Training Policy for Medical Devices v6
Policy No: RM45
Version: 6.0
Name of Policy: Training Policy for Medical Devices
Jubilee Day Unit
Effective From: 11/06/2018
Date Ratified 16/04/2018
Ratified Medical Devices Management Group
Review Date 01/04/2020
Sponsor Director of Diagnostic and Screening Services
Expiry Date 15/04/2021
Withdrawn Date
Unless this copy has been taken directly from Pandora (the Trust’s Sharepoint document management
system) there is no assurance that this is the most up to date version
This policy supersedes all previous issues
Training Policy for Medical Devices v6 2
Version Control
Version
Release
Author/Reviewer
Ratified
by/Authorised by
Date
Changes
(Please identify
page no.)
1.0
March 2006 J Edwards Trust Policy
Forum
February
2006
2.0
November
2006
J Edwards Trust Policy
Forum
November
2006
3.0
07/08/2009 J Edwards PQRS 17/07/2009
4.0
24/10/2012 J Edwards MDMG 07/08/2012 Change risk
assessment tool to
comply with trust
format of 4 colours
rather than 3
5.0 16/03/2014 J Edwards MDMG 05/08/2014 Removed references
to NHSLA,
incorporated
authorised users
policy
Incorporated training
of maintenance staff
Change of risk
assessment tool
6.0 11/06/2018 J Reaveley/ D Pegg/R
Tuck
MDMG 16/04/2018 Updated to reflect
current
requirements,
Training Policy for Medical Devices v6 3
CONTENTS
Page No.
1. Introduction .................................................................................................................................. 4
2. Policy scope .................................................................................................................................. 4
3. Aim of policy ................................................................................................................................. 4
4. Duties - roles and responsibilities ................................................................................................ 5
5. Definition of terms ....................................................................................................................... 8
6. Medical Devices Training Requirements ...................................................................................... 8
6.1 Medical devices inventory ................................................................................................. 8
6.2 Process for identifying which t staff are authorised to use equipment identified
in the inventory .................................................................................................................. 9
6.2.1 Process for identifying which staff are authorised to maintain equipment
identified in the inventory ..................................................................................... 10
6.3 Process for determining the training required to use and maintain the
equipment identified on the inventory and the frequency of updates required .............. 10
6.4 Process for identifying training needs for all permanent staff are met ........................... 14
7. Training ......................................................................................................................................... 16
8. Equality and diversity ................................................................................................................... 17
9. Process for monitoring compliance with the policy ..................................................................... 17
10. Consultation and review of this policy ......................................................................................... 18
11. Implementation of this policy ...................................................................................................... 19
12. References .................................................................................................................................... 19
13. Associated documentation ........................................................................................................... 19
Appendices
Appendix 1 - Medical Devices Training Levels ........................................................................................... 20
Appendix 2 - Medical Devices Training and Re-Training Assessment Matrix ........................................... 22
Appendix 3 - Medical Devices Risk Assessment Matrix ............................................................................. 24
Appendix 4 - Medical Devices Training Passport for Temporary Staff ...................................................... 25
Appendix 5 - Medical Devices Risk Assessment Tool ................................................................................ 26
Training Policy for Medical Devices v6 4
Training Policy for Medical Devices
1. Introduction
Healthcare professionals working for the Trust, as employees or contractors, have a professional
duty to ensure their skills and training remain up to date.
The Trust has a duty to ensure continuous professional development and training activities include
the safe use and maintenance of medical devices as appropriate to individual roles.
The development of this policy is based on the criterion specified within the CQC Fundamental Care
Standards and is based on essential elements of former NHSLA Risk Management Standards still
relevant today. It takes into account the principals highlighted in DB 2000 ‘Equipped to care: the
safe use of medical devices in the 21st
century’, DB 2001 ‘Devices in practice: a guide for health and
social care professionals’, Managing Medical Devices (April 2015), Single-use medical devices:
implications and consequences of reuse December (2013).
The principle being to ensure practice within the Trust is such, to effectively reduce identified risks
and promptly mitigate adverse consequences associated with the use of medical devices to
subsequently protect patients, staff and others.
Recent advances in medical technology have led to an increase in the use of medical devices which
subsequently increases the potential number of medical device related incidents and intensifying
the burden of training. Acknowledgement of this requires all healthcare professionals working for
the Trust, as employees or contractors, to own professional responsibility for ensuring their skills
and training remain up to date, to support the delivery of safe effective care. In tandem to this the
Trust has a duty to ensure continuous professional development and training activities which
includes the safe use and maintenance of medical devices as appropriate to individual roles.
Human Factors have been identified as a key feature associated with device related incidents. It is
believed this is largely due to the wide range of complex devices now available. If training cannot
correspond to the rate of technology advancement there is scope for significant risks to develop. It
is therefore essential for any member of staff required to use medical devices to do so only once
they have undertaken suitable training and consequently reached the required level of competence
to use devices unsupervised. Those that have not reached the required level of competency or
those that have not undertaken training must not use devices unless working under the direct
supervision of a competent user.
2. Policy scope
This policy applies to all staff employed by Gateshead Health NHS Foundation Trust i.e. permanent,
temporary, bank and those in training, both professional and support workers who have access to,
and are required to use and maintain medical devices within their role. It is pertinent to all medical
devices used by staff for the delivery of treatment, care, diagnosis, monitoring etc.
The recommendations made in this policy are approved by the Chief Executive, although the
implementation of its recommendations will be carried by qualified staff that are responsible for
the day to day care. Support will be offered by departmental managers, technical staff and trainers
etc. who have shared responsibility for ensuring appropriate action is taken in response to the
recommendations.
3. Aim of policy
This policy aims to ensure systems are in place to reduce the risks associated with the use and
maintenance of medical devices.
Training Policy for Medical Devices v6 5
It aims to inform all technical staff and clinical users’ devices of their roles, responsibilities and
accountabilities in relation to instruction and training; including an account of which equipment
they can and cannot use/ maintain depending on their role, specialism, and area of work or
departmental requirements, (see Appendix 1).
The Trust will;
• Ensure all who use or maintain medical devices in this organisation attend induction
training in the first instance and retain competency by accessing training and updates.
• Introduce competency training for all staff using or maintaining high and moderate risk
devices throughout the trust.
• Support standardisation of medical devices.
• Ensure all users have access to training, retraining, updates and support to develop and
maintain knowledge, skill and competency levels.
