Why using automated HLD systems is better for your patients compared to using manual disinfection wipes.

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According to studies, best practices in ultrasound probe high-level disinfection (HLD) are achieved by manual cleaning, followed by an automated HLD system for the following reasons: 

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Insufficient Validation

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The Robert Koch Institute (RKI) in Germany stated that disinfection with manual wipes cannot be validated on site, which is a requirement for the final disinfection step of semi-critical devices such as endocavity ultrasound probes.

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• There is no guideline or standard to advise the requirements regarding how a manual wipes step process can be documented by an individual in a reproducible manner.^3,6-15
• No standardized documentation that the disinfecting agent has been applied effectively to all probe surfaces.
• No standardized documentation that the correct level of mechanical force of a disinfectant wipe has been applied to the probe surface.
• No standardized documentation that the disinfectant agent has been applied effectively to crevices and indents on the probe.

As a result, the RKI currently does not consider the final wipe disinfection of semi-critical medical devices to be validatable.¹³

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According to ISO standard 17664-1, Processing Health Care Products, an automated disinfection system is preferred over a manual method.¹⁶

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Section 6.7.1.1: Information is to be provided by medical device manufacturer for at least one validated automated disinfection method for their medical device classified as critical or semi-critical.

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Section 6.7.1.2: states If an automated system can’t be specified, a validated method of manual disinfection is possible.

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Best Practices

Manual cleaning followed by an automated HLD system constitutes to be best practice.³

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The use of an automated validated process for decontaminating reusable invasive medical devices is internationally recognized as providing a reproducible disinfection process to enhance risk reduction for infection transmission.^3,6-15‍

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References

1. CDC Sexually Transmitted Disease Surveillance, 2020 https://www.cdc.gov/std/
statistics/2020/default.htm

2. Meyers C, Milici J, Robison R (2017). PLoS ONE 12 (10): e0187377.

3.C.R. Bradley, et al. (2018). HIS: https://doi.org/10.1016/j.jhin.2018.08.003

4. Hoyer et al. Antimicrobial Resistance and Infection Control (2016)

5. Nyhsen, C. M., et al. (2017). Insights Imaging 8(6): 523-535.

6. Health Facilities Scotland, NHS National Services Scotland, Health Protection Scotland. Scotland, March 2016. Document: HPS/HFS Version 1.0.

7. Health Service Executive (HSE) Quality Improvement Division (2017). Document: QPSDGL-028-1.

8. Kollmann, C. and K. Salvesen (2017). European Committee for Medical Ultrasound Safety (ECMUS).

9. JACQUES S. et al. (2017) GUIDELINES FOR CLEANING TRANSVAGINAL ULTRASOUND TRANSDUCERS BETWEEN PATIENTS World Federation for Ultrasound in Medicine & Biology.

10. Carrico, R. M., et al. (2018). Am J Infect Control 46(8): 913-920.

11. AAMI ST58:2013 Chemical sterilization and high-level disinfection in health care facilities 12. ACIPC-ASUM. Guidelines for Reprocessing Ultrasound Transducers. Australasian Journal of Ultrasound in Medicine. 2017;20(1):30-40.0

13. RKI Clarification: https://www.rki.de/DE/Content/Infekt/Krankenhaushygiene/Aufb_MedProd/Aufb_MedProd_node.html

14. C. Kyriacou, et al. Ultrasound Obstet Gynecol 2022; 60: 132–138 DOI: 10.1002/uog.24834.

15. DEGUM Guidelines & Recommendations (2018) DOI https://doi.org/10.1055/s-0044-102006

16. ISO standard 17664-1

 https://www.iso.org/standard/81720.html

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