its duties ensure that devices are regularly checked for functionality prior to use by the user in line with the manufacturer s instructions and throughout the expected lifetime of the device. This is undertaken by technicians and the Head of Medical Devices having the required foresight and capabilities to determine if, devices can be maintained in house or if external support is required, their insight of how the removal of a device from clinical care will impact on patient care and hence plan is required; e.g. knowledge of how to access alternative devices and guide clinical staff accordingly to prevent delays in patient care. Technicians must provide a rough indication of the time required to maintain the device so clinical staff can plan care accordingly, and ensure this projected time is realistic and meets the needs to the Trust as well as ensuring thorough high quality repairs are undertaken. To enable accurate response and repair times technical staff must fully understand which spare parts are readily available, (if not understand how to access in a timely manner) in addition appreciate how to retrieve manufacturer information such as circuit diagrams, preventive maintenance schedules, trouble-shooting guides, repair procedures, parts list, and special tools list and support. The Medical Devices Regulations require a manufacturer to provide: all the information needed to verify whether the device can operate correctly and safely, plus details of the nature and frequency of the maintenance and calibration needed to ensure that the device operates properly and safely at all times. Policy for the Procurement Management and Use of Medical Devices v5 16

17 Within the Trust not only the maintenance teams but also the users have a role in ensuring that medical devices are adequately maintained and repaired (see below). As stated earlier the Trust must carry out a risk-benefit analysis before finalising the specification of any maintenance and repair service (see appendix 2). Cost alone should not be the determining factor, in practice this role is undertaken in by Head of medical devices, supplies or clinical teams. Ideally when looking for external maintenance we choose a service provider or third-party repairer who complies with relevant quality system standards, such as European Standard BS EN ISO 13485:2012 or BS EN ISO 9001:2008 These standards ensure their work is consistently of the nature and quality intended. A manufacturer may wish to supply and maintain devices exclusively to guarantee the standard of repair. Alternatively, a manufacturer may stipulate strict criteria on the training, equipment and resources of an in-house department to which we must comply. Whichever means of maintenance is decided we must ensure the technicians have access to the necessary equipment and up-to-date detailed maintenance records, we also need to be able to compare the track record of the service providers to ensure we are receiving the most suitable level and quality of maintenance; this could be supported by monitoring response times, availability of loan devices while original devices are out of use, undergoing maintenance and the level of detail submitted in service reports etc. See appendix 7 comparison of in house maintenance with external provider To minimise the possibility of maintenance induced faults all in-house technicians are trained and have a high level of experience in the sphere of medical engineering. All the necessary testing, measuring and repair equipment required to carry out maintenance must be adequately maintained and calibrated in its own right, as required. Test equipment, such as jigs, templates, and computer service and validated diagnostic software must be checked regularly to ensure that they can adequately demonstrate device safety, these checks are set up as planned maintenance jobs in Backtraq (as any other device would) this will enable evidence that demonstrates the checks have been carried out. Maintenance/ calibration tests will be evidenced by certification. Current certificates of calibration are maintained for all test and repair equipment that has a measuring or calibration function which is applicable to the operation of the medical device; the certificates are held within the Medical Devices Engineering dept. in a specific folder. Calibration is traceable to recognised standards and will normally be carried out by the test equipment, manufacturer or agent. Records are maintained for each piece of test, repair or maintenance equipment in a folder in Medical Devices Engineering department. Before devices are put back into service, they must be adequately tested for electrical safety where applicable and for performance. When the device is allocated to a clinical department, individuals working in the department generally have primary responsibility for the way they treat the device and the state in which it is left. These responsibilities can also include performance checks before use and routine maintenance, such as charging batteries. It is essential that all individuals Policy for the Procurement Management and Use of Medical Devices v5 17

18 are aware of the medical device management system within the Trust and the part that they play to ensure that medical devices are managed correctly. Routine maintenance by the user: The user should ensure that the device continues to function correctly. This entails regular inspection and care, as recommended in the manufacturer s user information or in local procedures. This should clearly show the routine tasks and how they should be carried out. Instructions for user maintenance of medical devices should be provided to the users. These will include: Checking that it is working correctly before use Regular cleaning Specific daily/weekly checks Noting when it has stopped working properly or when obvious damage has occurred, and then discontinuing use Contacting the relevant servicing organisation. Any problems the user finds can then be referred to Medical engineering. Minor changes that do not affect the safe working of the device can be recorded for attention during the preventive maintenance sessions. Users may need to be trained to carry out routine maintenance. For example, they may require training on how to remove, change and insert batteries correctly in line with the manufacturer s instructions. The Trust must take all reasonable steps to ensure that medical devices are repaired and maintained to a suitable standard. Within Backtraq the technicians have full access to device history and are able to determine frequently returned devices the technicians should then use professional judgement to determine if the device has a recurrent fault or if there are issues with the quality of previous maintenance. In house maintenance The decision to maintain devices in house is taken by the Head of Medical Devices as described earlier the decision is taken based on a number of factors to ensure that equipment is safely and suitably maintained by competent staff using correct and appropriate recourses Electronic medical devices are logged onto an inventory (Backtraq), stating date of acceptance, manufacturer, maintenance history and location of device within the Trust. They are put through an acceptance check carried out by Medical Engineering Department (see section Roles & Responsibilities of Medical Engineering Dept), following this check the equipment is labelled with a pre-planned (next) service/maintenance date. The Trust has 2 systems working simultaneously for pre-planned maintenance 1. If the device is classed as a resuscitation and life support devices the Medical Engineering Department will recall the equipment for servicing as the pre-planned date approaches (lifesaving equipment only), Backtraq will flag due dates as part of the planned maintenance schedules This will inform technicians of approaching maintenance dates accordingly. Any work carried out on devices during the preplanned service will require a record entry into Backtraq so a full maintenance history for each device can be formulated This process also applies to fixed static or non-portable devices Policy for the Procurement Management and Use of Medical Devices v5 18

