Simplifying AAMI TIR 99: Dilators, Probes, and Accessories, Oh My!

AAMI TIR99:2024 outlines how to safely process dilators and ultrasound probes in healthcare facilities. This article breaks it down into manageable steps to help your sterile processing and infection prevention teams apply the new guidance with confidence.

By: Vanessa Frank, Clinical Resource Manager at ASSI

The Association for the Advancement of Medical Instrumentation (AAMI) has rolled out a new Technical Information Report (TIR) that focuses on reprocessing dilators and ultrasound probes in healthcare settings. Wondering what that means for you and your facility? AAMI TIR99:2024, titled “Processing of Dilators, Transesophageal and Ultrasound Probes in Health Care Facilities,” is all about making sure these devices are used safely and effectively in patient care. The report offers detailed steps for cleaning, disinfecting, and sterilizing a variety of probes and dilators.

Let’s be real: these documents can be a bit intimidating and tough to put into practice. Even the title might seem overwhelming. But don’t worry, this article is here to break down the key points so that you can easily grasp and apply the information, even if AAMI lingo isn’t your first language.

At Advantage Support Services, we know these updates can be complex. That’s why this guide simplifies key AAMI recommendations—so you can feel confident applying them in your facility.

Understanding the Scope of AAMI TIR99

What Devices Does It Cover?

AAMI TIR99 discusses a wide range of devices including:

Dilators used for vaginal, rectal, urethral, cervical, tracheal, nasal, and esophageal procedures
Ultrasound probes used intraoperatively, transesophageally, transrectally, transvaginally, ophthalmically, and externally

Rather than detailing each model, AAMI TIR99 offers general recommendations that should be paired with manufacturer Instructions for Use (IFUs) and your facility’s internal policies.

Spaulding Classification

A key part of the TIR is the Spaulding classification, which groups devices based on the infection risk they pose. Here’s a quick rundown:

Critical devices: These touch sterile tissue, the bloodstream, or non-intact mucous membranes—think intraoperative ultrasound and vaginal or esophageal dilators.
Semi-critical devices: These come into contact with mucous membranes or non-intact skin—like endocavitary ultrasounds or external ultrasounds.
Non-critical devices: These only touch intact skin, so the risk is lower—usually, this involves external ultrasound procedures.

Sometimes, depending on the procedure, a device might need a higher level of processing than usual, based on the Spaulding classification. Always follow your institution’s guidelines on this.

Handling Device Accessories

Accessories such as biopsy needle guides, bite guards, and dilator wires must be either single-use or properly reprocessed. For reusable accessories, sterilization is required if they are categorized as critical.

While non-critical probes may not require sheaths, AAMI suggests sterile sheaths for all critical and semi-critical probes to minimize cross-contamination.

Reprocessing Guidelines for AAMI TIR 99

General Considerations

Before reprocessing, always review the device’s IFU. Facilities should:

Use PPE in compliance with OSHA
Set up separate spaces for cleaning and high-level disinfection
Follow related AAMI standards such as ST79 (for steam sterilization), ST58 (for chemical sterilization), and ST91(for endoscope processing)

Step-by-Step Cleaning Process

Cleaning Steps

The cleaning process starts with point-of-use treatment.
PPE should be worn as per the manufacturer’s IFU and facility policy, then the cover and accessories should be removed and discarded.
Wipe the device down with a single-use cleaning wipe, and transport it using durable, easy-to-clean, puncture-proof, and leak-proof containers to keep contaminated parts separate from clean ones.
Manual cleaning should be done in dedicated areas using verified solutions, brushes, and tools.
After cleaning, but before disinfection or sterilization, the devices should be rinsed with critical water and thoroughly dried to prevent microbial growth.

Be sure to change PPE from soiled to clean and perform hand hygiene after manual cleaning and before handling high-level disinfected or sterilized devices.

Electrical Leak Testing

For transesophageal (TEE) probes, electrical leak testing is crucial. This should be done according to the manufacturer’s IFU and documented—either on paper or electronically.

Water Quality

Water quality is key for reprocessing ultrasound probes and dilators, especially when it comes to removing residual chemicals and debris. Refer to AAMI ST108 for water quality standards and perform a risk assessment to determine the appropriate water quality for each step of the reprocessing cycle.

Disinfection and Sterilization

Semi-critical devices should ideally be sterilized; if that’s not possible, they must go through high-level disinfection. Automated processing is preferred because it reduces human error and exposure to harsh chemicals. All chemical solutions and equipment used must align with the manufacturer’s IFU, and all probes, dilators, and accessories should be inspected for cleanliness and integrity before HLD or sterilization.
For some types of transducers, the handle and connector don’t touch the patient and thus don’t require the same level of processing as the patient-contacting parts. Follow the IFU for these separate cleaning steps and make sure to keep the sections apart to maintain the integrity of the HLD section.
Liquid Chemical Sterilization (LCS) is another option if both the device and sterilant manufacturers have validated the process. If devices are processed this way, they need to be used immediately or reprocessed again before patient use.

Transport and Storage with AAMI TIR 99

To prevent cross-contamination, AAMI recommends transporting clean and soiled items separately. Use clearly labeled containers, and ensure soiled items have red biohazard markings.

For storage:

Keep clean and dirty areas physically separated
Maintain HEPA-filtered airflow in storage spaces
Control temperature and humidity
Dry devices thoroughly before storage

According to AAMI ST91, water splatter from sinks can reach up to 8 feet. Conduct a risk assessment to ensure stored items remain protected.

Quality Assurance

Documentation Is Key

Every reprocessing step should be logged, either electronically or on paper. Consistent documentation supports compliance and helps trace potential issues.

Ongoing Evaluation

Facilities should adopt a quality improvement program to evaluate reprocessing effectiveness. Section 16 of TIR99 includes root cause analysis tools and helpful matrices to improve outcomes.

References and Supplemental Information

Annex A: Studies linking probes and dilators to hospital-acquired infections.
Annex B: Information on ultrasound gels, warmers, and processing probes at the point of use.

By following the guidelines in AAMI TIR 99, healthcare facilities can boost the safety and effectiveness of their reprocessing procedures for ultrasound probes and dilators, improving patient care and reducing the risk of infections.

Need a guide for managing accessories and IFU compliance? Check out our SPD resources or request a custom department assessment from our team.

Association for the Advancement of Medical Instrumentation (AAMI).

ANSI/AAMI TIR99:2024 Processing of dilators, transesophageal and ultrasound probes in health care facilities.