AAMI ST58 Mythbusters Series: Compliance Meets Clarity

Breaking down myths around chemical sterilant monitoring, exposure, and documentation.

Sterile processing departments are under more pressure than ever to stay compliant, ensure patient and staff safety, and align with evolving standards. Among the most critical, but often overlooked, guidelines is AAMI ST58:2024, which outlines best practices for using chemical sterilants like hydrogen peroxide (H2O2) and high level disinfectants like peracetic acid (PAA).

With complex terminology, everyday expectations, and new interpretations, it’s easy for myths to take root. In this “AAMI ST58 Mythbusters” blog series, we’re tackling the confusion head-on, starting with the most common misconceptions surrounding chemical monitoring, H2O2 and PAA exposure, documentation, and compliance.

Myth #1: PAA evaporates quickly, monitoring isn’t necessary.

BUSTED!
PAA may break down quickly, but even short-term exposure to vapors can cause eye, respiratory, and skin irritation. ST58:2024 now emphasizes the importance of continuous air monitoring for PAA to protect staff, especially in areas where ventilation is limited.

ChemDAQ’s real-time monitors detect PAA levels down to parts per million, providing early warnings before symptoms appear or thresholds are breached.

Myth #2: A logbook is enough documentation for compliance.

BUSTED!
While manual logbooks are still used, AAMI ST58:2024 supports digital documentation, which offers better traceability, accuracy, and accessibility. Paper-only records can be incomplete or difficult to audit, especially when exposure trends over time need to be analyzed.

ChemDAQ’s systems store automated exposure logs, making it easier to demonstrate ongoing compliance during audits or inspections.

Myth #3: If the chemical sterilizer passes its cycle, there’s no exposure risk.

BUSTED!
Just because a sterilizer completes a cycle doesn’t mean it’s leak-proof or that emissions can’t escape post cycles when the door is opened. Small leaks from gaskets, doors, valves, or waste lines can release hazardous vapors into the workspace.

ST58:2024 recommends continuous monitoring as a best practice for early detection and to prevent unnecessary exposure, especially in high-throughput reprocessing departments.

ChemDAQ’s sensors offer 24/7 continuous alerts and have been adopted by leading facilities to strengthen their overall safety programs.

Myth #4: ST58 is just a guideline, it's not enforceable.

BUSTED!
While AAMI ST58 is a voluntary consensus standard, it’s often used by regulatory bodies and accreditation agencies (including The Joint Commission) as a benchmark for best practices. Facilities that don’t align with ST58 could be cited under OSHA regulations or receive deficiencies during audits for unsafe practices and inadequate documentation.

Partnering with organizations like ChemDAQ and ASSI (Advantage Support Services) helps bridge the gap between written standards and real-world application.

Partnership Spotlight: ChemDAQ + ASSI
Navigating ST58 compliance is no small task. That’s why ChemDAQ has partnered with ASSI, combining monitoring technology with hands-on support for implementation and training.

Together, we provide:

• Tailored Clinical Assessments

• Customized monitoring strategies

• Installation and integration support

• Ongoing calibration and compliance documentation

• Staff education and readiness resources

This partnership ensures that Sterile Processing teams don’t have to figure it out alone. You get expert guidance with the tools to back it up.

Clarity Leads to Compliance

The updated AAMI ST58:2024 standard isn't just about checking a box, it’s about protecting your staff, improving patient safety, and staying ahead of regulatory risk. Dispelling myths is step one. Putting reliable systems and partnerships in place is step two.

Stay tuned for future editions of the AAMI ST58 Mythbusters Series, where we’ll break down even more key concepts, including ventilation strategies, emergency response planning, and how to interpret short-term exposure limits (STELs).

To learn more about AAMI ST58, don't forget to sign up for The Advantage Workshop on September 3rd at 3:00EST as we Clear The Air with Alex Hilliker!