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RDF19 Poster Details

RDF19 Poster Detail

Poster Title 
Overcoming challenges to implement a medical device trial in a clinic setting

In order to take part in an NIHR funded study for the treatment of diabetic foot ulcers, participating centres must implement a hydrosurgical debridement technique (HD) into podiatry clinics. HD is currently in routine use in the NHS within a theatre setting but has seen limited use within the clinic environment as an outpatient procedure. A number of challenges were identified during the process of putting this technique into clinical practice for the trial, most of which were new to the hospital teams.

We have developed guidance and a training package which covers all aspects for consideration including:

  1. Application to new devices panel (where applicable)
  2. Whether this is required according to Trust policy, meeting dates and how to be included as an agenda item.
  3. Liaison with infection control
  4. Outline of the considerations (preparation of the room, cleaning before and afterwards, disposal of clinical waste) and providing a draft SOP for use of the device.
  5. Medical engineering insurance indemnity requirements
  6. Is the provider listed on the DoH master indemnity agreement (MIA) register? What are the additional paperwork requirements (e.g. MIA call off)?
  7. Procurement/purchasing requisites
  8. Which items need to be purchased and whether they are available on NHS supplies, raising purchase order numbers where needed.
  9. Logistical coordination
  10. Identify someone to take responsibility for delivering the devices for medical engineering checks. Establish where equipment be stored and the most suitable location.
  11. Training
  12. Which HCPs require training and the timelines.

Our experience can be adopted by other NHS centres who wish to use HD in this or similar settings, both within a trial and also in standard practice. This work package can also be adopted in future trials where implementation of new devices at NHS organisations is required, to streamline the process and reduce set up times.

  • GILBERTS, Rachael (Senior Trial Manager, University of Leeds Clinical Trials Research Unit)
  • RUSSELL, David (Consultant Vascular Surgeon, Leeds Teaching Hospitals NHS Trust)
  • McGINNIS, Elizabeth (Clinical Coordinator, University of Leeds Clinical Trials Research Unit)
  • DEWHIRST, Nikki (Clinical Coordinator, University of Leeds Clinical Trials Research Unit)
University of Leeds