• Maintain records of training.
4. Duties – Roles and Responsibilities
Chief Executive Is responsible for ensuring that the Trust complies with all safety regulations
and approved guidance via processes managed within the Trust to promote
patient, staff and visitor safety.
Trust Board Is responsible for overseeing the delivery of education and training, to
ensure compliance with regulations. The Trust board will also review the
systems and processes for all governance issues surrounding equipment use
and maintenance including risk management, CQC
requirements, safety, incident investigation, associated learning and
sharing, procurement, service contingency planning, policy development
and monitoring, developing and dissemination safety alerts and its
associated monitoring.
The Medical
Devices
Management
Group (MDMG)
Is responsible for ensuring policies, procedures and guidelines are in place
which meet Trust and external regulatory requirements. Members of the
MDMG are responsible for feeding information back to their respective
division (see group terms of reference, available on trust intranet.)
Minutes of meetings should be held locally by each ward or department and
can also be accessed via Medical Device Links, Head of Medical Devices, or
medical devices shared drive.
Head of Medical
Devices
Is responsible for:-
• Ensuring departments have an identified medical devices link/s.
• Ensuring competency training is in place for medical devices in the trust.
• Developing a framework in which all users of medical devices will be
assessed.
• Developing a network in which medical device information/ updates can
be easily accessed and up dated (intranet site, email, shared drive,
booklets).
• Centralise records of staff trained to use medical devices and develop
trust wide training-needs analysis.
• Acting as a link with the medical devices group and departmental medical
devices link.
• Providing induction training and medical devices awareness sessions.
• Support wards and departments in the development of new
competencies for new equipment.
Medical Devices � Will work to improve incident reporting this will include:-
Training Policy for Medical Devices v6 6
Safety Officer 1. Supporting wards and departments to report medical device
incidents and ensure lessons are learnt and shared.
2. Delivering / coordinating training on incident reporting.
3. Deliver identified training identified as a result of an incident.
� Will manage or review incidents in the Trust for data quality, where
necessary investigate and collect additional info from reporters, including
liaising with Datix systems administrator to ensure incidents meet the
required quality prior to NRLS upload.
� In addition will receive and respond to requests for more info from
patient safety domains.
� Implement Medical Device Initiatives and support daily operations to
improve safety through training.
� Ensure a medical devices management group deliver set responsibilities.
• Act as a main contact for NHS England, MHRA and manufacturers,
represent the Trust at the National Medical Devices Safety Network.
• Will receive feedback data on the quality of MD incident reports every 6
months.
Point of Care
Devices
Coordinator
Is responsible for:-
• Ensuring departments have an identified a point of care link.
• Ensuring competency training is in place for point of care devices in the
trust.
• Developing a framework in which all users of a point of care devices will
be assessed.
• Developing a network in which point of care information/ updates can be
easily accessed (intranet site, email, booklets).
• Maintaining records of staff trained to use point of care devices.
• Acting as a link with the medical devices group and departmental point of
care link.
• Providing training and clinical skills awareness sessions.
Medical
Engineering
Chief Technician
Is responsible for:-
• Ensuring the Medical Engineering department is aware of its
responsibilities in relation to training and competency.
• Liaise with department manager to establish a list of devices maintained
in-house and those maintained on a contract.
• Ensuring competency training is in place for all devices maintained in-
house.
• Develop an assessment framework for all technicians carrying out
maintenance.
• Develop a network in which medical device maintenance information/
updates can be easily accessed and up-dated as required (intranet site,
email, shared drive, manuals).
• Centralise records of staff trained to maintain medical devices and
subsequently develop a training needs analysis.
• Acting as a link to cascade info from senior managers to technical staff in
relation to equipment governance.
• Supporting induction training and medical devices awareness sessions.
Medical
Engineering
Technicians
Staff that maintain medical devices have an individual responsibility to:-
• Recognise their own limitations with regards to maintaining specific
medical devices.
• Ensure they attend medical device awareness and training sessions.
• Identify own training needs and ensure competency is achieved within a
designated time frame.
• Complete training records and ensure they are up-to date
Training Policy for Medical Devices v6 7
• Ask colleagues for support guidance and supervision prior to competency
achievements.
Departmental
Managers /
Preceptors
Departmental managers are responsible for:-
• Identifying a medical devices link on their ward or dept.
• Ensuring training programmes are available and accessible to all staff
within their area.
• Ensuring that staff do not use medical devices until they have been
trained and deemed competent in their use unless working under direct
supervision. This includes the induction of new staff, temporary and
locum staff.
• Ensuring training records and Skills/Training Matrices are completed and
up to date.
• Determining which staff are authorised to use which devices locally and
consequently ensuring Appendix 1 of this Training policy is completed;
indicating the authorised users of medical devices including permanent,
locum, bank and agency staff.
• Ensure staff are informed of their responsibilities and the devices they
have authority to use.
• Ensure staff don’t use devices they do not have authority to use, unless
approved by senior staff.
• Supporting induction process by identifying medical device training needs
of new staff.
• Supporting staff during Personal Development Plans and appraisal in
identifying medical device training needs and monitor the outcome.
• Ensuring all devices are risk assessed in their department.
Medical Devices
Link or Trained
Trainer
The Medical Device Links should be a qualified member of staff; in some
areas this role is supported with a care assistance
The Link person with support from the Head of Medical Devices is
responsible for:-
• Ensuring agreed frameworks /training processes are in place for all
medical devices used within the ward or department.
• Ensuring all staff using medical devices within the ward or department are
aware of their individual responsibilities for receiving training prior to
unsupervised device use; and consequently completed necessary
competency assessments.
• Ensure all medical devices training records, documents and files are kept
up to date.
• Ensuring staff within the area attend updates and retraining.
• Acting as a link to the Head of Medical, informing of any progress /
problems within the area, and updates of staff.
• Ensuring supplementary material (Manufacturing training manuals, CD
ROMS etc.) is stored safely.
Individual Staff Staff that use medical devices have an individual responsibility to:-
• Recognise their own limitations with regards to using specific medical
devices.
• Identify own training needs and seek training on a device to ensure
competency is achieved within a designated time frame.
• Ensure they attend medical device awareness session.
• Complete training records and ensure they are up-to date.
• Ask colleagues for support guidance and supervision prior to competency
achievements.
