HLD mitigates infection risk
Ultrasound is used in almost all hospital departments and can contact intact skin, mucous membranes, non-intact skin, sterile tissue or the bloodstream. Failure to perform HLD before some of these procedures has led to outbreaks and death:
The TJC released an alert in 2017 reporting that 74% of all “immediate threats to life” were from improper sterilization or HLD of devices.1
In 2012 a patient died from hepatitis B infection after an endocavitary ultrasound procedure where the probe was improperly reprocessed.2
- A population-level study has established the epidemiological link between endocavitary probe low level disinfection and increased infection risk.3
- A meta-analysis found a pooled-prevalence of 12.9% for pathogenic bacteria and 1% for pathogenic viruses on endocavitary probes after low level disinfection with use of a cover between patients.4 The probability of infection transmission of viral pathogens to patients from these procedures has been estimated to be 1-6%.5
HLD is recommended by federal agencies and national standards
The Spaulding classification specifies medical device reprocessing requirements based on the intended use of the device. This classification is used by the CDC, FDA and CMS and in national standards (AAMI).
Under the Spaulding classification, semi-critical probes (e.g. endocavitary probes, probes scanning broken skin) must undergo HLD with use of a sheath.6,7 Critical probes must be sterilized, however if sterilization is not possible the CDC permits high level disinfection with use of a sterile sheath.6
Observing recommendations from evidence based guidelines is important for patient safety and is the foundation of healthcare accreditation requirements for reimbursement.
When developing policy at your facility, it is important to apply the Spaulding classification to ultrasound probes used in each type of procedure.
- The Joint Commission (TJC). Improperly sterilized or HLD equipment – a growing problem. May 2017. Available at: https://www.jointcommission.org/assets/1/23/qs_33a_2017.pdf
- Medicines and Healthcare Products Regulatory Agency (MHRA). Medical Device Alert: Reusable transoesophageal echocardiography, transvaginal and transrectal ultrasound probes (transducers) (MDA/2012/037). 28 June 2012. Available at: https://assets.publishing.service.gov.uk/media/5485abf1ed915d4c0d000261/con160567.pdf
- Scott D, Fletcher E, Kane H, et al. Risk of infection following semi-invasive ultrasound procedures in Scotland, 2010 to 2016: A retrospective cohort study using linked national datasets. Ultrasound. 2018;26(3):168-177
- Leroy, S. (2013). “Infectious risk of endovaginal and transrectal ultrasonography: systematic review and meta-analysis.” J Hosp Infect 83(2): 99-106.
- Leroy, S., et al. (2014). “Impact of vaginal-rectal ultrasound examinations with covered and low-level disinfected transducers on infectious transmissions in France.” Infect Control Hosp Epidemiol 35(12): 1497-1504.
- CDC 2008. Guideline for Disinfection and Sterilization in Healthcare Facilities. Available at: https://www.nanosonics.us/wp-content/uploads/2019/10/CDC-Guidelines_2008_04102019.pdf
- FDA 2019. Marketing Clearance of Diagnostic Ultrasound Systems and Transducers.