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Pharmaceutical Manufacturing and Packing Sourcer

On a Road Called Progress

JD Hansford of the Institute of Decontamination Sciences describes the development of sterile services, from its inception in post-war Britain to its current essential position in the medical sphere


The originators of sterile services were probably American personnel in military medical services whose aim was to improve the methods used to supply their armed services based in Europe during World War II. One of the leaders was a certain Dr Perkins, who described layouts for work areas and procedures for processing and distribution. The results of the pioneers work was quickly recognised in civilian hospitals and UK service units in time for the conflict in Korea and the Suez crisis in the mid-1950s.

In the UK one early worker was Dr David Stark Murray, a medical officer in London who organised a syringe reprocessing service for clinicians working with bomb victims. He became a pathologist at Kingston-upon-Thames in peacetime and showed a keen interest in the progress of sterile services. Syringe services were the starting point for many units, particularly in cities. Their mantra was simple: “disassemble the syringe or device, clean it, dry it thoroughly, lubricate it with silicone oil and pack it”. Most syringes were made of heat resistant glass (some with metal nozzles) and barrels and plungers were interchangeable. A popular packaging system was the use of round extruded tubular aluminium containers with a constriction near the top to prevent the syringe nozzle making contact with the base of the tube. The top was sealed with a foil cap coated on the inside with glue that with pressure and heat formed a bond with the side of the container. Other syringe makes had glass barrels and ceramic plungers which were packed separately. Specialist syringes for chest aspiration, injections into haemorrhoids and dental syringes were packed disassembled in aluminium box containers.

The prepared syringes were stacked into wire mesh cages and loaded into hot air ovens for sterilisation; alternatively they were sent through a tunnel on a conveyor heated by infrared heaters to 195°C for five minutes. Sterilisation by dry heat requires that the load is placed in an enclosed hot air steriliser. When the oven is switched on, the internal temperature will increase slowly up to the sterilisation temperature of 160°C, which is held for a minimum of one hour, during which the door is locked to prevent any change of conditions within the chamber. When the heat is turned off, the load remains in the chamber and cools slowly, often during hours when the building is unoccupied. Once near ambient temperature is reached the door may be opened, and the load and any process monitors can be removed and checked. A recording chart of conditions within the chamber is checked, signed by the operator and filed with details of the load.


The introduction of the NHS in the UK in 1948 increased the demand for sterile services for both in- and out-patients. By the mid-1950s, concern was being expressed that the recruitment of nurses for training was less than required and a review was undertaken into the jobs which nursing staff traditionally undertook that could be carried out by less qualified staff without loss of quality. The outcome increased the pressure to develop sterile services to produce procedure packs and supplementary items, thereby reducing the need to pack sterilisation drums with such materials. This increased efficiency and released nursing time to care for patients. Sterilisation drums, whether round or rectangular containers, had external panels with holes that, before processing, were moved to overlay corresponding holes in the wall of the drum. At the conclusion of the sterilisation process the operative was required to move each cover so that the holes in the drum were covered. The age of these drums and their frequent use resulted in unacceptable time delays in covering these holes.

At about this time two influences helped to sway opinion in favour of sterile services. Firstly, a group of respected researchers in Birmingham published results showing the prevalence of Streptococcus and Staphylococcus infections in the wounds of hospital patients. One suspected factor was ineffective processing in steam sterilisers. At that time, many autoclaves used the entry of steam to displace residual air – this was considered a possible fault as failure to remove all the air resulted in a chamber in which air reduced the anticipated temperature of steam. New sterile services departments from this point were equipped with prevacuum high pressure steam sterilisers in which vacuum pumps removed residual air prior to steam entry. The replacement of sterilisation drums by improved sterilisation wrapping materials would lengthen the sterile shelf life of contents.

Secondly, the Nuffield Provincial Hospitals Trust invested money and expertise to assist and advise in the planning of departments. With the help of others, a blueprint was produced and used in the development of a new department for Addenbrookes Hospital, Cambridge, and a new build department at Musgrove Hospital, Belfast. The Nuffield Trust published a book giving guidance to others on the development of sterile services.


This early period saw an increased interest in single-use products. Transfusion and infusion sets and urinary drainage catheters, previously made of red rubber and re-used, were now made in plastic to be used only once, cutting down the risk of spreading hepatitis B and other infections.

A decision in Edinburgh to build a Theatre Sterile Services Unit, in preference to a Central Sterile Supply department at the Royal Infirmary, signalled a future trend – hospital departments would now concentrate on reprocessing surgical instruments, while single-use dressing and supplementary items would be sourced from commercial providers. This change was helped by the more common use of mechanical washers, mainly developed for the catering industry. Some were top- or front-loading, but conveyor washers which passed the load from wash to rinse tanks were introduced and proved successful. Some types such as the Johnson and Eastland machines came with the ability to dunk the load in each of the tanks before off-loading.

