Raising standards in decontamination

The Institute of Decontamination Sciences (IDSc) conference, held in Blackpool, provided a forum to discuss topical issues in the field of decontamination – from improving “process control” and efficiency, to the implications of revised Health Technical Memoranda, the challenges of centralisation of sterile services, and the “wet vs dry” debate. The programme opened with a thought-provoking, keynote address by David Hurrell, managing director, Healthcare Sciences, who delivered an engaging presentation on the theme Decontamination: where are we now? – which identified key areas where the sector could improve. David Hurrell pointed out that there have been a number of initiatives and significant investment aimed at improving decontamination services, over the last decade – initially prompted by a review (which highlighted a need to raise standards), as well as increased concern over the potential risks of transmission of vCJD. Previously, feedback showed that sterile services staff found the Health Technical Memoranda cumbersome and a decision was made to revise these to ensure these were more user-friendly and accessible. Unfortunately, the Health Technical Memoranda have not offered the clarification and transparency that was hoped for, in his view. He described the revisions as confusing and contradictory in places; while the new HTM documents are now even longer. Decontamination has moved from being performed by theatre nurses to being performed in dedicated sterile services departments, and quality assurance systems are now in place. However, the press has seized on stories of “dirty instruments stopping surgery” and some of the fundamental problems that have been associated with sterile services, still cause problems today. According to the Healthcare Commission’s core standards (now the Care Quality Commission), 13% of hospitals failed to meet the basic standards required for decontamination.

Training and skills testing

He used the example of road safety to illustrate how major reductions in traffic fatalities have been achieved (despite more cars being on the road) – through better regulation, improved                 safety design features, and more stringent testing of drivers. Drawing comparisons with decontamination services, he explained that a two-fold approach to improve patient safety is needed. “This should include a major change in equipment to ensure it is more reliable, safer and easier to operate, but, even more importantly, major improvements are required in the training of those who use it. In decontamination, people are not tested on the operation of equipment based on theory and hazard perception, combined with a practical test on how to use it. “They are thrown in at the deep end                      and expected to get on with it, so we should not be surprised when this does not produce the right results,” he commented, adding: “We need trained and dedicated staff – attainment of the required skills should be mandatory and they should be tested.”

Industrial management techniques

He also commented on the move to Central Sterile Services Departments (CSSDs), stating the function of the CSSD is essentially a production department and it must be organised along industrial lines, therefore. “Whether the department is owned by a health authority or a commercial supplier is not the issue, in my view. What is important is that the techniques of industrial management are applied. This means that there is a need for continuous improvement and a quality standard must be worked to – we are looking for reliability. Industrial management systems strive to measure, analyse, control and improve and this must be the way forward for decontamination. “We need to identify the uncontrolled aspects of every part of the decontamination process, then implement process control to ensure the output that we generate is exactly what we want.” Examples of some of the key defects that need to be controlled, included:

• Torn/damaged packaging.
• Missing instruments.
• Wrong sort of instruments.
• Dirty instruments.
• Late delivery.
• Wrong set.
• Water in the set.
 • Release of product that has not been through the steriliser.

Some of the causes of torn or damaged packaging may be due to the sharp nature of the contents, the wrapping may be pulled too tightly over the instruments, too many instruments may be packed into the tray, or staff may carry the tray in an inappropriate manner such as under the arm. However, this requires careful analysis, as the instruments should not be used if the packaging is not intact. He cited a study, conducted in 2007, which investigated the consistency of staff in identifying damaged packaging. The experiment found that there was a 6.7% detection rate when the packaging was. compromised by a hole of 1.1 mm diameter. This is large enough to allow penetration by bacteria and raises the question of whether inspection of packaging is enough to identify problems with the sterile barrier wrap. Even with a 10 mm diameter hole, more than 3% were not detected. “This is an incredible failing,” he commented. He also highlighted instrument recognition as a key area requiring improved training, commenting: “Today’s staff do not have the same instrument recognition capabilities compared to staff 15-20 years ago. It may be tedious and time consuming to learn how to recognise them, but this is crucial to ensure that trays are packaged properly.” The problem, in his view, is compounded by the fact that in some cases the turnover of staff may be just two or three years, which does not allow the time required to develop this level of knowledge. “There is also a lack of real-time tracking across the NHS. It is not expensive and it solves many problems,” he added. Other key issues which need to be addressed, in his opinion, included the fact that some manufacturers continue to provide equipment that “does not meet current European and international standards”. “There is a tendency to view the EU standards as ‘the gold standard in the distance’ and not consensus documents that represent the lowest common denominator on which we all agree,” he exclaimed, while calling for a radical change in attitudes and better enforcement of compliance.

