Click to edit Master subtitle style Safer Spinal Connectors? Trying to prevent injection of drugs into the wrong place. A simulation-based evaluation Tim.

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Click to edit Master subtitle style Safer Spinal Connectors? Trying to prevent injection of drugs into the wrong place. A simulation-based evaluation Tim Cook, Sonja Payne, Elena Skryabina, Dom Hurford, Emma Clow, Andy Georgiou Royal United Hospital, Bath

Click to edit Master subtitle style 12/09/10 Spinals Epidurals Lumbar punctures IT chemo injections

Click to edit Master subtitle style 12/09/10 Spinals Epidurals Lumbar punctures IT chemo injections

Click to edit Master subtitle style 12/09/10 Spinals Epidurals Lumbar punctures IT chemo injections

Click to edit Master subtitle style Spinal and epidural injections Approx 700,000 in UK pa With lumbar punctures/chemotherapy injections >1 million in UK per year

The Problem

Wayne Jowett Death 2001

Myra Cabrera Fatal IV Bupivacaine 2004

Joe Gibbs Fatal IV bupivacaine in ICU Fatal 2008

Grace Wang Epidural Chlorhexidine 8ml Australia June 2010

The Problem An Organisation with a Memory 2000  55 cases worldwide of intrathecal injections of vinca alkaloid chemotherapy agents  Eliminating wrong route errors one of four specified aims NRLS  regular reports of wrong-route errors  – 3 deaths due to epidural infusion given IV NAP 3  11 cases of wrong route drug administration  1 death

Wrong route errors and HF A ‘feeding ground’ for HF

‘Learning from error’ DH video

The Plan

Objective Evaluate usability vs

CE marking

Manikin evaluation Anaesthetists (25) – Spinal anaesthesia – Epidural injection/catheter Haematologists-oncologists – Intrathecal injection – (adult/paediatric) Physicians – Lumbar puncture

Non-Luer Connectors - B-link Ltd (UK) - InterVene Ltd (UK) Neurax® Spinalok®

Methodology

Likert scale (1-5) Appearance Handling Ease of attaching syringe Connection security CSF visibility through hub Ease of injecting Robustness +/- epidural catheter 0 – 10 Overall usability 'Cross-connectivity'

Results – lots!

Results – Spinal * P<0.05 * P<0.01

Results – Spinal  25 anaesthetists participated

Results –Epidural * P<0.05 * P<0.01

Results - Epidural  25 anaesthetists participated

Results – chemo and LP * P<0.05 * P<0.01

Results – LP/Intrathecal Chemo  19 clinicians participated

Usability Non-Luer connectors less acceptable? Bias Diversity of opinion Unable to assess connector independently

Cross-Connectivity Neurax® - epidural filter approx 70N

Cross-Connectivity Needle connector - Spinalok® male-male

General manufacturers response Not true Not relevant User evaluation Too variable No standards Irrelevant to ISO CE etc

12/09/10

Feedback to manufacturers Revised connectors….issues resolved? 12/09/10 Neurax® increase 2mm in diameter Spinalok increase 2mm in diameter

Click to edit Master subtitle style Seven different options None user evaluated No funding for such

Click to edit Master subtitle style Conclusions User evaluation (equipment HF) is an important part of development of any new equipment.....whether designed with safety in mind or not Currently it is not happening

Independence Companies invited to - Train in use - Take no other part in study Grants - RUH Bath R&D funds - NPSA Dr Cook is a representative of the RCoA on the NPSA external reference group. This presentation is un- related to that role.