Training in the Safe Use of Medical Devices Policy
Contents
1. pump Battery battery empty Occlusion out of pump DOOR open ATTN pump on hold NO cassette Page 8 of 10 BATT low battery FEED Empty Lock pump locked DOSE Done ER System fail 8 State battery charge times and how long a fully charged battery will last 9 Demonstrate storage and cleaning of equipment during and after use 70 Explain policy procedure to be taken in the event of an incident or pump malfunction Self assessment statement Having said yes to all the questions above amp taken into account my personal assessment of my competence with the device declare that am competent to use this device without further training Signature Date require further training before can use this device in a competent manner Signature Date Indicate how you plan to meet your learning needs Peer Trainer Assessment statement have peer assessed and they are competent to use this device without further training Signature Date Print name Keep this form in your personal portfolio or training record Ensure that your manager has seen the form amp entered details of your competence in their records Page 9 of 10 THE NEWCASTLE UPON TYNE HOSPITALS NHS FOUNDATION TRUST IMPACT ASSESSMENT SCREENING FORMA This form must be completed and attached to any procedural document when submitted to the appropriate committee for cons2. 4 d Can we reduce the impact by taking different action N A Comments Action Plan due or Not Applicable N A If any reader of this procedural document identifies a potential discriminatory impact that has not been identified on this form please refer to the Policy Author identified above together Date 11 09 2013 with any suggestions for the actions required to avoid reduce this impact For advice on answering the above questions please contact Frances Blackburn Head of Nursing Freeman Walkergate or Christine Holland Senior HR Manager On completion this form must be forwarded electronically to Steven Stoker Clinical Effectiveness Manager Ext 24963 steven stoker nuth nhs uk together with the procedural document If you have identified a potential discriminatory impact of this procedural document please ensure that you arrange for a full consultation with relevant stakeholders to complete a Full Impact Assessment Form B and to develop an Action Plan to avoid reduce this impact both Form B and the Action Plan should also be sent electronically to Steven Stoker within six weeks of the completion of this form IMPACT ASSESSMENT FORM A
3. The Newcastle upon Tyne Hospitals NHS Foundation Trust Training in the Safe Use of Medical Devices Policy Effective From 29 January 2015 Expiry Date 30 September 2016 Date Ratified 29 January 2015 Ratified By Medical Device Steering Group Introduction 1 1 1 2 1 3 This policy applies to all staff and their managers who are required to use any type of medical device or therapeutic equipment as part of their work It defines processes to ensure that staff are prepared and trained to safely operate use equipment and that risk management systems are in place and used It is the Trust s aim to ensure all staff using medical devices are competent in their use To be competent is to be adequately trained knowledgeable and capable of operating a device in a safe and effective manner Education and training is essential to ensure that users of medical devices have appropriate knowledge and skills to operate medical devices Only staff whose training and competence has been established should use any medical device independently For the purpose of this policy the term Medical Device encompasses devices as defined in MHRA Bulletin 17 Medical Devices and Medicine Products amended April 2006 and can be summarised 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 t
4. agers of Users of Medical Devices are responsible for e Ensuring that all equipment used is recorded on the Trust inventory e Agreeing with individual members of staff which equipment from the inventory they are expected to use and the process for training and competency assessment including frequency of updates e Ensuring that training is made available for all users of devices where training is necessary and that all equipment users are properly trained and competent e Ensuring that users complete competency records for appropriate medical devices The Medical Devices Steering Group is responsible for e Developing implementing and monitoring compliance with this policy to ensure best practice e Developing action plans where there is limited assurance of compliance with the policy Training The ward department manager or nominated deputy is required to compile an inventory of medical devices used in their area of responsibility Assistance to compile this inventory can be obtained by clicking on Estates Log and Query on the Trust intranet page enter the department telephone number and select Show Assets for your Department This inventory must be reviewed annually and or when new equipment devices are introduced into their area of responsibility An example of documentation used to record this can be found as Appendix 1 alternatively the updated printed list from the intranet may be used A training needs r
