To reduce ultrasound probe cross infection risk, you need to know why and when to perform the high level disinfection process.

Why HLD ultrasound probes?

HLD ensures that you deliver a standard of care for patient and staff safety during ultrasound procedures while maximising compliance.

1. Deliver Patient and Staff Safety

If certain standards of care are not met, the consequences can be serious.

  • Patients have previously been put at risk of infection transmission due to inadequate cleaning or disinfecting and non-compliance with recommended reprocessing procedures1
  • The prevalence of healthcare acquired infections in the UK and Ireland is around 8% (or 2 in 25 cases)2,3
  • 20-30% of HAIs are preventable; this number increases to 70% in some healthcare settings3
  • Death has been associated with improperly reprocessed ultrasound probes4
  • First population-level study of its kind reveals increased risk of infection and antibiotic prescriptions following semi-invasive ultrasound probe procedures5


2. Maximise Compliance
HLD is advised in Scottish and Irish guidelines as the minimum standard in ultrasound probe reprocessing for intracavity ultrasound probes that contact mucous membranes.6,7 Additionally, they advise HLD for non-invasive surface probes used on broken skin.

The Welsh guidelines highlight automation, validation, and traceability as key features of disinfection systems for ultrasound probes.8 The guidelines require disinfection of ultrasound probes between patient use in accordance with the manufacturer’s instructions.

However, these minimum standards are not always met.

Multiple guidelines now recommend HLD between patients to reduce the risk of cross contamination.

Infection-control professionals need to ensure that their internal policies are consistent with national guidelines to ensure compliance.

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“The guidelines stated that in Germany, Merz et al., like others, favours automated systems for high level disinfection, in particular devices using hydrogen peroxide (Trophon® EPR), now approved by the US Food and Drug Administration. Another important aspect of automated systems is the standardised and reproducible decontamination process thus avoiding operator-associated errors or variations. Ultraviolet (UV) light is less effective in eradicating microbes in comparison to hydrogen peroxide.”

Nyhsen CM, Humphreys H, Koerner RJ, Grenier N, Brady A, Sidhu P, et al. Infection prevention and control in ultrasound - best practice recommendations from the European Society of Radiology Ultrasound Working Group. Insights Imaging. 2017:doi: 10.1007/s13244-017-0580-3.

“HLD using the manual multi-wipe system is the least preferred option for disinfecting semi-invasive ultrasound probes. Internationally it is recognised that the use of an automated validated process … will provide enhanced risk reduction of infection transmission.”Ireland's Health Service Executive Guidance, 2017

“Health Facilities Scotland (HFS) conducted a national survey of TOE, TV and TR ultrasound probes to identify current decontamination practice for SIUPs across NHS NHSScotland which concluded that there is an ongoing risk to patient safety with regard to decontamination of these SIUPs.”NHSScotland Guidance for Decontamination of Semi-Critical Ultrasound Probes; Semi-invasive and Non-invasive Ultrasound Probes, 2016

“… health facilities should investigate and work towards the use of automated and validated decontamination system.”Welsh Health Technical Memorandum 01-06: Decontamination of flexible endoscopes – Part C: Operational management, 2014


GUIDELINES FOR DECONTAMINATION ULTRASOUND PROBES

 
 

When to HLD?

After manual cleaning, HLD should be performed on ultrasound probes that are used in semi-critical procedures, as defined by the Spaulding Classification. Applying the correct level of disinfection is based on the procedure the probe is going to be used for on the next patient.

Ultrasound probes used in examinations that may have a remote chance of contacting dry/cracked skin (or other non-intact skin) and bodily fluids (including blood) should be minimally high level disinfected, according to the Scottish and Irish probe decontamination guidelines.6,7

If the patient is high-risk or the skin is not intact then general purpose probes should be high level disinfected.

Heat-sensitive devices can be HLD, at a minimum, when sterilisation cannot be done due to the potential damage to the device.

 

High Level Disinfection (HLD):
Is one of three disinfection levels used in hospital and clinics for reprocessing ultrasound probes.

HLD results in the complete elimination of all microorganisms in or on a probe, except for bacterial spores, small numbers of which may remain.6,7

Using trophon is a safe, versatile and simple way to HLD your ultrasound probes to meet the Ireland, Scotland and Wales Guidelines.

