SMTL Blog
- Details
In February 2020, SMTL were asked to assess two models of face masks in the Welsh pandemic stores. Working with Alex Grubb from SFP in Dorset and SMTL's medical device testing labs, we were able to demonstrate that the masks were fit for purpose and met the filtration requirements of the standard.
It wasn't the first time we had assessed these masks for filtration efficiency and various other physical characteristics, but little did we know that face masks (and other types of PPE) would come to dominate our working lives for the next 4 months.
Within a month, SMTL found themselves immersed in providing technical advice and testing services on medical gloves, gowns, masks and respirators. As the Covid 19 crisis intensified, SMTL's expertise in the testing and performance requirements of medical devices was being used to support our Procurement colleagues as they dealt with thousands of queries from manufacturers hoping to be able to provide much needed PPE to the Welsh NHS.
SMTL and NWSSP Procurement set up a process so that once Procurement had identified potential suppliers (working in conjunction with the Life Sciences Hub), SMTL would check their documents to ensure they complied with the various regulations, had an appropriate Quality Management System in place, and finally check that the test data and reports demonstrated compliance with the relevant standards.
SMTL's usual medical device testing schedule continued, but with a focus on gowns and gloves particularly. The volume of work was so great at times that SMTL had to sub contract testing to labs in Belgium, the USA and the UK. SMTL's physical and biological testing labs undertook testing of devices to support the UK regulators when deciding whether gowns bought through the national procurement routes were fit for use.
In case the UK experienced significant shortages of PPE, a 4 Nations group was setup to evaluate whether it was possible to reuse some of the PPE safely. SMTL participated in this group and provided testing facilities to check whether medical gowns could be reprocessed and used more than once.
As well as testing and assessing medical devices, SMTL provided advice on standards, testing and specifications to Welsh Government, UK Government, and Welsh Industry.
As of July 2020 SMTL's workload has returned to some semblance of normality,
- Details
In Autumn 2019, SMTL hosted UKAS, the United Kingdom Accreditation Service, for our annual independent inspection.
Over a period of four days, two inspectors asked SMTL staff to undertake a variety of tests, observing whether they complied with our QMS (Quality Management System) and adhered to the requirements of ISO 17025, the international standard for testing labs.
The two inspectors covered the fields of physical and biological testing, inspecting a variety of paperwork, including testing projects, training records, calibration certificates and inter-laboratory proficiency tests.
This year the inspection was longer than usual because UKAS were also assessing SMTL's migration of their Quality Management System from ISO 17025:2005 to ISO 17025:2017. This necessitated a complete revision of our Quality Manual and a number of Standard Operating Procedures, and took over 12 months to complete. In addition UKAS also inspected testing to the new British Standard BS 661210:2018 Graduated compression hosiery, anti-embolism hosiery and graduated support hosiery which has now been included on our UKAS schedule.
The inspection went well, with the inspectors again complimenting SMTL on their management and control of testing. They recommended that SMTL maintain their accreditation status and granted our accreditation transition from ISO/IEC 17025:2005 to ISO/IEC 17025:2017 in January 2020.
SMTL's latest UKAS accreditation schedule is available to down load from the UKAS website (PDF download), and our UKAS certificate of accreditation (web link) is now also available electronically.
- Details
Dr James Evans, a healthcare researcher at SMTL, has had a paper published in Applied Health Economics and Health Policy (Dale, M., Evans, J., Carter, K., O’Connell, S., Morgan, H., Carolan-Rees, G., 2019. iFuse Implant System for Treating Chronic Sacroiliac Joint Pain: A NICE Medical Technology Guidance. Appl Health Econ Health Policy. https://doi.org/10.1007/
James carried out the work whilst working at Cedar. The paper presents the process undertaken for the development of National Institute for Health and Care Excellence (NICE) Medical Technology Guidance on iFuse, an implant for the treatment of chronic sacroiliac joint pain.
Clinical results suggested that iFuse led to improved pain, improved Oswestry disability index (ODI) and improved quality of life when compared to non-surgical treatment. The economic analysis indicated that iFuse becomes cost saving at 8 years (approximately £129 per patient) compared to non-surgical treatments and that these cost savings continue to increase after 8 years. NICE published guidance in October 2018 recommending that the case for adoption of the iFuse system in the UK National Health Service (NHS) was supported by the evidence
- Details
SMTL are pleased to formally welcome two new members of staff to the team.
Chloe Parry joins our office team to cover maternity leave. Chloe has worked in various office administration roles in a number of local companies and joined the Office team at SMTL in February 2020.
Lisa Tully joins the SMTL Biologial team on a research project investigating methods of measuring residual protein on surgical instruments. With a BSc in Biomedical Science and a Master’s degree in Integrative Bioscience and Business, Lisa has worked for several research based companies, most recently for Jellagen, a marine biotechnology company who develop scientific products based on collagen, including Jellyfish collagen. Lisa also started in February 2020.
Finally, we said goodbye to Angela Clarke, who retired from SMTL in November. We would like to thank Angela for her hard work, diligence and loyalty since she started in SMTL and send her and her husband Mike our best wishes for the future.
- Details
SMTL have recently published and updated three articles on medical compression hosiery:
