Medical Devices Policy. Policy & Procedures for medical device management

Transcription

1 Policy & Procedures for medical device management Date Approved by Clinical Policy Steering Group Version Issue Date Review Date 03/11/11 Seven January 2013 Procedure/Policy CP0077V.7 Number Procedure/Policy type Clinical Policy January 2014 Executive Lead Executive Director of Finance & Corporate Governance Information Asset Owner Executive Director of Finance & Corporate Governance Author M.J.Cox K. Mansfield Date Equality impact assessment completed: CQC Outcomes: 4,8,11,14, 18,19,21 July 2011 Outcome: Low Clinical Policy Number CP0077.V6 Policy Version: 7 Page 1 of 72

2 Contents Page No. 1. POLICY POLICY INTRODUCTION DEFINITION OF A MEDICAL DEVICE PURPOSE OF THE POLICY AIM POLICY MONITORING SAFETY REQUIREMENTS CONFIDENTIALITY AND SECURITY REQUIREMENTS REPAIR AND MAINTENANCE PROVISION RISK ASSESSMENT PROCESS 9 2. PROCUREMENT OF EQUIPMENT AIM CASE OF NEED EQUIPMENT EVALUATION & SELECTION BUSINESS CASE EQUIPMENT TRIALS ORDERING PROCEDURE BUSINESS CASE SUBMISSION CAPITAL MEDICAL EQUIPMENT SUB-GROUP LEASING, GIFTS, DONATIONS, CHARITABLE FUNDS LOANS AND HIRINGS MEDICAL DEVICE TRAINING DUTIES AND RESPONSIBILITIES PROCESS FOR IDENTIFYING AUTHORISED USERS OF MEDICAL DEVICES PROCESS TO DETERMINE TRAINING REQUIREMENTS FOR USING MEDICAL DEVICES PROCESS TO DETERMINE FREQUENCY OF TRAINING UPDATES TRAINING OF MEDICAL STAFF CONTENTS OF USER TRAINING TECHNICAL TRAINING TRAINING RECORDS NEW DEVICES USER INSTRUCTIONS PROCESS FOR MONITORING COMPLIANCE WITH MEDICAL DEVICE TRAINING OPERATION AND MAINTENANCE ACCEPTANCE CHECKING LICENSING SYSTEM EQUIPMENT REGISTER ACCEPTANCE PROCEDURES FOR MEDICAL DEVICES (SOUTH TYNESIDE ONLY) PROCEDURES FOR REMOVAL OF MEDICAL DEVICES FROM SERVICE DEVELOPMENT, MANUFACTURING AND MODIFICATION OF MEDICAL DEVICES EQUIPMENT MAINTENANCE REPORTING BREAKDOWNS (SOUTH TYNESIDE ONLY) REPORTING BREAKDOWNS (COMMUNITY SERVICES IN THE SUNDERLAND AREA) REPORTING BREAKDOWNS (COMMUNITY SERVICES IN THE GATESHEAD AREA ) 30 Page 2 of 72

3 4.32 EQUIPMENT RETURNED AFTER REPAIR COST LOAN EQUIPMENT EQUIPMENT REPLACEMENT CONDEMNING PROCEDURE INCIDENT REPORTING PROCEDURE TO BE FOLLOWED AFTER AN ADVERSE INCIDENT WITH A MEDICAL DEVICE DISTRIBUTING AND IMPLEMENTING MEDICAL DEVICE ALERTS 37 GLOSSARY APPENDICES 40 APPENDIX 1 POLICY GUIDANCE 41 APPENDIX 2 SAFETY REQUIREMENTS 43 APPENDIX 3 RISK ASSESSMENT PROCESS 44 APPENDIX 4 LIST OF APPROVED DEVICES 46 APPENDIX 5 BUSINESS PROFORMA 48 APPENDIX 6 CAPITAL PROCUREMENT PROCESS 51 APPENDIX 7 REVENUE PROCUREMENT PROCESS 51 APPENDIX 8 INDEMNITY FORM FOR TRIAL OR TESTING 53 APPENDIX 9 PRE-PURCHASE QUESTIONAIRE 55 APPENDIX 10 MEDICAL DEVICE TRAINING MATRIX 58 APPENDIX 11 ANNUAL COMPETENCY RECORD 59 APPENDIX 12 ANNUAL TRAINING RECORD 60 APPENDIX 13 COMPETANCY FORM 61 APPENDIX 14 PROCEDURE FOR DETERMINING MEDICAL DEVICE TRAINING REQUIREMENTS 62 APPENDIX 15 FLOW CHART TO ILLUSTRATE RECORDING OF MEDICAL DEVICE TRAINING ACROSS THE TRUST- 63 APPENDIX 16 EQUIPMENT REGISTER 64 APPENDIX 17 NOTICE OF OBSOLESCENCE 65 APPENDIX 18 DISPOSAL CERTIFICATE 66 APPENDIX 19 INDEMNITY FORM FOR SALE OF EQUIPMENT 68 APPENDIX 20 INDEMNITY FORM EQUIPMENT ON LOAN 69 APPENDIX 21 DECONTAMINATION FORM 70 APPENDIX 22 PROCEDURE TO FOLLOW FOR A DEFECTIVE A MEDICAL DEVICE 71 APPENDIX 23 MEDICAL DEVICE ALERT REPORTING 72 Page 3 of 72

4 DOCUMENT INFORMATION AND AMENDMENT RECORD Document Number: CP0076.V7 Document Title: Status: Issuing Authority: Operational Policy and Procedures Executive Director of Finance & Corporate Governance Date Amendment Details Responsibility Amendment No 20/06/2003 Device modifications In house user Head of BME 01 instructions 17/3/2004 Management of manufacturers Head of BME 02 instructions 20/3/2005 Management of end user Head of BME 03 Instructions 28/11/2005 Integrating Medical Device Training Head of BME 04 policy 28/11/2005 Foundation Trust Titles Head of BME 05 24/05/2007 Inclusion of processes for Medical Head of BME 06 device training including flow charts 24/05/2007 Links and Flow Chart for SAB Head of BME 07 +distribution 24/05/2007 Update to comply with the Trust s Head of BME 08 policy on policies 24/05/2007 Risk assessment procedure Head of BME 09 25/05/2010 Update Medical Device Training Head of BME 10 25/05/2010 Update approved Medical devices Head of BME 11 11/07/2011 Harmonisation with community Policies 04/10/2012 Further harmonisation and merge of templates 29/11/2012 Removal of superceeded maintenance documentation Head of BME 12 Clinical Business 13 Manager Head of BME 14 Page 4 of 72

5 1. POLICY 1.0 Policy Introduction This policy is based upon guidance documents produced by the Department of Health and Medicines and Healthcare products Regulatory Authority (MHRA) and related documents from other government organisations as listed in Appendix 1 South Tyneside NHS Foundation Trust attaches the greatest importance to the safety and care of its patients and considers it essential to provide effective training for its staff in the use of medical devices and safe medical equipment for patient care. The policy refers to the procurement, maintenance, decontamination, record keeping, staff training and competency requirements. 1.1 Definition of a Medical device There is often some confusion over what is regarded as a Medical Device. The European Medical Devices Directive defines a medical device as an Instrument, apparatus, appliance, material or other article, whether used alone or in combination, together with any software necessary for its proper application, which is intended by the manufacturer to be used for the purposes of: diagnosis, prevention, monitoring, treatment or alleviation of disease diagnosis, monitoring, treatment, or alleviation of, or compensation for, an Injury or physical impairment. Investigation, replacement, or modification of the anatomy or of a physiological process Control of conception 1.2 A medical device does not achieve its principle intended action in or on the human body by pharmacological, immunological or metabolic means. 1.3 This definition includes devices intended to administer a medicinal product, such as a syringe driver, or which incorporate a substance defined as a medicinal product, such as a drug-eluting stent. 1.4 This policy document is intended to cover the management of medical devices examples of which are given in table 1 Page 5 of 72

6 Table 1 Function Diagnosis or teatment of disease Monitoring of patients Critical care Improve function and independence of people with physical impairments Community-based healthcare Emergency services Examples Anaesthetic equipment, catheters, diagnostic laboratory equipment, dressings, implants, scanners, surgical instruments, surgical gloves, syringes, X-ray machines ECG, pulse oximeter Baby incubators, blood-gas analysis, defibrillators, ventilators, pressure relief mattresses. Communication aids. Environmental controls, hoists, orthotic and prosthetic appliances, supportive seating and pressure care, walking aids, wheelchairs. Catheters, dressings, domiciliary oxygen therapy systems, glicose tests, pressure care equipment, syringes, urine drainage systems Stretchers, trolleys, resuscitators. 1.5 Purpose of the policy The purpose of this policy is to provide guidance on the management of medical devices within the Trust 1.6 South Tyneside NHS Foundation Trust (the Trust ), as an employer, is fully committed to ensuring the provision and maintenance of a healthy and safe working environment for all staff, patients and any other persons who may be affected by its work activities. To this end, the Trust commits itself to the implementation of the Health and Safety at Work etc. Act 1974 and associated relevant statutory provisions as a minimum acceptable standard. 1.7 The Board of the Trust through its officers, will seek to ensure that statutory requirements are met by the formulation, implementation and development of a Medical Device Policy, together with the setting of objectives and performance standards. Appropriate action will be taken at Senior Management level to underpin this commitment. 1.8 The Trust will endorse appropriate Medical Device Management Standards recognising that a successful Medical Device Management System is one which is integrated with other management activities, with the aim of achieving a progressive and prioritised improvement in Medical Device Management. 1.9 Authorised users of medical Devices at all levels will be provided with appropriate information, instruction, training, supervision and communication systems to ensure the safety of patients under their care. The Trust has a Medical Devices Group which looks at aspects of training from a Trustwide perspective. Provisions will be made in all appropriate budgets for financial and physical resources for medical device management. Page 6 of 72

7 1.10 The Trust recognises its legal responsibility to provide safe and reliable medical devices and equipment for the treatment of our patients. By the provision of information, advice and training of staff, significant risks arising out of the use of medical devices will be identified and measures will be taken to reduce them to the lowest reasonably practical level Systems will be put in place to ensure that the safety implications of any new acquisitions, are assessed as part of the normal planning process. The aim will be to ensure that no member of staff, patient or any other person who could be affected by it s operation is endangered The Trust s Medical Device Policy is regularly reviewed/updated and Published on the Trust s Intranet, Sharepoint and keylink site for all staff to consult Aim. The overall aim is to ensure that whenever a Medical Device is used it : Is suitable for its intended purpose Is properly understood by the Professional User, who has undertaken appropriate training and deemed competent. Is maintained in a safe and reliable condition Has been appropriately assessed, procured and the benefits of standardisation considered This policy will aim to be accessible to everyone regardless of age, disability, gender, race, sexual orientation, religion/belief or any other factor which may result in unfair treatment or inequalities in health / employment Policy Monitoring Elements of this policy will be monitored by a number of established groups within the Trust such as: Risk Management Committee incidents relating to medical devices Capital Medical Equipment Sub-Group purchasing of new equipment Medical Devices Group to review Trust wide training issues Community Medical Devices Management Group STFT infection control committee Training and Development Department 1.16 Safety requirements All medical equipment and devices purchased for use within the South Tyneside NHS Foundation Trust must comply with the relevant safety requirements which are listed in Appendix 2. This should also be in place where South Tyneside Foundation Trust staff are providing services within premises owned by others and is also a stipulation of the Trust's insurers. Page 7 of 72

