By Garland-Rhea Grisby
Many healthcare organizations and patients have been focused on endoscope processing for quite a while now. However, the processing of ultrasound probes and dilators has often been overlooked.
In the healthcare space – regardless of the type of instrument used in a procedure – the proper processing and disinfection of medical equipment, including ultrasound probes, is of utmost importance to ensuring that patients are receiving the best possible care, while preventing healthcare-acquired infections (HAIs).
There is clearly variance when it comes to manufacturer instructions on how to properly process and care for ultrasound probes. In some instances, processing areas (e.g., end-user or centralized processing department) need to use different cleaning agents depending on the fleet of inventory that they have. Technical Information Report (TIR) 99 published by the Association for the Advancement of Medical Instrumentation (AAMI) provides guidance specifically for the processing of ultrasound probes and dilators.
Why Is AAMI TIR99 Needed?
Ultrasound probes are instruments used for diagnostics, and for imaging various parts of the body to assist with treatment planning based on the diagnosis. Ultrasound probes vary in their degree of patient contact. Some come in contact only with the intact surface of the patient’s skin, while others may be used to enter sterile tissue of the patient. We can’t take lightly what is needed for these probes to be ready for use on our next patient. Facilities should have a protocol in place that not only follows the instructions from both the ultrasound manufacturer and cleaning/disinfection solution manufacturers, as well as the relevant information in guidance documents like AAMI TIR99. Understanding the type of procedure (i.e., how the device was used) and following the IFUs for processing can mitigate the risk of cross-contamination and transmission of infectious agents between patients.
What Is Not Included in AAMI TIR99:
AAMI TIR99 does not cover the following:
- Vascular or ophthalmic dilators;
- Manometry catheters;
- Endoscopes;
- Steam sterilization or ethylene oxide sterilization processes;
- Devices that have been exposed to prions;
- Single-use items not intended to be processed prior to patient use;
- Devices and other cleaning technologies not cleared by the FDA at the time AAMI TIR99 was published.
What Is Included in AAMI TIR99?
The TIR focuses on establishing standardized procedures for the cleaning, disinfection, and, if possible, sterilization of ultrasound probes. The Spaulding classification has been applied to ultrasound probe processing to better understand the disinfection or sterilization method that should be used. It provides guidance not only to sterile processing personnel, but also to healthcare providers and infection preventionists about the following aspects.
- Cleaning Process: Proper cleaning is the critical first step in the processing of ultrasound probes. AAMI TIR99 emphasizes the use of various acceptable cleaning techniques to effectively remove organic and inorganic debris from the probe. TIR99 discusses proper room design and setup for cleaning regardless of the location. The guidance includes proper decontamination sinks as well as required utilities for processing.
- Disinfection Methods: Some health care professionals that utilize ultrasound probes believe that a simple wipe achieves cleanliness and disinfection. However, ultrasound probes must undergo some form of disinfection after cleaning to eliminate microorganisms that may remain on the surface. AAMI TIR99 discusses the various disinfection methods based on the Spaulding classification, as well as the probe material compatibility and effectiveness against a broad spectrum of pathogens. As usual, consult the probe manufacturer’s instructions for use (IFU), which will outline validated compatible chemicals for their products.
- Sterilization Methods: In certain medical procedures, and based on the Spaulding classification, sterilization may be required to achieve a higher level of microbial elimination. AAMI TIR99 provides guidance on sterilization methods as well as the procedures that might require sterilization.
Implementing Best Practices
Implementing the guidance from AAMI TIR99 could present challenges for some healthcare facilities. Many facilities do not have the financial resources to change their practice, obtain more inventory, or build an appropriate processing area. Other challenges may hinder hiring qualified staff or training existing staff for specialized roles.
In addition to implementing guidance, education and training, quality assurance measures and understanding of technological advances are also imperative. What is included in AAMI TIR99 can not only help to enhance patient safety by reducing the risk of HAIs but can also facilitate compliance with regulatory requirements and accreditation standards. If you do not have this document, I recommend that you add it to your current inventory of guidance documents as it serves as a critical resource in the healthcare industry, guiding healthcare providers in the proper processing of ultrasound probes to safeguard patient health and maintain operational excellence.
In short, considering this guidance document, healthcare facilities can adhere to current infection control measures, mitigate risks associated with medical device contamination, and ultimately enhance the quality of patient care in diagnostic imaging practices. Our patients are why we do what we do!