19 2. Non resuscitation and life support devices used in clinical areas also requires pre planned maintenance. Due to the frequent movement of portable devices across the trust it would be unachievable for technicians to seek each device via its asset number; for this reason the responsibility has been assigned to any user of any device. This means the user of a device must, as part of the pre use check, ensure the device is within its service date. This can be viewed on the sticker attached to the device See Appendix 7 licence scheme We therefore rely upon the vigilance of staff working in the clinical areas. As the expiry date approaches, or if expired, the user must return the device to the Medical Engineering Department. Should no sticker be visible or for some reason the date illegible, the user must seek confirmation from the Medical Engineering Department The Medical Engineering Dept will support the clinical areas by issuing a list of devices due to expire within the next 3-6 months within that ward or dep., Wards may at times find expired equipment not listed- this will be due to the equipment being moved from another area; if this occurs the user must retain their level of responsibility and return the device accordingly to the Medical Engineering Dept. if equipment listed cannot be found Medical Engineering must be informed so they can identify equipment as missing on the asset register If staff working in clinical areas suspect a fault or failure with a medical device complete the repair request electronically via Backtraq, then send the device to the medical engineering department. If the device repair is urgent or a fixed structure technicians can be called out or bleeped via switchboard. Devices either awaiting planned maintenance or repair maintenance will be prioritised by chief technician using a minimal disruption to service approach; this takes into account the risks and the potential level of harm if a device is out of use and focuses on possible replacements available. This ensures equipment turnaround times are based on their need of urgency to be returned to clinical areas Manufacturer/ Contract Servicing and Maintenance Many medical devices are maintained or serviced by the manufacturer or third party, Leasguard are a third party company that support the Trusts access to appropriate contracts; details of service contracts are agreed at the procurement stage and monitored by clinical/specialist areas, e.g. endoscopes, stacking systems. Contractors or manufactures visit clinical areas to service equipment at agreed times or on request for maintenance. Medical Device contracts along with records of maintenance carried out are to be held in Supplies, Estates or the local area visited depending on the device. Leasguard are a third party company that support the Trusts access to appropriate contracts Breakdowns Even with comprehensive maintenance schedules, breakdowns may still occur. In the event of a breakdown the equipment must be removed from service as soon as practically possible and the problem reported to the Medical Engineering Department via Backtraq s electronic request or by paging a technician via switchboard if urgent. This shall be by means of completing an on-line Defect and Policy for the Procurement Management and Use of Medical Devices v5 19

20 Maintenance Request; if the breakdown is not reported on-line then a Repair and Maintenance form plus a decontamination certificate must accompany the equipment when sent for repair to Medical Engineering. Wherever possible, temporary repairs should be avoided. But if this is needed, because the impact of the loss is too great, the temporary repair should be carried out and all concerned should be informed of any special precautions or limitations on use until a permanent solution is available. This should be documented on the equipment records in Backtraq. The equipment should be replaced or withdrawn from service as soon as possible and properly repaired before it is used again. The job will remain open on the Backtraq system until the full repair is made. 6.3 Disposal/ Decommissioning of Equipment When equipment is either to be permanently removed from service or disposed of the point of contact is the Medical Engineering Department. Decommissioning aims to make devices safe and unusable, by removing critical components or disabling such parts while minimising damage to the environment. Any device deemed unfit for use should be decommissioned. If need be Medical Engineering will contact the manufacturer at this stage for information on decommissioning. The manufacturer should be able to provide details of any environmental, disposal, recycling or structural requirements. If the manufacturer has ceased trading, contact the MHRA for further guidance. Decommissioning should include decontamination, making safe and making unusable while complying with current legislation. This is to ensure that an inappropriate person does not use the device and expose themselves and / or others to hazards. Wards must ensure devices are decontaminated prior to leaving the dept. it is not the duty of medical engineering to clean ward devices prior to decommissioning. For devices that are mobile or housed in general facilities, safety checks, such as power disconnection and cooling system disconnection, should be carried out. Decommissioning larger installations often involves removal from a purpose-built room or surroundings. Decommissioning of device incorporating radioactive sources must be carried out in accordance with the Ionising Radiations Regulations Support and advise can also be sought from waste management The Waste Electrical and Electronic Equipment Regulations primarily impose duties on producers, i.e. manufacturers and importers; however in-house technicians need to be aware of the content of the regulations. Special consideration should be sought for wastes containing certain metals (e.g. mercury above 3%, some batteries) Oil wastes (including polychlorinated biphenyls PCBs) Wastes from coolants Radioactive waste Healthcare wastes from human or animal origin Human waste from natal care, diagnosis, treatment or prevention of disease. Policy for the Procurement Management and Use of Medical Devices v5 20

21 Where applicable, devices should be decontaminated before disposal or transfer to a third party, and supplied with a certificate of decontamination Erasing stored data If a device stores patient identifiable data, this should be certified as securely erased to an appropriate standard, such as BS ISO/IEC and British HMG Infosec Standard 5, or IS5 before disposal. Data on any device should be forensically unrecoverable, i.e. patient data must be over-written. 6.4 Selection and procurement of equipment All purchases of medical devices should satisfy the necessary standards as laid down by the Medicines and Healthcare products Regulatory Agency and other statuary bodies. In addition to purchasing and leasing, which are the most common methods of acquisition, there are other ways to acquire medical devices, including: loans from manufacturers or other healthcare organisations. Hospitals may loan each other devices to avert temporary problems; manufacturers may loan products as part of an evaluation or as an incentive to purchase associated products. In all cases, it must be clear from the outset who is responsible should a problem arise. Prior to acquisition an agreement needs to be reached by those in a procurement role e.g. Head of Medical Devices, Supplies etc. in relation to the intended clinical needs, those of the end user and, technical operation, This can be achieved by reviewing the manufacturer s description of the intended use, the instructions for use, safety performance and reliability information (including detailed specifications of the medical device), and comparing against the performance specifications contained within the acquisition requirement stipulated by clinical teams. Data should be sought on safety issues and any limitations on use, software compatibility with current systems, compatibility with other devices and any medicinal products that it is likely to be used with: validation of, ease of use, durability, and design mollification against misuse. User feedback in addition to published clinical evaluations may also help support decision making and reviewing the availability of the devices; access to training (both user and technical), consumables, maintenance, manufacturer support & guidance, compliance to infection control and prevention requirements and decontamination requirements. Further consideration must be given to operating and environmental conditions required for suitable use & storage and disposal requirements as the device reaches the end of its life A measure of the projected service life of the product, warranty details, maintenance and replacement costs should be understood prior to purchase. It may be that the devices are available on another ward or dept. in the Trust or a standardised model may have already been agreed within the Trust. Final rationalisation must be evident at the time of purchase; the majority of this information is available on per-purchase questionnaires completed by the manufacturer or supplier. Completed PPQ forms are stored within Medical Engineering When medical devices are issued, it is essential that any residual risks concerning devices and their accessories are balanced against the anticipated benefits to the user or others. Where risks could not be removed during the design process, subsequent warnings of any residual risk should have been clearly displayed in the user instructions and product markings. Having a variety of device models in circulation for the same purpose can increase the risk of operators confusion; which could subsequently lead to possible misuse and complicated Policy for the Procurement Management and Use of Medical Devices v5 21