8 1.17 Single Use Devices All medical devices that are for single use only will NOT be re-used under any circumstances within South Tyneside NHS Foundation Trust Single Patient Use It is essential that medical devices used for single patient use (i.e. may be reused by the same patient) are processed in accordance with the manufacturer s guidelines. Inappropriate processing will result in the warranty for the device/s becoming void. This means that the manufacturer can evade their legal obligations and liabilities associated with damage or injury resulting from the use of such a device. In addition to the above, the use of single patient medical devices within the clinical environment must address the following: Device labelling which clearly identifies the patient/ service user Pre-use checks which ensure that the device is only used by the intended patient. Appropriate and timely device cleaning / replacement in line with agreed recommendations. An example would be certain types of respiratory equipment i.e oxygen masks, ventilator tubing 1.19 Confidentiality and security requirements PC Controlled Diagnostic and Therapeutic equipment :- In todays modern NHS many medical devices including monitoring, diagnostic and therapeutic equipment is either software driven or uses computer software to store the results of patient episodes. Interfaces to databases located on a laptop, PC or network server are now common place. To the untrained eye this equipment looks like a standard PC seen in any office. As part of the safe guards required to protect patient confidentiality and data integrity it is necessary to ensure that only directly related programs are loaded onto the system It will also be necessary to demonstrate that down loaded data/images are available only to authorised users and that modified or unauthorised data/images are prevented from being loaded onto the system A backup of the system software should be taken to ensure the proper restoration of the system files in the event of a system failure. A structured process of backups should be instigated to prevent loss of patient data to a recognised backup media. Both system software and patient data should be stored in a secure area remote from the equipment in accordance with the Trust s IM & T Security Policy. Page 8 of 72

9 1.22 Repair and maintenance provision All medical equipment purchased for use within South Tyneside NHS Foundation Trust must be subjected to a risk assessment during the evaluation phase of procurement. This risk assessment will establish the frequency and nature of the maintenance level required for the device. It is well known within the service that medical equipment in general is very reliable in normal operation with enough safeguards and alarms to prevent harm to patients. So much so that the frequency of maintenance visits can be reduced depending upon how often a device is used and where it is used. For example a device which is in constant use within an acute area such as ITU where staffing levels are such that failure of a device will be spotted very quickly may be considered a low risk. However the same device on a general ward or in a community location which is rarely used or not seen on a regular basis may be considered a high risk and the maintenance level and frequency adjusted accordingly All medical equipment within South Tyneside NHS Foundation Trust will have as a minimum, cover for breakdown maintenance when not already covered by an external service contract. When a device breaks down it will be repaired and (if required), calibrated to manufacturers specifications Planned maintenance levels and frequency will depend upon the level of risk associated with the device in question All life support and high risk devices will be maintained and (if required) calibrated to manufacturers specifications Risk Assessment process The management of risk will be supported by the adoption of a standard system for risk evaluation across the Trust Appendix Once the level of risk associated with the device has been asertained a maintenance plan will be developed to support the device. The risk level will be logged along with the details of the device in the Trust s equipment register. Page 9 of 72

10 2. PROCUREMENT OF EQUIPMENT 2.0 Aim The Trust's procurement procedure will ensure that :- Equipment used on the Trust's behalf complies with the recommended standards particularly those relating to safety. Safe guards are in place to prevent unauthorised downloading, uploading or modification of data in PC controlled medical equipment/systems. Users are aware of the technical and revenue implications of their choice of equipment. A standardisation of common types of equipment is achieved to lessen possible confusion of operation, to facilitate ease of training and equipment availability. The current list of approved equipment is shown in Appendix 4. To keep maintenance and revenue cost to a minimum. Risk to our patients and the Trust are minimised. Compliance with Standiing Financial Instructions and Standing Orders and budget manual. 2.1 Case of need A case of need must be established before proceeding with any Capital equipment selection procedure. To avoid unecessary work being carried out on any formal business case, the Trust standard Business proforma must be completed (Appendix 5) and submitted to the Capital Medical Equipment Sub-Group. This group will prioritise and authorise within the resources available, all purchases up to the financial limits if appropriate (i.e. all purchases up to the group s financial limits -currently 25,000, set by the Trust board for medical equipment). Purchases above this limit will require approval from the Capital Medical Equipment Sub-Group to proceed to the next stage. The capital procurement process is shown in Appendix The next stage requires a thorough business plan preparation for submission to the Executive Board via the Capital Medical Equipment Sub-Group for further approval. 2.3 The following criteria will need to be taken into account at each stage :- Do the devices already exist within the unit, ward, department or service? Is the device a replacement or additional to existing equipment? Does the device appear on the list of Trust approved devices? Is the purchase price less than 5000 including VAT ( i.e. is it a revenue item)? Consider the cost of accessories and comsumables. Consider the cost and provision of Maintenance. Does the device meet the safety requirements for its type? If software driven does it have password protected operating systems or safety lock out? Can the device/equipment be cleaned and decontaminated? Page 10 of 72

11 2.4 Procurement of revenue equipment and devices must go through a similar approval route ( Appendix 7) if department budgets cannot be used for purchase. If Major revenue is required for purchase (e.g. multiple devices which have an individual purchase price of under 5000 inc VAT) then approval must be sort from The Capital Medical Equipment Sub-Group and the Financial Risk Management Group for revenue. 2.5 Equipment Evaluation & selection Selection of new equipment can prove to be difficult with a wide selection of equipment available on the market today. A formal device evaluation should be undertaken as part of the tendering process and users must be involved in this and the specification process. A number of factors need to be taken into account before making a final decision :- The service requirements Can the device be shared with other services Performance Safety and compliance with standards and information updates Electro Magnetic Compatibility Equipment Standardisation Maintenance costs Spare parts availability and cost Training Financial aspects Revenue requirements Cleaning and decontamination Support requirements of other departments Page 11 of 72

12 2.6 Business Case. If the capital equipment or system is above the approval limits of the Capital Equipment Sub-Group or there is a revenue element to the purchase (i.e. Maintenance costs, Staffing, high consumable costs) It will be necessary to prepare a Business Case for consideration at Executive Board level which must be submitted via the Capital Medical Equipment Sub-Group first. The detail of the case will depend upon the impact on service provision, the proposed clinical procedure, complexity of the device and its cost. When drawing up such a case you must consider the following points:- 2.7 Clinical requirements. Does the device augment existing clinical practices? Anticipated benefit to patient care. Anticipated impact on service i.e increased capacity, reduced waiting times. Does it introduce new procedures and techniques?, if so are they approved and safe? 2.8 Installation. Does the device require services not already available? Are further safety measures required? ie laser regulations, C.O.S.H.H etc. 2.9 Staffing. Are additional staff required to operate or carry out this service? Is additional staff training required? 2.10 Consumables. Does the device use additional consumables? Are they supplier specific or are they readily available from other sources. What is the annual consumable cost? 2.11 Maintenance. How do you intend to maintain the device? What level of cover do you require, including response time in the event of a breakdown. Are spare parts readily available? If you intend to have the device maintained "in house" have you spoken to the relevent Head of maintenance provision at either of the three Foundation Trusts (Gateshead, Sunderland or South tyneside) to see if they have the necessary resources to undertake the task? Does the device require calibrating at regular intervals and is special equipment required for this function? Does the device require the support of departments other than (EBME) Page 12 of 72

13 2.12 Service manual. Is a full service manual available, complete with circuit diagrams and set up procedures, to allow Trust staff to repair and maintain the equipment in the event of the supplier going into liquidation? Such service manuals will require to be included in the purchase. Provision must also be made for manufacturers technical updates to be sent to the Bio-Medical Engineering department and this should be stipulated in the purchase specification Training. Identification of authorised users Training of end users to be included in the purchase. Training of support staff ( i.e maintenance, cleaning) to be included in the purchase Cleaning and decontamination. Can the equipment be easily cleaned and decontaminated in accordance with the Trust s cleaning and decontamination policies? Are specialist cleaning products required? Who will be responsible for cleaning and decontamination? Where will cleaning & decontamination take place? 2.15 Equipment trials. It is strongly recommended that a Business case is approved prior to the commencement of device trials by various suppliers. Such trials must be carried out on the suppliers indemnity, a list of companies signed to the NHS Master Indemnity list is available from the Supplies Department on the District Hospital site. If the supplier is not listed then they must be directed to the BME department to complete an indemnity form before such trials can continue (Appendix 8) Such questions as maintenance, consumables, training and compliance to safety standards etc can be conveniently raised at this point. Agreements on cost must be coordinated by the Supplies & Procurement Department Before such trials are carried out the equipment/device must be logged onto the equipment loan register which is held by the BME Department, to ensure it is traceable, is suitable for its intended purpose and that an electrical safety check is carried out. Any equipment/device evaluation which is conducted as part of a capital programme must be organised and conducted via the procurement department as part of the tender process. This process requires a technical specification and an evaluation document to be completed and included in the tender documentation submitted to the vendors. The evaluation form must be used throughout the trial to score the equipment or device against each section of the specification and returned to the procurement department after the trial. Page 13 of 72

14 2.18 Equipment/device trials conducted as one off evaluation to gain knowledge of new devices and procedures prior to any procurement programme must also be logged onto the equipment loan register which is held by the BME Department, to ensure it is traceable, is suitable for its intended purpose and that an electrical safety check is carried out where required. On acceptance the equipment will be given a unique reference number which will also be used on the Equipment Evaluation Form. The number will be of the format:- EV year.sequential number e.g. EV EV Equipment evaluation. 00 year separator. 009 ninth item of equipment evaluated so far Ordering procedure. To order equipment that meets the requirements of the capital sub group (i.e. equipment that falls within the financial limits of the capital subgroup under 25,000) or is regarded as revenue equipment (i.e. costing less than 5000 inclusive of VAT) and authorised in accordance with the Trust scheme of delegation. Mark requisition "requires BME acceptance check". Submit to the Supplies department for purchase Business Case submission After completion of your business case, approval and/or discussion should be sort from your Director/Business Manager. It is at this point where it would be advantageous to discuss in greater detail the issues of clinical requirements, revenue costs (in particular maintenance and training) Once the plan is approved by the Director/Business Manager it will be forwarded to the Capital Medical Equipment Sub-Group for submission to the Executive Board at it s next sitting Capital Medical Equipment Sub-Group The Capital Medical Equipment Sub-Group will call upon a number of facilities available to them such as advice from BME, supplies and other departments to enable the Trust to gain the greatest benefit in terms of value for money and service Checks will be made to verify that the equipment is supportable and that break down and maintenance cover is available The manufacturer or supplier will be required to state in writing that the equipment complies with the relevant safety requirements. (This is on form PPQ Appendix 9) Page 14 of 72

15 2.25 Leasing, Gifts, Donations, Charitable Funds Equipment which is leased, donated, presented as a gift must still meet the requirements of the general conditions. It must undergo Acceptance Testing and be logged on to the Trust s Equipment Register, be maintained and/or calibrated according to the general conditions explained earlier Equipment purchased through charitable funds should satisfy the same product selection criteria as any other device. Procurement of this equipment should follow the Trust procurement process and be authorised by the same groups which authorise Trust funding of new and replacement equipment. The ongoing revenue required to run the equipment needs to be taken into consideration before procurement starts ( i.e maintenance, consumables etc) Loans and Hirings Equipment which is on loan or hired from an organization other than South Tyneside NHS Foundation Trust must still meet the requirements of the general conditions. It must undergo Acceptance Testing and be logged on to the Trust s Equipment Loan Register, be maintained and/or calibrated by that organisation unless a service level agreement is in place to provide this service in house. Page 15 of 72

