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

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 the FDA and CDC guidelines on the Spaulding Classification

Read the report at Joint Commission Online

Lia Moshkanbaryans, PhD is the global clinical communications manager at Nanosonics Ltd

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