Medical Devices Training Procedure. Documentation Control. Version 4.0 Supersedes NUH version 3.0 (March 2010) All staff who use medical devices

Transcription

1 Documentation Control Reference Approving Body CL/CGP/028 Trust Board Date Approved Implementation Date Version 4.0 Supersedes NUH version 3.0 (March 2010) Consultation Date of Completion of Equality Impact Assessment Target Audience Medical Devices Training Group November 2010 All staff who use medical devices Supporting Documents and References Review Date March 2014 Refer to NUH Management of Medical Equipment and Devices Policy (CL/CGP/004) Personal Development Review/Appraisal Policy (HR/T&D/001) Lead Executive Author/Lead Manager Further Guidance/Information Stephen Fowlie Medical Director Sue Haines Assistant Director of Nursing Dan Clark, Head of Clinical Engineering Medical Devices Executive Committee and Medical Devices Training Group 1

2 CONTENTS Paragraph Title Page 1 Introduction Policy Statement 3 Roles and Responsibilities 4 Risk Management 5 Medical Device Inventory Information 5 Education and Training 6 Competency 7 8 End Users 8 9 Technical/Service Personnel 8 10 Monitoring and Audit 8 11 Equality and Diversity Statement 9 12 Equality Impact Assessment Statement 9 13 Here for You Statement 10 Appendix 1 Medical Device Training/Competency 11 Appendix 2 Generic Template for use when developing competency statements for equipment 11 Appendix 3 Example competency statement Fisher Paykel 13 Humidifier 850 and Max venture with Opti Flow Appendix 4 Training Analysis 14 Appendix 5 Patient use of medical devices when leaving hospital agreement form (End User Agreement) 15 Appendix 6 Equality Impact Assessment 16 Appendix 7 Certification of Employee Awareness 18 2

3 Medical Device Training Procedure 1. Introduction Any instrument, appliance or health care product that can be used in the diagnosis, treatment or monitoring of a patient is referred to as a Medical Device. The delivery of safe and effective treatment in healthcare is becoming increasingly dependent on the development and use of various medical devices. Whilst the use of medical devices can help support successful outcomes for patients, there is also a potential for causing patient harm. NUH is committed to reduce the risks associated with the use of medical devices by implementing competency based approaches to device training as recognised by best practice. 2. Policy statement It is the responsibility of all managerial staff (including Clinical Directors, Heads of Department, Service Managers and Consultants) to ensure that staff that use medical devices are suitably trained and competent to do so and those devices must not be used by untrained staff. Staff have a responsibility to only use medical devices for which they have had adequate training and can demonstrate competence. Where appropriate, standard protocols, guidance or procedures for the use (and user maintenance) of devices must be followed. The Trust will promote the safe and appropriate use of all medical devices by ensuring that the health care workers who use such devices: are aware of the associated risks and have access to training and support to develop and maintain their knowledge and skills. Health care professionals are individually accountable for their practice and for delegation of certain aspects of care delivery to others. Therefore they have a responsibility for ensuring that, as part of their continuing professional development, they acquire, maintain and disseminate knowledge and skills in the safe use of medical devices. Providing education and training that will allow staff to grow in confidence and achieve competence in the use of medical devices will ultimately result in the delivery of high quality care. 3

