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AAMI: What’s on the Horizon for HDO Sterilization Guidance?
INDUSTRY INSIGHTS
AAMI
What’s on the Horizon for HDO Sterilization Guidance?
In this special AAMI Update, the co-chairs of WG 40, the Steam Sterilization Hospital Practices Working Group, describe what the working group has in store for sterile processing professionals and clinicians alike. Co-chair Sara Friedberg is a senior microbiology manager at Stryker, while co-chair Susan G. Klacik, is clinical educator for HSPA.
Continuous Growth of ST79
A widely recognized standard, ANSI/AAMI ST79, Comprehensive guide to steam sterilization and sterility assurance in health care facilities is used by healthcare delivery organizations (HDOs) for the processing of reusable medical devices. Its content includes processing area design and personnel considerations; handling of contaminated items; cleaning, disinfection, and decontamination steps for soiled items; and packaging and sterilization. It also covers installation and maintenance of sterilizers, process monitoring, quality process improvement and new product evaluation.
ST79 was last updated and revised in 2017. At AAMI Sterilization Standards Week in 2018, the committee met to discuss the revised standard and determine whether any additional changes were needed at that time. This led to four new amendments that were added in 2020 in the areas of (1) environmental services, fans, food, and drink; (2) inspection of insulated instruments; (3) modification of content pertaining to frequency of cleaning for routine care of sterilizers; (4) and content about recording biological indicator lot numbers in sterilizer records for sterile processing in HDOs.
ST79 is up for full review within the next year. At that point, the standard likely will be fully opened for comments and updates, including the topics that were previously tabled for the next update.
The most notable changes to be reviewed pertain to terminology, water quality, point-of-use-treatment, inspection, and drying. Common issues that have been brought up as a result of research and user feedback may be addressed; these include special techniques for processing ophthalmic instruments, additional packaging considerations, and cleaning equipment.
AAMI TIR79: Guidance on Complying with ST79
In addition to ST79, WG 40 also oversees the AAMI technical information report TIR79, ST79 Selfassessment for health care facilities. This TIR provides a checklist of specific recommendations contained in ST79 that HDOs can use to assess and monitor their compliance with the standard, in order to aid in preparing for an accrediting audit. An update will be made to TIR79 in the near future in order to align it with the four amendments made to ST79 in 2020.
WG 40 also recently initiated a project to develop AAMI TIR109, External transport of medical devices processed by health care facilities. This is a much-needed document for the industry. Historically, medical devices to be processed at HDOs were transported from the point of use to the sterile processing department (SPD). This typically involved moving the devices on a cart or in a container through the halls of the HDO, potentially on an elevator, and into the SPD. As HDOs have expanded and begun centralizing operations, this activity can now include transporting devices across a campus to another building, across town to a separate building, or even over a highway several towns away.
This increased transport distance brings up new concerns and issues that are not already addressed in the transport section of ST79. The goal of this new TIR is to introduce best practice guidance for transport-
INDUSTRY INSIGHTS
AAMI
ing clean, disinfected, sterilized, and soiled devices across longer distances, including addressing requirements for the transport vehicles used to transport the devices. For regular updates about this developing technical information report, check aami.org.
Processing Dental Instruments
The guidance in ST79 is focused extensively on medical device processing in HDO settings. Of important note, roughly 80% of dentists practice in small outpatient clinics, and as a result, ST79 has not been widely embraced by the dental profession. AAMI has established a new Working Group, ST-WG 44 (Steam Sterilization Dental Practices) to develop a guidance document for the processing of dental instruments based on the best practices in ST79.
The development of this document will involve a collaboration between AAMI and the American Dental Association (ADA) Standards Committee on Dental Products. WG 44 met for the first time in September 2021 to begin work on this new standard. Members of WG 40 have joined WG 44 in order to provide input on developing the new standard and to ensure that the requirements do not deviate from those detailed in ST79.
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