A new guidance document on the sterile processing of dilators and ultrasound probes in health care facilities has been published by the Association for the Advancement of Medical Instrumentation.
AAMI TIR99:2024; Processing Of Dilators, Transesophageal And Ultrasound Probes In Health Care Facilities provides comprehensive information for health care providers and sterile processing professionals on the selection, labeling, and processing of dilators and ultrasound probes. The document furthers AAMI’s core mission of pursuing optimal health outcomes for patients by providing a much-needed resource on infection control and preventing hazards inside health care facilities such as hospitals that process their own medical devices.
This technical information report (TIR) was produced by AAMI’s Endoscope Reprocessing Working Group, which is comprised of subject matter experts from healthcare delivery organizations, regulatory bodies, academia and industry.
Garland-Rhea Grisby, endoscope service manager at Kaiser Permanente and co-chair of the working group, anticipates that the use of AAMI TIR99’s guidance will promote patient safety and assist the health care workers who work with these medical devices.
“This TIR addresses questions about the appropriate and acceptable way to store, transport, clean, disinfect and sterilize ultrasound probes in a health care setting,” he explained to AAMI News. “Adoption of this TIR will give users and processing areas a more standardized process, regardless of the setting where ultrasound probes are used or processed.”
AAMI TIR99 addresses:
- Proper procedures for cleaning, decontamination, disinfection, and sterilization of dilators and ultrasound probes.
- Information to be provided to endoscope and probe users by original equipment manufacturers (OEMs).
- Transporting and handling of contaminated devices, and transportation after processing.
- Assigning Spaulding classification to clinical use of ultrasound probes and dilators.
- The use of accessories like ultrasound gel and acoustic coupling agents.
- Criteria for selection and use of sterile packaging systems.
- Personnel considerations like training and qualifications, and design criteria for processing areas.
The new guidance is expected to greatly benefit individual sterile processing professionals and health care facilities alike. Those interested in a full copy of the guidance document can find AAMI TIR99:2024 in the AAMI store.
AAMI Adopts ISO Radiation Sterilization Guidance
Association for the Advancement of Medical Instrumentation also announced the official adoption of a key international guidance document related to radiation sterilization.
The guidance document, entitled ANSI/AAMI/ISO 13004:2022; Sterilization Of Health Care Products—Radiation—Substantiation Of Selected Sterilization Dose: Method VDmaxSD, is a newly adopted American version of a pre-existing standard produced by the International Standards Organization (ISO).
ANSI/AAMI/ISO 13004:2022 applies to sterility assurance, a key part of the sterilization of medical devices. The document’s guidance directly applies to industrial sterilizers and is important to the work of healthcare delivery organizations.
The standard establishes a method for ensuring that a sterilization dose selection results in a sterility assurance level of 10-6 or less for radiation sterilization used on medical devices. It also specifies a method of sterilization dose audit that can show the effectiveness of the verified sterilization doses.
The newly adopted guidance is meant to be used with ISO 11137-1 Sterilization of health care products, and makes several major changes to existing guidance. The standard:
- Cancels and replaces ISO/TS 13004:2013.
- Determines sample item portions for materials like powders, liquids, and gels.
- Has been reworded to match language in ISO 11137-2.
- Adds additional guidance on when to re-substantiate sterilization dose based on bioburden shift.
AAMI’s Radiation Sterilization Working Group helped make this ISO adoption a reality. The working group has produced many of AAMI’s radiation sterilization guidance documents and is co-chaired by Elaine Daniell of EDan-SA LLC Consulting and Niki Fidopiastis, director of microbiology at Medtronic’s Global Laboratory Services.
This adoption is a substantive next step in support of AAMI’s mission of promoting the safe and effective use of healthcare technology and promoting optimal patient outcomes. International harmonization efforts and the use of guidance documents from groups such as ISO is a key part of this project.
Questions about getting access to the standard or its contents? Reach out to the AAMI Standards team at standards@aami.org.