16 3. MEDICAL DEVICE TRAINING 3.0 In the course of their duties the majority of clinical staff need to use medical devices in all hospital areas, hospices, health centres, clinics and home based care settings. Clinical staff includes Doctors, Nurses, Midwives, Health Visitors and Allied Health Professionals (AHP s). This also includes temporary, locum, students and agency staff working within the Trust. In recognition of the recommendations for good practice relating to medical devices, STNHSFT aims to ensure that staff who use medical devices are trained to do so safely and effectively. The Medical Devices Group provides advice and direction on appropriate training programmes for a range of medical devices and monitor adverse incidents/near misses in relation to training issues. This has representation from Nursing, Midwifery, Biomedical Engineering, Health & Safety, Infection Control and Medical and Non medical Education & Training. 3.1 The aim is to support safe practice and not constrain autonmous practioners. Clinical judgement should be exercised at all times and as such clinical need/emergency situations may overide policy. However if any practice falls out with the policy, it must be logged as an incident in line with the Trust risk management policy. 3.2 There is a wealth of information supporting the view that the misuse of medical devices results in many adverse patient incidents. In order to minimise error and improve patient safety the Trust requires that all staff using medical devices undertake specified relevant training. Any staff member who has not received training or demonstrated competence in the use of a medical device should not be allowed to operate the device. 3.3 Duties and responsibilities The Head of Biomedical Engineering is responsible for ensuring that the Trust inventory of Medical devices is kept up to date and that Business and departmental managers can access this information. 3.4 The Medical Device Co-ordinator and nominated community staff are responsible for co-ordinating and delivering refresher training on a quarterly basis on generic medical devices for those staff requiring updates. The duties will also include: Co-ordinating training programmes to support the introduction of new devices into the Trust as required. Supporting the development, updating and standardisation of medical device competency based training materials used within the Trust as required. Responsiblity for the monitoring of the training section of the medical devices policy within thetrust. All identified trainers will attend refresher/update training annually for the devices they deliver training for. Page 16 of 72

17 3.5 All clinical staff are accountable for ensuring that they use medical devices safely. Equally, the Trust must ensure that staff can access training. It is the responsibility of Matrons and Heads of Services to ensure that ward, departmental or service Managers maintain a medical devices list for their area and indentify which staff are authorised to use these devices. The Trust expects that all clinical staff comply with the following: They must not use any piece of equipment unless they and their immediate supervisor are confident they are competent in its use They must attend relevant training specified by the Trust Staff who have not successfully completed their training / been signed as competent may only use medical devices under supervision Staff must identify training needs with their line manager, and this should be formally reviewed annually as part of the Trust s appraisal process Staff must use only those disposables / accessories that have been recommended by the manufacturer Staff must ensure they comply with infection control standards when using medical devices. 3.6 Process for identifying authorised users of medical devices. It is the responsibility of the ward, departmental or service managers to ensure that their staff are appropriately trained, safe and competent in the use of medical devices and this is appropriately recorded within the department/service. They will also ensure that the medical devices file incorporating staff training is available for inspection. This file will include a list of devices that each staff member is authorised to use and the staff training record associated with each device. This training record within the hospital environment should be copied to the Learning and Development department for inclusion into the Central Oricle Learning Management system OLM training database. In due course this system will be extended to cover community based staff. Within the community setting an annual integrated audit is carried out to support monitoring of compliance with the policy. 3.7 The learning and development department will: Centrally record all medical device training registers forwarded to them from hospital staff via the Oracle Learning Management training database to assist in monitoring the delivery of training. Support an organisational wide awareness raising programme relating to the safe use of medical devices. 3.8 Process to determine Training requirements for using medical devices All staff beginning employment with the Trust must complete Corporate Induction Training. Medical device awareness training is part of this programme. This session provides generic information including user responsibilities, reporting procedures, signposting etc. 3.9 Training needs require initial assessment at local induction and on an ongoing basis. Training may involve demonstration, discussion and / or formal updates. Page 17 of 72

18 The Trust has developed competency-training template (refer to appendix medical devices, to ensure training is provided in a consistent way. ) for 3.10 Individual training needs should be assessed annually through the appropriate appraisal system Recognised training Recognised training can be accessed via the following sources; Mandatory training and updates organised by the Learning & Development Department and the Education Centre. Biomedical Engineering Manufacturer/supplier led through the quarterly medical device training days held at South Tyneside District hospital. E-learning Medical Device Co-ordinator Any member of staff that the Trust has deemed as competent trainers e.g. Consultants and Senior Medical Staff, Specialist Nurses/Practitioners, AHPs. Standards for practice workbooks 3.12 Medical devices in general use: User training for all medical devices in general use will be delivered initially by the manufacturer where possible, the Medical device Co-ordinator and also by appropriately trained staff attached to each disipline. The Biomedical Engineering department will support this training when required Induction and refresher training will be delivered on a quarterly basis for both new staff and those who require updates. This will be delivered initially by the manufacturer with the support from the Medical Device Co-ordinator. Decontamination and cleaning of devices will be included in the training programme. Further training will be delivered at departmental level by appropriately trained staff Medical Devices used in Specialist areas: User training for devices intended to be used in specific areas such as critical care, coronary care, radiology, main operating theatres, etc will be delivered within the department by the supplier. This includes induction and refresher training. The Biomedical Engineering department will support this training when required Community based Devices It is acknowledged that there are unique risks using devices in the community such as those presented by lone working. To reduce these risks the level of training required is linked to the risk matrix for each medical device. Specialist training is required for equipment classified as high risk and all staff must attend specialist training and undergo a competency based assessment which is signed off by a competent user. Page 18 of 72

19 3.16 Process to determine Frequency of Training Updates Competency will be deemed to require reassessment when: The member of staff identifies that they have not used the medical device for a period of six months or longer. Changes in clinical practice indicates that reassessment is necessary Following the reporting of an adverse incident relating to a medical device where a training need is identified. There is an an agreed timescale (maximum of three years) for reassessment for a specific piece of equipment e.g.patient controlled analgesia machines Training of Medical Staff All medical staff require training in the use of defibrillators. There is a stratified approach to medical staff training when using medical devices. Foundation Trainees (F1 and F2 level trainees) It is acknowledged that junior doctors rotating to different clinical areas may require training on medical devices that are specialty specific and therefore training will be delivered either as part of departmental (local) induction or by the supervising consultant on the department on which the trainee is working. There are also sessions within the Foundation Programme Professional Learning Programme which focus on clinical practice, but include the correct use of medical devices, e.g. urinary catheterisation, central line insertion. There are 15 directly observed procedures, which involve the correct use of medical devices. These are mandatory assessments for all F1 trainees to complete during their first 12 months of training. These are formally assessed and recorded in their training e portfolio, which is assessed by an external ARCP panel to ensure all trainees meet these competencies. Training needs analysis is undertaken in line with the agreed national curriculum and any Trust based training is recorded on ESR by the Learning & Development team. Specialty Trainees (Junior doctors above foundation level) Junior doctors on rotation with the Trust on specialty training programmes, including general practice, receive training on the appropriate medical devices for the speciality. This should be delivered during their mandatory induction programme and recorded on ESR by the Learning & Development team. Access to Medical device training for generic equipment is available and organised on a quarterly basis by the Training & Development Centre. This is monitored by the Education Centre team as part of the Induction audit process. Any other medical device training needs are identified for each individual through discussion with the relevant Clinical and/or Educational Supervisor at the start of Page 19 of 72

20 each rotation and are recorded in the trainee s Eportfolio to ensure that the trainee is able to meet the requirements of their curriculum. Progress and the achievement of competencies is monitored via regular meetings with the Educational Supervisor (a minimum of 3 per rotation, at the start, in the middle and at the end). Senior Medical Staff (Consultants, Specialty Doctors) This group of medical staff receive training on use of defibrillators as part of the annual update for senior medical staff. As and when new equipment is purchased for use by senior medical staff, training is delivered by the supplier and details are recorded on ESR by the Learning & Development Team. This takes the form of demonstration, practical training and supervision in the clinical environment Contents of user training All medical device training as a minimum will contain the following elements: The main applications of the device Approved consumables to be used with the device Correct operating procedures and monitoring performance Completion of appropriate documentation Cleaning pre and post use according to Manufacturer Instructions and Trust policies Storing and charging in accordance with Manufacturer instructions Incident reporting procedure Routine maintenance checks required Procedure for returning malfunctioning devices to the Biomedical Engineering Department for repair NHS Training for Innovation (TFI) is a resource for developing evidence based training curricula in the safe use of advanced medical devices with an objective of promoting standardisation of training and skills assessment. The Trust promotes the use of the criteria produced by TFI in the development of training materials to ensure the safe and efficient use of medical devices. Further details can be obtained from Technical Training Technical training for all biomedical engineers, MLSO s, AHP s and physiological measurment technicians for life support and high risk medical devices must be delivered by the manufacturer. All training for other devices can be delivered by the manufacturer or via. the train a trainer route. It is intended to develop, in time, competency based training for all technical staff Training Records There is a robust risk management system within STNHSFT that requires all training records to be held centrally. All medical device training records for both users and technical staff should be copied to the Learning & Development department for inclusion in the central Oricle Learning Management system OLM training database. It is the ward, departmental or service managers responsibility, with the support of the Medical Device Co-ordinator and nominated staff in the Page 20 of 72

21 community to ensure that the departmental training plans, materials and records for medical devices are kept up to date. In the acute areas all training needs identified through the appraisal system should be recorded and passed on to the training and development department. Competency records and annual training records should be recorded using the forms in appendix 11 and 12 and 13. At present this information is held by service leads for all community teams with monitoring systems in place New Devices The ward, department or service manager must ensure they are in receipt of the equipment paper based manual or able to access the electronic user manual when accepting the equipment. They should ensure that all users of new equipment are identified and receive appropriate training, preferably by the manufacturer, before it is put into use (see appendix 10). This training must be delivered by the methods outlined above and shown in Appendix 14. Provision should also be made for documentation of such training to be recorded with the training & development department Appendix User Instructions All users need access to the original manufacturers instructions both for reference purposes and to ensure that the device is operated properly and safely at all times. These instructions should be kept up to date by both the purchasing department and the head of biomedical engineering. In order to manage this process and to ensure that only one version of the device instructions are always available, new device manuals should be placed onto the Medical devices page of the Trust s intranet or keylink/sharepoint End Users On occasion, patients and their families (i.e. end users) may need to be trained to use a specific device as part of a clinical management plan for the patient. This must be provided to suit the individual needs and requirements and verbal instructions must be complemented by clear written instructions. The end user should also be provided with contact details for where further advice and help can be sought, particularly in an emergency Process for Monitoring compliance with medical device training Compliance with the policy on medical device training will be monitored by the Medical devices Group which meets on a six weekly basis. A programme of audit is in place to monitor compliance with medical device training at departmental level including an annual integrated audit across all clinical services. The Medical device group will review incidents relating to medical devices under their remit on an ongoing basis to identify and address any training issues. Page 21 of 72