4 3. Roles and Responsibilities All users of Medical Devices are responsible for ensuring that they acquire, maintain and disseminate knowledge and skills in the use of medical devices. This will include the completion of competency statements signed by an Authorised Trainer (as defined by the Authorised Trainers List) for appropriate medical devices and ensuring copies of these statements are passed to their line manager. All managers of users of Medical Devices are responsible for ensuring that training is available for users and competency statements are completed for appropriate medical devices. This will include the induction of new staff and any temporary staff including agency staff and locums. Staff should also be available to attend training. (See also section 6.) The Medical Devices Co ordinator has a key role to many aspects of medical device management, from acquisition of new devices, supporting training of professional staff, identifying risks associated with devices and responding to specific issues when they arise. However, the Co ordinators role is very much one of support and facilitation; the responsibility for ensuring compliance with the policy will remain with the local managers. The Pracitse Development Matron for Medical Devices and the Medical Devices Training Officers (MDTO s) provide a portfolio of training and competency assessments and have an overview of the Trust wide medical device related training. The Medical Devices and Equipment Committee (MDEC) is responsible for managing all risks related to medical devices on behalf of the Trust. This will include the risks related to staff competency in the safe use of medical devices. MDEC will receive reports from the Medical Devices Training Group (and others) to assess the levels of training related risks, escalating to the Clinical Risk Committee where appropriate. All Authorised Trainers are responsible for maintaining their own knowledge and skills to a sufficiently high level to enable them to cascade training to staff members. This practitioner will have a recognised level of knowledge, as approved by the Pracitse Development Matron for Medical Devices and the Medical Devices Training Officers MDTO s; on a particular device or more specialised advice e.g. resuscitation/back care as agreed by Heads of Service or Doctors locally and the skills to pass this on. They will also deliver training according to a standardised Training Delivery Plan that has been approved by the Medical Devices Training Group (MDTG). 4

5 The Medical Devices Training Group (MDTG) is responsible for promoting the safe use of medical devices and equipment by review/monitoring of the medical device training needs analysis, identifying best practice and developing a Trustwide approach to equipment training and competency. Clinical Teams who issue or prescribe the use of medical devices in the community are responsible for ensuring that the end users (patients, relatives, careers or other users) receive appropriate training in the safe use of that device and provide them with, when appropriate written instructions. Clinical teams must also ensure that appropriate handover documentation is maintained, (see also Procedure for Managing Loan Devices.) Clinical Engineering webpage has information about the standardised inventory, competency statements and other information related to medical device training. spx 4. Risk Management Staff who cannot demonstrate their competence in the safe use of medical devices present a risk to patients, visitors, other staff, the Trust and themselves. It is therefore essential that staff receive the appropriate induction, training and competency assessment. The flowchart in Appendix 1 shows the procedure for identifying training needs and sourcing training opportunities Local managers must use this (or equivalent) approach to ensure that staff in their area are trained and competent to use the required equipment. If circumstances exist that prevent a manager from following this procedure for staff and devices, then the manager must follow the locally agreed governance route for escalation of risks. Advice on assessing this risk can be sought from the Medical Devices Training Group, the Medical Devices and Equipment Committee or the Medical Devices Training Unit. The Medical Devices Training Group will report to MDEC on trust wide risks related to staff competency in the safe use of medical devices. MDEC will assess this risk, establish controls and action plans and escalate to Clinical Risk Committee where appropriate. 5. Medical Devices Inventory Information Clinical Engineering webpage has information about the standardized inventory of diagnostic and therapeutic equipment (NHSLA 2.7.b), competency statements and other information related to medical device training. (See also section 4.3, Asset Management Medical Equipment Inventory of the Management of Medical Equipment and Devices Policy.) 5

6 spx Local Managers must ensure that all medical device users are aware of this facility. 6. Education and Training Education and training in the use of medical devices must take into account: degree of risk and therefore level of priority the need for flexible approaches to learning accessibility for all medical device users the constantly changing face of medical devices Users are encouraged to use education and training in a manner that suits their individual learning needs. This will include learning from: device operating manuals, competent colleagues, clinical educators, practice development matrons, local competency based training, intranet based information, a ward based manual, and the Medical Devices Training Officer. 6.1 Process for identifying which permanent staff are authorised to use medical equipment on the inventory (NHSLA 2.7.c) An analysis of the devices required for department function will be periodically performed to identify which staff, by professional role, are required to use which devices in each clinical area. The full details of this analysis is held on a central database with local managers having access to relevant sections. An example of this analysis is given in Appendix 4. All line managers of users of Medical Devices are responsible for: ensuring that staff are aware of the identified equipment for use in their area ensuring any changes to department function or local inventory requirements that may effect this analysis are reported to the MDTG 6.2 Process for determining the training required to use the equipment identified on the inventory (NHSLA 2.7.d) All line managers of users of Medical Devices are responsible for: identifying which staff need to be trained on the devices in use within that area with reference to the analysis in 6.1 and the medical equipment inventory as appropriate (Clinical Engineering can provide support in reviewing the inventory) ensuring that Medical Devices training is provided as part of Local Induction for new and any temporary staff including agency staff and locums. 6

