SMTL - Business as Usual
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SMTL UKAS inspection October 2020
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In October 2020 SMTL hosted their first virtual UKAS annual inspection.
During a two day process the inspectors watched SMTL staff test medical devices whilst being filmed using Android tablets.
The aim of the inspection is to ensure that SMTL complies with our QMS (Quality Management System) and adhere 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, test reports, projects, training records, calibration certificates and inter-laboratory proficiency tests.
The inspection went well, with a small number minor improvements suggested. The inspectors complimented SMTL on their management and control of testing, and recommended that SMTL maintain their accreditation status subject to closing out the observations.
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.
SMTL and Covid 19 - Spring 2020
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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,
BBC article on SMTL and PPE
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On 5th August 2020, the BBC visited SMTL to film some of the PPE testing which SMTL have been undertaking for NHS Wales, the wider NHS and UK industry. Laura Price from SMTL's physical testing team was filmed undertaking linting testing of gowns, and SMTL's Director, Pete Phillips, gave an interview covering the types of problems we had uncovered in recent months, as well as the benefits of sourcing PPE from local manufacturers.
A number of video clips were shown on BBC Wales News throughout the day, an article and video footage was available on the BBC Wales website, and a short radio interview was given by Pete to BBC Radio Wales on the drivetime programme at the end of the day.
Paper published on iFuse Implant System for Treating Chronic Sacroiliac Joint Pain
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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
