Chemical indicators: inside the pack, outside the pack, and what a failed one means

Inside the pack: a chemical indicator in every package

Place a chemical indicator on the inside of each package (CDC, 2003 dental infection-control guidelines). The package is the unit here: each pack carries its own internal indicator, not one per load (CDC, 2003 dental infection-control guidelines). The CDC's checklist for dental settings records the same expectation as a check you can mark yes or no: a chemical indicator is used inside each package (CDC, Infection Prevention Checklist for Dental Settings).

On this page, the indicator inside the pack is the internal indicator, and the one on the package itself is the external indicator. Knowing which is which settles most of the questions below.

Outside the pack: only when the internal one is hidden

You need an external indicator exactly when the internal indicator cannot be seen from the outside of the package (CDC, 2003 dental infection-control guidelines; CDC, 2008 disinfection and sterilization guideline). The two CDC guidelines phrase this from opposite directions, and they agree.

The 2003 dental guideline says: if the internal indicator is not visible from the outside, also place an exterior chemical indicator on the package (CDC, 2003 dental infection-control guidelines). The 2008 sterilization guideline says: if the internal chemical indicator is visible, an external indicator is not needed (CDC, 2008 disinfection and sterilization guideline).

Every load, including unwrapped cycles

Monitor each load with mechanical indicators — for example time, temperature and pressure — and with chemical indicators (CDC, 2003 dental infection-control guidelines). Mechanical monitoring is done for every sterilizer load (CDC, Best Practices for Sterilization Monitoring in Dental Settings).

Unwrapped cycles get the same checks: use mechanical and chemical indicators for each unwrapped sterilization cycle (CDC, 2003 dental infection-control guidelines). One limit applies to implants here: do not sterilize implantable devices unwrapped (CDC, 2003 dental infection-control guidelines).

What a failed indicator means

A failed indicator stops the pack: do not use instrument packs if mechanical or chemical indicators indicate inadequate processing (CDC, 2003 dental infection-control guidelines).

The decision covers the load, not just the one pack that caught your eye: if either the mechanical indicators or the internal or external chemical indicators indicate inadequate processing, items in the load should not be used until they are reprocessed (CDC, 2003 dental infection-control guidelines). The dental checklist puts the same rule in checkable form: instrument packs are not used if mechanical or chemical indicators indicate inadequate processing (CDC, Infection Prevention Checklist for Dental Settings).

What to record

None of this reaches a record unless someone writes it down. The sources name what belongs on it.

• The mechanical readings for the load: check the sterilizer gauges, computer displays or printouts, and document the sterilization pressure, temperature and exposure time in your sterilization records (CDC, Summary of Infection Prevention Practices in Dental Settings).
• A note that those readings reached the levels recommended by the sterilizer manufacturer (CDC, Best Practices for Sterilization Monitoring in Dental Settings).
• The mechanical check recorded for every sterilizer load (CDC, Best Practices for Sterilization Monitoring in Dental Settings).
• The pack label: the sterilizer used, the cycle or load number, and the date of sterilization (CDC, Summary of Infection Prevention Practices in Dental Settings).

Dental Logbook is being built so that these items live on one record per load: the readings, whether the internal indicators all passed and how many failed, who ran the cycle, and the outcome of the load. A good log also keeps what was done about a failed load next to the load itself.

Common questions

Do I need an external indicator if I can see the indicator inside the pouch?

No. If the internal chemical indicator is visible, an external indicator is not needed (CDC, 2008 disinfection and sterilization guideline).

One pack in the load failed its indicator. Can I use the other packs?

Not until they are reprocessed. If either mechanical indicators or internal or external chemical indicators indicate inadequate processing, items in the load should not be used until reprocessed (CDC, 2003 dental infection-control guidelines).

Does an unwrapped cycle need the same checks?

Yes. Use mechanical and chemical indicators for each unwrapped sterilization cycle (CDC, 2003 dental infection-control guidelines).

How your state's rules treat this

Where your office is changes who says this, and how.

New Jersey requires dental offices to comply with the CDC's recommended infection-control practices for dentistry, as amended and supplemented (New Jersey rule 13:30-8.5). Pennsylvania treats failing to follow the CDC's current infection-control recommendations as unprofessional conduct (Pennsylvania rule 49 Pa. Code 33.211). Georgia's board treats the CDC's current recommendations as the minimum standards of acceptable and prevailing dental practice (Georgia rule 150-8-.01).

Two states are silent on the per-cycle checks in this guide (New York State infection-control training syllabus; Florida rule 64B5-25.003). New York's dental rules set no per-cycle indicator requirements; the state's infection-control training syllabus lists the monitors, but it is guidance, not a rule (New York State infection-control training syllabus). Florida's dental sterilization rule sets no per-cycle checks (Florida rule 64B5-25.003).