When it comes to the new ANSI/AAMI ST108 standard, not all requirements carry the same weight. If you’ve skimmed through the pages, you’ve seen two key words repeated over and over: “shall” and “should.”
These aren’t just stylistic choices. They define the difference between what you must do to be in compliance and what’s recommended to help you stay there.
“Shall” = Compliance
In the language of ST108, “shall” is mandatory. If your sterile processing department (SPD) isn’t doing it, you’re not compliant. These statements outline the non-negotiable actions—things like meeting specific water quality parameters, performing testing at required intervals, and documenting corrective actions when limits are exceeded.
Think of “shall” as your compliance foundation—the minimum bar you must clear.
“Should” = Best Practice
“Should” indicates a recommendation. These aren’t technically required to pass an audit, but they’re often what keep you from failing one. Many “should” clauses exist to support the “shall” requirements—things like proactively monitoring seasonal water changes or adding safeguards that prevent quality drift.
Ignoring “should” doesn’t break the rules—but it can increase your risk.
Why SPDs Need to Pay Attention to Both
While the “shall” statements are the compliance bottom line, the “should” statements often act as an insurance policy. Facilities that adopt the “should” recommendations tend to:
Experience fewer corrective action events
Have smoother accreditation surveys
Reduce unexpected downtime
Extend instrument life
How to Prioritize
When resources are tight, focus first on:
Every “shall” statement in the standard—make sure there’s no gap.
“Should” statements that directly prevent a “shall” failure—these keep your compliance from slipping.
Remaining “should” actions for continuous improvement.
The Bottom Line
ST108’s “shall” statements keep you compliant. Its “should” statements keep you prepared. The most resilient SPDs treat both as essential—because patient safety and operational excellence depend on it. For more insight on this topic, check out our whitepaper: Distinguishing “Shall” vs. “Should” in ANSI/AAMI ST108 and How SPDs Can Prioritize Compliance Efforts