22 training requirements. There is however an advantage to restricting purchases and holding stocks with fewer model varieties in so far as it may support a reduction in the aforementioned risks. Where there is an appropriate opportunity for equipment standardisation this should be taken, advice must be sought and made readily available to users, as to the most appropriate equipment to purchase; i.e. wards and departments requiring a device purchase must liaise with Medical Engineering or Supplies to determine if a standardised ' make and model' for the particular device has previously been chosen or approved by the Trust., The standardised device will then be ordered unless a robust case can be made for variation, which must be presented to the Supplies Procurement Group. Despite this, consideration of the risks associated with standardisation to one model must also be considered. Reliance on 1 model could also incur problems such as:- Proven unreliability. Subject to manufacturer recall. Manufacturer withdraws models as they become obsolete or designs improve Manufacturer ceases to trade The selection of new equipment is very important to ensure that the maximum benefits are obtained from the purchase. Processes implemented within the Trust for managing medical devices need to take account of the different ways that the devices can be deployed. Equipment can be allocated to individual departments the dept then assumes responsibility for its management e.g. fixed or installed devices such as X-Ray. Equipment can be allocated to the Medical Equipment Library, who assumes responsibility for issuing and managing the devices. Equipment can also be allocated on a loan basis. In order for assets to be assigned the necessary acceptance / pre use checks, commissioning, and planned maintenance schedules they must be referred to or delivered to medical engineering prior to initial use. This processes must be followed to ensure Medical Engineering are made aware of new reusable medical devices supplied the Trust so an asset record can be created and managed appropriately for specific devices throughout their life cycle. Backtraq enables the monitoring of equipment utilisation and could be used to support identification of underutilisation particularly in library stock; it can also identify locations of devices that can possibly be re-deployed to other clinical areas at times of need. Some devices, such as medical gloves, dressings, catheters and syringes are delivered in bulk packs, so it would be inappropriate to check each one on delivery. For such consumable devices key issues are: Expiry dates are clearly shown on packaging, as required Appropriate marking for tracing lots, if there is a recall or modification required Instructions and safety information are available, as necessary Packaging is appropriate for storage Environmental conditions for storage are clear. All equipment must also be purchased in line with the Trusts Standing Orders & Standing Financial instructions and in line with EU Legislation and Public Contract Regulations. Pre purchase questionnaires (PPQ s) MUST be completed for all new type devices this will provide details prior to purchase which will ensure the device, aftercare, training needs etc. Policy for the Procurement Management and Use of Medical Devices v5 22

23 are met by the device & manufacturer. Completed PPQ s should be stored within Medical Engineering for reference purposes Equipment purchased via charitable funds should satisfy the same product selection criteria as those purchases made through exchequer monies. Requisitions must be vetted by the Financial Services Department to ensure adequate funds are available prior to purchase. Expenditure from charitable funds must be approved as per relevant procedure. For all second hand devices usage and service history should always be available for prospective purchasers before sale and then supplied with the device, at the point of sale. As a minimum, there should be a: Record of any reconditioning work carried out, including a record of replacement parts Copy of all maintenance and servicing that have been carried out, including the name of the maintenance/servicing organisation Record, type and frequency of usage over its working life Fault log Record of decontamination status Date of installation Tube usage (in the case of X-ray devices) Helium level (in the case of MRI). Modifying existing devices or using them for purposes not intended by the manufacturer (off-label use) has safety implications. It may also count as manufacture of a new device under the Medical Devices Regulations. The original manufacturer s liability is limited and liability may be partly or wholly transferred to the organisation or person making the modifications, if the device is implicated in an adverse incident. It is essential that modifications outside of the manufacturer s intended use are only considered as part of a fully documented risk management process within the healthcare organisation s risk management policy and procedures. For this reason we do not modify the use of devices as a rule within the Trust. In specific cases, where it is deemed that using an alternative accessory to that specified by the device manufacturer would give improved benefits, then a risk assessment should be carried out to ensure that all components within a system are compatible and can be used safely, If a device fails in use following replacement of a part with one not corresponding to the device manufacturer s specifications and this leads to the death or serious injury of a patient/user, there is a greater likelihood of the organisation responsible for medical device repair/maintenance being held liable for the injuries caused. 6.5 Equipment on loan within / to or from the organisation In principle equipment from the medical devices library should never leave the Trust sites, the following is the exception this; Emergency transfer to other trusts. Where possible ambulance transfer equipment should be used, where this is not possible the accompanying nurse should ensure the equipment is exchanged at the receiving hospital. Should a patient be transferred without a nurse or doctor escort, equipment from the trust must not be transferred with the patient, Ambulance or paramedic teams must use their own equipment for which they will be competent in the use of. Policy for the Procurement Management and Use of Medical Devices v5 23

24 A discharge plan is required for all patients discharged from hospital with a medical device into a continuing care setting. The plan must be prepared in advance by ward staff stating aspects of the required treatment/ therapy offered by the device, the plan needs to share details of how and when the device will be acquired (hospital owned equipment must not be issued to patients at a time of discharge). It is the responsibility of the discharging nurse to ensure that a discharge plan contains all the relevant information relating to medical devices and to clarify all arrangements are made within an appropriate time scale to maximise patient safety, ideally all arrangements need to be made prior to discharge so the devices are available for the patient to use as soon as they are discharged from hospital. The discharging nurse needs to ensure the patient has all the relevant instructions / information / training and accessories to accompany the device- this should include return of the device and instructions The Trust regularly has medical devices on loan for assessment purposes and it is important that the safety of the equipment can be demonstrated prior to it being used. This will not only help to ensure the safety of any patient that it is being used upon but also our staff who may be operating the equipment. All devices on loan from manufacturers should be subject to a written agreement which defines the device management requirements, responsibilities and liabilities.. Delivery receipt and pre-use procedures for loan device should be the same as those for purchased device, unless otherwise specified in this written agreement. The procedure to ensure that any potential risk offered by the use of loan equipment is controlled is twofold and includes:- Product Liability Indemnity. To ensure that the supplier of the loan equipment is aware of their responsibilities and clearly understands that although the equipment is being used by our staff, on the premises they still retain responsibility for the safe use and function of the device. This stage is covered by ensuring that a suitably authorised representative of the company reads and signs the trusts Equipment on Loan for Trial or testing indemnity form. Should the equipment supplier already be registered within the NHS Supplies Master indemnity Scheme, then the requirement is only for completion of a Delivery Note for the Equipment on Loan and Fee Issue that identifies the equipment by the serial number. Electrical Safety Testing for loaned devices This shall be carried out by a technician from the Medical Engineering & Medical Engineering Department who will as part of the testing regime complete an equipment acceptance sheet for the equipment. Upon completion of the testing a coloured label shall be attached in a prominent position on the equipment, advising that the test has been carried out It shall be the responsibility of the user to ensure that they are confident in the correct and safe operation of the equipment. It shall be the responsibility of the person carrying out the assessment of the equipment to ensure that the correct procedure is followed insofar as ensuring that the necessary paperwork and safety tests have been carried out Policy for the Procurement Management and Use of Medical Devices v5 24

