SMTL Blog

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.

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.

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, 

 

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.

 

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.

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