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188宝金博页面版: Left to dry_ unseen risks lurking on reusable medical devices_2025_Terra A. Kremer
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内容提示: Left to dry: unseen risks lurking on reusable medical devicesTerra A. Kremer 1,2 , Gerald McDonnell 1 , Jamie Fogarty 1 , Cindy Rodriguez 1 , Christopher H. Ratanski 1 & Neil J. Rowan 2,3?In this study, the intricate relationship between the complexity of reusable medical devices and their cleaning ef f i cacy is explored to the point of cleaning failure. The results identif i ed complex device features that require manual cleaning regardless of soil drying time, as well as device designs (i.e., features)...
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Left to dry: unseen risks lurking on reusable medical devicesTerra A. Kremer 1,2 , Gerald McDonnell 1 , Jamie Fogarty 1 , Cindy Rodriguez 1 , Christopher H. Ratanski 1 & Neil J. Rowan 2,3?In this study, the intricate relationship between the complexity of reusable medical devices and their cleaning ef f i cacy is explored to the point of cleaning failure. The results identif i ed complex device features that require manual cleaning regardless of soil drying time, as well as device designs (i.e., features) that are appropriate for a fully automated cleaning process. All features were evaluated for cleaning performance under conditions where the soil was not allowed to dry, as well as replacing manual cleaning steps with non-manual methods, (i.e., substituting manual brushing and fl ushing with soaking and sonication). Findings revealed that soil drying on reusable medical devices can increase the cleaning challenge specif i c to the device feature. Devices engineered with visually accessible challenging geometries, as opposed to those with enclosed or concealed features, successfully met the requirements for soil drying times and semi-automated cleaning evaluations. However, device features with occluded geometries such as ball bearings, leaf springs, threaded screws, and mated surfaces proved more challenging to clean ef f ectively. Since device features vary in their cleaning complexity, each device should be assessed based on their features. By recognizing the risks associated with soil drying on reusable devices, healthcare facilities can implement appropriate practices that streamline more ef f ective cleaning processes that will inform patient safety along with paving the way for future automation.Keywords Reusable medical devices, Device features, Cleaning regimes, Drying time, Patient safetyAs the bright lights blur and consciousness fades during the countdown to surgery, most people are unlikely to be pondering the odds of an unsterilized instrument being used 1,2 . Th e US FDA 3 noted that “Infections can occur through multiple situations including inadequate cleaning, disinfection and sterilization of reusable medical devices”. For example, an estimated risk of infection transmitted by endoscopy is 1 per 1.8 million procedures, and infectious agents such as Helicobacter pylori, Salmonella spp., Pseudomonas aeruginosa, Strongyloides sterocoralis, and hepatitis B and C viruses have been attributed to gastrointestinal endoscopy 4 . However, due to a number of factors such as inadequate or no surveillance and low occurrence or absence of clinical symptoms, the true risk of infection is dif f i cult to estimate 5 . Hospital-Acquired Infections (HAIs) are infections that occur 48 h or more af t er a patient is admitted to a healthcare facility, which were neither present nor incubating at the time of admission 1 . It was observed that on any given day, about one in 31 patients has at least one HAI 6 . Moreover, in the ‘2015 HAI Hospital Prevalence survey’, the CDC reported that about 72,000 of the estimated 687,000 (or 10.48%) patients with HAIs died during their acute hospital stay in the US 7 .T h e occurrence of HAIs has a direct medical cost impact on hospital fi nances and many researchers have performed analysis to understand the economic benef i ts of investing in an infection prevention and control program 8,9 . Additionally, the risk of contracting an HAI can be mitigated by ef f ective device processing 2 . However, the complexity of device features and the importance of implementing appropriate cleaning processes are majorly underappreciated 2,10 . For example, the US Food and Drug Administration (FDA) posted 35,039 adverse event reports related to outbreaks, injuries, and reprocessing failures associated with medical devices in 2024 11 . Th is is corroborated by ‘Sedgwick’s 2025 US State of the Nation Recall Index report’ 12 that noted the medical device sector recorded an 8.6% increase in recall events, reaching 1,059 in 2024. Th is report noted that device failures lead recall causes, accounting for 11.1% of medical device recalls, the highest rate in over fi ve years. Moreover, Ofstead and co-workers 13 recently noted that “processing breaches in endoscopes are common and of t en involve profound errors in multiple steps”. In summary, there are notable published reports highlighting that improperly reprocessed medical devices caused HAIs 14–25 .1 Microbiological Quality and Sterility Assurance, Johnson & Johnson, Raritan, NJ, USA. 2 Centre for Sustainable Disinfection and Sterilization, Technological University of the Shannon Midlands Midwest, Athlone Campus, Athlone, Ireland. 3 Research-Ireland-funded CÚRAM Centre for Medical Device Research, University of Galway, Galway, Ireland. ? email: neil.rowan@tus.ieOPENScientif i c Reports | (2025) 15:28540 1 | https://doi.org/10.1038/s41598-025-13740-7www.nature.com/scientificreports
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