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SMTL Newsletter - Vol 1 No1 Oct 1997

A new beginning...

Welcome to the rejuvenated and combined "Dressings Times" and "M&S News".

As before, this newsletter aims to keep NHS users and purchasers up to date with news, views and information on the medical disposables and dressings scene. However, by combining both newsletters we hope to be able to produce the newsletters on a regular basis.

In the future, we we aim to cover developments within Europe (particularly regarding the Medical Device Directive), new and revised standards, key documents and publications from the Department of Health, and Welsh contracting news.

Please let us know your opinions on the articles you find inside and whether there are any topics you wish to see in future issues. Contact information is on the last page of this issue.

S. Thomas, P Phillips

A brief history of SMTL.

For those of you who have not heard of SMTL before, or who are unclear about its role within the NHS in Wales, the following is a potted history.

The Surgical Materials Testing Laboratory (SMTL) was established in 1977 as a quality control laboratory for Mid Glamorgan Health Authority. Since then the mix of work undertaken by the laboratory has changed considerably.

Welsh Office funded SMTL to provide health authorities in Wales with a materials testing service for dressing and medical and surgical products. SMTL now provides testing services both to the whole of the NHS in Wales and to manufacturers of health care products. The testing covers surgical dressings and medical disposables and includes compliance testing, product evaluation and development of test methods.

SMTL are presently based in Bridgend General Hospital, employing a total of 18 staff including pharmacists, biologists, technicians and research nurses.

SMTL is the only NHS laboratory in the UK dedicated to the testing and evaluation of surgical dressing and medical disposables. Working closely with Welsh Health Supplies (part of WHCSA), SMTL provide technical and quality information to support purchasing for the All Wales contracts.

For those of you who have not heard of SMTL before, or who are unclear about its role within the NHS in Wales, the following is a potted history.

The Surgical Materials Testing Laboratory (SMTL) was established in 1977 as a quality control laboratory for Mid Glamorgan Health Authority. Since then the mix of work undertaken by the laboratory has changed considerably.

Welsh Office funded SMTL to provide health authorities in Wales with a materials testing service for dressing and medical and surgical products. SMTL now provides testing services both to the whole of the NHS in Wales and to manufacturers of health care products. The testing covers surgical dressings and medical disposables and includes compliance testing, product evaluation and development of test methods.

SMTL are presently based in Bridgend General Hospital, employing a total of 18 staff including pharmacists, biologists, technicians and research nurses.

SMTL is the only NHS laboratory in the UK dedicated to the testing and evaluation of surgical dressing and medical disposables. Working closely with Welsh Health Supplies (part of WHCSA), SMTL provide technical and quality information to support purchasing for the All Wales contracts.

Range of services.

Examples of product groups handled by the laboratory include:

1. Wound dressings of all types.
2. Bandages
3. Urine catheters and drainage bags
4. Examination and surgical gloves
5. Medical fabrics

Other services include microbiological and bio-compatibility studies, clinical trials, defect reporting (for medical disposables and dressings) and test method development. Although the SMTL undertakes routine testing to ensure compliance of submitted materials with nationally or internationally agreed standards, particular attention is given to the development of performance based tests.

In recent years the laboratory has played a leading role in the development of such tests for alginates, hydrocolloid dressings and extensible bandages and some of these tests are currently being considered as the basis of British Standard specifications or monographic standards in the British Pharmacopoeia.

P. Phillips

 

Hazard and Safety Notices

This section of the newsletter summarises hazard and safety notices in the medical disposables field that may have escaped your attention.

Reconnection of partly used IV bags (March 1997).

WHSN (97)02 / MDA HN 9702. This Hazard Notice, issued in March 1997, advises users not to reconnect partly used bags of intravenous fluids to administration sets, because of the risk of air embolism and microbiological contamination of the fluid.

The notice arose out of two incidents where patients suffered air embolism (and subsequently died) due to the reuse of partially used intravenous fluid containers with pressure infusion devices.

The notice advises managers and staff to ensure that partly used bags of IV fluids are discarded immediately on disconnection from an administration set, and to ensure that they are not reconnected under any circumstances.

Baxter blood administration sets (April 1997).

MDA HN 9703, issued in April 1997, advises users of Baxter sterile blood administration sets, Code FMC 2090A (batch numbers between 96H28V278 and 97B24V339), Code FMC 2090 (batch numbers between 96H30V275 and 97C25V338), and Code FMC 2071A (batch numbers between 96I03V461 and 97C03V522), to be aware of potential failures of the roller clamp.

Sims Portex 4F umbilical cannula (April 1997).

