Needs to Know about AAMI , published in December 2023 . The document is intended to assist IPs in selecting , interpreting and utilizing advisory documents regarding medical devices / equipment . It provides an overview of the purpose of AAMI guidance documents ; outlines the consensus document development process ; reviews the differences between Standards vs . Technical Information Reports ( TIRs ); and emphasizes the importance of reviewing the scope & definitions ; as well as reviews the AAMI documents ( current and in development ) about which the IP should know .
“ IPs should reference the AAMI Standards Monitor Online for updates specific to AAMI guidance documents ,” Ormsby said . “ If you ’ re confused about something that ’ s written in any document , go back to the scope of the document to see if it applies to your unique setting or situation , as well as the definition .”
The speakers pointed to the release in January 2024 of the APIC Toolkit : Patient Hand Hygiene , which focuses on patient hand hygiene in acute-care hospitals , longterm care facilities , as well as facilities for pediatric , outpatient and behavioral health services . The document provides IPs with an audit tool and a quality improvement action plan for patient hand hygiene .
“ This document serves to help IPs implement patient hand hygiene in our settings ,” Ormsby said . “ We know hand hygiene is so important for both our healthcare workers and for our patients .”
Also published in January 2024 was the guidance document , Heightening Awareness for the Infection Preventionist in the Behavioral Health Setting , published in January 2024 to address the unique challenges and enhance the awareness of IPs when addressing questions and concerns with both patients and staff in this setting .
“ This document reviews everything from the environment of care , surveillance , medication safety , vaccination , PPE , as well as transmission-based precautions . Some key points , for example , relate to PPE , making sure it ’ s secured and stored in a location in which a patient in a behavioral health setting couldn ’ t use the ties of a gown or the metal nosepiece in a mask to hurt themselves . As well as ingesting alcohol-based hand sanitizer and other unique tips and tricks for the behavioral health setting .”
The co-presenters also reviewed the practice tools that are currently in development , including creating guidance specific to the long-term care setting , as well as a revision to APIC ’ s position paper , Safe Injection , Infusion , and Medication Vial Practices in Health Care ( 2016 ).
Right now , the group has been trying to prioritize what will be the focus and it has been decided that we ’ re going to try to pare down these implementation guides and not repeat things that are in other documents .” — Jennifer A . Ormsby , DNP , RN , CPN , CIC , CPNP-PC
Ormsby announced the creation of the new Implementation Guides Subcommittee within APIC , which has completed a review of SHEA compendiums compared to APIC Implementation guides to identify which guidance may be outdated . “ Right now , the group has been trying to prioritize what will be the focus and it has been decided that we ’ re going to try to pare down these implementation guides and not repeat things that are in other documents . For example , if SHEA or CDC has a great reference list , we ’ re going to refer to that as opposed to having it in a 50-page implementation guide . We ’ re going to try to make them more concise , the goal being concise , updated documents that primarily contain implementation information only .”
The co-presenters provided an update on standards from the Association for the Advancement of Medical Instrumentation ( AAMI ) as well as reviewed the key AAMI documents that IPs should be aware of . ANSI / AAMI ST 58 : Chemical sterilization and high-level disinfection in healthcare facilities , published in 2013 and addressing liquid chemical sterilants ( LCS ) and high-level disinfectants ( HLD ), will soon receive an update . Another key standard is ANSI / AAMI ST79 : Comprehensive guide to stream sterilization and sterility assurance in healthcare facilities , published in 2017 . “ This one has some outdated terms based on what AAMI has been changing to , and we hope that this one will be coming in the draft form soon ,” said Phillips .
TIR 99 : Dilators , transesophageal and ultrasound probes processing in health care facilities , was published this year , and It includes information on selection and use of cleaning , disinfection and sterilization systems that have been cleared for marketing by the FDA for use in hospitals and other healthcare facilities . Topics addressed include information to be provided by the original
equipment manufacturer ( OEM ); assigning the Spaulding classification to clinical use of probes and dilators ; the use of probe covers , ultrasound gel and accessories ; design criteria for processing area ; processing personnel specifications ; receiving / transporting / handling of contaminated devices ; transportation post-processing ; cleaning and disinfection ; preparation , packaging and storage ; quality control and continuous quality improvement ; as well as automated probe processors ( APP ). Phillips explained that ultrasound-guided percutaneous procedures are not considered semi-critical , therefore HLD is not required ; however , if contamination of probe with blood or other bodily fluids occurs during the procedure , LLD is required . “ I ’ ve seen in some IFUs that if contamination of the probe with blood or body fluid occurs , that doesn ’ t require any kind of high-level disinfection . You ’ re going to clean it , then disinfect it with a low-level disinfectant ,” Phillips said .
ANSI / AAMI ST 108 : Water for the processing of medical devices , was published in 2023 and covers the selection and maintenance of effective water quality suitable for processing medical devices . It provides guidance on water treatment equipment , water distribution and storage , quality control procedures , considerations for ongoing maintenance , monitoring and quality improvement of the water treatment system , as well as maintenance , monitoring and record-keeping via a multidisciplinary team .
In development , Phillips said , is TIR 119 : Guidance of Healthcare Implementation and Use , a companion to ST 108 .
“ ST 108 is a very long , robust document ,” Ormsby said . “ There ’ s a lot of information and it ’ s been hard for all settings to implement this guidance ; when this was being developed , people knew it was going to be challenging to implement , which is why a companion guide is coming out soon . I would have eyes on this guidance if you ’ re having staining , rusting , pitting or discoloration of your instruments or the pads under your instruments , as it will give you tips and tricks on what to do .”
Also in development , according to Phillips , is TIR 109 : External transport of medical devices processed by health care facilities . “ If you have instruments that are in an outpatient clinic and they need to be transported to and from your main sterile processing department in the hospital , this will give you the guidance on what you need to do and what you should not be doing ,” noted Phillips . “ A key thing to note about this is there ’ s a lot of up and down about if you need to be environmentally monitoring these instruments during transport ; the answer is no , but just keep that in mind .”
16 • www . healthcarehygienemagazine . com • july 2024