POLICY DOCUMENT Burton Hospitals NHS Foundation Trust MEDICAL DEVICES TRAINING POLICY Approved by: Trust Executive Committee On: 25 January 2017 Review Date: December 2019 Corporate / Directorate Clinical / Non Clinical Department Responsible for Review: Distribution: Essential Reading for: Corporate Non Clinical Medical Director All Clinical Staff Information for: Learning & Development Policy Number: Version Number: 78 7 Signature: Date: Chief Executive
Burton Hospitals NHS Foundation Trust POLICY INDEX SHEET Title: Medical Devices Training Policy Original Issue Date: September 2006 Date of Last Review: June 2015 Reason for amendment: Update Responsibility: Stored: Medical Director Intranet site Linked Trust Policies: Risk Management Policy Medical Devices Policy Learning and Development Policy Induction Policy Policy for the Reporting and Management of Adverse Incidents and Near Misses Managing Performance and Supporting Staff E & D Impact assessed EIA 136 Consulted Corporate Nursing Divisional Nurse Directors Equipment Library Learning & Development Manager Medical Director Medical Electronics Lead of Allied Healthcare professional.
REVIEW AND AMENDMENTS LOG Version Type of Change Date Description of Change 7 Amendment to Appendix F July 2015 Removal of Competence must be assessed by an authorised trainer. Insertion of competence verified by Trainer/Senior Sister/Line Manager Amendment to approved by November2016 Trust Executive committee Review date November 2016 Review date November 2019 Amendment to Consulted November 2016 Removal Head Nurses, Insertion of Divisional Nurse Directors Amendment to Consulted November 2016 Removal of Head of Therapies, insertion of Lead Allied Health Care Professional Amendment to 5.5 November 2016 Removal of Head Nurses, insertion of Divisional Nurse Directors. Amendment to 7.2 November 2016 Removal of on the trust database, insertion of in the Medical Device Training Files Amendment to 8.5 November 2016 Removal of competent colleague, insertion of cascade trainer or trained super user. Amendment to 8.8 November 2016 Insertion of and have documentary evidence in their medical devices training file. Amendment to 9 November 2016 Insertion of Overall monitoring of compliance is the responsibility of the medical director Removal of clinical, insertion of Division Risk and Patient safety Amendment to Appendix A November 2016 Insertion of Baxter Insertion of Freego feeding pump Amendment to Definitions 5.5 November 2016 Removal of Head Nurse, insertion of Divisional Nurse Directors Addition of Appendix G November 2016 Insertion of Appendix G Insertion of Patient form
MEDICAL DEVICES TRAINING POLICY CONTENTS Paragraph No Subject Page No. 1 Introduction 1 2 Scope 1 2 Aims & Objectives 1 4 Definitions 2 5 Duties and Responsibilities 2-3 6 Risk Assessment 3-4 7 Training Needs Analysis 4-5 8 Training and Education 5-7 9 Monitoring Compliance 7-8 10 Sources 8 Appendix A Non-Specialist High Risk Device List 9 Appendix B Authorised User Device Record 10 Appendix C Training Requirements Flow Chart 11 Appendix D Low Risk Staff Self-Assessment Record 12 Appendix E High/Moderate Risk Self- Assessment Record 13 Appendix F Generic Competency Document 14 Appendix G End-User Agreement 15
Burton Hospitals NHS Foundation Trust MEDICAL DEVICES TRAINING POLICY 1. INTRODUCTION The use of medical devices within the clinical areas plays an ever increasing role in the assessment, management and evaluation of patient care. There is well established evidence that a significant number of adverse patient events relate to the use or misuse of medical devices, it is therefore important that the appropriate staff are trained to operate such equipment safely. 2. SCOPE 2.1 Training in the use of therapeutic and diagnostic medical devices applies to all bands and disciplines of clinical and scientific staff operating such devices within their role. 2.2 This policy applies to all clinical and scientific departments. 3. AIMS AND OBJECTIVES The aims of this policy is to ensure the Trust meets the requirements and guidance issued by the various bodies e.g. The Medicines and Healthcare products Regulatory Agency (MHRA), NHS Litigation Authority Risk Management Standards (NHSLA), Care Quality Commission (CQC) and The Health and Safety Executive (HSE) related to training. This policy will provide a framework for the identification, provision and recording of medical device training. This policy will: Provide a clear framework for training requirement and the safe use of medical devices. Ensure that a consistent approach to training is in place across all disciplines throughout the Trust. Define the minimum standards required for any training in the safe use of medical devices, based on a risk scoring system. Provide a list of non-specialist high risk equipment (Appendix A). 1
4. DEFINITIONS 4.1 The EU Directive for the registration of medical devices defines a medical device as: any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the software necessary for its proper application intended by the manufacturer to be used for human beings for the purpose of: Diagnosis, prevention, monitoring, treatment or alleviation of disease, Diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap, Investigation, replacement or modification of the anatomy or of a physiological process, Control of conception, and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means 4.2 In day to day use the terms medical device and equipment are often interchangeable. This policy applies primarily to re-usable electro-mechanical medical equipment. 4.3 Please refer to the Trust s Medical Devices Policy for further detail on the classification and management of medical devices. 5. DUTIES AND RESPONSIBILITIES 5.1 All Staff/User of Medical Devices Are responsible for: ensuring they are trained and competent in the use of any medical device within the requirements of their position. maintaining personal records to verify their training status. acting in accordance with professional codes of conduct, including not operating equipment on which they have not received training or skills updates, or do not feel competent. ensuring that they attend any equipment training sessions their line manager has arranged for them. 5.2 All Line Managers Are responsible for: ensuring that the departmental equipment training records are updated on a monthly basis 2