25 Privately owned medical devices It occasionally happens that a patient may bring their own Medical Device into hospital with them. Where possible Trust owned devices should be the first choice of equipment to use with the patient. In unavoidable cases the patient or a relative must be encouraged to ensure that the operation manuals are provided and that the operation of the equipment is discussed with the appropriate staff. Privately owned equipment should also be subject an electrical safety test where appropriate and at an opportune time. 6.6 Ensuring devices are used safely and correctly used Staff within the Trust are personally accountable when they use devices and therefore must ensure that they have appropriate training. They are also personally accountable for ensuring users and carers have received appropriate training and know how to use the device that has been provided. An individual healthcare professional that uses the device in a way not intended, or against the instructions of the manufacturer may be liable for any consequences. Below details a check list staff should use to ensure that medical devices are used safely Before use: assessment What are the clinical and social needs of the patients or clients? Which of the medical devices available best meets those needs? Has a risk assessment been done? Are the risks associated with this device acceptable and can they be minimised? If the device has been bought privately is the patient or client aware of their personal responsibility? If the medical device is to be used by patients and/or carers, have the following been taken into account: Physical capabilities e.g. manual dexterity Sensory capabilities e.g. vision, hearing, ability to understand and remember Previous experience with the medical device The patient s or client s expectations The environment in which device will be used. Before use: knowledge of device Will the device be used in the way intended by the manufacturer? What are the limitations and contra-indications for use? Has the device been maintained in line with the manufacturer s instructions? Has the device been checked/calibrated after maintenance? Is the device within its expiry or use-by date? Who is authorised to carry out pre-use checks? Policy for the Procurement Management and Use of Medical Devices v5 25

26 Are there any signs of wear, damage or faults? Where can you get a replacement device? Do you know how to set up and use this device? Have you read the user instructions, and are they attached to the device, if this is possible? Have you been trained in its use? How was your competency to use this device assessed? Do you know how this device should perform and the monitoring that needs to be done to check its performance? Are you using the correct additional equipment, eg disposable infusion sets for an infusion pump? Do you know what to do if the device fails? Do you know how and to whom to report a device-related adverse incident? Has the device been modified? If so, has liability been checked with the manufacturer? In the case of devices purchased over the counter, have I advised the user to register with the manufacturer for ease of contact in case of urgent upgrades or recalls? During use Have you documented the details (name and serial number) of the device being used? Does checking the medical device show it is working properly and to the manufacturer s specifications? Has this been documented? Do you know what to do if the device is not working properly? Have the regular checks of the device been recorded? Is the equipment still appropriate in the light of the patient or client s changing needs? After use What cleaning and/or decontamination does the device need? Does the medical device show any signs of wear, damage or faults that should be reported? Policy for the Procurement Management and Use of Medical Devices v5 26

27 Does it need servicing, maintenance or repair? Were there any problems in using this device which should be noted and could be fixed for the future? Eg was any information missing from the manufacturer s instructions which would have been useful? If it is used in the home, how will the medical device be returned to the owner, disposed of, or safely stored? Responsibilities of users and carers Some staff or specialities within the Trust provide medical devices to patients and carers. It is important to make sure that these groups of people have adequate information about the use of the device. These members of staff are personally accountable for ensuring that users and carers have appropriate training in the use and maintenance of the device provided. This checklist will make sure that users and carers are fully aware of their responsibility for medical devices. Has the user or carer been trained to use the device and assessed as competent? Have they been given written guidance on using the device? Does the guidance cover; The name of the device? How to use the device and any accessories? Their responsibility for checking the device while in use? The maintenance required and its frequency? Recognition of device failure and fault? Action to be taken in the event of a device failure or fault/ Their responsibility for reporting problems with the device to the supplier of the equipment? Contact telephone numbers to use in an emergency, including out of hours? Their responsibilities if they have bought the device themselves? Instructions for the end user All necessary information on storage, pre-use checks, use, maintenance and cleaning should be passed on to the end user. A failure to pass on to the end user the manufacturer s original instructions may compromise the end user s ability to use the device safely, and may lay the Trust open to legal liability Some users or carers with particular disabilities or medical conditions may need additional instructions or training. For example, people who are visually impaired may not be able to easily read some forms of written information. The Trust may also on occasions need to supply its own information to explain any additional administrative arrangements e.g. contact details for maintenance, consumables or spare parts. Policy for the Procurement Management and Use of Medical Devices v5 27

28 6.7 Single use medical devices 2 SYMBOL FOR DO NOT REUSE (single use only) on medical device packaging Key Points Devices designated for single use must NOT be reused under any circumstances The reuse of single use devices can affect their safety, performance and effectiveness exposing the patients and staff to unnecessary risk. The reuse of single use devices has legal implications:- Anyone who reprocesses or reuses a device intended by the manufacturer for single occasion bears full responsibility for the safety and effectiveness. Anyone who reprocesses a single use device and passes it to another Trust or user has the same legal obligation under the Medical Devices Regulations as the original manufacturer of the device. If a reprocessed device is shipped to another Trust or user and the device is not fit for its intended purpose the re-processor and user may be committing an offence under one or more of the following. Health & Safety at Work Act 1974 Part 1 of the Consumer Protection Act 1987 General Product Safety Regulations 1994 Medical Devices Regulations1994 Reprocessing single use devices may affect the capability and/ or the materials from which the device is made. Single use devices may not be designed to allow thorough decontamination and /or resterilization processes This may result in:- Inadequate cleaning and decontamination. Material alteration e.g. Corrosion, cracking, Mechanical failure. Cross infection. 6.8 Adverse incidents If an adverse incident occurs involving the use of a medical device e.g. due to device failure, lack of maintenance, improper use, inadequate training or insufficient instruction, it must be reported via Datix. All of these incidents types have the potential to cause harm to the patient and/ or user, treatment could be interrupted or compromised, misdiagnosis could occur leading to inappropriate treatment being delivered, or deterioration in the patient's condition. The priority is to see to the patients or staff clinical needs and offer any stabilising or corrective treatment Policy for the Procurement Management and Use of Medical Devices v5 28

