Envision^™ Ultrasound Probe Covers & Scanning Pads

Sterile Envision Ultrasound Probe Covers and Scanning Pads

• Reduce risk of contamination by removing ultrasound gel from the procedure.
  • Ultrasound gel contributes to increasing nosocomial infection, the spread of hospital-acquired infections.^1,2,3,4
  • Gel can cause bacteria to be introduced into the blood stream.^3,6
  • Gel can make the disinfection or sterilization process of devices, including ultrasound probes, less effective.⁵
• Improve quality of FNA specimens by eliminating the need for ultrasound gel near the puncture site.
  • Gel impairs the visibility of cells and interferes with staining of cells.⁷
  • Gel causes a significant increase in the number of slides with artifacts.⁷
  • Gel causes widespread cell lysis, increasing the risk of misinterpretation and a false positive diagnosis.⁸
  • Gel mimics colloid, creating difficulty in differentiation between artifact and colloid.^7,9
• Covers serve as an effective viral barrier for protection against microbial migration, including viruses, bacteria and bloodborne pathogens.¹⁰
• Specifically tested by an independent laboratory under protocol complying with ASTM F1671 to evaluate the barrier properties to penetration by bloodborne pathogens using viral penetration as a test system. Based on the results of the study, CIVCO ultrasound probe covers provide effective barrier to the penetration of microbial migration.¹⁰
• CIVCO covers provide protection against human viruses with an effectiveness of 27 nanometers (nm) and above. Human viruses larger than 27nm include, but are not limited to:
  • SARS coronavirus
  • Human papillomavirus (HPV)
  • Hepatitis B virus
  • Yellow fever/Zika virus
  • Junin arenavirus/Lassa virus
  • Ebola virus
  • Rotavirus
  • Human immunodeficiency virus (HIV)
  • Hantaan virus
  • Herpes virus
  • Measles virus.¹⁰
• Transducer cover use lowers contamination levels in interventional and endocavity procedures where skin is not intact.¹¹
• Sterile transducer covers are useful and safe alternatives to sterile working conditions during invasive, interventional and non-invasive ultrasound procedures.¹²

Customers are advised this testing does not imply that tested products will prevent an infection resulting from exposure to blood-borne pathogens. Additionally, this testing does not imply protection from acquiring a disease-state associated with such viral exposure. CIVCO transducer covers have not been cleared or approved by the FDA as devices that prevent healthcare workers from acquiring viral or bacterial infections.

Sources

1. 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 Control and Hospital Epidemiology Dec. 2012, vol. 33, no. 12
2. Esteban C. Nannini, Adriana Ponessa, Rosa Muratori, Patricia Marchiaro, Viviana Ballerini, Luis Flynn, Adriana S. Limansky "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
3. Shaban RZ, Maloney S, Gerrard J, Collignon P, Macbeth D, Cruickshank M, Hume A, Jennison AV, Graham RMA, Bergh H, Wilson HL, Derrington P "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" AJIC 45 (2017) 954-8
4. Centers for Disease Control and Prevention "Pseudomonas aeruginosa respiratory tract infections associated with contaminated ultrasound gel used for transesophageal echocardiography - Michigan, December 2011-January 2012." MMWR Morb Mortal Wkly Rep. 2012 Apr 20; 61:262-4.
5. William A. Rutala, Ph.D., M.P.H.1,2, David J. Weber, M.D., M.P.H.1,2, and the Healthcare Infection Control Practices Advisory Committee "CDC - Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008" www.cdc.gov/infectioncontrol/pdf/guidelines/disinfection-guidelines.pdf
6. Australian Government Department of Health Therapeutic Goods Administration "Safety Advisory risk of bacterial contamination" 2017 https://www.tga.gov.au/alert/meditech-ultrasound-gel2A. Lalzad, D. Ristitsch, W. Downey, A. F. Little and M. E. Schneider-Kolsky "Effect of ultrasound transmission gel on ultrasound-guided fine needle aspiration cytological specimens of thyroid" Cytopathology 2012, 23, 330333
7. A. J. Molyneux, S. B. Coghill "Cell Lysis Due to Ultrasound Gel in Fine Needle Aspirates; an Important New Artefact in Cytology" Cytopathology 1994 5, 41-45
8. Royer MC, Davidson DD, Dimitrov RK, Kuo CY, Kokaska MS "Ultrasound gel causes fine needle aspiration artifact? A clear choice." Acta Cytol. 2012;56(2):146-54
9. Selecting the right medical adhesive tape Challenges facing the medical device designer Maggie G. Tebrake, PhD - Technical Specialist, Medical Specialties, 3M
10. https://viralzone.expasy.org/678,
11. Infection Prevention and Ultrasound Probe Decontamination Practices in Europe: A Survey of the European Society of Radiology, C. Nyshen. 2016
12. Sterile Working in Ultrasonography: The Use of Dedicated Ultrasound Covers and Sterile Ultrasound Gel, Peter Marhofer, Department of Anesthesia, Intensive Care Medicine and Pain Therapy, Medical University of Austria and Gerhard Fritsch, Department of Anesthesiology, Perioperative Medicine and Critical Care Medicine, Paracelsus Medical University, Salzberg, Austria, 2016