ensuring that staff are released from their duties when required to attend training informing the Medical Engineering Department if there are any local device list changes so that the central inventory can be updated accordingly ensuring that all devices are used according to manufacturer s guidelines providing an up to date inventory of user manuals for staff to access reviewing medical device training needs as part of the appraisal process escalating any medical device training issues via the Trust governance procedures ensuring all equipment is decontaminated and returned to Medical Equipment Library after use as appropriate 5.3 Medical Equipment Officer Is responsible for: co-ordinating medical device training producing audits and reports for senior clinical staff on medical equipment training performance advising line managers on any medical device training issues to assist Heads of Department and Line Managers to risk score medical devices ensuring that all devices have been appropriately risk scored 5.4 Clinical specialists/practice Development Are responsible for: cascading their expert knowledge to device users according to their particular specialist field 5.5 Chief Nurse / Chief Operating Officer / Divisional Nurse Directors and Heads of Department Are responsible for: ensuring that all staff are aware of their responsibilities according to this policy taking appropriate action in the event of non-compliance with this policy ensuring that all devices have been appropriately risk scored 5.6 Medical Director Is responsible for: the overall implementation and monitoring of compliance with this policy 6. RISK ASSESSMENT 6.1 In line with the Trust Risk Management policy all medical devices will be assigned a risk score using the Trust risk assessment matrix. This inherent risk score will be 3
used to determine the level of training required and the frequency of updates for each device. For the purposes of risk assessing medical devices, the Low risk score and Moderate risk score of the Trust s risk matrix have been combined to Low Risk 6.2 The risk scores generated will determine which category each device falls into: Risk Matrix Category Device Risk Category High Risk High Risk Score 15-25 Score 15-25 Significant Risk Moderate Risk Score 8-12 Score 8-12 Moderate Risk Score 4-6 Low Risk Low risk Score 1-6 Score 1-3 Low Risk (Score 1-6) - Devices whose failure or misuse is unlikely to result in serious consequences. Moderate risk (Score 8-12) - Devices whose failure or misuse would have a significant impact upon patient care or temporary adverse health consequences, but would be unlikely to cause direct serious harm High risk (15-25) - Devices that have the potential to cause serious adverse consequences or death should they fail or be misused. Devices recently associated with serious harm. 6.3 All risk scores will be subject to an annual review or may be reviewed following a clinical incident or MHRA alert by the Medical Equipment Officer. 7. TRAINING NEEDS ANALYSIS 7.1 Equipment Inventory The Medical Engineering Department hold a full inventory of all diagnostic and therapeutic equipment. Departmental Managers will be responsible for maintaining a local equipment inventory will be linked to a centrally based medical equipment database. Inventories will highlight which risk category each device falls into and 4
must be reviewed and updated by Departmental Managers in conjunction with Medical Engineering on a six monthly basis or if any new equipment enters the department. 7.2 Authorised Users On local induction each member of staff will have their training recorded. Line managers must then decide and record in medical device training files, which medical devices it will be necessary for that staff member to use within their role. Staff should keep a copy of their authorised devices using the form in Appendix B. For Moderate and High risk devices staff should be made aware that until evidence of competence has been produced they should not be used unsupervised. 7.3 Annual Review As part of the annual appraisal process line managers will review medical equipment training needs prioritising high risk devices. 8. TRAINING AND EDUCATION 8.1 Training Requirements Departmental Managers will use the flow chart found in Appendix C to determine what level of training and frequency of updates is required for each device, however, the line manager or staff member may at any time decide that additional training is required. Advice and support on how to access the required training is available from the Medical Equipment Officer, Practice Development Team, Learning and Development and Specialist Nursing teams i.e. Outreach, Palliative Care. 8.2 Low Risk Devices Self-assessments can be used for low risk devices or for staff that have successfully completed previous competency assessments and have continued to maintain that level of competency by continued regular use of the device. The self-assessment form found in Appendix D can be used for this on induction. Once this has been completed unless there is a device update, clinical incident or change in practice no further evidence would be required. 8.3 Moderate Risk Devices All moderate risk devices require initial formal/informal training followed by competency assessment, then dependant on the frequency of use, staff may selfassess as competent on a yearly basis. The form in Appendix E should be used for this and countersigned by the line manager. Formal/informal training and 5
