When it comes to processing multi-use medical devices, sterilization often gets the splashy headlines, but cleaning is just as – if not more – important, and with ANSI/AAMI ST98:2022, cleaning is the star.
The new standard, which formalizes requirements for cleaning validation methods, not only advances understanding of and conformance with cleaning best practices but has the potential to have an impact on the design and development of medical devices for years to come.
Many of the core ideas behind ANSI/AAMI ST98:2022, Cleaning validation of health care products—Requirements for development and validation of a cleaning process for medical devices have been part of important discussions since 2014, when thought leaders were working to revise ISO 17664 and TIR12. These documents cover information to be provided by manufacturers for the processing of re-sterilizable medical devices and compliment the new cleaning standard.
Nupur Jain, director of sterility assurance and reprocessing at Intuitive Surgical and co-chair of the AAMI Cleaning of Reusable Medical Devices Working Group (AAMI ST-WG93) noted how the standard builds upon previous guidance from AAMI, FDA and other organizations, as well as its close ties to a technical information report (TIR) used by manufacturers, AAMI TIR30.
“AAMI TIR30 and ANSI/AAMI ST98 have two main differences. The first difference is related to the scope of the documents: AAMI TIR30 covers reusable medical devices, while ANSI/AAMI ST98 has a broader range and applies to devices that require processing before clinical use per the Spaulding scale, including single-use devices that require processing by the health care facility prior to use,” Jain explained. “The other key difference is that instead of only providing an overview of cleaning test methods, ANIS/AAMI ST98 specifies requirements for cleaning validations.”
“ANSI/AAMI ST98 is built on a lot of other activities, and [a lot of the same] people have been involved in that, so it is evolutionary,” said Ralph J. Basile, vice president of marketing and regulatory affairs for Healthmark Industries. “But then it is also revolutionary in the sense that it is really the first document, globally … that gives requirements for device manufacturers as far as what they need to do to validate their cleaning [and ensure] their cleaning instructions actually produce a clean device.”
“Where it’s unique is in specifics for the design of medical devices, and that’s an area that has been very lacking in consistency and scientific content for a long time,” added Dr. Gerald McDonnell, senior director of microbiological quality and sterility assurance for Johnson & Johnson. “This gives us the opportunity to have the same opinion [on cleaning] across multiple companies across multiple parts of the world.”
ANSI/AAMI ST98 has two sections: normative and informative. The normative section (the main text of the standard) lists the requirements for cleaning validations. The informative content found in the annexes provides guidance on applying the normative requirements. While the normative content provides important and detailed information on the cleaning validation and what test methods are most suitable for various types of medical devices, the informative content helps guide manufacturers on providing end users with validated processes.
Currently, processing and sterilization professionals are burdened by budgetary constraints – hospitals are more likely to devote extra dollars to new surgical suites, which generate revenue, rather than cleaning and sterilization departments, which don’t. Another consideration is time – professionals have to process similar devices from numerous manufacturers, each of whom can provide a very different set of Instructions For Use (IFUs). And as devices have become more complicated, having numerous IFUs has become an even bigger burden, Basile said.
“The validation testing that we’re doing needs to really reflect what’s happening at the health care facility so that the instructions device manufacturers give actually result in a clean device,” Basile added.
Cleaning vs. Sterilization
In fact, McDonnell explained that many of the contamination problems the medical device industry has experienced in recent years has been due to issues with cleaning rather than with sterilization or disinfection – words that are often used interchangeably but that, at least in the field of medical devices, have very different meanings. While sterilization can kill many varieties of live microbes, dead or non-living things, such as prions, can be just as dangerous, and they aren’t always vulnerable to standard sterilization methods.
Once ANSI/AAMI ST98 gains a critical mass of industry adoption, Basile and McDonnell expect to see device manufacturers take things even further. It is anticipated that manufacturers will consider cleaning from the start, building cleanability into their designs for new or updated devices. They also suggest that training – and, potentially, certification – of processing professionals will become more stringent.
“I think there’s going to be a trend definitely toward designing devices that are easier to clean, and I think you’ll also see some innovations in who cleans them,” McDonnell said. “I think you’ll see that it is a talent and a professional thing to make sure devices get reprocessed correctly. It’s not cleaning dishes. People need to be trained. They need to be competent. And in the past, it wasn’t always that way. We still argue in the United States [about whether] you need to be certified to work in those departments.”
There’s also optimism that ANSI/AAMI ST98 will help inspire a similar international standard, helping companies in a global market further streamline their cleaning, validation, and instruction processes, and encouraging them to continue to push for stronger cleaning practices in health care facilities around the world.
“I’m looking forward to having a little bit more clarity on what’s required and what is considered acceptable in the design of devices, and that will also help in the regulatory approval of devices,” McDonnell said. “I think that will overall have an impact of streamlining the development process and having more consistent products in the marketplace that would be safer for patient use.”
