Job responsibilities
. JOB DETAILS
Job Title: Medical Devices Safety Officer
Reports to: Technical Service Manager
Band: Band 5
Department: Medical Physics &
Engineering
Location St Jamess Hospital
AfC
Job No: 2550
2. JOB PURPOSE/SUMMARY
This
post is a customer-facing one, where the post holder will work with clinical
teams on medical devices governance (adverse incidents Trust-wide,
maintenance and training compliance, inventory data quality). The post-holder
will prepare monitoring reports from databases and then liaise with clinical
teams to plan actions. The post is
based St Jamess.
The
Medical Physics & Engineering (MP&E) Departments responsibilities
include the management of an extensive range of highly specialist medical
equipment and related services throughout the Trust, community and private
healthcare. The department provides a
medical equipment library on both main Trust sites, coordinates and provides
medical devices training, provides maintenance for Trust medical devices and
liaises with external maintenance suppliers to arrange and monitor external
maintenance. It also monitors
compliance with regulatory standards for medical device management.
Post
holder works across whole Trust to monitor incidents on Datix together with
investigation outcomes, identifies and facilitates required actions. They work with and advise clinical teams on
medical device issues in order to improve safety. They make suggestions for
operational policies that impact on medical devices governance across the
whole Trust.
Prepares
medical device reports from adverse incident system (Datix), equipment
inventory, Trust Medical Devices Training database and has responsiblity for
maintaining records on those systems.
Liaises
with MHRA on Medical devices safety.
Clinical-facing
role which links to Medical Physics &Engineering equipment maintenance
teams, medical device training team and equipment pool staff.
3. ORGANISATIONAL CHART
Head
of Clinical Engineering
|
Technical
Services Manager
|
Post
Holder----- Medical Devices Safety Officer
The
post holder has no line management responsibilities.
4. PRINCIPAL DUTIES & AREAS OF
RESPONSIBILITY
Writes queries for SQL databases
regularly eg Datix.
Runs Trust-wide, medical
device-related monitoring reports on adverse Incidents, staff Training and
Maintenance and reports findings to Medical Devices Group.
Prepares departmental assurance
reports for Clinical Engineering services. (for example covering turnaround
of work, patient waiting time, responses to Field Safety Notices.
Liaises with other medical device
management teams to identify outcomes of incident investigations.
Use judgement to weigh up factors
to identify and advise on learning from complex medical device
incidents.
Works with Clinical teams on
learning from Medical devices incidents and patient safety. Work is often unwelcome, such that
sensitivity, negotiation and persuasion are required.
Trains staff on specific medical
devices (e.g. controllers for beds) and software (E.g. MELVIS).
Plans and organises routine
meetings, mindful of the need for re-prioritisation due to clinical demand.
Work is guided by departmental and
Trust procedures, and national guidelines.
Travels to other hospitals, health
centres and patients homes if necessary to carry out work.
5.
THE LEEDS WAY VALUES
Our
values are part of what make us different from other trusts, so we see this
as a strength, as well as a responsibility. They have been developed by our
staff and set out what they see as important to how we work. Our five values are:
Patient-centred
Collaborative
Fair
Accountable
Empowered
All
our actions and endeavours will be guided and evaluated through these values
Additionally,
the following are core values which relate specifically to this post:
Patient safety.
Timeliness, safety, reliability and
quality in all work.
Delivery of quality improvement
outcomes.
6. WEST YORKSHIRE ASSOCIATION OF ACUTE
TRUSTS (WYAAT)
Leeds
Teaching Hospitals NHS Trust is part of the West Yorkshire Association of
Acute Trusts (WYAAT), a collaborative of the NHS hospital trusts from across
West Yorkshire and Harrogate working together to provide the best possible
care for our patients.
By
bringing together the wide range of skills and expertise across West
Yorkshire and Harrogate we are working differently, innovating and driving
forward change to deliver the highest quality care. By working for Leeds Teaching Hospitals NHS
Trust this is your opportunity to be a part of that change.
WYAAT
is the acute sector arm of the West Yorkshire and Harrogate Health and Care
Partnership, one of the largest integrated care systems in the country. The
Partnerships ambition is for everyone to have the best possible health and
wellbeing, and the work of WYAAT, and each individual trust, supports that
ambition.
