CSC News Bulletin – October 2024

Bumper issue! – Grab a cuppa this is a 25+ minute read

This month we bring you an overview of the 2024 Autumn Study Day (ASD), held on the 14th October at the Crowne Plaza NEC, Birmingham.

If you know someone who isn’t a member yet and might find some value in this newsletter, please do pass it along.

CSC Activities

Autumn Study Day 2024 was another fully booked, successful event and the first meeting John Prendergast opened as the new Chair.
It was great to see a packed room and a welcome relief for the committee officers to see all the hard work that goes on in the background finally come to fruition – great job Team CSC

The theme for the ASD was ‘The Generation Game’
With constant development of new technologies and the workforce dynamics changing we wanted to explore the past, present and future to review and question processes, rational for why we do what we do and where the gaps are now.

Tribute to Wayne Spencer

John opened the meeting with a tribute to Wayne Spencer who was a past Chair of CSC, an independent AE(D) and proactive member of the BSi committee, amongst many other ways in which he contributed to the field of Decontamination of reusable medical devices.

Wayne was a gentleman, always approachable and known for his pragmatism and ‘get it done’ approach. We will all miss this proud Welshman, his shoes will be hard to fill.

Wayne was diagnosed with Type 1 diabetes in his early twenties and his loving family have created a fundraiser in Memory of Wayne for Breakthrough T1D and would welcome any donations in his memory.

After Wayne’s tribute John invited the audience to log in and use a new app (well it’s not that new but it’s new to CSC!) called Mentimeter designed to prompt interaction and capture real life feedback. To encourage some practice he asked the audience to vote on:

1. Whether Decontamination is given the necessary priority today
2. Whether the discipline has lost focus and standards are dropping
3. Whether there are other areas in healthcare that need our decontamination resources and focus

See the results below:

First Session – ‘The Past’

John handed over to Andrea Wadey, who chaired the first session titled ‘Past,’ introducing Gavin Hughes to talk on ‘The risks with Surgical Screws and Plates’

Gavin is a Director of Surgical Material Testing Labs (SMTL) who are a medical device and PPE test laboratory, part of NHS Wales Shared Services Partnership. They provide their services to Welsh NHS, Industry and the UK Health Service. They are unique in leading testing and technical services on medical devices and PPE throughout the UK, lead on several British and European Standards committees for medical devices and represent the Welsh Government on medical device issues.

The focus of Gavin’s presentation for this meeting was on small orthopaedic single use implants such as screws and plates that are prepared for surgery, but not used in the surgery and are often reprocessed many times even though they are categorised as ‘single use.’

The concerns highlighted were:

1. What impact does multiple episodes of reprocessing have on the quality of the medical devices
2. What are the regulatory implications
3. How is traceability of the individual items impacted
4. What are the potential contamination issues

NHS Scotland moved to pre-packaged single use screws and plates in 2008 and SMTL were asked to consider whether this was something Wales should do. They originally published their findings in 2010 which did not lead to any official recommendations at the time. However, now that more than 10 years have passed, there has been more evidence published in literature and an increasing number of data bases to source information from, so in 2023 the document was updated after undertaking an more extensive literature review and republished.

Here you can find the updated version.
Gavin shared the findings of the review and provided compelling evidence for the need for National Guidance in this area.

The main findings to consider are:

1. The legal status of reprocessing unused single-use devices
2. Traceability of devices
3. Effects of reprocessing on the quality of the devices
4. Contamination status of the implantable devices
5. Practicalities of switching to pre-packaged, pre-sterilised, Single-Use (PPS) devices

The working group concluded that they believe there are genuine clinical risk-management benefits in moving to single use PPS implants, and that the only way to achieve full traceability is by using PPS implants.
As NHS Scotland have already implemented this approach it was felt that many of the logistical and cost implications could be surmounted from lessons learned by others.

Following Gavin was Pat Cattini, Associate Director Infection Prevention and Control and Decontamination Lead at University Hospitals Sussex, giving her views and opinions on decontamination practices over the years, based on experience from 31 years in healthcare and IPC.

