The Association for the Advancement of Medical Instrumentation (AAMI) has published an updated international standard designed to help manufacturers of certain medical devices ensure their products are in fact sterile.
Â
The standard, 14160, deals with liquid chemical sterilizing agents used on devices that utilize animal tissues and their derivatives. The standard contains a new feature to help manufacturers identify microorganisms that are hard to kill, says Charles Roberts, convener of the ISO/TC 198/WG 10, Liquid Chemical Sterilization Working Group, which updated the document. It now includes an annex with a table listing rare and obscure microorganisms that manufacturers could encounter.
Manufacturers have to figure out a way to sterilize devices so that no viable microorganisms survive, says Roberts, director of research and development for Advanced Sterilization Products, a subsidiary of Johnson & Johnson.
Most devices are sterilized using steam, but not all materials can withstand exposure to it. Certain heart valves that contain animal tissue are particularly susceptible to damage from heat. Thats where liquid chemical sterilization comes in.
The formal name of the standard is ANSI/AAMI/ISO 14160:2011, Sterilization of health care productsLiquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivativesRequirements for characterization, development, validation, and routine control of a sterilization process for medical devices.
The list price for the standard is $100 and the AAMI member price is $50. The document is available from the AAMI website.
Stay prepared and protected with Infection Control Today's newsletter, delivering essential updates, best practices, and expert insights for infection preventionists.
Reducing Hidden Risks: Why Sharps Injuries Still Go Unreported
July 18th 2025Despite being a well-known occupational hazard, sharps injuries continue to occur in health care facilities and are often underreported, underestimated, and inadequately addressed. A recent interview with sharps safety advocate Amanda Heitman, BSN, RN, CNOR, a perioperative educational consultant, reveals why change is overdue and what new tools and guidance can help.
What Lies Beneath: Why Borescopes Are Essential for Verifying Surgical Instrument Cleanliness
July 16th 2025Despite their smooth, polished exteriors, surgical instruments often harbor dangerous contaminants deep inside their lumens. At the HSPA25 and APIC25 conferences, Cori L. Ofstead, MSPH, and her colleagues revealed why borescopes are an indispensable tool for sterile processing teams, offering the only reliable way to verify internal cleanliness and improve sterile processing effectiveness to prevent patient harm.
Getting Down and Dirty With PPE: Presentations at HSPA by Jill Holdsworth and Katie Belski
June 26th 2025In the heart of the hospital, decontamination technicians tackle one of health care’s dirtiest—and most vital—jobs. At HSPA 2025, 6 packed workshops led by experts Jill Holdsworth and Katie Belski spotlighted the crucial, often-overlooked art of PPE removal. The message was clear: proper doffing saves lives, starting with your own.
Unmasking Vaccine Myths: Dr Marschall Runge on Measles, Misinformation, and Public Health Solutions
May 29th 2025As measles cases climb across the US, discredited myths continue to undercut public trust in vaccines. In an exclusive interview with Infection Control Today, Michigan Medicine’s Marschall Runge, PhD, confronts misinformation head-on and explores how clinicians can counter it with science, empathy, and community engagement.
Silent Saboteurs: Managing Endotoxins for Sepsis-Free Sterilization
Invisible yet deadly, endotoxins evade traditional sterilization methods, posing significant risks during routine surgeries. Understanding and addressing their threat is critical for patient safety.