Version: 5.0. Policy for the Procurement Management and Use of Medical Devices. Name of Policy: Effective From: 24/10/2012

Transcription

1 Policy No: RM30 Version: 5.0 Name of Policy: Policy for the Procurement Management and Use of Medical Devices Effective From: 24/10/2012 Date Ratified 26/09/2012 Ratified Medical Devices Management Group Review Date 01/09/2014 Sponsor Director of Estates and Facilities Expiry Date 25/09/2015 Withdrawn Date This policy supersedes all previous issues.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 26/09/2012 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 Selection and procurement of equipment Equipment on loan to or from the organisation 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 Appendix 1 Request to repair document Appendix 2 - Decontamination Certificate Appendix 3 - Decontamination Guidelines Appendix 4 Decontamination pathway Appendix 5 Decontamination of devices subject to investigation Appendix 8 Maintenance licence scheme Policy for the Procurement Management and Use of Medical Devices v5 3

4 1. Introduction 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 E.g. needles, syringes, infusion pumps, endoscopes, examination gloves, dressings and Point of Care testing (PoCT) devices. PoCT is the current term used to describe the analysis of a patient s sample, where the analysis takes place outside of the central laboratory. Common examples include blood glucose, blood gas, HbA1c, INR, haemoglobin, urinalysis and pregnancy testing. A medical device can be defined as any instrument, apparatus, appliance, material or health care product excluding drugs, used for a patient or client for the purpose of: Diagnosis, prevention, monitoring, treatment or alleviation of disease/ or an injury or handicap. Investigation, replacement or modification of the anatomy or of a physiological process. Categories of Medical devices:- Equipment used in diagnosis or treatment of disease. Equipment used in life support. In vitro diagnostic medical devices. Equipment used in the care of disabled people. Aids to Daily Living. The policy is developed in line with requirements for achievement towards NHSLA Risk Management Standards and The Essential Standards of Safety and Quality. It also addresses 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 Managing Medical Devices 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) Recent advances in healthcare technology have led to the provision of more complex devices being used in clinical care; this in consequence has widened the Policy for the Procurement Management and Use of Medical Devices v5 4

5 scope for medical device related incidents to arise. 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, and use of for 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, or disease. The recommendations made in the policy are approved by the Chief Executive, although the implementation of the recommendations will be carried by qualified Clinical Staff who are responsible for the 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, Local Policy for authorised users of Medical Devices RM 46). 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 maintained in a safe and reliable manner. It has been appropriately assessed, procured and the benefits of standardisation considered. 4. Trust-wide Roles and Responsibilities for the safer use, management and procurement of Medical devices The Chief Executive Is responsible for ensuring that the Trust complies with all health and safety regulations and approved guidance. In practice the tasks and responsibilities for ensuring compliance to regulations and guidance relating to medical equipment are delegated to senior managers but overall responsibility will remain with the Chief Executive. Policy for the Procurement Management and Use of Medical Devices v5 5

6 The Trust Board Director of Estates and Facilities Management Clinical Directors Specialist Service Manager Is overall responsible for formally reviewing the systems and processes for ensuring safe acquisition, decontamination, storage, deployment and use of medical devices. 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 Specialist Service Manager. Responsible for regular monitoring and review of decontamination procedures and advising the Trust Board accordingly. In liaison with service managers will be responsible for ensuring systems and arrangements in place cover all staff groups including medical staff. The Specialist Services Manager has the delegated responsibility from the Director of Estates & Facilities Management for the management of medical equipment across the Trust. These duties include:- Liaises with the Director of Estates & Facilities Management and other senior members of staff on matters concerning medical 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 and 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 Electronics and 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. Departmental Budget Holder and Signatory for Medical Electronics 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. Policy for the Procurement Management and Use of Medical Devices v5 6

7 Divisional Managers Matrons or equivalent responsibilities Supplies Manager General Ward or Department Managers The Medical Devices Clinical Risk & Equipment Library Manager 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 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 directorate 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 decisions locally for who authorised users are of the equipment used in the clinical areas, this will be forwarded 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 Leads, 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 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 Policy for the Procurement Management and Use of Medical Devices v5 7

