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Medical Device Managementand the Safe use of Medical
Devices within RCHT
Janine Webster(Medical Device Training Officer)
“Medical Device” DefinitionAny instrument, apparatus, appliance or
other article, whether used alone or in combination”
RCHT Medical Device &
Equipment Management Policy
Medical device can be classified under four categories. Treatment Diagnostic Monitoring Prevention
Examples of common medical devices:
Ventilators Surgical Instruments
Contact lensesThermometers
Mattress Contraception devices including condoms
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.
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
.
• 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?
Training needs analysis
How do I get medical devices training?
1. Log onto NLMS for training prospectus for available training courses: Classroom or on-line
2. Existing Specialist Equipment: Training provided by Company Clinical Trainer or in-house specialist trainer ( Key Trainer).
3. New Equipment to the Trust: Training provided by Company Clinical Trainer.
How do I evidence my medical device training?
MD04 Form (Individual record of training)
NLMS/ESR
MD07 Form ( Record of training received )
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.
How Safe is YOUR PRACTICE?
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?
Decontamination
Devices should be cleaned after use with the recommended cleaning procedure appropriate for the device.
Device must be cleaned before going for repair.
Safe Practice
Use it!
Check it!
Clean it!
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 theward/department or Medical Physics intranet site
• Return to Medical Physics via the porters
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
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)
Loaning medical devices to
patients and carers!
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
Contact
Janine Webster
Medical Device Training Officer
For any queries, comments, or concerns
by e-mail or ext. 2275