5. e the way services are provided and the way staff are treated reflects their individual needs and does not unlawfully discriminate against individuals or groups This policy has been properly assessed 8 Monitoring the Compliance Effectiveness of this Policy Standard process Monitoring and audit Directorate activity Via a quarterly My Devices The Medical Quarterly compliance with report on training System Manager Devices processes for identifying activity to the Steering which staff are authorised Medical Devices Group to use the equipment Steering Group Process for determining Sample spot check Medical Device The Medical Annual training requirements and Steering Group Devices any identified training Steering needs are met Group Monitoring of themes and Via a quarterly The Medical Quarterly trends relating to Medical report on incident Devices Device incidents activity relating to Steering accidents and near Medical Devices to Group misses the Medical Devices Steering Group Medical Device Training Via an annual The Chair of the The Medical Annual activity report on training Medical Device Devices activity to the Trust Steering Group Steering Education Board Group 9 Consultation and Review of this Policy This policy has been reviewed in consultation with the EME Services Officer Medical Equipment Loan Library Manager Risk Management Quality and Safety Lead Head of Unit Medical Physics and t
6. eir responsibilities and are shown to be competent through generic and specific training programmes That adequate records are maintained or available at Directorate Department level to account fully for training of all staff Duties Roles and Responsibilities All Users of Medical Devices are responsible for e Being familiar with their responsibilities under this policy and complying with them e Ensuring their own competence in the use of an item of equipment and have successfully completed training where necessary to use the equipment independently Ensuring that on the completion of competency assessment this information is recorded on the Trust Medical Devices training recording system Medical Devices Training My Devices recording system accessible via the Learning Zone on the Trust Intranet All users of Medical devices must adhere to the following principles before using any medical equipment e Only use equipment identified on the Trust Medical Devices Inventory e Do not use equipment unless trained competent to do so Page 2 of 10 4 2 4 3 5 1 5 2 e Identify their training requirements with line manager supervisor e Have completed necessary training and be deemed competent through self assessment or by a supervisor trainer to operate independently e Always visually inspect the equipment for signs of damage prior to use e Know where the user manual instructions are located All Man
7. eview in relation to medical devices within the directorate should be undertaken by department managers or nominated deputies to identify training and competency needs at appointment local induction and as part of annual reviews This should include training updates as well as training on new devices Consideration must be given to ensure competencies set meet individual staff needs Personal Learning plans can be used to assist this process see example attached as Appendix 2 Page 3 of 10 5 3 5 4 6 1 6 2 6 3 6 4 6 5 6 6 6 7 In the event of the appropriate training being unavailable from any source this must be raised as a risk and included on the risk register Until this issues has been resolved or rectified the equipment must not be used No medical equipment shall be used clinically and independently unless the operators who use the device s have received appropriate competency assessment device training which includes pre use checks to be made prior to the use of any medical device Competency Statements It is essential that all practitioners using items of medical equipment independently are deemed competent in the safe and effective use of the equipment and can demonstrate this to their manager Training should be provided by a practitioner competent in the functions and operations of the device An example of a competency statement is attached as Appendix 3 Where a competency statement does not
8. exist expert users within areas can develop the statement for assessment using the competency statement template on the EME Loan Library intranet site This must then be authorised by the Matron Clinical Manager for the area of use The competency statement must then be posted by the authorising person on the EME Loan Library intranet site Should a member of staff be unable to demonstrate competence their ward department manager must arrange re training before the individual can operate the medical device in a clinical environment independently Staff beginning employment with the Trust must complete the Trust corporate induction program where the following medical device related topics will be covered Infection Control Fault Reporting Clinical Risk Competency Assessment Reporting procedure for adverse incidents Safe lifting amp handling When a new medical device is introduced into an area a review of device training needs should be undertaken and if required staff should receive training or competency instruction before using the equipment All training and competency assessment information should be recorded on the Trust Medical Devices Training My Devices recording system accessible via the Learning Zone on the Trust intranet Reference should be made to the Management of Medical Devices Policy Page 4 of 10 7 Equality and Diversity The Trust is committed to ensuring that as far as is reasonably practicabl
