DECONTAMINATION & STERILISATION
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.
Rob Warburton said: “There is also a need for a standardised process for accurate and practical biofilm sampling.”
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:
n Physical design in terms of accessibility – has it got flush ports, for example?
n Material selection – what are the effects of detergent, ultrasonic, and steam sterilisation?
n 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.
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 IDSc Chair, Trevor Garcia
58 Health Estate Journal August 2025
“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.
AdobeStock / Brigitte
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