Australian innovation delivering standardised frontline ultrasound infection prevention

Nanosonics Limited
Sunday, 01 May, 2022


In Australia, patients will suffer from an estimated 165,000 healthcare-associated infections (HAIs) each year.1 35–55% of HAIs are preventable.2 Medical device reprocessing is one of the key strategies required to help break the chain of infection transmission. With ultrasound probes now used throughout most healthcare departments, solutions that standardise ultrasound infection prevention practice at the point of care (POC) are important to support patient safety. Nanosonics is an Australian infection prevention (IP) company dedicated to manufacturing pioneering innovations, to improve the safety of patients, clinics, their staff and the environment.

The need for ultrasound IP standardisation

Two separate outbreaks in Europe and North America last year are a reminder about the need for standardised ultrasound IP practices.3,4 Sourced to contaminated lots of non-sterile ultrasound gel used in ultrasound-guided procedures, the outbreaks impacted hospitalised patients across multiple facilities.3,4 The UK Health Security Agency and US CDC issued safety alerts, calling upon immediate action to implement the routine use of sterile, single-use ultrasound gel in preparation for and during relevant procedures to prevent further adverse events. The CDC additionally called for a review of ultrasound probe reprocessing practices.4

Low level disinfection wipes and sprays can fail to systematically eliminate bacteria and virus from ultrasound probes.5-8 A landmark epidemiological study commissioned by the Scottish government identified “unacceptable risk” of infection associated with the use of endocavitary ultrasound, when low level disinfection of the probes was the standard of care.9 Scottish guidelines mandating high level disinfection (HLD) for endocavitary probes were released after the study period.10

A recent survey of Australian emergency departments (EDs) identified only 31% of respondents had access to ultrasound probe HLD.11 The ED is a complex healthcare delivery environment. Procedures are often performed under time pressure with patients of unknown infectious status, and ultrasound is often used in invasive procedures. Standardised, reproducible and easy-to-use HLD options are key to support staff and patient safety. Probe HLD should be performed when clinically indicated following the Spaulding classification, adopted in Australian reusable medical device reprocessing standards and guidelines.12,13

trophon: the global standard of care for ultrasound probe HLD

Nanosonics’ trophon® technology is recognised as the world’s leading automated HLD solution for ultrasound probes. With over 28,000* units operating worldwide, approximately 91,000 people each day are protected from the risk of cross-contamination with trophon technology. The trophon family includes trophon EPR and trophon2 devices which share the same core technology of ‘sonically-activated’ hydrogen peroxide.

Designed for the patient POC

POC ultrasound has become a cornerstone in the treatment and diagnosis of patients in the emergency department, intensive care, obstetrics and gynaecology and many other departments. The trophon device makes POC reprocessing possible, saving staff time with a simple, fast and integrated workflow solution.

The trophon device is a closed, automated system that does not expose staff and the environment to toxic and dangerous chemicals. The trophon disinfectant is enclosed in a cartridge and automatically emptied only when inserted and sealed inside the trophon device. After disinfection, residual hydrogen peroxide is removed from the trophon device’s decontamination chamber and passed through destructors where it is broken down into environmentally friendly water and oxygen gas as by-products.

Consistent protection for every patient

The trophon device simplifies the user experience, delivering standardised, automated HLD in every department. Sensors monitor critical parameters, including temperature, mist volume and flow rates with sophisticated software controls monitoring the process throughout the cycle, ensuring effective and reproducible disinfection is delivered with every cycle. Consistent patient protection is delivered without reliance on human factors associated with manual HLD.

Masterful microbial defence

The trophon device goes further to deliver the broadest patient protection.+ The trophon device is the only automated HLD technology for transvaginal, transrectal and surface probes to meet mandatory microbial efficacy test requirements for TGA listing, CE marking and FDA clearance. Regulatory bodies thoroughly assessed trophon2 technology and deemed trophon2 as equivalent to the trophon EPR device in terms of efficacy, disinfectant, critical parameters and independent cycle verification (chemical indicator).14,15

The trophon device also eliminates an extended range of clinically relevant pathogens such as multi-drug resistant bacteria (including MRSA), blood borne viruses (including hepatitis B) and sexually transmitted pathogens (including HPV).16-18 In addition to microbiological testing, trophon efficacy has been demonstrated on patient-used probes in the clinical setting, passing acceptance criteria within its standard label cycle time.6,19

Why trophon is so effective: sonicated hydrogen peroxide

The trophon system uses proprietary hydrogen peroxide disinfectant that is ‘sonically-activated’ to create a very fine mist. Free radicals in the mist have superoxidative properties enabling the disinfectant to act quickly and destroy pathogens.

Each trophon cycle consumes only approximately 2 millilitres of disinfectant, and the very fine mist particles penetrate even shadowed areas formed by crevices, grooves and imperfections on the probe surface. This ensures all surfaces of the ultrasound probe undergo HLD delivering reliable, consistent patient protection with every trophon cycle. Ultrasound probes do not require extra cleaning steps for shadowed areas before HLD in trophon devices, beyond the minimum cleaning instructions from probe manufacturers for each model.