competency assessment should always be completed if there is a software update, clinical incident or change in practice. 8.4 High Risk Devices All high risk devices require update training and competency assessment using Trust competency documents (Appendix F) on a minimum 3 yearly basis. Some manufacturers provide competency based user training and will supply competency documents. These are acceptable as long as they do not, nor subsequently allow a user to, contradict a Trust standard configuration or usage. A list of non-specialist high risk equipment can be found in Appendix A. This is not designed to be an exhaustive list of high risk equipment across the Trust it is recognised that there are other high risk devices in use in specialist areas. The Trust aims to have all of its authorised users of high risk devices evidenced as competent in their use. Any failure to comply with this will be escalated to the Head of Department and subsequently to the Medical Devices User Group and Director of Nursing via the Medical Equipment Officer for an action plan to be formulated. 8.5 Competency Competency can be established in a number of ways: Formal Training Classroom based training In-House Training Department based training either by a designated trainer, cascade trainer or trained super user. External Training Training via an accredited course For example Advanced Life support (Defibrillators) Qualifications If the user holds a qualification which includes instruction in a devices then the user would be competent whist they maintain that qualification Manufacturer Device manufacturer will often provide training on request and may train trainers to cascade the training to other users Clinical Specialists Other staff member who have knowledge of a specific device may train others in its use Healthcare professionals who as part of their professional qualifications gained competence to use particular devices and have continued on a daily basis to use such devices may self-assess their own competence on low, moderate and some high risk devices using the competency statement in Appendix F. The form in Appendix E should be used to record this and countersigned by the line manager. However, it may be necessary for a formal update to take place in circumstances such as software updates, clinical incidents, new devices, changes in practice or should the line manager deem it necessary. 6
8.7 Delegated Duties This policy is primarily aimed at registered healthcare professionals, however, it is recognised that the use of medical devices and equipment may be delegated to a Health Care Assistant or other associated support staff, but the registered professional remains accountable at all times for ensuring the competence of individuals and that delegation is appropriate and safe. 8.8 Training of Bank, Agency or Locum staff If Bank, agency and /or locum staff are required and authorised to use equipment, then equipment training will be provided as part of their induction. Each department employing temporary staff must ensure that they are competent to use relevant equipment and have documentary evidence in their medical devices training file.. In the case of short term or short notice employment it may be necessary to limit the use of certain devices if competency cannot be determined. The ward/department manager (or their deputy) must inform the individual of equipment that they are authorised to use and any exceptions. 8.9 Non-Attendance Any member of staff not attending pre-arranged equipment training will have this documented by the trainer and escalated to their line manager. Should a particular member of staff persistently not attend this may result in their access to medical devices being restricted and their performance being reviewed by their line manager. 8.10 End-User Training As part of effective clinical management and improving outcomes some patients may continue their therapeutic intervention using Trust owned devices in a location other than Burton Hospital. In this case the patient, carer or family member must be trained in the use of such devices. It is the responsibility of the healthcare professional discharging the patient with the medical device to ensure that a suitably qualified person has carried out training appropriate to the individual patient, carer or family member. Written instruction will be provided along with contact numbers where help and advice can be sought particularly in an emergency. The form in Appendix G will be completed and retained in the patients notes. 9. MONITORING COMPLIANCE Monitoring of the Trust s staff and their competency in the use of medical equipment that their individual role requires of them, is an essential element of the governance 7
arrangements within the Trust. Overall monitoring of compliance is the responsibility of the Medical Director The Medical Equipment Officer will produce a quarterly medical device training audit report which will be reviewed by both the Head Nurses and the Medical Equipment User Group. Regular review of related adverse incident reports will be undertaken by the Divisional Risk and Patient Safety Manager. Trends and patterns may emerge to indicate success or failings of the training strategy, highlighting areas which require focused attention. 10. SOURCES Devices in Practice A Guide for Health and Social Care Professionals MHRA 2008. The Medical Devices Regulations SI 2002/618. Information. London: Office of Public Sector Medicines Healthcare Regulatory Agency. (2008). MDA2008/001 Reporting Adverse Incidents and Disseminating Medical Device Alerts. Medicines Healthcare Regulatory Agency (MHRA). Medicines Healthcare Regulatory Agency. (2006). DB 2006(05) Managing Medical Devices. Medicines Healthcare Regulatory Agency (MHRA). Directive 2007/47/ec of the European Parliament and of the council of 5 September, 2007, which amended the Council Directive 93/42/EEC of 14 June, 1993 8