Wet vs Dry

Wayne Spencer, Spencer Nixon, gave an overview of a hotly debated revision to the Health Technical Memoranda, now in      draft form, which states that re-usable theatre instruments should be kept “wet” after use, before being reprocessed. The aim of this proposed strategy is to ensure proteins do not dry on to surfaces, making removal more challenging. Concern over vCJD and the risk from prions have been influential in driving this proposed change. However, the controversial revision raises many issues concerning the practicalities of the management of instruments between theatre and the sterile services department – whether this is situated on-site or at an off-site, commercial provider. He commented that that there are already many products on the market designed to keep instruments moist: “Pre-soaking using sprays, forms and gels are likely to take place in theatre. But the question arises: ‘do theatre staff have the room or the time?’” He further raised the question: “Should the ‘wet’ approach be adopted for all instruments or just high-risk instruments?”, adding: “If we adopt this for all instruments there are advantages in terms of ensuring consistency of approach in sterile services. Staff will be using just one system instead of having to operate two separate systems and will not have to identify which instruments constitute ‘high risk’, therefore.” This will also ensure training of SSD staff is more straightforward, he pointed out. Other issues raised by the draft include: “At what stage should the instruments be treated in this way?” In addition, should instruments be treated during the procedure, at the end as the patient exits, or between cases? There are also issues in relation to COSHH regulations (Control Of Substances Hazardous to Health) with regards to some chemicals used – so careful thought may need to be given as to where this performed, in order to protect patients and staff. In addition, how should wet instruments be contained? Could other items be contaminated on the tray transport system being used? How should instruments be managed during long procedures? Furthermore, how frequent should transport and collection be scheduled – at the end of a procedure, the end of a session, at the end of the day or the end of the weekend? Wayne Spencer also cited research that showed that just under half of SSDs have special arrangements in place for devices required during weekends and bank holidays, with delays before cleaning of 72 hours experienced, in some cases. A large amount of instrumentation is also collected at the end of the day, he pointed out. “This will have an impact if the instruments must be kept ‘wet’ until reaching a reprocessing centre. Procedures, such as neurosurgery, can also take many hours, so the type of surgery will need consideration. “Ultimately, for this to be successful, the system will need to be undertaken as a whole package across theatres and sterile services. This is not something that can be performed in isolation,” he concluded. Diane Gilmour, president of the Association for Perioperative Practice (AfPP) commented that the association’s response to the HTM consultation document had been to recommend that the section on “wet and dry” instruments be removed. The AfPP’s president was invited to speak at the conference as part of IDSc’s recognition of the need to work in partnership with allied professionals – which has involved collaborative discussion with the Department of Health over matters of joint interest.