22 4.0 Roles and responsibilities 4. OPERATION AND MAINTENANCE 4.1 It is the ward, department or service manager s responsibility to ensure that all equipment is maintained and checked for electrical safety on a regular basis. The Head of BME will lend assistance in either providing this service by the in house" team or by a service contractor. The in house provision and monitoring of medical device maintenance and a systematic medical device inventory is the responsibility of the Head of BME who reports to the Executive Director of Finance & Corporate Governance. 4.2 Acceptance checking On arrival new equipment and devices are acceptance checked by the BME department to the guide lines laid down by the MDA s supplement DB2006 (5) November Providing the equipment passes the specified test criteria, and the manufacturer s performance test, the equipment is licensed for use within the Trust and logged onto the equipment register. The Biomedical engineer will attach a label with a unique equipment number and barcode to the device. A green licence label will also be attached at this time. This will indicate to the end user that the device has passed through the acceptance check procedure. 4.3 Licensing System The licensing system will allow a device to be used over a specific period before it requires an inspection. This inspection may be a visual check, performance check or a routine service visit. In previous systems there was a requirement on the part of the maintainer, patient or user of a device to ensure that the routine checks are performed on a specific date. The licensing system is intended to allow some flexibility in periodic inspections in that when the renewal date is reached the device is inspected at the next convienient time arranged between the user and the maintainer. The device however can still be used until the inspection is carried out. 4.4 Equipment register The BME department operates a computerised equipment register for all medical equipment within South Tyneside NHS Foundation Trust. Sunderland and Gateshead community equipment registers are held and maintained by the local Foundation Trust (Sunderland and Gateshead FT) in accordance with a Service Level Agreement agreed between each FT and South Tyneside NHS Foundation Trust. 4.5 Each item of equipment is given a white label containing a unique registration number, called the Equipment Number and is designated the format : ******** BARCODE ie This allows the Equipment register system to log information such as location, owner, purchasing details, maintenance schedules, breakdown records and general equipment history. Page 22 of 72

23 4.6 A sample page from the equipment register is shown in Appendix 16 sorted by model number. 4.7 Maintaining this database is the responsibility of the relevent BME department who will continue to update device information on a regular basis. Information contained on this data base is readily available to managers and hard copies can be obtained by contacting the Head of the relevent BME department. 4.8 Acceptance Procedures for medical devices (South Tyneside only) Receiving New Equipment Prime Responsibility: Biomedical Engineer 1. New equipment is to be referred to the Biomedical Engineering Department on receipt. A Biomedical Engineer will check whether the equipment is to be maintained by Biomedical Engineering or elsewhere within the Trust. This process will be carried out in the reception area of central stores. According to this decision, and any appropriate liaison, the equipment may be referred elsewhere for receipt and inspection. Otherwise the receipt and inspection may be delegated to other Engineers within Biomedical Engineering. 2. The inspection required is limited to outer packaging. Discretion should be used as to whether damage should be reported to the supplier. The severity and any equipment damage should be considered before the supplier is contacted. 3. The Biomedical Engineer assigned to the delivery will obtain the necessary paperwork to assertain the destination of the equipment. 4.9 Commissioning New Equipment Prime Responsibility: Biomedical Engineer 1. For new equipment the Biomedical Engineer will carry out acceptance checks and inventory registration. This will include a power up to ensure all controls lamps and indicators are working, and that nothing gives any cause for alarm, e.g. smells, odours, smoke, etc. Corrective action would be taken as necessary, depending on what is found during the tests. 2. The Biomedical Engineer will also ensure that all documents are present for the equipment, including manuals etc. 3. After completion of all tests and registration the Biomedical Engineer will issue a licence for eighteen months using a green label. The equipment must now be logged onto the Electro-medical equipment (EMS) database. Page 23 of 72

24 4.10 Commissioning Trial or Loaned Equipment Prime Responsibility: Biomedical Engineer 1. On notification of equipment for trial or loan, the Head of Biomedical Engineering will ensure the supplier of the equipment either provides an IFA number or signs an indemnity form (appendix 8) indicating the period of the trial or loan. 2. For trial or loaned equipment the Biomedical Engineer will carry out acceptance checks and inventory registration. If the supplier is not known, or the equipment is unusual consult with the Head of Biomedical Engineering to determine if full safety checks are required. This will include a power up to ensure all controls lamps and indicators are working, and that nothing gives any cause for concern, e.g. smells, rattles, odours, smoke, etc. Corrective action will be taken as necessary, depending on what is found during the tests. 3. The Biomedical Engineer will also ensure that all documents are present for the equipment including manuals etc. 4. After completion of all tests and registration the Biomedical Engineer will issue a licence for the loan period using a blue label. The equipment must now be entered on to the database as an evalution Used Unlicensed Equipment Page 24 of 72

25 Prime Responsibility: Biomedical Engineer 1. The Biomedical Engineer assigned to receive the equipment will endevour to trace the owner. It may not belong to the Trust and some investigation may be involved in identifying the owner, who may not be the current user. 2. In identifying the equipment owner the biomedical engineer needs to establish at least the following points: Who is going to accept financial responsibility for maintenance? Check if the equipment is fully supported by the manufacturer? 3. If there is any doubt refer to the Head of Biomedical Engineering. 4. If the equipment cannot be maintained the Biomedical Engineer should issue an Advance Notice of Obsolescence and follow the Obsolescence & Withdrawal of Support procedure below. 5. If the equipment is to be maintained a full electrical/mechanical safety test should be carried out together with a generic planned maintenance schedule. The equipment may then be licensed for eighteen months or less using the green label Planned Maintenance Arrangements Prime Responsibility: Head of Biomedical Engineering 1. Once equipment has been satisfactorily commissioned, the Head of Biomedical Engineering will evaluate the management of the maintenance requirements for the equipment. This will involve using the medical equipment risk assessment and experience gained over time to prioritise the maintenance requirements and the comparison of maintenance costs. 2. This evaluation will be used in considering the current workload, expertise, and other resource requirements in determining whether an outside company should be used for repair and/or maintenance. 3. If this is the case, tenders will be drawn up and distributed to potential suppliers for their response. These suppliers may include some who are already providing repair and/or maintenance services. 4. An appropriate supplier will be selected and their details entered on the database if necessary along with the equipment they are to repair and/or maintain. This now follows the priority level and requirements identified during the risk assessment evaluation. 5. The device placed on external contract will have a yellow contract maintenance label attached which will display the contract number to be used in all communications involving the maintenance provider or the BME department Procedures for removal of Medical Devices from service Obsolescence & Withdrawal of Support Page 25 of 72

26 Prime Responsibility: Head of Biomedical Engineering Formal notification of obsolescence or withdrawal of support may not be received from the manufacturers. Notification may be received from any source (i.e. during conversation when requesting parts or repair) that a certain type of equipment is no longer maintained or serviced by the manufacturer. Also spares parts may no longer be available rendering the equipment obsolete. 1. When it is known that an item of equipment is obsolete or support has been withdrawn, the Biomedical Engineer will update the database for all those items. 2. The Head of Biomedical Engineering will check which equipment is at immediate risk due to the notice of obsolescence and take action according to the situation which could be to wait for the next planned maintenance visit or to immediately issue an advance notice of obsolescence (appendix 17). 3. When an item of equipment which no longer has support is noticed at planned maintenance or repair. The Head of Biomedical Engineering or the Engineering Manager will complete an advance notice of obsolescence of medical equipment. 4. If the equipment is still serviceable and in full working order then the Biomedical Engineer will license the equipment for up to one year only using a green label. On returning the equipment to the team, unit, ward or department, obtain the signature of the ward, departmental or service manager on the advanced notice. Leave them with a copy and return a copy to the Head of Biomedical Engineering or the Engineering Manager Process for decommissioning of equipment by Biomedical Engineering Prime Responsibility: Head of Biomedical Engineering at South Tyneside NHS Foundation Trust 1. In all cases if there is any risk of the device being contaminated, decontamination must be carried out prior to any other action in accordance with the Trust s Infection Control Guidance for Cleaning & Decontamination of reusable Medical devices & Non Medical Devices. 2. If during repair or planned maintenance the biomedical engineer finds an item to be beyond economical repair, unsafe to use, etc. the item should retained in the service workshop. A defective equipment label must be attached. 3. The biomedical engineer should make an assessment of the item of equipment and Trust Form FPN15 should be completed and passed to the Head of Biomedical engineering (Appendix 18). 4. Medical devices have a finite life which in some instances is set as part of a capital or revenue replacement programe. On other occasions the ward, departmental or service manager may decide that the device is in need of replacement for other reasons. The accepted reasons for replacement are: Electrically unsafe Page 26 of 72

27 Mechanically unsafe Beyond economic repair Unreliable Clinically or technically obsolete More cost effective devices available Spare parts no longer available The ward, departmental or service manager must complete section A of the Trust disposal form FPN15 (15) and pass this onto the Head of Biomedical Engineering. 5. On receipt of a completed disposal form FPN15, the Head of Biomedical Engineering will take actions according to instructions that are noted on the form. If the item is considered to be suitable for decommissioning then the form will be passed onto the supplies manager. 6. The Database inventory should now be updated. 7. Where appropriate the equipment can be disassembled and serviceable parts can be salvaged. They will then be either labelled or bagged and labelled with reference to the machine, equipment or manufacturer they came from. 8. Unusable equipment or parts should be disposed of by the supplies department who will arrange collection. Care must be taken to do this following the Trust's waste disposal policy. 9. If the item of equipment is considered to be suitable for sale or transfer to another organisation then a sale of goods indemnity form will need to be completed (Appendix 19) by the buyer or receiver of the equipment Development, manufacturing and modification of medical devices The in-house design, development and manufacture of medical devices must comply with current Medical Devices Regulations and MHRA Directive Bulletin 18a before being accepted into service. Special care should be taken to ensure adequate documentation such as user and service manuals are produced and relevant information such as who holds circuit diagrams and computer programmes, where relevant. The manufacture, design and clinical evaluation stages should be of an equivalent standard to those required by the regulations. No authorisation should be given for the use or sale of these devices outside the control of South Tyneside NHS Foundation Trust The modification of existing medical devices, or using them for purposes not intended by the manufacturer is forbidden unless such modifications have been santioned by the manufacturer as a legitimate product upgrade actioned as a result of a safety notice. Such modifications should only be performed by a competent person If user instructions are developed in house for existing devices to augment the manufacturers literature then they should be suitable for both end users and their carers. Any disability or medical condition of the user should be taken into Page 27 of 72

28 account. These instructions should be produced in accordance with the guidelines developed from the MDA document DB 2006(5) Equipment maintenance A formal system is essential to ensure that the equipment functions safely and accurately throughout its life. Such a system will provide for :- Day to day maintenance by the user. Performance / preventative maintenance. Breakdown maintenance Day to day maintenance. The user will carry this out on a routine basis in accordance with the training or instructions given by the manufacturer or supplied in the user manual Performance / preventative maintenance. This may be achieved by:- External Service contractor Other NHS Service contractor (Sunderland FT or Gateshead FT). BME department 4.21 Service contractor (External to NHS). If requested by the ward, departmental or service managers or if the Head of Biomedical Engineering does not have the resources to maintain the equipment "in house", a service contract will be raised, for the equipment to be serviced. In consultation with the supplies manager the Head of BME will agree :- Type of contract required. ie comprehensive, preventative or breakdown. The Contractor. Number of visits required The Head of Biomedical Engineering will agree to :- Raise the contract via the supplies department. Monitor the contract. Enter job details onto the computerised record system. Authorise completion of work carried out. File copies of the service report 4.23 The ward, departmental or service managers will agree to :- Liaise with the contractor to make the equipment available for servicing. Supply the Head of BME with a copy of the service report for device history records. Page 28 of 72