29 7. Training Quarantine the equipment and consumables and label as potential hazard, the device should state the contamination status, (if decontamination will not interfere with the investigation the device should be cleaned according to guidelines). Settings should NOT be altered. As soon as possible after the event an incident form should be completed, giving as much information and detail as possible, it is a requirement that asset numbers or batch numbers are included so investigation will focus on the specific device involved. The patient and the family should be informed of what has happened and an apology made, this is not an admission of liability. (See Being Open Policy) The incident will be reported to MHRA by medical devices clinical risk manager if appropriate. The equipment should not be sent back to a manufacturer until all investigations are carried out locally. Investigations carried out locally and nationally by the MHRA may provide feedback which governs a change in practice, policies, and procedures training etc to prevent similar incidents occurring in the future. A bimonthly report detailing incidents reported in the preceding 2 months is presented to at each Medical Devices Management Group Safety alerts If following identification of an issue related to the use of a medical devices and it is deemed necessary to share the detail across the Trust, then production of an in-house safecare alert may be required, these are drafted by the medical devices clinical risk manager and approved via the safe care team. Wards and depts. are expected to comply with the requirements to ensure other patients are not in receipt of the same issue Nationally produced safety alerts are received into the trut via the Head of Medical devices who is responsible for further cascading the info to the appropriate wards and departments, again compliance is expected and evidence of such is required See policy for the dissemination of safety alerts RM 63, policy for reporting defects and failures RM05 and Policy for incident reporting and investigation RM04 Provision of education & training will allow staff to develop confidence and achieve competence in the use of medical devices, which will ultimately result in the delivery of high-quality care. Any person using a medical device should be adequately trained in the safe and correct operation of the equipment. Training extends to those responsible for the provision of in-house maintenance and repair of medical devices. Training records must be evident to demonstrate training has been undertaken prior to any repair or maintenance carried out unsupervised. Training can be both specific and generic and can be obtained from the following sources - manufacturer and other third party training, cascaded internal training, peer to peer and selfstudy, any of these identified training strands will form the basis of competency required to perform maintenance work unsupervised. Policy for the Procurement Management and Use of Medical Devices v5 29

30 Training in the use of all medical devices will be undertaken using a wide variety of methods including centrally and locally delivered sessions to directorates or wards/ departments Centrally delivered training will avoid potential duplication of effort and ensure a consistent standard across the Trust. Local training will reflect the particular needs at ward or directorate level (See Medical Devices Training Policy RM45 ) Training of Patients and Carers Occasionally patients and their carers may need to be trained in the use of a certain device as part of their clinical management; this must be done to suit the individuals needs and requirements. Verbal instructions must be complemented with written ones, written information must include contact numbers for support and guidance and information regarding return, servicing maintenance etc See Policy for patients discharged from hospital with a medical device RM Equality and diversity The Trust is committed to ensuring that, as far as is reasonably practicable, the way we provide services to the public and the way we treat our staff reflects their individual needs and does not discriminate against individuals or groups on any grounds. 9. Process for monitoring compliance with the policy Monitoring the organisation s performance on medical device management is important to minimise or eliminate risks to patients and staff. Much of this activity should be by internal audit, as part of the organisation s governance arrangements. The Trust however needs to review the policies and systems for managing the use of medical devices regularly. This internal audit should be performed by the medical devices management group on a regular basis. An audit report should be submitted to the board via Health & Safety Committee. There will in addition be external monitoring and audit components by organisations such as Care Quality Commission (CQC). The CQC will inspect against their Essential standards of quality and safety Audit will monitor the effectiveness of systems used to maintain safe equipment; audit will also assess achievement towards and adherence to this medical devices policy and will provide relevant information to assist in the development of recommendations or action plans required for practice development or change. Reports and subsequent action plans shall be delivered to the Medical Devices Management Group (MDMG) and Health and Safety Committee, Action plans following audit shall be reviewed annually and re-addressed within the following MDMG. Standard / process / issue Monitoring and audit Method By Committee Frequency Departmental managers are to ensure all staff are aware and adhere to this policy this will be checked via the incorporation of an annual audit programme Annual Audit Medical devices clinical risk manager MDMG 18 months -2 years Policy for the Procurement Management and Use of Medical Devices v5 30

31 Standard / process / issue Monitoring and audit Method By Committee Frequency Incident forms related to Interrogation Medical devices MDMG 18 months medical devices will be monitored by the Medical Devices Clinical Risk Manager to identify maintenance & decontamination issues; and ensure systems/plans are arranged to address issues. of Datix clinical risk manager -2 years Medical Devices Clinical Risk Manager will, with the assistance of Medical Device Department Leads annually audit ward & departments adherence to this policy including those departments responsible for maintenance Training records of maintenance staff shall be checked to demonstrate competency in the field prior to performing maintenance unsupervised, this will partly demonstrate all reusable medical devices and equipment are properly maintained Part of the annual audit plan will be to focus on the management of external maintenance contracts PoCT will periodically audit PoC devices, staff competency and the use of those devices. Audit reports will provide relevant information to assist in the development of recommendations or action plans required for practice development or change. ICNA audit of management of patient equipment (general and specialist) should be Annual Audit Medical devices clinical risk manager/ ward links Annual Audit Medical devices clinical risk manager Annual Audit Medical devices clinical risk manager/ Head of medical devies MDMG MDMG MDMG 18 months -2 years 18 months -2 years 18 months -2 years Annual Audit Path labs MDMG 18 months -2 years Annual Report Medical devices clinical risk manager Annual Audit Safe care / Modern Matrons MDMG/ safe care Safe care 18 months -2 years 18 months -2 years l Policy for the Procurement Management and Use of Medical Devices v5 31

32 Standard / process / issue Monitoring and audit Method By Committee Frequency performed annually in appropriate clinical areas. Trust Safe Care Department will coordinate this with the Modern Matrons and liaise with Infection Prevention and Control Nurses for guidance on completing action plans if non-compliant. Medical Devices can be incorporated into the 5 Weekly Ward Measure audits for the cleaning and maintenance of equipment on wards and departments 10. Consultation and review weekly Ward managers Infection prevention & control Annual18 months -2 years This policy has been reviewed in consultation with Risk management / Compliance & Medical Devices Management Group Membership, Medical Engineering and Library staff 11. Implementation of this policy Policy development will continue to grow in a bid to remain up to date with achievable best practice and legislation. Clinical staff will be informed accordingly. In recognition of the aims of policies clinical staff need to appreciate their responsibilities in embedding the systems within their individual role/practice, ward or department. Following ratification of the policies they will become available to all clinical staff via the Trust Intranet. The medical devices clinical risk manager will access all wards and departments to ensure an up to date record of all current medical device links is available. This will ensure the correct members of each ward teams are receiving necessary communication and support. The medical devices clinical risk manager will liaise with ward and department managers and requested updates are discussed at any up and coming team meetings etc. Meetings will be arranged to highlight and discuss changes to the policies, while simultaneously instilling individual roles and responsibilities. Individual wards will have the opportunity to view their audit results relating to policy and compliance; this should give a basis to channel support. The outcomes of these sessions/meetings aim to determine a combined ward/dept and clinical risk manager action plan for the implementation of required changes. Following the development of ward action plans a further review will be planned to determine the effectiveness of the policy this will take the form of a repeat audit and provision for staff to feedback, all ward and department links will be requested to assist in the audits. Policy for the Procurement Management and Use of Medical Devices v5 32