7 6.3 Process for ensuring that the identified training needs of all permanent staff are met (NHSLA 2.7.e) All line managers of users of Medical Devices are responsible for: ensuring, through individual Performance and KSF reviews, that staff have attended all appropriate training relating to Medical Devices taking any remedial action required. ensuring that staff are released to attend training ensuring that staff complete the training and competency statements ensuring that any issues in meeting the requirements set out within this procedure are reported to the Chair of MDEC and escalated through local and Trust agreed Risk Management processes. ensuring that all records of training are recorded on the Trust s training database Oracle Learning Management (OLM). Advice from sourcing and accessing medical devices training is available from MDEC, MDTG, Practice Development Matron for medical devices or the MDTOs. 7. Competency Staff using medical devices must be competent in their use. Healthcare professionals must undertake assessment of competence. For the majority of medical devices verification of this assessment must be by direct observation by an authorised trainer. For certain devices, alternative verification may be used which must be agreed by Heads of Service. This verification process must be documented locally and approved by Clinical Risk Committee. Line managers are responsible for identifying devices used in their areas and ensuring that all users are competent in their use. Competency assessments must be reviewed regularly (NHSLA 2.7.d). The frequency of this reassessment may vary; general guidance is available from the Medical Devices Training Group, The Practise Development Matron for medical devices or the Medical Device Training Officers, but would be expected to be at least every 3 years. For some medical devices this frequency will be predefined. E.g. defibrillators are set at 1 year. The frequency of reassessment is included on the Competency Statements. An individual can voluntarily refer themselves for competency assessment and further training as required. All records of training/competence must be recorded the Trust s training database Oracle Learning Management (OLM) which will include competency review dates. It is the responsibility of the individual user and their line manager to review competency in the use of medical devices at the time of their appraisal. 7

8 Clinical Engineering webpage has information about the standardised inventory, competency statements and other information related to medical device training. spx 8 End Users It is the responsibility of staff issuing or prescribing medical devices to end users (patient, relatives, carers and other users) to ensure that the end user is appropriately trained and competent to use the device in accordance with DB2006 (05). Completion of the Agreement Form for Patient Use of Medical Devices When Leaving Hospital (Appendix 5) is to be retained within the patients medical files. When appropriate, end users must also be issued with appropriate written instructions that will include details of who to contact in the event of a problem with the device, how to return the device and who to contact for further information. (See Procedure for Managing Loan Devices for further guidance.) 9. Technical/Service Personnel Service and maintenance personnel called to work on medical devices and equipment (whether in house staff or external agents) must be appropriately trained and competent. Further advice can be sought from the Medical Devices and Equipment Committee. 10. Monitoring and Audit (NHSLA 2.7.f) Healthcare professionals delivering or co ordinating medical devices training must ensure that attendance records are completed signed and documented centrally on the Trust s training database Oracle Learning Management (OLM). Line managers will monitor medical device training and competency records as part of appraisals and mandatory training requirements. OLM reports are reviewed periodically by MDTG and escalated to MDEC and CRC when appropriate. All incidents and near misses, related to the use of medical devices will be investigated through local directorate governance forums to see if training, or the lack of it, was a factor. Reports on such incidents will be reviewed by MDEC and devolved to MDTG when appropriate. Where appropriate, such incidents and trends will be escalated to CRC. 8

9 11.0 Equality and Diversity Statement All patients, employees and members of the public should be treated fairly and with respect, regardless of age, disability, gender, marital status, membership or non membership of a trade union, race, religion, domestic circumstances, sexual orientation, ethnic or national origin, social & employment status, HIV status, or gender re assignment. All trust polices and trust wide procedures must comply with the relevant legislation (non exhaustive list) where applicable: Equal Pay Act (1970 and amended 1983) Sex Discrimination Act (1975 amended 1986) Race Relations (Amendment) Act 2000 Disability Discrimination Act (1995) Employment Relations Act (1999) Rehabilitation of Offenders Act (1974) Human Rights Act (1998) Trade Union and Labour Relations (Consolidation) Act 1999 Code of Practice on Age Diversity in Employment (1999) Part Time Workers Prevention of Less Favourable Treatment Regulations (2000) Civil Partnership Act 2004 Fixed Term Employees Prevention of Less Favourable Treatment Regulations (2001) Employment Equality (Sexual Orientation) Regulations 2003 Employment Equality (Religion or Belief) Regulations 2003 Employment Equality (Age) Regulations 2006 Equality Act (Sexual Orientation) Regulations Equality Impact Assessment Statement NUH is committed to ensuring that none of its policies, procedures, services, projects or functions discriminate unlawfully. In order to ensure this commitment all policies, procedures, services, projects or functions will undergo an Equality Impact Assessment. Reviews of Equality Impact Assessments will be conducted inline with the review of the policy, procedure, service, project or function. 9

