Mary Ann Drosnock: New Sterile Processing TIR Will Help Reduce Confusion

Have you heard the good news? AAMI has recently accepted a new work item proposal for the construction of a brand-new technical information report, TIR 99, which will focus on the  proper processing of dilators, transesophageal and other ultrasound probes in healthcare facilities. This TIR would provide detailed guidance on the proper steps of processing probes and dilators just as ST91 does for flexible and semi-rigid endoscopes.

Currently, there is much confusion on the topic of proper processing of probes and dilators and few resources available to guide facilities on the processing steps for these important devices. Clear and concise recommendations do not exist currently, yet facilities are being cited by surveyors for not performing these steps adequately.

The plans for this TIR are that it will be limited to the processing of dilators, transesophageal and ultrasound probes (e.g., TEE probes, vaginal probes, rectal probes, and dilators such as Savory and Maloney types). Flexible and rigid endoscopes are excluded since they are covered by ST91.

For this new TIR, we in AAMI ST/WG 84 (the working group responsible for endoscope reprocessing) plan on providing an extensive list of definitions and abbreviations related to the topic, to outline the role of the medical device manufacturers in setting processing requirements, proper labeling of reusable devices, and medical device compatibility with processing products. We will assign Spaulding classifications to the clinical use of probes and dilators, being sure to specify that from procedure to procedure the same device can have different Spaulding classifications (e.g. surface abdominal scan to central line placement). The working group will also outline how to integrate decision making about the classification of these devices into a clinical workflow, how to manage probe inventory to support variety of clinical procedures, as well as how to properly use probe covers, ultrasound gel, and accessories. The design of processing area will be discussed along with general considerations for processing these types of devices.

Just like other devices that are cleaned and disinfected or sterilized, proper workflow from dirty to clean is very important, so area setup will be discussed in detail. Other items that we plan to include in the document are personnel considerations and general policies and procedures that a facility should have related to proper processing of these devices. As well, we will discuss what the expectations are for education, competency, and training of the staff that will be reprocessing these ancillary devices. Of course, an AAMI document wouldn’t be complete without a section on proper attire and the personal protective equipment needed for processing these devices.

I expect that the TIR will also cover in great detail the individual steps of precleaning, transport, electrical leak testing (if necessary), manual cleaning, high-level disinfection (both manual and automated), sterilization, storage, and clean transport.

I see this new TIR as being a welcome addition to the projects of WG84 and one that will be very valuable to healthcare facilities. My hope is that one day this TIR will become a new standard so that facilities have the important requirements that they need!

Want to get involved in the development of this TIR and in other standards activities? Find out how at www.aami.org/standards

Mary Ann Drosnock is senior manager of clinical education at Healthmark Industries in Fraser, MI, and co-chair of AAMI ST/WG 84, the working group responsible for endoscope processing.

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