Dr Steve Thomas (previous director of SMTL), wrote an article in 1983 explaining how the laboratory started. Parts of that article are reproduced below, followed by developments which take the laboratory up to the present time.
Introduction
The annual expenditure on surgical dressings purchased on contract by the hospitals in Wales is currently [1983] in the region of £2.5 million, a figure which is generally taken to represent 80-85 per cent of the total dressings bill.
In order to derive the maximum benefit from the use of hard—pressed NHS resources it is essential to exercise considerable care in the selection, storage and use of these materials in order to ensure that all the items which eventually reach the patient are of a quality, purity and efficacy appropriate to their intended use.
These requirements imply a need for an on—going programme of monitoring and evaluation to provide valuable information to influence purchasing and contracting arrangements throughout Wales.
This paper outlines the way in which one such facility in Mid-Glamorgan was established and provides a brief insight into the general approach and philosophy which has evolved.
Historical background
In March 1965 the document HM(65)22 was issued by the then Ministry of Health which made recommendations relating to the quality control of drugs and dressings within the hospital service. In the case of dressings, it was proposed that these activities be divided into three categories depending upon the complexity of the tests, the equipment required and the degree of expertise available. Simple tests were to be performed at hospital or group level, tests requiring sophisticated equipment would be carried out at regional level and any highly specialised work would be carried out by outside consultants.
Prior to the publication of this report, little or no formal quality control work had been carried out in Wales but its publication resulted in the provision of limited finance for the purchase of basic analytical equipment.
In the majority of instances the apparatus purchased was primarily for the examination of drugs and medicinal substances, little attention was devoted to the need for similar work to be carried out on surgical dressings and allied materials. However, one small dressings testing facility was established at Caerphilly Hospital which, working in conjunction with the Welsh School of Pharmacy, produced much valuable information on the quality of dressings purchased on contract by the hospital in the locality. A limited monitoring service was also provided for the hospitals in Wales by the Ministry of Health who reported on the quality of samples of materials sent to them in accordance with an agreed programme. Following the 1974 re-organisation of the National Health Service however, this facility was withdrawn.
The Welsh Office recognising both the need for such a service and the potential of the limited work being carried out in Mid-Glamorgan as part of the routine work of the Quality Control Department, issued a document (WHN(77)156) which notified other Area Health Authorities in Wales that these facilities would be developed to replace the monitoring service previously provided by the Ministry of Health. Funding was made available and essential equipment was purchased.
The document was implemented in early 1978 when the unit began to examine samples of dressings sent in by quality control pharmacists from all over Wales in accordance with an agreed monitoring schedule. Since that time the workload of the department has increased considerably as in addition to the monitoring role much time is now spent devising test methods and evaluating some of the new materials which are offered for sale in the United Kingdom.
In Wales the pharmacists’ responsibility for the procurement, storage and distribution of surgical materials has been confirmed in a Welsh Office circular WHC(79)8 which includes them in the duties of the Chief Administrative Pharmaceutical Officer.
The role of the quality control department
- To ensure that all surgical dressings contracted for by the hospitals in Wales are of a quality and purity appropriate to their intended use. This aim may be achieved by purchasing material of a specified quality from an approved manufacturer who has submitted samples of the product in question for evaluation prior to the awarding of a contract. It is the responsibility of the department to evaluate such samples and carry out visits to various dressings manufacturers’ premises if required, in order to ensure that they are able to continue to provide a product of the required quality on a routine basis.
- To ensure that product quality is maintained for the duration of a contract. This may be done by the introduction of a monitoring programme which permits the quality of the dressings samples, chosen at random, from all over Wales to be compared with that of the material examined at the time of the adjudication.
- To deal with complaints relating to the quality of surgical dressings. By channelling all complaints through one department irrespective of their origin, it is possible to assess the nature and frequency with which problems occur, determine trends and identify particular problem areas which otherwise might not become apparent.
- To examine new surgical materials as they become available and evaluate them against other existing products where appropriate.
- To give advice on the storage, handling, packaging and use of surgical dressings requested by other professional staff.
- To carry out research projects related to the quality control of surgical dressings in its widest sense.
Conclusions
In the past the selection, purchase, and distribution of surgical dressings have often lacked the quality control and technical back—up which is now being developed in Wales. Purchasing staff have had to select the most appropriate dressings from a bewildering and extensive range of materials promoted by manufacturers.
In the absence of expert advice these decisions have been mainly influenced by cost factors alone, forcing manufacturers to reduce costs and produce increasingly cheaper products frequently at the expense of quality and functional efficacy. If this trend continues it can only result in products deteriorating to the point where they are no longer acceptable in terms of performance and therefore cease to be cost effective.
