How to label sterilized instrument packs in a dental office

Write these four things on every pack

CDC's infection prevention checklist asks for at least these four items on a sterile pack (CDC, Infection Prevention Checklist for Dental Settings):

• The sterilizer used
• The cycle or load number
• The date of sterilization
• The expiration date, if one applies

The label goes on the outside of the packaging material, and when the facility uses more than one sterilizer it names the one that ran the load (CDC, 2003 dental infection-control guidelines).

Two CDC documents phrase the sterilizer item differently. The 2003 guideline asks for the sterilizer used when the facility has more than one; the 2016 summary and checklist list the sterilizer used on every pack (CDC, 2003 dental infection-control guidelines; CDC, Summary of Infection Prevention Practices in Dental Settings, 2016). Naming the sterilizer on every pack meets both.

The cycle or load number is the number that one run of the sterilizer carries in your records. It is what ties a pack on the shelf to one load record.

The expiration date appears only when one applies to your process; that is the full extent of the wording, "if applicable", with no number of days set (CDC, Infection Prevention Checklist for Dental Settings).

What to record

The label is half the trail. The other half is the load record. For each cycle, record these fields (CDC/HICPAC, Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008):

• the type of sterilizer and the cycle used
• the load identification number
• the load contents
• the load contents
• the exposure parameters (e.g., time and temperature)
• the operator's name or initials
• the results of mechanical, chemical and biological monitoring

Keep the log for each sterilizer cycle current, with the results from each load, and in line with state and local regulations (CDC, Infection Prevention Checklist for Dental Settings).

Record the results of biological monitoring, and keep the monitoring records — mechanical, chemical and biological — long enough to comply with state and local regulations (CDC, 2003 dental infection-control guidelines).

The spore test and its control come from the same lot number (CDC, 2003 dental infection-control guidelines).

Nothing in these documents says the log has to be paper or electronic, or that it needs a signature. The field list asks for the operator's name or initials and no more (CDC/HICPAC, Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008).

Trace a pack back to its load

The label exists for one reason: when a sterilization failure turns up later, the label is what lets the office retrieve the affected processed items (CDC, 2003 dental infection-control guidelines).

No source we read requires patient identifiers in a sterilizer record. A good log keeps patient names out of the sterilizer record and traces packs through the load number instead. If your office needs to trace a pack to a patient, the load number goes in your own patient chart.

Dental Logbook will give each load a number to write on its packs and keep the same number in the load record, so a shelf of packs can be matched to loads without opening a binder.

Expiration dates and how long to keep records

Write an expiration date only when one applies (CDC, Infection Prevention Checklist for Dental Settings).

How long to keep the records is set by state and local rules; the CDC documents say to keep them long enough to comply with those rules (CDC, 2003 dental infection-control guidelines).

What the states say

State rules differ on this topic, and some are silent.

New Jersey, Pennsylvania and Georgia make CDC infection-control recommendations binding for dental offices (New Jersey rule 13:30-8.5; Pennsylvania rule 49 Pa. Code 33.211; Georgia board rule 150-8-.01).

Which CDC text each state adopts is not settled. New Jersey's rule names CDC's 1993 dentistry practices "as amended and supplemented"; Pennsylvania and Georgia name the current CDC recommendations (New Jersey rule 13:30-8.5; Pennsylvania rule 49 Pa. Code 33.211; Georgia board rule 150-8-.01).

New York's dental rules and Florida's sterilizer rule are silent on what a sterilizer record must contain (New York rules 8 NYCRR part 29; Florida rule 64B5-25.003).

In 2023 Georgia's infection-control committee dropped a proposed list of record fields like the one above after members said it was “too onerous” for some offices; because the list “comes directly from the CDC guidelines”, which dentists already follow, the committee kept only the three-year rule (Georgia Board of Dentistry infection-control committee minutes, March 31, 2023).