New publication on usability testing of NRFit/ISO 80369-6 connectors
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SMTL undertook a multicentre simulation of the (at the time) proposed ISO 80369-6 connector for the neuraxial route in 2014 (the standard was published in 2016, and the connectors are now known as NRFit connectors).
The standard was produced to help mitigate the risk of wrong route injections, such as the case of Wayne Jowett in 2001 where intravenous chemotherapy was accidentally injected spinally, resulting in Wayne Jowett's death.
Thirty-eight doctors and 17 nurses performed simulated clinical procedures on manikins, using devices fitted with either Luer connectors or draft ISO 80369-6 ‘non-Luer’ connectors. The procedures included spinal anaesthesia; intrathecal chemotherapy; lumbar puncture, cerebrospinal fluid collection and pressure measurement; epidural catheter placement with bolus injection and critical care use. Participants attempted cross connection between neuraxial connectors and a range of other medical device connectors to check that the design achieved the deiredlevel of non-connactability.
The results of the usability testing have been published in Anaesthesia:
Cook TM, Wilkes A, Bickford Smith P, Dorn L, Stacey M, Kinsella SM, Sharpe P, Phillips P. Multicentre clinical simulation evaluation of the ISO 80369-6 neuraxial non-Luer connector. Anaesthesia. 2019 May;74(5):619-629.
Most cross-connection attempts failed, even using above clinical forces and, when successful, were judged of low clinical risk potential; the exception was a malaligned connection between the non-Luer slip and female Luer connectors. This led to revision of the dimensional tolerances of the non-Luer connector to reduce this risk, before publication of the final specification in 2016.
The authors concluded that the ISO 80369-6 neuraxial non-Luer connector was suitable for clinical use.
New BS 661210 British Standard published for compression garments
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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.
Thumb Loop Apron specification - July 2021
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In July 2021, the NHS PPE Decision Making Committee approved the newly drafted specification for Thumb Loop Gowns (PDF Download).
The specification states:
Introduction
This specification is intended to provide performance requirements for thumb loop aprons which exhibit sufficient mechanical properties, resistance to microbiological challenge, and resistance to chemical/liquid penetration for standard clinical use by healthcare staff. It is based on the “Essential technical requirements for new High-Volume Manufacture of Personal Protective Equipment (PPE) and Medical Devices (MD) during COVID-19” with additional microbiological and chemical penetration requirements taken from British Standards used for protective clothing. The terms thumb looped aprons and gowns are used interchangeably. In this document no distinction is made between these terms.
Scope
This document specifies design and performance requirements for fluid-resistant single-use Thumb Looped Aprons, also known as Thumb Looped Gowns, intended to provide fluid and splash protection for healthcare workers when undertaking healthcare procedures. This specification specifically excludes surgical and medical gowns. Thumb loop aprons are single transient use items, worn by healthcare workers for single episodes of care or other tasks in a healthcare environment. They may be used in situations where exposure to splashes, droplets and fluids containing infectious agents or chemicals is likely, such as endoscopy. Thumb looped aprons may also be used to protect medical or surgical gowns in the clinical environment. Thumb looped aprons are not intended for use in environments where they will be exposed to heat, sharp objects or significant mechanical stress.
Dr Steve Thomas awarded an OBE for services to the NHS
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All of us at SMTL are delighted to hear that Dr Steve Thomas, Director of the Surgical Materials Testing Laboratory (SMTL) from 1989 until 2005, has been awarded an OBE (Officer of the Order of the British Empire) for services to the NHS in the 2018 Queen\'s Birthday Honours.
Steve studied pharmacy at Cardiff University followed by a PhD on gluteraldehyde. His initial post in the NHS was as QC Pharmacist for Mid Glamorgan Health Authority, where he started in 1970. As the laboratory grew Steve developed an interest in wound dressings and medical devices, and his expertise was recognised by the Welsh Office who appointed him as the Surgical Dressings QA Pharmacist for Wales. When the laboratory moved from East Glamorgan Hospital to Bridgend General Hospital in 1989, Steve became the first Director of SMTL.
Steve is recognised internationally as a world expert on woundcare products, establishing the first NHS medical device and dressings testing lab in the UK for the Wesh Office. He has written over 150 papers and articles on surgical dressings, bandages and maggots and set up the first European sterile production centre for maggots used for wound debridement, reintroducing maggot debridement therapy to Europe, and turned this into a commercial venture which was spun off by the NHS as Zoobiotics in 2005 when Steve left the NHS.
As Director of the Welsh NHS Surgical Materials Testing Laboratory (SMTL) he developed it into an internationally recognised leading centre for its work in on medical devices and surgical dressings. Steve was editorial advisor to the British National Formulary (BNF), founder member of the editorial board of the Journal of Wound Care, Senior editorial advisor to World Wide Wounds and editor of the Formulary of Wound Management Products. He developed the first performance-based test methods for modern wound- care products, which were adopted by the British Pharmacopoeia and the European Standards organisation CEN, as well as the test method used for over 30 years for bandages.
He was long term member of Committee L of the British Pharmacopoeia, editorial advisor to MIMs as well as a member of multiple BSI and CEN standards committees. He was a twice winner of the Nicholas Award (Guild of Hospital Pharmacists), and in 2001 gained the Queen’s Award for Innovation for the LarvE project. In 2002 he was joint winner of the William Hunting Award (British Veterinary Association), again for his work with maggot therapy.
After leaving Zoobiotics in 2007, he set up a medical device consultancy, Medetec, which continues to provide expert advice and consultancy to the dressings industry and the NHS in Wales. He published a number of recent papers on the effects of humidity on dressing performance and measurement of sub-garment pressure, which lead to the development of an apparatus used in the Welsh NHS as part of their evidence-based procurement programme, and which is under consideration for adoption as a UK standard.
Steve continues to be relied on for advice to European Working Groups on dressings test methods, for indusry as an expert witness in legal cases, and has recently been commissioned by NHS Wales to produce Health Technology Assessments. He is the author of several patents related to dressings and maggot production and distribution. His 2010 book on “Surgical Dressings & Wound Management” is considered internationally to be the standard reference on dressings.
Welsh NHS FAQ for neuraxial (NRFit) non-Luer connector deployment
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The Neuraxial connectors FAQ has been updated after discussions within the WNCRG (Welsh Non-Luer Connectors Reference group). This version is bespoke to the Welsh NHS.
The document is based on an original FAQ coordinated by Rory Jaffe at CHPSO (California Hospital Patient Safety Organization) and GEDSA (Global Enteral Device Supplier Association) including contributions from a number of UK experts.
