From focus groups, it was identified that IPs in long-term care, didn’ t really know what a surveillance plan was, how to get the data, what definitions to use, how to analyze data, or what to focus on.”
— Jennifer A. Ormsby, DNP, RN, CPN, CIC, CPNP-PC infection prevention and control strategies using data-driven approaches.
As Ormsby noted,“ From focus groups, it was identified that IPs in long-term care, didn’ t really know what a surveillance plan was, how to get the data, what definitions to use, how to analyze data, or what to focus on. They said they felt like they were just putting out fires all the time and many of these IPs reported wearing multiple hats beyond the IP hat, such as an educator hat, a nursing hat or a leadership hat. And so, they needed some guidance around how to build a surveillance plan. This document provides all of that background information as well as a checklist, and it has this checklist outlining the steps to build a long-term care surveillance plan. Helping IPs get the data they need was something that was built into this toolkit, also knowing that IPs in long-term care need to understand how to analyze your data, what is a numerator, what is a denominator, and using standardized tools to conduct an assessment, look at your data, analyze your data, determine your risks, and then move forward,” she said.
Ormsby pointed to another new resource, an updated CAUTI Implementation Guide from APIC designed to align with the updated Compendium from the Society of Healthcare Epidemiology of America( SHEA).“ It has good background information as well as essential and advanced elements of CAUTI prevention, plus additional tools such as two new algorithms sets for acute urinary retention and alternatives to indwelling urinary catheters.”
Ormsby said probably one of the more anticipated new resources from APIC is the Modernizing Medical Device Instructions for Use( IFU) toolkit, which is intended to be used as a resource“ to assist with navigating the complex and sometimes cumbersome world related to implementing manufacturer IFUs in healthcare facilities.” It will contain definitions, an algorithm for IFU discrepancies, a risk assessment template, a risk-benefit matrix, case studies and other resource tools from agencies such as the EPA, and FDA.
In the same presentation to APIC attendees, Bethany Phillips reviewed what’ s new from the Association for the Advancement of Medical Instrumentation( AAMI), including AAMI TIR109:2025; External transport of reusable medical devices for processing. This document provides extensive information on quality-systems issues such as safety, inspection, and documentation; department assets and characteristics like climate control, loading area design, and overall facility design; equipment such as protective packaging, reusable and single-use transport carriers, and motor vehicles; logistics such as preparing for transport, moving to or from loading areas, receipt of processed items, and clinical considerations.; as well as other considerations: decontamination, containment breaches, staff training, and handling contaminated and processed items.
“ You will use this if you have instruments that go from a clinic to the sterile processing department( SPD), where you’ re transporting between offsite locations and internal departments, and what you need to do to make that successful and safe,” Phillips explained.
Another key document from AAMI is ANSI / AAMI ST58:2024; Chemical sterilization and high-level disinfection in healthcare facilities, which addresses how to select liquid chemical sterilization, high-level disinfection, and gaseous chemical sterilization systems; processing recommendations for facilities that clean and sterilize medical devices; transport and storage of sterilized and disinfected devices; quality control and quality process improvement; work area design for processing areas; safety considerations, including PPE, spill containment, and storage; as well as personnel considerations, including education, training, and certification.“ This TIR is for any time you are not using steam sterilization in your facility’ s SPD, so liquid, chemical sterilization,” Phillips clarified.
She pointed to a number of new AAMI documents in progress, including:
• Outpatient dental: ST113, Comprehensive guide to steam sterilization and sterility assurance in dental facilities will provide guidance for outpatient dental practices“ tabletop” sterilizers, hand hygiene, PPE, transport and other topics.
• Manufacturers’ instructions for use: TIR 12, Designing, testing and labeling medical devices intended for processing by healthcare facilities: A guide for device manufacturers will provide technical guidance, including APIC advocacy for limiting the number of steps in an IFU, ensuring feasibility of reprocessing, notifying IPC of IFU changes, limiting brand / trade names, and limiting reassembly at the point of use. There will also be a new data table to help manufacturers in their design to reduce complications with disinfection.
• UV disinfection: TIR 118, Guidance on ultraviolet( UV) disinfection for medical devices in healthcare facilities will focus on high-level disinfection( HLD) as well as provide guidance on how to use UV machines for HLD and low-level disinfection( LLD)/ intermediate-level disinfection( ILD).
• Tattoo machine devices: TIR117, Guidance for processing tattoo machines and accessories in the healthcare setting will focus on how to process reusable devices for tattoo machines.
“ I can almost guarantee no one here is working at a tattoo parlor,” Phillips joked with the audience.“ However, you might be surprised that there are medical tattoo machines in your facility, and this document will give us guidance on how to actually process those complex devices.”
Additional work in progress from AAMI, according to Phillips, is TIR 119 Guidance on Implementation and use of ST108 related to water quality; TIR121, Low level disinfection of patient-care equipment; and a new workgroup( WG17) focusing on cleaning and disinfection( LLD / ILD), including TIR127 – Validation for Disinfection / ISO25224 Flexible endoscope sampling and culturing.
“ We all probably know about ST 108 that came out last year or the year before, which is very technical and can be hard to implement,” Phillips said.“ There has been work going on for the last year or so to create a companion document to ST 108 that will provide guidance on how to implement the water standards. It is still early in the document-drafting process, so if you’ re holding out for this to implement your water program, you may be waiting longer than you want but just know that help is coming. Regarding the two brand-new AAMI documents for low-level disinfection and the flexible endoscope sampling and culturing guidance, this is kind of different for AAMI to be involved
18 • www. healthcarehygienemagazine. com • jul-aug 2025