Clearing the Air Part 2: AAMI ST58 Roundtable discussion
March Mailbag

On February 17, we hosted the AAMI ST58 Educator Roundtable, bringing together industry experts and participants for a practical discussion on what it really takes to meet the standard with confidence. Often referred to as the “Am I doing it right?” standard, as described by Vanessa Frank, Clinical Resource Manager at ASSI, AAMI ST58 reinforces that education is the foundation of compliance. When teams understand the why, they’re far more likely to remember the how.

The conversation emphasized that achieving and maintaining compliance is not a one-time effort. Like training for the Olympics, it requires consistent daily focus, strong processes, and reliable tools. Panelists also highlighted a simple truth: if you don’t know what staff are being exposed to, you can’t protect them. Making real-time chemical monitoring a critical component of worker safety. And across every topic, one message was clear: there is no substitute for thorough, accurate documentation.

Have questions? Click here to submit them to our panelists. On April 1 at 1:30 PM EST, we’ll review submissions and answer them live. Be sure to follow us on LinkedIn. We may feature your question (and our response) so others can benefit from the discussion. In case you missed the webinar, click here to watch the recording. 

Below, you’ll find a summary of the key takeaways from the session.

ST58 Is No Longer Guidance, It’s the Standard: What Sterile Processing Leaders Need to Know

Sterile processing departments operate in an environment of rising expectations, heightened scrutiny, and expanding regulatory pressure. The recent updates to ST58 from the Association for the Advancement of Medical Instrumentation (AAMI) signal an important shift in how chemical sterilants and high-level disinfectants must be managed.

This isn’t just an update to recommended practice. It’s a structural change in how compliance, documentation, and exposure monitoring are evaluated.

Here’s what that means for SPDs.

ST58 Is Now Elevated and Expanded

ST58 has evolved from a recommended practice to a formal standard. Placing it on par with standards such as ST79. That elevation alone should prompt departments to re-evaluate current workflows and documentation practices.

Key updates include:

• Integration of ethylene oxide guidance (formerly ST41)
• New annexes addressing hydrogen peroxide, peracetic acid, and vapor monitoring
• Reinforced expectations around safe handling and exposure control

For sterile processing departments, this means ST58 is no longer aspirational; it’s enforceable. Surveyors and accrediting bodies will expect alignment, not familiarity.

Chemical Exposure Is a Real (and Often Underestimated) Risk

One of the most important themes reinforced in the updated standard is awareness of chemical exposure.

In many departments, staff still rely on smell to detect the presence of sterilants. The problem? Odor is unreliable. Some sterilants, including hydrogen peroxide at low concentrations, are odorless. And even when odor is detectable, human senses are not calibrated to parts-per-million (ppm) thresholds.

The updated ST58 reinforces that:

• Exposure monitoring should be measurable and documented
• Spill preparedness must be proactive
• Spill kits must be accessible, and staff must be trained in their use
• Departments must verify, not assume safe exposure levels

If a department cannot produce exposure documentation when asked, it introduces both compliance and liability risk.

Education Must Go Beyond “What” to “Why”

Policies alone do not create safety; understanding does.

When staff perform chemical sterilization tasks daily, routines can become automatic. Without understanding the “why” behind exposure limits, ventilation requirements, and cartridge-handling procedures, complacency sets in.

Departments seeing the strongest compliance outcomes are those that:

• Incorporate daily or weekly education into staff huddles
• Reinforce chemical safety in small, repeatable segments
• Use interactive training methods to test comprehension
• Connect procedures directly to staff health and patient safety

When teams understand the why, compliance follows.

Education isn’t a one-time in-service. It’s an ongoing risk mitigation strategy.

Documentation Is the Safety Net

The updated ST58 does not necessarily introduce entirely new rules. What it often does is expose gaps that already exist.

High-performing departments share one common characteristic: documentation discipline.

They maintain:

• Detailed records of staff training and in-service trainings
• Exposure monitoring logs
• Clear chemical handling procedures
• Accessible spill response documentation

Accrediting bodies such as The Joint Commission increasingly expect documentation that is both accessible and defensible. If it’s not documented, it didn’t happen.

Documentation is not about paperwork for its own sake. It is what protects departments during surveys, validates safe practice, and shields leadership from preventable compliance findings.

Built-In Guardrails Reduce Human Error

Staffing shortages, turnover, and high instrument volumes create pressure inside SPDs. Under pressure, even well-trained teams can miss steps.

The solution isn’t expecting perfection. It’s building systems that protect staff regardless of workload.

Built-in guardrails may include:

• Automated, continuous exposure monitoring systems
• Instrument tracking systems that document chemical cycles
• Data-driven ventilation verification
• AI-supported compliance tracking
• Real-time alerts tied to measurable thresholds

Safety systems should protect staff, even on short-staffed days.

Data collection strengthens compliance efforts, supports defensible documentation, and shifts departments from reactive to proactive risk management.

The Bigger Picture: Compliance Is Leadership

At its core, the elevation of ST58 reinforces something larger than regulatory alignment. It reinforces a moral obligation.

Chemical sterilants are powerful tools. Mishandled, they pose real health risks. Properly monitored and documented, they protect both patients and staff.

The departments that will thrive under the updated standard are those that:

• Treat exposure monitoring as essential, not optional
• Invest in ongoing staff education<
• Strengthen documentation practices
• Leverage technology to reduce risk

ST58 is no longer a suggestion. It is a measurable benchmark for safe chemical sterilization practices in modern sterile processing departments.

The question for leaders isn’t whether they are aware of the standard. It’s whether their systems can prove compliance when it matters most.