33 12. References MDA DB 9801 Medical Device and Equipment Management For Hospital And Community Bases Organisations. Checking & Tests Of Newly Delivered Medical Devices MDA DB2000 Medical Devices and Equipment Management: Repair and Maintenance Provision MDA DB2000 Single use Medical Devices: Implications and Consequences of reuse National Audit Office HC475 The Management of Medical Equipment in the NHS Acute Trusts in England MHRA, The CE Mark Bulletin 2 Dec 2005 MDA 2001 Devices in practice: a guide for health and social care professionals MDA 2000 Equipped to Care; the safe use of medical devices in the 21 st century MHRA 2006(5) Managing Medical Devices April 2015 MDA DB2002(02) March 2002 Management of In Vitro Diagnostic Medical Devices MDA DB2002(03) March 2002 Management and use of IVD Point of Care Test Devices Department of Health Decontamination guidance MHRA MAC guidelines (2006) Epic 2 Guidelines (2007) MHRA Devices in Practice checklists for using medical devices June Associated Documents This policy should be read in conjunction with:- OP 31 Operational Policy Medical Device Engineering and Library RM45 Training Policy For Medical Devices Medical Devices Strategy RM 44 Local Policy for Authorised users of Medical Devices RM 46 Local policy for training required by Locum, Bank & Agency Staff IC04 Cleaning & Disinfection. RM05 Reporting of Defects & Failures Policy PC-MAN-POL-001.UN Policy for the procurement management and use of Point of Care Tests (PoCT) PC-MAN-POL-002.UN Point of Care Provision for Pathology South of Tyne & Wider Community Policy for the Procurement Management and Use of Medical Devices v5 33

34 Appendix 1 Different types of devices Used in the Used in life diagnosis or support: treatment of disease, or monitoring of patients Anaesthetic machines Blood glucose measuring devices Defibrillators Patient monitors In vitro diagnostic medical devices and their accessories Blood glucose measuring devices Cholesterol test kits Used in general care Adjustable beds Patient hoists and other transfer equipment Pressure relief equipment Stoma care equipment. Equipment used by people with disabilities External prostheses and orthoses Hearing aids Devices supplied by pharmacists: Condoms Contact lens care products Chiropody and podiatry equipment Pulse oximeters Pregnancy test kits Incontinence aids Chlamydia test kits CT scanners Ventilators. Urine test Prescribable Cholesterol test kits strips. footwear Dental instruments, Standing frames Pregnancy test kits equipment and materials Dressings Urine drainage Sphygmomanometers systems Endoscopes Walking aids Thermometers Examination gloves Wheelchairs Stoma equipment and special support seating Iintravenous (iv) administration sets and pumps Nebulisers Ophthalmic equipment Pacemakers Peak flow meters Surgical instruments Suction equipment Syringes and needles Ultrasound dopplers Urinary catheters. Urine test strips Policy for the Procurement Management and Use of Medical Devices v5 34

35 Appendix 2 Comparison of in-house maintenance with an external provider Maintenance / repair organisation Outside organisations In-house Possible advantages Predictable costs. Possible to specify response times. Possible to specify equipment down times. Loan equipment. Fast response possible for problem solving and breakdowns. In-house teams may be flexible in accessing equipment for scheduled preventive maintenance thus reducing down times. In-house equipment management departments can co-ordinate and manage an appropriate mix of in-house, manufacturer and thirdparty service. Possible disadvantages Hard to maintain fast response cover for critical care or high dependency breakdowns without additional costs. Equipment may need to be sent away for repair and servicing. Equipment loans may be required. Hard to maintain adequate stocks of spare parts across a wide range of devices. Special tools and test equipment may not be available. Specialist training costs can be high. Manufacturers are sometimes reluctant to provide training. Policy for the Procurement Management and Use of Medical Devices v5 35

36 Appendix 3 DECLARATION OF CONTAMINATION STATUS A "Declaration of Contamination Status" should be completed in duplicate for all items of equipment being sent for inspection, repair or servicing. The certificate attached to this policy can be either copied or can be obtained from Supplies. The top copy certificate should be attached to the equipment with the second copy being retained by the Head of Department/Ward Sister. If the equipment is to leave the premises the certificate/statement should be enclosed in an envelope affixed to the outside of the package. The envelope should be marked "Examine enclosed documents before unpacking".gateshead HEALTH NHS FOUINDATION TRUST D E C L A R A T I O N O F C O N T A M I N A T I O N S T A T U S Prior to the Inspection Servicing, Repair or Return of Medical and Laboratory Equipment To: Make and Description of Equipment: Model/Serial/Batch Number: Trust Reference Recipients Service or Returns Authorisation or Order number: Reference of Contact Name:... Tick box A if applicable. Otherwise complete all parts of B, providing further information as requested or appropriate. A 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. B 1. Has the equipment/item been exposed internally or externally to hazardous materials as indicated below? YES/NO Blood, body fluids, respired gases, pathological samples. YES/NO Other biohazards. YES/NO Chemical or substances hazardous to health. YES/NO Other hazards. 2. Has this equipment/item been cleaned and decontaminated? YES/NO Indicate the methods and materials used. If the equipment/item could not be decontaminated please indicate why: Such equipment must not be returned/presented without the prior agreement of the recipient whose reference or contact name must be given above. 3. Has the equipment/item been suitably prepared to ensure safe handling/transportation? YES/NO I declare that I have taken all reasonable steps to ensure the accuracy of the above information, in accordance with HSG(93)26. Authorised signature: Unit. Name (printed):. Department:.. Position:. Telephone number:. Date: NOTE: This form to be completed in duplicate. Top copy to accompany the equipment, second copy to be retained by Head of Department/Ward Sister. Policy for the Procurement Management and Use of Medical Devices v5 36