WHSN (97)07 / MD HN 9707, issued in April 1997, advises that managers and staff identify and isolate all stocks of SIMS Portex 4F umbilical cannulae product code 200/105/040, Lot no 96J02 and 96J09, and return all affected stocks to SIMS Portex.

This is due to the potential for failure of the Luer mount to the cannula joint. Contact Miss V Wilkinson, SIMS Portex Ltd., Tel:01303-208041, Fax:01303-266761 for further information.

Shelf Pessaries (May 1997).

WHSN (97)09 / MDA HN 9708, issued in May 1997, advises of a problem with shelf pessaries (Simpson Pessaries) made by GTS and supplied by Southern Syringe. The coating of these pessaries is liable to disintegrate or peel, and this is compounded by inadequate packaging, so that there is no way of identifying the product or manufacturer. In addition, no sterilisation or usage instructions are supplied.

The notice advises that the pessaries should not be used, and devices in use should be replaced with an alternative product as soon as possible.

Enquiries on technical aspects to Dr Alison Austin at the MDA (+44 (0) 171-972-8223), on clinical aspects to Dr S. Ludgate at the MDA (+44 (0) 171-972-8123), or to Mr Ian Paul, Southern Syringe Services, UK (+44 (0) 181-882-1971).

Epidural catheters and minipacks (June 1997).

WHSN (97)10/MDA HN 9709, issued in June 1997, advises users that a proportion of epidural connectors supplied with SIMS Portex epidural catheters, minipacks and regional anaesthesia trays, contain a defective component, which prevents the connector from being fully tightened. Sims Portex are withdrawing all affected product from the market. The bulletin lists the affected product codes and batches. Further information from Mr J. Hulme, SIMS Portex , UK Tel: +44 (0) 1303-208040, Fax +44 (0) 1303-240743. Copies of Safety Action Bulletins and Hazard Notices may be obtained from the Health Commissioning Division, Welsh Office health Department, Cathays Park, Cardiff CF1 3NQ, Tel: 01222-823350 Fax: 01222-825479 The titles and numbers (no full text unfortunately) of the MDA bulletins are available in the publications section of the MDA web site, URL

https://www.gov.uk/drug-device-alerts

P. Phillips

Standards news

European Glove Standards

CEN, the European standards organisation, has now published the first 2 parts of EN-455 (Medical gloves for single use). Part 1, which dealt with pinhole testing, was published in 1994, and Part 2 (Requirements and testing for physical properties) was published in 1995.

Part 3 (Requirements and testing for biocompatibility and labelling) is at a draft stage, but there is presently no indication when it will be published. This part includes tests for determination of the total protein in a glove. Total protein analyses is important as protein is the cause of Type 1 hypersensitivity reactions. Although the draft does not include limits for the protein in a glove, it is expected that customers will demand this type of information before purchasing gloves in future This will ensure that manufacturers control the protein levels in their gloves, helping reduce the number of users and patients who become sensitised.

SMTL are using all three parts in their evaluation of gloves for the All Wales glove contract to be adjudicated later on this year.

British Standard for gloves amended.

BS 4005 (the British Standard for surgeons gloves) was updated and issued in December 1996. The standard now acts as a 1 page skeleton, calling up EN-455 parts 1 and 2 for pinholes, dimensions and strength, and retaining a section on packaging and marking.

The previous version of this standard (BS 4005:1984) included monographs covering the detailed sizing of surgeons gloves as well as glove thickness requirements and cuff strength. These have all been dropped to bring the standard in line with the European standard.

The monograph that will probably be missed most of all is the one related to the sizing of gloves. EN-455-2 covers sizing in a minimalist manner, requiring minimum lengths and a size range for the palm widths. Users in Wales are already experiencing difficulties with gloves which comply with the European standard, but where the sizing of the glove overall is unacceptable.

DoH Glove Standards Withdrawn.

Now that the European Standard EN-455 Part 2 (Medical gloves for single use - Part 2: Requirements and testing for physical properties) has been published, the Medical Devices Agency (MDA) have withdrawn their own glove standards (TSS/D/300.010/1, TSS/D/300.011/1, and TSS/D/300.012) for latex and vinyl examination gloves.

P. Phillips

SMTL on the Web

In October 1996, SMTL launched its Internet Web site dedicated to wound management, dressings and disposables. Construction of the site was made possible through a Welsh Office grant from the Value for Money Unit and from Sophos Convatec. It contains: In October 1996, SMTL launched its Internet Web site dedicated to wound management, dressings and disposables. Construction of the site was made possible through a Welsh Office grant from the Value for Money Unit and from Sophos Convatec. It contains:

Wound Management Practice Resource Centre

The Wound Management Practice Resource Centre (WMPRC), which includes dressing information (such as the SMTL dressings data cards), clinical papers and publications (such as the fungating wound booklet), and primary care information (such as the VFM sponsored prescribers guide).

