Test Reports and Results - testing of non-luer neuraxial connector devices, Welsh contract 2011-2013.
As part of SMTL's role in providing testing and technical advice on medical devices for the NHS in Wales, SMTL embarked on a test programme for the second contract process for these devices in November 2011. The terms of the contract were that by participating in the procurement process, SMTL would test the devices using a range of appropriate methods, and SMTL and NHS Wales Procurement Services could publish the results of testing and assessments without restriction or censure. Whilst the contract eventually had to be annuled (for various reasons detailed on http://smtl.co.uk/nhs-services/58-nhs-device-testing/157-neuraxial-non-luer), some of the testing had already started or been completed. This page includes the test reports where testing was complete.
Microbiological Integrity Testing
SMTL used the NHS Pharmaceutical Quality Assurance Committee document "Microbiological Protocol for the Integrity Testing of Syringes (1st Edition, February 2006)" to test the integrity of the syringe/cap combinations for their suitability to store aseptically dispensed medicines.
The results are available as a PDF Test Report (see links below). Each manufacturer has been asked to provide comments (both at face-to-face meetings and via email), and these are also reproduced below in a separate document.
- SMTL Microbiological Integrity Testing Test Report 12/3783/2 (PDF download - updated 6th Dec 2012)
- Manufacturers Responses (PDF Download - updated 5th Dec 2012)
PASG have commissioned dye intrusion tests for Surety and Corectinject, and these test reports and the latest PASG position statement is now available:
- Correctinject dye intrusion tests
- Surety dye intrusion tests
- PASG position statement (June 2013), based on the Intervene investigation (May 2013).
Members of the Welsh NHS team undertaking the microbiological testing of the devices have concerns about the Intervene document and the conclusions drawn as a result of it. Details are in the following report:
Physical Leak Testing to the draft ISO standard.
SMTL undertook leak testing of a small number of devices to the draft ISO 80369-6 for small-bore neuraxial connectors. This was originally intended as the first screening stage of the full testing process, but no further testing took place when the contract process was annulled. The results are available as PDF Test Reports (see links below).
- SIGNED-report-3783-3-BD.pdf
- SIGNED-report-3783-4-Flexicare.pdf
- SIGNED-report-3783-5-Intervene.pdf
- SIGNED-report-3783-6-Pajunk.pdf
- SIGNED-report-3783-7-Sarstedt.pdf
- SIGNED-report-3783-8-Smiths-Medical.pdf
Cross connection testing.
SMTL were asked by Welsh Government to investigate potential cross connections with the submitted devices. The results of the first phase are available as a test report (see link below).
