Neuraxial Project for the Welsh NHS - General Information
ISO standard developments - May 2013
A useful document has been published by AAMI (Association for the Advancement of Medical Instrumentation) giving an update on the ISO standards process: http://www.aami.org/newsviews/newsdetail.aspx?ItemNumber=1025 In addition they have published a proposed timeline for the whole series of small bore connector standards
Further clinical papers published
A paper by Paul Sharp and colleagues has been published on the assessment of non-luer devices in Anaesthesia, May 2013. There are now a number of publications covering these devices in the literature:
- Sharpe P, Scott S, Gross JM. An evaluation of non-Luer safety connectors for neuraxial procedures. Anaesthesia. 2013 Jun;68(6):562-70.
- Buckingham M. Non-Luer needles. Anaesthesia. 2013 May;68(5):546.
- Toft B, Cousins D. Clinical evaluation of non-Luer needle and syringe systems. Anaesthesia. 2013 Apr;68(4):426.
- Griffiths R, Jubb R, Quass CG. Non-Luer can become Luer. Anaesthesia. 2013 Feb;68(2):220-1.
- Kinsella SM. The shock of the 'Nuer': the UK experience with new non-Luer neuraxial equipment and implications for obstetric anaesthesia. Int J Obstet Anesth. 2013 Jan;22(1):1-5.
- Kinsella SM, Goswami A, Laxton C, Kirkham L, Wharton N, Bowen M. A clinical evaluation of four non-Luer spinal needle and syringe systems. Anaesthesia. 2012 Nov;67(11):1217-24.
- Cook TM. Non-Luer connectors: are we nearly there yet? Anaesthesia. 2012 Jul;67(7):784-92.
- Howes B, Kinsella SM, Youngs P. Non-Luer neuraxial equipment and anaesthetists' attitudes to change. Anaesthesia. 2011 Jan;66(1):59-60.
- Cook TM, Payne S, Skryabina E, Hurford D, Clow E, Georgiou A. A simulation-based evaluation of two proposed alternatives to Luer devices for use in neuraxial anaesthesia. Anaesthesia. 2010 Nov;65(11):1069-79.
- Lawton R, Gardner P, Green B, Davey C, Chamberlain P, Phillips P, Hughes G. An engineered solution to the maladministration of spinal injections. Qual Saf Health Care. 2009 Dec;18(6):492-5.
ISO standard developments - April 2013
At the meeting of ISO TC 210 on the 15 March 2013, Tokyo, Japan, the ISO Technical Committee dealing with the small bore connectors series of standards made some important decisions:
- ISO have agreed with CEN's wishes that these standards should include an Annex ZA, which means that they will be able to be used to assess compliance with elements of the Medical Device Directive Essential Requirements.
- ISO are now formally setting up a reservoir connectors group, which will deal with all reservoir connectors (i.e., IV spike replacements, to prevent the insertion of an IV giving set into enteral/epidural/etc infusions). Although initially dealing with enteral feed connectors, this now creates a group which can deal with standardisation of epidural reservoir connectors as well.
March 2012 Update
The Welsh tender has been annulled - see http://smtl.co.uk/nhs-services/58-nhs-device-testing/157-neuraxial-non-luer for further details. We expect to restart the process in the near future.
November 2011 Update
Since the publication of the NPSA alert in Autumn 2009, SMTL have been involved in helping the Welsh NHS devise a strategy to enable them to comply with the alert.
At present, the following actions have been completed:
- The Welsh Assembly Government (WAG) set up a committee - the Welsh Neuraxial Connectors Reference Group (WNCRG), chaired by Pete Phillips, Director, SMTL. The aim of the group is to aid the Welsh NHS in publicising and implementing this alert.
- WAG have issued a CMO letter explaining the role of the WNCRG in this process and asking Trusts and Health Boards to set up local implementation groups.
- WAG have funded a full time procurement officer working jointly between SMTL and WHS (now Procurement Services).
- SMTL/WHS held a series of meetings with each company likely to participate in this field in Spring/Summer 2010, to explain the Welsh process and to determine which connector design the company intended to supply.
- A series of benchtop evaluations/supplier days were held between Sept 2010 and Jan 2011. Each supplier was asked to bring along samples of their production ready product and clinicians were able to evaluate each suppliers' devices in a room without interference from the supplier.
Procurement Services (formerly Welsh Health Supplies) initiated a tender process for the Welsh NHS in Summer 2011. The first phase (ITPD) is now (Oct/Nov 2011) underway. This process includes a comprehensive test programme at SMTL, where devices will be tested to the draft ISO standard for small bore connectors, followed by mannequin testing with clinicians, and will conclude with clinical assessments in hospitals throughout Wales. Details of the evaluation programme are available on the SMTL neuraxial test programme page.