training policy for medical devices - nhs gateshead...training policy for medical devices v6 2...

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Withdrawn Date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,


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

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.


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:-


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


• 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


• 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


• 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.


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.


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.


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


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


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/


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.


• 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.


• 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.


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.


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



issue



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



issue



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.


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


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


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


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.


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


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


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


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


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

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