Training Policy for Medical Devices v6 8
5. Definition of Terms
The term ‘Medical Device’ covers any healthcare product excluding drugs used for treatment,
monitoring, prevention, diagnosis and alleviation of patient’s illness, disease injury or disability. It
also covers devices used for control of conception.
Training definition - Organised activity aimed at imparting information and/or instructions to
improve the recipient's performance or to help him or her attain a required level of knowledge or
skill.
Competency is the ability of an individual to do a job properly.
Temporary staff – includes all staff not employed on a permanent contract i.e. visiting practitioners
locums, bank and agency staff, those in training.
6. Medical Devices Training Requirements
The Care Quality Commission, regulate healthcare services provided by the Trust and seek
assurances that service delivery is:-
• Safe; i.e. people are protected from abuse and avoidable harm.
• Effective; i.e. does the care and treatment achieve good outcomes and promote a good
quality of life, and is it evidence based where possible.
• Caring; i.e. do staff involve and treat people with compassion, kindness dignity and respect.
• Responsive; i.e. to people’s needs.
• Well led; i.e. leadership management and governance of the Trust assure the delivery of
high-quality patient centred care supportive of learning and innovation and promotes an
open and fair culture.
As the delivery of most healthcare procedures relies heavily upon the use of medical devices the
Trust MUST ensure that their use is safe, effective, responsive to people’s need and well led. An
initial but essential step in ensuring medical devices are used safely, effective and respond to
people’s needs is to ensure staff know how to use them correctly and in accordance with the
manufacturer guidance. This is essentially achieved by training and competency development. The
Trust has an obligation to ensure learning and innovation is considered across the breadth of
equipment use.
6.1 Medical Devices Inventory
The inventory provides details of devices available and used within the Trust; it specifies
owners or locations of specific devices therefore offers an indication of which
departments require training on which devices.
New re-usable devices purchased or brought into the Trust for loan or trial purposes,
require acceptance testing, performed by the Medical Engineering Department. This
includes assigning a unique asset number to each device and subsequently logging asset
details such as make, model, location, date of delivery, planned dates of maintenance
location of use, etc. within the Trust’s asset management database ‘Backtraq’. Backtraq is
controlled by Medical Engineering Staff and is used as a Trust wide equipment inventory. It
is used to determine which equipment is available within the trust, its whereabouts, and its
use; Backtraq also provides full maintenance histories details of planned preventative
maintenance schedules and specifies equipment maintained in-house or on an external
maintenance contract.
Training Policy for Medical Devices v6 9
Each ward or department is required to formulate its own inventory of device types used
within that area; this should mirror the trust wide Backtraq inventory for that area; but
should also include devices loaned from the equipment library. Departmental inventories
will support the basis of identifying which equipment must be considered in Appendix 1, to
formulate a local account of who is authorised to use which devices in that ward or
department. The inventory of authorised users will then identify which staff groups require
training on which devices and consequently formulate the contents of training packs for
individuals and support development of a training needs analysis.
This policy (Appendix 1) will inform device users which medical devices they can and cannot
use depending on their role, specialism or area of work.
A training needs analysis can be derived once details of equipment types used on each
department are entered onto a standardised excel framework; in addition to details of
competency achievements of each staff member. Hence this info can be collected and
correlated centrally by the medical devices team.
Maintenance teams having access to Backtraq can view details of equipment requiring their
attention in-house or that which requires further support externally.
Inventories of disposable devices and other non-electrical devices are managed through the
supplies dept. The supplies dept. record orders and deliveries which indicate ward usage.
6.2 Process for identifying which staff are authorised to use equipment identified in the
inventory
Clinical departments
Within the organisation there are differences to the extent individual staff groups within
the same profession rely on medical device use, it is dependent on their ward/department
speciality. It is therefore necessary to determine locally the potential authorised users of
specific medical devices.
It is the responsibility of the Department Managers to agree locally the level of authority
attributed to each clinical staff group and medical device used within their department. This
could be related to profession, grade or the procedure for which the device is to be used
for.
Each clinical area is then required to complete Appendix 1 which indicates authorised users
of specific devices within the department. This gives an indication to all clinical personnel
practicing on that ward/department, which devices they can and cannot use or specific
function they are authorised to use. This policy should confirm all medical devices used
within the local area, therefore duplicating details held on the Trust-wide inventory
Backtraq system but also considering devices loaned from equipment library. All staff must
be informed locally of their responsibilities, and levels of authority to use specific devices.
This must include temporary staff and those in training.
Staff working within the area ward or department must stay within the remit of agreed
authorised level of use unless deviation is approved by a Service Managers or equivalent.
Training Policy for Medical Devices v6 10
6.2.1 Process for identifying which staff are authorised to maintain equipment
identified in the inventory
Maintenance MUST only be undertaken by those authorised and trained to do so
The Medical Engineering Department is responsible for performing maintenance on
medical devices, however this does not cover all devices within the Trust; some are
maintained by external contractors.
The Medical Engineering Department manager is responsible for determining which
devices are maintained in-house and which are on a contract. It is the managers’
responsibility to ensure the technicians are aware of the devices they can and
cannot maintain. This info is managed and replicated within the Trust Wide
inventory and is used as a reference point for all technicians responsible for
carrying our maintenance on devices.
6.3 Process for determining the training required to use the equipment identified on the
inventory and the frequency of updates required
All devices used within the Trust require a risk assessment to determine the potential level
of risk patients and staff are exposed to using such equipment. Risk assessment outcomes
can be concluded using the Trust’s medical devices risk assessment tool (Appendix 5)
Medical devices falling into a high or moderate category should not be used unless the user
has been trained and assessed as competent, or unless the user is working under direct
supervision of a competent user.
The Electronics Department / Laboratory Point of Care Support Team and Head of Medical
Device are available to assistance in the risk assessment of medical devices.
Department managers are responsible for ensuring all medical devices in their area are risk
assessed and identified as high and moderate or low risk.
On completion of a risk assessment the device must be labelled if appropriate according to
the risk assessment outcome, stickers (as below) are available from the medical equipment
library.
The outcome of risk assessments must be held locally on each ward and replicated on the
training matrix to demonstrate this process had been achieved. This data and can be used
as a reference point for staff working within that area to determine the level of training
required; i.e. all staff using devices with a high or moderate risk outcome must attend
training and subsequently be able to demonstrate competency prior to using the device
unsupervised. Low risk devices do not warrant competency assessment however staff
should self-assess competency following a review of the manufacturer’s literature.
