1. Janine Webster (Medical Device Training Officer)
Medical Device Management and the Safe use of Medical Devices within RCHT
Janine Webster (Medical Device Training Officer)

2. “Medical Device” Definition
Any instrument, apparatus, appliance or
other article, whether used alone or in combination”
RCHT Medical Device &
Equipment Management Policy
So effectively anything you use on a patient……………

3. Examples of common medical devices:
Medical device can be classified under four categories.
Treatment Diagnostic
Monitoring Prevention
Examples of common medical devices:
Ventilators
Surgical Instruments
Contact lenses
Thermometers
Mattress
Contraception devices including condoms
Extract from the Care Quality Commission handbook of Essential Standards

4. Healthcare Professionals: Roles and Responsibility
Healthcare professionals are individually accountable for their own practice
Healthcare professionals are bound by their Code of Ethics and Scope of Professional Practice, which clearly set out the individual’s responsibilities and duty of care when using medical devices and of the situation that may arise when undertaking actions that they are not trained to perform.
Procedures on the use of medical devices
Procedures for acting when we receive an alert from the manufacturer, or professional body (eg MHRA)

5. Identifying Training Needs
Medical Device Link Person (LMDL) or Ward Manager
Local Ward or Departmental Induction
MD08i/MD04 Training Needs Analysis Form and Individual Record of Training

6. Training needs analysis.
Training needs analysis
Can you identify the risk level of the device( high, medium, low)
Do you require training?
Have you received previous training?
Are you competent?
Are you confident?
Is the member of staff using this medical device competent to do so – is the patient safe?

7. How do I get medical devices training?
Log onto NLMS for training prospectus for available training courses: Classroom or on-line
Existing Specialist Equipment: Training provided by Company Clinical Trainer or in-house specialist trainer ( Key Trainer).
New Equipment to the Trust: Training provided by Company Clinical Trainer.

8. How do I evidence my medical device training?
MD04 Form (Individual record of training)
NLMS/ESR
MD07 Form ( Record of training received )

9. Where will my training records located?
Training competencies are kept in a medical devices folder in a secure location within your area of practice.
An overview of staff training is recorded and kept on the Medical Devices shared drive.
Training records are also accessible within ESR if the training provided was available on NLMS.

10. How Safe is YOUR PRACTICE?

11. Pre-checks for medical devices
Is the device working properly?
Is the device set up properly according to manufacturer instruction or local policy. (e.g. correct consumable)?
Is the device clean?
Am I confident and competent to use the device?

12. Decontamination
Devices should be cleaned after use with the recommended cleaning procedure appropriate for the device.
Device must be cleaned before going for repair.

13. Safe Practice
Use it!
Check it!
Clean it!

14. What do I do when a medical device is faulty?
Remove the device from clinical service immediately
Fill in a Decontamination/Fault form located on the
ward/department or Medical Physics intranet site
Return to Medical Physics via the porters

15. Incident Reporting and Safety Alerts
How do I know if I should report a medical device incident?
If a fault on a device caused harm to a patient
If a fault may have caused harm to a patient (near miss)
If you have concerns with a functional design of a device

16. How do I Report an Incident with a medical device?
Incidents must be reported via Datix. (available on the intranet)
Incidents may be reported directly to MHRA website. (Medicines and Healthcare Products Regulatory Agency)

17. Loaning medical devices to
patients and carers!

18. Documentation is essential when lending out medical devices to Patients and Carers ( End Users of medical devices)
MD11 Form: Located on the Medical Physics Intranet Site
Record relevant patient information
Identify training needs and provide appropriate support
Identify and record relevant information from the device
Identify expected return of the device to the Trust

19. Medical Device Training Officer
Contact
Janine Webster
Medical Device Training Officer
For any queries, comments, or concerns
by or ext. 2275