8 The Medical Devices Management Group The Point of Care Coordinator 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. Acts as the Trusts Liaison Officer for the dissemination of Medical Device Alerts 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 Safe care Provides feedback in the form of an annual report to the Safe care 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. 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 Is responsible for:- Ensuring there are appropriate systems in place to manage PoCT devices within the trust. The implementation of improvements, efficiency and quality of Policy for the Procurement Management and Use of Medical Devices v5 8

9 Infection Control Team All users of medical devices 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 advise 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 advise 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. 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 Electronics Department for Repair Policy for the Procurement Management and Use of Medical Devices v5 9

10 Medical Engineering Dept Point of Care Team 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 Director of Estates and Facilities Management has the delegated responsibility for maintaining medical equipment. In practice this responsibility lies with the Specialist Service Manager. 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 of common faults and assists with defect and failure reports. Identify equipment beyond economic repair, following damage, ware & tear. Safely decommission or dispose of unusable devices. Electronics department shall ensure maintenance and service requirements are considered prior to purchase; roles and responsibilities of medical device engineers is further expanded within OP 31 Carry out maintenance duties as appropriate Maintain an equipment register of all PoCT devices Maintain records of device calibration, planned maintenance, inspection activities and expected replacement dates. At the users request they will contribute to user training in the use of PoCT equipment. Policy for the Procurement Management and Use of Medical Devices v5 10

11 Medical devices library/ assistant 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 the property that is owned by the organisation a record of the organisation's current assets, including ownership, assets to hand, and the value 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 6. Inventory for Reusable Medical Devices Used Within the Organisation Within the organisation details of reusable diagnostic and therapeutic medical devices/equipment require entry onto the inventory (Backtraq) to log details of purchase date, supplier, maintenance logs and location of devices. Newly purchased or loaned electronic equipment also requires entry in to the inventory system; this is done during the initial acceptance check. Policy for the Procurement Management and Use of Medical Devices v5 11

12 Acceptance checks will ensure the correct product has been delivered, with complete accessories and manuals. It will ensure that they are in good condition and working order. Any initial safety checks, calibrations or training is to be carried out by specially trained staff only this could be trust technicians of manufacturer, who ever performs the initial check in-house or external there must be a record kept within Backtraq. All electronic medical devices require allocation of a unique ID number which allows the equipment to be traced during use and allow recall for maintenance and servicing; the unique ID number or Asset number as they are know will be assigned during the acceptance testing stage The main equipment asset inventory 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 most information is duplicated centrally onto the medical engineering inventory, however it is managed locally 6.1 Process for Ensuring Decontamination of Re-Usable Medical Devices All decontamination procedures must be in accordance with guidelines issued by the manufacturer We must ensure that:- There are Trust wide 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 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. All relevant staff are aware of the need to receive decontamination instruction and training. All reusable medical devices /equipment are to be decontaminated according to those processes described by the manufacturer. Decontamination issues are covered at procurement stages. The manufacturer is required to provide details of decontamination procedures Effective decontamination of reusable devices /loan devices is essential in reducing the risk of transmission of infectious agents. Decontamination allows the safe handling of devices for:- Medical device Library staff. Policy for the Procurement Management and Use of Medical Devices v5 12

13 Subsequent users, patients, carers or the patient's family. Maintenance staff. Required levels of decontamination depends on 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 3-5 for examples of equipment stored in clinical areas. 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, IC 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 CSSD Responsibility for the decontamination of re-usable surgical instruments lies with specially trained CSSD staff. Refer to CSSD Process Manuals 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 Decontamination of medical devices taken from clinical areas for Maintenance or loan to another area Policy for the Procurement Management and Use of Medical Devices v5 13

14 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 loan form appendix 9). Equipment sent for repair. Equipment returned to manufacturer. Equipment being investigated following an incident. Equipment loaned form one area to another. Decontamination must be carried out as stipulated by the manufacturer. In occasional circumstances decontamination may not be feasible e.g. following an incident where decontamination may interfere with the investigation, in a case such as this the user MUST ensure they alert the recipient or person performing the investigation. It is the responsibility of the department sending or holding equipment for repair, maintenance or loan to ensure it is decontaminated before the next recipient receives it. 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 2) A local policy for the transportation of equipment from the point of use to the store should be implemented. 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 apparatus needs to be impermeable, capable of being cleaned with compatible cleaning and disinfection agents. The transport apparatus or vehicle should be cleaned on a weekly basis 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 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 Specialist Service Manager 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 Policy for the Procurement Management and Use of Medical Devices v5 14