Her first experience was from Kingston Hospital at a time when across the UK there were a lot of small local SSD’s and many departments undertook their own reprocessing of devices. Small sterilisers like the ‘Little Sisters’ used to be around and it was common practice if something dropped on the floor, ‘ ‘one could pop it in to the little autoclave and press a button.’

Pat recanted a time when she visited a GP practice and noticed a water bath on the side and on asking what it was used for she was told it was for ‘sterilising’ speculums, but on questioning the process of cleaning, the chemistry used, the duration of contact time etc it was apparent at the time there was no assurance about the decontamination process in place.

Another occasion in a care home identified a ‘bucket’ of chlorine solution used for ‘sterilising’ forceps used for dressing and again no work instructions and therefore no understanding of the whole process of cleaning and decontamination.

There were a lot of unregulated processes pre the epidemic of BSE and the identification of prion proteins as an infectious agent.

In the early 2000’s Pat was part of the first national SSD assessments which later led to centralised services, clamping down on local reprocessing through improved audits, and a move towards single use items.

Pat remembered they spent a long time persuading people to go to single use instruments so that clinical staff weren’t reprocessing, and where they had too she provided training to those staff to support the principals of cleaning prior to decontamination.

Local reprocessing however, has never really gone away and Pat provided the example of baby bottle disinfection and the use of wipes for non-lumen scopes, which means there is still room for error. In Pat’s opinion local reprocessing is about the ‘process.’
Single use is great because of no requirements to clean and decontaminate, but the consequences are:

• Increased costs
• Increased waste
• The environmental costs
• human costs in terms of slave labour in non-regulated countries undertaking manufacturing of instruments
• The potential for ‘single use’ items to not be used as ‘single’ use!

Pat posed the question ‘do we need to go backwards a little bit in order to go forward?’
Acknowledging that today we have accredited decontamination departments and local reprocessing both with robust audit trails and full management, Pat wondered whether it was time to explore the ‘clinically clean’ option for items that need to be sterilised but do not need to be sterile at point of use.

In Sussex they have started to investigate new technologies such as UV cabinets for nasendoscope disinfection and reusable anaesthetic masks.

In conclusion Pat commented that perhaps we need to re-evaluate some of our beliefs and re-examine some of the processes with the aid of modern technology to keep our patients and the planet safe. ‘Risk is a balance’ and with the sustainability platform growing in strength we have to weigh up and balance infection risks vs environmental risks.

Second Session – ‘The Present’

Next up was a look at the ‘Present’ chaired by Tracy Walley, who introduced our overseas (Netherlands) innovative and inspirational speaker, Associate Professor Tim Horeman to present his work that he started in 2015 on ‘Sustainable Surgery and Translational Technology.’

Tim’s work has gained exposure over the years as a keynote at worldwide conferences, author in over 100 scientific papers, being interviewed in the public media, contributing to three chapters in books, developing eight products, receiving awards for 5 grant applications and being recognised with Engineering awards and his contribution to healthcare.

Tim’s research group developed the first computational model of circular material flow in Operating Rooms (OR) waste to product, by characterising all the waste and the steps that go in to make the products used. They could then relate the properties needed, to the parts and the type of waste, which informed the approach to the recycling process.

From this they have created a facility that processes different hospital waste streams including surgical instruments and trade marked the process as ‘Urban Hospital Mining’

They now have 30% of their components and parts made from 100% of recycled waste from the OR’s with the main materials being stainless steel, polyethylene terephthalate (PET) and polypropylene. Because these materials are used in OR having high exposure to patients, they are high quality materials which would have previously been waste to be incinerated.

This was a starting point which led to the first ‘waste free’ robotic platform. The evolution of robotic surgery has lead to an increase in waste and environmental pollution due to high numbers of single use items used in the process. Tim highlighted that 2/3rds of the market leaders income in this field is coming from single use items. The consequence is a 43.5% increase in green house gases (GHG) and 40% increase in procedure costs and 24% increase in waste production.