Collaboration with allied professionals

During her presentation, Diane Gilmour emphasised the need for teamwork and communication between theatre staff and sterile services to ensure patient safety and to improve outcomes. She explained that the perioperative practitioner’s current role within the sterile services lifecycle currently relates to the transportation of instruments to and from sterile services units. However, the main influence over the last 18 months, which has affected practice and the way these two departments work together, has been the National Decontamination Programme and the centralisation of sterile services, the World Health Organization’s Safe Surgery Checklist, and the Productive Theatres initiative. “The perioperative practitioner’s role depends on sterile services to reprocess their instruments. In the NHS, the one constant is change – and change, in some theatres, has seen a destabilisation of where instruments come from and where they are sent. This has primarily resulted from centralisation changes. Practitioners have experienced a loss of ownership. Staff expressed fears such as: ‘What if I drop an instrument and then it has to be transported somewhere else?’; ‘Will we get our instruments back on time?’. There were also concerns over transport issues,” she commented. Interestingly, AfPP conducted a survey of their members and discovered that there were problems – such as wrong sets, for example – irrespective of whether sterilisation was performed off-site or on-site. In fact, she revealed that there was no major difference in terms of the distribution of such problems – with roughly a 60/40 split between off-site and on-site services. “Ultimately, the priorities are compliance and patient outcomes. For some, the investment to move off-site was the best investment for their organisation as financially they could not sustain their own services,” said Diane Gilmour. She explained that, in the previous 18 months, the AfPP and the IDSc had been in dialogue with the Department of Health, to express concerns in relation to decontamination, commenting: “We felt we needed to be heard and listened to. During this time, we have been working together in the area of loan instruments to look at a more robust process and more realistic timelines, as well as a variety of other issues such as tracking and traceability, and centralisation challenges around ‘pooling’ of instruments.”

Theatre Support Pack

Together, the two associations helped to develop the National Decontamination Programme: Theatre Support Pack1 to provide clinical teams with clear and concise advice on the processes underpinning the transfer of instrument decontamination services as part of the National Decontamination Programme. “The pack has helped staff understand the issues that underpin the centralisation of sterile services. One of the recommendations was that a theatre practitioner should be made available, or even seconded, to support the transfer of services if this is undertaken, which I believe is extremely important,” she commented. The WHO Surgical Safety Checklist aims to ensure theatre teams “do all of the right things, on the right patient, all of the time”. For theatre practitioners, this means that any issues with equipment or other concerns must be raised. “We need to check our instruments sets every time – and ahead of time. We need to be prepared and re-organise a list if there are problems with equipment. “Checking of instruments, and efficient planning of the list accordingly, will avoid wasted time and chaotic ‘panic’ at the last minute,” said Diane Gilmour. Another important development has been the Productive Theatre initiative, inspired by “lean” production principles – first developed within the automotive manufacturing sector. This includes briefings and debriefings at the start and end of the list. “My hope is that this will include greater involvement with sterile services staff. The main aim will be to improve quality, the patient experience and outcomes,” she commented, adding that efforts are also currently underway to improve pre-planning. “We need to discuss ‘what will the list look like next week? What will we need? Have we got all the equipment available?’ Previously, I worked at an organisation where meetings were held once a week to discuss what special equipment would be required, what latex was needed, whether there was any pressure on the number of sets, and what the lists would look like – so that the sterile services unit manager could manage the workload accordingly. This communication is vital. “At present, there is much more we can do to support and understand one another. Much will remain unresolved by these initiatives unless theatre practitioners and sterile services communicate more,” she continued. Few perioperative staff understand how each instrument is reprocessed and many have never set foot inside a sterile services unit, she pointed out, adding: “If we do not understand the process, how can we come back to the sterile services team and have conversations about what is happening and why the right sets are not being provided? “Sterile services staff also need to understand what each instrument is used for and how it is used. Do they appreciate the cost of new instruments, for example? We need to improve dialogue, training and integration; to encourage shadowing opportunities; and to work together to understand what the issues are – instead of filing yet another complaint.” In conclusion, she reminded delegates of the World Health Organization’s message which underlines the importance of team-working: “The quality of outcome and safety of the patient during a surgical procedure relies on everybody involved in the surgical pathway.”

Reference 1 National Decontamination Programme: Theatre Support Pack, Department of Health, 25 March 2009, www.dh.gov.uk/en/Publications andstatistics/Publications/Publications PolicyAndGuidance/DH_096890