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COVE R S TORY


with mucous membranes and non-intact or broken skin to be high-level disinfected. In particular, automated and validated processes for ultrasound reprocessing are preferred. This is supported by a study relating to manual disinfection methods, which found that only 1.4% of reprocessing systems were fully compliant when using manual methods, compared to 75.4% when using semi- automated disinfection methods.3


The Spaulding classification system The Spaulding classification system must be applied before a procedure commences so that information about what tissues or body sites may be contacted is taken into account. This classification system is a widely adopted disinfection framework for classifying medical devices, based on the degree of infection transmission risk, and requires the following approaches: l Critical devices are defined as those that come into contact with sterile tissue or blood. Probes in this category should generally be cleaned and sterilised. Where sterilisation is not possible, high-level disinfection is acceptable with the use of a sterile cover for ultrasound probes.


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l Semi-critical devices contact intact mucous membranes and do not ordinarily penetrate sterile tissue. Ultrasound probes scanning over non-intact skin are also considered semi-critical. Semi-critical ultrasound probes include endocavity probes, which should be used with a sheath or cover in addition to being high-level disinfected.


l Non-critical devices only contact intact skin. This category also includes contact surfaces that are not intended for patient contact in health settings. These devices and surfaces should be cleaned and low- level disinfected.


It is important to note the difference between cleaning and low-level disinfection. Cleaning is the removal of soil and visible material


JANUARY 2021


until the item is macroscopically clean. Low- level disinfection is the elimination of most bacteria, some fungi and some viruses. A final and important point for consideration is the use of probe covers. While many ultrasound users and sonographers believe that their transvaginal ultrasound patients are protected from infection risk by using barrier shields and/ or condoms, research has shown that up to 13% of condoms fail and up to 5% of commercial covers fail. Probe covers may have microscopic tears or breakages which can allow microorganisms to pass through.4


Conclusion


Ultrasound users should work with their decontamination colleagues to understand the current UK and European guidelines for reprocessing ultrasound probes. There are patient risks associated with ultrasound usage when proper disinfection procedures are not followed, as well as from ancillary products such as contaminated ultrasound gel. While the increased use of ultrasound has brought many benefits for patients, effective education and disinfection protocols are required to minimise the risk of infection.


References 1 Scott D, et al. Risk of infection following semi-


invasive ultrasound procedures in Scotland, 2010 to 2016: A retrospective cohort study using linked national datasets. Ultrasound. 2018;26(3):168-77.


2 Medicines and Healthcare products Regulatory Agency (MHRA). Medical Device Alert. Reusable transoesophageal echocardiography, transvaginal and transrectal ultrasound probes (transducers) Document: MDA/2012/037. 2012.


3 prospective study on the impact of human factors and automation, Gastroenterol Nurs.2010;33(4):304-11.


4 Basseal JM, Westerway SC and Hyett JA 2020. Analysis of the integrity of ultrasound probe covers used for transvaginal examinations. Infect Dis Health. 2020 Mar;25(2):77-81. doi: 10.1016/j. idh.2019.11.003. https://pubmed.ncbi.nlm.nih. gov/31862265/


Nanosonics Europe Ltd. Unit 2 Linfit Court, Colliers Way Clayton West, Huddersfield HD8 9WL United Kingdom.


Tel: 01484 860581


Email: ukinfo@nanosonics.co.uk, Website: www.nanosonics.co.uk.


WWW.CLINICALSERVICESJOURNAL.COM l 7


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