37 Appendix 4 DECONTAMINATION GUIDELINES FOR MEDICAL DEVICES All medical devices and equipment used in either a hospital or community environment have the potential to become contaminated and therefore present a risk to those who are handling or using them. This expands to those who inspect, repair, service or receive returned loan equipment. Decontamination of equipment is necessary to ensure the equipment is safe to be handled by all personnel who are likely to come into contact with it during & following its use, through transit to the intended recipient or reprocessor. The level of decontamination required for any medical device, depends on how the device was used, i.e. its function, the risk of the equipment transmitting infection or acting as an infection source. The choice of decontamination method will depend not only on the nature of the contaminate but also on the time required for reprocessing, the heat, the pressure, moisture and chemical tolerance of the device, the availability of the processing equipment and the risks associated with the decontamination methods. The levels of decontamination are: Cleaning Cleaning followed by disinfection and or sterilisation The choice of decontamination method should be related to the degree of infection risk associated with the intended use of the equipment. RISK APPLICATION OF ITEM RECOMMENDATION High In close contact with broken skin or broken mucous membrane. Introduced into sterile body areas. Medium Low In contact with mucous membrane Contaminated with particularly virulent or readily transmissible organisms Before use on immunocompromised patients In contact with healthy skin No contact with patient Cleaning followed by sterilisation Cleaning followed by sterilisation or disinfection N.B. Where sterilisation will damage equipment cleaning followed by high level disinfection may be used as an alternative Cleaning Other factors to consider when choosing a method of decontamination include: Nature of contamination Time required for reprocessing Heat, pressure, moisture and chemical tolerance of the object Availability of the processing equipment Quality and risks associated with the decontamination method All medical devices decontamination equipment and surfaces should be appropriately dealt with after use on those patients known to have or who are in risk category for CJD. Refer to IC Policy No. 22 TSE Where items of equipment cannot be decontaminated the advice of either a Consultant Microbiologist or an Infection Prevention and Control Nurse, should be sought on the most appropriate means of disposal. Policy for the Procurement Management and Use of Medical Devices v5 37

38 WHEN TO DECONTAMINATE Items subject to inspection, maintenance, repair or disposal either on the Trust site or those to be returned to the manufacturer or agents premises, should be decontaminated appropriately beforehand. DEVICES INTENDED FOR SINGLE USE SHOULD NOT BE RE-PROCESSED THESE ARE IDENTIFIED BY THE SYMBOL All reusable devices require cleaning between uses. Cleaning is also a prerequisite for sterilization and disinfection of medical devices The manufacturing supplier has a responsibility to provide full instruction on the decontamination of the supplied device. The decontamination methods advised should have full validation of suitability. It is to be noted that contamination may present not only as microbiological hazards but also in the form of chemicals that could be corrosive, toxic, irritant, cytotoxic or radioactive. 2 The following is a guide only. The manufacturer s decontamination instructions are to be referred to in all cases to ensure the correct method is chosen. If you are unable to locate a copy of the decontamination instructions held within the trust you will need to contact the manufacturer direct. If they are unable to issue you with the information required then the MHRA are to be informed. CLEANING Cleaning is a method of decontamination for non-invasive or low risk (of cross contamination) items. Cleaning should not be used as the only process of decontamination with devices that have a high or intermediate risk of cross contamination, as sterilization or disinfection is required for these risk categories. Although mechanical methods of cleaning (e.g. washer disinfectors and ultrasonic washers) devices are more advantageous than manual cleaning, as they are more easily controlled, protect the user from exposure to aerosols chemical and vapours, it is not always an option due to unavailability or inappropriate for specific devices. Manual cleaning immersion Always check manufacturer s instructions first Wear protective clothing according to policy e.g. waterproof clothing, robust gloves and eye protection. Ensure you are competent and trained in this activity, are aware of the nature of the soil and method of soil removal, temperature of water, concentration of detergent and accessibility of fluid to the device as these may affect the efficiency of the method Dismantle the device if required according to the manufacturer s instructions Immerse the device in a clean sink or receptacle containing a compatible water/detergent solution warmed to no greater than 35ºC, ensure the cleaning solution reaches all surfaces including internal surfaces of lumened or cannulated devices (if the cleaning solution becomes obviously soiled or contaminated it should be changed and the process repeated Brush, wipe, agitate, irrigate, jet wash or hand spray to dislodge and remove all visible soiling, this action should be undertaken beneath the surface of the solution Policy for the Procurement Management and Use of Medical Devices v5 38

39 Remove the device from the solution draining off excess solution over the sink/ receptacle then transfer to a clean receptacle or sink and rinse thoroughly with clean water again ensuring the device is fully immerged Remove the device from the water and carefully hand dry using non shedding cloth or hot air dryer or place in a drying cabinet Wash and dry the receptacles/sinks Brushes etc to be decontaminated if reusable Complete decontamination certificate Protective clothing should be removed on completion of the procedure and hands washed thoroughly Manual cleaning non-immersion Non immersion manual cleaning methods are used for certain types of equipment where soaking in aqueous solutions will compromise the device e.g. electrical and electronic equipment. Alcohol wipes should be used to clean electrical contacts on equipment. Always check manufacturer s instructions first Ensure the device is disconnected from the mains power supply before commencing the cleaning procedure Wear protective clothing according to policy e.g. waterproof clothing, robust gloves and eye protection. Ensure you are competent and trained in this activity, are aware of the physical application, nature of the soil, concentration of detergent and accessibility of cleaner to the device as these may effect the efficiency of the method Immerse the cleaning cloth in the compatible detergent solution and wring thoroughly Commencing with the upper surface of the device, wipe thoroughly ensuring that the detergent solution does not enter the electrical component Periodically rinse the cloth in clean water and repeat the steps above Surfaces should be carefully hand-dried using a cloth or industrial hot air dryer or placed into a drying cabinet Safely dispose of cleaning materials and alcohol wipes if used Note Non-immersion, manual cleaning is not a disinfection process, but where an alcohol wipe is used to dry surfaces, this may have a disinfecting effect The pooling of alcohol on equipment should be avoided and alcohol evaporation ensured, Care should be taken to ensure that alcohol does not enter the item e.g. via ventilation slots For further information relating to mechanical cleaning e.g. thermal washer-disinfectors, ultrasonics. Chemical disinfection or sterilization contact Sterile Services, Infection Control or refer to MAC (Microbiology Advisory Committee) Manual July 2002 Policy for the Procurement Management and Use of Medical Devices v5 39