10 13.0. Here for You Standards We Are Here For You Statement: This Trust is committed to providing the highest quality of care to our patients, so we can pledge to them that we are here for you. This Trust supports a patient centred culture of continuous improvement delivered by our staff. The Trust established the Values and Behaviours programme to enable Nottingham University Hospitals to continue to improve patient safety, outcomes and experiences. The set of twelve agreed values and behaviours explicitly describe to employees the required way of working and behaving, both to patients and each other, which would enable patients to have clear expectations as to their experience of our services. 10

11 Appendix 1 Medical Device Training/Competency Process for identifying, determining and ensuring which permanent staff are authorised to use medical equipment on the inventory, frequency of updates and staff training needs are met (NHSLA 2.7) Consider any previous medical equipment training and competency assessments Evidence required Training or competency renewal requirement identified A training analysis is available locally from your manager or by contacting the PDM for Medical Devices, MDTO S or the MDTG Training/Competency Arrange to attend training and or competency assessment Supervised practice or competent assessed Supervised practice Trainee may use the equipment under direct supervision until feeling confident to be competency assessed Assessment competency assessment repeated every 3 years unless stated otherwise Equipment competency assessment undertaken and verified. Record verification on OLM via PDM medical devices Staff not achieving full competency assessment MUST re book for further training and undertake a full competency re assessment 11

12 Appendix 2 Example Generic Template for use when developing competency statements for equipment Competency Statement Verified Assessment Generic Product (Re assessment Period) Surname: Title (Mr/Mrs/Miss/Dr etc): Forename(s): Extension No: Job Title/Designation: Dept/Directorate & Ward/Unit: Verification of competence is undertaken by assessment against the following statements: These statements are designed to indicate competence to use this device. Responsibility for use remains with the user, so if you are in any doubt regarding your competence to use the device, you should seek education to bring about improvement. Various methods including, self directed learning, coaching & formal training may be initiated. (Consider local resources, product operating manual, the intranet & discussion with colleagues or the Medical Devices Trainer) You must be able to score at least level I (Independent) to all the questions before being considered competent. If you are not competent, instigate learning and then a repeat assessment.. Competence must be verified by Authorised Trainers. The Learner Must Be Able To Safely And Competently Demonstrate: Pre operational inspection and correct set up of the device 1. How to be sure that this is the most appropriate device for the intended use? 2. How to check for damage / wear / faults? 3. How to switch on the device? 4. How to be sure that all relevant accessories are available? 5. How to check that the device is working? Ability to operate the device safely 6. How to use all functions of the device? 7. Are there any limitations or contra indications for the use of the device? 8. Know what default settings may be present & how to change these if necessary? 9. Is the device within its use by / service date? 10. How to check the progress / operation of the device? 11. What factors may affect safe operation or accuracy of the device? Review maintenance and take appropriate action 12. The limitations of this device? 13. What action to take if there is an error or failure with the device? 14. How to clean / decontaminate the device? 15 How to store the device safely? Minimum Level 1. I 2. I 3. I 4. I 5. I 6. I 7. I 8. I 9. I 10. I 11. I 12. I 13. I 14. I 15. I Final assessment date: Statement I have demonstrated competence and knowledge relevant to this device and I certify that I am aware of my professional responsibilities for continuing professional development and I am accountable for my own actions. I am competent to use this product without further training. Signature: Date: I require further training before I can use this product in a competent manner Signature: Date Competence Verified By: Name (Print) Verifiers Signature Date Keep this form in your personal portfolio or training record. Ensure that your manager has seen the form & checked that details of your training/competence have been recorded on OLM. Medical Device Competency Page 12 of 18 Version: Date Of Issue: Author: NUH 12

