SMTL Blog

Announcement: SMTL are now offering testing of disposable pulp products to BSI PAS 29

SMTL are pleased to announce the availability of a new test method for pulp products used in healthcare, to  BSI "Product Assessment Specification PAS 29:1999 Disposable pulp products for use in healthcare".

Please contact SMTL as below if you want a quote.

Tel: +44 (0) 1656 752820
Email: physical@smtl.co.uk

 

Dr James Evans, one of SMTL's health services researchers, has recently had a paper published in Applied Health Economics and Health Policy ("Thopaz+ Portable Digital System for Managing Chest Drains: A NICE Medical Technology Guidance", Evans, J.M., Ray, A., Dale, M. et al. Appl Health Econ Health Policy (2019)).

The work,  undertaken when James was working for CEDAR, assessed the  clinical evidence for Thopaz+, and  showed shorter drainage times and length of hospital stay, lower rates of chest drain re-insertion and higher rates of patient satisfaction when used in patients following pulmonary resection compared to conventional chest drainage. One comparative study of the use of Thopaz+ in patients with spontaneous pneumothorax was identified and showed shorter drainage times and length of hospital stay compared to conventional drainage.

The authors concluded that the use of Thopaz+ in patients following pulmonary resection and patients with pneumothorax led to cost savings compared to conventional drainage. The main driver for cost savings was a reduction in length of hospital stay.

 

Pete Phillips and James Evans were  invited to the 9th RCSEd All Wales Medical & Dental Student Surgical Research symposium at Margam Orangery in October 2018 to judge poster and oral presentations and to present the SMTL award for best science paper.  

The winner was Jeremy Chan and his colleagues Ren Chet Teh, Jacky Cheng, Pushpinder Sidhu for their poster on "Inappropriate blood tests in cardiac surgery intensive care".

Jeremy and his colleagues demonstrated that £75,000 could be saved in a single CSICU by eliminating unnecessary blood tests, and reducing the risk of anaemia due to iatrogenic blood loss. The poster exhibited three clear aims, a methodology which could be replicated, simple reporting of the results, good discussion of their limitations and a concise set of conclusions.

The photo shows Pete Phillips, Director of SMTL, handing Jeremy his award trophy

Since the first British Standards for compression hosiery were published in the 1980's, the use of compression garments to treat various clinical complications has changed significantly.  Performance requirements and test parameters which seemed appropriate 33 years ago  are now causing confusion for users of the products and operational difficulties for test houses and manufacturers.

To address these issues a new standard - BS 661210:2018 - has recently been published.  BS 661210 is a revision and merger of three previous standards (BS 6612:1985, BS 7563:1999 and BS 7672:1993) for graduated compression hosiery, anti-embolism hosiery and graduated support hosiery. The BSI Panel took the opportunity of the revision to address inconsistencies in the previous standards, clarifying various test parameters and technical issues,  and producing a  single consistent test method to test both medical and non-medical compression garments.

As well as specifying the test method, the Standard sets out performance requirements  for the compression and stiffness of these devices, and these have been updated to reflect current clinical UK guidance .  A new  informative Rationale Annex (Annex C) has been included to explain the thinking behind most of the major changes in the Standard, and another new Annex (Annex D) explains the variety of classes and compression profiles used in the UK that are referenced in various standards and clinical guidance documents.

Peter Phillips (Director of SMTL) is chair of BSI committee CH/205/1, under which the Panel operated, and Dr Gavin Hughes (Deputy Director, SMTL) acted as Editor of the standard.

The SMTL physical testing department has recently completed a testing programme for the NWSSP Procurement Services (ProcS) Lymphoedema contract, working closely with Lymphoedema Network Wales. This was the second time SMTL and ProcS have undertaken this exercise, the first being in 2014 and most recently in 2018.
 
The aim of the test programme was to standardise and rationalise the range of garments in use within NHS Wales whilst addressing a number of known quality issues (such as sizing) for lymphoedema garments identified by the clinical members of the group. Using this information, a performance specification was agreed with the lymphoedema specialists, based on average patients' leg and arm dimensions ProcS then grouped the different products into Lots, and manufacturers were then asked to supply appropriate off the shelf and made to measure garments to fit the selected patient's dimensions in specific Lots. Using these clinician-specified dimensions, SMTL set up their Hatra Mark 2 hosiery tester (specified in a number of British Standards) to mimic the size of these patients, and then undertook a programme to test the pressures exerted by the garments, and assess whether they complied with the specification.
 
For the 2018 contract 6 manufacturers tendered garments for the various lots that SMTL would test. Only 2 out of 5 sets of upper limb garments (such as arm sleeves) and 17 out of 28 sets of lower limb garments (stockings) passed the pressure requirement specification, with most failures being due to pressures falling below the minimum compression level.
 
Alongside testing for contracts, SMTL also investigates medical device defects and incidents for the NHS in Wales. When the contract process for lymphoedema was first started many clinicians were not aware of the defect process and dealt directly with manufacturers. However, since explaining the defect reporting process for medical devices to the lymphoedema clinicians in 2014, the SMTL has investigated over 150 incidents, with most reports being due to incorrect sizing, durability and manufacturing issues . The combination of a highly specified contract process and a well-publicised defect reporting system has lead to the number of defective garments dropping significantly, with only 10 incidents being reported to SMTL between January and August 2018.
 
The success of this initiative has been resulted in the team winning two prestigious awards - the 2015 Government Opportunities (GO) "GO Procurement Innovation Award" and the 2016 "Procurement: Patient Safety Award" at the Patient Safety Congress (organised by the Health Service Journal and Nursing Times) where Dr Gavin Hughes and Louise Barry from SMTL were in attendance to receive the award.

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