Appendix A Non-Specialist High Risk Equipment List Baxter olumetric Infusion Pumps yringe Drivers Automated External Defibrillators (AED) Suction Units (wall mounted and portable) Patient Controlled Analgesia Pumps (PCA s) Oxygen Flowmeters Humidification Devices Nebulisers Freego feeding pump 9
Staff Authorised Devices Record Appendix B Name Department Personal Number Date Device Name Device Model Competent Y/N Evidence Provided Review Date I understand that the above is the list of devices that I have been authorised to use and I am professionally accountable for maintaining my own competency Staff.. Line Manager 10
Appendix C Medical Devices Training Flow Chart OR OR 11
Appendix D Low Risk Device Self-Assessment Record Name Personal Number Department Role/Designation Device Name/Model Initial Training Given By Date Competent Yes/No The above is a list of the low risk devices that I use as a part of my normal working duties. Where I have self-assessed as competent in their use I understand that is is my professional responsibility to maintain this competence and I may be asked to demonstrate my knowledge at any time. Where I have self-assessed as not competent I will inform my line manager and complete appropriate training as soon as possible. Signed. 12
Appendix E High/Moderate Risk Device Self-Assessment Record Name Personal Number Department Role/Designation Device Name/Model Initial Training Given By Date Volumetric Infusion pumps Syringe drivers Automated External Defibrillators (AED) Suction Units (wall mounted and portable) Patient Controlled Analgesia Pumps (PCA) Oxygen Flowmeters Humidification Devices Nebulisers Competent Yes/No The above is a list of the high/moderate risk devices that I use as a part of my normal working duties. Where I have self-assessed as competent in their use using the competency document in Appendix F of the Medical Devices Training Policy I understand that is is my professional responsibility to maintain this competence. I may be asked to demonstrate my knowledge at any time. Where I have self-assessed as not competent I will inform my line manager and complete relevant training as soon as possible. Signed. Date I certify that the staff named has the appropriate skills and knowledge to self-assess for the above high-moderate risk devices and I agree with their assessment. Line Manager Name.. Signature. Date 13
Generic Medical Device Competency Statement Appendix F Verified Assessment: Device Name and Model Name: Personal Number: Job Title/Designation: Ward/Department: Verification of Competence is undertaken by assessment against the following criteria: These statements are designed to indicate competence to use this device, however, responsibility for its use remains with the user. If you are in any doubt as to your level of competence for this device please complete any relevant education to improve your skills. This can be from a variety of sources i.e. self-directed, e-learning, taught course etc. The Learner must be able to safely and competently demonstrate: Achieved Independently Date Achieved Pre-operational inspection and correct set-up of device: 1. How to be sure that this is the most appropriate device for the intended use? 2. How to check for damage, wear and faults? 3. How to switch the device on? 4. Which are the correct consumables/accessories for this device? 5. Is the device within its service date? Ability to operate the device safely: 6. How to check that the device is working? 7. How to use all available functions of the device? 8. Are there any limitations/contraindication for the use of this device? 9. Know what default settings may be present on this device and how to change them if necessary? 10. How to check the progress/operation of the device? 11. What factors may affect safe operation or accuracy of this device? Troubleshooting and Maintenance: 12. How to recognise device alerts/alarms and rectify safely? 13. Know what action to take if there is an error or failure of this device? 14. How to clean/decontaminate this device? 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14. 15. How and where the device should be stored safely? Statement: I have demonstrated competence and knowledge relevant to this device and I am aware of my professional responsibilities for continuing professional development. I am competent to use this device with no further training. Signed Date. Competence Verified by Trainer/Senior Sister/Line Manager Name (Print) Signed. Designation.. 15. 14
Patient End-User Agreement Form Appendix G Name. B Number. D.O.B. Name of Medical Device. Asset Number.. I have explained the use of the medical device to the patient and/or their carer I have explained the intended benefits and reasons for the use of the medical device I have explained the appropriate cleaning and storage instructions I have explained the pre-use checks I have explained what device alerts and alarms may occur I have explained where to get further advice and given appropriate contact numbers I have given appropriate written instructions on the use of this device I confirm that I have given the patient and/or carer all of the above information and that they have no further questions regarding its use Name.. Signed Designation/Role Date... Statement of Patient/Carer I understand how to use this medical device and where to get further information should I require it. Name. Signed Date Relationship to patient (if applicable)... 15