Tim collaborated with Johnson and Johnson (J&J) on a project to create a validated process to recycle the J&J Echelon Flex Endopath Stapler (a single use item that costs ~£500) , showing a video demonstrating the multiple steps taken from the OR room to the collection point in the hospital, from the hospital to the decontamination unit, to the recovery and harvesting of the components, quality assessment of those components which were then sent back to the manufacturer.

After processing 200 thousand of these complex instruments he started to question the technology and began to investigate the different types of systems available, highlighting that from the first introduction of robotic instruments 25 years ago, there has not been a significant change to address the sustainability global agenda in how the technology has developed. They are still using disposables and cable driven devices.

For new growth there has to be a new starting point and on exploring the general trend of development in AI, SILS and flexible laparoscopy, no one was addressing the sustainability aspects in their ‘new’ developments, which is why Tim and his team created ‘AdLap-RS’ (The Advanced Laparoscopy Robotic System). The real difference is in the gear box and the instruments. They use a shaft instead of cables that can be used either in the robotic arm or a hand held device. It can be decontaminated or thrown away and because it uses a shaft it is narrower and more robust.

They use a Life Cycle Assessment tool to evaluate it for sustainability and as a comparison to others devices.

Tim concluded that with a vision for global use and sustainability you can develop a simple system that is a ‘familiar design, fully reusable and interchangeable with other instruments.

The Alzheimer’s question

Completing the morning session was Jim Tinsdeall reviewing the Alzheimer’s question with a focus on lumened devices, prompted by a recent publication in nature medicine linking transmission of Alzheimer’s to patients who have had growth hormone back in the 1980s.

One of the elements related to CJD and the cleaning of instruments was that it was always envisioned that it would be a continuous improvement process rather than a pass/fail indicator.

Jim highlighted two paragraphs from the peer review paper to highlight the links between CJD and the history of decontamination practices today. It identified Alzheimer’s disease as ‘characteristic’ of conventional prion diseases (CJD link) and that the primary prevention of iatrogenic Alzheimer’s disease should be ‘by ensuring effective decontamination of surgical instruments’ (link to cleaning and decontamination)

Jim asked the audience to think about CJD vs Alzheimer’s from a mathematical perspective in terms of risk, because today there are very few people with CJD (which prompted the initial change in our practices) but there is an increasing number of people, especially in those who are 65 and above, who have been diagnosed with Alzheimer’s or a Dementia.

Jim continued with answering the question of why it has been so difficult to tackle prion protein related diseases with the fact that even after 40 years, when the first incidence of Alzheimer’s was reported, we are still learning about this mis-folded protein. The last disease that took 40 years to become visible was Asbestosis. Prion proteins have been found to be heat resistant at the sterilisation temperatures the industry accepts and although we can measure for ‘protein’ left on an instrument we are unable to identify if it is the ‘affected’ protein.

For more context, in 2020 the NHS reported 131 deaths of sporadic CJD, No recorded deaths from vCJD, 6 deaths from familial CJD and 1 death from iatrogenic CJD caused by receiving HGH before 1985. Jim surmised that each NHS trust is likely to see at least 1 CJD patient a year.

Jim reviewed the history of cleaning instruments which started in the 1980’s with the identification of vCJD which caused the epidemic of ‘Mad Cows’ disease. A consequence of reprocessing all the offal and waste from animal carcasses back into the animal feed effectively changing the natural herbivore diet of the cow.

In the 1990’s the prion protein was identified as the transmissible agent and public health concerns were raised.

In 2000’s national audits took place across the sterile service departments looking at the cleanliness and reprocessing of reusable surgical instruments. Tests such as the Ninhydrin test were introduced to look for the presence of proteins and since that time to date, we’ve developed the methods of testing, swabbing, ultrasonics, washer disinfectors and sterilisers. The perception being that sterilisation made things absolutely safe and residual protein wasn’t necessarily seen as a risk in its own right.

