Sterile Processing Compliance and Standards Update

“ST58:2024 is a complete revision and reorganization of the previous edition of the standard, which was published in 2013,” Benedict explained. “It presents processes for different chemical sterilization and HLD modalities — essentially anything other than steam sterilization. This includes ethylene oxide (EtO) sterilization, which was previously a standalone document (AAMI/ANSI ST41).”

“While fewer facilities are now using EtO sterilization, ANSI/AAMI ST58:2024 will serve as an all-in-one resource for HLD and sterilization modalities outside of steam sterilization,” said Berg. “Based on the criticality and clinical use of the device (Spaulding classification), those responsible for HLD or sterilization can use the document to find the appropriate modality.”

AAMI TIR99:2024

Also published last year, AAMI TIR99:2024, Processing of dilators, transesophageal and ultrasound probes in health care facilities “provides guidance for the proper processing of dilators and ultrasound probes in health care facilities to assist in making them safe and effective for use in patient care.” 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 health care facilities.”²

“AAMI TIR99 came up for discussion when we were working on the revision of ST91 for endoscope reprocessing,” said Benedict. “There was some thought about whether to include these types of devices in ST91, but we concluded they needed their own guidance because of concerns around inappropriate reprocessing.”

“ST91 is typically used by GI and SP departments, and we knew the types of devices covered under TIR99 typically aren’t the ones that go to GIs or the SPD for reprocessing,” Berg added. “These devices are used by OB/GYN, interventional radiology, emergency departments, and Cath Labs and reprocessed by these departments. The individuals performing this reprocessing typically need additional guidance because they are not certified or receive the level of training provided to SP or GI technicians.”

“Technical reports such as AAMI TIR99 tend to serve as a stake in the ground as the industry moves to more alignment and agreement on what should be required as a minimum effectiveness threshold for the practice,” said Benedict. 

AAMI TIR119

In the February 2025 issue of HPN, we covered ANSI/AAMI ST108:2023, Standard for water quality systems in medical device processing. Given the excitement around this standard and questions among healthcare facilities on how to implement it, AAMI is in the process of developing a new companion document AAMI TIR119, Guidance on healthcare implementation and use of AAMI ST108. 

“The reason why we develop companion or implementation documents is to help clarify what the standards look like in practice,” said Benedict.

“The end users for AAMI TIR119 cover a broad spectrum of facilities, from hospitals to small clinics,” noted Berg. “Unlike hospitals, many of these smaller sites don’t have facilities management to support them in ST108 implementation so this will serve as a valuable resource.”

ANSI/AAMI ST79

One of the biggest pieces of news is that ANSI/AAMI ST79, Comprehensive guide to steam sterilization and sterility assurance in health care facilities, is now under revision. Benedict commented on the status, stating:

“We have made the decision to open it up for revision, although the work won’t start in earnest until September 2025. There are strategies being discussed at the leadership level and we are putting the infrastructure in place to effectively manage the revision, because it'll be a major undertaking to reopen this particular document.”

“It is not just steam sterilization, it's all aspects of sterility assurance,” she explained. “It addresses packaging, facility design, general competency, training and education requirements for personnel, and so on. We’ve been getting a lot of questions because the current edition is eight years old. The amendments in 2020 were just small changes but with this revision basically everything is up for potential change and updates to bring it up to current practice.”

ISO healthcare harmonization

Benedict, who is the committee manager for ISO technical committee (TC) 198 Sterilization of health care products (ISO/TC 198), explained how ISO standards are increasingly including elements applicable to healthcare organizations both globally and in the U.S.

While the U.S. has a robust national standards development program through AAMI, which includes several American National Standards aimed at healthcare facilities, not all countries have this type of program, according to Benedict. Therefore, healthcare organizations outside of the U.S. often turn to ISO for guidance on SP practices. 

She pointed out how some ISO guidance documents share commonalities with AAMI standards.

One example is the ISO 11607 series, which offers guidance on packaging for terminally sterilized medical devices applicable to industry and healthcare facilities. Benedict noted that the intent of some of the content is similar to the sterile packaging guidance offered in ANSI/AAMI ST79:2017. She also cited ISO 15883 Parts 1 and 2, which offer guidance on washer/disinfectors employing thermal disinfection for critical and semi-critical medical devices.

Benedict shared information on recently published ISO/TC 198 guidance documents and those under development with relevancy to the SP profession. 

Recently published:

• ISO 22441, Sterilization of health care products — Low temperature vaporized hydrogen peroxide — Requirements for the development, validation and routine control of a sterilization process for medical devices. This document “provides requirements for the development, validation, and routine monitoring and control of a low temperature sterilization process for medical devices using vaporized hydrogen peroxide (VH2O2) as the sterilizing agent.”³
• ISO 17665, Sterilization of health care products — Moist heat — Requirements for the development, validation and routine control of a sterilization process for medical devices. The new document, which combines information from the three documents that previously formed the ISO 17665 series, includes an annex that is focused on healthcare facility applications.