Devices loaned from one clinical area to another must be reassessed upon receipt to
ensure the outcome is the same. There is the possibility the same device may have
different risk outcomes when assessed within different medical specialties or
environments.
Low
risk device refer
to user manual
High risk
device!
Competency must
be assessed
Moderate Risk device Is
Competency
Assessed
Training Policy for Medical Devices v6 11
Users of medical devices are responsible for ensuring they are able to risk assess the device
they use.
Stages of the Training Cycle
Individuals MUST NOT use medical devices unsupervised until they have completed stage 3
in the training cycle, and hold evidence of effective training and /or competency.
Stage One
The first stage of the training cycle is intended to target all new employees to the Trust; it is
therefore delivered at Corporate Induction. This training must portray theories, best
practices, roles and responsibilities, risk management strategies and detail the benefits of
incident reporting deemed necessary for ensuring devices are used safely . Training must
also incorporate legislation and regulation surrounding the subject. Delivery of stage one
training at corporate induction is the responsibility of the medical devices management
team; information presented must be reviewed at least annually by the team (or more
frequently if regulation or legislation changes) to ensure it is up-to-date and relevant.
Stage Two
Stage two training should consist of practical hands on training, facilitated by a trained
competent user for all medium of high risk devices.
Any low risk device still requires full understanding and competency completing however
this can be taken from user manuals.
All staff must undergo stage two training for each device (listed in Appendix 1), this can be
achieved:-
• During local induction in clinical areas; training delivered by trained trainers or
trained competent users and is required for all new employees.
• As new devices are introduced to the clinical area, either procured, or for loan or
trial purposes– training usually delivered by manufacturer clinical trainers, and
cascaded throughout clinical teams by trained trainer, or trained competent users.
• By scheduled re-training to update and refresh users on the safe use (see Appendix
2 to determine how often retraining/ re-assessment of competency is required).
Training and competency must include/ demonstrate the essential points described in
Appendix 3.
Stage Three
Following device training individuals are required to demonstrate full understanding of its
use by demonstrating significant levels of competency prior to using the devices
unsupervised subsequently each individual is required to complete and retain necessary
competency documentation.
Competency is a term of which training is only part, staff need to be aware of their
responsibilities in acquiring the necessary level of competency
Other attributes of competency are as described in the following pneumonic ‘SKATE’
� Skills
� Knowledge
� Aptitude
� Training
� Experience
Training Policy for Medical Devices v6 12
Stage three is essentially:-
� the demonstration of competency following training and completion of
associated competency documentation,
� or a user’s ability to demonstrate their on-going competency at the
specified re-training or re-assessment stage by successfully completing self-
assessment documentation. See appendix 3.
Staff that are unable to fully complete competency documentation are required to go back
to stage 2 and undergo further training; this includes initial training or re-training and must
be identified as a training need on ward or department TNA’s.
Only once a member of staff is able to demonstrate an acceptable level of competence by
successfully answering all questions poised on the competency documents can they then
use the devices in practice unsupervised.
Following successful achievement of competency all staff must undergo retraining/ re-
assessment as detailed in Appendix 2.
New Clinical Employees:-
• Will attend Trust wide induction training, in which the medical devices session will
give an overview of the safe use medical devices, and sign post topics requiring
training. Attendance will be closely monitored within the electronic OD & Training
database.
• To the Trust will during their induction period, with the support of a preceptor,
work through the medical devices competencies specific to their department.
Competency forms will help identify training efficacy; they will either demonstrate
full understanding or identify further training needs. Competency forms are
available via the trust intranet, Point of Care Team or Head of Medical Devices.
Attainment of previous competency must be presented in an acceptable format
(signed competency transfer document Appendix 4) during the induction period if
they are to be considered to be transferable from one clinical area to another.
• Personal development plans will detail how training is to be achieved, i.e. locally via
trained competent colleagues, Head of Medical Devices, Manufacturing
Representatives or other Trust professionals. There is an indication in Appendix 1 as
to which devices new staff require training on and consequently competency
development.
• With department managers support will discuss time scales of training and
competency achievement.
• Once training and competency are complete, the re-training matrix should be
completed to indicate next update- training or re-assessment of competency (see
appendix 2).
• Will require a copy of Medical Devices Policies to offer an indication of the level at
which they will be expected to use specific devices.
• Will require a copy of ‘Medical Devices What Do I Need to Know’ booklet, Available
via Trust Intranet.
• Are to have access to all training manuals, documents, CDROMS and intranet web
page.
• Are responsible for ensuring they only use medical devices under direct supervision
until competency assessed and approved.
• Are responsible for keeping a personal copy of training needs, and achievements.
Ensuring copies of training records are available for departmental manager/
Training Policy for Medical Devices v6 13
medical devices links, to add to ward excel training record of which a copy must be
forwarded to the Head of Medical Devices.
• Contact the Head of Medical Devices to inform of any difficulties accessing training.
• Medical staff must ensure their clinical training lead has evidence of competency of
which must be stored within the division.
New maintenance staff
Maintenance training should follow a similar sequence of training i.e.
Stage 1 induction, etc. for all new staff.
Stage 2 hands-on maintenance training.
Stage 3 competency, achievement and recording.
To the trust will hold a degree in electronic engineering but will be required to develop
competencies for the maintenance of all devices maintained in-house therefore:-
• Will during their induction period, with the support of a preceptor, work through
the medical devices competencies specific to their role, Competency forms will help
identify training efficacy; they will either demonstrate full understanding or identify
further training needs. Competency forms are available via technical manager
Attainment of previous competency must be presented in an acceptable format
during the induction period if they are to be considered to be transferable.
• Personal development plans will detail how training is to be achieved, i.e. locally via
trained competent colleagues or manufacturer representatives
• With department managers will discuss time scales of training and competency
achievement.
• Will attend Trust wide induction training, in which the medical devices session will
give an overview of the safe use medical devices, and sign post topics requiring
training. Attendance will be closely monitored within the electronic OD & Training
database.
• Once training and competency are complete, the re-training matrix should be
completed to indicate date of next re-training or re-assessment (see appendix 2).
• Are to have access to all training manuals, documents, CDROMS and intranet web
page.
• Are responsible for ensuring they only maintain medical devices under direct
supervision until competency assessed and approved.