29 Note Service contracts are costed to the user departments cost centre. They are not funded from the BME department. It is the Business manager or Head of Department / service responsibility to secure funding for all service contracts Bio-Medical Engineering (BME) department. All equipment not covered by service contract and logged onto the equipment register will be maintained by the BME department in accordance with the general conditions. Small items of equipment will be inspected to cover the Trust under the Electricity at Work Regulations In house maintenance schedules are produced by a computerised maintenance system, should managers require a copy of the schedule for their sphere of influence this is available from the Head of BME. The service is provided on the following conditions:- Life support and other critical equipment will be given priority. Equipment breakdown has over riding preference over maintenance. Equipment is made available for service Service Level Agreements with other NHS Providers: Maintenance provision for medical devices and equipment for the Trust s community service within Sunderland and Gateshead is covered by a Service Level Agreement with the individual EBME departments at City Hospitals Sunderland NHS Foundation Trust and Gatehead Health NHS Foundation Trust. These departments will provide a similar service to South Tyneside NHS Foundation Trust for the medical devices in their respective areas Maintenance provision for medical devices and equipment that are the property of the NHS South of Tyne and Wear Commissioning arm will be covered by a Service Level Agreement between South Tyneside NHS Foundation Trust Biomedical Engineering Department and the NHS South of Tyne & Wear Estates Department for medical devices within South Tyneside. Similar arrangements are in place with Sunderland Foundation Trust and Gateshead Foundation Trust for their respective areas Breakdown maintenance: Breakdown maintenance will receive preference over other maintenance, priority will be given to critical care areas. Page 29 of 72

30 4.29 Reporting Breakdowns (South Tyneside only) Please telephone the BME Department. Electromedical equipment (answer machine for out of hours) Anaesthetic / ventilators / gas driven equipment Emergency out of hours service (engineer on call 24/7Hospital only) 0 Electromedical equipment (answer machine for out of hours) Supply the following information: Location Equipment's Registration number ie Nature of fault (not working properly is not very helpful) When the equipment is available for pickup. Please ensure the equipment is clean and decontaminated if applicable and has a signed completed cleaning/decontamination form if required. The documentation is currently under review and may change in the near future. (Please see policy document and MHRA SN 9516 July 1995 an engineer may refuse to repair an item of equipment unless this criteria is met) Reporting Breakdowns (Community Services in the Sunderland area) Please telephone the Medical Electronics Department in City Hospitals Sunderland NHS Foundation Trust. Electromedical equipment (answer machine for out of hours) Reporting Breakdowns (Community Services in the Gateshead area ) Please telephone the Electronics & Medical Engineering Department at Gateshead Health NHS Foundation Trust. Electromedical equipment (answer machine for out of hours) Equipment returned after repair Equipment will usually be returned to the department which has ownership according to the asset register. If the equipment has been loaned from another department and you wish it be returned to you, you must inform the engineer. The equipment will be returned with a stick on label. This notifies the user that the equipment has been repaired and that function checks may be required as dial readings will have been altered. It also quotes a job number. This is the number you should quote to the Head of BME in case of query. Page 30 of 72

31 4.33 Cost "In house" labour costs to the user are free of charge, spare parts are free of charge if revenue has been provided for maintenance at the point of purchase otherwise they will be charged to the user department cost centre. Accessories (i.e ECG leads and electrodes, Pulse oximeter probes, etc) are not covered by inhouse or contract maintenance service Labour costs and cost of spare parts in the Sunderland and Gateshead community areas are covered by a Service Level Agreement Loan equipment Loan equipment has two main categories, they are:- Equipment borrowed from another organisation or Trust. Equipment loaned to other users, Trusts or organisations Equipment borrowed from another NHS organisation or Trust Managers of all teams, units, wards, and departments within the Trust are responsible for ensuring that all equipment borrowed for their area of responsibility is fully maintained and fit for purpose. They are also responsible for ensuring that all staff, required to use or operate this equipment are trained in its use, care and maintenance. Equipment should not be borrowed unless it is fit for purpose, regularly maintained and that the manager concerned is confident that those using it are trained to do so Accurate records of any loans from other NHS Organisations/Trusts are essential, these must include:- Trust name, address, telephone number and Equipment number Details of Trust Biomedical Engineering Department taking responsibility for the equipment to include name and telephone number of Engineer. A signed decontamination form if required provided by the loan organisation Services provided by external agencies/trusts/primary care centres: Services provided by external agencies/trusts/primary care centres that includes equipment as part of our patients on going care needs or in an emergency when extra capacity is required will also cover the maintenance and calibration of such devices. This currently affects ITU, ward 10, community and SCBU and involves renal dialysis equipment, EEG equipment, ventilators, etc Special arrangements exist with Sunderland Royal Hospital who provide an EEG and Renal dialysis service to South Tyneside NHS Foundation Trust. This equipment is operated by technicians and nursing staff from Sunderland. The responsibility for device safety lies with Sunderland Medical Electronics Department. Page 31 of 72

32 4.40 Equipment borrowed from outside Agencies/Organisation. Accurate records of any loans from outside Agencies are essential, these must include:- Agency name, address, telephone number and Equipment loan registration number Details of agency taking responsibility for the equipment to include name and telephone number of agency s local representative or engineer. An indemnity/loan form must be signed by the outside agency taking responsibility for the equipment and the person in charge of the team, unit, ward or department or the Head of Bio-Medical Engineering. Instruction manuals should be included and should cover equipment care, maintenance and availability of disposable supplies essential to the equipment operation. On delivery, the equipment must undergo Acceptance Testing and be logged on to the the Trust s Equipment Loan Register, before it is commissioned and/or calibrated to the manufacturer s specification. At this point a blue Licence label will be attached signifying that the device is on loan to the Trust for the period of the licence. A signed decontamination form if required which is located on the Trust intranet, on the medical devices page Heads of service/matrons must ensure they are in receipt of the equipment user manual when accepting the equipment. They should ensure that that all users of the equipment receive appropriate training, preferably by the manufacturer, on equipment before it is put into use. Provision should also be made for documentation of such training to be recorded. The equipment will be maintained and/or calibrated by the outside agency/organisation unless arrangments have been made through a service level agreement to provide this service in house Service level agreements are in place for equipment borrowed from community equipment stores i.e The STAR centre in South Tyneside run by the local authority, Central Equipment Store in Sunderland a joint venture between the Trust and the local authority and the Gateshead Equipment Store in the team valley funded by the local authority/pct commissioners and delivered by Trust staff. They are responsible for the maintenance and cleaning of equipment held in their stores The equipment loaned to the team, unit, ward or department should be made available for maintenance or exchange when requested by the outside agency/organisation Equipment on loan to other users Heads of Service/Matrons within the Trust are responsible for ensuring that all equipment allocated to the area of their responsibility is fully maintained and fit for use. They are also responsible for ensuring that all staff, patients, and carers required to use or operate this equipment are trained in its use, care and maintenance. Equipment should not be loaned unless it is fit for use, regularly maintained and that the manager concerned is confident that those using it are trained to do so. Page 32 of 72

33 4.45 Internal loans. When a medical device is loaned out it is the responsibility of the Service or Departmental Manager to check over the device with the borrower and to ensure that they have been trained, are competent to use the equipment and are aware of the maintenance/care requirements whilst in their possession. A record must be kept by the team, unit, ward or department loaning the device and the borrower must sign this record that he/she takes the responsibility for the device whilst on loan The Service or Departmental manager is responsible for ensuring that the device is recalled for routine maintenance/servicing whilst out on loan Loan Procedures for Patients/Carers. Certain specialist equipment is provided by the specialist unit, ward or department responsible for prescribing the ongoing treatment. This currently affects community services, The ARAS team, Cardiography and Pulmonary function department, Ward 12, SCBU and Outpatients and involves equipment such as ambulatory Blood Pressure and ECG recorders, Enuresis Alarms, Apnoea Alarms, Nebulizer Compressors, Infusion Devices, Syringe Drivers and Oxygen Saturation Monitors It is the responsibility of the Service or Departmental manager to ensure that the device on loan is returned for maintenance at regular intervals Accurate records of any loans to outside agencies/patients/carers are essential, these must include:- Individual s name, address, telephone number and Trust Equipment Number Details of carer/agency taking responsibility for the equipment on the patients behalf to include name, address, telephone number. An indemnity/loan form (Appendix 20) must be signed by the patient or carer/agency taking responsibility for the equipment, following instruction from the person in charge of the service, ward or department. Instruction should be both verbal and written to include, how to use the equipment, care and user maintenance, how to clean and decontaminate equipment during use and prior to return, availability of disposable supplies essential to the equipment. These instructions should be evaluated for their adequacy by the service or departmental manager or a representative of the manufacturer. A signed decontamination form (appendix 21) should be completed for equipment on return to the Trust. It is the responsibility of the person receiving the equipment to ensure that it is cleaned, decontaminated and to complete the form located on the medical devices page of the Trust Intranet The borrower must also agree to return the equipment to the service, ward or department for maintenance or exchange when requested by the service or departmental manager The service or departmental manager or practitioner in charge at the time is responsible for ensuring that the person the equipment is loaned to is capable of taking responsibility for this equipment. Page 33 of 72

34 4.52 External loans from community stock to carers/patients: Medical Devices are loaned to patients/carers on discharge from the Trust as part of their on going care needs or as part of their outpatient treatment. A medical device is normally provided to the individual and not to the home or environment where they live and should include a 20mA RCCD circuit breaker if main electricity is used as the primary power source. All electrical and gas driven devices should be checked by the biomedical engineering department on a regular basis for electrical safety and performance When a patient is discharged into the care of the Community, the Discharge Team will ensure that all details of the outgoing treatment and associated devices required is passed on to the Community Teams. It is the responsibility of the community teams to ensure that the device on loan is returned for maintenance at regular intervals in accordance with the general conditions and to complete the decontamination form Appendix External Loans to outside agencies and Trust: Medical Devices should not be loaned out to any external agency or Trust that has no service level agreement with South Tyneside NHS Foundation Trust. Any SLA should include procedures for the delivery, maintenance and recall of devices loaned. Methods of delivering and charging for consumables should also be included in the SLA. The device should be checked by the biomedical engineering department for electrical safety and performance, prior to leaving the Trust property and on it s return Privately owned Medical Devices On occasions a patient may use their own Medical Device within their own home. Where possible Trust owned devices should be the first choice of equipment to use with a patient. In unavoidable cases, the patient or a relative must be encouraged to ensure that operation manuals are provided and that the operation of the equipment is discussed with the appropriate staff. Page 34 of 72

35 5. EQUIPMENT REPLACEMENT 5.1 Equipment type and operating systems vary widely across the whole spectrum of medical equipment. Life expectancy can be as low as 5 years for software driven systems to 15 years plus for solidly made devices with simple control circuits. Each item of equipment must be taken on merit. 5.2 Condemning procedure 5.3 When a decision has been made that an item of equipment has reached the end of its working life, the service or departmental manager and/or the BME engineer will fill out a Condemning and Disposal certificate FPN15 for Medical Devices. The service manage or departmental manager / BME engineer shall complete part (A) and the Head of BME part (B). 5.4 The certificate will then be counter signed by an executive director in part (C). The form will then be passed on to the Supplies Manager (the disposal officer) who will arrange disposal and sign part (D). A decision will also be made in part (D) as to the most cost effective and safe means of disposal. It is the service, ward or departments responsibility to ensure that the device is cleaned and decontaminated prior to disposal and together with the supplies department must agree to a disposal method. The disposing officer will arrange for completion of the indemnity form by the purchaser for assets that are sold, a copy of which should be retained by the signatory. 5.5 Finally once the device has been disposed of a copy of the disposal certificate should be sent to the corporate accountant in the finance department and the Head of BME. 5.6 On disposal of the equipment the Head of BME shall remove the equipment from the department inventory, cancel the maintenance schedule and any outstanding service contract via the supplies department. Note: All condemned devices must not be resold in europe unless CE marked. Cannibalisation of equipment in order to keep similar equipment in use is not an option. The disposal certificates will be retained by the disposing officer for audit purposes. Page 35 of 72

