Standard Operating Procedure 4 (SOP 4)

Training - User Training on Medical Devices Why we have a procedure? Professionals in health and social care are personally accountable when they use medical devices and therefore must ensure that they have appropriate training. This procedure is to ensure all staff are trained in the use of medical devices as deemed necessary by their line manager. An individual who uses the device in a way not intended, or against the instructions of the manufacturer may be liable for any consequences. This procedure is in compliance with CQC Fundamental Standardssection C of Regulation 12: Safe Care and Treatment. This regulation states that persons providing care or treatment to service users should have the qualifications, competence, skills and experience to do so safely.

What overarching policy the procedure links to? Medical Devices Policy

Which services of the trust does this apply to? Where is it in operation? Group Mental Health Services Learning Disabilities Services Children and Young People Services

Inpatients   

Community   

Locations all all all

Who does the procedure apply to? All medical staff, nursing staff and allied health professionals Ward/Department Managers

When should the procedure be applied? When a new member of clinical staff joins the Trust including bank staff and students in training When clinical staff are identified as requiring training through training needs analysis

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How to carry out this procedure Baseline Assessment Ward/Department Managers/Supervisors have the responsibility to ensure that all new clinical staff (including bank staff and students in training) have received training on all medical devices relevant to their specific area. To identify which medical devices the staff member will use within their ward/department a baseline assessment will be undertaken using the Medical Equipment Competency Review form contained in the local induction pack (see enclosed Example of Medical Equipment Competency Review Form). Each ward/area/department has a list of commonly used equipment and this has been included on the form Once completed the form is returned, as directed in the Local Induction Pack, for recording on the Medical Device Training Database A training needs analysis will be developed by Medical Device Training team for each area to determine training requirements for staff in that area. This will form the basis for appropriate training and updates Ward/Departmental Managers to identify any training needs and notify the Medical Device Trainers who will coordinate/deliver the training Medical/Clinical Device Training Delivery Training will be delivered by any of the following personnel: Manufacturers / Company Trainers Medical Device Trainers and / or other Matron/Practice Development Nurse Ward/Department Staff who have undertaken relevant Train the Trainer courses These will be Ward / Department Managers or other staff nominated, who will become Device Training Link Staff (Train the Trainers). Staff with a supervisory / managerial role within an area must demonstrate ability to teach and take a lead role in supporting junior staff in the use of equipment within their area of work. The training provided will be in the safe use of the device itself but not in the clinical interpretation of any result arising from the use of the equipment. This may be delivered in groups or on an individual basis as deemed necessary. Relevant assessment of competency in the use of the equipment will be checked by trainers. These can be undertaken either on the ward or in a simulated environment i.e. training room. Link staff will be responsible for checking competency on the use of devices, after receiving appropriate training, confirming clinical competence and identifying any staff for whom there is a need to provide additional training Further training and support will be given where deemed appropriate and / or when identified through incident reporting mechanisms, on an individual and / or group basis

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Equipment Training Medical devices are risk categorised as High, Medium or Low risk. The Medical Device Trainer will liaise with the local Medical Device Leads and MD group to assess any new equipment. For new high risk devices introduced to an area, the ward / department managers will ensure that 75% of identified users are trained in the use of the device prior to introduction. For medium and low risk devices the ward / department managers, in consultation with the training provider, will ensure that devices will only be used when competency is attained by the required user. Training will be developed in all risk categories as follows: For High Risk Equipment, i.e. all infusion devices, ventilators etc.

Training will be followed with a competency package or observational assessment by a nominated expert user of the dedicated equipment. Reassessment of competency will be prompted for review on a 3 yearly basis via the TNA and retraining delivered as appropriate.

For Medium Risk Equipment, i.e. NIBP equipment, cardiac monitors etc.

Training will be followed by a competency package or observational assessment at the time of training delivery. Reassessment of competency will be prompted for review on a 6 yearly basis via the TNA and retraining delivered as appropriate. Training is a one off session with a competency package or observational assessment at the time of training delivery.

For Low Risk Equipment, i.e. tympanic thermometers, beds etc.

