The Central Sterilising Club’s 60th anniversary annual scientific meeting finally took place in Stratford Upon Avon, having been delayed by the pandemic. It hosted some lively discussion around the key challenges in decontamination – from difficulties in reprocessing TOE probes and contaminated neonatal incubators, to whether hospitals can function safely without Authorised Engineers (decontamination). Louise Frampton reports.
High on the agenda at the Central Sterilising Club (CSC) annual scientific meeting was the need to drive improvement and learn from the mistakes of the past, while approaching today’s problems with the discipline of a science, informed by guidance and evidence-based practice. At the same time, decontamination professionals must also remain vigilant, scanning the horizon for new threats and challenges – whether it is the next pandemic, difficult to reprocess new technologies, or tackling the healthcare sector’s significant contribution to climate change.
The first opening sessions – introduced by CSC chair, Jimmy Walker – were delivered by Robert C Spencer, a retired microbiologist who has occupied senior positions within the NHS, Health Protection Agency and Public Health England; Geoff Ridgway, who was previously a consultant in clinical microbiology at UCLH, a member of the Committee on CJD incidents (among others) and past chair of the CSC; and Peter Hoffman (Kelsey lecturer), who recently retired from being a consultant clinical scientist with the UK Health Security Agency.
Together, they reflected on the origins of the CSC, as well as the historical challenges faced by healthcare – intermingled with personal anecdotes and horror stories from the past 60 years.
The discussion included some highprofile incidents, the lessons learnt, and subsequent evolution of decontamination practice. They painted a picture of how far decontamination had come, during this time, but also how far it still needs to go...
The past
In 1957, the Nuffield Trust published its report on the planning and organisation of central syringe services, for example. Syringes were previously boiled and the process decentralised, so it was often poorly supervised. Contaminated equipment would be added to the steriliser just before syringes that were required for use were taken out. The maintenance of syringes was also poor, so needles were often blunt. The report underlined the importance of safe methods of sterilisation and discussed the move to central sterilisation.1
In 1958, the Trust also published damning findings from its study of sterile supply arrangements in six hospitals – including open windows in decontamination facilities that allowed dust to ingress, extreme build-up of scale on stainless steel from the use of hard water in sterilisers, and the cleaning of instruments by simply washing under a tap. The report acted as a catalyst to driving improvement in decontamination practice.2
The ‘Devonport incident’ – one of the most infamous pharmaceutical disasters – also hit the headlines in the early 1970s, when the release of non-sterile dextrose infusion bottles onto the market resulted in the (known) deaths of at least four patients from endotoxic shock.3 The conclusion of the inquiry into the incident (summarised in the Clothier Report, July 1972) was a sombre lesson to all:
“The committee considers that too many people believe that sterilisation of fluids is easily achieved with simple plant operated by men of little skill under minimum supervision, a view of the task which is wrong in every respect.”4
The incident highlighted the importance of quality assurance of processes, as well as traceability. A third of the bottles from the implicated batch had failed to reach sterilising temperature, probably due to the retention of air within the steriliser. The drain to the steriliser was blocked. Steam would enter the steriliser, layer at the top, and would produce locally high temperatures near the sensor at the top of the machine, while air would be found at the bottom layer. This meant that the top bottles reached sterilising temperature, the middle bottles got to around pasteurising temperature and the bottom bottles would have had an insignificant rise in temperature. Three bottles were taken from the machine for quality assurance testing, but it was likely that these were taken from the most accessible level – the top layer – so any issues were missed.
It was estimated that around 64 affected bottles were shipped to Devonport, and the hospital probably received all of the bottles from the lowest layer in the machine. All the bottles from the identified batch were retrieved, apart from eight – so it is reasonable to assume that all eight were used. The death toll from the batch was probably around 12. Contamination from the endotoxins would have resulted in 100% fatality.
However, the inquiry further looked at the autoclave records and found 70 occasions where there had been an inadequate cycle, ‘generally no rise in temperature’, or a temperature below the necessary. Based on the available data, it is possible to estimate that there could have been as many as 3,500 contaminated bottles produced during the timeframe – however, as some records were missing, it is likely this is just the tip of the iceberg. Hoffman commented that it is likely that the incident resulted in “hundreds of deaths; possibly thousands”.
When it comes to quality assurance, it is important to monitor the process, as opposed to just focusing on the end product
Today’s challenges
“Sterilisation standards, today, are comfortingly excessive. I’m not suggesting they are inappropriate, but I am suggesting that steam sterilisation is not the problem with decontamination, at present,” Hoffman asserted.