The industry-leading probe compatibility program

Nanosonics has implemented an industry-leading probe compatibility program, conducted in partnership with probe manufacturers to determine compatibility with trophon devices. This collaboration ensures the technical expertise of the probe manufacturer informs the compatibility protocol development guaranteeing required materials compatibility and functional parameters are effectively measured. Probes are listed as compatible only if the probe manufacturer and Nanosonics jointly approve the compatibility.

More than 1,100 surface and endocavitary probes from all major and many specialist probe manufacturers are approved for use with trophon devices.

Demonstrated compliance

National standards require facilities to collect reprocessing cycle information, medical device identifiers, and link this to the patient record.13,20 This is referred to as tracking, or traceability. Traceability is essential in outbreak investigations to determine the extent of patient notifications and device recalls.12,13,20

The trophon2 device with AcuTrace® radio-frequency identification (RFID) technology simplifies the creation of accurate reprocessing workflow compliance digital records, easily obtained from the trophon2 device to meet audit requirements. AcuTrace RFID technology records operator, probe and cycle data to capture and demonstrate traceability compliance to national standards.13,20

Introducing Nanosonics AuditProTM: Your key to IP standardisation

The new Nanosonics AuditPro provides facilities with the opportunity to improve and standardise ultrasound infection control compliance across all ultrasound procedures, supporting the management of organisational and facility risk and patient care.

Nanosonics AuditPro comprises a mobile scanning device (MSD) for ultrasound users coupled with sophisticated software to manage compliance. The MSD uniquely sits with the ultrasound console at point of care enabling users to incorporate infection control considerations as part of everyday practice. With built-in education as part of the workflow, users qualify every procedure against the Spaulding classification for probe disinfection requirements, standardising the IP decision every time.

The software combines ultrasound patient procedures and probe disinfection information, including HLD records from the Nanosonics trophon2 device, and interrogates data captured through the clinical workflow to create non-compliance notifications and intuitive information-rich dashboards.

Australian innovation for enhanced safety

Standardising ultrasound infection prevention practices is important to help manage risk across facilities. Australian-manufactured and with local support, Nanosonics’ trophon2 device and AuditPro system mitigate risk to patients and healthcare facilities, arming healthcare staff, IPs and risk and quality managers with tools to drive compliance and patient safety.

References

1. Mitchell, BG et al. Infect Dis Health. 2017 Sep;22(3):117-128.
2. Schreiber PW, et al. Infect Control Hosp Epidemiol. 2018;39(11):1277-95.
3. UK Health Security Agency National Patient Safety Alert NatPSA/2021/010/UKHSA. 11 November 2021.
4. CDC. 8/19/21. Multistate Outbreak of Burkholderia cepacia Infections Associated with Contaminated Ultrasound Gel. Website.
5. Westerway SCW & Basseal J. (2020). Ultraschall Med. 2020 Jul 30. doi: 10.1055/a-1168-6602.
6. Buescher, D. L., et al. (2016). Ultrasound Obstet Gynecol 47(5): 646-651.
7. Leroy, S. (2013). J Hosp Infect 83(2): 99-106.
8. M’Zali, F., et al. (2014). PLoS One 9(4): e93368.
9. Scott D et al. (2018) Ultrasound. Aug;26(3):168-177. doi:10.1177/1742271X18774594.

10. HFS/HPS 2017. NHS Scotland Guidance for Decontamination of Semi-Critical Ultrasound Probes; Semi-invasive and Non-invasive Ultrasound Probes
11. Manivel V et al (2021). Australas J Ultrasound Med. 2021 Sep 12;24(4):187-207. doi: 10.1002/ajum.12283
12. ACIPC-ASUM Guidelines for Reprocessing Ultrasound Transducers. Australasian Journal of Ultrasound in Medicine. 2017;20(1):30-40
13. AS/NZS 4187:2014
14. FDA Pre-market notification, trophon2 K173865. Accessible at: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpm/pmn.cfm?id=K173865
15. TGA ARTG, the trophon devices. Accessible at: https://tga-search.clients.funnelback.com/s/search.html?collection=tga-artg&profile=record&meta_i=159484.

16. Vickery K et al. 2014. J Infect Public Health. 7(2):153-60.
17. Becker B et al. 2017. GMS Hygiene and Infection Control 12: Doc02.
18. Ryndock E et al. 2016. J Med Virol. 88(6):1076-80.
19. Ngu A et al. 2015. Infect Control Hosp Epidemiol. 2015;36(5):1-4.
20. ACSQHC NSQHS Standards 2021. Action 3.17.

*As at 31 December 2021.
+Broadest efficacy spectrum as compared to ultrasound probe disinfection with UVC and ClO2 wipes systems.

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