Tristel Regulatory News (TSTL)

Tristel plc

("Tristel" or the "Company")

Tristel's Wipes and foam disinfectants included in Journal of Ultrasound in Medicine & Biology

Tristel plc (AIM: TSTL), the manufacturer of infection prevention, contamination control and hygiene products, announces that the World Federation for Ultrasound in Medicine & Biology has provided guidance to healthcare organisations worldwide regarding the safe and effective cleaning and disinfection of transvaginal and transrectal ultrasound probes.

The Technical Note identifies various high-level disinfectants that are recommended by ultrasound manufacturers and comments that Tristel's chlorine dioxide is being used extensively in the United Kingdom and Australia. Both the Trio Wipes System and the Duo Foam product are named. Tristel is pursuing a regulatory approval from the United States Food and Drug Administration (FDA) for the Duo Foam.

The Technical Note concludes that disinfection of the ultrasound probe is mandatory. However, in many countries probes are not disinfected even though the probe is used in gynaecological procedures where there is a proven high risk of contamination of the instrument by pathogens such as human immunodeficiency virus (HIV) and human papillomavirus (HPV). HPV is proven to be the main causal agent for cervical cancer. In addition, specific concerns include gonorrhoea and syphilis for vaginal probes and Clostridium difficile for transrectal probes.

The study has been published as a Technical Note in the Journal of Ultrasound in Medicine & Biology

[Abramovich, J. S., Evans, D. H., Fowlkes, J. B., Marsal, K., terHaar, G. 'Guidelines for Cleaning Transvaginal Ultrasound Transducers Between Patients', (2017). DOI: 10.1016/j.ultrasmedbio.2017.01.002].

Paul Swinney, CEO of Tristel plc, comments: "Ultrasound scans in women's health are one of the world's most commonplace diagnostic procedures. It is astounding that so many of these procedures are undertaken without the instrument being properly disinfected between patients. Our Trio and Duo products are two of very few disinfectant products that are designed specifically for women's health. Guidance such as this from the World Federation can only encourage patients to demand that the instrument being used on them is safe because it has been properly disinfected."

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