13 Appendix 3 Example Competency Statement Competency Statement Verified Assessment Fisher & Paykel Respiratory Humidifier 850 and Max Venturi meter with Opti flow interface. 3 Yearly Re assessment Period Surname: Title (Mr/Mrs/Miss/Dr etc): Forename(s): Extension No: Job Title/Designation: Dept/Directorate & Ward/Unit: Verification of competence is undertaken by assessment against the following statements: These statements are designed to indicate competence to use this device. Responsibility for use remains with the user, so if you are in any doubt regarding your competence to use the device, you should seek education to bring about improvement. Various methods including, self directed learning, coaching & formal training may be initiated. (Consider local resources, product operating manual, the intranet & discussion with colleagues or the Medical Devices Trainer) You must be able to score level I (Independent) to all the questions before considering yourself to be competent. If you are not competent, instigate learning & then repeat assessment. Competence must be verified by Authorised Trainers. The Learner is able to safely and competently demonstrate: Min Level Verifier Rating Date: Pre operational inspection and correct set up of the device. 1. How to correctly assemble the unit and identify the component parts? Ability to operate device safely. 2. How the humidifier connects with its heated wire circuit? (Explain in detail). 3. What external precautions should be considered when setting up the unit to prevent it from alarming? 4. The causes that may trigger the unit to alarm? 5. What information is available from the unit to help troubleshoot the alarm? 6. Which fluid should be attached to the Auto Feed Humidification Chamber? 7. The optimum temperature for the Tracheostomy setting? 8. The optimum temperature for the facemask setting? 9. How to change between the two pre set modes of delivery? 10. Which parts of the unit s circuitry are disposable? 11. The potential hazards that using this unit may present? 12. How to use other circuits safely with this unit? 13. When this humidifier should not be used? 14. The optimal position for the unit to be placed? 15. What effect increasing the gas flow through the unit will have and what may happen? 16. How to use this unit safely on neonates and children? (if applicable) Use with a Max Venturi Opti system: 17. How to connect the system to the humidifier? 18. Which mode to select and how to do this? 19. Switch the unit on and calibrate to room air? 20. How you would conduct 100% oxygen calibration? 21. How to set the flow rate and oxygen content? 22. How to attach the Opti flow delivery interface to the patient? 23. How to disconnect the Opti Flow Nasal High Flow Cannula? Review maintenance and take appropriate action 24. How to effectively clean the humidifier? 25. How to identify and report faults, when and where to return the device for servicing? Statement I have demonstrated competence and knowledge relevant to this device and I certify that I am aware of my professional responsibilities for continuing professional development and I am accountable for my own actions. I am competent to use this product without further training. 1. I 2. I 3. I 4. I 5. I 6. I 7. I 8. I 9. I 10. I 11. I 12. I 13. I 14. I 15. I 16. I 17. I 18. I 19. I 20. I 21. I 22. I 23. I 24. I 25. I Signature: Date: I require further training before I can use this product in a competent manner Signature: Competence Verified By: Name (Print) Verifiers Signature Date Date Keep this form in your personal portfolio or training record. Ensure that your manager has seen the form & entered details of your competence in their records. Medical Device Competency Page Version: NUH 1.1 Fisher Paykel Respiratory Humidifier & Max Venturi Opti Flow System 13 of 18 Date Of Issue: April 2011 Author: D Williams 13

14 Appendix 4 Training Analysis Apple Tree Ward Equipment Registered Nurse Midwives Allied Health Professional Clinical Support Worker Healthcare Assistant Auxiliary Rehabilitation Assistant Transitional Care Support Worker Play Leader Nursery Nurse Consultant Medical Medical Other Dental Braun Pro 3000 Tympanic Thermometer Y Y Y Y N N Bed Frames & Mattresses DXU BVI 3000 Bladder Scanner Y N N N N N Graseby 3200 Y N N N N N Graseby 500 Y N N N N N Hoists Y Y Y Y N N Medisense Optimum Exceed BGM Medtronic Lifepak AED 1000/20e Defibrillator Nutricia Flocare Infinity Enteral Feeding Pump Welch Allyn Spot Vital Signs 420 Monitor Dinamaps Y Y Y Y N N ECG 12 Lead Y N N N N N Graseby 3100 Y N N N N N Hoist Y Y Y Y N N McKinley T34 Y N N N N N Opthalmoscope N N N N Y Y Secca Scales Y Y Y Y N N Smiths Omnifuse Y N N N N N 14