36 6. INCIDENT REPORTING 6.0 The Medicines and Healthcare products Regulatory Agency (MHRA) role is to take all reasonable steps to help safeguard public health by working with users, manufacturers and lawmakers to ensure that medical devices meet appropriate standards of safety, quality and performance and that they comply with the relevant Directives of the European Union. One way in which they do this is by investigating reports of adverse incidents involving medical devices. 6.1 An adverse incident involving a device should be reported to the MHRA if the incident had lead to, or were it to occur again could lead to: - a death life/threatening illness or injury deterioration in health temporary or permanent impairment of a body function or damage to a body structure the necessity for medical or surgical intervention to prevent permanent impairment of a body function or permanent damage to a body structure; unreliable test results leading to inappropriate diagnosis or therapy 6.2 Procedure to be followed after an adverse incident with a Medical Device Appendix 22 for flow chart 1. If a member of staff identifies a health & safety problem with a medical device their Line Manager should be informed immediately, who will in turn inform the MHRA liaison officer who will issue an adverse incident report form and a device/equipment information form. These forms / datix must be completed by the departmental manager or senior member of staff on duty and returned to the MHRA liaison officer. 2. The device must be taken out of use, quarantined and a red incident report label attached (obtained from head of BME). Details of settings, dose rates or other volitile data must be recorded if appropriate. The Head of BME will inform the Health & safety officer of the incident and both may be required to carry out an inspection of the device and incident. If required a joint report will be completed and sent to the MHRA liaison officer who will forward this to the MHRA via the online reporting system. The MHRA will issue an incident number as receipt of acknowledgment. Under no circumstances should the medical device be returned to the manufacturer without prior consultation with the Health and Safety Officer or the Head of BME. 3. The MHRA liaison officer or depuitising member of staff will forward a copy of the adverse incident report form and the device/equipment information form to the BME department for action if required. 4. The Health and Safety Officer / Head of BME /Medical Device Lead will consider the appropriate course of action to be taken and if necessary will contact the Medicines and Healthcare products Regulatory Agency. 5. The MHRA liaison officer will report the incident if appropriate to the Chief Executive, and the appropriate Executive Director. Page 36 of 72

37 6.3 Distributing and implementing medical device alerts The Medicines and Healthcare products Regulatory Agency will issue medical device alerts to the Central Alerting system (CAS) Liaison Officer of South Tyneside NHS Foundation Trust via . It is the CAS Liason Officer s responsibility to ensure the effective distribution of these alerts throughout the organisation. 6.4 Please refer to STNHSFT policy for receiving, distributing and implementing medical device alerts (Appendix 23). 6.5 Where the results of investigations have implications for patients or users, MHRA issues a Hazard/Safety notice or a Device Alert advising of hazardous products or unsafe procedures. Page 37 of 72

38 GLOSSARY A Adverse Incident ARAS An event which gives rise to, or has the potential to produce, unexpected or unwanted effects involving the safety of patients, users or other persons. Acute Respiratory Assessment Service AHP B Biomed BME C CE Marking CNST C.O.S.H.H. CAS D Departmental Manager E EEG EMC Allied healthcare professional Biomedical engineer who is responsible for the maintenance of medical devices Ext / Biomedical Engineering responsible for the maintenance of a wide range of medical devices and non medical electronic and communications equipment. Conformite Europeene which literaturely means European Conformity. Clinical Negligence Scheme for Trusts. Control Of Substances Hazardous to Health. Central Alerting system Head of Department / Ward or nominated person in charge of medical devices. An Electroencephalogram is a recording of electrical activity in the brain. Electro-Magnetic Compatability. F F.R.M.G Financial Risk Management Group FPN15 Financial Procedure Note 15 Page 38 of 72

39 H Head of BME Head of Biomedical Engineering Ext.4158 HSO Health & Safety Officer Ext I IFA IPS ITU M Master Indemnity List MHRA MLSO Indemnity Form Authorisation Intergrated Personnel System Intensive Therapy Unit. The Medicines and Healthcare products Regulatory Agency list of manufacturers and suppliers that provide indemnity against against injury as a result of a product failure in operation. The Medicines and Healthcare Products Regulatory Agency is charged with ensuring that medical devices for sale or use in the UK meet appropriate standards of safety, quality and effectiveness and that they comply with the relevant European Community directives. Medical Laboratory Scientific Officer. P PPQ S SCBU SLA S.F.I S.O Supplies manager Pre-Purchase Questionaire sent to every supplier prior to purchase to obtain relivant information pertaining to compliance with standards, maintenance and cleaning of the medical device. Special Care Baby Unit. Service Level Agreement. Standing Financial Instructions. Standing Orders. Head of the supplies department Ext. Page 39 of 72

40 7. APPENDICES

41 Appendix 1 Policy Guidance This policy is based on the guidance produced by:- Department of Health, Medicines and Healthcare products Regulatory Agency. National Audit Office. Electricity at Work Regulation. Medical Devices regulations (SI 1994/3073) Health and Safety at Work Act and recommendations made in the Clothier report.95 Guidance is based upon:- MDA DB2006(4) Single-use Medical Devices:Implication & Consequences of reuse MDA DB 2003(05) Management of medical devices prior to repair, service or investigation MDA DB2006(5) Managing Medical Devices. MDA DB 2006 (01) Reporting Adverse Incidents and Disseminating Medical Device Alerts National Audit Office HC475 The Management of Medical Equipment in NHS Acute Trusts in England. NHS Executive CQC standards. NHS Litigation Authority Risk Management Standards for Acute Trusts, Primary Care Trusts and Independent sector Providers of NHS Care 93/42/EEC European Medical devices directive This document is linked to:- South Tyneside NHS Foundation Trust Infection Control Guidance for Cleaning & Decontamination of reusable Medical devices & Non Medical Devices. South Tyneside NHS Foundation Trust Health & Safety Policy. South Tyneside NHS Foundation Trust Procurement Strategy. South Tyneside NHS Foundation Trust Waste Disposal Policy. South Tyneside NHS Foundation Trust policy for Receiving, Distributing & Implementing Medical Device Alerts. Community Equipment Service Catalogue City of Sunderland Social Services Directorate in partnership with South Tyneside NHS Foundation Trust. South Tyneside NHS Foundation Trust Infection Prevention and Control Policy Community health services Cleaning and Decontamination of Equipment and Medical Devices in Community Settings (2011) Community Health services Toy Policy (2008).

42 References:- MHRA Device Bulletin, Management of Medical Devices MDA DB2006(5), published by themhra (November 2006), ISBN/ISSN DOH, Clinical Negligence Scheme for Trusts- General Risk Management Standards, published by the NHS Litigation Authority (April 2005) MDA, Equipped to Care - The safe use of medical devices in the 21st Century, published by Medical Devices Agency (2000), ISBN MDA, Devices in Practice-a guide for health and social care professionals, published by Medical Devices Agency (2002), ISBN

43 Appendix 2 Safety Requirements a) Electromedical Equipment:- EN : Medical electrical equipment. part 1 - General requirements for safety For specific equipment a part 2 may apply ie Section 2.2: Specification for high frequency surgical equipment. b) Laboratory and measurement equipment EN : Safety requirements for electrical equipment for measurement control and laboratory use. General requirements c) Medical Equipment:- BS4272 part : Anaesthetic and Analgesic machines. BS5682: Terminal units, hose assemblies and connectors for use with medical gas pipelines. EN : Medical gas cylinders, valves and yoke connections. EN : Terminal units for compressed medical gases and vacuum. EN737-2: Active anaesthetic gas scavenging systems. EN738: Pressure regulators for use with medical gases. EN738-2: Manifolds and line pressure regulators. EN738-3: Pressure regulators integrated with cylinder valves. EN738-4: Low-pressure regulators intended for incorporation into medical equipment. EN794 : Lung ventilators. EN794-1: Particular requirements for critical care ventilators. EN794-3: Particular requirements for emergency and transport ventilators.

44 Appendix 3 Risk Assessment Process A number one to five indicating the likelihood of the risk occurring. Likelihood Rating Descriptor 1 Rare Do not believe this will happen again 2 Unlikely Do not expect it to happen again 3 Possible May reoccur occasionally 4 Likely Will probably re-occur, not a persistent issue 5 Almost certain Likely to re-occur on many occasions A number one to five indicating the impact of the risk occurring. Impact Rating 1 None/Insignificant 2 Minor 3 Moderate 4 Major 5 Catastrophic Descriptor See below for descriptor Catastrophic (Code Red) These are unacceptable risks and represent a very high risk to patients, staff and visitors or the Trust as a whole, eg death or significant permanent disability through the misuse of an infusion device, very high financial implications ( 100, ,000). Devices at this risk level will not be accepted within South Tyneside. Major (Code Yellow) These risks have a high potential to cause harm to patients, staff or visitors as well as the Trust as an organisation, eg serious injury to patients due to the failure of a life support system, or high financial implications( 25, ,000). Medium (Code Blue) These risks have moderate potential to cause harm to patients, staff, visitors or the Trust, eg some injury to patients or staff from the misuse of a defibrillator or disruption to organisation by loss of facility that can be managed. Low/Negligible (Code Green) These risks have low potential to cause harm to patients, staff and visitors and should be managed at ward, team or department level within the Trust.

45 Risk Matrix Likelihood Descriptor 1. Rare don t believe this will happen again 2. Unlikely don t expect it to happen again 3. Possible may re-occur occasionally 4. Likely will probably re-occur, not a persistent issue 5. Certain likely to re-occur on many occasions Consequence Descriptor 1 Insignificant 2 Minor 3 Moderate 4 Major 5 Catastrophic

46 Appendix 4 List of Approved Devices List of Approved Medical Devices Device Manufacturer Model Price Anaesthetics machine Drager medical Primus 33,180 Anaesthetics machine Drager medical Fabius Tiro 21,000 Bladder Scanner Verathon BVI ,500 Blood Glucose meter Roche medical Advantage 21 Blood Glucose meter Roche Medical Accu-Check inform Blood Pressure Gauge Welch Allyn DS Blood Warmer CMS BIEG 150 1,740 BIPAP Philips Respironics Focus 6,000 Defibrillator Philips Medical M4735A 5,978 Defibrillator Philips medical FR2 & FR2+ 3,100 Ear Syringe Mirage Dental Propulse 3NG 130 Echo Scanner Philips IE33 100k ECG Halter unit 24hr Reynolds Medical CF 1,200 ECG Machine(Archive) Cardiac Science Atria ECG Stress Analysis System Cardiac Science Q-Stress 24K ECG Telemetry unit Spacelabs Medical Electronic Baby Scale Seca Electronic Bariatric Scale Seca Electronic Chair Scale Seca Electronic Portable Scale Seca Electronic Standing Scale Seca Electronic Thermometer Welch Allyn 692 SureTemp 240 Endoscopy systems Flexible Keymed Ltd Various 75K Endoscopy systems Rigid Stortz Various 75K Entonox valves Oxylitre XPRU3/L 160 Flowmeters Oxyliter F Foetal Monitor Philips Medical FM 30 Avalon 8,300 Gas Cylinder Regulators Oxyliter R Hand Held Blood Flow Monitor Huntleigh Medical D Hand Held Foetal monitor Huntleigh Medical FD1 300 Hand held Pulse Oximeter Nellcor N Humidifier Fisher Paykal MR850 2,500 Infant Incubator Drager Medical C2HS-1C 14K Infant Life Support SLE 2000HFO 23,259 Infusion Pump Volumetric Baxter Healthcare Collegue 1,500 Infusion Pump 3 Channel Baxter Healthcare Collegue 3 3,500 Infusion Pump Syringe Alaris Medical P7000 2,183 Infusion Pump PCA Alaris Medical P5000 4,112 Infusion Pump Ambulatory McKinley T

