Neuraxial non-luer compatible test programme for the Welsh Contract.
March 2013 update
At the March meeting of the WNCRG, a position statement was agreed for the Welsh NHS:
The NHS in Wales and the WNCRG remain committed to implementing both parts of the NPSA alert, NPSA/2011/PSA001 & NPSA/2009/PSA004B. The WNCRG take their responsibilities in this matter seriously, and will continue to expend significant time, effort and resources so that Wales can implement the alerts in such a manner that clinicians are comfortable that the final decision reflects the totality of the risks. At the present time, the WNCRG have expressed a preference to focus on a partial Part B implementation, allowing the NHS in Wales to address what is perceived as the main patient safety risk, namely wrong-route bupivicaine/Local Anaesthetic infusion, whilst delaying the immediate adoption of the more complex and clinically sensitive near-patient devices used for spinal injection, where there is still concern over the design and availability issues. The intention is to continue investigating the implementation of Part A in parallel with this approach, taking cognisance of ISO 80369 developments.
Note: at present there are no formal testing or clinical evaluations planned for the immediate future. Wales will re-start their evaluation programme once an All Wales procurement process is agreed.
December 2012 Update
The results of the testing undertaken for the Welsh contract process which was annulled in early 2012 have now been published, alongside the manufacturers responses: http://medidex.com/medical-devices/784-non-luer-test-data-2012.html
August 2012 Update
Mannequin Pilot Study
Obstetric anaesthetists Rachel Collis and Mark Stacey, from the University Hospital of Wales in Cardiff, have undertaken a pilot study of non-luer devices in a controlled environment on mannequins, using a combination of quantitative and qualitative techniques. The data has been coded and is being analysed at present.
Initial analyses appears to show that the tools under consideration will provide useful information regarding the acceptability of the new non-luer devices currently, and their potential effect on clinical practice. The study was funded through a research grant from the AAGBI.
Other Welsh News
The WNCRG is creating a list of devices and procedures which will be covered by the the Part B implementation. As noted previously, the current intention is to implement Parts A & B of the NPSA alert jointly.
March 2012 Update
Procurement Services, the procurement organisation for the Welsh NHS, annuled the most recent contract process in Feb 2012.This process started in August 2011, and all suppliers who were successful in passing through the PQQ gateway were asked to submit samples for testing by 10th November 2011.
The issues with the samples included:
- Wrong size or wrong design of spinal needles supplied;
- Insufficient numbers of samples provided (multiple suppliers);
- Late submission of samples (>3 weeks late for some);
- Incomplete sample submission – e.g., no 1ml, 10ml, or 20ml syringes (multiple suppliers);
- One supplier did not provide lock syringes as requested;
- Introducer needles were either not provided at all or they were Luer compatible (at present the Welsh NHS preference is for introducers that do not connect with Luer devices);
- Luer spinal needles were provided instead of non-Luer spinal needles.
Sample submission varied amongst the suppliers however overall no single supplier supplied everything required by the target date.
A letter from Dr Tony Jewell (Chief Medical Officer, Welsh Government), Dr Chris Jones (Medical Director NHS Wales) and Professor Roger Walker (Chief Pharmaceutical Adviser) has been issued (19th March) advising the Welsh NHS of the annulment, and requiring them to manage the residual risk through their corporate risk register (a template risk register is linked in the letter). The letter also notes that, given the enforced delay, the WNCRG is now considering the possibility of implementing Parts A & B of the NPSA alert simultaneously and that:
The group is also consulting with regards to initiating a test programme outside of a procurement process which will provide NHS Wales with performance data on all candidate devices, and will continue to update NHS Wales.
Feb 2012 Update
NHS Wales has recently annuled the procurement process for neuraxial connectors. Meetings have been scheduled with all relevant suppliers to discuss next steps in early March. Further detail on NHS Wales' position will be provided after the supplier meetings.
Please note that the information below regarding timescales is not now accurate. We will revise the dates and the evaluation programme once a new procureement process is agreed.
ORIGINAL NHS Wales Neuraxial connectors Programme (now annulled)
SMTL's Director, Pete Phillips, chairs the WNCRG (Welsh Neuraxial Connectors Reference Group) on behalf of the Welsh Government, which is tasked with aiding the Welsh NHS in publicising and implementing the NPSA Alert, designed to make the NHS replace luer connectors with non-luer compatible connectors for spinal and epidural devices by 2013.
