Continuous professional development to ensure competency has been identified as an essential requirement for the decontamination sector, in the wake of the findings of the HSSIB report on a serious failure in decontamination. With this in mind, the IDSc was instrumental in the development and introduction of NHS Estates Technical Bulletin NETB/2024/1 version 2.0 — documenting the competency framework for staff working in decontamination. This document is to be read in conjunction with the Health Technical Memorandum 01-01 series, and its contents must be implemented in the same way.
The objective of the NETB is to:
1. Outline the knowledge, skills, abilities, and behaviours, required by staff working in decontamination units to ensure the highest standards of decontamination are achieved; and
2. To give general recommendations for improving Board-level commitment and oversight of decontamination quality.
Since the findings of the original HSSIB investigation, the IDSc has been busy developing professional, levelled qualifications to support efforts to raise standards in training and competency. This is in addition to the educational conference programme, organised on an annual basis, which provides expert insights into current challenges, best practice, and regulations and legislation, as well as innovation.
Respected individuals lost
Sadly, the decontamination sector has recently lost some high profile and well-respected individuals who were well known for their contributions to promoting learning and professionalism within the sector.
IDSc’s Chair, Trevor Garcia, paid tribute to Graham Stanton, Wayne Spencer, John Harrison, and Gillian Sills — who all made their mark on the world of decontamination with a shared passion for raising standards. Each of these individuals left behind an impressive legacy, through their contributions to ensuring patient safety, and will be sadly missed.
“We have lost so much experience and knowledge,” Trevor commented. “It is a timely reminder to us that we need to work hard to develop and encourage the new generation — we need to ensure they are competent, that they have the skills and knowledge to take over the running of decontamination services, and that they can keep these services safe,” he continued.
As part of its commitment to providing educational opportunities within the sector, the IDSc scientific conference provided topical insights into some of the key challenges facing sterile services departments in the UK.
Instructions for use: current challenges
Instructions for Use (IFUs) proved to be the subject of lively discussion at the conference. Stuart White, Decontamination Lead for East Suffolk and North Essex NHS Foundation Trust, has over 25 years’ experience in decontamination in both the public and private sector, including with the robotics manufacturer, CMR Surgical — where he applied his expertise to ensure the company’s technology can be safely reprocessed.
Stuart White reviewed the current challenges facing decontamination units related to the design of medical devices and IFUs, and discussed ‘risk, liability and mitigation’. He remarked that “everybody has a problem with IFUs”, but patient safety needs to be at the forefront.
“Manufacturers’ IFUs tell the user what has been validated and how they should use the device or reprocess it, to get the same results as the validation. But they also say — and this is important — that if you do not follow the instructions for use, then liability passes to the user,” he explained. He considered the Spaulding Classification, ISO, and the various standards relating to validation, pointing out that there are national and global standards.
“In the UK, we have HTMs, and in Germany they have KINKO — they are all different,” Stuart White explained.
He highlighted the scale of the challenge from a manufacturer’s perspective: “As a medical device manufacturer, you are trying to encompass all these different standards — and just when you think you have got it right, you’ll go to one part of Germany and they’ll have one standard, and then you’ll go to the South of Germany and it will be a different local practice. This is very evident when you go to the US and some other countries.” This raises the question: what should the manufacturer validate to?
Stuart White went on to look at some of the common reprocessing challenges experienced by decontamination staff — some devices can’t be dismantled, some may have a complex design, there could be articulation, or they could have limited use.
“It really ought to fit into a standard process,” Stuart White commented. He considered the need to ‘design for reprocessing’: “How many of us have picked up an instrument and said this was never designed for it to be reprocessed?” There were a lot of nods in the room…
Considerations should include:
- Physical design in terms of accessibility — has it got flush ports, for example?
- Material selection — what are the effects of detergent, ultrasonic, and steam sterilisation?
- Biological safety — will it be safe to be reused on different patients?