He pointed out that there are key issues associated with the acquisition of new instruments that are impossible to sterilise, which remains a problem today. He also highlighted the need for manufacturers to produce satisfactory instructions for decontamination.
Hoffman recalled that, on a previous visit to a hospital, he found that staff were unaware that a brush was needed to clean the internal channels of an endoscope. Subsequent cleaning with a brush produced a large amount of ‘gunge’ suggesting the endoscope in question had never been properly reprocessed. There are now considerable amounts of guidance on decontamination, but endoscope decontamination is not nearly as secure as steam sterilisation, he observed.
In addition, transoesophageal echocardiogram (TOE) probe decontamination is not performed well and there have been reported incidents involving patient-to-patient transmission of infection. A key factor is the design of the device. Parts of the TOE probe cannot be immersed – a factor that could be overcome by the manufacturers, he argued.
The technology for fully immersible devices exists with endoscopes, yet it is not incorporated into TOE probes, which poses the question of ‘why?’ Hoffman believes there is insufficient pressure being placed on manufacturers to engineer solutions to make these devices easier to reprocess.
He highlighted the fact that there are other types of equipment that continue to present issues around decontamination. A before and after disinfection study of neonatal incubators, by Butin et al (2019),5 for example, found that (62%) of incubators remained colonised with methicillin-resistant clone Staphylococcus capitis NRCS-A after the disinfection procedure. The reality is that decontamination is often performed in crowded facilities, with little worktop space, in one sink/drainer, so it is impossible to have a defined ‘dirty to clean’ flow
There are lots of other problematic items throughout healthcare too – including pulse oximeters, BP cuffs, physio equipment, thermostat knobs on splint pans, seating in showers, mattresses, pillows, clipper handles, blood glucose monitors, hoists, baby scales, EBM kit, bodies of tympanic thermometers, doppler probes, ultrasound keypads/rollerballs, IT tablets, IT mice, burns hydrotherapy baths, supports for singleuse bedpans, theatre gel limb supports, commodes, over-bed tables, wheelchairs, ice machines, calculators, laryngoscope bodies, privacy screens, patient trollies and many more...
The problem, he explained, is that items are often designed for function – all too often, decontamination is an afterthought. He warned that decontamination of equipment on the wards is currently inadequate – often taking place in poor local facilities, rather than specialist units. Training is also variable. Ward staff do not receive good training on decontamination
The future
“The question is: how much of this equipment could be reprocessed by specialists? A few years ago, it was unheard of for an endoscope to leave the endoscopy unit; now they are sent to a unit for specialist decontamination,” Hoffman commented. He added that there may even be the potential for an SSD outreach on the wards.
“We need to start thinking about where the problems are and how decontamination experts can contribute to solving those problems,” Hoffman continued.
He called for manufacturers to have a role in developing devices that are easier to decontaminate but added that the UK is a small player in the global market, so it is difficult to exert influence on the sector. In his closing comments, he said that decontamination of medical devices and the environment remains problematic – most of the easy problems have been addressed.
“We must maintain vigilance on sterilisation, but we must continue to look for where the problems are,” he concluded.
Do we need independent AE(D)s?
The event also debated whether hospitals lack the expertise to function safely without an independent Authorised Engineer (Decontamination) [AE(D)]. Sulisti Holmes, the strategic lead for medical device safety for NHS Scotland, argued that hospitals do need an independent AE(D) to safely function, while Wayne Spencer, AE(D) and convenor of the ISO TC 198 working group 12 (responsible for ISO 17664 for reprocessing instructions), argued that hospitals do not need independent AE(D)s to safely function.
During the light-hearted duel between the two experts, Holmes joked that the AE(D) is like the “Mary Berry of the decontamination world”. Both carry out inspections, ensuring a good quality product with “no soggy bottoms”. She argued that AE(D)s are mentioned frequently in the decontamination guidance – in the event of an incident, you will be asked: “why didn’t you follow the guidance and listen to the expertise of the AE(D)?” she pointed out.
In addition, AE(D)s can have an important role to play in learning from incidents – after all, as the philosopher George Santayana, is quoted as saying: ‘those who fail to learn from history are doomed to repeat it’
The need for earlier engagement of expertise was highlighted during a public inquiry into an incident involving the contamination of the water supply at the newly built Queen Elizabeth Hospital. A tenyear-old girl tragically died after a Hickman line became infected, and there were further deaths and infections, linked to the water supply – “causing pain, agony and sorrow”.
“Safety and the lives of our patients are paramount,” she commented. “I hope you don’t need surgery. But if you do, which one will you choose? The one that follows the guidance, that learns from previous incidents, that has gone through independent review by an independent expert – an AE(D) – or one that doesn’t?”