  • Semi-critical probes should be high level disinfected even if a sheath is used5,6,8
  • Critical probes should be sterilised, or can also be high level disinfected and used with a sterile sheath8
  • Ultrasound probes used in examinations that may have a remote chance of contacting dry/cracked skin (or other non-intact skin) and bodily fluids (including blood) should be minimally high level disinfected5,6,8
  • Non-intact skin includes any breakage or damage to healthy intact skin, including but not limited to dry/cracked skin, wounds, cuts, incisions, lacerations, gashes, grazes, abrasions, avulsions, eczema, rashes and burns
  • If the intended use of an ultrasound probe should change prior to or during a procedure, the ultrasound probe should be reprocessed appropriately before commencing or continuing the examination
CRITICAL: A device that may come into contact with sterile tissue should be sterile. Such devices should minimally be sterilised, which is defined as the destruction of all microbial life. In the case of ultrasound probes, high level disinfection (HLD) is acceptable as a sterile cover is used.8

Sterilisation: All viable microorganisms must be destroyed

SEMI-CRITICAL: A device that may come into contact with intact mucous membranes and does not ordinarily penetrate sterile tissue. These devices should minimally receive HLD which is defined as the destruction of all vegetative bacteria, mycobacteria, enveloped and non-enveloped viruses, fungal spores, and some bacterial spores.8

High Level Disinfection: All viable microorganisms must be destroyed, except a small number bacterial spores

NON-CRITICAL: Devices that do not ordinarily contact the patient or contact only intact skin. These devices should be low level disinfected.

Low Level Disinfection: Most vegetative bacteria and viruses destroyed, except bacterial spores, mycobacteria, fungi, or small non-lipid viruses.

  1. CDC Health Alert Network September 11, 2015. Available from: http://emergency.cdc.gov/han/han00382.asp.
  2. Smyth ET et al. Four country healthcare associated infection prevalence survey 2006: overview of the results. J Hosp Infect. 2008 Jul;69(3):230-48.
  3. SPICe Briefing, Healthcare Associated Infections. The Scottish Parliament. 16 November 2011. 11/80. Available at: http://www.parliament.scot/ResearchBriefingsAndFactsheets/Factsheets/SB_11-80.pdf [Accessed March 2017.
  4. GOV.UK Medical Safety Alert; Reusable transoesophageal echocardiography, transvaginal and transrectal ultrasound probes (transducer) – failure to appropriately decontaminate. (https://www.gov.uk/drug-device-alerts/medical-device-alert-reusable-transoesophageal-echocardiography-transvaginal-and-transrectal-ultrasound-probes-transducers-failure-to-appropriately-decontaminate.)
  5. Health Protection Scotland, NHS National Services Scotland. NHSScotland Risk Based Recommendations for the Decontamination of Semi-Invasive Ultrasound Probes: Risk of infection following semi-invasive ultrasound procedures in Scotland, 2010 to 2016. Version 1.0. October 2017. Accessible at: http://www.hps.scot.nhs.uk/pubs/detail.aspx?id=3366
  6. Health Service Executive (HSE) Quality Improvement Division – Decontamination
    Safety Programme. Ireland, January 2017. HSE Guidance for Decontamination of Semi-critical Ultrasound Probes; Semi-invasive and Non-invasive Ultrasound Probes. Document: QPSD-GL-028-1.
  7. Health Facilities Scotland, NHS National Services Scotland, Health Protection Scotland. Scotland, March 2016. NHS Scotland Guidance for Decontamination of Semi-Critical Ultrasound Probes; Semi-invasive and Non-invasive Ultrasound Probes. Document: HPS/HFS Version 1.0.
  8. Welsh Health Technical Memorandum WHTM 01-06. Wales, 2014. Decontamination
    of flexible endoscopes Part C: Operational management(Including guidance on non channelled endoscopes and ultrasound probes).
  9. Rutala WA, Weber DJ, HICPAC. Guideline for Disinfection and Sterilization in Healthcare Facilities. USA: Centers for Disease Control; CDC 2008. (http://www.cdc.gov/hicpac/Disinfection_Sterilization/acknowledg.html.)
  10. Federal Drug Administration. Guidance for Industry and FDA Reviewers: Content and Format of Premarket Notification [510(k)] Submissions for Liquid Chemical Sterilants/High Level Disinfectants. 2000.