TJC quality and safety update reveals key compliance gaps in ultrasound probe reprocessing

September 2021

By Lia Moshkanbaryans, PhD

The U.S. Joint Commission (TJC) has reaffirmed this August that healthcare organizations must follow the minimum level of ultrasound probe reprocessing based on intended use (per Spaulding classification adopted by FDA) and manufacturer instructions for use.

The TJC reported 22% of healthcare facilities were non-compliant with their standard on cleaning and low level disinfection of medical devices in 2020. Ultrasound findings included failure to clean or low level disinfect non-critical surface probes used on intact skin, and failure to high level disinfect visibly soiled surface ultrasound probes per the manufacturer IFUs.

TJC also reported 46% of healthcare facilities were non-compliant with their standard on intermediate, high level disinfection and sterilization of medical devices. Findings included failure to high level disinfect probes as required by the Spaulding classification and manufacturer IFUs, and improper use of products not FDA cleared for use as sterile probe sheaths.

“Health care organizations must determine intended use(s) based on how the surface ultrasound transducers and endocavity probes are used within their organization and resolve any discrepancies with the manufacturer.”

The TJC also reaffirmed the use of sheaths does not replace these minimum reprocessing requirements. Consistently applying the Spaulding classification to ultrasound probes will ensure they are properly disinfected for the intended use in a procedure, helping keep your patients safe from infection risk.

Learn more about Canadian National Standards on the Spaulding Classification now

Read the report at Joint Commission Online


March 2020

Read important information regarding trophon® efficacy against coronavirus

CIN114 trophon efficacy against SARS-CoV-2 Canada

Read High Level Disinfection – Why and When
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Reclassification of Sonex-HL as a medical device (from a drug classification) by Health Canada.

March 2019
Sonex-HL®, (Nanosonics’ proprietary disinfectant with 35% hydrogen peroxide chemistry for use with trophon®), was successfully submitted for reclassification to Health Canada as a class II medical device, and approved in 2018:

  • Nanosonics have updated the trophon EPR medical device licence (MDL 77877) to include Sonex-HL as a component of trophon EPR medical device system.
  • Similarly, trophon2 approval by Health Canada included Sonex-HL as a medical device (MDL 100935).

Therefore, Sonex-HL reclassification in Canada has been completed by Nanosonics.

Please note that Sonex-HL has not changed in formulation or efficacy, it simply has had a reclassification regulatory-wise by the Canadian government.

Videos from AIUM (American Institute of Ultrasound in Medicine) in New York!

In March 2018 Nanosonics exhibited at the American Institute of Ultrasound in Medicine (AIUM) Annual Meeting in New York.

The AIUM show is the place to be for medical ultrasound professionals. It brings together experts from more than 20 medical ultrasound specialties, searching for new and innovative solutions to improve patient care.

Two of the Nanosonics’ team (Keith Koby, Senior Vice President of North America and Gina Cummings, US Clinical Applications Specialist) were interviewed at the booth for a real-time stream on Facebook.

Just because you weren’t there doesn’t mean you have to miss out on the action.

You can watch these new videos here!

Scottish population study
Keith Koby discusses a hot topic in ultrasound probe infection prevention. There’s a new population study out, conducted by government in Scotland that directly shows an increased risk of infection and an increase in antibiotic prescriptions among patients following semi-invasive ultrasound probe procedures. This study really highlights the importance of maintaining proper HLD processes for endocavitary procedures.

Human Papillomavirus
Hear Gina Cummings discussing the ongoing challenge that Human Papillomavirus (HPV) presents for infection prevention. With ultrasound probes being a potential source of HPV infection it is a serious issue in patient safety.
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Keith Koby elaborates on the importance of keeping adequate HLD documentation. trophon offers a simple traceability solution, making it easy for healthcare facilities to maintain compliant reprocessing records.