Considering the worst-case conditions
“We’ve got to look at the worst-case conditions; simulated use has got to match the clinical conditions, and you’ve got to have representative soiling,” Stuart White continued.
The detergent is also an important focus of validation — the manufacturer needs to tell the users what detergent they used and enzymatic pH, but validation should also be undertaken at an independent test house. “It’s no good if manufacturers mark their own work,” he asserted.
In terms of reprocessing and validation, manufacturers need to look at the whole process — from point of use, manual cleaning and main cleaning, through to disinfection, and sterilisation. Ensuring consistent point of use processing tasks in theatres can be challenging, he pointed out.
“In some cases, it’s part of the validation — so, we need to be careful here. It’s critical to avoid drying — we know from our own HTMs that, wherever possible, we should avoid allowing the device to dry before reprocessing; we need to keep it moist.
“The initial manual cleaning also facilitates the additional steps. If you don’t do the initial manual cleaning, the automated process won’t work. If it’s been validated with initial manual cleaning, you cannot avoid it,” he continued.
Packaging is another consideration — what type of containers and packaging can be used, and what exactly has been validated?
“We see a lot of containers on the market that say, ‘we are validated containers’, but have those containers been validated with the contents?” Stuart White commented.
In terms of sterilisation, different countries stipulate different temperatures and different times. America is a large supplier of medical devices to the UK, but its validation parameters differ to ours, which can present issues when it comes to IFUs that have been designed with a US market in mind.
Drying times are also part of the validation: “I have talked to some people who say, ‘we’ve got our drying time down to 20 minutes or 15 minutes’, but does that fit the IFUs?” Stuart pointed out. “We’ve got to look at what’s been validated, and whether the liability then passes to the user.”
Ultimately, IFUs must be clear, well laid out, well-illustrated, and must fit into standardised practice. Stuart cautioned delegates to “look out for precautions within the IFU”. For example, is point of use part of the validation? Is there a need for soaking before you go into initial manual cleaning? (This is common with some robotic instruments, and can be important.)
“The initial manual cleaning time may also be significant — for example, does it say that you’ve got to brush it for five minutes because that’s what they validated it for, allowing for human factors?” Stuart White asked.
When it comes to validation, he had further words of caution for the audience: “If a company says to you, ‘oh, we haven’t got that, but don’t worry, we’ll get it validated for you next week’, it won’t happen. It can’t happen that quickly. It is likely you will get a letter that’s not worth the paper it’s written on. So, just be careful — if you get a surgical site infection incident, the first thing they’ll ask you is ‘Have you followed the IFUs?’ Have you followed a validated process?”
During the Q&A, audience members shared their frustrations at the current status quo. One delegate commented: “I can’t get my head around how these products can be placed on the market if the IFU isn’t fit for use and it doesn’t replicate what we do!”
Stuart acknowledged their frustration, commenting that a large American company had come to him with an IFU that was not fit for the UK. “I said to the rep, ‘How many other Trusts have you got this in?’ They replied: ‘About 30 Trusts, but you are the first one to question the IFU.’ How often have you had that said to you?” he commented. Stuart strongly urged delegates to take an active role in challenging the procurement of devices that cannot be cleaned effectively. “If IFUs are not fit for purpose, and devices cannot be safely reprocessed, we have got to be strong and push back!” he warned.
Reviewing the Spaulding Classification
Other hot topics explored at the event included discussion of whether it is time to review the Spaulding Classification. Dr. Gerald McDonnell, Vice President, Microbiological Quality and Sterility Assurance, and his team at Johnson & Johnson, have produced a number of papers on the topic in recent years, which he highlighted during his session. During his discussion, he highlighted ‘Kremer’s cleaning classification’ — a risk-based approach based on device features and risks of cleanliness.