7. INFECTION CONTROL
The
jobholder must comply at all times with the Leeds Teaching Hospitals NHS
Trust Infection Control policies, in particular by practising Universal Infection
Control Precautions. Hand hygiene must be performed before and after contact
with patients and their environment.
8. HEALTH AND SAFETY / RISK MANAGEMENT
All
staff are responsible for working with their colleagues to maintain and
improve the quality of services provided to our patients and other service
users. This includes complying at all
times with the Leeds Teaching Hospitals NHS Trust Policies, including Health
and Safety policies, in particular by following agreed security and safer
working procedures, and reporting incidents using the Trust Incident
Reporting system
9. EQUALITY AND DIVERSITY
The
jobholder must comply with all policies and procedures designed to ensure
equality of employment and that services are delivered in ways that meet the
individual needs of patients and their families. No person whether they are staff, patient
or visitor should receive less favourable treatment because of their gender,
ethnic origin, age, disability, sexual orientation, religion etc.
10. TRAINING AND PERSONAL DEVELOPMENT
CONTINUOUS PROFESSIONAL DEVELOPMENT
The
jobholder must take responsibility in agreement with his/her line manager for
his/her own personal development by ensuring that Continuous Professional
Development remains a priority. The jobholder
will undertake all mandatory training required for the role.
11. COMMUNICATION & WORKING
RELATIONSHIPS
Communicates with team members,
other Clinical Engineering teams. Develop effective working relationships
with clinical teams, liaising with all teams on incidents and safety.
Discusses complex equipment faults
and technical issues with equipment manufacturers and suppliers, conveys
technical information to non-technical staff e.g. nurse.
Provides routine advice, basic user
training and instruction on equipment both within the Trust and within
community and private care areas.
12. SPECIAL WORKING CONDITIONS
i) PHYSICAL EFFORT:
Mainly desk based work, but goes to
clinical areas and workshops in course of undertaking duties.
Travel to other Trust sites.
Required to review records and
process data from databases with speed and accuracy requiring hand-eye
coordination.
Occasionally moves equipment (up to
10Kg) that has been involved in an adverse incident, with a trolley when
necessary.
ii) MENTAL EFFORT:
Required to concentrate for periods
of several hours on a daily basis in order to analysis safety data and
produce complex reports.
iii)
EMOTIONAL EFFORT:
Accept rare exposure to challenging
behaviour, when investigating adverse incidents or negotiating a change in
working practice.
iv)
WORKING CONDITIONS:
Occasionally comes into contact
with contaminated medical devices, and is expected to use PPE as
appropriate.
Person
Specification
Post
Title Medical Devices Safety
Officer (Post
Ref: 2550 )
Band Band 5
Department Medical Physics & Engineering
Directorate
Leeds Cancer Centre
Summary
of Role 1. Monitors incidents
on DATIX, investigations outcomes, identifies and facilitates required
actions.
2.
Prepares Medical device reports from Datix, inventory, Melvis and updates
records.
3.
Works with and advises clinical teams on medical device safety issues
(availability, training, maintenance).
4.
Liaises with MHRA on Medical device incidents.
Criteria:
Essential
Desirable Evidence obtained from:
Qualifications
and Training: Graduate level or
equivalent professional qualification.
Specialist database training. Sight
of formal qualification certificates
Training
record, certificates, CV and through interview questions. Certificates of
attendance.
Special
Knowledge including experience:
Professional knowledge of medical
device safety policies, procedures and practices to degree level, or
equivalent.
Substantial
experience in the healthcare or medical device industry or in healthcare.
Sound
knowledge of databases and queries/ I.T. skills.
Proven
ability to interpret complex facts, analyse and identify outcomes in complex
situations.
Understanding
of medical devices safety policies, procedures and practices.
Governance
structure for medical devices including NHS England, MHRA, Health and Safety
Executive, CQC. NHS Litigation Authority.
Patient
Safety Alert NHS/PSA/D/2014/006.
Risk
Management in Healthcare and Risk assessment.
Patient
Safety practices and policies.
Familiar
with LTH organisational structure and role of others.
Experience
in working with databases and ability understand and to write queries. in Structured Query Language (SQL) or
similar.