• Are responsible for keeping a personal copy of training needs, and achievements.
Ensuring copies of training records are available for departmental manager to add
to ward excel training record.
• Inform manager of any difficulties accessing training.
Existing Clinical Staff:-
• Are responsible for keeping up to date with training in relation to medical devices.
All documentation required is available via trust intranet or the Medical Devices
Support Officer.
• Training needs will be identified during competency assessments, which are
required for all medium and high risk devices used in the ward or department.
• Must be aware of local policies which direct them to their level of operation for
specific medical devices within the area of employment.
• Will identify during ‘Personal Development Plans’ or ‘Contact Appraisal’ individual
training needs with a ward/department manager, and discuss how and when these
are to be achieved e.g. via competent colleagues (locally), trained trainers (locally)
Point of Care, Head of Medical Devices, Manufacturing representatives of other
Trust Professionals.
Training Policy for Medical Devices v6 14
• Will attend updates or re-training for the use of pertinent medical devices.
Attendance must be recorded locally and within the ward excel database.
• Must be able to demonstrate competency for all medical devices used, if staff are
to work unsupervised.
• Must have documentation to show training / achievement of competency.
• Must attend training for any new devices, software updates or revised models,
prior to initial use.
• Training matrix to be completed after all competency achievements and an
indication of next training update (Appendix 2).
Existing Maintenance staff:-
Are responsible for keeping up to date with training in relation to medical devices they
maintain.
• Training needs will be identified during competency assessments, which are
required for all medium and high risk devices used in the ward or department.
• Must be aware of local guidance which will direct them to their authorised level of
maintenance for specific medical devices.
• Will identify during ‘Personal Development Plans’ or ‘Contact Appraisal’ individual
training needs with a ward/department manager, and discuss how and when these
are to be achieved e.g. via competent colleagues (locally) or manufacturing
representatives.
• Will attend updates or re-training for the maintenance of pertinent medical
devices. Attendance must be recorded locally and within the excel database.
• Must be able to demonstrate competency for all medical devices maintained if
working unsupervised.
• Must have documentation to show training / achievement of competency.
• Must attend training for any new devices, software updates or revised models,
prior to initial maintenance.
• Re-training matrix to be completed after all competency achievements and an
indication of next training update.
Temporary or bank staff – training document
All staff working within the trust must use devices under direct supervision unless they are
able to demonstrate or evidence competency.
All temporary staff must undergo induction training and be advised of their roles and
responsibilities by appropriate manager such as Bank staffing manager, clinical lead for
bank staff.
Upon completion of competency they must transcribe details into training passport as
detailed in Appendix 4.
6.4 Process for ensuring that the identified training needs of all staff are met
• All staff using or maintaining medical devices must complete competency
assessments for any medical devices they use or maintain in their employment. Full
knowledge of training points (see Appendix 3 for clinical or specialist developed
competencies for maintenance staff) relevant to the device use or maintenance
must be expressed during assessment or completion of competency
documentation; this will prove full understanding of the device and its safe use or
how it is to be maintained. The required information is available in operator
manuals and should be discussed at all training sessions.
Training Policy for Medical Devices v6 15
• For Medium and Low risk devices, once staff are trained and deemed as competent
they uphold that required level by continued regular use or regular maintenance
activity then a self-assessment can be carried out at the subsequent re- assessment
date (frequency detailed in Appendix 2).
• Medical staff must address training needs as part of their re-validation If not all
questions can be answered fully at the time of competency assessment or re-
assessment then further training is required and must be sought by the individual
• All staff must be able to fully demonstrate on-going safe use or appropriate safe
methods of maintenance of the device following training and competency
assessment.
• Competency documents are available via the Trust Intranet, Point of Care Team,
Head of Medical Devices, maintenance competencies are retained within the
electronics department for technical staff to access.
• Each member of staff is responsible for completing competency assessments,
holding a copy of their achievements and informing the department’s medical
devices link, so it can be uploaded onto the ward excel database.
• Department managers and medical device links are to ensure ward files indicating
staff’s training needs and level of competence are up to date, this data must also be
uploaded onto the wards excel database.
• The Head of Medical Devices will need to access training data from the local excel
database to determine Trust wide training needs and support this accordingly.
• All clinical areas have access to Trust intranet, operator manuals, and
competencies. All staff must be aware of how to access this data
• Attendance for induction and update training is to be monitored and followed up as
required.
• The excel training database will allow the identification of those members of staff
requiring training and those who have attended the required level.
• Review of Personal Development Plans and Contact Appraisals between staff and
managers, will identify training needs and/or achievement or completion of
induction packages.
• Audits will check training and competency levels in all clinical areas, audits will be
undertaken by Medical Devices Support Officer and the Medical Device Links.
• Training records must be available and complete prior to usage of new equipment
in patient areas. Likewise maintenance teams must undergo some form of training
if they are to be considered for planned preventative maintenance or repair work.
• New or updated devices or implementation of updated software versions to devices
must not be released for use until training has been initiated within relevant clinical
areas.
• Training needs may be identified following investigation of Incident Reports relating
to the use of medical devices.
• Staff providing device training to end users must hold a copy of the “lesson” plan as
well as a signed document from the user acknowledging the training provided.
Community Staff
• Community staff using equipment owned/provided by other organisations are
required to complete training and hold the relevant documentation if they are to
use the equipment unsupervised.
• It is the responsibility of the equipment provider to provide the training and
competency documentation for the equipment they provide.
• It is the users responsibility to ensure they have received the relevant training prior
to using a device unsupervised.
Training Policy for Medical Devices v6 16
New medical devices into the Trust
Training via Manufacturer’s Representative
All new high & moderate risk devices to the trust are to have competency training packages
provided by the device manufacturers which must be agreed at the procurement stage. The
manufacturer’s representative is to link with supplies, the Head of Medical Devices or the
Specialist Service Manager link to approve assessment criteria, (see pre purchase
questionnaire). Only once training has been undertaken by clinical users are new device
types to be issued following commissioning by medical engineering.
Point Of Care Devices
Training for point of care devices i.e. blood glucose monitoring, urine meter, blood gas
machines and INR monitoring is provided and monitored by the Point of Care Team.
Defibrillators
Training for automated external defibrillators, is provided by, the resuscitation officer and
basic life support cascade trainers. Training for manual & semi-automated defibrillators is
provided by the resuscitation officer. A competency document is still required after training.