47 Device Manufacturer Model Price Nebuliser Philips Respironics Portaneb 120 Neonatal Respiration Monitor Graseby medical MR NIBP Analysis 24 Hr Reynolds Medical Tracker 1,400 Opthalmoscope Welch Allyn Oxygen Monitor Viamed MX Patient Life Support Drager Medical Evita XL 34,267 Patient Monitor (basic) Spacelabs Medical ,500 Phototherapy Light Natus UK NeoBlue 2,938 Portable Life Support Drager Medical Oxylog ,000 Portable Incubator Drager Medical TI500 14K Pulmonary Function System Jaeger Medical PST 40k Pulse Oximeter Nellcor N-600 2,500 Resuscitaire Drager Medical RW82 12K Smokelyser Bedfont Medical Pico+ 186 Smoke Extraction unit ERBE ICC 300 2,000 Suction Pump Laerdal LSU 750 Surgical Diathermy ERBE ICC 350 9,500 Tympanic Thermometer Tyco Genius VACC Pump KCI Activac 18K Vital Signs Monitor Welch Allyn VSM300 1,196 Vital Signs Monitor(Spot) Welch Allyn 420 1,600 Wall Suction Units Oxylitre S Wall Suction Units Oxylitre S The following device are to be order for the community service only: Handheld Pulse Oximeter BCI Handheld Pulse Oximeter Nonin Onyx Spirometer Vitalograph ,860

48 Appendix 5 Business Proforma SOUTH TYNESIDE NHS FOUNDATION TRUST CAPITAL, MAJOR REVENUE AND CONTRACTS PROPOSAL FORM SECTION A TO BE COMPLETED BY THE FINANCE DEPARTMENT Proposal Number Proposal Number PF001 Date Submitted 28/06/2012 Present to Capital IT SECTION B THIS SECTION MUST BE COMPLETED IN FULL BY THE PROPOSER Proposal Title Provide a brief title for the proposal Proposer Note - this is the person completing the form Proposers Name Proposer s Post Title Lead Note this is the person with responsibility for leading and delivering the proposal (if approved) Lead Name Lead s Post Title Description Provide a detailed description of the proposal Is the proposal to replace existing equipment? Yes No Objectives and Benefits Set out the expected objectives and benefits of the proposal 1) 2) 3) 4) 5) Consequences of Non Approval Detail the implications 1) (and the likelihood of 2) occurrence) if the 3) proposal is rejected 4) 5) Set-Up Costs and Funding Estimated set-up costs Less than 5,000 Between 5,000 and 25,000 Between 25,000 and 100,000 Greater than 100,000 Detailed set-up costs (if known) How is it proposed costs will be met? 1) 2) 3) 4) 5) Existing Revenue Budgets Major Revenue Funds Capital Programme Charitable Funds Recurring Costs/Savings and Funding With regard to recurring costs and savings please consider maintenance, calibration, consumables, staffing, etc. Detail any affect on 1)

49 recurring revenue the proposal is may have (include costs/savings if known) If the project has a net cost how will this be met? If the project has a net saving how will this be utilised? Procurement Process Will the proposal be subject to competitive tender? 2) 3) 4) 5) Proposal to Generate Savings Reserves (please detail below) Contribution to CIP (please give details below) Offset an existing overspend (please give details below) Yes Existing Revenue Budgets Additional Funding Required No (please provide reasons below) Implementation Timescales Please provide as much detail as possible to allow the sub-group to factor your proposal into the programme Implementation required by date Additional Information Is the proposal included in the department business plan? Yes No (please provide reasons below) Has the proposal been discussed with relevant stakeholders (including IT, Estates, Facilities, etc.)? Yes (please detail below) No (please provide reasons below) Purpose of Submission What is the form seeking approval for? Outright approval (based on information provided on the form) Approval to begin a competitive tendering process CBM/Head Of Service Sign Off Authorisation to submit this form must be sought from the CBM or Head of Service for your department CBM/Head of Service Name CBM/Head of Service Post Once this form has been completed please it to proposalform@stft.nhs.uk If the form has not been completed in full it will be returned to the proposer. Once fully completed the form will be made available to all relevant Heads of Service for sign off. If signed off the form will be added to the agenda of the next relevant Capital Sub-Group for consideration. The Proposal Lead will be requested to attend the Capital Sub-Group to present the proposal. If this is not possible a representative, who has been fully briefed, must attend. Progress of the proposal can be tracked using the following link: Sharepoint Tracking Site SECTION C TO BE COMPLETED BY HEADS OF SERVICE PRIOR TO DISCUSSION AT SUB-GROUP Post Title Approved for Comments Agenda Head of Procurement Head of Estates (Capital Projects) Head of IT and Information Divisional Director - Clinical Services Head of Facilities Head of BME

50 SECTION D TO BE COMPLETED BY AT SUB-GROUP (Tick one box only) Decision Tick to Select Comments Approved for purchase Approved to progress to competitive tender Approved Deferred implementation to be factored into programme when resource is available Deferred further information requested Rejected outright Business Case Business case required To Executive Board To Board of Directors Business case to be based on actual or estimate costs Actual Costs (pre completion of tender evaluation) Estimated Costs (post completion of tender evaluation) Requested date for submission of business case to sub-group Completion Date Expected Completion Date Sub-Group Sign Off Name Designation Signature Date SECTION E FOR COMPLETION WITHIN ONE WEEK OF SUB-GROUP MEETING Resources Procurement lead Finance lead Estates/Facilities lead (if required) IT lead (if required) BME lead (if required) Other (please state) Other (please state) Other (please state)

51 Appendix 6 Capital Procurement process GUIDE TO CAPITAL MEDICAL EQUIPMENT PURCHASES These are single devices that have a value of over 5000 or are a collection of assets valued individually at less than 5K which are functionally interdependant and together form a single collective asset under single managerial control aquired and disposed of about the same date and together have a value of over 250. Case of need established and business proforma produced Business proforma sent to finance for financial analysis and inclusion in Capital equipment group papers Business Proforma presented to Capital Medical Equipment Sub-Group for authorisation Yes Is revenue funding required for all or part of the purchase No Is the total cost over the Capital Medical group s 25k authorisation limit No Yes Business proforma or business case to FRMG for approval Business case to Executive board for approval to purchase Is the total cost over the Executive Board authorisation limit Yes Business case to Trust Board for approval to purchase Procurement starts Approved

52 Appendix 7 Revenue Procurement process GUIDE TO REVENUE MEDICALEQUIPMENT PURCHASES These are devices that have a value of under 5000 inc VAT and can work independantly of any system or network Is the equipment a Medical, Laboratory, Gas, Dental, Radiology or Chiropody device? Yes Is it replacing existing equipment Yes No Is it a new type or model of equipment not in use elsewhere in the No Trust? No Yes No Gather the following information Maintenance cost Consumable costs Training costs Safety compliance Service manual cost Calibration requirements Installation costs Cleaning costs Project Dead No Does it meet the safety requirements Yes Complete requisitions form and submit to Supplies department Mark form Requires PPQ form No Is the device a Trust approved item? Yes Supplies Department Check with BME for current PPQ Obtain signed copy of PPQ cover sheet to purchase Place order and mark Requires BME Acceptance check. Complete requisitions form and submit to Supplies department Mark form Requires BME acceptance check.

53 Appendix 8 Indemnity Form for Trial or Testing FORM OF INDEMNITY FOR TRIAL OR TESTING FREE ISSUES AN AGREEMENT made the day of 200_ BETWEEN (South Tyneside NHS Foundation Trust) And (the Supplier). WHEREAS (1) The Supplier is the owner of the goods described in the Schedule (the Goods). (2) The Supplier wishes to give the Goods to South Tyneside NHS Foundation Trust so that South Tyneside NHS Foundation Trust may use the Goods for the benefit of the Supplier for the purpose of evaluation, testing, research, design investigation or trial demonstration. IT IS HEREBY AGREED that the Supplier shall transfer the Goods free of charge to South Tyneside NHS Foundation Trust on the terms set out below. 1. The transfer of the Goods shall be deemed to be a contract for the transfer of goods as defined by Section 1 (1) of the Supply of Goods and Services Act The Supplier agrees that this transaction and the transfer of goods effected by it shall be subject to the current National Health Service Conditions of Contract for the Purchase of Goods (except Conditions ). SIGNED on behalf of the South Tyneside NHS Foundation Trust SIGNED on behalf of the Supplier

54 THE SCHEDULE 1. The Goods Model/Mark No: Serial No: Value: Description: FIA No: (if applicable) (if applicable) The above goods will only be used in the premises or location identified in '3' below and will NOT be used elsewhere or for any other purpose than that specified in '4' below without the written consent of the supplier. 2. Date of Transfer of Goods day of 200_. 3. The Premises / Location 4. The Purpose of the Free Issue 5. Health and Safety BY signing this schedule both parties acknowledge their responsibilities under the Health and Safety at Work Act and COSHH Confidentiality By signing this schedule both parties acknowledge the confidentiality requirements of this agreement. SIGNED on behalf of the South Tyneside NHS FoundationTrust SIGNED on behalf of the Supplier

55 Appendix 9 Pre-Purchase Questionaire Request For Product Information For Purchaser's Use Ref. No. FORM PPQ(A) Completed forms PPQ and PPQ(A) should be returned to Supplies Department South Tyneside NHS Foundation Trust Harton Lane. South Shields Tyne & Wear NE34 0PL Buyers Name: This section to be completed by the Purchaser Supplier Address Equipment Description Equipment Type Model number or code Department for which Equipment is intended Date The Purchaser should list (below) standards, other than BS5724 and ESCHLE, to which compliance is sought i) ii) This section to be completed by the Supplier Supplier's Response Attached is a current completed and signed Form PPQ dated: Which I am authorised to release. Signature Name (please print) Position in Company Date

56 PRE-PURCHASE QUESTIONNAIRE EXTENDED FORM PPQ June 2003 Produced by NHS Purchasing and Supply Agency, Scottish Healthcare Supplies, Northern Ireland CSA Regional Supplies Service and Welsh Health Supplies in conjunction with the Association of British Healthcare Industries This form is intended to supply prospective purchasers with information about equipment being considered for purchase. It is intended principally for pre-purchase information on electrical medical, dental, ophthalmic and laboratory equipment. The form may also be used for other products, including non-electrical items, and to give information prior to equipment being supplied on loan, in which case not all the questions will be relevant. Please ensure all relevant questions are answered. For issue and completion by purchaser: PPQ Master Reference: A unique reference (preferably ten characters maximum) must be given by the supplier: Supplier's Reference: Generic Device Type: Country of Origin: Supplier: Fax No: Equipment Model: Manufacturer: Telephone No: CE MARKING 1. a) Does the product carry the CE marking? YES NO b) If YES, to which EC Directive(s): i) Active Implantable Medical Devices Directive (90/385/EEC) YES ii) Medical Devices Directive (93/42/EEC) YES If YES, state classification of device (93/42/EEC Annex IX) iii) In Vitro Diagnostic Medical Devices Directive (98/79/EC) YES If YES, is the device: For self-testing? YES Covered by Annex II: List A? YES List B? YES NO For ii) and iii) above, Identification No. of Notified Body, if applicable iv) EMC Directive (89/336/EEC or superseding directive)) YES v) Low Voltage Directive (73/23/EEC) YES vi) Other Directive(s) (please specify) 2. a) Is the product a custom-made device (93/42/EEC)? YES NO b) Is the product intended for clinical investigation (93/42/EEC) or performance evaluation (98/79/EC)? YES NO If YES to a) or b) above, does the device comply with the UK Medical Devices Regulations? YES NO MANAGEMENT SYSTEM STANDARDS 3. a) Is the manufacturer currently registered to any management system standards (eg ISO 9001, ISO 14001, ISO 13485)? YES NO If YES, please state the standard(s) and certification body: b) Is the supplier's service and repair organisation currently registered to any management system standards? YES NO If YES, please state the standard(s) and certification body: SAFETY STANDARDS 4. For products not CE marked to 1 b) i), ii) or iii) above, with which safety standard(s) does the product comply? Standard Test House Certificate Number Date SERVICE / SPARES / INSTALLATION 5. Is service/repair information available? YES NO If NOT f.o.c. please state current price Indicate contents below: (Please state YES, NO or N/A) Full circuit diagrams Fault finding procedure Preventative maintenance Repair information Spare parts listing List of special tools/test equipment/etc If YES, please state whether also available on: Disk Website If Web, please state address 6. a) In addition to the service/repair information/manual, will training be required before competent technical personnel can provide: First-line maintenance Calibration (Please state YES, NO or N/A) Planned preventative maintenance Repair b) Is the supplier able to provide this training for the purchaser s or a third party s technical personnel? YES NO If YES, will this be free of charge? Or chargeable? If NO, please indicate if details of an organisation that is able to provide this training are available on request? YES NO

