AAMI Releases Guidance on Dilator, Ultrasound Device Sterilization

A new guidance document on the sterile processing of dilators and ultrasound probes in healthcare facilities has been published by the Association for Advancement of Medical Instrumentation (AAMI).

AAMI TIR99:2024; Processing Of Dilators, Transesophageal And Ultrasound Probes In Health Care Facilities provides comprehensive information for healthcare providers and sterile processing professionals on the selection, labeling, and processing of dilators and ultrasound probes. The document furthers AAMI’s core mission of pursuing optimal health outcomes for patients by providing a much-needed resource on infection control and preventing hazards inside healthcare facilities.

The document was produced by AAMI’s Endoscope Reprocessing Working Group, which is comprised of subject matter experts from healthcare delivery organizations, regulatory bodies, academia, and industry.

Garland-Rhea Grisby, endoscope service manager at Kaiser Permanente and co-chair of AAMI’s Endoscope Reprocessing Working Group, anticipates that the use of AAMI TIR99’s guidance will promote patient safety and assist the personnel working with these medical devices. He stated:

This TIR addresses questions about the appropriate and acceptable way to store, transport, clean, disinfect ,and sterilize ultrasound probes in a healthcare setting. Adoption of this TIR will give users and processing areas a more standardized process, regardless of the setting where ultrasound probes are used or processed.

AAMI TIR99 addresses:

• Proper procedures for cleaning, decontamination, disinfection, and sterilization of dilators and ultrasound probes.
• Information to be provided to endoscope and probe users by Original Equipment Manufacturers (OEMs).
• Transporting and handling of contaminated devices, and transportation after processing.
• Assigning Spaulding classification to clinical use of ultrasound probes and dilators.
• The use of accessories like ultrasound gel and acoustic coupling agents.
• Criteria for selection and use of sterile packaging systems.
• Personnel considerations like training and qualifications, and design criteria for processing areas.

The new guidance is expected to greatly benefit sterile processing professionals and healthcare providers alike. Those interested in a full copy of the guidance document can find AAMI TIR99 here.

Press-ready copies of the guidance document can be made available to journalists. Garland-Rhea Grisby is also available as a subject matter expert for writers working on stories related to sterile processing. Questions? Reach out to AAMI’s press team at dvisnovsky@aami.org.