Low Risk Devices
This applies to all devices which have been assessed as low risk. Although competency
based assessment is not required for these devices, each area is responsible for ensuring
training is accessed or that user manuals are available.
High Risk Devices
This applies to all devices which have been assessed as high risk. High risk devices require
staff to complete a competency assessed document and training should be sought from a
trained trainer which should be listed in the local training policy (appendix 1)
Retraining
As technology and software advances there is a need to keep up to date therefore as new
devices or software are introduced, training or update training is required, devices that are
used infrequently also need refresher retraining sessions (see Appendix 2 retraining
matrix).
Training records and preceding training history will be identified within archived training
matrix.
Standardisation
Medical devices are monitored and managed by the medical devices team this enables the
Trust to support standardisation of specific devices to limit the makes and models requiring
differing training, It therefore essential prior to orders being placed for new equipment
that checks are made to ensure standardised equipment is procured. The Supplies
Department will work in liaison with the medical device team to support standardisation.
7. Training
With an aim to ensure patient safety is promoted and maintained at a high level, adverse incidents
will be monitored to determine the likely contribution of use error or human factors to an incident,
in addition the level of competence held by the user at the time of the incident needs to be
investigated.
Training Policy for Medical Devices v6 17
Healthcare professionals are individually accountable for their practice, as part of their continuing
professional development they have a responsibility to ensure they gain the knowledge and skills
required to use medical devices safely.
All users of medical devices require training and subsequently need to demonstrate competency of
use prior to using devices unsupervised. Training should consist of the points identified in Appendix
3; competency should also demonstrate Skill, Knowledge, Aptitude, Training and Experience as well
as full understanding of the points identified in Appendix 3:-
Operators of diagnostic equipment who are unable to interpret the information produced by the
device e.g. interpretation of an ECG must forward them to a competent member of staff for
interpretation; this should be done within an agreed specified time according to procedure
protocols.
Cavendish 2013 highlighted concerns over healthcare assistant’s using devices to monitor patient’s
vital signs but lacking full understanding of the implications if the results varied from normal.
Generic medical devices used throughout the Trust will have trust wide training packages
developed by either teams of competent medical device links/users or via the manufacturer and
the Head of Medical Devices.
Specialist medical devices used within specific areas may require training packages developed by
competent users of that area if not available presently.
Training packages are designed to support training and are not in place of training. They can be
accessed via the Trust’s medical devices intranet site..
8. Equality and diversity
The Trust is committed to ensuring that, as far as is reasonably practicable, the way we provide
services to the public and the way we treat our staff reflects their individual needs and does not
discriminate against individuals or groups on any grounds. This policy has been appropriately
assessed.
9. Process for monitoring compliance to this policy
Standard / process /
issue
Monitoring and audit
Method By Committee Frequency
Departmental managers
are responsible for
ensuring all records are
maintained and training
needs are covered in
Personal Development
Plans, Contact appraisal
and Induction
interviews
A random sample
of 50% of the
wards &
departments will
be audited on an
annual rolling
programme to
demonstrate the
process has
occurred in that
area
Head of
Medical
Devices
Medical
Devices
Managemen
t Group
12 -18 months
Staff performing
medical device
assessments should
ensure all
Spot check of
wards will ensure
all documentation
is up to date. Each
Head of
Medical
Devices
Medical
Devices
Managemen
t Group
12 -18 months
Training Policy for Medical Devices v6 18
Standard / process /
issue
Monitoring and audit
Method By Committee Frequency
documentation is
complete, and
forwarded accordingly
for recording
ward will be
checked within an
18 month period
Incident forms related
to all medical devices
will be monitored by
the Head of Medical
Devices . This will form
the basis of a report
delivered at Medical
Devices Management
Group meetings
This report will
form the basis of a
standing agenda
item at the Medical
Devices
Management
Group on a 2
monthly basis
Head of
Medical
Devices
Medical
Devices
Managemen
t Group
2 months
All locally used medical
devices must be risk
assessed to determine
the level of training
required
Spot check of
wards will ensure
all documentation
is up to date. Each
ward will be
checked within an
18 month period
Head of
Medical
Devices &
Deputy / Ward
Manager
Medical
Devices
Managemen
t Group
12-18 months
The Head of Medical
Devices will monitor
records of staff for
medical devices
awareness & update
sessions.
Each Ward & Dept
will forward an
updated Excel
matrix of training
to Head of Medical
Devices
Head of
Medical
Devices &
Deputy / Ward
Manager
Medical
Devices
Managemen
t Group
12-18 months
Excel training matrix will
assist in producing
annual reports
demonstrating level of
training and
competency required
and /or achieved for
individual members of
staff. This will emulate
the inventory held
locally for identified
authorised users and
will therefore form the
basis of training needs
analysis. Reports will
also indicate the uptake
of re-training
A random sample
of 50% of the
wards &
departments will
be audited on an
annual rolling
programme to
demonstrate the
process has
occurred in that
area
Head of
Medical
Devices /
Ward
Manager
Medical
Devices
Managemen
t Group
12 months
All staff have access to
training aids,
documentation and
support.
Spot check of
wards will ensure
all documentation
is up to date. Each
ward will be
checked within an
18 month period
Head of
Medical
Devices &
Deputy / Ward
Manager
Medical
Devices
Managemen
t Group
12-18 months
Training Policy for Medical Devices v6 19
Standard / process /
issue
Monitoring and audit
Method By Committee Frequency
Every ward will be
audited to ensure they
have identified
authorised users of all
reusable medical
devices used within that
area, and that levels of
training are
consequently decided in
relation to this
Spot check of
wards will ensure
all documentation
is up to date. Each
ward will be
checked within an
18 month period
Head of
Medical
Devices /
Ward
Manager
Medical
Devices
Managemen
t Group
12-18 months
10. Consultation and review of this policy
This policy has been reviewed in consultation with Medical Devices Team & Medical Devices
Management Group Membership and Health & Safety Committee for information.
11. Implementation of policy (including raising awareness)
Medical device policies have been developed with an aim to guide and support all staff who directly
or indirectly interface with medical devices within their role of employment to ensure safe and
effective procurement, use and management; and therefore safeguard public health. We need to
ensure the Trust has systems in place that meet appropriate safety, quality and efficiency
standards. The overall systems believed to be worthy of attaining of these standards are described
within the updated policies and encompass risk identification, management & monitoring.
