click to edit master subtitle style safer spinal connectors? trying to prevent injection of drugs...
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Click to edit Master subtitle style 12/09/10 Spinals Epidurals Lumbar punctures IT chemo injectionsTRANSCRIPT
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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
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Click to edit Master subtitle style
12/09/10
Spinals
Epidurals
Lumbar punctures
IT chemo injections
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Click to edit Master subtitle style
12/09/10
Spinals
Epidurals
Lumbar punctures
IT chemo injections
![Page 4: Click to edit Master subtitle style Safer Spinal Connectors? Trying to prevent injection of drugs into the wrong place. A simulation-based evaluation Tim](https://reader036.vdocument.in/reader036/viewer/2022081404/5a4d1bbd7f8b9ab0599d16f8/html5/thumbnails/4.jpg)
Click to edit Master subtitle style
12/09/10
Spinals
Epidurals
Lumbar punctures
IT chemo injections
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Click to edit Master subtitle style
Spinal and epidural injectionsApprox 700,000 in UK pa
With lumbar punctures/chemotherapy
injections >1 million in UK per year
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The Problem
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Wayne Jowett
Death 2001
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Myra Cabrera
Fatal IV Bupivacaine
2004
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Joe Gibbs
Fatal IV bupivacainein ICU
Fatal
2008
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Grace Wang
Epidural Chlorhexidine 8ml
Australia June 2010
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The ProblemAn 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 2000-4 – 3 deaths due to epidural infusion given IV
NAP 3 11 cases of wrong route drug administration 1 death
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Wrong route errors and HF
A ‘feeding ground’ for HF
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‘Learning from error’ DH video
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The Plan
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Objective
Evaluate usability
vs
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CE marking
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Manikin evaluationAnaesthetists (25)
– Spinal anaesthesia– Epidural injection/catheter
Haematologists-oncologists – Intrathecal injection– (adult/paediatric)
Physicians– Lumbar puncture
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Non-Luer Connectors - B-link Ltd (UK) - InterVene Ltd (UK)
Neurax® Spinalok®
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Methodology
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MethodologyLikert scale (1-5)AppearanceHandlingEase of attaching syringeConnection securityCSF visibility through hubEase of injectingRobustness +/- epidural catheter
0 – 10Overall usability
'Cross-connectivity'
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Results – lots!
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Results – Spinal
* P<0.05
* P<0.01
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Results – Spinal 25 anaesthetists participated
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Results –Epidural
* P<0.05
* P<0.01
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Results - Epidural 25 anaesthetists participated
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Results – chemo and LP* P<0.05
* P<0.01
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Results – LP/Intrathecal Chemo 19 clinicians participated
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Usability Non-Luer connectors less acceptable?
Bias Diversity of opinion Unable to assess connector independently
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Cross-Connectivity
Neurax® - epidural filter approx 70N
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Cross-Connectivity
Needle connector - Spinalok® male-male
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General manufacturers response
Not true
Not relevant
User evaluation.......
Too variable
No standards
Irrelevant to ISO CE etc
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12/09/10
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Feedback to manufacturersRevised connectors….issues resolved?
12/09/10
Neurax® increase 2mm in diameter
Spinalok increase 2mm in diameter
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Seven different optionsNone user evaluatedNo funding for such
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ConclusionsUser 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
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IndependenceCompanies 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.