SMTL Blog

The EN 13726 series of standards published in the early 2000s cover the test methods for primary wound dressings.  During a systematic review in 2012 it was apparent that a number of test methods were not being used. and other methods needed significant revision to ensure the test results remained relevant to modern dressing design. It was agreed that a full revision of the standard was required to address these issues.

In the intervening period SMTL have been heavily involved in organising the inter-laboratory workstreams, data analysis and subsequently re-writing of the standard, with Pete Phillips (Director of SMTL) chairing the CEN Project Group TC/205/WG15/PG1, under which the Panel operated, and Dr Gavin Hughes (Deputy Director, SMTL) acting as the Editor of the standard.

A new prEN 13726 (Test methods for wound dressings - Aspects of absorbency and moisture vapour transmission, waterproofness and conformability) has been produced which will eventually supersede EN 13726-1:2002, EN 13726-2:2002, EN 13726-3:2003 and EN 13726-4:2003. 

prEN 13726 has been out for enquiry across Europe, and the ballot has recently been approved.  The working group are currently updating the draft standard with comments submitted during the enquiry,  with the aim to have the updated standard ready for the dispatch of formal vote-draft in March 2022. It is anticipated that the standard will be published later in 2022.

SMTL have welcomed a new member of the Biological Testing Team to SMTL - Jotika Ramnik Halai. Jotika was previously working in the Covid testing Lighthouse Laboratory in Newport before taking up her new position at SMTL.
 
Dr James Evans, one of SMTL's research officers, became a father for the first time in March. We are happy to report that Joseph (James' son)  and James' wife Beth are all well, and that James is back in work following a relaxing bout of patermity leave.
 
Finally, Elaine Morgan takes early retirement in July so she can spend more time with her growing brood of grandchildren. Fortunately for SMTL, Elaine is going to return part time in the role of office manager in a job share, and Jade Taylor will be acting up into the shared role during the transition.        
In Winter 2020, SMTL were asked to chair a group (the NHS Transparent Face Mask Working group)  brought together by NHS E&I (NHS England and NHS Improvement). to produce a technical specification for transparent face masks, to meet a demonstrated demand for transparent face masks at the time of writing (Spring 2021).  The group met between Jan and March 2021,
 
The aim of the group was to produce a  technical specification, based on test methods and some of the design and performance requirements in established standards, for transparent face masks, some of which could be considered for use as an alternative to Type IIR medical masks.

The final specification has now been published, and gives design and performance requirements for single-use TRANSPARENT FACE MASKS which are intended to provide comparable protection and source control to some or all of the properties of a Type IIR medical mask, using test methods and performance requirements from existing standards, whilst adapting them due to the transparency requirements.  It is important to recognise that masks complying with the technical specification cannot be referred to as Type IIR medical masks, as that term is defined in EN 14683:2019 and is reserved for products meeting the definition of a medical device that also comply wholly with the requirements for Type IIR medical masks in that standard. Masks complying with the new technical specification may, however, meet some of the requirements of EN 14683:2019.

The specification is available from the gov.uk web site.

The group note that due to the rate of development in this emerging field, further revision of the specification may be necessary later this year.

Atraumatic Diagnostic Lumbar Puncture - new advice from EBPB (May 2021)

The EBPB have issued advice and an evidence review for the use of atraumatic needles in diagnostic lumbar puncture (DLP). 

The EBPB concluded that there was a clear clinical benefit to using atraumatic needles for DLP, through a reduction of post-dural puncture headache (PDPH). Economic analysis suggests that despite the increased cost of atraumatic needles, cost savings could be achieved through PDPH reduction. The EBPB agreed that even without the potential for cost savings, patients would still benefit from this change in needle design. 

The full statement and evidence review are available on the EBPB pages.

COVID-19 continues to be a challenge for the NHS and the UK in general.  This has required SMTL to shift our focus and develop a range of new services to our stakeholders.  We have been heavily involved in providing Technical Assurance,  medical device testing and PPE testing services for the NHS, Welsh Government, the Department of Health and Industry.  In particular, we have been supporting our colleagues in NWSSP Procurement Services.
 
During the difficulties of 2020, SMTL has been able to maintain our extensive schedule of accredited tests and testing services, whilst also ensuring the welfare of our employees.  We have been able to expand our knowledge and skill base and increase capacity with the recruitment of additional staff.
 
We would like to thank all of our customers and stakeholders for your continued support, and we would like to reassure new and existing customers that we are continuing to provide our testing services as normal.
 
Please review our web site for our routine services, or email info@smtl.co.uk if you have a specific medical device/PPE testing query.

More Articles...

Joomla Template: by JoomlaShack