We’ve introduced track and trace, eliminated wire brushes, got the best washers with connections possible for every lumened device, excellent detergents, excellent independent monitoring systems, protein testing options, ultrasonics available, centralised decontamination facilities, guidance and standards as the law.
However, there are still some basics to re-focus on:

1. The time between use and wash
2. Keeping the instruments moist if we can’t wash straight away
3. Continuous improvement
4. Corrosion based on what is being used to keep instruments moist
5. Automation as an essential quality requirement
6. Staff and staff training – teach the ‘Why’ as well as the ‘How’
7. Communication! Requires a desire to continuously improve and learn from mistakes moving away from blaming and complaining.
8. ‘Safe’ return of reusable from single use if possible

We have a duty of care and moral obligation to the patient which is defined as:

• Is it ‘Foreseeable’?
• Can we take ‘Reasonable and Practicable’ actions to provide safe instrumentation?
• Do no avoidable harm – a 40 year feedback loop is a challenge, so with the evidence available this becomes a moral judgement
• Professions at large are expected to act reasonably and logically based on available evidence at the time and further guidance from government.

Jim then connected all these elements back to pictures of lumened devices taken this year (April 2024) showing evidence of pitting, corrosion and congealed blood after being cleaned and reprocessed. In asking the question why did this happen? He felt that the main theme was ‘Communication’ and went through 9 possible reasons why, starting with immediate after use flushing by the theatre staff.

After reviewing the why he then went through what actions were/are being taken to resolve the issue:

1. Immediate after use flush
2. Wrapping for moisture retention
3. Focus on reprocessing time
4. Manual wash followed by ultrasonic wash in alignment with the IFU options, with connection in the WD possibly added.
5. Inspection of the device using a borescope
6. The discolouration has reduced and is still being investigated

In conclusion Jim shared a picture of the Grenfell Tower incident called the ‘Web of Blame’ as an example of when things go wrong and everyone is blaming everyone else. Regardless of where we stand in the near miss / adverse event, in his opinion blaming only makes things worse and instead we, in the decontamination profession, should grab hold of the situation, do the root cause analysis and share the findings in a way that all can learn from the mistake.

Afternoon Session – ‘The Future’

Karen Johnson opened the afternoon session titled ‘The Future’ introducing Trevor Garcia who is the current IDSc Chair and a key contributor to the recently published NHS Estates Technical Bulletin (NETB/2024/1 competency framework for staff working within decontamination)

Trevor began by giving some background which led to the release of the NETB, by linking it with the Health Services Safety Investigations Body (HSSIB) report of May 2022, where they presented their findings on an investigation related to decontamination of surgical instruments. One of the five concerns that was highlighted related to ‘training and training standards for decontamination.’ Identifying that training of staff is set and carried out locally rather than through a national framework, which in turn creates challenges for Regulators, SSD and NHS Trust to assess the level of competency of staff. The premise being that if this ‘training’ varies across the country then the standard of decontamination may also vary.

Therefore they recommended that NHS England and NHS Improvement developed a competency framework for all sterile services staff and include it in the Health Technical Memorandum (HTM) 01-01.

Other finds of the document included:

1. Implementing standardised job profiles and descriptions
2. Enhancing CPD programmes
3. Clarifying of Decontamination Lead role and responsibilities
4. Defining minimum qualifications and IDSc membership for senior roles
5. Increasing board level oversight, governance and accountability
6. Expand apprenticeship training routes
7. Board level involvement in external certification audits and assurance processes for incidents related to decontamination

In May 2023 NHS England approached the IDSc requesting them to develop the NETB document which was issued in April 2024 and is now on version 2.

Trevor highlighted that a key purpose of this document was to enable decontamination services managers to take it to the higher levels within their respective organisations, and use it as a reference document to highlight the requirements for staff training, competency, registration and allow time for these training and development activities to take place.

Trevor reinforced the reasons for ‘why train staff?’ and reiterated that the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 states that staff should have the qualifications, competency, skills and experience necessary for their job role; and the Health and Social Care Act 2008: Code of practice for the prevention and control of infections and related guidance (2022) directed at decontamination of reusable medical devices and equipment states, ‘Staff are trained in cleaning and decontamination processes and the safe use of decontamination equipment and hold appropriate competencies for their roles.’

HTM 01-01 also describes the requirement for staff training as does the NHS Long Term Workforce Plan 2024 as it recognises that retention of staff can be increased through supporting individual career development and training.