Specialist equipment training Training with specialist devices will be delivered as outlined according to the frequency outlined in specialist areas where there is a concentration of Specialist Medical / Clinical Devices, e.g. ECT equipment. Staff must undergo specific training packages that are competency based for high risk equipment or undergo observational assessment by a nominated expert user of the equipment. Usage of specialist equipment outside of the specialist area will be kept to the absolute minimum. Where it is necessary for clinical reasons to use specialist equipment in general areas, the equipment will only be operated by a person competent to do so. Training on equipment used for manual handling and cardiopulmonary resuscitation will be delivered via designated mandatory training courses and recorded on the Mandatory Training Database.

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Medical Physics & Clinical Engineering Medical Devices Training Database Staff will be logged onto the database by name, department and payroll number. Maintenance and central administration of this training database will be carried out by designated staff within the Medical Physics & Clinical Engineering Department The Medical Device Training Database will record all completed Medical Device Competency Review Forms and basic / competency based training undertaken by staff. It will prompt the need for reassessments in line with the risk categorisation of the equipment To ensure that a comprehensive equipment training register is maintained all trainers / line managers will be responsible for collecting records on the training they deliver / arrange for their staff and for ensuring that these are forwarded to Medical Device Trainers for entry onto the database A report of generic and specialist equipment, and the training status for each member of staff required to use it will be developed for each ward / area / department and made available to the ward / department managers via the Departmental Training Needs Analysis reports. These will be provided quarterly or as requested and identify all training requirements The database will produce Group Attainment, Service Group/Speciality Attainment and Medical Attainment Reports. These will be provided quarterly or as requested

What do these terms mean? CQC - Care Quality Commission are the independent regulator of health and adult social care in England. They make sure health and social care services provide people with safe, effective, compassionate, high-quality care and encourage them to improve TNA - Training Needs Analysis is the process of identifying the training needs of staff across the organisation NIBP - Non-Invasive Blood Pressure Monitor used to closely monitor blood pressure in patients of all ages ECT - Electroconvulsive Therapy machine used for treatment for many psychiatric disorders

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User Training on Medical Devices Flow Chart New Member of Staff Joins the Trust Completes Medical Equipment Competency Review (Self-Assessment Form) Contained in Local Induction Pack

Ward / Department Manager ensure completed form is returned as directed in Local Induction Pack for recording on the Medical Device Training Database. Identifies any Training Needs from Medical Equipment Competency Review and arranges appropriate training.

If training is required, contact Medical Device Trainers who coordinates training

Generic Devices Training delivered by Medical Device Trainers / Train the Trainers or Company Trainers

Specialist Devices Training delivered by Train the Trainers or Company Trainers

When training is completed a record of training delivered sent to Medical Device Trainers to update database

MEDICAL DEVICE TRAINING DATABASE Monitoring Ward/Dept. TNA’s produced Quarterly 

TNA distributed to wards/depts.



Prompts refresher training

Group Attainment Reports Produced Quarterly for Group Managers and Governance Leads Service Group/Speciality Attainment Reports Produced Quarterly for Speciality Managers and Matrons

 High Risk (Red) every 3 years  Medium Risk (Amber) every 6 years  Low Risk (Green) one off training

Training Needs Analysis

Audit via random selection of TNA’s Quarterly by Ward Managers/Matrons & Medical Device trainers

Medical Device Trainers coordinate training as per red boxes above

Medical Attainment Reports Produced Quarterly for Group Medical Directors

From ward/dept. TNA Manager identifies training needs for all staff

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RWHT Medical Engineering Dept.: Tel:01902 307999 (ext. number above)

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Example of Medical Equipment Competency Review Form BCPFT MEDICAL EQUIPMENT COMPETENCY REVIEW (EXAMPLE) NAME: DATE: ESR/ ASSIGNMENT NUMBER:

DEPARTMENT /TEAM: JOB TITLE & BAND:

LINE MANAGER:

Other info:

If you are unsure of the equipment description please ask Department/Ward Manager, or contact the Medical Device Trainers on 07920 278520 or at [email protected] IF YOU HAVE PUT

YES IN COLUMN (1) YOU MUST COMPLETE COLUMN (2)

Generic Equipment

(1) Do You Use Equipment Yes / No

(2) Are you Competent to use this equipment Yes / No

High Risk Equipment (Devices listed will be relevant to team / location) Medium Risk Equipment

( Devices listed will be relevant to team / location)