Policy development will continue to grow in a bid to remain up to date with achievable best
practice and legislation. Clinical staff will be informed accordingly.
In recognition of the aims of policies clinical staff need to appreciate their responsibilities in
embedding the systems within their individual role/practice, ward or department.
Following ratification of the policies they will become available to all clinical staff via the Trust
Intranet.
The Head of Medical Devices will access all wards and departments to ensure an up to date record
of all current medical device links is available. This will ensure the correct members of each ward
teams are receiving necessary communication and support.
The Head of Medical Devices will liaise with ward and department managers and requested access
to any up and coming team meetings etc. If this is not an option the Head of Medical Devices shall
coordinate a meeting with the ward manager and medical devices link directly. Meetings will be
arranged to highlight and discuss changes to the policies, while simultaneously instilling individual
roles and responsibilities. The format of the meetings shall be that of an informative presentation
followed by and informal discussion which should facilitate opinion, concerns etc. from clinical
staff.
Individual wards will have the opportunity to view their audit results relating to policy compliance,
this should give a basis to channel support. The outcomes of these sessions/meetings aim to
determine a combined ward/dept and Head of Medical Devices action plan for the implementation
of required changes.
Training Policy for Medical Devices v6 20
Following the development of ward action plans a further review will be planned to determine the
effectiveness of the policy this will take the form of a repeat audit and provision for staff to
feedback, all ward and department links will be requested to assist in the audits.
12. References
NHS Litigation Authority Risk Management Standards for Acute Trusts
Department of Health Introducing Fundamental Standards January 2014
DB 2000 ‘Equipped to care: the safe use of medical devices in the 21st century’
DB 2001 ‘Devices in practice: a guide for health and social care professionals’
Managing Medical Devices April 2015
Single-use medical devices: implications and consequences of reuse December 2013
13. Associated documentation
• OP 31Operational Policy For Medical Devices Engineering & Library
• RM30 ‘Policy For The Procurement Management And Use Of Medical Devices
Training Policy for Medical Devices v6 21
Appendix 1 MEDICAL DEVICES- ward or department authorised users
It is the responsibility of the Ward or Department Managers to agree locally the level of authority
attributed to each medical device used within their ward or department. This could be related to
profession, grade or the procedure for which the device is to be used for.
Each clinical area is required to complete this Appendix 1 which indicates authorised users of specific
devices within the ward or department. This gives an indication to all clinical personnel practicing on that
ward/department which devices they can and cannot use or specific function they are authorised to use.
Please complete for all devices used within the ward or dept., consider all professional groups medical
nursing AHP’s and those in training.
•
Below indicates authorised users on ward
Type of
Device
Make &
Model
List the
Device
Functions
Proposed
users for
each
function
Exceptions to
proposed
users
Risk
assessment
outcome
How to access
training
Example
Patient
Monitor
Welch Allyn
Spot vital
signs 420
Pulse
BP
Oxygen
sats
Qualified
nurses,
Student
nurses, care
assistants
As above
As above
Those that
have not
undergone
training or self-
assessment
following on-
going use
Medium Trained competent
user-
Clinical trainer-
manufacturer
Trained trainer – in
house
Medical devices
team
Training Policy for Medical Devices v6 22
Appendix 2
MEDICAL DEVICES TRAINING AND RE-TRAINING ASSESSMENT MATRIX 2012
UNLESS a new device is introduced to your ward or department from a different manufacturer, or there is a
software update or model upgrade your re-training /assessment guide is as follows
You must access competency
based training and complete a
competency document prior to
using this device unsupervised
You must be able to produce evidence of
your level of competence and your
competency training/ assessment
Daily /
weekly Less than
twice / year
2-3 times /
year Monthly
Competencies for, medium
or low risk devices every
2 -3 years
Competencies for medium and low
risk devices every 18 months- 2
years
Competency training every
1 year for medium risk
devices and self-assess for
low risk devices
Competency training
every 12 months
medium risk devices and
self-assess for low risk
devices
If you have been absent
from my usual work
place 3-6 months, on
your return you need to
self-assess
I have been absent from
my usual place of work
6-12 months or longer on
your return you need a
competency assessment
Are you authorised to use this device?
check Appendix 1
No
What is the risk assessment outcome of this device?
Yes
You should not use this device
unless directly supervised
High
Risk
Moderate
Risk
Low
Risk
You must complete a self-assessment
competency document once you have
read the manufacturer guidance on this
device
You must access competency
based training and complete a
competency document prior to
using this device unsupervised
In clinical practice how often do you use this device
(on average)?
Competency assessments for high risk devices should be carried out every 12 months
Training Policy for Medical Devices v6 23
The above are the maximum retraining targets if you feel you need training more frequently then
remember it is your responsibility to seek this, no one will be judged if they need more training.
Patient and user safety is our ultimate goal.
If new devices are introduced to your ward or department from a different manufacturer, or there is
software updates or model upgrades re -training and competency assessment must be carried out
prior to device use.
Guidelines for re-training competency and self-assessment with medical devices
If you take a break from your usual job due to long term sickness, maternity leave or secondment etc.,
hence limited or no use of medical devices, you are to ensure you hold the same level of competency
on return to using the devices.
If you have been absent from your usual post for 3-6 months you must complete a self-assessment on
your return (if your absence time added to the time of your last assessment takes you over the matrix
time for re-training you must take part in a competency based assessment).
If you have been absent for 6-12 months or longer you are to have a competency based assessment
carried out on return to your ward/dept.
If you have successfully completed competency assessments for high and moderate risk devices and
have maintained this level of competency by continuing regular use (i.e. daily or weekly) your next
retaining assessment may be in the form of a self-assessment.
If you have achieved an initial accepted level of competency but had had limited opportunity to
maintain this level due to infrequent use (i.e. 2-3 times a year or less), you are required to undertake a
competency assessment at the point of retraining assessment.
Training related to risk categories
High risk devices – training is to be delivered via a trained trainer, manufacturing representative or
Head of Medical Devices (if appropriate).
Moderate risk devices - training delivered via trained trainers, manufacturing representatives or Head
of Medical Devices (if appropriate).
Low risk devices – training delivered via CD ROMS, instruction manuals or trained trainers each dept is
responsible for ensuring training is available for low risk devices. Competency assessment is not
required following training (for low risk devices only).