To round up his presentation Trevor highlighted some points that decontamination managers can do for staff, and expect from them when implementing this NETB. He also stated the urgency and need to consider the development of the next tranche of ‘managers,’ as it has been forecast that 50% of current managers will be hitting retirement age over the next 10 years!

Trevor ended with a few training and education quotations followed by a couple of comments from participants of the IDSc training scheme.

This session was then opened up to a discussion panel consisting of Jon Windeatt (HSDU Manager of Royal Devon and Exeter Hospital); Andrea Wadey (SSD Manager of Worthing and St Richards Hospital) and Tony Sullivan (Past Durham and Darlington Decontamination Manager)
The session was facilitated by Becky Hill who opened with a Mentimeter question ‘Do you think the technical bulletin should be enforced? And as can be seen from the response of the 68 who voted 71% (48) said ‘Yes’ , 13% (9) said ‘No’ and 16% (11) were undecided.

Initial thoughts were solicited from the panel and then the audience were invited to ask their questions via the Menti app and the discussions began. Below are some of the points that came out:

1. The document is ‘well overdue’
2. A lot of elements that are already done and a lot also not done
3. An audit around the country would inform where various departments are in relation to the document
4. Commending Trevor for getting this document done and out
5. Feel progression will be down to 3 factors: Cost, Time, Pay increase
6. Cost in time, cost in attending a physical course
7. Qualifications over Training – only Apprenticeships and the Technical Certificate IDSc training are recognised as ‘qualifications’
8. End point assessment variations in apprenticeship training is dependant on the college and the trainer, they are either very good or very poor, so there is a feeling that we need to look at a more ‘standard’ approach with a suggestion of an ‘online version’ similar to the NHS ESR
9. Engaging staff that have been doing the job for 25 years or more who have not followed the traditional route of education, but have the experience of working in decontamination departments was touched on, with a view that these people may need more nurturing, coaching and ‘gentleness’ to encourage them through the learning process. Online delivery of a standardised programme was muted as a preferable way forward.
10. There has been no formal framework of training for Decontamination Sciences and consequently the discipline is currently not recognised at Senior Executive level. It was felt that this document is the starting point that will ultimately lead to a culture change at leadership level, although it was acknowledged that it will probably take 10 plus years for full implantation.
11. In the current climate managing the short term challenges of funding, low staffing levels and time were seen as major management challenges to implementation.
12. There have been many training providers in the past providing NVQ level certification but most have fallen by the wayside, so there is a need for a standardised training course.
13. ‘Levelled’ qualification means that it is a recognised qualification throughout England, Scotland, Wales, Ireland etc and as such is differentiated from an ‘Accredited’ course that other providers may offer such as City and Guilds (unless expressly stated that it is a ‘levelled’ course)
14. Concern raised about the experienced department manager who has worked their way up the career ladder learning on the way and unlikely to get a BSc or Masters, will that limit their ability to apply for other decontamination manager roles. Currently there are no courses for BSc, MSc and PhD however, it was felt these should be included and are aspirations for the future, although a recognition that it may discourage some capable people away from the role and discipline.
15. A point was made about the variation of the structure and roles defined in the HTM 01-01 and how this is interpreted across the different NHS Trusts.

Check out the whole discussion by clicking on this link
There were more questions than we had time for and Trevor kindly offered to write up his responses to the questions / comments posed. You can find his responses here posted in the new ‘Educational resources’ page.

For the last part of the ‘Futures’ section Mike Simmons reminded us that the NHS is a good example of a ‘Complex Adaptive System’, everything is connected, the future is rapidly changing, therefore it is increasingly important to understand where the ‘human’ fits in. Nicely leading into introducing Ian Walker, a Professor of Environmental Psychology, to share some lessons from experiences in other areas of behaviour change.
Ian set the scene for looking at a high level view of some general principals of what influences behaviour and why it is often a lot more complicated than just asking people to do things differently.

As a human being we feel that we generally do things we want to do, but then don’t. We make mistakes, we forget, we’ve done things by accident, so we do things that we don’t intend to do! This is a challenge because so much organisation/lay thinking has this idea that we are rational, logical humans behaving in exact accordance with our rational self-interest.

