Education
they have KINKO – they are all different,” Stuart explained.
He highlighted the scale of the challenge
from a manufacturers’ 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 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 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 lot of nods in the room… Considerations should include:
l Physical design in terms of accessibility – has it got flush ports, for example?
l Material selection – what are the effects of detergent, ultrasonic and steam sterilisation?
l Biological safety - will it be safe to be reused on different patients?
“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 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,” Stuart 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 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 their 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 and who say,
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.
66
www.clinicalservicesjournal.com I April 2025
‘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 advised. 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
Brigitte -
stock.adobe.com
Page 1 |
Page 2 |
Page 3 |
Page 4 |
Page 5 |
Page 6 |
Page 7 |
Page 8 |
Page 9 |
Page 10 |
Page 11 |
Page 12 |
Page 13 |
Page 14 |
Page 15 |
Page 16 |
Page 17 |
Page 18 |
Page 19 |
Page 20 |
Page 21 |
Page 22 |
Page 23 |
Page 24 |
Page 25 |
Page 26 |
Page 27 |
Page 28 |
Page 29 |
Page 30 |
Page 31 |
Page 32 |
Page 33 |
Page 34 |
Page 35 |
Page 36 |
Page 37 |
Page 38 |
Page 39 |
Page 40 |
Page 41 |
Page 42 |
Page 43 |
Page 44 |
Page 45 |
Page 46 |
Page 47 |
Page 48 |
Page 49 |
Page 50 |
Page 51 |
Page 52 |
Page 53 |
Page 54 |
Page 55 |
Page 56 |
Page 57 |
Page 58 |
Page 59 |
Page 60 |
Page 61 |
Page 62 |
Page 63 |
Page 64 |
Page 65 |
Page 66 |
Page 67 |
Page 68 |
Page 69 |
Page 70 |
Page 71 |
Page 72 |
Page 73 |
Page 74 |
Page 75 |
Page 76 |
Page 77 |
Page 78 |
Page 79 |
Page 80 |
Page 81 |
Page 82 |
Page 83 |
Page 84 |
Page 85 |
Page 86 |
Page 87 |
Page 88 |
Page 89 |
Page 90 |
Page 91 |
Page 92 |
Page 93 |
Page 94 |
Page 95 |
Page 96 |
Page 97 |
Page 98 |
Page 99 |
Page 100