This section will also contain evidence-based practical information on the management of problem wounds such as leg ulcers and pressure sores.

Medical Devices Resource Centre

The Medical Devices Resource Centre (MDRC), which covers the field of disposable medical devices, such as gloves, catheters, administration sets and nebulisers. Summaries of the Hazard Notices and Safety Bulletins issued by the MDA and Welsh Office are available, as well as a News section and a Standards update page.

Biosurgical Research Unit.

The Biosurgical Research Unit is the part of SMTL which carries out research into the use of maggots in wound healing as well as breeding them for sale. This section of the site contains articles on maggot therapy as well as details on how larvae may be ordered.

World Wide Wounds

In July 1997, SMTL launched "World Wide Wounds - the electronic journal of wound management practice". World Wide Wounds is an independent journal dedicated to promoting good practice and better communication in the speciality of wound management, and is edited by the ex-editor of the Journal of Wound Care, Andrew Heenan.

The latest issue has articles on

1. Compression bandaging in the treatment of venous leg ulcers - Dr Steve Thomas explains the classification of bandages, and outlines how to choose an appropriate product.
2. Wound Dressings on the Drug Tariff - Andrew Heenan outlines the latest wound management products available on the Drug Tariff (Sept 1997).
3. Automatic quantitative analysis of healing skin wounds using colour digi tal image processing - William Paul Berriss and Stephen John Sangwine from Reading University review the state of the art in computer assisted wound measurement.
4. A comparative study of the properties of twelve hydrocolloid dressings. - Dr Steph en Thomas and Philip Loveless report on a laboratory study.
5. Recent advances in the use of lasers in dermatology, - Dr S. Lanigan, Consultant Dermatologist, discusses advances in the treatment of port wine stains, tattoos and other skin lesions.
6. A users guide to the selection of dressings - Dr Stephen Thomas discusses the factors which influence the selection and use of dressings for different types of wounds.

In addition to the articles, the journal also includes readers letters, news items, and a question and answer corner.

The SMTL Web site won an award for being the "Cool nursing site of the week" in May 97, and was reviewed in "Healix Health Intelligence Exchange" by Medical Consultant Dr James Cave, who said

"The Welsh Office and Convatec funded site is exactly what the World Wide Web should be about. Here is a specialist area of medicine, often poorly understood by health professionals, ... this is a a well thought-out site, obviously run by people who know their stuff."

Dr Cave gave the web site a 5/5 star rating.

The re-use of nebulisers.

SMTL have just completed a paper on the re-use of nebulisers.

Recent advice by the Medical Devices Agency has lead to most nebuliser manufacturers re-labelling their products as "Single use only.". This "re-classification" meant that hospital staff could no longer clean their patients' nebulisers between uses without becoming liable for any incidents which subsequently arose. The implication was that a fresh nebuliser should be used for each nebulisation, with a potential 120-fold increase in nebuliser expenditure (if each nebuliser were used 4 times a day for 30 days).

SMTL have been acting on behalf of WHCSA and NHS Trusts in Wales to determine what action has or will be taken by each manufacturer to enable re-processing to continue. The report covers the detailed procedures given my Medic-Aid (Sidestream nebuliser), Hudson RCI/Henleys (Micro Mist nebulisers), Lifecare and SIMS Intertech (series 22, 23 and 77 nebulisers). It notes that Intersurgical (as of August 1997) were unable to provide information regarding the reprocessing of their nebulisers.

The full report is available on the SMTL web site at www.medidex.com.

P. Phillips

 


 

SMTL News
The Medical
Disposables and
Dressings Newsletter
Vol. 1 No. 1
October 1997
Published by:
The Surgical Materials
Testing Laboratory
Edited by:
Dr Stephen Thomas
Email: This email address is being protected from spambots. You need JavaScript enabled to view it.
Peter Phillips
Email: This email address is being protected from spambots. You need JavaScript enabled to view it.

 

Contact Information
Tel: 01656-752820
Fax: 01656-752830
http://www.smtl.co.uk/
Princess of Wales Hospital
Coity Road
Bridgend
CF31 1RQ
©1999 by SMTL.
All rights reserved. No permission necessary to copy, reprint and distribute unaltered within the NHS as required.
This file is available from http://www.medidex.com/archive/765-smtl-newsletters.html