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Ultrasound Infection Control

THE REAL COST OF HAIs
687,000

annual healthcare-associated infections (HAIs) estimated in the U.S.3

$9.8 billion

U.S. annual costs for the top five types of healthcare-acquired infections1


PROTECTING THE PROBE & PATIENTS

3 times 3x

German study showed ultrasound probes contaminated with 3x more bacteria than toilet seats2

Covering Probes is Recommended for Infection Prevention

“The use of a sheath is recommended for every semi-critical use of the probe.” 4
- U.S. FDA


“Barriers used for internal and interventional percutaneous procedures must be single-use transducer covers that meet the sterility requirements of the procedure12
- AIUM

Probe Covers Not Always Used in Semi-Critical Procedures

ONLY

70%
cover the probe if blood/ bodily fluid is present6

ONLY

71%
cover with a sterile probe cover for an interventional procedure6

warning
The Spaulding Classification classifies a transducer as semi-critical when it contacts mucous membranes or non-intact skin, including for intracavity procedures (transvaginal, transesophageal).
Not All Covers Are Created Equal

2018 study evaluated leakage rates of endocavity probe covers and condoms following transvaginal examinations7

0% to 5%

Commercial endocavity cover leakage rate

0.4% to 13%

Condoms leakage rate


ULTRASOUND GEL POSES INFECTION RISK

Ultrasound gel has caused infection outbreaks in recent years

people

2013: Outbreak of Burkholderia cepacian complex (BCC) affected 11 patients in the neonatal, intensive care, and general medical units. “BCC stains were isolated only from ultrasound scanning gels.”13

people

2016: Two patients died from septic shock after outbreak traced to contaminated gel used in central line placements8

people

2017: 11 patients affected by outbreak of Burkholderia cenocepacia due to ultrasound gel used in central line placements and fluid drainages9


Reduce infection risk of gel:

1. Use gel-free probe covers

2. When necessary, only utilize single-use, sterile gel packets10


PROPER CLEANING & REPROCESSING OF ULTRASOUND PROBES

High-Level Disinfect Ultrasound Probes After Semi-Critical Use



AIUM recommends pre- cleaning probe after each use:

“with soap and water or quaternary ammonium (a low-level disinfectant) ...”12
CDC guidelines state that semi-critical probes:

“such as rectal and vaginal, cryosurgical, transesophageal probes or devices also should be high level disinfected between patients.” 5
Survey shows discrepancies between recommendations and reality:

Only 79% said they always disinfect with an approved high- level disinfectant when probe comes into contact with blood 6
  1. Zimlichman E, Henderson D, Tamir O, et al. Health Care–Associated Infections: A Meta-analysis of Costs and Financial Impact on the US Health Care System. JAMA Intern Med. 2013;173(22):2039–2046. doi:10.1001/jamainternmed.2013.9763
  2. Sartoretti T, Sartoretti E, Bucher C, Doert A, Binkert C, Hergan K, Meissnitzer M, Froehlich J, Kolokythas O, Matoori S, Orasch C, Kos S, Sartoretti-Schefer S, Gutzeit A (2017) Bacterial contamination of ultrasound probes in different radiological institutions before and after specific hygiene training: do we have a general hygienical problem? Eur Radiology 2017 Oct;27(10):4181-4187
  3. CDC, “HAI Hospital Prevalence Survey,” https://www.cdc.gov/hai/data/portal/index.html
  4. FDA, “Marketing Clearance of Diagnostic Ultrasound Systems and Transducers,” https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-clearance-diagnostic-ultrasound-systems-and-transducers
  5. CDC, “Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008,“ https://www.cdc.gov/infectioncontrol/pdf/guidelines/disinfection-guidelines-H.pdf
  6. Westerway SC, Basseal JM and Abramowicz J (2019) Medical ultrasound disinfection and hygiene practices: WFUMB global survey results. Ultrasound in Medicine and Biology. Vol 45 (2):344-352
  7. Basseal JM et al., Analysis of the integrity of ultrasound probe covers used for transvaginal examinations, Infection, Disease & Health, https://doi.org/10.1016/j.idh.2019.11.003
  8. Abdelfattah R, Aljumaah S, Alqahtani A, Althawadi S, Barron I, Almofada S. Outbreak of Burkholderia cepacia bacteraemia in a tertiary care centre due to contaminated ultrasound probe gel. Journal of Hospital Infection. 2017; pii: S0195-6701(17)30516-9.
  9. Shaban RZ, Maloney S, Gerrard J, Collignon P, et al. Outbreak of health care-associated Burkholderia cenocepacia bacteremia and infection attributed to contaminated sterile gel used for central line insertion under ultrasound guidance and other procedures. American Journal of Infection Control. 2017; 45(9):954-958 3.
  10. Oleszkowicz SC, Chittick P, Russo V, Keller P, Sims M, Band J. “Infections Associated with Use of Ultrasound Transmission Gel: Proposed Guidelines to Minimize Risk.” Infection
  11. Control and Hospital Epidemiology, Dec. 2012, vol. 33, no. 12. https://icap.nebraskamed.com/wp-content/uploads/sites/2/2019/06/Ultrasound-Gel-2013.
  12. AIUM Guidelines for Cleaning and Preparing External- and Internal-Use Ultrasound Transducers Between Patients & Safe Handling and Use of Ultrasound Coupling Gel, https://www.aium.org/officialStatements/57pdf 13. Nannini, Esteban, et al. “Polyclonal outbreak of bacteremia caused by Burkholderia cepacia complex and the presumptive role of ultrasound gel.” The Brazilian Journal of Infectious Diseases, 2015;19(5):543-545

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