One of the key projects the group is coordinating is the testing and evaluation programme, which consists of three key phases:
- Laboratory testing
- Mannequin testing with clinicians
- User evaluations in clinical practice
The logic behind this phasing is to eliminate poor quality devices before we get to user evaluations of the products on patients.
A flow diagram of the process is available.
Laboratory Test Programme
SMTL have previously undertaken testing of non-luer neuraxial connectors for the DoH Patient Safety Team (http://qualitysafety.bmj.com/content/18/6/492.abstract), using the standard test methods for Luer devices. Since that project, an ISO draft standard has been developed (based on the luer tests) covering basic performance criteria such as air & liquid leakage. SMTL will be using these draft test methods in their test programme.
Welsh Procurement Services had to re-advertise the tender in August 2011 due to insufficient suppliers being able to meet our sample supply and selection requirements (Jul 2011). The revised test schedule is as follows:
- Nov 2011 - Initial laboratory screening phase - leak testing of male/female connectors to draft ISO, using standard luer needles and syringes as the comparator.
- Nov 2011 - Feb 2011 - Microbiological stability/storage testing of all sizes, all brands, to verify that aseptically dispensed medicines (mainly cytotoxic medicines and antibiotics) can be stored safely in the new syringes. The test involves filling the syringes with sterile broth and incubating for 2 weeks in a bacterial suspension.
- Dec 2011 - Feb 2012 - Full draft ISO 80369 testing to be undertaken on all devices.
- Nov 2011 - Feb 2012 - Microscopical and functional examination of needles (burrs, bore, needle geometry, shaft).
- Nov 2011 - Feb 2012 - User cross-connectability evaluations to be undertaken with Welsh clinicians - to ascertain whether the devices will or will not cross connect with a range of standard luer products commonly available in the Welsh NHS.
Mannequin Evaluation programme
Clinicians and researchers at University Hospital of Wales in Cardiff are in the process of finalising a test programme where clinicians undertake simulated procedures (including drug mixing) in a controlled environment using a mannequin. This is scheduled to take place in Feb 2012 - Apr 2012 (timetable still to be finalised).
User assessment by clinicians.
A clinical assessment form has been developed by an anaesthetist from Swansea in consultation with clinicians across Wales. The key question will be whether clinicians would be happy to replace their existing devices with the non-luer designs. Only devices found suitable after Laboratory and Mannequin testing would go through to user evaluation.
The testing phases form the majority score which will be used as part of the award criteria for the tender evaluations organised by the Welsh NHS Procurement Services (formerly Welsh Health Supplies).
- We wish to avoid the use of multiple non-luer neuraxial connectors in the Welsh NHS.
- We are doing our utmost to ensure clinician engagement, so that the final choice of devices is a combination of those meeting basic technical criteria (leakage, microbiological stability) and clinician's requirements.
- We wish to avoid introducing new risks with the new connectors and devices whilst also avoiding further wrong-route injections.
- The rationale behind the lab test programme is to ensure that the devices being tendered for contract meet basic performance criteria (such as not leaking, not connecting with standard luer devices, and allowing drugs for neuraxial to be stored safely). Devices which meet these criteria will then be assessed by clinicians in a simulated environment using mannequins. Devices which pass the laboratory and mannequin test stages will then be assessed by clinicians in clinical practice. This extensive assessment programme is designed to ensure that clinicians only have to trial high quality devices.
- The evaluation process has been agreed by the WNCRG, which has a majority membership of clinicians.
- This evaluation process is part of a Welsh NHS procurement strategy. Whilst we understand that there is significant interest in the outcome from other parts of the NHS, it is important to understand that waiting for the outcome of the Welsh process would not necessarily be an appropriate solution, as the Welsh procurement programme has been designed to find a suitable supplier for the whole of the Welsh NHS. It is therefore possible that some suppliers who may be suitable for an individual Trust would not be be evaluated within Wales
IMPORTANT: All dates are provisional and rely on the ability of industry to meet the initial requirements of the contracting process.