By Susan Klacik, BS, CRCST, CIS, CHL, ACE, FCS
Two recent guidance documents have been updated, and both feature recommendations that affect Sterile Processing (SP) functions and the technicians who perform the work.
The Association for the Advancement of Medical Instrumentation (AAMI) updated TIR79 ST79 Self-assessment for health care facilities. The technical information report provides a checklist for the recommendations in ANSI/AAMI ST79:2017 & A1:2020, A2:2020 A3:2020 & A4:2020 Comprehensive guide to steam sterilization and sterility assurance in health care facilities and can be used to assess sterilization processes.
The revised document includes the following amendments:
- A1 Environmental Services/Fans/Food and Drink
- A2 Inspection of insulated instruments
- A3 Modification of content pertaining to frequency of cleaning for routine care of sterilizers for sterile processing areas in health care facilities
- A4 Content addressing recording BI lot numbers in sterilizer records for sterile processing in health care facilities
TIR79 is a valuable resource that can be used for annual compliance assessment and to prepare for a regulatory survey. It is available for purchase at AAMI.org.
AORN revises sterile technique guideline
In addition to TIR79, SP professionals should be aware of the latest updates to the Association of periOperative Registered Nurses’ (AORN’s) Guideline for Sterile Technique. Sterile technique involves specific actions aimed at reducing the level of environmental contamination in a room. It also helps maintain sterility by preventing contamination of the sterile field and sterile items during operative and other invasive procedures. While the guideline is primarily directed to the surgical suite, Sterile processing (SP) technicians’ primary role is to provide medical devices in a manner that supports sterile technique. The revised guideline contains recommendations related to SP areas and functions.
Some changes introduced in the new guideline pertain to the terms “donning” and “doffing” when referring to attire. “Don” and “donning” are now referenced throughout the document as “put on.” Similarly, “doff ” and “doffing” have been replaced with “to remove” or “removed.” The term changes may soon be applied to other guidelines and standards.
Additionally, there is new language to clarify an existing practice provided to perioperative teams about how to respond to retained bioburden, debris or moisture discovered in a sterilized
instrument set or package. The guideline language directs perioperative teams to consider the item(s) contaminated under certain conditions, such as when a device is processed assembled, organic material (e.g., blood, tissue or bone fragments) or other retained debris (e.g., bone cement, grease or mineral deposits that are not from the in-progress procedure) are present, or when an item has retained moisture, unless it has undergone immediate use steam sterilization.
The guideline further recommends that when contaminated instruments are found in an instrument set, the entire set should be considered contaminated and reprocessed. The liquid barrier performance and classifications, as defined in ANSI/AAMI PB70:2022 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities, have been incorporated into this guideline. The complete guideline is available for purchase at AORN.org.
– Susan Klacik, BS, CRCST, CIS, CHL, ACE, FCS, serves as a clinical educator for the Healthcare Sterile Processing Association (HSPA) and has served as an HSPA representative to the Association for the Advancement of Medical Instrumentation since 1997.