Under development:

• ISO 25224, Sterilization of health care products — Sampling and culturing for reusable thermolabile flexible endoscopes. 
• ISO/AWI TS 20327, Packaging for terminally sterilized devices — Receiving, handling, transporting, distributing and storing of packaged sterile medical devices under the control of health care facilities.

Commenting on ISO 25224, Benedict stated: “This is one that I'm really excited about. Different countries around the world have different ways of doing sampling and culturing. The intent of this document is to help provide more information and guidance on effective ways to do sampling and culturing for these types of flexible endoscopes.”

The hot topic of transportation

There has been a great deal of work across the board on new standards related to the transportation of sterile items. Berg noted how in addition to ISO/AWI TS 20327, which is under development, both AAMI and the Association of periOperative Registered Nurses (AORN) recently published their own guidance on the topic. 

One of the newest guidance documents, AAMI TIR109:2025, External transport of reusable medical devices for processing, was published in March 2025. Berg commented on the importance of this guidance, stating:

“The need arose from the fact that U.S. healthcare organizations are frequently transporting sterile items from one facility to another, and while ST79 has some information on this topic, it is very limited. This document provides guidance on transport from hospital to hospital and from hospitals to clinics and other non-acute facilities, whether it is a small ‘doc in a box,’ wound care clinic, or other care delivery location.”

According to Berg, AAMI TIR109:2025 considered global guidance and standards, which will also inform the development of ISO/AWI TS 20327. “Instead of reinventing the wheel, we are looking at other countries that have been doing this for years,” he stated. Berg added how HSPA plans to align its guidance with both the AAMI and ISO guidance documents.

UV disinfection of medical devices

Under development is brand new guidance on UV disinfection of medical devices in the SPD, AAMI TIR118, which was proposed by Berg who is leading one of the task force groups on the topic.

“UV disinfection in healthcare facilities has been around for a long time but it's not typically used in the SPD or for medical devices,” noted Berg. “It has been used primarily in cancer clinics or immunocompromised areas for disinfection of items such as clinicians’ cell phones, tablets, or stethoscopes that could harbor dangerous microbes.”

“It wasn’t until the COVID-19 pandemic that UV disinfection boxes were introduced to the SPD for personal protective equipment (PPE) disinfection in response to shortages of these items at the time,” Berg continued. “Since then, SPDs around the world have been using UV disinfection for medical devices, but the U.S. has been a bit behind on this type of usage.”

 “The goal of the document under development is to educate SP professionals on UV disinfection, including material compatibility and safety factors,” he explained. “Essentially what we are saying is, ‘if you're going to use UV disinfection, these are all the factors you need to take into consideration.’ It's really a first step in educating the U.S. market on expanding UV disinfection beyond environmental services (EVS) and into the SPD.”

The overarching importance of quality management

While standards documents like ANSI/AAMI ST79 tend to steal the spotlight in SPD, Hannah Schroeder, BSHA, CRCST, CHL, CIS, CER, Clinical Education Specialist, Pure Processing, explained to HPN how she is doing a “deep dive” into ANSI/AAMI ST90:2017; Processing of health care products - Quality management systems for processing in health care facilities. She stated:

“We hear a lot about ST79 and ST91 and see them referenced pretty much daily. We know we need to achieve those standards but how do we get there? That’s the kind of question ST90 answers for us. While it doesn't necessarily tell us every aspect of quality assurance that's needed, it's absolutely a guide and a skeleton framework of exactly what you need to build a strong quality assurance program in your healthcare facility. Now that we have standards around water quality in ST108, ST90 can serve as a compass.”

ST90 specifies minimum requirements for quality management systems (QMS) to effectively, efficiently, and consistently process (transport, clean, decontaminate, disinfect, inspect, package, sterilize, and store) medical devices to prevent adverse patient events and nonmanufacturer-related device failures.⁴

According to Schroeder, ST90 is helpful to SPD professionals in understanding the quality assurance process as “taking in an input and converting it into an output.” She provided this example:

“Think about the cleaning cycle where our input is soiled instrumentation, and the output, or final conversion, really should be ready and safe-to-use medical devices. The quality assurance standard offers the micro steps it takes to get there, including measuring success through metrics and customer feedback. What are our end users experiencing when they receive those clean, high-level disinfected or sterilized medical devices?”

Another helpful aspect of ST90 is guidance on the necessary stakeholders for standards implementation, as Schroeder explained:

“It doesn’t tell you, ‘You need to do A, B, and C;’ rather, it gives you the environment around it. Who is responsible for what? You have your end users, managers, leadership, and reprocessing technicians who are the frontline stakeholders of your quality assurance program. They're the ones who are going to make standards work overall in their processes.”

“With ST108, you also have your water quality team,” she continued. “We are starting to see more involvement from third party water quality management consultants who interpret the standard for everyday professionals.”

For those wanting to leverage ST90, Schroeder recommends starting with a risk assessment to prioritize quality improvements. “You might have some changes that fall into the red zone and must be addressed immediately, such as risks to patients or staff members. At the same time, you will likely surface some simple changes that can yield positive improvements without a heavy lift or heavy costs.”