AAMI News October 2018

Standards Spotlight: AAMI TIR99 to Provide Much-Needed Guidance for Reprocessing Dilators and Probes

Sterilization Working Group 84 (ST/WG 84), which develops guidance on endoscope reprocessing, is developing a new technical information report, TIR99, that will provide “much-needed guidance” on reprocessing dilators and transesophageal and ultrasound probes, according to AAMI’s Amanda Benedict, director of standards.

Interest in TIR99?Mary Ann Drosnock, MS, FAPIC, CIC, CFER, RM (NRCM), senior manager of clinical education at Healthmark Industries, and Rose Seavey, MBA, BS, RN, CNOR, CRCST, CSPDT, president and CEO of Seavey Healthcare Consulting, LLC, previewed the scope of this TIR.

Q What problems are you seeing in the field for clinicians and reprocessing staff?

Rose Seavey Improper infection prevention practice associated with ultrasound probe and dilator use has been linked to infection risks and outbreaks. While guidelines for reprocessing and use of probes exist, it is unclear how extensively these have been adopted in practice. Dilators and ultrasound probes are not specifically addressed in ST58, ST91, or ST79. I see a huge issue with staff competencies and compliance with instructions for use of dilators and ultrasound probes, which are widely used and are often processed by clinical staff who are not trained in reprocessing of reusable medical devices.

Mary Ann Drosnock There is much confusion on the topic of proper processing of probes and dilators. Yet there are very few resources available to guide facilities on what the processing steps are 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.

Q What are the challenges of reprocessing these devices and components?

Rose Seavey In addition to concerns of staff competencies and compliance, these items are used and processed in many different areas of hospitals, ambulatory centers, clinics, or doctors’ offices. According to the current Spaulding classification system, some of these items can be considered semi-critical devices or non-critical devices depending on their usage. They may need high-level disinfection, medium-level disinfection, low-level disinfection, or just cleaning. Many dilators have very long and very narrow lumens, which are a huge cleaning challenge. And of course, if it is not clean, it can’t be properly disinfected. Most guidelines tell us to use cleaning verification tools, but I do not see these tools being used on these devices—mainly, I believe, because they are not processed in a central processing location. The other big challenge is storage of processed devices, which are often stored in closed plastic cases, in drawers unprotected, or on top of other equipment.

Q How will the TIR address these challenges?

Rose Seavey This TIR would provide detailed guidelines on the proper processing of dilators and ultrasound probes for all healthcare facilities. These guidelines are intended to provide comprehensive information and direction for healthcare personnel in processing these devices and accessories. The TIR will cover design of processing areas, personnel, attire and personal protective equipment, cleaning, disinfection, storage, transport, traceability, and quality control issues.

Mary Ann Drosnock We plan on having an extensive list of definitions and abbreviations on this topic, to outline the role of medical device manufacturers in setting processing requirements, proper labelling of reusable devices, and medical device compatibility with processing products. We will assign Spaulding classification 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. The working group will 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.

I expect that we will have great detail in the new TIR about 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. In my opinion, this new TIR will be a welcome addition to the projects of WG 84 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 they need!


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