Maximal steps in cleaning are required for high-risk scenarios where the device has complex features and there is a high risk of soil or microbial retention; moderate steps may only be required for intermediate risk devices, where the device features require a specific intervention (e.g. lumens and mated surfaces), and minimal cleaning steps are required for low-risk devices, where all surfaces are exposed for cleaning. This classification can help in validating IFUs, development of IFUs, and optimising efficiency in decontamination units.
The Spaulding Classification, which most sterile services staff will already be familiar with, is a patient exposure risk-based approach used in decontamination. Dr. McDonnell suggested that the Kremer classification could complement the Spaulding Classification and enable clearer guidance for manufacturers’ IFUs.
Biofilms
Further issues raised at the event included the risk of biofilms in flexible endoscopes — discussed by Rob Warburton, Trust Decontamination Lead at Manchester University NHS Foundation Trust. He gave an overview of the current literature on endoscope processing challenges, biofilm accumulation in new flexible gastroscope channels in clinical use, and endoscope sampling and culturing methods. The literature shows that methods of improving endoscope reprocessing, screening for contamination, and evaluating endoscope damage, are vital to preventing future infections and outbreaks. The latest research by Pineau et al (2024) says that background contamination rates in studies vary from 0.4% to 49%. Sampling and culturing methods vary widely. Bioburden extraction efficacy varied from 1%-39% using different culturing methods — hence, they recommended a harmonised and standardised sampling and culturing method for flexible endoscopes.
Biofilms are extremely challenging, once established, and Rob Warburton pointed out that high-level disinfection (HLD) may not be effective. Chemical disinfection may even make the biofilm’s protective mucilage ‘more robust’, according to the findings of research by Sheffield University.
He pointed out that we also need to review manual cleaning processes — brushing may not always be effective. It has been suggested that automated pre-cleaning devices could provide a possible solution to the ongoing challenge of biofilm. Currently, these automated pre-cleaning devices include technologies that use nano particles/nano metals or high-pressure air and water. We also know that residual moisture stimulates bacterial replication, and can lead to biofilm formation. The 3-hour rule for scope drying may need to be reviewed, and he questioned whether we should be getting the scope dried immediately? Rob Warburton concluded that more research into biofilms and identification methods is required. There is also a need for a standardised process for accurate and practical biofilm sampling. Currently, biofilm testing is not routine, and he pointed out that the accuracy of tests is not confirmed.
Plates and screws: should we be using pre-sterile?
Jack Walters, Managing Director, Sterile Management Systems, revisited the issue of plates and screws, and implants. Jack has a background in material science, and his expertise in sterilisation has stemmed from research and development into the effects of sterilisation on materials. Presenting as a member of the IDSc research committee, he considered the question: ‘What are the safety concerns related to the repeated reprocessing of these single-use devices?’
He pointed out that there are pros and cons of reprocessing implants versus using pre-sterile implants. However, on balance, pre-sterile implants may have a favourable risk/benefit ratio.
“Despite the effort we put into validating sterilisation and cleaning processes, they’re never going to be 100% effective. So, there’s always a risk of contamination slipping through the net,” he commented, adding that: “Continuous sterilisation and disinfection can also put stress on materials — they may weaken, or may not implant in the patient as effectively.”
Jack Walters commented that many people say, ‘How can we convince theatres that they should stop using these implants?’ He pointed to the planned changes to the Medical Device Regulations, that state there is likely to be a need for traceability of the implants going into patients.
“I’m assuming, from the questions raised, that theatres aren’t necessarily keeping that information and they’re not recording the batch number and manufacturer of the screws that are going into the patient. If we don’t have full traceability, what kind of alerts and safety issues are slipping through the net, and what kinds of things might hospitals not be responding to?” he asked.
Jack Walters presented some of the published research and evidence around the effects of repeated reprocessing. The studies showed mixed results. However, there was some evidence to suggest that repeated exposure of plates and screws to sterilisations may have the potential to negatively affect their strength or corrosion potential. Stainless steel was more affected than titanium.