40 Appendix 5 A medical device should be decontaminated after each patient use, or prior to repair, service or investigation IF THE DECONTAMINATION OF A DEVICE IS LIKELY TO REMOVE EVIDENCE OF A FAULT OR HINDER A SUBSEQUENT INVESTIGATION OR, USUAL DECONTAMINATION REGIMES MAY EFFECT THE CONDITION OF THE DEVICE UNDER INVESTIGATION THEN INFORMATION SHOULD BE SOUGHT FROM THE MANUFACTURER, SERVICING DEPT, INVESTIGATING BODY WITH REGARD TO SAFE TRANSPORTATION AND HANDLING OF THE DEVICE ` Following the use of a medical device ask is it single use only? NO YES Dispose of device according to waste management policy Device in contact with a break in the skin or mucous membrane Introduced into a INTERMEDIATE sterile body area HIGH Infection risk associated with the use of the device MEDIUM In contact with healthy skin Not in contact with patient Cleaning Sterilization In contact with mucous membrane. Contaminated with particularly virulent or Even cleaning of contaminated Sterilization is to be done in readily transmissible organisms. equipment needs to be carried designated areas and Prior the use on immunocompromised out in designated area. departments only e.g. sterile patients Consider the manufacturing services Sterilization or disinfection instructions, nature of Consider the manufacturing Sterilization and disinfection should only occur in designated areas with the contamination, heat, pressure, instructions, nature of correct facilities available e.g. sterile services, equipment library. Consider the moisture or chemical tolerance contamination, heat, pressure, manufacturing instructions, nature of contamination, heat, pressure, moisture or of the device availability of moisture or chemical tolerance of chemical tolerance of the device availability of decontamination equipment, risks decontamination equipment, the device availability of associated with decontamination, adequate training on the disassembly of risks associated with decontamination equipment, risks contaminated items if required. Only equipment on loan from the equipment decontamination, adequate associated with decontamination, library is to be returned to the library for decontamination. All CSSD equipment to training on the disassembly of adequate training on the be returned to CSSD, ward held medical devices to be decontaminated at ward contaminated items if required. disassembly of contaminated level All ward held re-usable medical items if required. All reusable devices require equipment to be re-sterilized, decontamination at ward level. should be returned to CSSD as See guidelines & manufacturer indicated in decontamination instructions policies and process manuals Policy for the Procurement Management and Use of Medical Devices v5 40 LOW

41 Appendix 6 DECONTAMINATION OF EQUIPMENT THAT IS THE SUBJECT OF COMPLAINT OR INVESTIGATION Add new diagramme Anticipated location for investigation Is decontamination Is decontamination likely to prevent Off-site On-site likely to prevent full investigation? full investigation? No Yes Yes No Inform investigating body Inform investigating body Decontaminate equipment Investigating body Arrange visit by agree despatch? No investigating body Arrange visit by investigating body Yes Pack and despatch with declaration of contamination status and note fault/defect. Pack well, label and despatch with declaration of contamination status and note of fault/ defect. Label with declaration of contamination status and store in secure place. Decontaminate equipment prior to visit and complete declaration of contamination Once decontamination has been completed the item should be labelled accordingly. This should be readily accessible to the recipient of the equipment. Devices intended for single-use only do not require decontamination except where they are implicated in an adverse incident and may need to be sent to MHRA or manufacturer for investigation. In this situation contact the manufacturer to find out the most appropriate method of decontamination. HOW SHOULD DECONTAMINATION BE CARRIED OUT All decontamination methods should be operated and carried out in accordance with the manufacturers guidelines ensuring all contaminated areas are incorporated into the process. Only those chemicals proven to be compatible with the device and at the correct concentrations as recommended by the manufacturer should be used. Any equipment used for decontamination should also be: Commissioned Validated and revalidated Subject to planned maintenance Staff using decontamination equipment should: Be trained in the use of decontamination equipment Use personal protective equipment/clothing Be aware of legal requirements Policy for the Procurement Management and Use of Medical Devices v5 41

42 Appendix 7 Medical Devices Licence Scheme The scheme is aimed at providing all clinical staff working with Medical Devices connected to patients with a user-friendly visual indication that their equipment is being appropriately maintained. The scheme works in a very similar way to getting a car licensed with a road tax disk. This system ensures that the essentials to equipment safety are met, and that it is compliant with all relevant regulatory requirements. To obtain an equipment licence the device must first have: Been registered in the Trust Inventory, this is indicated by an asset label with a registration number. This tells you that the Trust recognises that this equipment is in existence, and that it has been properly commissioned. Undergone appropriate maintenance, and been checked for electrical and mechanical safety and function, either by an external contractor or ourselves. Full technical support from the manufacturer. All parts and technical information must be available to Medical Engineering and Medical Engineering. A technical department is normally available to assist our engineers with any unusual technical problems. All Safety Notices issued by the Medicines and Healthcare products Regulatory Agency (MHRA) have been actioned. Before equipment is licensed Medical Engineering and Medical Engineering must have carried out all outstanding safety work. When the above conditions have been met a green and yellow circular sticker is attached to the equipment Indicating to users that the device is serviceable and may be used. The green GO section of the licence indicates the licence expiry date; ideally the equipment should not be used beyond that date. However for clinical and resource reasons, it may be expedient to use the equipment beyond the licence expiry date. Hence the yellow Cautionary section of the label indicates that the equipment may still be used for up to a further 3 months, but should be withdrawn from service as soon as practically possible. What should I do if I find an expired licence label? Firstly equipment with an expired licence does not mean that it is unsafe to use. Should a member of your staff notice an out of date licence contact Medical Engineering and Medical Engineering. If it is after normal working hours there is no immediate safety problem. They should certainly contact Medical Engineering and Medical Engineering at the earliest opportunity. In the mean time we recommend that you consider the following factors: If it is not in use on a patient you should contact Medical Engineering and Medical Engineering on the next available working day and they will either arrange for the device to be re-licensed, or advise you on what alternative action to take. If the equipment is connected to a patient you should complete the clinical procedure that the equipment is being used to perform, then contact Medical Engineering and Medical Engineering. Clinical care of the patient is paramount; remember if equipment is working perfectly OK on the 2nd of the month it does not suddenly becoming unserviceable on the 3rd because it s licence has expired. Remember to carry out manufacturers pre-use checks. Medical Engineering and Medical Engineering set service intervals to meet the specific needs of equipment taking account several factors. To help you demonstrate to the safety auditors or your manager that your Medical Devices are properly maintained the 'expiry date' is used, as distinct to a last tested date. We recommend that you do not use any equipment without a valid licence. Below is a sample of the licence label. size 30mm by 40mm Note: The licence is not applicable to major life support equipment such as anaesthetic trolleys and ventilators. These devices operate on the traffic light card system. Policy for the Procurement Management and Use of Medical Devices v5 42