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

“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……………

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

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)

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

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?

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.

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 the ward/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

Medical Device Training Officer Contact Janine Webster Medical Device Training Officer For any queries, comments, or concerns by e-mail or ext. 2275 Janine.Webster@rcht.cornwall.nhs.uk