Consider changing implants
“I would say that changing implants as a contamination/infection reduction method should certainly be considered. The evidence is somewhat mixed, although the material effects of repeated reprocessing seem to have some kind of impact on implants. It’s not entirely clear how much of a clinical impact this has. It is highly dependent on implant design — not all implants are created equal,” he commented.
“It may be that individually packed screws increase theatre costs and operation times, but we really need to see a much more detailed analysis to look at the whole life cycle, the reprocessing costs, and postoperative infection rates,” he continued. Jack Walters’s conclusion was that there is “a need for further research”. However, traceability is also an important issue, as highlighted by the case of the PIP breast implant scandal, in which the manufacturer changed from medical grade silicone to industrial grade silicone. The lack of traceability with the breast implants meant that it was extremely difficult to identify which patients had been affected.
“A similar thing could theoretically happen in the implant sphere — we could end up with some contaminants within the materials,” he warned.
Ultimately, there is a lack of robust data on patient outcomes and infection rates when comparing pre-sterile versus reprocessed implants. Improved traceability and post-market surveillance of implants is needed, which the UK is proposing to mandate through new Medical Device Regulations. Jack explained that the new regulations are expected to be much more stringent on traceability requirements. The proposal is for healthcare institutions to store the Unique Device Identification (UDI) numbers for all implantable devices.
“Not only should the hospital be recording the batch number of each implant, but MHRA wants to move to a system where every patient that gets an implant gets an implant card — and this is for all implantable devices,” he concluded.
Looking forward
As the UK’s lead professional body for medical device reprocessing, the IDSc continues to embrace the challenges that arise within the sector, and to support decontamination professionals with education, to ensure high standards of patient safety.
Sharon Fox, Director of Finance, at IDSc, commented: “Reflecting back on my own career, without education, development, and support, I would not have had the opportunity to progress from a technician to a decontamination lead for one of the largest Trusts in the UK. I had some very good mentors, who were very insightful about the value of education. Sharing knowledge is so important, particularly as part of succession planning. If you don’t offer that support and education, staff will move on to pastures new. Providing this development will keep staff motivated. Having been a member of the IDSc for around 20 years, I have found the support that it provides is absolutely vital. If I have a problem, for example, I know I can go to someone within the organisation, who has had a similar experience, and they will offer me support. From an educational perspective, we now have the Technical Certificate, which really underpins the knowledge that you need to be a decontamination practitioner. It gives people the theory and the reasons behind what they do, as well as providing them with mentors.”
She pointed out that IDSc’s annual conference brings together experts in decontamination — covering operational and day-to-day technical issues. As the event is attended by influential decision-makers, they have the ability to take action forward and deliver real change. This makes the event a powerful forum in which to share real-world challenges, exchange ideas, and drive forward solutions. The conference sessions delve into the practicalities and detailed knowledge that decontamination departments need for their everyday practice, but the IDSc is also focusing on innovation to help solve some of the key challenges faced on the frontline of decontamination.
“We ensure the decision-makers are part of our committees, part of our conferences, and part of our branches, and come up with strategies for the best way forward,” Sharon Fox continued. “It is all about collaboration.”
The next educational event, hosted by the Midlands IDSc branch, will be free of charge to members and non-members, and will take place in July. It will provide the underpinning knowledge needed within sterile services to support staff undertaking the Technical Certificate. For further details on the event, venue details, and dates, please contact Midlands Branch Secretary, Agnieszka Strzalkowska Miltko, at: Agnieszka.StrzalkowskaMiltko@uhb.nhs.uk For more details on the IDSc and annual conference, visit: https://idsc-uk.co.uk
Acknowledgement
- This article, titled, ‘The importance of education in sterile services’, first appeared in a Decontamination & Sterilisation supplement within the April 2025 issue of HEJ’s sister publication, The Clinical Services Journal. HEJ thanks the author, CSJ’s editor, Louise Frampton, for allowing its re-publication in slightly edited form here.