Late in the decade Professor AC Cunliffe was commissioned to report on the role of commercial providers and his conclusions were welcomed and implemented to form the basis of policy for the next 30 years. Some manufacturers, notably Johnson & Johnson, developed techniques for the use of their packs.

The expenditure on surgical instruments was considerable as departments had to equip each service with sufficient stock to maintain the flow of instrument sets to their user departments. Turnaround times were calculated and arrangements were made to fast-track instrument sets that were often needed at short notice.

Suppliers of prosthetics often required that specialist instruments were used to fit their prosthesis that had no other application. Such suppliers then made instrument sets available on differing terms – long term loan, one returnable set with each prosthesis. An instrument set was usually sent to an operating theatre ahead of the time of the procedure. Care had to be taken that the instrument set was prepared according to local tracking procedures. Ultimately, in 2009 the Institute of Decontamination Sciences (IDSc) would agree on a procedure with other stakeholders, organisations representing operating theatre practitioners and the Association of British Healthcare Industries. The agreement was based on a timetable stating when supplies should be available to the operating theatre or sterilising unit, or when they should be delivered and available for return after decontamination. The plan was created with the aim of avoiding some of the tensions that have been experienced in the past.


The 1970s heralded a new era. The Association of Sterile Service Administrators had been formed and there was interest in the reprocessing of patient-associated equipment, including resuscitation devices and items that were normally serviced by medical physics departments but had the potential to carry infection from patient to patient, or to a member of staff. A pilot scheme to involve sterile services staff was introduced at Pinderfields Hospital in Wakefield. A range of items were listed in this category, including many that were not heatresistant, such as endoscopes and diagnostic aids. Attention was paid to low temperature steam disinfection processes, which could also sterilise if formaldehyde was added. Dr G Alder at Bristol, Professor Gillespie at Sheffield and Professor G Ayliffe at Birmingham worked on a variety of cycles. There was reluctance to recommend gluteraldehyde for endoscopes or ethylene oxide for larger items, but in Cardiff the latter was introduced for anaesthetic and bulky resuscitation equipment. In time, and following the introduction of the Health and Safety at Work Act, emission limits were introduced for enclosed spaces resulting in prosecutions in two health trusts where staff were adversely affected by gluteraldehyde fumes. Skin conditions from direct contact and compromised respiratory function were among the most serious and debilitating symptoms.

The 1970s were noted for the emphasis placed on quality control and processes. It became common practice to send instrument sets out with lists included – the forms were signed by the packer and kept with the set, to be signed off as complete by the scrub nurse taking the case before return and reprocessing. Gradually, computer programmes became available and were the forerunner of today’s complete tracking system. The first cases of Creutzfeld-Jacob Disease (CJD) in the population were diagnosed with the prospect of more to follow. Fortunately the number of cases forecast of the two forms of this disease have not materialised. However, retrospective examination of tissue samples of lymphoid tissue from tonsillectomy and adenoidectomies confirmed the presence of the prion, and the need for caution in this form of surgery. It may be that in those cases where removal of these glands is imperative that single-use instruments will be used as routine. Understanding the behaviour of prion agents became a priority, and scientists at Porton Down have since collaborated with Southampton University to give advice on the most effective detergents and the best decontamination cycles that were also effective against endotoxins and biofilms. And so the mantra holds good that ‘the instrument must be clean before it can be sterilised.’


The Association gained members quickly and identified the need for a training scheme and textbook for staff. A training scheme was divided into several modules, each with a syllabus. Trainers in each part of the UK were engaged in teaching and supporting local managers. At the conclusion of the modular course a written examination was taken and those who passed were eligible for membership of the Association. During this time departments were increasing their workload, and twilight shifts were introduced to meet demand. The Government was also encouraging private enterprise to participate in hospital activities: cleaning, catering, security and other contracts were going out to tender. Companies such as Sodexo, Hayes and Synergy were involved with the health service.

The Department of Health published the Hospital Technical Memorandum (HTM) 2010, setting standards for sterilisers. With this publication came the introduction of Authorised Persons (Sterilisers), with specific responsibilities to advise on the purchase of sterilisers, audit the performance of all such machines and oversee the HTM’s 2030 for washer/disinfectors, and 2031 prescribing standards of steam and water for Sterile Services departments to follow. The standards for final rinse water in washer/disinfectors and automated endoscope disinfectors are exact and expensive to provide and maintain. In 2007 one district hospital estimated that £30,000 had been spent on providing mineral-free water for the final processing stage of its surgical instruments and endoscopes.

Administrative Developments

As theatre sterile service units were being created in most acute hospitals, there was concern that patients with exotic infections might be treated before confirmation of their condition. Precautions were issued to prevent the spread of these serious infections to other patients or staff. There was more interest in single-use instruments for ear, nose and throat surgery, as well as some eye and neurological conditions. The quarantining of instruments used on those considered to be high risk of developing CJD continues until confirmation of a diagnosis is made. Some hospitals subsequently have difficulty in locating these isolated instruments.

