SMTL Blog
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There is currently no standard for assessing the antimicrobial properties of wound dressings.
The European Committee for Standardization (CEN - www.cencenelec.eu) established a working group (CEN/TC205/WG15/PG2) in 2010 to draft a standard, and since its inception SMTL have been heavily involved in the development of candidate test methods.
Considerable inter-laboratory testing has been performed in the development of the method which has resulted in a draft standard prEN 17854 Antimicrobial wound dressings — Requirements and test method which has been published for comment.
Dr Pamela Ashman and Elizabeth Davies from SMTL attended the November 2022 meeting held in Sweden to discuss the comments received for the draft standard, and are pictured along with other members of the working group on the Swedish Institute Standards roof on a mild Stockholm winter afternoon.
There is a further meeting scheduled for February 2023 to discuss any further comments on the changes made in the meeting, with an intention to publish the standard later in 2023.
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An addendum to the European standard BS EN 455-1:2020+A1:2022 Medical gloves for single use - Requirements and testing for freedom from holes has been published (January 2023).
The 2022 addendum has reintroduced the option to statistically sample gloves using multiple sampling plans. The new document rectifies an anomaly that SMTL identified with the 2020 standard, where the option to statistically sample using multiple sampling plans had been inadvertently removed.
The 2022 addendum also clarifies that testing should be performed on each lot and a definition has been provided (lot - collection of gloves of the same design, colour, shape, size and formulation, manufactured at essentially the same time, using the same process, raw materials of the same specifications, common equipment and packed in the same type of individual container)
SMTL are UKAS accredited for BS EN 455-1, 2 and 3 testing.
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Dr James Evans, SMTL's Research and Development Manager, presented at the recent Procurex Wales 2022 Conference held in Cardiff.
James' presentation, "Evidence, testing and technical assurance in procurement decisions", highlighted the many ways SMTL supports Procurement colleagues in their decisions on procuring disposable medical devices for NHS Wales and further afield. The presentation was part of a well-received NHS Wales session that included interesting presentations on the Covid-19 vaccine roll-out and decarbonisation in NHS Wales.
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The COVID pandemic has meant that UKAS have not been able to perform assessments in their traditional form, and for the last 2 years assessments have been conducted virtually with technical activities witnessed by ‘live stream’.
In a return to 'business as usual' SMTL had the pleasure of hosting assessors within the laboratory again for our 2022 annual inspection. The aim of the assessment is to determine whether SMTL have the necessary technical competence and that our Quality Management System conforms with the requirements of ISO/IEC 17025:2017 General requirements for the competence of testing and calibration laboratories.
The audit was a surveillance visit performed by 3 assessors, 2 of which were new to SMTL. It's always a step into the unknown when new auditors arrive, but all assessors were very complimentary on the competency and knowledge of our staff, with only 1 minor improvement finding identified during the audit.
SMTL's latest UKAS accreditation schedule is available to download from the UKAS website (PDF download), and our UKAS certificate of accreditation (web link) is now also available electronically.
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SMTL OCP and Staff News
During the pandemic, SMTL tested medical devices & PPE products at an unprecedented level. The demand for SMTL post-pandemic continues at a high level which has stretched the laboratory services. Together with impending staff retirements these situations have highlighted the requirement to reevaluate our service and structure.
SMTL senior team have been working closely with NWSSP People and Organisational Development colleagues on an Organisational Change Process (OCP) to develop a structure that ensures resilience of the laboratory as well as supporting future development, both in terms of capacity and breadth of service. We are pleased to announce that the OCP has been completed and a number of new appointments have been made.
Dr Gavin Hughes has succeeded Pete Phillips and been appointed Director for SMTL services from his previous deputy role. Gavin succeeds Pete Phillips who has semi-retired and has taken on a part time Technical Director role.
Louise Barry has been appointed as Technical Manager for Physical Testing and Dr James Evans takes on a new role of Research and Development Manager. Matthew Alderman’s role as Operations Manager has developed into a wider encompassing position to include managing SMTL’s strategic and operational direction.
At Easter we said goodbye to Claudia Padurariu who secured a position in a laboratory closer to her home in Cardiff, and we wish her the very best in her new role. We are happy to welcome Conciliah Mofokeng to SMTL’s Biological Testing Department as Claudia’s replacement. Conciliah joins us after completing an MSc in Public Health and Health Promotion from Swansea University.
We would like to extend a warm welcome to all of the new appointments at SMTL.
