Education
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
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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 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: should we be getting the scope dried immediately? Rob 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
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