Of the many professional disciplines working in the NHS at the present time, only the pharmacist has the scientific background to provide the necessary expertise and knowledge to take an active role in the testing and evaluation of these materials. In so doing he can help to reverse this trend and raise the standard of the materials available to medical staff which will only result in benefit to the profession, the NHS and most importantly the patient.
Dr Steve Thomas, "The development of a surgical dressings monitoring facility", Proceedings of the Guild, 1983. (Nicholas Award Winner 1982).
1983 - 1989
The initial success of the dressings testing facility prompted WHTSO (the Welsh Health Technical Services Organisation) to request the Welsh Office to fund another QC pharmacist post, this time to focus on medical devices.
Funding was made available in 1982, and the initial incumbent stayed for 6 months before moving back to a clinical role. The post was re-advertised, and in May 1983, Pete Phillips took up the post of 'All Wales Medical and Surgical Quality Assurance Pharmacist".
Another technician was taken on in 1984, and around the same time, the Welsh Office decided to fund the Dressings pharmacist as a full time post, and the QA Pharmacist post for Mid Glamorgan was re-advertised. In 1984, Bruce Fisher took up the QA post, giving a staffing of:
- Dr Steve Thomas - Dressings QA Pharmacist
- Pete Phillips - Medical & Surgical QA Pharmacist
- Bruce Fisher - Mid Glamorgan QA Pharmacist
- Paul Hay - Microbiologist
- Chris Dawes - Surgical Dressings technician
- Marcia Watkins - Laboratory Secretary
- Lyn , a Junior lab technician
Some technicians were replaced during the mid-late 1980's, and by 1988 it was clear that the laboratory portacabin was not an acceptable building in which the lab could develop. The Welsh Office agreed to refurbish the recently vacated Pathology laboratory in Bridgend General Hospital, and the laboratory moved there in 1989.
The Chief Pharmaceutical Officer, Clive Jones, took this opportunity to install a corporate structure, renaming the laboratory from "Mid Glamorgan QC laboratory" to "The Surgical Materials Testing Laboratory - SMTL". Dr Steve Thomas was appointed the Director, Pete Phillips the Deputy Director, and Bruce Fisher the Quality Manager.
A more formal departmental structure was also implemented, with three separate departments:
- Quality Assurance - headed by Bruce Fisher
- Biological Testing - headed by Paul Hay
- Physical Testing - headed by Phil Loveless
In the early 1990's, a chance meeting between a member of SMTL and an entomologist made SMTL aware of efforts to re-introduce maggot therapy back into the UK. Steve persuaded Bridgend and District NHS Trust to fund some development into the production of sterile maggots, and within 6 months a method had been developed and the first few patients were treated. SMTL started selling the maggots throughout the UK, and also to Europe.
At the same time, SMTL took on extra technicians to develop their commercial testing services and generate income for the laboratory. Wound-care nurses were also employed to undertake clinical trials of wound-care products.
1989 - present.
By the late 1990's, Bridgend General Hospital was almost vacant, with most departments having moved to Princess of Wales hospital, less than a mile away. The Welsh Office agreed to fund a new SMTL laboratory on the POW site, and SMTL moved in to the new premises in 1999.
The clinical trials which had been successful in the late 1990s had started to struggle in their quest for sufficient patients, and that programme was brought to a close in 2001. Mary Jones, the lead nurse for the wound-care team then started developing a clinical support service for the maggot business, and three sales reps and a marketing manager were also added to the team, turning the Biosurgery Research Unit (BRU) into a professionally managed production and sales team.
Maggot sales took off in the early part of the millennium, and the larvae production unit soon outgrew the new premises. ·A decision was taken by the Trust Board to spin the production facility out as a commercial entity, and by 2005 the process was completed, with a new organisation, Zoobiotic, being established, and relocated to new premises in Bridgend (now known as Biomonde). Steve moved out of the NHS to become the Technical Director of the new business, and then took early retirement in 2007, after successfully gaining Drug Tariff status for LarvE, the brand name for the sterile maggots.
Various staff changes took place during the first decade of the new millennium, and the laboratory added an R&D Officer, an IT manager, extra technicians to the Biological testing team, and new office staff.
In 2016, SMTL moved from ABMU Health Board to NWSSP, placing the lab alongside a number of other All Wales professional and scientific services such as Specialised Estates and Procurement Services, and starting a new chapter in SMTL's history.
The current establishment can be seen on the SMTL Staff Page.
