Ultrasound infection prevention workflow: standardisation unlocking risk management

Ultrasound is a versatile medical technology used in a broad spectrum of procedures. Infection preventionists (IPs) and quality and risk managers understand the challenges of ensuring compliance with best practice ultrasound infection prevention and the need to respond to clinical developments. Nanosonics is dedicated to developing solutions for facilities that partner with these responses, enabling standardised clinical integration to enhance patient and staff safety.

Ultrasound risk

Studies demonstrate ultrasound probes can be contaminated with microorganisms after patient use, even with the use of probe sheaths. Over 90% of transvaginal ultrasound probes can be contaminated with bacteria after use and almost 50% of ultrasound probes in Emergency and ICU settings can be contaminated.^1-3 Studies show that even after low level disinfection with manual wipes and sprays, probes can be contaminated with virus and bacteria, including pathogens that cause sexually transmitted infections like human papillomavirus and Chlamydia trachomatis.^1,4,5

Standard precautions dictate every patient must be assumed to be infectious to help break the chain of infection transmission. In medical device disinfection, this means applying the Spaulding classification to the probe before use on a patient (Figure 1).⁶ Spaulding forms the basis of National standards and Federal guidelines on medical device reprocessing. ^7-10

Figure 1. The Spaulding classification divides infection transmission risk based on the type of patient tissue the device will contact during use, which determines the level of disinfection.^6-11 If sterilisation of critical ultrasound probes is not possible, they can minimally undergo HLD and be used with a sterile sheath.^7,11

A landmark epidemiological study by the Scottish health authority reported an increased risk of infection in the 30 days following an endocavitary ultrasound scan, where low level disinfection was the practiced standard of care.¹² The study followed almost 1 million patient journeys retrospectively through linked national patient datasets between 2010 and 2016. The Scottish government has mandated high level disinfection (HLD) for semi-critical probes including endocavitary probes since 2016, in line with minimum standards in Australia and New Zealand.¹³

Surface ultrasound probes can also carry risks. An intraoperative probe was the source of an outbreak, in patients undergoing hepatic surgeries with the contaminated device.¹⁴ Improper probe reprocessing was identified as one of the factors. Another study found ultrasound was associated with increased bloodstream infection risk when guiding central line insertions at the femoral and jugular sites. Contaminated gel was ruled out and confounding variables such as number of insertion attempts were controlled.¹⁵ Surface probes can be non-critical, semi-critical or critical depending on their use; it’s important Spaulding is applied to help manage infection risk.

Automation enables standardised disinfection

Probe disinfection should be successful every time to reproducibly protect the next patient from infection transmission risk. Reproducibility depends on meeting the critical parameters required to achieve the disinfectant’s validated label efficacy claims on all surfaces of a probe. Critical parameters can include contact time, temperature and chemical concentration or dosage depending on the methods used.

Automation enables reproducibility in medical device reprocessing by minimising human factors. Human factors are recognised to impact compliance and reproducibility in manual endoscope reprocessing in the literature and by regulators.^16,17 The Robert Koch Institute (RKI), the German public health institute, recently reported they were unable to identify any standards or guidelines that demonstrated the validation of manual wipes as a final disinfection step for semi-critical devices.^18,19 In a U.S. National survey of IPs, 91% of respondents preferred to use automated processes for probe reprocessing.²⁰

Digitisation enables standardised record keeping

Documentation is essential for communication and continuity of patient care through the healthcare system. Whether considering laboratory, pharmacy, imaging, communications or other hospital sub-systems, standardisation of data collection and linkage to the patient is critical for meaningful interpretation and reporting.

In medical device reprocessing, traceability documentation is essential for decision making about device recalls or patient notifications in outbreak settings.^7,10,11 Documentation is also evidence of a an ultrasound infection prevention quality control program. Adopting digitisation can streamline workflows and standardise data collection when compared to paper-based record keeping, enabling demonstrated compliance in the creation of accurate digital records. AS/NZS 4187:2014 recognises ‘HSOs should be working towards an electronic tracking/process record system.’⁷

Nanosonics AuditPro^TM: Your key to infection prevention 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 the patient point of care, enabling staff to incorporate infection control considerations as part of everyday practice.

With built-in education as part of the workflow, staff qualify every procedure against the Spaulding classification for probe disinfection requirements, standardising the IP decision every time.

