click to edit master subtitle style safer spinal connectors? trying to prevent injection of drugs...
DESCRIPTION
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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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 injectionsApprox 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 bupivacainein ICU
Fatal
2008
Grace Wang
Epidural Chlorhexidine 8ml
Australia June 2010
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
Wrong route errors and HF
A ‘feeding ground’ for HF
‘Learning from error’ DH video
The Plan
Objective
Evaluate usability
vs
CE marking
Manikin evaluationAnaesthetists (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
MethodologyLikert scale (1-5)AppearanceHandlingEase of attaching syringeConnection securityCSF visibility through hubEase of injectingRobustness +/- epidural catheter
0 – 10Overall 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 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
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.