15 Appendix 5 Affix Patient label here Patient name.. Hospital No.. Date of birth. Agreement form for patient use of a medical device(s) when leaving hospital (End User Agreement) Name(s) of medical device(s): I have explained the use of the medical device(s) to the patient and/or their carer. I have explained the intended benefits/reasons of the medical device(s). I have explained storage instructions. I have explained pre user checks and any potential problems of the medical device(s). I have explained maintenance and cleaning instructions. I have explained how to get further advice. I understand that I will receive relevant literature (when applicable) from the supplier. Statement of patient/carer I understand how this/these medical device(s) work and what their intended purpose is. Signature Print Name... Date...Relationship to patient (if applicable). I have confirmed that the patient/carer has no further questions regarding the use of this/these medical device(s) Signature. Print Name.. Date....Contact Number... Job Title This form must be retained in the patients notes. This information can be provided in different languages and formats. For more information please contact Clinical Engineering on ext

16 Appendix 6 Equality Impact Assessment Report Outline Remember that your EIA report should demonstrate what you do (or will do) to make sure that your service/policy is accessible to different people and communities, not just that it can, in theory, be used by anyone. A one size fits all approach can often inadvertently exclude. 1. Name of Policy or Service 2. Responsible Manager Sue Haines 3. Name of person Completing EIA Dan Clark 4. Date EIA Reviewed November Description and Aims of Policy/Service (including relevance to equalities) It is the responsibility of all managerial staff (including Clinical Directors, Heads of Department, Service Managers and Consultants) to ensure that staff that use medical devices are suitably trained and competent to do so and those devices must not be used by untrained staff. Staff have a responsibility to only use medical devices for which they have had adequate training and can demonstrate competence. Where appropriate, standard protocols, guidance or procedures for the use (and user maintenance) of devices must be followed. The Trust will promote the safe and appropriate use of all medical devices by ensuring that the health care workers who use such devices: are aware of the associated risks and have access to training and support to develop and maintain their knowledge and skills. 6. Brief Summary of Research and Relevant Data N/A 16

17 7. Methods and Outcome of Consultation Consultations have been carried out with the following: CRC Medical Devices Training Group Medical Device Co ordinators Comments from the above consultations have been received and incorporated where appropriate 8. Results of Initial Screening or Full Equality Impact Assessment: Equality Group Assessment of Impact Age None Gender None Race None Sexual Orientation None Religion or belief None Disability None Dignity and Human Rights None Working Patterns None Social Deprivation None 9. Decisions and/or Recommendations (including supporting rationale) Following initial monitoring no impact has been identified therefore a full Impact Assessment is not required. 10. Equality Action Plan (if required) N/A 11. Monitoring and Review Arrangements (including date of next full review) Recommend that this policy and EIA be reviewed 3 years in order to assess its functionality. An earlier review date may be implemented if any patient safety issues are raised or changes to regulations are identified. 17

18 Appendix 7 CERTIFICATION OF EMPLOYEE AWARENESS Document Title Version (number) 4.0 Version (date) (Author / HQ to insert) I hereby certify that I have: Identified (by reference to the document control sheet of the above policy/ procedure) the staff groups within my area of responsibility to whom this policy / procedure applies. Made arrangements to ensure that such members of staff have the opportunity to be aware of the existence of this document and have the means to access, read and understand it. Signature Print name Date Directorate/Department The manager completing this certification should retain it for audit and/or other purposes for a period of six years (even if subsequent versions of the document are implemented). The suggested level of certification is; general manager (clinical directorates) and deputy director or equivalent (non clinical directorates). The manager may, at their discretion, also require that subordinate levels of their directorate / department utilize this form in a similar way, but this would always be an additional (not replacement) action. 18