In the 1970s the Department of Health surveyed the ages of current managers and concluded there would be a shortage of suitably qualified applicants for senior posts in the future. Later, in 2002, the Department conducted an assessment of departments in England and found that a significant number needed capital monies to meet the expected standards of the anticipated European Medical Devices Directive. The Government set aside £200 million for this purpose, part of which was to meet the needs of day patient treatment centres and the extensive use of endoscopy.

Monitoring the compliance with European Standards is the responsibility of the competent authority appointed by the Government – here the role of the Department of Health. They in turn appoint and approve notified bodies, usually quality systems auditors who annually visit departments to audit working practices, conditions, staff conditions and training and report their findings to the competent authority.

It eventually became apparent that one injection of money might not be sufficient. In the age of private financial initiatives the Government launched a decontamination programme in which ‘supercentres’ would be established in those areas which fail to meet current standards, by either expanding an existing facility to serve hospitals within a county or counties, or alternatively a contract would be let to a commercial enterprise to develop a supercentre as a new build. This plan was started with a pilot scheme in Bradford and Leeds and rolled out over the country. The interest from commerce was less than expected but economic conditions were against long term capital ventures. Nevertheless, some centres are up and running, including a few financed by private healthcare providers. Nuffield Health have centres at Wetherby, Oxford and Tiverton, for example. There are also NHS-owned decontamination units on individual sites which have received investment and also meet the requirements of the Medical Devices Directive.


Tracking instruments and their trays or boxes have become very important, and much has developed to give practitioners a full history of this equipment. This is part of the comprehensive environment in which sterile services now operate. The International Quality System Standard 9001 and later numbers is now in universal use, and is accompanied in the UK by the Medical Devices Directive 93/42, which defines the working environment, surface finishes and materials for reception and decontamination, store areas, clean areas for preparation, assembly zones and sterilisation spaces. Positive pressure is required for these, with 15 air changes per hour, 16 to 21°C temperatures and a constant humidity. The staff wear protective clothing made of low-linting materials, head covers, non-shedding foot wear and protective gloves if required. IDSc was established to embrace all the activities of the Institute of Sterile Services Management, and a wider range of topics included in their training programme. This programme has six stages, from an easy-to-follow learning programme for new entrants to a degree course accredited by a university and involving partners at the Eastwood Park Training Centre in Gloucestershire and The City and Guilds of London Institute. This emphasises the Institute’s commitment to training and the qualification structure available to its membership. Some 15 years earlier the Institute produced its own guide to good manufacturing practice to bring together all the changes and requirements of this range of documentation.

In a decontamination area clothing should be lightweight and non-linting, with liquid and soil resistant aprons for really dirty tasks. Goods are registered on the computer as they arrive with the identification code of the technician. This follows the set or equipment on its journey through the department and is recorded on the sterilisation log. Any changes to instrumentation such as the replacement of instruments considered to be not fit-forpurpose are noted. Packaging materials have altered as changes are made. In the 1980s hospital textiles went out of fashion as drapes and wrapping materials.

The publication of BS/EN868 standards defined the requirements for single-use wraps, and part 8 of the standard is devoted to sterilisation boxes intended for instrument sets. Man-made materials and paper for single-use are preferred. The European standard is modelled on the preexisting British standards. Today, there is a revised edition of HTM 01 that consolidates all previous requirements for decontamination machinery, particularly washers, disinfectors and steam sterilisers.


If we consider the future, it seems certain that demand for services will grow. The marketplace will be tested by a new generation of single-use instruments, and if these are for use in general surgery they may succeed in gaining the approval of practitioners. The experience of the past is that acceptance of new designs is not instant but comes with familiarity in use. I envisage that computer technology will advance and desktop machines may be replaced by hand held devices for information gathering and communications. One concern is the cost of energy and materials required to provide the quality of service expected. It may be that synthetic materials will replace natural materials. Energy requirements are high but hospitals have a great deal of roof space suitable for solar panels.

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After gaining experience in operating theatres, JD Hansford qualified as a clinical tutor. He became involved in sterile services shortly after its inception, and followed its progress through more than 40 years, most of this time being spent in the NHS. He was elected as National Chairman of the Association of Sterile Services Administrators for two consecutive terms and was appointed as its first Director of Education for four years. In the 1990s he was also Director of Education for a European companion organisation and introduced a training syllabus for colleagues in Europe. He managed five departments during his career and was involved in education programmes in Portugal and Kuwait following the Gulf War. He is the senior Fellow of the Institute of Decontamination Sciences, which last year awarded him its Lifetime Achievement Award. 
JD Hansford
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