“I like that [AuditPro includes] the Spaulding classification on the MSD, it educates the sonographer, makes them critically think. I really like that part of it.”²¹

The software combines ultrasound patient procedures and probe disinfection information, and interrogates data captured through the clinical workflow to create non-compliance notifications and intuitive information rich dashboards. The standardised reporting can support data driven decision making at the system level about training needs, providing inputs into quality and risk management programs. The AuditPro software also combines HLD records from the Nanosonics trophon^®2 device with ultrasound patient procedures and probe information, streamlining data searching capabilities.

trophon^®2: leader in automated ultrasound probe HLD

Nanosonics trophon^® technology is the global standard of care in ultrasound probe HLD helping protect patients from the risk of cross contamination. The trophon family includes trophon^® EPR and trophon^®2 which share the same core technology of ‘sonically activated’ hydrogen peroxide. trophon technology is bactericidal, fungicidal, virucidal and mycobactericidal. trophon efficacy has been demonstrated in peer review in microbiological studies and in clinical settings.^22-26

Every day, 87,000 patients are protected from cross contamination risk because the ultrasound probe used in their procedure has undergone HLD with trophon devices. Over 25,000 units are used across North America, in over 5,000 hospitals and clinics including all luminary hospitals.

trophon devices are designed with point-of-care placement in mind to support staff and patient safety, throughput and cost effectiveness. trophon technology uses a proprietary hydrogen peroxide disinfectant that is sonically activated to create a mist in the probe chamber, penetrating crevices, grooves and imperfections on the probe body and handle. trophon devices are a closed, automated HLD solution that mitigate the risk of exposure to hazardous chemicals often associated with manual methods.

Nanosonics’ second generation device, trophon2, launched in 2018 and is enabled with AcuTrace^® RFID technology to deliver digitised capture of the reprocessing record.

“We love the traceability and reassurance a good trophon disinfection gives our transvaginal probes. Having just expanded our fleet of units to include the new trophon2 model we are enjoying some of the new features — shorter warm up times, the ability to wake the trophon2 up automatically at the start of the work day and the additional benefit of being able to access logs for our disinfection cycles is there if we should ever need it. Even with all the new features it is still super simple to use and navigate the menus. We love our new trophon2’s!” — Karen Rocke, Ultrasound Supervisor SKG Radiology, Western Australia

Together, trophon2 and AuditPro devices mitigate risk to patients and healthcare facilities, arming healthcare staff, IPs, risk and quality managers with tools to drive compliance. Discover how Nanosonics AuditPro can standardise your ultrasound IP practices, help you meet accreditation requirements and deliver best practice patient care across your organisation.

For more information, click here.

_References

_{1. Buescher DL et al. 2016. Ultrasound Obstet Gynecol 47(5): 646-651. 2. Oide S et al. 2019. J Med Ultrason 46(4): 475-479. 3. Keys M et al. 2015. Crit Care Resusc 17(1): 43-46. 4. Leroy S, et al. J Hosp Infect 2013;83(2): 99-106. 5. M'Zali, F., et al. 2014. PLoS One 9(4): e93368. 6. Spaulding EH 1968. Chemical disinfection of medical and surgical materials. Disinfection, sterilization, and preservation. Lawrence C, Block SS. Philadelphia, Lea & Febiger: 517-531. 7. AS/NZS 4187:2014. 8. AS/NZS 4815:2006. 9. NHMRC, ACSQHC. 2019. Australian Guidelines for the Prevention and Control of Infection in Healthcare. 10. ACSQHC. 2nd ed. Sydney. NSQHSS: 2021. 11. ACIPC, ASUM 2017. AJUM 20(1): 30-40. 12. Scott D et al. 2018. Ultrasound 26(3): 168-177. 13. HPS, HFS 2016. NHS Scotland Guidance for Decontamination of Semi-Critical Ultrasound Probes 14. Gery A et al. 2021. J Hosp Infect 111: 184-188. 15. Buetti N et al. 2020. Clin Infect Dis. 2020. doi: 10.1093/cid/ciaa1817. 16. FDA. 7/24/20. The FDA is Recommending Transition to Duodenoscopes with Innovative Designs to Enhance Safety: FDA Safety Communication. Website. 17. Ofstead CL et al. 2010. Gastroenterol Nurs 33(4): 304-311. 18. RKI 2020. Aufbereitung von Medizinprodukten. Zur Frage der Validierbarkeit der abschließenden Desinfektion von semikritischen Medizinprodukten mittels Wischtüchern 19. RKI 2021. Validierung der abschließenden Desinfektion von semikritischen Medizinprodukten mittels Wischdesinfektion 20. Carrico RM et al. 2018. Am J Infect Control 46(8): 913-920. 21. AuditPro usability study. Nanosonics Ltd. 22. Vickery K et al. 2014. J Infect Public Health. 7(2):153-60. 23. Becker B et al. 2017. GMS Hygiene and Infection Control 12: Doc02. 24. Ryndock E et al. 2016. J Med Virol. 88(6):1076-80. 25. Ngu A et al. 2015. Infect Control Hosp Epidemiol. 2015;36(5):1-4. 26. Buescher DL et al. 2016. Ultrasound Obstet Gynecol 47(5): 646-651.}