15 Decontamination of all devices is required prior to sending them for repair or maintenance work N.B. it is illegal to send contaminated items through the post In house The decision to maintain devices in house is taken by the Specialist Services manager the decision is taken based on a number of factors to ensure that equipment is safely and suitably maintained by competent staff using the 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. Electronic devices 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 (life saving 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 pre planned 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 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 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 Policy for the Procurement Management and Use of Medical Devices v5 15

16 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 dept, 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 Should staff working in clinical areas suspect a fault or failure with a medical device they must complete the repair request form (appendix 1) or complete an electronic request electronically via Backtraq, then send the form with the device to the medical engineering department. If the device repair is urgent or a fixed structure technicians can be called out or bleeped 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 turn around times are based on their need of urgency to be returned to clinical areas Also See operational policy for medical devices engineering and library OP Manufacturer/ Contract Servicing and Maintenance Many medical devices are maintained or serviced by the manufacturer or third party, 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 Disposal of Equipment When equipment is either to be permanently removed from service or disposed of the point of contact is the Medical Engineering Department. Policy for the Procurement Management and Use of Medical Devices v5 16

17 6.3 Selection and procurement of equipment The selection of new equipment is very important to ensure that the maximum benefits are obtained from the purchase. A number of factors are to be taken into consideration before the final decision is made, details and advice can be sought directly from medical engineering or supplies alternatively refer to Operational Policy for Medical Device Engineering and Library OP Purchase 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. Information should be sought by the purchasing department relating to the equipments country of origin, Manufacturer, CE marking, Quality Assurance, Safety Standards, Service/Spares/Installation, Decontamination and Warranty prior to purchase. 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 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 Committee/ Medical Devices Management Group for consideration before the order will be progressed. The Specialist Service Manager must give approval before an order is placed. All equipment must also be purchased in line with the Trusts Standing Orders & Standing Financial instructions and in line with the 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 are met by the device & manufacturer. Completed PPQ s should be stored within Supplies for reference purposes Purchases via Charitable Funds 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. Policy for the Procurement Management and Use of Medical Devices v5 17

18 6.4 Equipment on loan to or from the organisation In principle equipment from the medical devices library should never leave Gateshead Health NHS 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. A discharge plan is required for all patients discharged from hospital with a medical device into a continuing care setting. The plan will be prepared in advance by hospital 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. 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. Policy for the Procurement Management and Use of Medical Devices v5 18

19 Electrical Safety Testing This shall be carried out by a technician from the Electronics & 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 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. 6.5 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. Policy for the Procurement Management and Use of Medical Devices v5 19

20 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 re-sterilization processes This may result in:- Inadequate cleaning and decontamination. Material alteration e.g. Corrosion, cracking, Mechanical failure. Cross infection. 6.6 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 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. Policy for the Procurement Management and Use of Medical Devices v5 20

21 7. Training 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 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 self study, any of these identified training strands will form the basis of competency required to perform maintenance work unsupervised. 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 ) 7.1 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 Policy for the Procurement Management and Use of Medical Devices v5 21

22 individual needs and does not discriminate against individuals or groups on any grounds. 9. Process for monitoring compliance with the policy 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 Safe care, Action plans following audit shall be reviewed annually and re-addressed within the following MDMG. Standard / process / issue 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 Incident forms related to 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. 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. Monitoring and audit Method By Committee Frequency Annual Audit Medical devices MDMG Annual clinical risk manager Interrogation of datix Annual Audit Annual Audit Annual Audit Medical devices clinical risk manager Medical devices clinical risk manager/ ward links Medical devices clinical risk manager Medical devices clinical risk manager/ specialist service manager MDMG MDMG MDMG MDMG Annual Annual Annual Annual Annual Audit Path labs MDMG Annual Policy for the Procurement Management and Use of Medical Devices v5 22

23 Standard / process / issue 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 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 Monitoring and audit Method By Committee Frequency Annual Medical devices MDMG/ Annual Report clinical risk safe care manager Annual Audit Safe care / Modern Matrons Safe care weekly Ward managers Infection prevention & control Annual Annual 10. Consultation and review This policy has been reviewed in consultation with Risk management / Compliance & Medical Devices Management Group Membership 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. Policy for the Procurement Management and Use of Medical Devices v5 23