9. he Medical Device Steering Group 10 Bibliography NHSLA Risk Management Standards for Acute Trusts published by the NHS Litigation Authority January 2010 MHRA Devices in Practice August 2008 Author Chair of Medical Devices Steering Group Review by EME Services Officer RVI Page 5 of 10 Appendix 1 Medical Device Inventory for wards departments Site Directorate Department Equipment specify type Potential operators for this Managers Signature manufacturer amp model quip Page 6 of 10 Appendix 2 Personal Learning Plan Department Date What do want to What will do to What resources How will know Target Date Review learn achieve it support will need have succeeded Page 7 of 10 Appendix 3 The Newcastle upon Tyne Hospitals NHS Foundation Trust Self Assessment Peer Assessment Competency statement for Abbott FreeGo feeding Pump HIGH RISK DEVICE DO NOT USE this item until you have received training in its operation Surname Forename s Job Title Designation Personnel Number Directorate Ward Department Self verification Peer assessment 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 abo
10. ideration and approval Policy Title Training in the Safe Use of Medical Devices Policy Policy Author Jackie Moon Chair of Medical Devices Steering Group Yes No You must provide evidence to support your response 1 Does the policy guidance affect one group less or more favourably than another on the basis of the following denotes protected characteristics under the Equality Act 2010 e Race No e Ethnic origins including gypsies and travellers No e Nationality No e Gender No e Culture No e Religion or belief No e Sexual orientation including lesbian gay and bisexual people No e Age No e Disability learning difficulties physical disability sensory impairment and No mental health problems e Gender reassignment No e Marriage and civil partnership No 2 Is there any evidence that some groups are affected differently No 3 If you have identified potential discrimination which can include associative discrimination i e direct discrimination against someone because they associate No with another person who possesses a protected characteristic are any exceptions valid legal and or justifiable 4 a Is the impact of the policy guidance likely to be negative No If yes please answer sections 4 b to 4 d 4 b If so can the impact be avoided N A A c What alternatives are there to achieving the policy guidance without the impact N A
11. o be used for human beings for the purpose of e diagnosis prevention monitoring treatment or alleviation of disease e diagnosis monitoring treatment alleviation of or compensation for an injury or handicap e investigation replacement or modification of the anatomy or of a physiological process e 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 Page 1 of 10 1 4 2 1 2 2 3 1 3 2 3 3 This purpose of this policy is to support safe practice It does not constrain your Clinical autonomy whatsoever your own clinical judgement is to be exercised at all times and as such clinical need emergency situations may over ride this policy In exercising your own professional judgement any alteration from this policy must be noted on a Datix incident form This is important for legal accountability Scope The Newcastle upon Tyne Hospitals NHS Foundation Trust aims to ensure that all clinical staff who operate diagnostic or therapeutic medical devices do so in a safe manner It is a Trust requirement that all clinical staff involved with the care of patients adhere to the principles of this policy Aims To ensure that all staff operating diagnostic or therapeutic equipment can do so in a safe and effective manner That all staff are made aware of th
12. ut improvement Various methods including self directed learning and formal training may be initiated Carry out an initial assessment You must be able to answer yes to all the questions before considering yourself to be competent If you are not competent instigate learning amp repeat self verification Peer assessment will involve the practitioner demonstrating competence against the following statements to an experienced colleague who had already undergone assessment Self Assessment peer assessment statements Initial Final Assessment Assessment 1 Identify clinical use for the FreeGo feeding pump Y N Y N 2 Explain demonstrate pre use safety checks precautions setting up Y N e Connect power supply to the pump e Identify correct consumables to be used with the pump e Explain correct positioning of the device e Demonstrate loading of the giving set e Turn the pump on 3 Demonstrate priming the giving set manually Y N 4 Demonstrate priming the giving set automatically Y N 5 Explain identify the control dial functions and touch panel control keys Y N including e Power off Charge e Set rate e Set dose e Run e Hold e Volume fed e Clear volume e Lock feature e Adjusting the alarm volume and display light 6 Demonstrate attaching the set to the patient and initiating feeding Y N 7 Explain all screen information obtained during feeding including how to Y N rectify alarms Occlusion into
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