Evaluation Background: Automated Reprocessors for Endovaginal, Endorectal, and Surface Ultrasound Probes
May 11, 2022 | Evaluations & Guidance
Here's background for our Evaluations of automated ultrasound probe reprocessors that perform high-level disinfection of probes used for endovaginal, endorectal, and transcutaneous imaging. We outline the key considerations for making wise purchasing decisions, how the technology is used, which specs are important, and what factors we test for. We also review our latest product ratings and ECRI's data describing hospitals' interest in each model.
The primary purpose of the automated ultrasound probe reprocessors (AUPRs) that we evaluated is to facilitate and automate disinfection of ultrasound probes that are categorized as semi-critical devices under the Spaulding classification; examples include endovaginal (EV) and endorectal (ER) probes (Spaulding 1971). Some devices can also be used to disinfect probes used transcutaneously, sometimes referred to as surface probes—most commonly those surface probes used on nonintact skin or to guide interventional procedures.
These systems deliver measured doses of a liquid or vapor disinfectant to a chamber containing the precleaned and dried ultrasound probe. An automated cycle exposes the probe to the disinfectant at a specific temperature and for a specific length of time to achieve high-level disinfection (HLD). The systems also automate probe rinsing with water to remove the disinfectant and render the probe ready for clinical use. These systems have the potential to minimize the risk of operator or patient exposure to toxic chemicals. Defining characteristics of devices we evaluated include being marketed as capable of automating HLD of EV, ER, and surface probes using liquid or vapor products.
As a broad category, AUPRs are a mature technology, with the first systems being FDA cleared in 2005 for HLD of transesophageal echocardiography (TEE) probes. Systems designed specifically to perform HLD of EV, ER, and surface probes are a more recent introduction. As the technology develops, manufacturers continue to add features that enhance workflow, as well as to facilitate data tracking and archiving, which is required for facility inspections.
Probes that are used to perform EV or ER exams and used on nonintact skin are considered semi-critical devices under the Spaulding classification, because they may come in contact with mucous membranes or body fluids. Thus, after each patient procedure these probes must be reprocessed, including cleaning, drying, and HLD (Westerway and Basseal 2020).
Reprocessing of ultrasound probes must be performed and documented for compliance with regulatory standards as demonstrated through, for example, Joint Commission and voluntary laboratory accreditation. All of the systems we evaluated automate recording of the date and time of reprocessing, operator ID, probe ID, and results of minimum recommended concentration (MRC) tests.
In June 2021, the Joint Commission published updated guidelines regarding the level of reprocessing expected for surface probes (see Reprocessing Surface Ultrasound Transducers). Several other medical organizations also publish guidelines regarding ultrasound transducer reprocessing; for ECRI's guidelines, see Cleaning and Disinfecting Diagnostic Ultrasound Transducers: Our Recommendations.
These systems consist of a wall-mounted or...