57 Supplier's Reference: c) Is the provision of service/repair information conditional upon completion of training? YES NO d) In order to undertake maintenance/repair/calibration, is any special software/test equipment/tooling required? YES NO If YES, please indicate that details of special software/test equipment/tooling are provided on a separate sheet: YES 7. a) Is the supplier able to provide an 'as required' repair/maintenance service in the UK? YES NO b) Is the supplier able to provide a contract repair/maintenance service? YES NO If YES, please confirm that details of repair/maintenance contracts are provided on a separate sheet. YES c) i) If repairs are normally performed by the supplier on the purchaser's site, please state typical response time: ii) If repairs are performed off-site, where will these be carried out? Company: Location: Typical turnround time: iii) Is free of charge loan equipment normally available? YES NO 8. Please state if repair parts will be available to the purchaser s or a third party s suitably trained and equipped personnel: YES NO If YES, is the supply of repair parts conditional upon acquisition of repair information? YES Or training? YES NO 9. Please indicate when this model was first placed on the market: 10. a) For how many years from the date of last manufacture is the supply of spare parts guaranteed? b) Is the product still in current production? YES NO If NO, indicate year of last manufacture: 11. Is installation necessary? YES NO If YES, please confirm that details of all services required are provided on a separate sheet: YES 12. Will software upgrades be notified? N/A YES NO IONISING RADIATION 13. Does the product contain a source of ionising radiation or is it capable of emitting ionising radiation? YES NO DECONTAMINATION / REPROCESSING 14. a) i) Will the item be reprocessed (cleaned, disinfected, sterilised)? YES NO If NO, go to Question 15. ii) If YES, is the item intended to be: Non-sterile for single use Sterilised Disinfected Other iii) Is there a recommended maximum number of uses? YES NO If YES, please state: iv) Are decontamination/reprocessing instructions supplied? YES NO v) Are instructions available for safe disposal? YES NO b) i) Is manual cleaning the only cleaning method specified before further reprocessing? YES NO ii) What is the maximum temperature that can be used for thermal disinfection? Temp: iii) Are there any restrictions on detergent/disinfectant types? YES NO If YES, please state: iv) Can the item withstand autoclaving at 137 o C for 3 mins? YES NO v) Is the item compatible with other sterilization methods? YES NO If YES, please state: vi) Does reprocessing require the use of specified equipment? YES NO If YES, please state equipment type (eg containers, processors, etc) and, where appropriate, parameters of operation (eg temp, pressure, etc): c) i) Are tools required to aid dismantling/reassembly, or are lubricants required? YES NO ii) If YES, are they supplied with the device or available optionally? Supplied Optional Neither d) Is decontamination/reprocessing training available? YES NO If YES will this be: Free of charge? Chargeable? e) Are reprocessing instructions available on the Web? YES NO If YES, please state address: WARRANTY 15. Please confirm that a copy of the warranty is provided on a separate sheet: YES DECLARATION When reference is made to this form and its attachments within the process of obtaining the item, we agree that the purchaser will be entitled to rely upon the contents and subsequent non-compliance with the statements contained herein will entitle the purchaser to seek redress. Name: Company/Address: Position: Date:

58 Appendix 10 Medical Device training matrix Training Generic Medical Device Matrix Feb 2012 Medical Device Description Medical Device Model Risk Score Minimum Band of staff used Training provided by Internal (I) by Manufacturer (M) or E-learning (EL) BLOOD FLOW DETECTOR Dopplex D900 M 5 M / I - via leg ulcer / tissue viability team & standards of practice workbook BLOOD PRESSURE MONITOR M5-1 / M7 L 2 M / I - Cascade training & standards of practice workbook AMBULATORY BLOOD PRESSURE MONITOR B L 2 M / I - train the trainer AUTOMATED EXTERNAL Heartstart FR, M 2 M / I - Yes as part of Stat Mand DEFIBRILLATOR FR2, FR2+ EAR SYRINGE Propulse II / lll M 5 M / I - standards of practice workbook available ECG RECORDER Mac 1200 / 1200ST L 3 M / I - standards of practice workbook available AMBULATORY ECG MACHINE 24-HR B L 3 M / I - train the trainer INFUSION PUMP Colleague H 5 M & EL PULSE OXIMETER Onyx 9500 L 3 M / I - via respiratory nurses & assessed via observed practice SPIROMETER 2120 L 3 M / I - via respiratory Nurses & standards of practice workbook available SYRINGE DRIVER T34 H 5 I / M / EL - via train the trainer TYMPANIC THERMOMETER Genius 2 / Gentle temp L 2 M / I - cascade training & competency assessed by observed practice VITAL SIGNS MONITOR 420 Spot L 2 M BLOOD GLUCOSE MONITOR ACCU-CHECK H 2 M / I / EL - via train the trainer & standards of practice workbook available ENTERAL FEED PUMP FLOCARE 800 H 5 M HEMOCUE B-HEMOGLOBIN H 5 M / I - via diabetes workshop NEBULISER 2002HF L 5 M / I - via respiratory workshop ULTRASOUND MACHINE SSA-770A L 6 M VACUUM ASSISTED CLOSURE UNIT ACTI VAC M 5 M / I - standards of practice workbook available CRYOTHERAPY MACHINE M 5 M & I via train the trainer ELECTRONIC BABY SCALES Seca 724 L 2 M / I ELECTRONIC CHAIR SCALES Seca 958 L 2 M / I PORTABLE SUCTION Laerdal LSU M 5 M / I Please note that the above is a generic list of medical devices applicable to a number of services. There is a separate matrix developed for each speciality for medical devices not commonly used by services Refresher training and/or competency assessments for all devices are recommended every 3 years or at the point where models are replaced with different ones or earlier if a member of staff has not used the device for a period of 6 months

59 Appendix 11 Annual Competency Record Medical Devices Competency Record The named health care worker has received instruction on the use of the stated device. The teaching programme used is the STNHSFT Medical Devices Training guide for this device. The named health care worker is required to demonstrate competence in using the stated device to the Ward/Unit Manager or nominated deputy in their clinical area. If the Assessor and health care worker are both satisfied then both sign below to evidence that competence has been maintained. If both parties cannot reach agreement then retraining on that specific device must be undertaken. This should be reviewed as part of the annual appraisal process. Name: Ward/Dept: Training Year: Medical Device MD Code Authorised User Y N Signed Assessor Date Produced by: E. Gordon Created: April 2011, for Review: April 2013

60 Appendix 12 Annual Training Record Medical Devices Training Record If any training needs have been identified on the previous page please use the table below to record when the training has been carried out. Name: Ward/Dept: Training Year: Medical Device MD Code Signed Assessor Date Produced by: E. Gordon Created: April 2011, for Review: April 2013

61 Appendix 13 Competancy Form Generic Competency Standard for Medical Equipment (Document to be used as a checklist and all staff should meet all elements prior to be signed off as competent) Element Completion Yes No N/A Comments Underpinning knowledge and skills Links with other policies and procedures Safe and appropriate use of equipment Record keeping and documentation Servicing and maintenance of equipment Local Arrangements Evidence of appropriate training in use of the equipment (training document signed) Has accessed Medical Devices aspect of statutory / mandatory training. Applies the principles throughout. Demonstrates awareness and understanding of / adherence to manufacturer s instructions Demonstrates awareness of safety alerts cascade process and personal responsibility within this Demonstrates awareness of and adherence to Demonstrates awareness and application of Trust s procedure for decontaminating medical equipment prior to and post patient use Demonstrates awareness of Trust s Health and Safety Policy including Risk Assessment Demonstrates awareness of personal responsibility to report any incidents via the Trust s incident reporting process. Explains the clinical application of the equipment Identifies any appropriate equipment to be used in conjunction with this device Demonstrates any safety checks and precautions prior to use. Assembles the equipment in accordance with manufacturer s instructions Correctly dismantles and disposes of any contaminated equipment and prepares equipment for future use. Demonstrates adherence to Record Keeping Policy and use of appropriate documentation Demonstrates awareness of the local arrangements for servicing, maintenance, repair and disposal of equipment. Demonstrates understanding of the need for compliance with servicing arrangements Knows who the Medical Devices Lead / Link person is in the team/ward/department. Demonstrates awareness of what to do with personally assigned equipment when moving to another post / team or on long term sick / maternity leave Demonstrates awareness of the local Medical Devices File and is familiar with its contents

62 Appendix 14 Procedure for determining medical device training requirements Need for a new/replacement Medical Device established using a business proforma/business case. Authorised end users training requirements identified. Training update frequency agreed and Competency Assessment developed by medical devices group. Medical Device purchased and received into Biomedical Engineering Department Checked, logged and bar coded Initial Training by Medical Device Suppliers Supported by Medical Device Co-ordinator & Biomedical Engineering Department Training cascaded to identified authorised users Mandatory refreshers and updates undertaken (when specified) by Medical Device Trainers supported by Supplier and Medical Device Co-ordinator Training for devices used in specified area e.g. theatres will be delivered in the department by the supplier supported by the Biomedical Engineering Department Training is competency assessed and logged at ward, department level. Records of training will be forwarded to Training and Development to be added to the centrally held Trust database N.B. Training is mandatory for all new staff who use medical devices

63 Appendix 15 Flow Chart to illustrate recording of medical device training across the Trust- Internal competent Trust trainer inc. Biomedical Engineering and Medical Clinical device Risk Co-ordinator Trainer Manufacturer based at external venue or within ward or department Manufacturer led at quarterly device training day Induction Induction training training organised by organised Learning & by Development Learning & Department and Education Development Centre Department and Education Centre Standards for for practice workbooks (community) e-learning (community) Attendance register completed Certificate issued Local Medical Device File updated Copies of all training registers are forward to the Learning and Development Department for input onto the Oracle Learning Management Database Database (hospital) Quarterly monitoring reports are produced and circulated to Service Leads and Business Managers for review. These will then be cascaded to Ward/Departmental/Team Managers to review, update local medical device training file and ensure all identified training needs are met (hospital) Annual Integrated audit tool used to monitor monitor compliance compliance (community)

64 Appendix 16 Equipment Register