If at any time you feel you need training or you feel you do not hold the required level of competency
even after training you need to seek further training. Remember you are responsible for the care you
give and is not safe care if you do not have training or understand the training given.
Training Policy for Medical Devices v6 24
Appendix 3 - Generic Training and Competency Questions
Medical devices training must cover the following points, likewise as part of the competency assessment,
self-assessment the user must be able to show full understanding of the following points;-
I know the risk category of the device.
I have authority within my role to use this device as detailed in the ward or department training policy
I have had previous experience using the device.
I know how to assess the patients abilities and suitability for this device
I fully understand how the manufacturer intends this device to be used
I am aware of and understand all the functions this device offers relevant to my role or authority to use, including
all alarms, displays, indicators and buttons
I have access to the manufacturers operational manuals
I am fully aware of the suitability of this device being used in conjunction with other devices
I have knowledge of which consumables/ disposables are to be used with this device
I can give an explanation to patient about my intentions and the purpose of the device.
I maintain the patients’ privacy, dignity and comfort throughout device use.
I fully understand how to attach the device to the patient and how to monitor the patient while this device is in
use
I perform visual checks for signs of external damage, wear and tear and contamination, I understand my
responsibilities if I find evident damage or contamination
I know how to recognise if maintenance is due and ensure it is not used beyond the given service date, I know
how to access maintenance if due
I know how to set up this device including pre use checks and calibrations as required
I know how to recognise faults and what to do should they occur
I am aware of any safety alerts associated with this device
I know how to report an incident if it occurs
I know how to decontaminate this device
I know how this device is to be stored, or if it is to be returned to the equipment library following use
I know how to obtain assistance in the use of this device if required
I am aware I am to retrain or self-assess my competency for this devices
Training Policy for Medical Devices v6 25
Appendix 4
Medical devices personal transferable training passport
This document enables individual staff members frequently working in different locations to provide
assurances to all departments they have the necessary level of competency to work unsupervised on the
devices listed below, this document is not in place of full competency documents but is to support them.
NAME
Profession Band
Device type Make & Model Competency
achieved
YES NO
Date achieved Signature of
manager to
confirm
competency
Date retraining or
reassessment
required
Training Policy for Medical Devices v6 26
Appendix 5 RISK ASSESSMENT FORM
The use of medical devices
Division
Department
Activity/Task:
Complete the relevant detail of the activity being assessed.
The use of medical devices to deliver care or treatment or to support diagnosis
Hazards:
List all hazards associated with the activity/task
The device may be used incorrectly or may fail during use which could lead to harm of the
patient or user
Who might be
exposed to the
hazards:
e.g person performing task, patients, others.
The member of staff using the device or the patient the device is used on
Existing control
measures:
List current controls in place e.g. safety switches, training, policies.
Device training, and supervised use of staff without competency
Determine the risk
of devices failing or
being used
incorrectly
Consequence x Likelihood = Risk Score
1 - 3
Very Low
4 - 6
Low
8 - 12
Medium
15 - 25
High
Device Consequence Likelihood Risk score
Date Name Signature Next review date
Use a box each time this assessment is reviewed
Training Policy for Medical Devices v6 27
Review annually and after any relevant accident or incident
All devices used within the Trust require a risk assessment to determine the potential level of risk patients
and staff are exposed to using such equipment. Risk assessment outcomes can be concluded using the
Trust’s medical devices risk assessment Matrix
MEDICAL DEVICES RISK ASSESSMENT MATRIX
This matrix should be used to assess the risk category of a medical device. It assumes:-
• The device is safe to use at commencement of treatment, diagnosis etc
• The practitioner possesses the required competency to use the medical device safely and
effectively
Consequence Like
liho
od
1
Negligible
No obvious
harm injury
2
Minor
Non-
permanent
harm (up to 1
month medical
treatment)
3
Moderate/
serious
Significant/ semi-
permanent harm
(up to 1 yr. medical
treatment)
4
Major
Permanent
harm
5
Catastrophic
Single or
multiple deaths
1 – Rare
1:1000,000
1 2 3 4 5
2 – Unlikely
1:10,000
2 4 6 8 10
3 – Possible
1:1000
3 6 9 12 15
4 – Likely
1:100
4 8 12 16 20
5 – Almost Certain
1:10
5 10 15 20 25
Risk
1-6 Low Risk
8-12 Moderate Risk
15-25 High Risk
All staff using devices with a high or moderate risk outcome must attend training and subsequently be able
to demonstrate competency prior to using the device unsupervised. Low risk devices do not warrant
competency assessment however staff should self-assess competency following a review of the
manufacturer’s literature.
The following categories demonstrate the possible outcomes
HIGH RISK DEVICE
Score 15-25
Any device which if misused or fails during use could cause direct harm
to the patient and/or user which could potentially result in death
MODERATE RISK DEVICE
Score 8-12
Any device which if misused or fails during use could potentially result in
temporary adverse consequences for the patient and/or user
An information providing device, if the produced information not acted
upon or is misinterpreted could have serious adverse consequences
LOW RISK score 6-4 LOW RISK
DEVICE
For the purposes of medical devices 'low risk' and' very low risk' are to be
regarded in the same way i.e. a score of 1-6 covers any device that if
used incorrectly or fails during use would be unlikely to have a serious
consequence VERY LOW RISK
Score 1-3
Training Policy for Medical Devices v6 28
Medical devices falling into a high or moderate category should not be used unless the user has been
trained and assessed as competent, or unless the user is working under direct supervision of a competent
user.
On completion of a risk assessment the device must be labelled if appropriate according to the risk
assessment outcome, stickers (as below) are available from the medical equipment library.
The outcome of risk assessments must be held locally on each ward and replicated on the training matrix to
demonstrate this process had been achieved. This data and can be used as a reference point for staff
working within that area to determine the level of training required; i.e. all staff using devices with a high or
moderate risk outcome must attend training and subsequently be able to demonstrate competency prior to
using the device unsupervised. Low risk devices do not warrant competency assessment however staff
should self-assess competency following a review of the manufacturer’s literature.
Devices loaned from one clinical area to another must be reassessed upon receipt to ensure the outcome is
the same. There is the possibility the same device may have different risk outcomes when assessed within
different medical specialism’s.
Users of medical devices are responsible for ensuring they are able to risk assess the device they use.
Low
risk
device refer to user
manual
High risk device!
Competency must
be assessed
Moderate
Risk device Is Competency
Assessed