Low Risk Equipment

( Devices listed will be relevant to team / location)

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(1) Do You Use Equipment Yes / No

Generic Equipment

(2) Are you Competent to use this equipment Yes / No

Specialist / Unique Equipment to your Ward/Dept. (Please add below)

Name of the post holder (please print): Declaration Limits of Competency I have completed the enclosed Medical Equipment Competency Review. I will not use any equipment that I am not confident and competent to use or for which training needs have been identified. Date:

Signature:

Line Manager: (please print) Declaration Limits of Competency I verify that I have reviewed the Medical Equipment Competency Review form with the above named post holder and have identified outstanding training needs to be addressed. I have reinforced the restriction on the use of any equipment for which training needs have been identified. Date:

Signature:

Date copy sent to the Medical Device Trainers: Print this assessment document as a double sided form

Please send a copy of this form via e-mail to [email protected] or fax 01902695732 for the attention of the Medical Device Trainers. N.B. A copy must be retained in the employee’s personal file

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Where do I go for further advice or information? Medical Devices Group Responsible for the development and implementation of Medical Devices Policy and associated procedures Ensure that medical device related training requirements are identified and training programmes developed Define persons responsible for device management task, training and safe device operation Ensure that the Trust has access to appropriate expert advice as required Nominated Medical Device Leads (Clinical Groups) and Team Leaders in Community Services Ensure that requests for medical devices include the Risk Assessment, Acceptance Checks, training and maintenance arrangements Ensure all medical devices have been identified within their areas of responsibility Ensure all managers, staff, and end users have completed a competency review form and return it to the Medical Device trainers so that staff are trained appropriately and highlight when there are any areas for further training i.e. patient specific training. This will ensure that adequate training in the safe use, operation and decontamination of medical devices is evidenced on the devices record folder Team Leaders/Ward & Department Managers/Senior Nurses/Operational Managers Take ownership and be responsible for the medical devices used in their areas Identify the level of clinical risk and training required for medical devices in use within their service Ensure that all staff who use equipment have completed a competency review form and return it to the Medical Device trainers so that staff are trained appropriately and highlight when there are any areas for further training, i.e. patient-specific training. This will ensure that any training undertaken is recorded on the Trust’s medical device training database by the Medical Device Trainers in line with this procedure Retain instruction manuals, technical instructions etc. relating to medical devices and make them available to end users All clinical wards/departments have responsibility for having an up-to-date inventory of all their medical devices within the area under their control and work closely with MPCE in keeping their list up to date Infection Prevention & Control Team Advise accordingly in line with this procedure The Medical Physics and Clinical Engineering department Assist the Trust to develop an ‘approved products list’ for all medical devices used across all departments Provide monthly reports in relation to devices maintenance and training Preparation ready for implementation of the device which includes commissioning the equipment and training the staff how to use it Training - User Training on Medical Devices

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Technical and clinical support of the equipment and staff during its life time Training Staff may receive training in relation to this procedure, where it is identified in their appraisal as part of the specific development needs for their role and responsibilities. Please refer to the Trust’s Mandatory & Risk Management Training Needs Analysis for further details on training requirements, target audiences and update frequencies. Monitoring / Review of this Procedure In the event of planned change in the process(es) described within this document or an incident involving the described process(es) within the review cycle, this SOP will be reviewed and revised as necessary to maintain its accuracy and effectiveness Equality Impact Assessment Please refer to overarching policy Data Protection Act and Freedom of Information Act Please refer to overarching policy

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Standard Operating Procedure Details Unique Identifier for this SOP is

BCPFT-CLIN-POL-12-4

State if SOP is New or Revised

New

Policy Category

Clinical

Executive Director whose portfolio this SOP comes under Policy Lead/Author Job titles only Committee/Group Responsible for Approval of this SOP

Deputy Chief Executive & Director of Resources Medical Devices Group Medical Devices Group

Month/year consultation process completed

April 2015

Month/year SOP was approved

November 2015

Next review due

December 2018

Disclosure Status

‘B’ can be disclosed to patients and the public

Key words relating to this SOP

Using equipment, safe treatment, TNA, high risk equipment, medium risk equipment, low risk equipment

Review and Amendment History Version

Date

Description of Change

1.0

Dec 2015

New Procedure established to supplement Medical Devices Policy

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