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SMTL undertook a multicentre simulation of the (at the time)  proposed ISO 80369-6 connector for the neuraxial route in 2014 (the standard was published in 2016, and the connectors are now known as NRFit connectors).

The standard was produced to help mitigate the risk of wrong route injections, such as the case of Wayne Jowett in 2001 where intravenous chemotherapy was accidentally injected spinally, resulting in Wayne Jowett's death.

Thirty-eight doctors and 17 nurses performed simulated clinical procedures on manikins, using devices fitted with either Luer connectors or draft ISO 80369-6 ‘non-Luer’ connectors. The procedures included spinal anaesthesia; intrathecal chemotherapy; lumbar puncture, cerebrospinal fluid collection and pressure measurement; epidural catheter placement with bolus injection and critical care use. Participants attempted cross connection between neuraxial connectors and a range of other medical device connectors to check that the design achieved the deiredlevel of non-connactability.

The results of the usability testing have been published in Anaesthesia:

Cook TM, Wilkes A, Bickford Smith P, Dorn L, Stacey M, Kinsella SM, Sharpe P, 
Phillips P. Multicentre clinical simulation evaluation of the ISO 80369-6
neuraxial non-Luer connector. Anaesthesia. 2019 May;74(5):619-629.

Most cross-connection attempts failed, even using above clinical forces and, when successful, were judged of low clinical risk potential; the exception was a malaligned connection between the non-Luer slip and female Luer connectors. This led to revision of the dimensional tolerances of the non-Luer connector to reduce this risk, before publication of the final specification in 2016.

The authors concluded that the ISO 80369-6 neuraxial non-Luer connector was suitable for clinical use.

 

 

 

Dr James Evans, a healthcare researcher at SMTL, has had a  paper published in the Pacing and Clinical Electrophysiology (PACE) journal  (Evans, J. M., Withers, K. L., Lencioni, M. , Carolan‐Rees, G. , Wood, K. A., Patrick, H. and Griffith, M. (2019), Quality of Life Benefits from Arrhythmia Ablation: A longitudinal study using the C‐CAP questionnaire and EQ5D. Pacing Clin Electrophysiol. Accepted Author Manuscript. doi:10.1111/pace.13675).

James carried out the work whilst working at Cedar. The study presents results for generic and arrhythmia related quality of life using patient reported outcomes gathered at baseline, post-ablation and at 1 year follow-up.

Results showed significant improvements in symptom severity, impact on life scores, EQ-5D-5L indices and VAS scores at baseline versus three months (post-ablation) and at baseline versus 1 year follow-up. Impact on life score showed additional improvement at 1 year follow-up versus three months, while improvements in symptom severity, EQ-5D-5L indices and VAS scores continued to be maintained between 3 months and 1 year follow-up.

Cardiac ablation therefore provides patients with arrhythmias relief from symptoms, and results in an improvement in quality of life.

 

 

 

Dr James Evans, one of SMTL's health services researchers, has recently had a paper published in Applied Health Economics and Health Policy ("Thopaz+ Portable Digital System for Managing Chest Drains: A NICE Medical Technology Guidance", Evans, J.M., Ray, A., Dale, M. et al. Appl Health Econ Health Policy (2019)).

The work,  undertaken when James was working for CEDAR, assessed the  clinical evidence for Thopaz+, and  showed shorter drainage times and length of hospital stay, lower rates of chest drain re-insertion and higher rates of patient satisfaction when used in patients following pulmonary resection compared to conventional chest drainage. One comparative study of the use of Thopaz+ in patients with spontaneous pneumothorax was identified and showed shorter drainage times and length of hospital stay compared to conventional drainage.

The authors concluded that the use of Thopaz+ in patients following pulmonary resection and patients with pneumothorax led to cost savings compared to conventional drainage. The main driver for cost savings was a reduction in length of hospital stay.

 

Announcement: SMTL are now offering testing of disposable pulp products to BSI PAS 29

SMTL are pleased to announce the availability of a new test method for pulp products used in healthcare, to  BSI "Product Assessment Specification PAS 29:1999 Disposable pulp products for use in healthcare".

Please contact SMTL as below if you want a quote.

Tel: +44 (0) 1656 752820
Email: physical@smtl.co.uk

 

Since the first British Standards for compression hosiery were published in the 1980's, the use of compression garments to treat various clinical complications has changed significantly.  Performance requirements and test parameters which seemed appropriate 33 years ago  are now causing confusion for users of the products and operational difficulties for test houses and manufacturers.

To address these issues a new standard - BS 661210:2018 - has recently been published.  BS 661210 is a revision and merger of three previous standards (BS 6612:1985, BS 7563:1999 and BS 7672:1993) for graduated compression hosiery, anti-embolism hosiery and graduated support hosiery. The BSI Panel took the opportunity of the revision to address inconsistencies in the previous standards, clarifying various test parameters and technical issues,  and producing a  single consistent test method to test both medical and non-medical compression garments.

As well as specifying the test method, the Standard sets out performance requirements  for the compression and stiffness of these devices, and these have been updated to reflect current clinical UK guidance .  A new  informative Rationale Annex (Annex C) has been included to explain the thinking behind most of the major changes in the Standard, and another new Annex (Annex D) explains the variety of classes and compression profiles used in the UK that are referenced in various standards and clinical guidance documents.

Peter Phillips (Director of SMTL) is chair of BSI committee CH/205/1, under which the Panel operated, and Dr Gavin Hughes (Deputy Director, SMTL) acted as Editor of the standard.

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