Spencer questioned whether AE(D)s are truly ‘independent’ – i.e. “not subject to control by others, not affiliated with a larger controlling unit, and not looking to others for opinions or guidance in conduct”. In any case, he argued that “independence can be overrated”.
There are 30 registered AE(D)s on the IHEEM website at present – only 27 are actually practising; 35% are not actually ‘independent’ of either the NHS or the public sector bodies that employ them, and only a third of the AE(D)s are actually independent.
Spencer commented that a lack of expertise does not necessarily mean you cannot function safely – people can get expertise from a variety of sources. However, the expertise is in the NHS – people succeed as AE(D)s because of the expertise they gained within the health service. He added that there will always be a struggle for the health service to retain expertise if we do not pay staff enough – decontamination staff can ultimately earn more elsewhere. He further pointed out that the average age of an AE(D) is probably around 60 years old – they will be retiring and there is already a struggle to find AE(D)s. It is going to get even harder, without succession planning.
“The role of a consultant or trainer is to empower the customer, not to make consulting indispensable. If we make ourselves indispensable, people will never have the expertise they need to manage without an ‘independent’ AE(D). AE(D)s should not be a ‘necessary evil’ but more of a ‘comforting blanket’,” he concluded.
One delegate argued that the definition of ‘independent’ used by Spencer was “too broad” and we should talk, instead, of being “free from conflicts of interest” – i.e. there is no manipulation of the advice due to commercial pressures. Spencer responded that there is a question over how independent some of the AE(D)s are in the devolved administrations from the NHS. Some may argue there is a conflict of interest as they are working for the same health body, with the same financial ‘pot’. Another delegate pointed out that AE(Ds can bring learning from other hospitals, which is extremely valuable.
She added that actions, that have already been recommended by the infection prevention team, are often subsequently reiterated by the AE(D) – but only then are they taken seriously; suddenly, it becomes “really important to implement them”. Other views put forward by the audience included the fact that AE(D)s can help with culture change – it is easier to hear you are doing something wrong from an outside party.
Concluding, Spencer commented that the comparison between Mary Berry and AE(D)s was an interesting one: “Mary Berry inspected the cakes and looked out for soggy bottoms but, ultimately, she left – and the show went on. ‘Bake-off’ didn’t die because Mary Berry left. Hospitals won’t collapse without AE(D)s. They will move to a different way of working. They can function safely, but it may be different.”
The motion was put to the audience vote and the majority sided with Wayne Spencer.
About the CSC
The CSC was formed in 1960 as a result of the enthusiasm of a small group interested in sterilisation processes and the provision of sterile supplies in hospitals, brought together by Professor Michael Damady. As topics discussed at meetings, and indeed the character of the meetings themselves, have changed over the years, the central themes have been maintained: applied and basic research topics; the general interchange of information; and the generation of CSC guidance documents, using multidisciplinary members. Several successful national groups have emerged from the Club’s membership, including the Institute for Decontamination Sciences (IDSc and formally the ISSM), the Infection Prevention Society (IPS, formally ICNA) and the Healthcare Infection Society (formally Hospital Infection Society). The 60th Anniversary Annual Scientific Meeting took place on 4-5 April 2022, at the Crowne Plaza Hotel, Stratford Upon Avon. The next Annual Scientific Meeting will take place on 3-4 April 2023 in Newcastle Upon Tyne. For further details, visit: https://centralsterilisingclub.org/ For membership please contact: membership@centralsterilisingclub.org
References
1. Nuffield Trust, The planning and organisation of central syringe services, 1957. Accessed at: https://www.nuffieldtrust.org.uk/research/theplanning-and-organisation-of-central-syringeservices
2. Nuffield Trust, Studies of sterile supply arrangements for hospitals: Present sterilizing practice in six hospitals, 1958. Accessed at: https://www.nuffieldtrust.org.uk/research/studiesof-sterile-supply-arrangements-for-hospitalspresent-sterilizing-practice-in-six-hospitals
3. https://blog.sciencemuseum.org.uk/rememberingthe-devonport-incident-50-years-on/
4. The Clothier Report, July 1972. Accessed at: https://api.parliament.uk/historic-hansard/ commons/1972/jul/12/dextrose-solution
5. Butin, M., Dumont, Y., Monteix, A. et al. Sources and reservoirs of Staphylococcus capitis NRCS-A inside a NICU. Antimicrob Resist Infect Control 8, 157 (2019). https://doi.org/10.1186/s13756-019- 0616-1