Underpinning the idea that you can shift what people want to do are the thoughts that:

1.  If you make someone think it’s a good idea, they are more likely to do it
2. If you make someone think that it is normal and everyone else does it, they’re more likely to do it
3. If you make it feel easy, they’re more likely to want to do it

But it doesn’t work all of the time and there are examples of behaviour change campaigns especially in public health, which provide all the reasons why, what to do and how, yet behaviour doesn’t change.

Ian then described some of the things that are worth thinking about if you are trying to shift other peoples behaviours in the future:

1. Putting ‘Why’ and ‘What’ together at the same time – Motivation to act is completely separate for the Ability to act. Motivating people to do something without making it easy to act is almost a cruelty!
2. The role of ‘Habits’ – ‘we’ve always done things this way’ – there’s good evidence to show that approximately 50% of all the actions we do is unconscious, not thought through, automatic repetition of past behaviours. The situation triggers the behaviour. The workplace is a hive of habitual behaviour. The automation of actions is generally a good thing until conditions change, a procedure comes in or a point at which what has been done in the past is problematic. Getting people to change their behaviours is extremely difficult when their behaviours have become automated for them triggered by their environment.
3. When the relationship to the environment breaks or there is a change in the environment this is the optimal time to maximise on changing behaviour. However, a single intervention is not going to make the change or sustain it, instead people need continued long term support which could be weeks.
4. The environment / surroundings is intrinsically connected to behaviours. You cannot just focus on people you must understand the wider social and physical environments of the individual, to impact change.
5. People’s readiness for change is subject to where they are in their own evolution and phase of life. One size does not fit all!
6. Is changing the behaviour of people the right approach? When looking at the hierarchy of controls for handling hazards, which is a systematic approach to avoid a danger, the last on the list is people. The idea is to create a self-sustainable safe system where you don’t require buy in from people.

Ian concluded his talk with 3 recommendations:

1.  Be lazy – look for solutions that don’t require continual intervention, persuading or agreement from everybody
2. Don’t ask water to flow up hill – Set up an environment to make the desired outcome easy and normal for a motivated person
3. Build Good habits – Ideally starting with a transition in the environment with long term opportunities for repetition to establish a self-sustaining system.

What next for ASM 2025

Concluding the day, John Prendergast explored a possible theme for the Annual Scientific Meeting 2025 around periodic testing regimes. He raised many questions around HTM’s, the history behind them and the testing regimes outlined in them, challenging whether these are still required or whether there is technology now available that can automate processes. He queried whether other areas such as the operating environment in theatres, the contamination inside endoscopes and sustainability directives need to be reviewed. Do we aim for continuous improvement or do we just continue to CATTNAP (Cheapest Available Technique to Narrowly Avoid Prosecution)

The audience was asked to vote on whether they think periodic testing regimes are:

 ‘Completely appropriate’
 ‘Outdated’
 ‘Need enhancing for greater assurance’

Here’s a view of the results.

The session was concluded with a request for feedback from the audience via the Menti app and the website survey – if you haven’t had a chance to complete the full survey we would still welcome your thoughts via this link.

Thank you to all our Speakers, to Pete Pinnington who organised the AV, to James Plummer for the Video recording, to Carly Elford our events partner, to the venue staff for their care and attention and YOU, our members and non-members who attended in person.

CPD certificates should be with you if you indicated at registration you would like one. If you haven’t received one and would still like it please contact Carly through [email protected]

The next CSC event will be the Annual Scientific Meeting, on the 14th – 15th April 2025 at the Crowne Plaza Chester.

Upcoming Events

DECON UK – The National Conference Centre, Birmingham, 19th March 2025

Decontamination and Sterilisation 2025 Conference and Exhibition – The National Conference Centre, Birmingham, 29th April 2025

Let us know what you’re thinking

Thanks again to our members for all your support.
Please let us know what you think about this news bulletin; any questions or topics you’d like to hear more about by sending a message to [email protected]

Look out for various communications regarding the Annual Scientific Meeting 2025.

We look forward to seeing you in the New Year

The CSC Committee